CTFR 18/065,056 CTFR 100139 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Claim Rejections - 35 USC § 103 07-06 AIA 15-10-15 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. 07-20-aia AIA 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. 07-23-aia AIA 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. 07-20-02-aia AIA 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. 07-21-aia AIA Claim s 11-15 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Truthan et al. 5,605,147, in view of Horn et al. 4,739,756 Regarding claim 11, Truthan teaches a fluid delivery system for delivery of aerosolized liquid to a ventilated patient (the abstract states “This device allows for the rapid administration of liquid medicants into the lungs of a patient “) comprising: an endotracheal tube configured to deliver breathing gases to a patient (34), the endotracheal tube including: an outlet end positionable inside the patient (Column 3 line 45 states “an endotracheal tube has been passed into the air passageways of a patient”) ; a wall defined by an outer diameter and an inner diameter (The wall of the ETT has an inner and outer diameter as depicted in figure 3) ; and an injection tip (ejection port 28, figure 1) having a set of orifices that (the tip can be 28 as shown, or can include “a "shower head" type end could be integrated to better aerosolize the medicant into the air stream”) , when receiving a pressurized liquid, aerosolize the liquid (Claim 5 states “wherein said ejection port has a plurality of openings to promote aerosolization of said liquid medicant.”) , but fails to teach at least one lumen at least partially contained in the wall and having a lumen outlet at the outlet end of the endotracheal tube; wherein the injection tip is positionable proximate the outlet end of the endotracheal tube in the at least one lumen within the wall. Horn discloses an analogous endotracheal tube that does teach at least one lumen at least partially contained in the wall (First lateral lumen 20, figure 3b) and having a lumen outlet at the outlet end of the endotracheal tube (Figure 2); wherein the injection tip is positionable proximate the outlet end of the endotracheal tube in the at least one lumen within the wall (injection tip is positioned proximate flexible hollow tubing 14). 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 Truthan with the teachings of Horn and include a lumen contained within the wall as it allows for medication to be delivered to the internal lining of the lungs (abstract). Regarding claim 12, modified Truthan teaches the fluid delivery system of claim 11, wherein the set of orifices are sized based on a viscosity of the liquid to be injected (Claim 5 states “said ejection port has a plurality of openings to promote aerosolization of said liquid medicant.” The size of the orifice and its openings would be based on the specific medicament being injected, therefore by default it would be accounting for the viscosity of the liquid). Regarding claim 13, modified Truthan teaches the fluid delivery system of claim 11, wherein the injection tip is a first injection tip and is positioned at a lumen outlet of a first lumen within the wall, and the fluid delivery system comprises a second injection tip positioned at lumen outlet of a second lumen within the wall (Figures 1 and 2 of Horn depicts two separate injection locations with respective lumens located within the wall of the ETT tubing). Regarding claim 14, Truthan teaches the fluid delivery system of claim 11, wherein the injection tip is wherein the injection tip is angled to target one of a left bronchi or a right bronchi (Figure 6). Regarding claim 15, modified Truthan teaches the fluid delivery system of claim 14, wherein the at least one lumen is a first lumen, and wherein the endotracheal tube further includes a second lumen contained in the wall of the endotracheal tube (Figures 1 and 2 of Truthan), wherein a gas is directable through the second lumen to bias a flow of aerosolized liquid from the injection tip (Column 3 line 59 states that tubing 15 carries a secondary air input). Regarding claim 20, modified Truthan teaches the fluid delivery system of claim 11, wherein the wall has a thickness, and the injection tip has a size that is less than or equal to the thickness (Figure 6 of Truthan depicts an injection tip that fits within tubing 13, therefore the injection tip would have to be less than the thickness of the wall of the ETT tubing as hollow tubing 13 leads to the lateral passageway 20 which is within the wall.) . Reasons for Allowance 12-151-07 AIA 07-97 12-51-07 Claim s 1-3 and 16-17 are allowed Regarding claim 1, Truthan teaches a fluid delivery system (The abstract states “This device allows for the rapid administration of liquid medicants into the lungs of a patient”) for delivery of aerosolized liquid to a ventilated patient (Claim 5) comprising: an endotracheal tube configured to deliver breathing gases to a patient (34); a multi-port connector coupled to the endotracheal tube (Ventilator adaption apparatus 10, figure 3), the multi-port connector including: a primary channel directing a flow of the breathing gases into the endotracheal tube (Channel between 16 and 12, figure 1); and a secondary channel having a first end and a second end (Connection 26), wherein the secondary channel is fluidly coupled to the primary channel at the second end at an angle that is 90 degrees or less from the flow of the breathing gases (Figure 2 depicts 26a at an angle of less than 90 degrees); and an injection ti p (ejection port 28, figure 4) configured to engage with the first end of the secondary channel (Shown in figure 4) and a pressure applicator (apparatus 18 has a pressure applicator that gets pressed down to dispense medicament), wherein the injection tip includes a set of orifices configured to aerosolize a liquid (Column 6 line 3 states “Instead of an open end at ejection port 28 or ejection port 28A, a "shower head" type end could be integrated to better aerosolize the medicant into the air stream” The option of a different type of orifice is described) when the liquid is applied at a pressure by the pressure applicator (The abstract states “The liquid medicant is then forced from the syringe and travels thru medication tubing (24) and medication tubing (24A) and expelled at the distal end of endotracheal tube (34) thru ejection port (28)”). Truthan fails to teach, disclose, or render obvious the secondary channel terminating at the primary channel such that the second channel does not extend into the first channel, a rigid body having a first end and a second end a membrane positioned proximate the second end a set of orifices, defined in the membrane , and a bend, between the first end and the second end, at an angle to cause the aerosolized liquid to be dispersed in a same direction as airflow through the primary channel . The prior art of record is mainly failing to teach the orifice membrane system as the orifice of Truthan is a fixed orifice and the injection mechanism does not contain a multiple orifice set. Furthermore, the configuration of the connection 26A does not allow for the liquid to be dispersed in the same direction as the airflow through the primary channel as the type of connection is needed to accommodate the medication tubing. Therefore, as basis of patentability is based on the combination of features disclosed above. 12-151-07 AIA 07-97 12-51-07 Claim s 4-8 and 18 are allowed Regarding claim 4, Novkov teaches a ventilation system comprising: a humidification system (humidifier 218) including: a first pump configured to pressurize water from a water reservoir (Water pump 418, figure 4); a first nozzle configured to atomize the water (Figure 4 depicts hollow cone atomizer 402, while figure 5 depicts this hollow cone atomizer as having a discharge orifice 520) wherein the first nozzle is positioned in a heated portion of a ventilation tubing (Figure 3 depicts the hollow cone atomizer within the heating tube 319) configured to deliver breathing gases to a ventilated patient such that atomized water interacts with the heated portion of the ventilation tubing to humidify the breathing gases (0054 states “The heating tube 319 is positioned directly downstream of the hollow cone atomizer 302, such that water sprayed from the hollow cone atomizer contacts the thermally-conductive material 306 of the heating tube 319. When the thin, hollow cone 323 of small droplets of water from the hollow cone atomizer 302 contacts the heated metal surface of the thermally-conductive material 306, the small droplets of water are immediately vaporized, turning into gaseous water vapor”); a first valve to control the flow of pressurized water from the first pump into the first nozzle (Valve 416); and Novkov fails to teach a fluid delivery system including: a second pump configured to pressurize a liquid from a fluid reservoir; a second nozzle positioned downstream in the line from the first nozzle of the humidification system, wherein the second nozzle is configured to aerosolize the liquid in the humidified breathing gases; a second valve to control the flow of pressurized liquid from the second pump into the second nozzle. Sjoeholm teaches an analogous nebulizer within a ventilatory system that does teach a fluid delivery system (delivers liquid medicament) including: a pump (Figure 2, pump 21) configured to pressurize a liquid from a fluid reservoir (reservoir 26); a nozzle (Nozzle 14), wherein the nozzle is configured to aerosolize the liquid in the humidified breathing gases (nozzle 14 sends the liquid medicament into the inspiratory channel below and aerosolizes it, abstract); a valve to control the flow of pressurized liquid from the pump into the nozzle (two-point valve 22); However, there would not be a motivation to combine both references as it would involve impermissible hindsight as both systems do not involve the other component, furthermore the prior art of record fails to teach, disclose, or render obvious a controller for controlling at least one of the fluid delivery system or the humidification system, wherein the controller is configured to pause delivery of the pressurized water of the humidification system during delivery of the pressurized liquid from the fluid delivery system . 12-151-07 AIA 07-97 12-51-07 Claim s 9-10 and 19 are allowed Regarding claim 9, Truthan teaches a method for delivering liquid into an invasive interface (ETT 34), the method comprising (The abstract states “This device allows for the rapid administration of liquid medicants into the lungs of a patient”): delivering breathing gases into an invasive interface through a primary port (port of ventilation male adaptor 16) and a primary channel of a connector (channel between 16 and 12), wherein the primary channel of the connector is fluidly coupled to a secondary channel of the connector (Figure 2, connection 26a); an injection tip (Figure 4, 28a), and pressurizing the liquid (The syringe injector uses pressure to inject the liquid) and injecting the pressurized liquid into the injection tip to aerosolize the liquid (Claim 5 states “ejection port has a plurality of openings to promote aerosolization of said liquid medicant.”), wherein the injection tip is coupled to a secondary port of the connector such that the aerosolized liquid travels through the secondary channel (Figure 4 depicts injector tip within connecter 26 a) and is carried into the invasive interface by the breathing gases in the primary channel (Claim 7 line 45 states “ejection port has a plurality of openings to promote aerosolization of said liquid medicant.” The breathing gasses would carry the medicament into ETT 34.). Truthan fails to teach based on properties of an injection tip, calculating a cumulative duration for delivery of set volume of a liquid; pressurizing the liquid; and injecting the pressurized liquid, for the cumulative duration. Khaitan discloses an analogous multi-port connector that does teach based on properties of an injection tip (Tip of syringe 1, figure 5), calculating a cumulative duration for delivery of set volume of a liquid (0045 states “the predetermined delivery rate of the syringe can be calculated as: predetermined volume/period of delivery/concentration of the agent”); pressurizing the liquid; and injecting the pressurized liquid, for the cumulative duration (0054 states “the syringe pump operates continuously over a delivery period such that a predetermined amount of the agent is delivered to the aerosolizer in a drop-by-drop manner at a predetermined delivery rate during the delivery period”). The prior art of record fails to teach, disclose, or render obvious the cumulative duration of liquid delivery being based on a set pressure of a liquid against a membrane of the injection tip. Khaitian does not teach this as a property for calculating the duration of liquid delivery and is instead only based on the predetermined volume and the concentration of the agent being delivered. Furthermore, other similar references involving injections only involve needle like syringes and do not involve syringes that include a calculation of liquid delivery, let alone a pressure acting on the membrane being one of the variables that is used, among others. Therefore, a basis of patentability is based on the inclusion of this variable as being able to aid in the calculation of a cumulative delivery, in combination with the other features of the claim. Response to Arguments Applicant’s arguments with respect to claim 11 has 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 07-96 AIA The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Omar et al. 2019/0232006 Rajan et al. 2010/0065062 Kimm et al. 2015/0314092 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. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROHAN DEEP PATEL whose telephone number is (571)270-5538. The examiner can normally be reached Mon - Fri 5:30 AM - 3:00 PM PST. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brandy S Lee can be reached at (571) 2707410. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /ROHAN PATEL/Examiner, Art Unit 3785 /BRANDY S LEE/Supervisory Patent Examiner, Art Unit 3785 Application/Control Number: 18/065,056 Page 2 Art Unit: 3785 Application/Control Number: 18/065,056 Page 3 Art Unit: 3785 Application/Control Number: 18/065,056 Page 4 Art Unit: 3785 Application/Control Number: 18/065,056 Page 5 Art Unit: 3785 Application/Control Number: 18/065,056 Page 6 Art Unit: 3785 Application/Control Number: 18/065,056 Page 7 Art Unit: 3785 Application/Control Number: 18/065,056 Page 8 Art Unit: 3785 Application/Control Number: 18/065,056 Page 9 Art Unit: 3785 Application/Control Number: 18/065,056 Page 10 Art Unit: 3785 Application/Control Number: 18/065,056 Page 11 Art Unit: 3785 Application/Control Number: 18/065,056 Page 12 Art Unit: 3785
Prosecution Insights