DETAILED ACTION
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 .
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required:
Claim 1: the expiratory circuit being separate from the bellows such that outgoing air moving along the expiratory circuit does not pass through the bellows.
Claim 9: wherein the incoming air is moved through the inspiratory circuit with just the bellows.
Claim 16: moving the outgoing air from the inlet port and along a conduit to a discharge port without moving through the bellows; wherein the incoming air is drawn into the inlet of the ventilator and moved through the outlet port and to the patient with just the bellows.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-2, 4, 6, and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Hewlett et. al 4,176,663, in view of Kuzelka et al. 2022/0143257 and Fisher et al. 2015/0083121
Regarding claim 1, Hewlett teaches a ventilator (abstract) comprising: an inspiratory circuit (Figure 1, 15 to inspiratory tube 32) comprising an inlet (Inlet 14), a bellows (Bellows 16), and an outlet port (outlet port connected to junction member 33); an expiratory circuit (expiratory tube 34) comprising an inlet port (inlet port connected to junction member 33 leading to tube 34), the expiratory circuit being separate from the bellows such that outgoing air moving along the expiratory circuit does not pass through the bellows (Figure 1 depicts the expiratory circuit separate from the inspiratory circuit as the outgoing air exits through valve 30); and the inspiratory circuit being adjustable to control a volume of the breaths (Column 3 line 23 states “This terminates filling of the bellows 16 to determine the maximum volume thereof, and this volume can be made variable by the provision of a suitably adjustable finger 23 if desired.”).
Hewlett fails to teach a discharge port, and a disinfectant chamber positioned downstream from the inlet port and upstream from the discharge port; and wherein the inspiratory circuit being adjustable to control a number of breathes per time period.
Kuzelka teaches an analogous ventilation system that does teach a discharge port within the expiratory system (Figure 1, exit port 120), and a disinfectant chamber positioned downstream from the inlet port and upstream from the discharge port (0038 states “the sterilization system 10 may be a self-contained canister 11 configured to attach within the exit assembly 104 of the ventilator system 2. In one example, the canister 11 is configured to be connected between an exhalation valve 106 and an exit port 120”). It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify Hewlett with the teachings of Kuzelka and include a discharge port, and a disinfectant chamber positioned downstream from the inlet port and upstream from the discharge port for the purpose of sterilizing the exhalation gasses before they are discharged to the atmosphere (0038).
Modified Hewlett still fails to teach wherein the inspiratory circuit is adjustable to control a number of breathes per time period. Fisher discloses an analogous respiratory support apparatus that does teach wherein the inspiratory circuit is adjustable to control a number of breathes per time period (0114 states “the portable life support system comprises a volume controlled ventilator that provides control of respiratory rate, tidal (breath) volume”, and this is done through the bellows as described in 0117.). It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify modified Hewlett with the teachings of Fisher and include wherein the inspiratory circuit is adjustable to control a number of breathes per time period as this allows for an optimal breathing rate to be delivered to the patient.
Regarding claim 2, modified Hewlett the ventilator of claim 1, further comprising a control module (0146 of Fisher states that “that a dedicated control board may be allocated for machine intelligence related to ventilator controls “) configured to control the number of breathes per time period that are output from the inspiratory circuit through the outlet port and the volume of the breaths (0114 of Fisher states that “the portable life support system comprises a volume controlled ventilator that provides control of respiratory rate, tidal (breath) volume, and delivered oxygen concentration”).
Regarding claim 4, modified Hewlett teaches the ventilator of claim 1, wherein the disinfectant chamber comprises a light source that emits UV light (0020 of Kuzelka states “UVC module 4d is positioned in the exhalation flow assembly 104, and in the particular example between the exhalation valve 106 and the scavenging system 110.” 0022 discusses the use of UV lighting in further detail.).
Regarding claim 6, Hewlett teaches the ventilator of claim 1, further comprising an arm (Figure 1 of Hewlett, arm 17) that is adjustable to control an extent of a size of the bellows in an expanded configuration to control the volume of the breaths (Column 3 line 23 states “This terminates filling of the bellows 16 to determine the maximum volume thereof, and this volume can be made variable by the provision of a suitably adjustable finger 23 if desired.”).
Regarding claim 8, modified Hewlett teaches the ventilator of claim 1, further comprising a housing that extends around and protects the inspiratory and expiratory circuits (Figure 15 of Fisher illustrates a housing covering the circuits within the ventilator), the housing comprising a front face with the outlet port of the inspiratory circuit and the inlet port of the expiratory circuit each positioned along the front face (219 and 235 are located on the face). It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to further modify modified Hewlett with the housing configuration as seen in Fisher as it provides a structure to house and protect the inspiratory and expiratory circuits of the ventilator.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over modified Hewlett, in view of Haj-Yahya et al. 2005/0098177
Regarding claim 3, modified Hewlett discloses the ventilator of claim 2, but fails to teach wherein the control module prevents the inspiratory circuit from moving air out of the outlet port concurrently with the expiratory circuit moving air from the patient into the inlet port. Haj-Yahya discloses an analogous ventilator valve assembly that does teach wherein the control module prevents the inspiratory circuit from moving air out of the outlet port concurrently with the expiratory circuit moving air from the patient into the inlet port (0012 states that “When control pressure is applied to chamber 212 above the diaphragm exceeds the pressure in inlet port 202, diaphragm 210 is held against valve seat 214, preventing exhalation flow from inlet port 202 to outlet port 204. When the control pressure is removed or sufficiently reduced, diaphragm 210 may be lifted from valve seat 214 by patient expiration pressure, allowing exhalation flow.”). It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to further modify modified Hewlett with the teachings of Haj-Yahya to include wherein the control module prevents the inspiratory circuit from moving air out of the outlet port concurrently with the expiratory circuit moving air from the patient into the inlet port as this prevents gas in the exhalation tube from circulating back towards the patient (0003).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over modified Hewlett, in view of Fumagalli et al. 3,818,806
Regarding claim 5, modified Hewlett discloses the ventilator of claim 1, and a bellows located in the inspiratory path that are used to move incoming air (Figure 1 of Hewlett), but fails to teach further comprising a rotating cam and a cam follower that rides along the cam and is operatively connected to the bellows to move the bellows between a contracted configuration and an expanded configuration. Fumagalli discloses an analogous pumping device for patient’s breathing that does teach further comprising a rotating cam (Figure 1, camming surface 102) and a cam follower that rides along the cam (Cam follower 100) and is operatively connected to the bellows (Block 78 connects the cam and follower setup to flange 36 which is connected to the bellow 10) to move the bellows between a contracted configuration and an expanded configuration (Figure 3 depicts the bellow moving to an expanded configuration due to the movement of the cam and follower setup). It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the bellows in modified Hewlett with the teachings of Fumagalli to include further comprising a rotating cam and a cam follower that rides along the cam and is operatively connected to the bellows to move the bellows between a contracted configuration and an expanded configuration in order to move incoming air through the inspiratory circuit as the inclusion of the cam and follower setup allows for a bellows that can reciprocate between a minimum and a maximum volume (abstract).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over modified Hewlett, in view of Friedman et al. 4,060,077
Regarding claim 7, modified Hewlett discloses the ventilator of claim 1, but fails to teach further comprising an alarm configured to emit an alarm when the bellows falls below a predetermined size. Friedman discloses an analogous respirator that does teach further comprising an alarm configured to emit an alarm when the bellows falls below a predetermined size (Figure 4 depicts an arm 40 which is connected to the end of the bellows 22. The arm includes a potentiometer which “Controls the monitoring, recording and alarm system exemplified in FIG. 5, primarily as a function of the volume of air received and discharged by the bellows in each full cycle.” As stated in column 2 line 62 it further states that “The circuit 43 is connected to the relay coil 44 which is adjusted to close the switch 45 if the integrated volume signal falls below a predetermined value, the visual or audible alarm A being thus set off.”) It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the bellows of modified Hewlett with the teachings of Friedman to include further comprising an alarm configured to emit an alarm when the bellows falls below a predetermined size as the use of an alarm allows for the attending medical personnel to be notified of a loss of volume of air being provided.
Claims 9 and 12-15 are rejected under 35 U.S.C. 103 as being unpatentable over Hewlett, in view of Fumagalli and Kuzelka
Regarding claim 9, Hewlett teaches a ventilator (abstract) comprising: an inspiratory circuit (Figure 1, 15 to inspiratory tube 32) comprising: an inspiratory inlet port to receive incoming air from an environment (Column 3 line 14 states “The inlet 14 is connected by a pipe 20 to a flow-controllable gas source 21.”); bellows positioned downstream from the inspiratory inlet port (bellows 16 is located after inlet 14) and movable between an expanded configuration and a contracted configuration (Column 3 line 31 states “the bellows expand and contract”); and an outlet port positioned downstream from the bellows to deliver the incoming air to a patient (outlet port connected to junction member 33); an expiratory circuit (expiratory tube 34) comprising: an expiratory inlet port to receive outgoing air that is exhaled from the patient (inlet port connected to junction member 33 leading to tube 34); and a control module comprising: a lever (Figure 1 of Hewlett, arm 17) that contacts against the bellows to control a size of the bellows in the expanded configuration to control an amount of the incoming air in each of the breaths (Column 3 line 23 states “This terminates filling of the bellows 16 to determine the maximum volume thereof, and this volume can be made variable by the provision of a suitably adjustable finger 23 if desired.”); wherein the incoming air is moved through the inspiratory circuit with just the bellows (The bellows 16 is the only device providing the movement of the incoming gas source through 21).
Hewlett fails to teach a discharge port to discharge the outgoing air and a cam to drive the bellows to adjust a number of breathes supplied to the patient;
Fumagalli does disclose a device with a bellow that does teach a cam to drive the bellows to adjust a number of breathes supplied to the patient (Cam surface 102, figure 1, Figures 1 and 3 show the contraction and expansion of the bellows, further more column 3 line 34 states “As the cam shaft continues to rotate the valves are returned to the position of FIG. 1, permitting air to flow again into the lungs through valve 13 and catheter 10, while the bellows is emptied through valve 11. The opening and closing of the bellows actuates the potentiometer 41 such that the indicated volume of respired air is recorded on the recorder 42 where it can be observed and correction made in the rate of supply, if necessary. When a proper rate has been determined upon, further adjustments need not be made unless a change in condition is shown by the alarm system or the need for variation is clinically indicated.”). It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the bellows of Hewlett with the teachings of Fumagalli to include a cam to drive the bellows to adjust a number of breathes supplied to the patient as this allows for an optimal breathing rate to be delivered to the patient.
Modified Hewlett still fails to teach a discharge port to discharge the outgoing air. Kuzelka does disclose a discharge port in the expiratory circuit that does discharge outgoing air (exit port 120, figure 1). It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify modified Hewlett with the teachings of Kuzelka and include a discharge port in the expiratory circuit for the purpose of venting exhalation gases from the patient to the atmosphere (0040).
Regarding claim 12, modified Hewlett teaches the ventilator of claim 9, wherein the expiratory circuit comprises a disinfectant chamber positioned downstream from the expiratory inlet port and upstream from the discharge port (0038 of Kuzelka states “the sterilization system 10 may be a self-contained canister 11 configured to attach within the exit assembly 104 of the ventilator system 2. In one example, the canister 11 is configured to be connected between an exhalation valve 106 and an exit port 120”), the disinfectant chamber comprising a light source that emits UV light (0020 of Kuzelka states “UVC module 4d is positioned in the exhalation flow assembly 104, and in the particular example between the exhalation valve 106 and the scavenging system 110.” 0022 discusses the use of UV lighting in further detail.). It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to further modify modified Fumagalli and include a disinfectant chamber comprising a UVC light source between the inlet and discharge port as this allows for a sterilization of gasses before they are released to the atmosphere (0038).
Regarding claim 13, Modified Hewlett teaches the ventilator of claim 9, and a bellows located in the inspiratory path that are used to move incoming air (Figure 1 of Hewlett). Fumagalli does further teach a cam follower that rides along the cam (Cam follower 100) and is operatively connected to the bellows (Block 78 connects the cam and follower setup to flange 36 which is connected to the bellow 10) to move the bellows between a contracted configuration and an expanded configuration (Figure 3 of Fumagalli depicts the bellow moving to an expanded configuration due to the movement of the cam and follower setup). It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to further modify modified Hewlett to include a cam follower that rides along the cam and is operatively connected to the bellows to move the bellows between a contracted configuration and an expanded configuration as the inclusion of the cam and follower setup allows for a bellows that can reciprocate between a minimum and a maximum volume (abstract).
Regarding claim 14, modified Hewlett teaches the ventilator of claim 13, further comprising an arm that is positioned adjacent to the bellows to contact against the bellows (Figure 1 of Hewlett, arm 17) to control a size of the bellows in the expanded configuration to control the volume of the breaths (Column 3 line 23 states “This terminates filling of the bellows 16 to determine the maximum volume thereof, and this volume can be made variable by the provision of a suitably adjustable finger 23 if desired.”).
Regarding claim 15, modified Hewlett teaches the ventilator of claim 1, but fails to teach a housing that extends around and protects the inspiratory and expiratory circuits, the housing comprising a front face with the outlet port of the inspiratory circuit and the expiratory inlet port of the expiratory circuit each positioned along the front face. Fisher does teach a housing that extends around and protects the inspiratory and expiratory circuits (Figure 15 of Fisher illustrates a housing covering the circuits within the ventilator), the housing comprising a front face with the outlet port of the inspiratory circuit and the inlet port of the expiratory circuit each positioned along the front face (219 and 235 are located on the face). It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to further modify modified Hewlett with the housing configuration as seen in Fisher as it provides a structure to house and protect the inspiratory and expiratory circuits of the ventilator.
Claims 10 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over modified Hewlett, further in view of Friedman
Regarding claim 10, modified Hewlett teaches the ventilator of claim 9, but fails to teach further comprising an alarm that sounds an audible signal when the bellows contracts to a size that is smaller than a predetermined amount. Friedman does teach further comprising an alarm (potentiometer 41) that sounds an audible signal when the bellows contracts to a size that is smaller than a predetermined amount (Column 3 line 9 states that “if the integrated volume signal falls below a predetermined value, the visual or audible alarm A being thus set off”). It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to further modify modified Hewlett with the teachings of Friedman to include further comprising an alarm that sounds an audible signal when the bellows contracts to a size that is smaller than a predetermined amount as the use of an audible alarm allows for the attending medical personnel to be notified of a loss of volume of air being provided.
Regarding claim 11, modified Hewlett in view of Friedman teaches the ventilator of claim 10. Friedman further teaches wherein the alarm comprises an arm that is pivotally mounted and contacts against the bellows (Figure 4 depicts an arm 40 which is connected to the end of the bellows 22 and mounted onto cam shaft 17. The arm includes a potentiometer which “Controls the monitoring, recording and alarm system exemplified in FIG. 5, primarily as a function of the volume of air received and discharged by the bellows in each full cycle.”). It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to further modify modified Hewlett with the teachings of Friedman to include wherein the alarm comprises an arm that is pivotally mounted and contacts against the bellows as the arm allows for the potentiometer to make a reading based on the movement of the arm (Column 3 line 1).
Claims 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over Fisher2 (from now on referred to as Duffin) et al. 2015/0059744, in view of Kuzelka and Manley et al. 4,067,328
Regarding claim 16, Duffin teaches a method of supplying incoming air to a patient (0088 states “the ventilator 12 is a device or machine that minimally maintains a flow of air to the patient.”), the method comprising: expanding a bellows and in response drawing the incoming air into an inlet of a ventilator (0092 states “Expansion of bellows 26 draws in fresh air from the atmosphere through fresh gas in line 18”); contracting the bellows and in response moving the incoming air that has been drawn into the ventilator out through an outlet port and to the patient (0092 states “Blower 27 applies pressure against bellows 26, compressing the gas and forcing or pushing it into breathing circuit 16 for inhalation by the patient.” The outlet port is located within the y-piece 14 leading to the patient as depicted in figure 5) receiving outgoing air that is exhaled from the patient through an inlet port (0026 states “the breathing circuit includes a carbon dioxide scrubber and a separate expiratory limb for receiving gas exhaled by the subject” Inlet port contained with Y-piece 14 leading to the expiratory tube); moving the outgoing air from the inlet port and along a conduit (expiratory limb 19e) to a discharge port without moving through the bellows (0164 states “The exhaled air less the anesthetic gas passes through reflector 70 and vents to atmosphere through vent tube 74 and mushroom valve 35.” When exhaled air travels through vent tube 74 and out valve 35, it will not make contact with the bellows as depicted in figure 5); wherein the incoming air is drawn into the inlet of the ventilator and moved through the outlet port and to the patient with just the bellows (0092 states “Expansion of bellows 26 draws in fresh air from the atmosphere through fresh gas in line 18. Blower 27 applies pressure against bellows 26, compressing the gas and forcing or pushing it into breathing circuit 16 for inhalation by the patient.”).
Duffin fails to teach disinfecting the outgoing air prior to moving the outgoing air through the discharge port; controlling a speed at which the bellows expands and contracts and controlling a number of breaths of the incoming air that are supplied to the patient through the outlet port; controlling a size of the bellows in an expanded configuration and controlling an amount of the incoming air that is supplied to the patient in each of the breaths;
Kuzelka does teach disinfecting the outgoing air prior to moving the outgoing air through the discharge port (0038 states “the sterilization system 10 may be a self-contained canister 11 configured to attach within the exit assembly 104 of the ventilator system 2. In one example, the canister 11 is configured to be connected between an exhalation valve 106 and an exit port 120”); It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify Duffin with the teachings of Kuzelka and include a disinfectant chamber to disinfectant the outgoing air as this allows for a sterilization of gasses before they are released to the atmosphere (0038).
Modified Duffin still fails to teach controlling a speed at which the bellows expands and contracts and controlling a number of breaths of the incoming air that are supplied to the patient through the outlet port; controlling a size of the bellows in an expanded configuration and controlling an amount of the incoming air that is supplied to the patient in each of the breaths; Manley discloses an analogous lung ventilator that does teach controlling a speed at which the bellows expands and contracts and controlling a number of breaths of the incoming air that are supplied to the patient through the outlet port (Column 2 line 25 states “and control 76 controls the inspiratory flow i.e. it determines the rate at which he bellows 10 collapse under the effect of biassing springs 30 to force gas into the patient's lungs.”); controlling a size of the bellows in an expanded configuration and controlling an amount of the incoming air that is supplied to the patient in each of the breaths (Column 1 line 54 states “moving on scale 16 is a pointer 18 which can be secured to the scale and of which the position determines the particular tidal volume which the bellows 10 can deliver during the inspiratory phase of the respiratory cycle.”); It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify modified Duffin with the teachings of Manley and include controlling a speed at which the bellows expands and contracts and controlling a number of breaths of the incoming air that are supplied to the patient through the outlet port; controlling a size of the bellows in an expanded configuration and controlling an amount of the incoming air that is supplied to the patient in each of the breaths as this allows for the physician to provide an optimal treatment for the patient.
Regarding claim 17, Duffin teaches the method of claim 16, further comprising supplying the incoming air to the patient and simultaneously receiving outgoing air that is exhaled from the patient through the inlet port (Figure 5 of Duffin depicts a y-piece in 14, due to the structure of the y-piece connecting to two separate inspiratory and expiratory circuits, air would simultaneously be supplied through the inlet of the y-piece while the outlet of the y-piece receives the exhaled air.).
Regarding claim 18, modified Duffin teaches the method of claim 16, further comprising adjusting an arm that is positioned adjacent to the bellows (lever 12 of Manley) and controlling the size of the bellows in the expanded configuration (Column1 line 52 of Manley states “Attached to the outer end of lever 12 is an arcuate scale 16 calibrated over a range of tidal volumes. Moving on scale 16 is a pointer 18 which can be secured to the scale and of which the position determines the particular tidal volume which the bellows 10 can deliver during the inspiratory phase of the respiratory cycle”).
Regarding claim 19, modified Duffin teaches the ventilator of claim 1, wherein the inlet of the inspiratory circuit is the only inlet in the inspiratory circuit (Figure 5 of Duffin depicts the only inlet of the inspiratory circuit as being inlet port 18).
Regarding claim 20, modified Duffin teaches the method of claim 16, further comprising drawing the incoming air that is delivered to the patient through the outlet port from just the inlet (0092 of Duffin states “Expansion of bellows 26 draws in fresh air from the atmosphere through fresh gas in line 18.”).
Response to Arguments
Applicant’s arguments with respect to claims 1, 9, and 16 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/ROHAN PATEL/ Examiner, Art Unit 3785
/BRANDY S LEE/ Supervisory Patent Examiner, Art Unit 3785
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