DETAILED ACTION
Primary Examiner acknowledges Claims 33-55 are pending in this application, with Claims 33-55 having been newly added, and Claims 1-32 having been cancelled by preliminary amendment on February 26, 2024.
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because:
Reference character “2” has been used to designate “patient interface”, “nasal cannula”, and “cannula” (Para 0037). Appropriate correction is required.
Reference character “4” has been used to designate “an integrated gases supply and humidifying device”, “blower-humidifier device” (Para 0037), “device” (Paras 0039, 0040, 0041 – 2 instances, 0043 – 3 instances, 0045, 0047 – 3 instances). Appropriate correction is required.
Reference character “9” has been used to designate “inlet” and “inlet port” (Para 0043- 2 instances). 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 “2” has been used to designate “patient interface”, “nasal cannula”, and “cannula” (Para 0037). Appropriate correction is required.
Reference character “4” has been used to designate “an integrated gases supply and humidifying device”, “blower-humidifier device” (Para 0037), “device” (Paras 0039, 0040, 0041 – 2 instances, 0043 – 3 instances, 0045, 0047 – 3 instances). Appropriate correction is required.
Reference character “9” has been used to designate “inlet” and “inlet port” (Para 0043- 2 instances). Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 33-55 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 33, Line 3 recites the phrase “sequential flow path”; however, it should be noted although the origin of the flow path is defined as the “safety manifold” and the terminus is defined as the “combined gases outlet”, the claims do not positively recite the specific order and arrangement of the intermediary structures of the “humidification chamber”, the “flow driver”, nor the “sensor”. Consequently despite the nomenclature of “sequential flow path”, it should be noted the claimed “sequential flow path” includes various permutations which would meet the structure and relationship without following the introduction of claim limitations as recited in the claim listing. Even with the reliance on the term “downstream” as recited in Claim 33, Line 6 and 12, again the order of the intermediary structures is not limited to the specific order of introduction of the claim limitations. Dependent claims, Claims 34-38, incorporate the indefinite subject matter from which they depend. Appropriate correction and clarification is required.
Specifically, Claim 33, Line 5 recites the limitation “ambient gas”; however, the breadth and scope of this limitation is unclear. Primary Examiner is unsure if the term “ambient gas” is meant to be coextensive with the concept of “air” regardless of its compressed or pressurized state, OR ALTERNATIVELY, if Applicant is attempting to recite the configuration of “air” at ambient pressure whereby the gas is not compressed or pressurized. Dependent claims, Claims 34-38, incorporate the indefinite subject matter from which they depend. Appropriate correction and clarification is required.
Specifically, Claim 33, Lines 6-7 recite the limitation “a flow of combined gases”; whilst, Claim 33, Lines 10-11 recite the limitation “the flow of combined ambient gas and pure oxygen”. It is unclear if these terms are meant to be coextensive or separate and distinct. Consequently, the meets and bounds of the claim limitations can not be determined. It would appear in a review of the remaining limitations of the claims within the claim listing that the recitation to “ambient gas and pure oxygen” as referenced in Claim 33, Lines 10-11 is at best erroneous and at worst appears to lack antecedent basis in the claims. Dependent claims, Claims 34-38, incorporate the indefinite subject matter from which they depend. Appropriate correction and clarification is required.
Specifically, Claim 33, Lines 7-8 recite wherein “allowing pure oxygen to disperse when the flow driver is not activated”; however, the breadth and scope of this limitation is unclear. How does the activation or deactivation of the flow driver effectuate the ability of “pure oxygen” to disperse? Still further, what happens to the “ambient gas” or “air” in the activation or deactivation of the flow driver. Dependent claims, Claims 34-38, incorporate the indefinite subject matter from which they depend. Appropriate correction and clarification is required.
Specifically, Claim 33, Line 9 recites “widened”; however, the breadth and scope of this limitation is unclear. Widening from what dimension? Widening compared to what structure? Dependent claims, Claims 34-38, incorporate the indefinite subject matter from which they depend. Appropriate correction and clarification is required.
Specifically, Claim 33, Line 19 recites “to exit”; however, the breadth and scope of this limitation is unclear. Exit to where? Exit to what? Exit the sequential flow path or exit to the patient? Dependent claims, Claims 34-38, incorporate the indefinite subject matter from which they depend. Appropriate correction and clarification is required.
Specifically, Claim 33, Line 23 recites “integrate the flow driver and the humidifier”; however the breadth and scope of this limitation is unclear. Primary Examiner is unsure if the term “integrate” is meant to mean the combination or encasement within the housing of the flow driver and the humidifier, OR ALTERNATIVELY, if Applicant is attempting to hint at the unrecited limitation of a processor/controller which undergoes mathematical integrations and other calculations to modulate the operations of the flow driver and the humidifier. Dependent claims, Claims 34-38, incorporate the indefinite subject matter from which they depend. Appropriate correction and clarification is required.
Specifically, Claim 33, Line 23 recites “humidifier” and Claim 33, Line 24 recites “a humidifier”; however, this recitation is unclear. It appears Applicant is attempting to distinguish between the “humidification chamber” and a “humidifier” yet, there has been no formal introduction of a “humidifier” until Claim 33, Line 24. Consequently, it is unclear whether the “humidifier” of Claim 33, Line 23 is the same as the humidifier of Claim 33, Line 24. Furthermore, it is unclear what structure(s) are required to distinguish a humidifier from the humidification chamber. By convention of the field of endeavor, the term “humidifier” is the combined structure which achieves humidification of water, whilst the “humidification chamber” and “heater / heater plate” are components of the “humidifier”. Hence, it is further unclear how one can “combine a humidifier and the humidification chamber” as claimed in Claim 33, Line 24. Dependent claims, Claims 34-38, incorporate the indefinite subject matter from which they depend. Appropriate correction and clarification is required.
Specifically, Claim 33, Lines 27-28 recite “the outlet”; however, the breadth and scope of this limitation is unclear. What outlet? The “combined gases outlet”? An outlet of the housing? Dependent claims, Claims 34-38, incorporate the indefinite subject matter from which they depend. Appropriate correction and clarification is required.
Specifically, Claim 36, Line 3 recites “the inlet port”; however, this limitation lacks antecedent basis in the claims. It appears the term “inlet port” was initially introduced in Claim 35, Line 1, however, the parentage of Claim 36 does not include Claim 35. Thus, it appears the dependency of Claim 36 should stem from Claim 35. Appropriate correction and clarification is required.
Specifically, Claim 37, Line 2 recites “tubing”; however, the breadth and scope of this limitation is unclear. The term “tubing” has not been previously addressed. Appropriate correction and clarification is required.
Specifically, Claim 38, Line 3 recites “the apparatus housing”; however, this limitation appears to lack antecedent basis in the claims. Primary Examiner is unsure of the breadth and scope of this limitation. Is the aforementioned term consistent with the “breathing assistance apparatus” or some other feature. Appropriate correction and clarification is required.
Specifically, Claim 39, Lines 9 and 14 recites “the apparatus”; however, this limitation appears to lack antecedent basis in the claims. Primary Examiner is unsure of the breadth and scope of this limitation. Is the aforementioned term consistent with the “breathing assistance apparatus” or some other feature. Dependent claims, Claims 40-47, incorporate the indefinite subject matter from which they depend. Primary Examiner notes Claim 42, Line 2 explicitly recites “the apparatus”. Appropriate correction and clarification is required.
Specifically, Claim 39, Lines 17, 18, and 19 each recite “the inlet”; however, this limitation lacks antecedent basis in the claims. Primary Examiner is unsure if this is “an inlet” of the manifold or “the housing inlet” of Claim 39, Line 15. Dependent claims, Claims 40-47, incorporate the indefinite subject matter from which they depend. Primary Examiner notes Claim 41, Line 2 explicitly recites “the inlet”. Appropriate correction and clarification is required.
Specifically, Claims 40-47 recite the preamble “The system”; however, this limitation lacks antecedent basis in the claims. It appears the recitation should be “The control system” to be consistent with the independent claim, Claim 39, that recites “A control system…”. Additionally, Claim 39, Line 1 reciting “the system” should also be changed to “the control system”. Appropriate correction and clarification is required.
Specifically, Claim 46 recites the limitation “the heater plate”; however, this limitation lacks antecedent basis in the claims. The term “heater plate” was introduced in Claim 43, Line 1; however, the parentage of Claim 46 does not include Claim 43. It appears perhaps the dependency of Claim 46 should be to Claim 43. For purposes of this rejection, Primary Examiner will presume the “heater plate” of Claim 46 can be interpreted to be any heater along the gas flow pathway. Appropriate correction and clarification is required.
Specifically, Claim 48 recites “the apparatus”; however, the breadth and scope of this limitation is unclear. What apparatus? Should this recitation be “the device”? Dependent claims, Claims 49-55, incorporate the indefinite subject matter from which they depend. Appropriate correction and clarification is required.
Specifically, Claim 48, Lines 13, 14, and 15 each recite “the inlet”; however, this limitation lacks antecedent basis in the claims. Primary Examiner is unsure if this is “an inlet” of the manifold or “the housing inlet” of Claim 39, Line 15. Dependent claims, Claims 49-55, incorporate the indefinite subject matter from which they depend. Primary Examiner notes Claim 51, Line 2 explicitly recites “the inlet”. Appropriate correction and clarification is required.
Specifically, Claims 49-55 recite the preamble “The system”; however, this limitation lacks antecedent basis in the claims. It appears the recitation should be “The device” to be consistent with the independent claim, Claim 48, that recites “A device…”. Appropriate correction and clarification is required.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 33, 34, 37-39, 41, 42, and 44-46 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Richardson (6,279,574) in view of Beasley (3,362,404).
As to Claim 33, Richardson discloses a system for sensing and displaying oxygen fraction in a combined gas flow of a breathing assistance apparatus (best seen Figure 3), the system comprising: a sequential flow path (defined by the pathway of fluid from 10/12 -11/13 – 80 – 82/84 – 96 – 126 – 142) comprising: an initial safety manifold (80, “Each are connected by conduits 11 and 13 respectively to a gas blender 80. The blender 80 functions to mix the gases and produce breathable gas which may be air, oxygen or a mixture of the two. The output of the blender 80 is supplied via a conduit 81 to a pressure regulator 82.” Column 5, Line 60 thru Column 6, Line 10) having a bifurcated intake structure (via 11/13, “Each are connected by conduits 11 and 13 respectively to a gas blender 80.” Column 5, Line 60 thru Column 6, Line 10) configured to intake ambient gas through one opening (via 10, “As before, a first source of gas is a source of compressed air 10; and a second source of gas is a source of oxygen 12.” Column 5, Line 60 thru Column 6, Line 10) and intake pure oxygen through another opening (via 12, “As before, a first source of gas is a source of compressed air 10; and a second source of gas is a source of oxygen 12.” Column 5, Line 60 thru Column 6, Line 10), thereby creating downstream a flow of combined gases (via 81, “The output of the blender 80 is supplied via a conduit 81 to a pressure regulator 82. The pressure regulator 82 senses the pressure of the breathable gas in the conduit 81 or received from the conduit 81 and operates to supply the breathable gas at its output via conduit 90 at a pressure selected by the user as more fully discussed hereinafter.” Column 5, Line 60 thru Column 6, Line 10) when a flow driver (82, “The output of the blender 80 is supplied via a conduit 81 to a pressure regulator 82. The pressure regulator 82 senses the pressure of the breathable gas in the conduit 81 or received from the conduit 81 and operates to supply the breathable gas at its output via conduit 90 at a pressure selected by the user as more fully discussed hereinafter.” Column 5, Line 60 thru Column 6, Line 10; also see: “Once breathable gas has been regulated to the desired driving pressure by the servo regulator 82, it passes through conduit 90 to an isolation valve 92.” Column 6, Lines 15-30; “The servo processor 162 adjusts the pressure as determined by the pressure regulator 82 through the blender controller 168 so that the proportional valve 102 is able to operate through a large portion of it's mechanical range. Increasing the pressure of the processed gas facilitates e control of the pressure and flow waveform of the gas delivered to the patient through the nozzle 130.” Column 8, Lines 5-25) is activated and allowing pure oxygen to disperse when the flow driver (82) is not activated; a subsequent, widened humidification chamber (96, “The breathable gas is supplied via conduit 94 to a humidifier 96 which operates to heat and humidify the breathable gas. A water level sense mechanism within the humidifier 96 controls a water pump 98 to keep a constant level of water within a reservoir in the humidifier 96. As the breathable gas pressure may vary between 2 and 25 psig, it is necessary to introduce water into the humidifier 96 under pressure using the water pump 98 rather than a simple gravity feed system as used by conventional, low pressure humidifiers. … From the humidifier 96, the now processed gas travels through a length of delivery tubing 100 to the inhalation valve 102 within the control module 88.” Column 6, Lines 25-55; also see: “The humidifier 96 temperature settings are controlled by the clinician using commands input through the touch screen 134, rotary knob and switches 132 and I/O processor 120. A signal reflective of the desired temperature setting is generated and supplied via the bus 176 and conductor means 185 for further transmission to a separate humidifier controller circuit 184. The humidifier controller circuit supplies signals via conductor 186 to the water pump to cause water to be supplied to the humidifier 96 and via conductor 187 to control the heater in the humidifier 96 all in accordance with preselected parameters to develop a desired humidity for the processed gas supplied at the output of the humidifier 96.” Column 9, Lines 10-25) configured to heat fluid ("The humidifier controller circuit supplies signals via conductor 186 to the water pump to cause water to be supplied to the humidifier 96 and via conductor 187 to control the heater in the humidifier 96 all in accordance with preselected parameters to develop a desired humidity for the processed gas supplied at the output of the humidifier 96.” Column 9, Lines 10-25) and thereby humidify the flow of combined ambient gas and pure oxygen (via 81); the flow driver (82) positioned downstream from the safety manifold (80) and configured to cause the flow of the combined gases (via 81) through the sequential flow path (defined by the pathway of fluid from 10/12 -11/13 – 80 – 82/84 – 96 – 126 – 142); a sensor (84, “Some portion of the breathable gas is available via conduits 81A and 81B to an oxygen sensor 84 which monitors the percentage of oxygen in the breathable gas and sends a signal via conductor 85 to trigger an alarm should the percentage vary significantly (e.g., more than 10%) from the desired value.” Column 6, Lines 5-20) in fluid communication with the combined gases (via 81) and configured to determine the fraction of oxygen (“percentage of oxygen in the breathable gas”) in the flow of combined gases (via 81); and a combined gases outlet (126, “The heating wire is placed in or about the gas delivery tubing 114 or 126. The temperature of the processed gas is detected downstream of the proportional valve 102 so that the processed gas has expanded to the delivery pressure. That is, absent further heating, the processed gas will be at a temperature close to that when it the processed gas is delivered to the patient through the nozzle 130. That is the gas could cool or heat from ambient conditions as it progresses through the tubing 126 and the nozzle 130 into the patient.” Column 6, Line 50 thru Column 7, Line 15; “When the proportional valve 102 opens, processed gas travels through the temperature sensing assembly 112 and through a length of delivery tubing 126 to the inlet port 136 of the nozzle 130. Processed gas is in turn directed into the central channel 138 towards the patient through a flowmeter 140 and then into an endotracheal tube 142.” Column 7, Lines 15-30) configured to allow the flow of combined gases (via 81) to exit; a housing (248 as shown in Figure 6, “FIG. 6 is a chassis for use with a ventilator system of the present invention.” Column 3, Line 65-70; “FIG. 6 is an example of a design for a chassis 248 suitable for the ventilator system of the current invention.” Column 12, Lines 5-20) for the breathing assistance apparatus (Figure 3) and the sequential flow path (defined by the pathway of fluid from 10/12 -11/13 – 80 – 82/84 – 96 – 126 – 142), the housing (Figure 6) configured to: support (via 276, “Not shown is the rear of the enclosure 276 which includes the power entry, gas connections and communications ports. A door provides access to the internal batteries. The oxygen sensor would also be mounted to the rear panel to allow access by the user for convenient replacement as required.” Column 12, Lines 35-45) the safety manifold (80) on an external surface (276, “rear of the enclosure 276” Column 12, Lines 35-45) of the housing (248); integrate (via “The internal system components would be supported on some form of metal support within that allows access for servicing” Column 12, Lines 5-20) the flow driver (82) and humidifier (via 250, “humidifier access door 250” Column 12, Lines 15-30); combine a humidifier (via 250) and the humidification chamber (96) such that the humidification chamber (96) can be removed from the housing (248) and replaced; provide support (via 256, “blended gas outlet 256” Column 12, Lines 15-30) for the combined gases outlet (126) such that the combined gases flow (via 81) from the housing (248) and the sequential flow path (defined by the pathway of fluid from 10/12 -11/13 – 80 – 82/84 – 96 – 126 – 142) and out through the outlet (256, “blended gas outlet 256” Column 12, Lines 15-30) toward a patient (142, “Processed gas is in turn directed into the central channel 138 towards the patient through a flowmeter 140 and then into an endotracheal tube 142.” Column 7, Lines 15-30); and support (via 243, “upper portion of the front 243” Column 12, Lines 15-30) a display (260 of Figure 6 and 170 of Figure 3, “The upper portion of the front 243 of the chassis includes all of the user interface such as for example the touch screen 260 similar to touch screen 134 and display 170 (FIG. 3).” Column 12, Lines 15-30) configured to receive output (via 85 to 118 to 185 to 120 to 170, “Some portion of the breathable gas is available via conduits 81A and 81B to an oxygen sensor 84 which monitors the percentage of oxygen in the breathable gas and sends a signal via conductor 85 to trigger an alarm should the percentage vary significantly (e.g., more than 10%) from the desired value.” Column 6, Lines 5-20; also see: “A second microprocessor 120 is most preferably a digital microprocessor and operates to communicate with the clinician. The second processor is labeled as the I/O (Input/Output) processor in FIG. 3 to show that its function is to interface with the operator or clinician. The I/O processor 120 is connected to a large, color LCD display 170, a floppy disk drive 172 and a number of serial and parallel communications ports 174 for attachment to other devices. … The I/O processor 120 receives commands from the clinician regarding the desired mode of ventilation (e.g., high frequency pulse, normal respiration, combinations of high frequency and normal respiration breath rate), PIP, PEEP, patient initiated operation (upon initiating an inspiration) or a system imposed regimen all through the interactive touch screen 134 and display 170. As an example, should the clinician desire to change the percentage of oxygen delivered to the patient, the oxygen percentage is depicted by an icon on the display. The icon would be touched to simulate the operation of a button via the touch screen 134 or through a rotary knob and switches 132 attached to the interface board 118. The knob can be turned until the desired percentage oxygen was displayed on the display 170.” Column 8, Lines 20-65) and on the housing (248), display (via 260 of Figure 6 and 170 of Figure 3) fraction of oxygen information (“the oxygen percentage is depicted by an icon on the display” Column 8, Lines 20-65) for combined gases (via 81) flowing through the system (Figure 3).
Although Richardson clearly discloses “ambient gas” in the form of “air” whereby the “air” is delivered under compression (“As before, a first source of gas is a source of compressed air 10; and a second source of gas is a source of oxygen 12.” Column 5, Line 60 thru Column 6, Line 10); yet, Richardson does not expressly disclose the “ambient gas” to be at atmospheric pressure and thus not compressed or pressurized prior to entry to the manifold.
Beasley teaches various sources of “air” are known to provide gas for a suitable for ventilation support a patient (Column 3, Lines 40-50). Explicitly, Beasley teaches “The source 10 may, by way of example, comprise a tank of compressed air or oxygen or a pump for compressing ambient air, or combination of the two.” (Column 3, Lines 40-50).
In light of the teachings of Beasley, the decision to modify the source of “air” to be in the form of a compressed air tank/cylinder or atmospheric pressure later compressed with a pump are functionally equivalent alternative structures suitable for imparting breathing gas to a patient that are well known, routine, and conventional practice – as Beasley was patented over thirty-five (35) years prior to the effective filing date of the instant application.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the air source of Richardson to be air at atmospheric pressure, as taught by Beasley to be a known configuration of air sources suitable for imparting breathing gas to a patient.
As to Claim 34, the modified Richardson, specifically Richardson discloses the sensor (84) oriented in proximity to the flow driver (82); yet, does not expressly disclose the configuration whereby “the sensor is included in the flow driver”
In light of the relationship of the sensor and the flow driver to modulate the flow profile and composition of gases, it would have been obvious to one having ordinary skill in the art to modify the location of the sensor to be “included in the flow driver”, since it has been held where the general conditions of a claim are disclosed in the prior art discovering the optimum or workable ranges involves only routine skill in the art.
In this particular case, the modification of the sensor to be “included in the flow driver” 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 cooperative interaction of the sensor and the flow driver to modulate the flow profile and composition of the gases. Consequently, one of ordinary skill in the art would have expected Applicant’s invention to perform equally well with the modified Richardson as the construction of the sensor to be “included in the flow driver” would yield the predictable results of enabling the cooperative interaction of the sensor and the flow driver to modulate the flow profile and composition of the gases.
Moreover, Applicant has not asserted the specific orientation of the “sensor included in the flow driver” provides a particular advantage, solves a stated problem, or serves a particular purpose different from that of enabling the cooperative interaction of the sensor and the flow driver to modulate the flow profile and composition of the gases; thus the use of the specific orientation of the “sensor included in the flow driver” appears to lack criticality in its design.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the location of the sensor to be “included in the flow driver”, a known result effective variable, in order to enable the cooperative interaction of the sensor and the flow driver to modulate the flow profile and composition of the gases.
As to Claim 37, the modified Richardson, specifically Richardson discloses the pure oxygen opening (via 12) is configured to accept an attachment from tubing (13, “Each are connected by conduits 11 and 13 respectively to a gas blender 80.” Column 5, Line 60 thru Column 6, Line 10) that feeds from the oxygen supply (12, “a second source of gas is a source of oxygen 12” Column 5, Line 60 thru Column 6, Line 10).
As to Claim 38, the modified Richardson, specifically Richardson discloses the pure oxygen opening (via 12) comprises a port (defined by the interaction of 13 and 80) to extend from the manifold (80) in a direction parallel to a surface of an adjacent face (via 276, “Not shown is the rear of the enclosure 276 which includes the power entry, gas connections and communications ports. A door provides access to the internal batteries. The oxygen sensor would also be mounted to the rear panel to allow access by the user for convenient replacement as required.” Column 12, Lines 35-45) of the apparatus housing (248).
As to Claim 39, Richardson discloses a control system for a breathing assistance apparatus (Figure 3), the control system (Figure 3) comprising: an input (via 132/134 of Figure 3 or via 260/264 of Figure 6, “a desired temperature for the processed gas can be selected by the user through operation of knobs and switches 132 or touch screen 134.” Column 6, Line 50 thru Column 7, Line 15; “The icon would be touched to simulate the operation of a button via the touch screen 134 or through a rotary knob and switches 132 attached to the interface board 118. The knob can be turned until the desired percentage oxygen was displayed on the display 170.” Column 8, Lines 45-65; “A similar set of commands can be introduced through the touch screen 134 as well as through the same rotary knob and switches 132”. Column 8, Line 60 thru Column 9, Line 10; “The humidifier 96 temperature settings are controlled by the clinician using commands input through the touch screen 134, rotary knob and switches 132 and I/O processor 120.” Column 9, Line 10-25; “The upper portion of the front 243 of the chassis includes all of the user interface such as for example the touch screen 260 similar to touch screen 134 and display 170 (FIG. 3). The upper portion 243 includes the display 170 and touch screen 134 with the fixed controls 262 and the rotary knob 264.” Column 12, Lines 15-30) configured to accept instructions from a user for a required humidity or temperature (via 184/122, “The humidifier 96 temperature settings are controlled by the clinician using commands input through the touch screen 134, rotary knob and switches 132 and I/O processor 120. A signal reflective of the desired temperature setting is generated and supplied via the bus 176 and conductor means 185 for further transmission to a separate humidifier controller circuit 184. The humidifier controller circuit supplies signals via conductor 186 to the water pump to cause water to be supplied to the humidifier 96 and via conductor 187 to control the heater in the humidifier 96 all in accordance with preselected parameters to develop a desired humidity for the processed gas supplied at the output of the humidifier 96.” Column 9, Lines 10-25; also see: “The temperature signal is processed through the interface board 116 and sent to the humidifier controller 184 which supplies signals back through the interface board 118 to regulate a heating wire 124 connected by conductor means 122. The heating wire is placed in or about the gas delivery tubing 114 or 126. … However, since the amount of the temperature change can be predicted between the temperature at the temperature sensing assembly 112 and the nozzle, a desired temperature for the processed gas can be selected by the user through operation of knobs and switches 132 or touch screen 134.” Column 6, Line 50 thru Column 7, Line 15) for a combined flow of gases (via 81, “The output of the blender 80 is supplied via a conduit 81 to a pressure regulator 82. The pressure regulator 82 senses the pressure of the breathable gas in the conduit 81 or received from the conduit 81 and operates to supply the breathable gas at its output via conduit 90 at a pressure selected by the user as more fully discussed hereinafter.” Column 5, Line 60 thru Column 6, Line 10) to be provided by the breathing assistance apparatus (Figure 3); at least one sensor (112, “However, since the amount of the temperature change can be predicted between the temperature at the temperature sensing assembly 112 and the nozzle, a desired temperature for the processed gas can be selected by the user through operation of knobs and switches 132 or touch screen 134.” Column 6, Line 50 thru Column 7, Line 15) of the combined flow of gases (via 81) inside the breathing assistance apparatus (Figure 3); a controller (120, “A second microprocessor 120 is most preferably a digital microprocessor and operates to communicate with the clinician. The second processor is labeled as the I/O (Input/Output) processor in FIG. 3 to show that its function is to interface with the operator or clinician. The I/O processor 120 is connected to a large, color LCD display 170, a floppy disk drive 172 and a number of serial and parallel communications ports 174 for attachment to other devices. … The I/O processor 120 receives commands from the clinician regarding the desired mode of ventilation (e.g., high frequency pulse, normal respiration, combinations of high frequency and normal respiration breath rate), PIP, PEEP, patient initiated operation (upon initiating an inspiration) or a system imposed regimen all through the interactive touch screen 134 and display 170. As an example, should the clinician desire to change the percentage of oxygen delivered to the patient, the oxygen percentage is depicted by an icon on the display. The icon would be touched to simulate the operation of a button via the touch screen 134 or through a rotary knob and switches 132 attached to the interface board 118. The knob can be turned until the desired percentage oxygen was displayed on the display 170.” Column 8, Lines 20-65) configured to receive a signal form the input (via 132/134 of Figure 3 or via 260/264 of Figure 6) reflecting instructions, to receive feedback signals from the at least one sensor (112), and to adjust energy to components (e.g. “humidifier 96” and “heating wire 124”) of the apparatus (Figure 3) to change the humidity (via “The humidifier 96 temperature settings are controlled by the clinician using commands input through the touch screen 134, rotary knob and switches 132 and I/O processor 120. A signal reflective of the desired temperature setting is generated and supplied via the bus 176 and conductor means 185 for further transmission to a separate humidifier controller circuit 184. The humidifier controller circuit supplies signals via conductor 186 to the water pump to cause water to be supplied to the humidifier 96 and via conductor 187 to control the heater in the humidifier 96 all in accordance with preselected parameters to develop a desired humidity for the processed gas supplied at the output of the humidifier 96.” Column 9, Lines 10-25) or temperature (via “The temperature signal is processed through the interface board 116 and sent to the humidifier controller 184 which supplies signals back through the interface board 118 to regulate a heating wire 124 connected by conductor means 122. The heating wire is placed in or about the gas delivery tubing 114 or 126. … However, since the amount of the temperature change can be predicted between the temperature at the temperature sensing assembly 112 and the nozzle, a desired temperature for the processed gas can be selected by the user through operation of knobs and switches 132 or touch screen 134.” Column 6, Line 50 thru Column 7, Line 15) of the combined flow of gases (via 81); a display (260 of Figure 6 and 170 of Figure 3, “The upper portion of the front 243 of the chassis includes all of the user interface such as for example the touch screen 260 similar to touch screen 134 and display 170 (FIG. 3).” Column 12, Lines 15-30) configured to interact with the input (via 132/134 of Figure 3 or via 260/264 of Figure 6), the at least one sensor (112), and the controller (120); a housing (248 as shown in Figure 6, “FIG. 6 is a chassis for use with a ventilator system of the present invention.” Column 3, Line 65-70; “FIG. 6 is an example of a design for a chassis 248 suitable for the ventilator system of the current invention.” Column 12, Lines 5-20) that supports the display (260 of Figure 6 and 170 of Figure 3) and input (via 132/134 of Figure 3 or via 260/264 of Figure 6, “The upper portion 243 includes the display 170 and touch screen 134 with the fixed controls 262 and the rotary knob 264.” Column 12, Lines 15-30), encloses the controller (120) and the at least one sensor (112) and integrates a gases supply (10/12 – wherein “10” supplies “air” and “12” supplies “oxygen” - “As before, a first source of gas is a source of compressed air 10; and a second source of gas is a source of oxygen 12.” Column 5, Line 60 thru Column 6, Line 10) ) and a humidifier (96, “The breathable gas is supplied via conduit 94 to a humidifier 96 which operates to heat and humidify the breathable gas. A water level sense mechanism within the humidifier 96 controls a water pump 98 to keep a constant level of water within a reservoir in the humidifier 96. As the breathable gas pressure may vary between 2 and 25 psig, it is necessary to introduce water into the humidifier 96 under pressure using the water pump 98 rather than a simple gravity feed system as used by conventional, low pressure humidifiers. … From the humidifier 96, the now processed gas travels through a length of delivery tubing 100 to the inhalation valve 102 within the control module 88.” Column 6, Lines 25-55; also see: “The humidifier 96 temperature settings are controlled by the clinician using commands input through the touch screen 134, rotary knob and switches 132 and I/O processor 120. A signal reflective of the desired temperature setting is generated and supplied via the bus 176 and conductor means 185 for further transmission to a separate humidifier controller circuit 184. The humidifier controller circuit supplies signals via conductor 186 to the water pump to cause water to be supplied to the humidifier 96 and via conductor 187 to control the heater in the humidifier 96 all in accordance with preselected parameters to develop a desired humidity for the processed gas supplied at the output of the humidifier 96.” Column 9, Lines 10-25) such that the gases supply (10/12) causes a flow of gases through the apparatus (Figure 3) and through the humidifier (96), the gases entering the housing (248) at a housing inlet (via 276, “Not shown is the rear of the enclosure 276 which includes the power entry, gas connections and communications ports. A door provides access to the internal batteries. The oxygen sensor would also be mounted to the rear panel to allow access by the user for convenient replacement as required.” Column 12, Lines 35-45); and on or about the housing inlet (via 276), a manifold (80, “Each are connected by conduits 11 and 13 respectively to a gas blender 80. The blender 80 functions to mix the gases and produce breathable gas which may be air, oxygen or a mixture of the two. The output of the blender 80 is supplied via a conduit 81 to a pressure regulator 82.” Column 5, Line 60 thru Column 6, Line 10) having air aperture (via 10, “As before, a first source of gas is a source of compressed air 10; and a second source of gas is a source of oxygen 12.” Column 5, Line 60 thru Column 6, Line 10) to entrain air (“air”) into the aperture (via 10) and into the inlet (via 13, “Each are connected by conduits 11 and 13 respectively to a gas blender 80.” Column 5, Line 60 thru Column 6, Line 10) and an auxiliary gases opening (via 12, “As before, a first source of gas is a source of compressed air 10; and a second source of gas is a source of oxygen 12.” Column 5, Line 60 thru Column 6, Line 10) configured to entrain auxiliary gases (“oxygen”) into the opening (via 12, “As before, a first source of gas is a source of compressed air 10; and a second source of gas is a source of oxygen 12.” Column 5, Line 60 thru Column 6, Line 10) and into the inlet (via 11, “Each are connected by conduits 11 and 13 respectively to a gas blender 80.” Column 5, Line 60 thru Column 6, Line 10) such that, when the gases supply (10/12) is operating, air and auxiliary gases form, at the inlet (via 11/13), the combined flow of gases (via 81).
Yet, Richardson does not expressly disclose the air to be “ambient” at atmospheric pressure.
Beasley teaches various sources of “air” are known to provide gas for a suitable for ventilation support a patient (Column 3, Lines 40-50). Explicitly, Beasley teaches “The source 10 may, by way of example, comprise a tank of compressed air or oxygen or a pump for compressing ambient air, or combination of the two.” (Column 3, Lines 40-50).
In light of the teachings of Beasley, the decision to modify the source of “air” to be in the form of a compressed air tank/cylinder or atmospheric pressure later compressed with a pump are functionally equivalent alternative structures suitable for imparting breathing gas to a patient that are well known, routine, and conventional practice – as Beasley was patented over thirty-five (35) years prior to the effective filing date of the instant application.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the air source of Richardson to be air at atmospheric pressure, as taught by Beasley to be a known configuration of air sources suitable for imparting breathing gas to a patient.
As to Claim 41, the modified Richardson, specifically Richardson discloses the manifold (80) includes a filter (304/306 as seen in Figure 4, “A source of compressed air 300 and oxygen 302 are connected to filters 304 and 306 respectively.” Column 10, Lines 10-25) configured to remove particulate matter from ambient air as that air is entrained into the inlet (via 11). Additionally, it is noted Beasley also teaches the use of a filter (22, Column 3, Lines 25-45) associated with the inlet source of air.
As to Claim 42, the modified Richardson, specifically Richardson discloses the gases supply (10/12) and the humidifier (96) each form a component (e.g. “humidifier 96” and “heating wire 124”) of the apparatus (Figure 3) and each is configured to accept energy (via 168 for the gases supply 10/12 – “If the proportional valve 102 is completely open and the pressure and/or flow measured at the patient is not as great as desired, the servo processor 162 may increase the gas pressure for the breathable gas and the processed gas by sending the appropriate commands to the blender controller 168. The servo processor 162 adjusts the pressure as determined by the pressure regulator 82 through the blender controller 168 so that the proportional valve 102 is able to operate through a large portion of it's mechanical range.” Column 8, Lines 5-20 AND via 187 for the humidifier 96 -“The humidifier 96 temperature settings are controlled by the clinician using commands input through the touch screen 134, rotary knob and switches 132 and I/O processor 120. A signal reflective of the desired temperature setting is generated and supplied via the bus 176 and conductor means 185 for further transmission to a separate humidifier controller circuit 184. The humidifier controller circuit supplies signals via conductor 186 to the water pump to cause water to be supplied to the humidifier 96 and via conductor 187 to control the heater in the humidifier 96 all in accordance with preselected parameters to develop a desired humidity for the processed gas supplied at the output of the humidifier 96.” Column 9, Lines 10-25) as controlled by the controller (120).
As to Claim 44, the modified Richardson, specifically Richardson discloses the at least one sensor (112) comprises a sensor (84, “Some portion of the breathable gas is available via conduits 81A and 81B to an oxygen sensor 84 which monitors the percentage of oxygen in the breathable gas and sends a signal via conductor 85 to trigger an alarm should the percentage vary significantly (e.g., more than 10%) from the desired value.” Column 6, Lines 5-20) configured to sense the fraction of oxygen (“percentage of oxygen in the breathable gas”) within the combined flow of gases (via 81) within the housing (248) and the display (260 of Figure 6 and 170 of Figure 3) is configured to show the sensed fraction of oxygen (“the oxygen percentage is depicted by an icon on the display. The icon would be touched to simulate the operation of a button via the touch screen 134 or through a rotary knob and switches 132 attached to the interface board 118. The knob can be turned until the desired percentage oxygen was displayed on the display 170.” Column 8, Lines 20-65)
As to Claim 45, the modified Richardson, specifically Richardson discloses the controller (120) is configured to control the flow of the combined gases (via 81) by adjusting the energy (via 168 for the gases supply 10/12 – “If the proportional valve 102 is completely open and the pressure and/or flow measured at the patient is not as great as desired, the servo processor 162 may increase the gas pressure for the breathable gas and the processed gas by sending the appropriate commands to the blender controller 168. The servo processor 162 adjusts the pressure as determined by the pressure regulator 82 through the blender controller 168 so that the proportional valve 102 is able to operate through a large portion of it's mechanical range.” Column 8, Lines 5-20) to the gases supply (10/12).
As to Claim 46, the modified Richardson, specifically Richardson discloses the controller (120) is configured to control temperature and humidity of the combined flow of gases (via 81) by adjusting the energy (via 187 for the humidifier 96 - “The humidifier 96 temperature settings are controlled by the clinician using commands input through the touch screen 134, rotary knob and switches 132 and I/O processor 120. A signal reflective of the desired temperature setting is generated and supplied via the bus 176 and conductor means 185 for further transmission to a separate humidifier controller circuit 184. The humidifier controller circuit supplies signals via conductor 186 to the water pump to cause water to be supplied to the humidifier 96 and via conductor 187 to control the heater in the humidifier 96 all in accordance with preselected parameters to develop a desired humidity for the processed gas supplied at the output of the humidifier 96.” Column 9, Lines 10-25) to the heater plate (interpreted to be 124 as within the breathing assistance apparatus, “The temperature signal is processed through the interface board 116 and sent to the humidifier controller 184 which supplies signals back through the interface board 118 to regulate a heating wire 124 connected by conductor means 122. The heating wire is placed in or about the gas delivery tubing 114 or 126.” Column 6, Line 50 thru Column 7, Line 15).
Claim 40 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Richardson (6,279,574) in view of Beasley (3,362,404), as applied to Claim 39 and further in view of Watt (5,618,126).
As to Claim 40, the modified Richardson, specifically Richardson discloses the manifold (80) associated with the housing (248); yet, does not expressly disclose the configuration whereby “the manifold is removable from the housing”.
Watt teaches a breathing assistance device (Figures 1 and 2) having a manifold (32 via 30, “The control panel 30 consists of an outer control housing 32 that surrounds a series of valves 34 and gauges 36 that monitor and control the pressure and flow of oxygen into and out of the chamber 12.” Column 4, Lines 25-35) to control the input of gases supplied to the housing (12, “The hyperbaric chamber 12 is a cylindrical pressure chamber adapted to receive oxygen at a pressure greater than one atmosphere.” Column 3, Line 65 thru Column 4, Line 10), wherein the manifold (32 via 30) is removable (“The attachment means allow the control panel to be demountably attached to the exterior of the hyperbaric chamber.” Abstract; “In the preferred embodiment of the invention, the mounting apertures 60 are threaded bores in the lifting lug plates 50. In this manner, the control housing 32 is securely but demountable attached to the lifting lug 46.” Column 5, Lines 20-40) from the housing (12) for the purpose of enabling “servicing” (Abstract).
Therefore, it would have been obvious to one having ordinary skill in the art to modify the manifold of the modified Richardson to be removable from the housing as taught by Watt to enable the manifold to be serviced.
Claim 43 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Richardson (6,279,574) in view of Beasley (3,362,404), as applied to Claim 42 and further in view of DiMatteo et al. (7,413,173).
As to Claim 43, the modified Richardson, specifically Richardson discloses a humidifier (96); yet, does not expressly disclose the configuration of “the humidifier comprising a heater plate integrated into the housing and a humidification chamber configured for rapid removal from the housing”.
DiMatteo discloses a humidifier (Figures 1 and 2, “As seen in FIG. 2, the humidifier has a ventilator dock 40 and a removable water chamber 42.” Column 3, Lines 15-30) comprising a heater plate (48, “The ventilator dock also has a heater plate 48 surrounded by a ledge 50. Heater plate 48 is used to deliver thermal energy to the removable water chamber 42.” Column 3, Lines 15-30) integrated into a housing (50 via 40, “a ledge 50” via “a ventilator dock 40” Column 3, Lines 15-30) and a humidification chamber (42, “removable water chamber 42” Column 3, Lines 15-30) configured for rapid removal (“removable”) from the housing (50 via 40). The resultant effect of this configuration is the ability to separate the components for ease of “cleaning and maintenance” (Column 3, Lines 30-45).
Therefore, it would have been obvious to one having ordinary skill in the art to modify the construction of the humidifier of the modified Richardson to include separable components of the heater plate and the humidification chamber, as taught by DiMatteo to provide ease of cleaning and maintenance.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Bowden discloses a breathing assistance apparatus (Figure 1) having an insert (8) attached to the outer housing (2) for receipt within an opening (3) of the outer housing (2); yet, Bowden does not expressly disclose the configuration of the insert on the gases supply side of the breathing assistance apparatus (Figure 1). Rather, Bowden’s insert (8) is located proximate the patient (via 14).
Kramer et al. (10,722,675) shares a common inventor/assignee with this instant application; however, at this time there does not appear to be double patenting. The closest patent claim appears to be Claim 9 – which depends from Claim 1, which positively recites the features of “the manifold comprising a substantially rectangular insert” and within Claim 1 a positive recitation of “downstream”. Yet, the patent claim, Claim 9, does not expressly recite the features of the instant independent claims, whereby Claim 33 requires the sequential flow path and the features of the housing to “support a display configured to receive output from the sensor and, on the housing, display fraction of oxygen information for combined gases flowing through the system”, whereby Claims 39 and 48 requires the features of the input, controller, and display.
Kramer et al. (8,733,353) shares a common inventor/assignee with this instant application; however, at this time there does not appear to be double patenting. The closest patent claim appears to be Claim 9 – which depends from Claims 1, 5, and 6, which positively recites the features of a display and controller. Yet, the patent claim, Claim 9, does not expressly recite the features of the instant independent claims, whereby Claim 33 requires the sequential flow path having the “downstream” orientation, whereby Claims 39 and 48 requires the features of the input which appears to be referenced in patent claim 2 but is not within the parentage of patent claim 9.
Kramer et al. (9,656,039) shares a common inventor/assignee with this instant application; however, at this time there does not appear to be double patenting. The closest patent claim appears to be Claim 8 – which depends from Claim 1, which positively recites the features of “the manifold comprises a substantially rectangular insert.” Yet, the patent claim, Claim 8, does not expressly recite the features of the instant independent claims, whereby Claim 33 requires the sequential flow path having the ”downstream” orientation and the features of the housing to “support a display configured to receive output from the sensor and, on the housing, display fraction of oxygen information for combined gases flowing through the system”, whereby Claims 39 and 48 requires the features of the input, controller, and display.
Kramer et al. (11,666,726) shares a common inventor/assignee with this instant application; however, at this time there does not appear to be double patenting. The closest patent claim appears to be Claim 20 – which positively recites the features of a display and a downstream orientation. Yet, the patent claim, Claim 20, does not expressly recite the features of the instant independent claims, whereby Claim 33 requires the sensor to determine the fraction of oxygen in the flow of the combined gases, whereby Claims 39 and 48 requires the features of the input and controller.
Kramer et al. (12,083,282) shares a common inventor/assignee with this instant application; however, at this time there does not appear to be double patenting. The closest patent claim appears to be Claims 1 and 21– which positively recites the features of a downstream orientation, a humidifier, a manifold, a user input, a controller, and a display with sensor concerned with fractional concentration of gases. Yet, the patent claim, Claim 20, does not expressly recite the features of the instant independent claims, whereby Claim 33 requires the flow driver, whereby Claims 39 and 48 requires the features of the sensor configured to empirically determine humidity or temperature.
Kramer et al. (12,156,970) shares a common inventor/assignee with this instant application; however, at this time there does not appear to be double patenting. The closest patent claim appears to be Claim 10 – which depends from Claim 1 and positively recites the features of “the manifold comprises a substantially rectangular insert.” Yet, the patent claim, Claim 10 does not expressly recite the features of the instant independent claims, whereby Claim 33 requires the sequential flow path having the ”downstream” orientation and the features of the housing to “support a display configured to receive output from the sensor and, on the housing, display fraction of oxygen information for combined gases flowing through the system”, whereby Claims 39 and 48 requires the features of the input, controller, and display.
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ANNETTE FREDRICKA DIXON
Primary Examiner
Art Unit 3782
/Annette Dixon/Primary Examiner, Art Unit 3785