DETAILED ACTION
Primary Examiner acknowledges Claims 1-20 are pending in this application as originally filed on April 18, 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 .
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 3, 15, 19, and 20 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 3, Line 1 recites “prism shaped”; however, the breadth and scope of this limitation is unclear. There are various shapes that can be defined as a “prism shaped” when considered in three dimensions. For example: a 3D triangle, a 3D rectangle, 3D square, 3D pentagon, 3D hexagon, 3D heptagon, 3D octagon, 3D trapezoid, etc. In each of these prism shapes, there is a number of faces, a number of edges, and a number of vertices. Although clearly a cylinder cannot be “prism shaped” as it has a curved surface, the shape of a cylinder as compared to a 3D octagon are significantly similar despite the curved surface instead of edges. Primary Examiner is unsure what structure constitutes a “prism shape”? Clearly there needs to be a space sufficient to receive the 3D object that is the variable volume reservoir, but must there be edges instead of curves? Appropriate correction and clarification is required.
Specifically, Claim 15 recites “the flexible main body”; however, this limitation appears to lack antecedent basis in the claims. It appears perhaps this claim should depend from Claim 14 which initially introduces “a flexible main body” instead of Claim 12. Dependent claims, Claims 16, 17, 19*, and 20*, incorporate the indefinite subject matter from which it depends. Appropriate correction and clarification is required.
Specifically, Claim 19, Line 1 recites “the heating element”; however, this limitation appears to lack antecedent basis in the claims. It appears perhaps this claim should depend from Claim 18 which initially introduces “a heating element” instead of Claim 17. Dependent claim, Claim 20, incorporates the indefinite subject matter from which it depends. 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, 2, and 6 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Dai et al. (2015/0272216).
As to Claim 1, Dai discloses a humidifier (Figure 1) for humidifying a flow of air to be delivered to the patient, the humidifier (Figure 1) comprising: a base unit (10, “FIG. 1 is a schematic diagram showing in cross-section an embodiment of a personal vaporizer, such as an electronic cigarette 10.” Para 0027) comprising at least one wall (14, “The electronic cigarette 10 may include a mouthpiece 12, a proximal cylindrical housing section 14 and a distal cylindrical housing section 16.” Para 0030; “The proximal cylindrical housing section 14 may contain a liquid storage chamber 36 that is defined by the proximal housing support 38 and a distal housing support 40.”Para 0032) defining a receiving space (via 14 to accept 32, wherein 32 – “The liquid storage chamber may include at least one air duct 30 that communicates between the vapor chamber and the liquid storage chamber, and a liquid reservoir 32 that includes an opening that may be connected to and controlled by the one-way valve 28 and the liquid transport device 26. The liquid reservoir 32 may be preferably designed to contain at least enough liquid to supply vapor during at least one session.” Para 0032; “The liquid reservoir 32 may be a collapsible liquid reservoir 32 and may resemble a bladder that is made of a plastic, a little or non-elastic thin film, or any type of material that is collapsible and may hold liquid or a solid tube with an inside sliding plug. The liquid reservoir 32 may be enlarged when filled with a desired liquid to be vaporized. As liquid is drawn from the reservoir, the liquid reservoir 32 may collapse and shrink. The liquid reservoir 32 may be filled with only liquid, without any gases inside the liquid reservoir 32. The pressure of the liquid in the liquid reservoir 32 may remain constant, e.g., at atmospheric pressure.” Para 0041); a variable volume reservoir (32, “The liquid reservoir 32 may be a collapsible liquid reservoir 32 and may resemble a bladder that is made of a plastic, a little or non-elastic thin film, or any type of material that is collapsible and may hold liquid or a solid tube with an inside sliding plug. The liquid reservoir 32 may be enlarged when filled with a desired liquid to be vaporized. As liquid is drawn from the reservoir, the liquid reservoir 32 may collapse and shrink. The liquid reservoir 32 may be filled with only liquid, without any gases inside the liquid reservoir 32. The pressure of the liquid in the liquid reservoir 32 may remain constant, e.g., at atmospheric pressure.” Para 0041) configured to hold a body of water (“liquid”, “The liquid reservoir 32 may be filled with only liquid” Para 0041, as water can be in a aqueous or liquid composition state of matter, there is not structure that would preclude, prevent, or hinder the application of water alone or in solution to be utilized) and receive the flow of air (40 via 30, “The proximal cylindrical housing section 14 may contain a liquid storage chamber 36 that is defined by the proximal housing support 38 and a distal housing support 40. The liquid storage chamber may include at least one air duct 30 that communicates between the vapor chamber and the liquid storage chamber, and a liquid reservoir 32 that includes an opening that may be connected to and controlled by the one-way valve 28 and the liquid transport device 26. … The distal housing support 40 may be designed to have at least one opening, or other passages that allow air to pass through the support 40. These openings or passages provide fluid communication between the liquid storage chamber 36 and the distal cylindrical housing section 16. The distal cylindrical housing section 16 may include at least one vent 17 that provide an opening to the atmospheric environment. Vent 17 may supply air into the distal cylindrical housing section 16, and through the distal housing support 40 into liquid storage chamber 14. Paras 0032 and 0033) to humidify the flow of air for delivery to the patient (via 12, “The electronic cigarette 10 may include a mouthpiece 12, a proximal cylindrical housing section 14 and a distal cylindrical housing section 16. The mouthpiece is hollow and includes a mouthpiece opening 18 that allows vapor to pass from the cigarette 10 into the mouth of a user.” Para 0030); and a heater (24, “The vaporization chamber 22 may house a heating element 24, a liquid transport device 26 connected to a one-way valve 28, all of which may be located on and/or supported by a proximal housing support 38.” Para 0031; “Liquid is drawn from the liquid reservoir 32, through the valve 28 and is applied to a surface of the heating element 24.” Para 0035) for heating the body of water (“liquid”), wherein the receiving space (via 14 to accept 32) is configured to receive the variable volume reservoir (32) and the variable volume reservoir (32) is conformable (“The liquid reservoir 32 may be enlarged when filled with a desired liquid to be vaporized. As liquid is drawn from the reservoir, the liquid reservoir 32 may collapse and shrink.” Para 0041) to the shape of the receiving space (via 14 to accept 32).
As to Claim 2, Dai discloses the variable volume reservoir (32) is collapsible (“collapsible”, “The liquid reservoir 32 may be a collapsible liquid reservoir 32 and may resemble a bladder that is made of a plastic, a little or non-elastic thin film, or any type of material that is collapsible and may hold liquid or a solid tube with an inside sliding plug. The liquid reservoir 32 may be enlarged when filled with a desired liquid to be vaporized. As liquid is drawn from the reservoir, the liquid reservoir 32 may collapse and shrink.” Para 0041) to a flat plate. The resultant effect of the withdraw of all the liquid would result in a planar structure that would produce a flat plate shape similar to an unfilled balloon.
As to Claim 6, Dai discloses the variable volume reservoir (32) does not comprise a metal plate. Rather, the variable volume reservoir (32) is explicitly made of plastic (Para 0041).
Claims 12-16 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Virag (4,198,969).
As to Claim 12, Virag discloses a humidifier (Figures 1-4) for use with a respiratory pressure therapy apparatus (via 16, “Oxygen inlet 14 communicates with oxygen line 16 at the exterior of the device, and includes an oxygen nozzle 18 for accelerating pressurized oxygen (in pure form or mixed with other gases as desired) to a velocity sufficient to permit aspiration of liquids by the Bernoulli effect.” Column 3, Lines 15-25), the humidifier (Figures 1-4) comprising: a flexible chamber (42a, “Alternatively, as shown in FIG. 4, ampule 42a may comprise a flexible collapsible container such as a plastic bag.” Column 3, Lines 55-65) configured to hold a body of water (44, “The mist that is added to the air stream may include water for the humidification of the oxygen supply to the patient, but also bronchodialators or mucolytic agents may be added and conveyed directly to the inner recesses of the lungs in mist form by the breathing of the patient.” Column 1, Lines 15-30, wherein 44 – “In accordance with this invention, nebulizing chamber 12 defines a spike member 38 at its lower end which is adapted to penetrate an access port 40 of an ampule 42 which contains the liquid 44 to be nebulized as shown.” Column 3, Lines 45-60; “If sufficient suction pressure for the specific opening size of port 30 is provided, a reduced pressure is created in nebulizing chamber 12 that causes liquid 44 to be sucked upwardly through spike 38 into nebulizing chamber 12 to create a liquid level 58 in chamber 12. … When the suction pressure through outlet 37 is terminated, the pressure within nebulizing chamber 12 quickly rises to ambient, with the result that the liquid 44 flows out of chamber 12 through spike 38 back into ampule 42.” Column 4, Lines 10-35) and receive a flow of air (via 38, “In this instance, no venting is required since the bag can simply expand and contract as liquid passes into and out of nebulizing chamber 12 by means of hollow spike 38.” Column 3, Lines 55-65) from the RPT apparatus (via 16) to humidify the flow of air; and a base unit (54, “Depending sleeve 54 is carried by nebulizer 10 and extends downwardly to surround and protect the lower portion of nebulizing chamber 12, spike 38 and ampule 52. Sleeve 54 may carry longitudinally positioned slots 56 extending from the lower end of sleeve 54 upwardly a substantial distance, for example, about halfway to permit the user to reach inwardly of the sleeve 54 with the fingers to engage and disengage ampule 42. Preferably, a pair of diametrically opposed slots 56 are used in sleeve 54.” Column 4, Lines 1-10) configured to support the flexible chamber (42a), the flexible chamber (42a) being configured to conform to a shape of ta receiving space (interior of 54) of the base unit (54) in use.
As to Claim 13, Virag discloses the flexible chamber (42a) is configured to expand during use (“In this instance, no venting is required since the bag can simply expand and contract as liquid passes into and out of nebulizing chamber 12 by means of hollow spike 38.” Column 3, Lines 55-65).
As to Claim 14, Virag discloses the flexible chamber (42a) comprises a flexible main body (“flexible” best seen Figure 4 “Alternatively, as shown in FIG. 4, ampule 42a may comprise a flexible collapsible container such as a plastic bag.” Column 3, Lines 55-65).
As to Claim 15, Virag discloses the flexible chamber (42a) comprises a rigidizing structure (38, “In this instance, no venting is required since the bag can simply expand and contract as liquid passes into and out of nebulizing chamber 12 by means of hollow spike 38.” Column 3, Lines 55-65) for the flexible main body (“flexible” best seen Figure 4).
As to Claim 16, Virag discloses the rigidizing structure (38) is one rib extending along an interior surface (best seen Figure 4) of the flexible main body (“flexible” best seen Figure 4).
Claims 1, 3, 4, 6, 7, and 10 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Dykes (6,256,454).
As to Claim 1, Dykes discloses a humidifier (Figure 1) for humidifying a flow of air to be delivered to a patient, the humidifier (Figure 1) comprising: a base unit (11, “Referring now to FIG. 1, there is shown a perspective view of the humidifier 10 constructed in accordance with the present invention and, as shown, comprises a housing 11 shown affixed to the chassis 12 of an incubator 14. As shown, the humidifier 10 includes a reservoir 16 that, as will be explained, is removable from the housing 11 of the incubator 14 for cleaning.” Column 3, Lines 1-20) comprising at least one wall (32, best seen Figures 2-6, “The housing 11 also includes a front downwardly curled lip 32 that also serves to hold the reservoir 16 in the upright, operative position by providing a support for the upper front edge 34 of the reservoir 16.” Column 3, Lines 35-55) defining a receiving space (defined by the space between 32 and 30 on 11 upon which 16 is inserted); a variable volume reservoir (16, “As shown, the humidifier 10 includes a reservoir 16 that, as will be explained, is removable from the housing 11 of the incubator 14 for cleaning. Internal of the reservoir 16 is a volume to contain the water to be heated and vaporized and an external face 18 of the reservoir 16 is transparent so that the user can visually see and monitor the level of the water contained within the reservoir 16.” Column 3, Lines 5-20) configured to hold a body of water (“water” Column 3, Lines 5-20) and receive the flow of air to humidify the flow of air for delivery to the patient; and a heater (27, “A heater 27 is also shown and which extends downwardly from the housing 11 of the reservoir 10 and heats the water in a confined area.” Column 3, Lines 25-40) for heating the body of water (“water” Column 3, Lines 5-20), wherein the receiving space (defined by the space between 32 and 30 on 11 upon which 16 is inserted) is configured to receive the variable volume reservoir (16) and the variable volume reservoir (16) is conformable (via fitment of 30, wherein 30 – “As can be seen, the reservoir 16 has a downwardly extending rounded lower edge 28 that rests on and is supported by a resilient latch 30 that is affixed to the housing 11 of humidifier 10. The resilient latch 30 is spring loaded and thus is movable with respect to the housing 11 as will be explained. In the position shown in FIG. 2, the resilient latch 30 is in its upward position and is biased toward that position to hold the lower edge 28 of the reservoir 16 in upright, operative position of FIG. 2. … Accordingly, as shown, the use of the resilient latch 30 and the confining of the upper front edge 34 by the lip 32 retains the reservoir 16 in the upright, operative position as shown in FIG. 2. Turning now to FIG. 3, there is shown a cross sectional view of the reservoir 16 of the present invention that has been moved downwardly against the bias of the resilient latch 30. ” Column 3, Line 35 thru Column 4, Line 5) to a shape of the receiving space (defined by the space between 32 and 30 on 11 upon which 16 is inserted).
With respect to the term “variable volume reservoir”, it is noted the reservoir (16) can receive and retain various volumes of water, by the inclusion of the transparent material “so that the user can visually see and monitor the level of the water contained within the reservoir 16.” (Column 3, Lines 5-20). In this consideration of varying the volume of water, water may be added through the opening (20, “In the position as shown in FIG. 1, the reservoir 16 is in its filling position such that a filler opening 20 is available with a cover 22 that can be removed by the user to pour water into the reservoir 16 for filling the reservoir 16.” Column 3, Lines 15-30). It is understood that in the absence of any additional flow direction structures, water could also be removed from the opening (20).
With respect to the concept of “the variable volume reservoir” being “conformable to a shape of the receiving space”, the movement of the spring loaded latch (30) within the receiving space (defined by the space between 32 and 30 on 11 upon which 16 is inserted) enables the insertion, fitment, securement, and removal of the variable volume reservoir from the receiving space (defined by the space between 32 and 30 on 11 upon which 16 is inserted).
Regarding the concept of “air”, it should be noted an incubator is an isolation chamber for the infant that provides a safe and controlled environment to support the life of the infant, and thus would clearly include a source of gas in the form of at least air/oxygen to prevent the infant from being in a hypoxic environment that would lead to harm and/or death.
Thus, Dykes discloses the features of Claim 1.
As to Claim 3, Dykes disclose the at least one wall (32) defines a prism shaped receiving space (defined by the space between 32 and 30 on 11 upon which 16 is inserted). Explicitly, the shape of the receiving space appears to receive the 3D structure of the variable volume reservoir (16) and appears to include several edges and corners.
As to Claim 4, Dykes discloses the variable volume reservoir (16) comprises a low thermal impedance material (via 60, best seen Figure 7, “Further, there is a rubber insulator 58 and a bottom bracket 60 the hold a plastic container 60 that depends downwardly into the water within the reservoir. Thus, as the plastic container 60 is immersed in the water within the reservoir 16, the plastic container 60 becomes filled with water and the heater element 44 can heat only a localized quantity of water contained in the plastic container 60 and not the entire reservoir filled with water. Thus, with the reservoir filled, there is sufficient quantity of water to provide humidification for a long period of time without refilling, however, at the same time, the heater does not have to heat the entire quantity of water but only the small localized quantity of water that is within the plastic container 60. Accordingly, the heated water vapor is collected in the plastic container 60 and rises to exit from the plastic container 60 out of the outlet 62 to be directly introduced into the infant compartment of an incubator.” Column 4, Line 60 thru Column 5, Line 25) configured to engage the heater (45 of 27, “Finally, in FIG. 7 there is an exploded view of the heater 27 and which includes a cartridge heater element 45 and is inserted into an aluminum sheath 46.” Column 4, Line 60 thru Column 5, Line 10) in use.
As to Claim 6, Dykes discloses the variable volume reservoir (16) having a metal feature (46, “Finally, in FIG. 7 there is an exploded view of the heater 27 and which includes a cartridge heater element 45 and is inserted into an aluminum sheath 46.” Column 4, Line 60 thru Column 5, Line 10) within. Yet, the shape of the metal feature (46) as best seen in Figure 7 is not a plate. Thus, Dykes meets the limitations of Claim 6, as the metal (via 46) within the variable volume reservoir (16) is not a “metal plate” as claimed.
As to Claim 7, Dykes discloses the variable volume reservoir (16) comprises the heater (27) as inserted therein (best seen Figures 1-6).
As to Claim 10, Dykes discloses the variable volume reservoir (16) includes an inlet (20, “In the position as shown in FIG. 1, the reservoir 16 is in its filling position such that a filler opening 20 is available with a cover 22 that can be removed by the user to pour water into the reservoir 16 for filling the reservoir 16.” Column 3, Lines 15-30) suitable for imparting the delivery/removal of water – thus a water inlet, and additionally for imparting the delivery/removal of air – thus an air inlet.
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.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Dykes (6,256,454) in view of Varga (2013/0081582).
As to Claim 5, Dykes discloses the configuration of a low thermal impedance material (via 60) in the form of plastic associated with the heater (45 of 27) to facilitate the vaporization of the water. (Column 4, Line 60 thru Column 5, Line 25).
Yet, does not expressly disclose the material composition to be at least one of “polyethylene or polyamide”.
Varga teaches an additional humidifier device (100, best seen Figure 1, “FIG. 1 shows a device 100 for humidifying respiratory gases, in accordance with embodiments of the present technology. The device 100 includes a humidification component 102 and a heating element 110.” Para 0043) having a base unit (106, “In one embodiment, the heating element 110 is integrated within a base unit 106, while the base unit 106 is coupled with the humidification component 102 and the heating element 110. In one embodiment, the base unit 106 supports the humidification component 102 at its base 112.” Para 0046) having a wall for receiving the variable volume reservoir (102, “The humidification component 102 holds a water volume 104.” Para 0043) and including a heater (110, “The device 100 includes a humidification component 102 and a heating element 110.” Para 0043).
Regarding the remaining limitations of the claims, Varga teaches the variable volume reservoir (102) receives heat from the heater (110) to vaporize the water within the variable volume reservoir (102), wherein the variable volume reservoir (102) includes at least a portion constructed of polyethylene (“Similarly, the material of construction of the humidification component is chosen to provide reasonable transmission of the target electromagnetic radiation wavelengths. For example, high density polyethylene may be used.” Para 0041; “In one embodiment, the humidification component 102 is made of cross-linked polyethylene.” Para 0044; “In another embodiment and as described herein, the at least a portion of the humidification component 102 through which the electromagnetic radiation 120 is transferred is transmissive to the electromagnetic radiation 120, by being a transmissive surface, such as an IR transmissive polymer, like a high density polyethylene.” Para 0052; “Examples of materials that may be used for the humidification component are, but not limited to, the following: polyphenylene sulfide; cross-linked polyethylene; polysulfone; polycarbonate; and a conductive polymer.” Para 0144). The resultant effect of using polyethylene is a known material suitable for permitting the conduction radiation of heat from the heater to the water.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the material construction of the variable volume reservoir of Dykes to be explicitly constructed of polyethylene, as taught by Varga to be a known material composition suitable for permitting the conduction radiation of heat from the heater to the water.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Dykes (6,256,454) in view of Klasek et al. (2008/0105257).
As to Claim 8, Dykes discloses a heater (27) for heating the water within the variable volume reservoir (16).
Yet, does not expressly disclose the construction of the heater in the shape of a “flexible tape heater”.
Klasek teaches a humidifier (Figure 3) for heating water (13, “In FIG. 3 a humidifier arrangement utilizing a floating heater 12 is illustrated. The floating heater 12 floats in the body of water 13 in the humidifier chamber tub 1 such that a substantial portion of the floating heater 12 is immersed but is still adjacent to the water surface 14 so as to heat that part of the water near the surface 14.” Para 0126) retained within a reservoir (1, “humidifier chamber tub 1” Para 0126) to facilitate the vaporization of the water (Abstract) through the energizing of the heater (12, “The floating heater 12 may comprise a length of flexible tape heater of similar construction to that discussed above with reference to FIGS. 1-A to 1-C and 2.” Para 0127).
Regarding the remaining limitations, Klasek teaches construction of the heater (12) in the form of a “flexible tape heater” provides the benefit that “enhances heat transfer with the gas flow while also providing low impedance to the gas flow.” (Para 0083), and increases “the available surface area for heat transfer between the gas flow and the surface of the flexible tape heater 3.” (Para 0089).
Therefore, it would have been obvious to one having ordinary skill in the art to modify the heater of Dykes to be a flexible tape heater as taught by Klasek to be a known configuration of a heater suitable to permit the vaporization of water for humidification whilst also enhancing the heat transfer of between the gas and the water.
Claims 11, 12, 14-16, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Dykes (6,256,454) in view of Rapoport (2016/0206493).
As to Claim 12, Dykes discloses a humidifier (Figures 1-7), the humidifier (Figures 1-7) comprising: a flexible chamber (16, “As shown, the humidifier 10 includes a reservoir 16 that, as will be explained, is removable from the housing 11 of the incubator 14 for cleaning. Internal of the reservoir 16 is a volume to contain the water to be heated and vaporized and an external face 18 of the reservoir 16 is transparent so that the user can visually see and monitor the level of the water contained within the reservoir 16.” Column 3, Lines 5-20; “In carrying out the present invention, there is a plastic reservoir container that is transparent to the extent that the level of water can be visually perceived from external of the reservoir and the incubator.” Column 2, Lines 10-35; also see: 60 of 16, best seen Figure 7, “Further, there is a rubber insulator 58 and a bottom bracket 60 the hold a plastic container 60 that depends downwardly into the water within the reservoir. Thus, as the plastic container 60 is immersed in the water within the reservoir 16, the plastic container 60 becomes filled with water and the heater element 44 can heat only a localized quantity of water contained in the plastic container 60 and not the entire reservoir filled with water. Thus, with the reservoir filled, there is sufficient quantity of water to provide humidification for a long period of time without refilling, however, at the same time, the heater does not have to heat the entire quantity of water but only the small localized quantity of water that is within the plastic container 60. Accordingly, the heated water vapor is collected in the plastic container 60 and rises to exit from the plastic container 60 out of the outlet 62 to be directly introduced into the infant compartment of an incubator.” Column 4, Line 60 thru Column 5, Line 25) configured to hold a body of water (“water” Column 3, Lines 5-20) to humidify the flow of air (Regarding the concept of “air”, it should be noted an incubator is an isolation chamber for the infant that provides a safe and controlled environment to support the life of the infant, and thus would clearly include a source of gas in the form of at least air/oxygen to prevent the infant from being in a hypoxic environment that would lead to harm and/or death.); and a base unit (11, “Referring now to FIG. 1, there is shown a perspective view of the humidifier 10 constructed in accordance with the present invention and, as shown, comprises a housing 11 shown affixed to the chassis 12 of an incubator 14. As shown, the humidifier 10 includes a reservoir 16 that, as will be explained, is removable from the housing 11 of the incubator 14 for cleaning.” Column 3, Lines 1-20) configured to support the flexible chamber (16), the flexible chamber (16) being configured to conform (via fitment of 30, wherein 30 – “As can be seen, the reservoir 16 has a downwardly extending rounded lower edge 28 that rests on and is supported by a resilient latch 30 that is affixed to the housing 11 of humidifier 10. The resilient latch 30 is spring loaded and thus is movable with respect to the housing 11 as will be explained. In the position shown in FIG. 2, the resilient latch 30 is in its upward position and is biased toward that position to hold the lower edge 28 of the reservoir 16 in upright, operative position of FIG. 2. … Accordingly, as shown, the use of the resilient latch 30 and the confining of the upper front edge 34 by the lip 32 retains the reservoir 16 in the upright, operative position as shown in FIG. 2. Turning now to FIG. 3, there is shown a cross sectional view of the reservoir 16 of the present invention that has been moved downwardly against the bias of the resilient latch 30. ” Column 3, Line 35 thru Column 4, Line 5) to a shape of a receiving space (defined by the space between 32 and 30 on 11 upon which 16 is inserted) of the base unit (11) in use.
Yet, Dykes does not expressly disclose the explicit use of a respiratory pressure therapy (RPT) apparatus to convey air.
Rapoport teaches incubators, such as the humidifier of Dykes, are constructed to provide ventilation supplementation in the form of a CPAP device or medical ventilator to the infant retained within the incubator to “recycle and circle air… to insure the appropriate concentration of the various comprising gases” whereby the “circling of air is humidified and/or used to heat the incubator” (Para 0003). Hence, the application of Dykes humidifier in the form of an incubator is known to be utilized with a respiratory pressure therapy device to ensure the environment of the infant is maintained at a safe and controlled levels.
Therefore, it would have been obvious to one having ordinary skill it the art to modify the humidifier of Dykes to be expressly utilized with a respiratory pressure therapy apparatus, as taught by Rapoport to be a known method of ensuring the ventilation and supportive care of gases are provided to the patient within.
As to Claim 11, Dykes discloses the variable volume reservoir (16) includes an inlet (20, “In the position as shown in FIG. 1, the reservoir 16 is in its filling position such that a filler opening 20 is available with a cover 22 that can be removed by the user to pour water into the reservoir 16 for filling the reservoir 16.” Column 3, Lines 15-30) suitable for imparting the delivery/removal of water – thus a water inlet, and additionally for imparting the delivery/removal of air – thus an air inlet.
Yet, does not expressly disclose the configuration of the air inlet having “an ISO standard connector for connecting to a respiratory apparatus”.
Rapoport teaches incubators, such as the humidifier of Dykes, are constructed to provide ventilation supplementation in the form of a CPAP device or medical ventilator to the infant retained within the incubator to “recycle and circle air… to insure the appropriate concentration of the various comprising gases” whereby the “circling of air is humidified and/or used to heat the incubator” (Para 0003). Hence, the application of Dykes humidifier in the form of an incubator is known to be utilized with a respiratory pressure therapy device to ensure the environment of the infant is maintained at a safe and controlled levels.
The specific connector “ISO standard connector” 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 convey gases to the patient within the incubator.
Therefore, it would have been obvious to one having ordinary skill it the art to modify the humidifier of Dykes to be expressly utilized with a respiratory apparatus as connected with an “ISO standard connector”, as taught by Rapoport to be a known method of ensuring the ventilation and supportive care of gases are provided to the patient within.
As to Claim 14, the modified Dykes, specifically Dykes discloses the flexible chamber (16) comprises a flexible main body (60 of 16, best seen Figure 7, “Further, there is a rubber insulator 58 and a bottom bracket 60 the hold a plastic container 60 that depends downwardly into the water within the reservoir. Thus, as the plastic container 60 is immersed in the water within the reservoir 16, the plastic container 60 becomes filled with water and the heater element 44 can heat only a localized quantity of water contained in the plastic container 60 and not the entire reservoir filled with water. Thus, with the reservoir filled, there is sufficient quantity of water to provide humidification for a long period of time without refilling, however, at the same time, the heater does not have to heat the entire quantity of water but only the small localized quantity of water that is within the plastic container 60. Accordingly, the heated water vapor is collected in the plastic container 60 and rises to exit from the plastic container 60 out of the outlet 62 to be directly introduced into the infant compartment of an incubator.” Column 4, Line 60 thru Column 5, Line 25).
As to Claim 15, the modified Dykes, specifically Dykes discloses the flexible chamber (16) comprises a rigidizing structure (46, “Finally, in FIG. 7 there is an exploded view of the heater 27 and which includes a cartridge heater element 45 and is inserted into an aluminum sheath 46.” Column 4, Line 60 thru Column 5, Line 10) for the flexible main body (60 of 16).
As to Claim 16, the modified Dykes, specifically Dykes discloses the configuration of the rigidizing structure (46) in the form of a rib that extends along an interior surface (best seen Figure 7) of the flexible main body (60 of 16).
As to Claim 18, the modified Dykes, specifically Dykes discloses the configuration of the heating element (27) in the base unit (11). Explicitly, Dyke states “A heater 27 is also shown and which extends downwardly from the housing 11 of the reservoir 10 and heats the water in a confined area.” (Column 3, Lines 25-40).
Claims 19 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Dykes (6,256,454) in view of Rapoport (2016/0206493), as applied to Claim 12 and further in view of Klasek et al. (2008/0105257).
As to Claims 19 and 20, Dykes discloses a heater (27) for heating the water within the variable volume reservoir (16).
Yet, does not expressly disclose the construction of the heater in the configuration of the heating element having “a plurality of heating regions” (Claim 19) and “wherein the flexible chamber is configured to engage each of the plurality of heating regions in use” (Claim 20).
Klasek teaches a humidifier (Figure 3) for heating water (13, “In FIG. 3 a humidifier arrangement utilizing a floating heater 12 is illustrated. The floating heater 12 floats in the body of water 13 in the humidifier chamber tub 1 such that a substantial portion of the floating heater 12 is immersed but is still adjacent to the water surface 14 so as to heat that part of the water near the surface 14.” Para 0126) retained within a reservoir (1, “humidifier chamber tub 1” Para 0126) to facilitate the vaporization of the water (Abstract) through the energizing of the heater (12, “The floating heater 12 may comprise a length of flexible tape heater of similar construction to that discussed above with reference to FIGS. 1-A to 1-C and 2.” Para 0127).
Regarding the remaining limitations, Klasek teaches construction of the heater (12) in the form of a “flexible tape heater” provides the benefit that “enhances heat transfer with the gas flow while also providing low impedance to the gas flow.” (Para 0083), and increases “the available surface area for heat transfer between the gas flow and the surface of the flexible tape heater 3.” (Para 0089).
With respect to the limitations of “a plurality of heating regions”, Klasek teaches the configuration of a “flexible tape heater” having “multiple heating elements” and “multiple zones” (“In other embodiment there may be multiple heating element circuits within the flexible tape heater 3. The multiple heating elements may be connected in series or parallel. The use of these multiple heating circuits within a flexible tape heater 3 enables additional heating to be applied as required in the operation of the respiratory apparatus. … Other conductors may also be present between each of these multiple layers, for example so as to form multiple heating circuits, such as to allow multiple heating zones along the length of the tape heater.” Paras 0103 and 0104; also see: “The heaters may comprise multiple heating circuits, so that each of the three heater zones may be operated independently.” Para 0140).
The resultant effect of the “plurality of heating regions” is the ability to customize the heating profile along the length of the heater within the chamber.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the heater of Dykes to be a flexible tape heater with a plurality of heating regions as taught by Klasek to be a known configuration of a heater suitable to permit the vaporization of water for humidification whilst also enhancing the heat transfer of between the gas and the water, so that the heating profile can be customized along the length of the heater as retained within the chamber.
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 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 and 15-23 of U.S. Patent No. 10,821,257.
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant independent claims, Claims 1 and 12 are merely broader than the dependent claims, Claims 1 and 15. 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 is thus much more specific. Thus, the invention of the instant 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”. See 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 Application:
Differences Underlined
Patent 10,821,257
Differences Underlined
1. A humidifier for humidifying a flow of air to be delivered to a patient,
the humidifier comprising:
a base unit comprising at least one wall defining a receiving space;
a variable volume reservoir configured to hold a body of water and receive the flow of air to humidify the flow of air for delivery to the patient;
and a heater for heating the body of water, wherein the receiving space is configured to receive the variable volume reservoir and the variable volume reservoir is conformable to a shape of the receiving space.
1. A humidifier configured to humidify a pressurized flow of air to be delivered by way of an air flow path to a patient,
the humidifier comprising:
a base unit comprising at least one wall defining a receiving space;
a variable volume reservoir comprising reservoir air inlet configured to form a sealed connection with the air flow path, the variable volume reservoir being configured to hold a body of water and receive the flow of air through the reservoir air inlet to humidify the flow of air for delivery to the patient;
and a heater for heating the body of water, wherein the receiving space is configured to removably receive the variable volume reservoir and the variable volume reservoir is conformable to a shape of the receiving space.
2. The humidifier of claim 1,
wherein the variable volume reservoir is collapsible to a flat plate.
2. The humidifier of claim 1,
wherein the variable volume reservoir is collapsible to a flat plate.
3. The humidifier of claim 1,
wherein the at least one wall defines a prism shaped receiving space.
3. The humidifier of claim 1,
wherein the at least one wall defines a prism shaped receiving space.
4. The humidifier of claim 1,
wherein the variable volume reservoir comprises low thermal impedance material configured to engage the heater in use.
4. The humidifier of claim 1,
wherein the variable volume reservoir comprises low thermal impedance material configured to engage the heater in use.
5. The humidifier of claim 4,
wherein the low thermal impedance material comprises at least one of polyethylene or polyamide.
5. The humidifier of claim 4,
wherein the low thermal impedance material comprises at least one of polyethylene or polyamide.
6. The humidifier of claim 1,
wherein the variable volume reservoir does not comprise a metal plate.
6. The humidifier of claim 1,
wherein the variable volume reservoir does not comprise a metal plate.
7. The humidifier of claim 1,
wherein the variable volume reservoir comprises the heater.
7. The humidifier of claim 1,
wherein the variable volume reservoir comprises the heater.
8. The humidifier of claim 7,
wherein the heater is a flexible tape heater.
8. The humidifier of claim 7,
wherein the heater is a flexible tape heater.
9. The humidifier of claim 8,
wherein at least a part of the heater is molded within a wall of the variable volume reservoir.
9. The humidifier of claim 8,
wherein at least a part of the heater is molded within a wall of the variable volume reservoir.
10. The humidifier of claim 1,
wherein the variable volume reservoir comprises an air inlet and a water inlet.
10. The humidifier of claim 1,
wherein the variable volume reservoir comprises a water inlet.
AND
Excerpt from Claim 1:
“…a variable volume reservoir comprising reservoir air inlet configured to form a sealed connection with the air flow path, …”
11. The humidifier of claim 10,
wherein the air inlet comprises an ISO standard connector for fluidly connecting to a respiratory apparatus.
11. The humidifier of claim 10,
wherein the reservoir air inlet comprises an ISO standard connector for fluidly connecting to a respiratory apparatus.
12. A humidifier for use with a respiratory pressure therapy (RPT) apparatus, the humidifier comprising:
a flexible chamber configured to hold a body of water and receive a flow of air from the RPT apparatus to humidify the flow of air; and
a base unit configured to support the flexible chamber, the flexible chamber being configured to conform to a shape of a receiving space of the base unit in use.
15. A humidifier configured to receive a pressurized flow of respiratory gas from a respiratory pressure therapy (RPT) apparatus by way of a gas flow path, the humidifier comprising:
a flexible chamber configured to hold a body of water and receive the pressurized flow of respiratory gas from the RPT apparatus to humidify the pressurized flow of respiratory gas; and
a base unit configured to support the flexible chamber, the flexible chamber being configured to conform to a shape of a receiving space of the base unit in use, wherein the flexible chamber is removable from the gas flow path.
13. The humidifier of claim 12,
wherein the flexible chamber is configured to expand during use.
16. The humidifier of claim 15,
wherein the flexible chamber is configured to expand during use.
14. The humidifier of claim 12,
wherein the flexible chamber comprises a flexible main body.
17. The humidifier of claim 15,
wherein the flexible chamber comprises a flexible main body.
15. The humidifier of claim 12,
wherein the flexible chamber comprises a rigidizing structure for the flexible main body.
18. The humidifier of claim 17,
wherein the flexible chamber comprises a rigidizing structure for the flexible main body.
16. The humidifier of claim 15,
wherein the rigidizing structure is one or more ribs extending along an interior surface of the flexible main body.
19. The humidifier of claim 18,
wherein the rigidizing structure is one or more ribs extending along an interior surface of the flexible main body.
17. The humidifier of claim 15,
wherein the rigidizing structure is an exoskeleton extending across an outer surface of the flexible main body.
20. The humidifier of claim 18,
wherein the rigidizing structure is an exoskeleton extending across an outer surface of the flexible main body.
18. The humidifier of claim 12,
wherein the base unit comprises a heating element.
21. The humidifier of claim 15,
wherein the base unit comprises a heating element.
19. The humidifier of claim 17,
wherein the heating element comprises a plurality of heating regions.
22. The humidifier of claim 21,
wherein the heating element comprises a plurality of heating regions.
20. The humidifier of claim 19,
wherein the flexible chamber is configured to engage each of the plurality of heating regions in use.
23. The humidifier of claim 22,
wherein the flexible chamber is configured to engage each of the plurality of heating regions in use.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Tapley (0,179,079), Eicher at al. (6,988,496), Bach et al. (2011/0290243), Dunne et al. (2012/0090603), Burolla et al. (2010/0132699) each disclose medical devices which impart breathing gas in the form of an aerosol to the patient wherein the liquid formulation prior to aerosolization is retained within a variable volume reservoir or flexible chamber.
Holsti et al. (2017/0252532) discloses an additional humidifier in the form of an incubator what utilized a humidifier (14) with a PAP device (via 17) to provide environmental control of gas and humidity to the patient within.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, 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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
ANNETTE FREDRICKA DIXON
Primary Examiner
Art Unit 3782
/Annette Dixon/Primary Examiner, Art Unit 3785
Prosecution Insights