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 .
Claim Objections
Claim 3 is objected to because of the following informalities: In claim 3, line 2 "the tubes" is suggested to be changed to --the first and second tubes-- to clarify. 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 1-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In claims 1 (line 12) and 12 (line 9), the limitation “the distal end” is unclear if the limitation is referring to the distal end of the tracheal tube or a distal end of the catheter.
All remaining claims are rejected based on their dependency of a rejected base claim.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-3, 5, and 11-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bartlett (2017/0095628) in view of Swartz (2021/0038844) and Sartore (2015/0099934).
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Annotated fig 16B of Bartlett.
With respect to claim 1, Bartlett discloses a system for administering an aerosolized liquid to a respiratory system of a patient (see figs 16A-16B and [0108]), the system comprising a patient interface including a laryngeal mask airway (1601, fig 16B) comprising a tracheal tube (see annotated fig 16B of Bartlett) and a laryngeal cuff (see annotated fig 16B of Bartlett) located at a distal end of the tracheal tube (see annotated fig 16B of Bartlett); an aerosolization device (nebulizer; 1602, fig 16B) comprising a liquid delivery device (external reservoir; see [0108]) configured to deliver a liquid (fluid delivery); a gas flow generator (ventilation air; [0009]) configured to generate a gas flow (ventilation); and including a first lumen (space in tubing 1603, fig 16B) configured to receive the gas flow at the proximal end (see [0108]), a second lumen (space in tubing 1606, fig 16B) configured to receive a flow of the liquid at the proximal end (see [0108]), but lacks the first lumen extends through the second lumen.
However, Swartz teaches a system (10, fig 2A) comprising a catheter (16, fig 2A) having proximal and distal ends (see fig 2D) and including a first lumen (37, fig 3C) configured to receive the gas flow at the proximal end (see [0221]), a second lumen (40, fig 2D and 3C) configured to receive a flow of the liquid at the proximal end (see [0221]), and wherein the first lumen extends through the second lumen (see fig 3C where the first lumen and second lumen extend within one another).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the first and second lumen of Bartlett to intersect one another and include intervening structure as taught by Swartz so as to provide a dual passage of gas and liquid.
Further, the modified Bartlett shows the nebulizer (1602, fig 16B of Bartlett) but is silent regarding a sprayer and a spray tip at the distal end configured to aerosolize the flow of the liquid using the gas flow.
However, Sartore shows a laryngoscope (10, fig 1) with sprayer (50, fig 1) and a spray tip (52, fig 2B) at the distal end of a catheter (distal end 60d of catheter 60 in fig 1) and a gas delivering conduit (80, fig 1).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the distal end of the modified Bartlett to include a sprayer as taught by Sartore so as to atomize the liquid at the end of the catheter to with the gas conduit to facilitate dispersal of medicament from the atomizer (see [0056] of Sartore).
With respect to claim 2, Bartlett discloses the catheter includes a first tube (see annotated fig 16B of Bartlett) forming the first lumen (cavity in the annotated tube), and a second tube (see annotated fig 16B of Bartlett) forming the second lumen (cavity in the annotated tube); the first tube extends through the second tube.
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Annotated fig 3C of Swartz.
With respect to claim 3, the modified Bartlett shows the catheter includes at least one rib extending between the first and second tubes, and along a longitudinal axis of the tubes (after modification by Swartz the first and second tubes are connected by ribs in annotated fig 3C of Swartz).
With respect to claim 5, the modified Bartlett shows the spray tip comprises a sleeve (see sleeve of atomizer 50 in fig 1 of Sartore) attached to a distal end of the second tube (attached at end 60d in fig 1 of Sartore).
With respect to claim 11, Bartlett discloses the liquid delivery device comprises a pump (see [0108]) consisting of a syringe pump (see [0063 and 108]).
With respect to claim 12, Bartlett discloses a method for administering an aerosolized liquid to the respiratory system of a patient using a system (see figs 16A-16B and [0108]), which comprises a patient interface including a laryngeal mask airway (1601, fig 16B) comprising a tracheal tube (see annotated fig 16B of Bartlett) and a laryngeal cuff (see annotated fig 16B of Bartlett) located at a distal end of the tracheal tube (see annotated fig 16B of Bartlett); and an aerosolization device comprising: a liquid delivery device (external reservoir; see [0108]); a gas flow generator (ventilation air; [0009]); and the method comprising inserting the distal end of the tracheal tube into the throat of the patient and positioning the laryngeal cuff in the pharynx of the throat (see fig 7); inserting the distal end of the catheter into the tracheal tube; delivering a gas flow generated by the gas flow generator through the first lumen from the proximal end of the catheter to the spray tip; delivering a flow of a liquid discharged from the liquid delivery device through the second lumen from the proximal end of the catheter to the spray tip; aerosolizing the liquid using the gas flow at the spray tip; and delivering the aerosolized liquid to the respiratory system of the patient through the tracheal tube (see claim 9 for delivering the gas and liquid to the user) but lacks the first lumen extends through the second lumen.
However, Swartz teaches a system (10, fig 2A) comprising a catheter (16, fig 2A) having proximal and distal ends (see fig 2D) and including a first lumen (37, fig 3C) configured to receive the gas flow at the proximal end (see [0221]), a second lumen (40, fig 2D and 3C) configured to receive a flow of the liquid at the proximal end (see [0221]), and wherein the first lumen extends through the second lumen (see fig 3C where the first lumen and second lumen extend within one another).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the first and second lumen of Bartlett to intersect one another and include intervening structure as taught by Swartz so as to provide a dual passage of gas and liquid.
Further, the modified Bartlett shows the nebulizer (1602, fig 16B of Bartlett) but is silent regarding a sprayer and a spray tip at the distal end configured to aerosolize the flow of the liquid using the gas flow.
However, Sartore shows a laryngoscope (10, fig 1) with sprayer (50, fig 1) and a spray tip (52, fig 2B) at the distal end of a catheter (distal end 60d of catheter 60 in fig 1) and a gas delivering conduit (80, fig 1).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the distal end of the modified Bartlett to include a sprayer as taught by Sartore so as to atomize the liquid at the end of the catheter to with the gas conduit to facilitate dispersal of medicament from the atomizer (see [0056] of Sartore).
With respect to claim 13, Bartlett discloses the catheter includes a first tube (see annotated fig 16B of Bartlett) forming the first lumen (cavity in the annotated tube), and a second tube (see annotated fig 16B of Bartlett) forming the second lumen (cavity in the annotated tube); the first tube extends through the second tube.
With respect to claim 14, the modified Bartlett shows the catheter includes at least one rib extending between the first and second tubes, and along a longitudinal axis of the tubes (after modification by Swartz the first and second tubes are connected by ribs in annotated fig 3C of Swartz).
With respect to claim 15, the modified Bartlett shows the spray tip comprises a sleeve (see sleeve of atomizer 50 in fig 1 of Sartore) attached to a distal end of the second tube (attached at end 60d in fig 1 of Sartore).
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bartlett, Swartz, and Sartore as applied to claim 2 above, and further in view of Baran (6,729,334).
With respect to claim 4, the modified Bartlett shows distal ends of the first and second tube (see annotated fig 16B of Bartlett) but lacks the distal end of the first tube is disconnected from the distal end of the second tube, wherein the distal end of the first tube is cantilevered.
However, Baran teaches a nebulizing catheter system (see fig 34) with a first tube (580, fig 34) and a second tube (584, fig 34) both with distal ends (end near spray particulates on right side of fig 34) wherein the distal end of the first tube is disconnected from the distal end of the second tube (see fig 34 and centering device 585 only near attachment of the two tubes), wherein the distal end of the first tube is cantilevered (second tube is not attached to the first tube in fig 34).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the distal ends of the first and second tube to be detached as taught by Baran so as to allow the gas and liquid to freely interact with one another before expelling into the user’s pharynx.
Claim(s) 6-7 and 16-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bartlett, Swartz, and Sartore as applied to claim 2 above, and further in view of Di Capua (8,631,790).
With respect to claims 6 and 16, the modified Bartlett shows all the elements as claimed above but is silent regarding the gas flow generator includes a source of compressed gas; a first valve configured to control a fluidic connection between the source of compressed gas and a first flow pathway connected to the first lumen; and a controller configured to selectively adjust the first valve to a first valve setting, in which the source of compressed gas is fluidically connected to the first flow pathway and the gas flow travels through the first flow pathway to the first lumen, and a second valve setting, in which the source of compressed gas is fluidically disconnected to the first flow pathway and the first lumen.
However, Di Capua teaches a ventilator system (10, fig 1) including a source of compressed gas (122, fig 2A); a first valve (control valve; 104, fig 2A) configured to control a fluidic connection between the source of compressed gas and a first flow pathway connected to a first lumen (see col. 5, lines 46-57); and a controller (electrical control system; 300, fig 4) configured to selectively adjust the first valve to a first valve setting (ON), in which the source of compressed gas is fluidically connected to the first flow pathway (see col. 8, lines 23-64) and the gas flow travels through the first flow pathway to the first lumen (see fig 2A) and a second valve setting (OFF), in which the source of compressed gas is fluidically disconnected to the first flow pathway and the first lumen (see col. 8, lines 23-64).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of the modified Bartlett to include the source of compressed gas and control valves with intervening structure as taught by Di Capua so as to provide automated ventilation to a patient.
With respect to claims 7 and 17, the modified Bartlett shows the first valve is configured to control a fluidic connection between the first flow pathway and atmospheric pressure (see col. 8, lines 37-40 of Di Capua); and the controller is configured to selectively adjust the first valve to a third valve setting, in which the first valve fluidically connects the first flow pathway to atmospheric pressure and the source of compressed gas is disconnected from the first flow pathway (see col. 8, lines 23-64 of Di Capua).
Allowable Subject Matter
Claims 8-10 and 18-20 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KELSEY E BALLER whose telephone number is (571)272-8153. The examiner can normally be reached Monday - Friday 8 AM - 4 PM.
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/KELSEY E BALLER/ Examiner, Art Unit 3785
/TU A VO/ Primary Examiner, Art Unit 3785