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 .
Information Disclosure Statement
The Information Disclosure Statement(s) have been reviewed by the examiner and are found to comply with the provisions of 37 CFR 1.97, 1.98, and MPEP § 609.
Drawings
The drawing(s) have been reviewed by the examiner and are found to comply with the provisions of 37 CFR 1.81 to 1.85.
Claim Objections
Claims 1 and 15, limitation g, are objected to because of the following informalities (emphasis added): the claim should read “at least one of the following: the mask member, and the gas delivery assembly”, “the controller further configured to control”, “and wherein the system is configured to operate”, and “and wherein the system is configured to be connected”. Appropriate correction is required.
Claims 13 and 21 are objected to because of the following informalities: “the piston having a led” should read “the piston having a leg”.
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 15, 25, 27 and dependents therein 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.
With regard to claim 15, the limitation “wherein the vitals sensor system operatively connected to the mask member and comprising one or more sensors configured to measure signals associated with physiological parameters of the subject, wherein physiological parameters comprising: temperature, blood oxygen saturation (SpO2), heart rate, blood pressure, partial pressure of carbon dioxide in the exhaled breath, positive end-expiratory pressure (PEEP), and tidal volume” is an open ended Markush grouping. If a Markush grouping requires a material selected from an open list of alternatives (e.g., selected from the group "comprising" or "consisting essentially of" the recited alternatives), the claim should generally be rejected under 35 U.S.C. 112(b) as indefinite because it is unclear what other alternatives are intended to be encompassed by the claim.
Regarding claim 25, the phrase "may" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claim 27, it is unclear if the auxiliary module is positively required in the claim. The auxiliary module is claimed in the alternative as a part of a Markush grouping, but then the claim later states that the auxiliary module is connected to the controller.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “gas delivery assembly” in claims 1 – 7, 12, 15-17, 19, and 24-27, “system monitoring means” in claims 1 – 27, and a “conduit management assembly” in claims 10 and 23.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
Claim(s) 1 – 3, 5, 8 – 9, 11, 15 – 16, 18, 20, 26 – 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Beck (US 20220313929) in view of Bazoberry (US 20250162712).
1. Beck discloses an emergency ventilating and monitoring system, the system comprising an emergency ventilating and monitoring apparatus (EVMA) (see Fig. 1, [0104], portable ventilator system with sensors), the apparatus comprising: a. a mask member comprising a mask body (see Fig. 1, 110) and a vitals sensor system (114, 116, 118, see Fig. 1, [0104]); wherein the mask body having an inner surface configured for engagement with at least partial facial area of a subject (see Fig. 1, illustrating an inner surface of mask 110 engaged with the patient, see also [0141]), and an opposed outer surface (see Fig. 1, 110 illustrating the opposed outer surface); wherein the mask body includes an inlet portion (see Fig. 1, illustrating the inlet to 108, [0104]); the inlet portion comprising an inlet opening defined by the mask body and extending between the inner and the outer surfaces of the mask body (see Fig. 1, illustrating the inlet to 108, [0104]; the inlet opening must pass through inner and outer surface in order to delivery ventilation to the mask); and wherein the vitals sensor system operatively connected to the mask member and comprising one or more sensors configured to measure signals associated with one or more physiological parameters of the subject (see [0104], sensors 114, 116, 118 are operatively connected to the mask via sensor 116, which measures EtCO2 at the user’s breathing passages, see Fig. 1, [0104], [0109]); b. a gas delivery assembly operatively connected to the inlet portion of the mask body and configured to generate and direct a gas flow with defined ventilation parameters to the inlet portion of the mask body (102, see Fig. 1, [0104], [0106]); c. a controller operatively connected to the gas delivery assembly and the vitals sensor system of the mask member (202, [0111], [0107], [0109]) and configured to receive the signals associated with a plurality of physiological parameters of the patient from the vitals sensor system of the mask member, process the signals, and control the ventilation parameters of the gas delivery assembly based at least partially on the signals associated with at least one of the physiological parameters received from the vitals sensor system of the mask member (see [0109]); d. a user interface operatively connected to the controller, wherein the user interface comprising user alert means and user control means; wherein the user control means configured to receive an input from the user to the controller, and the user alert means configured to provide an output to the user from the controller; and wherein the controller further configured to control the ventilation parameters of the gas delivery assembly based at least partially on the input from the user (see Fig. 1, 120, [0105], [0117]); a PEEP expiration valve operatively connected to the controller and configured to open and close based at least partially on a command received from the controller (see [0017]; the controller of Beck includes closed loop control of positive end-expiratory pressure (PEEP), see [0171]); g. at least one system monitoring means operatively connected to the controller (see [0104], flow/pressure sensors), and to at least one of the following: the mask member, the gas delivery assembly ([0109]); and wherein the means configured to at least send a signal to the controller; and wherein the controller further configured to control the ventilation parameters of the gas delivery assembly and operation of the PEEP expiration valve based at least partially on a signal received from at least one of the system monitoring means (see [0134 – 0138]); and wherein the system configured to operate in a feedback controlled mode [0111]; and wherein the system configured to be connected to a source of power (252, see Fig. 2, [0110]).
However, Beck does not disclose wherein the mask body includes an outlet portion; the outlet portion comprising an outlet opening defined by the mask body and extending between the inner and the outer surfaces of the mask body; e. a one-way inspiration valve operatively connected to the gas delivery assembly and the inlet portion of the mask body and configured to allow the gas flow from the gas delivery assembly to the mask member and to prevent backflow; f. at least one one-way expiration valve operatively connected to the outlet portion of the mask body and configured to allow the gas flow from the mask body to the atmosphere; and wherein the expiration valve operatively connected and configured to open and close based at least partially on a control command; and g. wherein the control command further configured to control operation of the one-way expiration valve based at least partially on a signal received from at least one of the system monitoring means. Nonetheless, Bazoberry discloses wherein the mask body includes an outlet portion; the outlet portion comprising an outlet opening defined by the mask body and extending between the inner and the outer surfaces of the mask body (opening covered by valve 48, see Figs. 1 and 2, [0096 – 0097], where passage of exhaled breath from the output interface through the valve would require an orifice in the mask body, note also general teachings in Figs. 6 and 7); e. a one-way inspiration valve operatively connected to the gas delivery assembly and the inlet portion of the mask body and configured to allow the gas flow from the gas delivery assembly to the mask member and to prevent backflow (see Fig. 1, 30, [0095, 0097]); f. at least one one-way expiration valve operatively connected to the outlet portion of the mask body and configured to allow the gas flow from the mask body to the atmosphere (48, see [0096, 0097], see Fig. 2); and wherein the expiration valve operatively connected and configured to open and close based at least partially on a control command ([0101, 0105, 0110, 0114]; see also Fig. 2 and general teachings in Figs. 6 – 7, illustrating the opening and closing); and g. at least one system monitoring means (e.g. 32, see [0097]; see also [0114]), and wherein the control command further configured to control the ventilation parameters of the gas delivery assembly and operation of the one-way expiration valve based at least partially on a signal received from at least one of the system monitoring means (the valve 48 is controlled to set PEEP at an adjustable level based on sensor input, as discussed in [0110], [0114]). Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to modify the mask of Beck according to the inspiration valve of Bazoberry for the benefit of preventing rebreathing of exhaled gas, see [0095]. It furthermore would have been obvious to a person having ordinary skill in the art at the time the invention was filed to modify the mask and PEEP controller of Beck according to a mask PEEP valve as taught in Bazoberry for the benefit of preventing rebreathing by venting exhaled CO2 on the mask, and controlling PEEP applied to the patient directly at its pressure interface.
2. Beck discloses a system as in claim 1, wherein the one or more physiological parameters comprising at least one physiological parameter selected from the group consisting of: temperature, blood oxygen saturation (SpO2), heart rate, blood pressure, blood glucose level, partial pressure of carbon dioxide in the exhaled breath, positive end-expiratory pressure (PEEP), tidal volume, cardiac function, and combinations thereof (see [104], [0109]).
3. Beck discloses a system as in claim 1, further comprising one or more auxiliary modules operatively connected to the controller and the gas delivery assembly, wherein the one or more auxiliary modules comprising at least one auxiliary module selected from the group consisting of a humidifier, a dehumidifier, an oxygen source, an air/oxygen mixer, a nebulizer, an air heater, and combinations thereof (see [0104], [0135]).
5. Beck as modified discloses a system as in claim 1, wherein the inspiration valve operatively connected to the controller and configured to open and close based at least partially on a command received from the controller (Bazoberry discloses that the inspiration valve is connected to a control command and configured to open and closed based on the control command per [0095]; therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to modify the controller of Beck according to the inspiration valve command of Bazoberry for the benefit of preventing rebreathing of exhaled gas while allowing easy inhaling of ventilation gas when appropriate).
8. Beck discloses a system as in claim 1, wherein the gas delivery assembly comprising a gas delivery unit, wherein the gas delivery unit comprising at least one device selected from the group consisting of: a pump, a blower, a compressible bag, and combinations thereof (see [0318]), and wherein the gas delivery unit having an inlet port and an outlet port (see Fig. 21, ports connected to oxygen/ambient, and port connected to tubing).
9. Beck discloses a system as in claim 8, wherein the gas delivery assembly further comprising a gas conduit configured to direct a gas flow from the gas delivery unit to the inlet portion of the mask body and extending between the gas delivery unit and the inlet portion of the mask body, the gas conduit having a first end and an opposing second end, wherein the first end configured to couple to the inlet portion of the mask body and the second end configured to couple to the outlet port of the gas delivery unit (see Fig. 21, patient circuit tubing).
11. Beck discloses a system as in claim 1, wherein the gas delivery assembly comprising a pump member having an inlet port and an outlet port (see [0318], Fig. 21, ports connected to oxygen/ambient, and port connected to tubing), wherein the gas delivery assembly further comprising a gas conduit configured to direct a gas flow from the pump member to the inlet portion of the mask body and extending between the pump member and the inlet portion of the mask body, the gas conduit having a first end and an opposing second end, wherein the first end configured to couple to the inlet portion of the mask body and the second end configured to couple to the outlet port of the pump member (see Fig. 21, patient circuit tubing).
15. As per claims 1 and 2 above, Beck in view of Bazoberry renders obvious an emergency ventilating and monitoring system, the system comprising an emergency ventilating and monitoring apparatus (EVMA), the apparatus comprising: a. a mask member comprising a mask body and a vitals sensor system; wherein the mask body having an inner surface configured for engagement with at least partial facial area of a subject, and an opposed outer surface; wherein the mask body includes an inlet portion and an outlet portion; the inlet portion comprising an inlet opening defined by the mask body and extending between the inner and the outer surfaces of the mask body, and the outlet portion comprising an outlet opening defined by the mask body and extending between the inner and the outer surfaces of the mask body; and wherein the vitals sensor system operatively connected to the mask member and comprising one or more sensors configured to measure signals associated with physiological parameters of the subject, wherein physiological parameters comprising: temperature, blood oxygen saturation (SpO2), heart rate, blood pressure, partial pressure of carbon dioxide in the exhaled breath, positive end-expiratory pressure (PEEP), and tidal volume; b. a gas delivery assembly operatively connected to the inlet portion of the mask body and configured to generate and direct a gas flow with defined ventilation parameters to the inlet portion of the mask body; c. a controller operatively connected to the gas delivery assembly and the vitals sensor system of the mask member and configured to receive the signals associated with a plurality of physiological parameters of the patient from the vitals sensor system of the mask member, process the signals, and control the ventilation parameters of the gas delivery assembly based at least partially on the signals associated with at least one of the physiological parameters received from the vitals sensor system of the mask member; d. a user interface operatively connected to the controller, wherein the user interface comprising user alert means and user control means; wherein the user control means configured to receive an input from the user to the controller, and the user alert means configured to provide an output to the user from the controller; and wherein the controller further configured to control the ventilation parameters of the gas delivery assembly based at least partially on the input from the user; e. a one-way inspiration valve operatively connected to the gas delivery assembly and the inlet portion of the mask body and configured to allow the gas flow from the gas delivery assembly to the mask member and to prevent backflow; f. at least one one-way expiration valve operatively connected to the outlet portion of the mask body and configured to allow the gas flow from the mask body to the atmosphere; and wherein the expiration valve operatively connected to the controller and configured to open and close based at least partially on a command received from the controller; g. at least one system monitoring means operatively connected to the controller, and to at least one of the following: the mask member, the gas delivery assembly; and wherein the means configured to at least send a signal to the controller; and wherein the controller further configured control the ventilation parameters of the gas delivery assembly and operation of the one-way expiration valve based at least partially on a signal received from at least one of the system monitoring means. and wherein the system configured to operate in a feedback controlled mode; and wherein the system configured to be connected to a source of power (see claims 1 and 2 above).
16. Beck discloses a system as in claim 15, wherein physiological parameters further comprising at least one of the following: blood glucose level, cardiac function, and combinations thereof (see claim 2 above, and note 112(b) to claim 15, wherein the open ended Markush claim may incorporate temperature, blood oxygen saturation, heart rate, etc., but is not necessarily exclusive to said physiological parameters).
18. Beck discloses a system as in claim 15, wherein the gas delivery assembly comprising a gas delivery unit, wherein the gas delivery unit comprising at least one device selected from the group consisting of: a pump, a blower, a compressible bag, and combinations thereof, wherein the gas delivery unit having an inlet port and an outlet port, wherein the gas delivery assembly further comprising a gas conduit configured to direct a gas flow from the gas delivery unit to the inlet portion of the mask body and extending between the gas delivery unit and the inlet portion of the mask body, the gas conduit having a first end and an opposing second end, wherein the first end configured to couple to the inlet portion of the mask body and the second end configured to couple to the outlet port of the gas delivery unit (see claim 11 above).
20. Beck discloses a system as in claim 15, wherein the gas delivery assembly comprising a pump member having an inlet port and an outlet port, wherein the gas delivery assembly further comprising a gas conduit configured to direct a gas flow from the pump member to the inlet portion of the mask body and extending between the pump member and the inlet portion of the mask body, the gas conduit having a first end and an opposing second end, wherein the first end configured to couple to the inlet portion of the mask body and the second end configured to couple to the outlet port of the pump member (see claim 11 above).
26. Beck as modified discloses a system as in claim 15, wherein the inspiration valve operatively connected to the controller and configured to open and close based at least partially on a command received from the controller (see claim 5 above).
27. Beck discloses a system as in claim 15, further comprising at least one of the following: an auxiliary module, supporting module, and combinations thereof, and wherein at least one of the auxiliary modules connected to the controller (see claim 3 above).
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Beck (US 20220313929) in view of Bazoberry (US 20250162712) in view of Archer (US 20110184253).
4. Beck discloses the system as in claim 1, but does not disclose further comprising one or more supporting modules, wherein the one or more supporting modules comprising at least one supporting module selected from the group consisting of an IV fluids warmer, suction pump, body fluids receptacle, a storage unit, a refrigeration unit, and combinations thereof. Archer discloses a ventilator further comprising one or more supporting modules, wherein the one or more supporting modules comprising at least one supporting module selected from the group consisting of an IV fluids warmer, suction pump, body fluids receptacle, a storage unit, a refrigeration unit, and combinations thereof (see [0048 – 49, 0053 – 0054]). Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to modify the system of Beck according to the supporting module(s) of Archer for the benefit of a an “all-in-one” system allowing the first responding medical personnel to treat or sustain life of the patient while awaiting transportation to a hospital.
Claim(s) 6 and 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Beck (US 20220313929) in view of Bazoberry (US 20250162712) in view of Gulley (US 20250325766).
6. Beck discloses a system as in claim 1, but does not disclose wherein the mask member may further comprising fastening means configured to secure the mask body on the head of the subject, and wherein at least one of the sensors of the vitals sensor system operatively connected to at least one of the fastening means. Gulley discloses wherein the mask member may further comprising fastening means configured to secure the mask body on the head of the subject, and wherein at least one of the sensors of the vitals sensor system operatively connected to at least one of the fastening means (see Figs. 15a – 15f, [0500], [0547]). Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to modify the vitals sensor system such as SpO2 sensor of Beck to be located the fastening means of the mask as taught in Gulley for the benefit of attaching both the mask and the sensor(s) simultaneously, see [0439].
25. Beck as modified discloses a system as in claim 15, wherein the mask member may further comprising fastening means configured to secure the mask body on the head of the subject, wherein at least one of the sensors of the vitals sensor system operatively connected to at least one of the fastening means (see claim 6 above).
Claim(s) 7, 17, and 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Beck (US 20220313929) in view of Bazoberry (US 20250162712) in view of Sniadach (US 20030024533).
7. Beck discloses a system as in claim 1, but does not disclose wherein the mask body further comprising at least one of the following: an oxygen port, an auxiliary port. Sniadach discloses wherein the mask body further comprising at least one of the following: an oxygen port, an auxiliary port (see [0002], Fig. 12). Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to modify the mask of Beck according to the oxygen/auxiliary port of Sniadach for the benefit of delivering supplemental oxygen directly to the user when necessary, and furthermore permitting the delivery of still further oxygen should its requirements dramatically increase. Examiner further notes that auxiliary ports may be used for other functions such as connection to sensor(s) for monitoring of the mask.
17. Beck as modified discloses a system as in claim 15, wherein the mask body further comprising at least one of the following: an oxygen port, an auxiliary port, and combination thereof (see claim 7 above).
24. Beck as modified discloses a system as in claim 15, wherein the mask body further comprising at least one of the following: an oxygen port, an auxiliary port, and combination thereof (see claim 7 above).
Claim(s) 10, 12, and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Beck (US 20220313929) in view of Bazoberry (US 20250162712) in view of Sullivan (US 20100229866).
10. Beck discloses a system as in claim 9, but does not disclose wherein the gas delivery assembly further comprising a conduit management assembly configured to at least partially receive at least a portion of the gas conduit. Sullivan discloses a distal end of the conduit for connection with the gas delivery pump further comprising a conduit management assembly configured to at least partially receive at least a portion of the gas conduit (see Fig. 1, [0061]). Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to modify the gas delivery assembly of Beck to include the conduit management assembly of Sullivan for the benefit of adding significantly to the available degrees of freedom of the gas delivery conduit.
12. Beck as modified discloses a system as in claim 11, wherein the gas delivery assembly further comprising a conduit management assembly configured to at least partially receive at least a portion of the gas conduit (see claim 10 above).
19. Beck as modified discloses a system as in claim 15, wherein the gas delivery assembly further comprising a conduit management assembly configured to at least partially receive at least a portion of the gas conduit (see claim 10 above).
Claim(s) 13, 14, 21, and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Beck (US 20220313929) in view of Bazoberry (US 20250162712) in view of Kuypers (US 20220193352).
13. Beck discloses a system as in claim 1, but does not discloses wherein the gas delivery assembly comprising a pump member, wherein the pump member comprising; a jacket, the jacket having an upper portion and a lower portion, wherein the lower portion including an inlet port and the upper portion including an outlet port; the jacket having an inner wall and an outer wall; at least partially open-ended drum positioned within the jacket, the drum having an outer surface and a drum cavity and a drum roof; a gas duct defined by the outer surface of the drum and the inner wall of the jacket; a piston assembly comprising a piston and piston driving means, wherein the piston having a led and a plunger, the leg having a first end and an opposing second end, and wherein the fist end of the leg connected to the plunger and the second end of the leg connected to the piston driving means, and wherein the piston driving means connected to the drum roof and operatively connected to the controller; a gas channel extending between the gas duct and the outlet port. Nonetheless, Kuypers discloses an electronically controlled gas delivery assembly comprising a pump member (see Fig. 9, as well as Figs. 5 – 8), wherein the pump member comprising; a jacket (housing surrounding outlet volute 166), the jacket having an upper portion and a lower portion, wherein the lower portion including an inlet port and the upper portion including an outlet port (upper portion surrounding inlet 117 and lower portion surrounding outlet 112); the jacket having an inner wall and an outer wall (inner and outer surface of the housing surrounding volute 166); at least partially open-ended drum positioned within the jacket (111), the drum having an outer surface and a drum cavity and a drum roof (outside and inside of drum respectively, the drum roof corresponding to platform holding 161/168); a gas duct defined by the outer surface of the drum and the inner wall of the jacket (out volute 166); a piston assembly comprising a piston and piston driving means, wherein the piston having a led and a plunger (114, 113, and 110, respectively, see [0198]), the leg having a first end and an opposing second end, and wherein the fist end of the leg connected to the plunger and the second end of the leg connected to the piston driving means (see Fig. 5), and wherein the piston driving means connected to the drum roof and operatively connected to the controller (see Fig. 5, [0-198]); a gas channel extending between the gas duct and the outlet port (see unlabelled channels between 166 and 112 in Figs. 5 and 7, allowing flow therethrough). Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to modify the pump of Beck according to the electronically controllable piston pump of Kuypers for the benefit of an electrically operable resuscitator for resuscitation of a patient who is not autonomously breathing and/or has never breathed air, see [0010], the resuscitator configured to provide respiratory measures such as tidal volume and PEEP in conjunction with patient breathing.
14. Beck as modified discloses a system as in claim 13, wherein the gas delivery assembly further comprising a gas conduit configured to direct a gas flow from the pump member to the inlet portion of the mask body and extending between the pump member and the inlet portion of the mask body, the gas conduit having a first end and an opposing second end, wherein the first end configured to couple to the inlet portion of the mask body and the second end configured to couple to the outlet port of the pump member (see Fig. 9 of Kuypers as well as Fig. 21 in Beck).
21. Beck as modified discloses a system as in claim 15, wherein the gas delivery assembly comprising a pump member, wherein the pump member comprising; a jacket, the jacket having an upper portion and a lower portion, wherein the lower portion including an inlet port and the upper portion including an outlet port; the jacket having an inner wall and an outer wall; at least partially open-ended drum positioned within the jacket, the drum having an outer surface and a drum cavity and a drum roof; a gas duct defined by the outer surface of the drum and the inner wall of the jacket; a piston assembly comprising a piston and piston driving means, wherein the piston having a led and a plunger, the leg having a first end and an opposing second end, and wherein the fist end of the leg connected to the plunger and the second end of the leg connected to the piston driving means, and wherein the piston driving means connected to the drum roof and operatively connected to the controller; a gas channel extending between the gas duct and the outlet port (see claim 13 above).
22. Beck as modified discloses a system as in claim 21, wherein the gas delivery assembly further comprising a gas conduit configured to direct a gas flow from the pump member to the inlet portion of the mask body and extending between the pump member and the inlet portion of the mask body, the gas conduit having a first end and an opposing second end, wherein the first end configured to couple to the inlet portion of the mask body and the second end configured to couple to the outlet port of the pump member (see claim 14 above).
Claim(s) 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Beck (US 20220313929) in view of Bazoberry (US 20250162712) in view of Kuypers (US 20220193352) in view of Sullivan (US 20100229866).
23. Beck discloses a system as in claim 22, but does not disclose wherein the gas delivery assembly further comprising a conduit management assembly configured to at least partially receive at least a portion of the gas conduit. Sullivan discloses a distal end of the conduit for connection with the gas delivery pump further comprising a conduit management assembly configured to at least partially receive at least a portion of the gas conduit (see Fig. 1, [0061]). Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to modify the gas delivery assembly of Beck to include the conduit management assembly of Sullivan for the benefit of adding significantly to the available degrees of freedom of the gas delivery conduit.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
US 20030000532 – controlled mask exhale valve
US 20120305001 – controlled mask exhale valve
US 20130228181 – controlled mask exhale valve
US 20220040428 – portable ventilator with sensor control
US 20230355905 – portable ventilator with sensor control
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/BRADLEY H PHILIPS/Primary Examiner, Art Unit 3799
