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 .
Response to Amendment
The following section is in reference to the Applicant’s Amendments, filed April 27, 2026. The Applicant’s election without traverse of Group I, Claims 1 and partially 6-11, has been acknowledged. Claims 2-5 have been withdrawn.
Claim Objections
Claims 1, 6, and 8 are objected to because of the following informalities:
Claim 1: “wherein the nebulizer is not removed” should read “wherein the nebulizer is configured not to be removed”.
The clause should be amended so as to avoid possible recitation as a method step within an apparatus claim.
Claim 6: “to the nebulizer (via air supply tube 174)” should read “to the nebulizer (via an air supply tube (174))”.
Reference characters corresponding to elements recited in the detailed description of the drawings and used in conjunction with the recitation of the same element or group of elements in the claims should be enclosed within parentheses so as to avoid confusion with other numbers or characters which may appear in the claims. See MPEP § 608.01(m).
Claim 8: “wherein the nebulizer is placed near the ventilator” should read “wherein the nebulizer is configured to be placed near the ventilator”
The clause should be amended so as to avoid possible recitation as a method step within an apparatus claim.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1 and 6-8 are rejected under 35 U.S.C. 102(a) as being anticipated by Smaldone et al. (WO 2019236899 A1, hereinafter "Smaldone").
Regarding Claim 1, Smaldone discloses: A breathing circuit apparatus (Annotated Figure 5, ventilator circuit apparatus 100) for the administration of nebulized drugs through an endotracheal or tracheostomy tube to a patient on a mechanical ventilator that provides breathing gases for inhalation by the patient (Paragraph 0002, This invention pertains to the administration of nebulized drugs to patients connected to a mechanical ventilator breathing circuit), comprising:
a mechanical ventilator with an inspiratory output port (Annotated Figure 5, inspiratory output port 103) and expiratory input port (Annotated Figure 5, expiratory output port 104), (Paragraph 0011, a ventilator circuit apparatus is provided for the administration of nebulized drugs through an endotracheal tube to a patient on a mechanical ventilator that controls breathing gases to the patient. The apparatus has a breathing circuit with an inspiratory limb and exhalation limb connected to the ventilator);
an inspiratory limb (Annotated Figure 5, inspiratory limb 107) with a first end connected via a Y connector (Annotated Figure 5, Y-connector 127) to an endotracheal tube intubated into a patient, and a second end connected to the inspiratory output port of the ventilator (Paragraph 0035, In an embodiment, nebulizer 101 , as discussed herein, produces an aerosol (when active) that is shunted through a T-fitting 106 to the inspiratory line 107 and the endotracheal tube 108 positioned downstream of the inspiratory line 107 where it is inhaled by the patient 110.);
an expiratory limb (Annotated Figure 5, expiratory limb 119) with a first end connected via the Y connector to an endotracheal or tracheostomy tube intubated into a patient, and a second end is connected to the expiratory input port of the ventilator (Paragraph 0034, The breathing tube 108 would connect to the endotracheal tube. For experimental purposes, a simulated lung 110 may be used, and various measurement devices (111 and 112) may be used (discussed below). An expiratory line (limb) 119 is also attached to the breathing tube 108 through Y-connector 127 conducting the exhaled air to the ventilator expiratory input port 104);
a breath-enhanced jet nebulizer (Paragraph 0026, the nebulizer is a jet nebulizer that nebulizes drug solutions by shear forces from a compressed air supply to the nebulizer jet), (Paragraph 0016, the present invention uses breath-enhanced nebulizers) and humidifier forming part of the inspiratory limb (Paragraph 0033, a humidifier 121 or heat and moisture exchanger (HME) (125, Figs. 3-5) on the inspiratory limb interposed between the nebulizer and the breathing tube 108, which in turn is in fluid communication with the endotracheal tube intubated in a patient),
wherein the nebulizer has an input port and an output port, wherein the input port is connected to the inspiratory output port of the ventilator (Paragraph 0012, a ventilator circuit comprising a T-fitting with three connections, wherein a first connection to the T-fitting is connected to the inspiratory tube […] wherein the input port of the nebulizer is connected to a three-way valve […] and wherein a third connection of the three-way valve is connected to an inspiratory output of the mechanical ventilator)
and wherein the output port of the nebulizer is connected to the input port of a humidifier, and the output port of the humidifier is connected to the Y connector (Paragraph 0012, a ventilator circuit comprising a T-fitting with three connections, wherein a first connection to the T-fitting is connected to the inspiratory tube, wherein a second connection of the T-fitting is connected to the output port of a humidifier […] and wherein a second connection of the three-way valve is connected to the input port of the humidifier, and wherein a third connection of the three-way valve is connected to an inspiratory output of the mechanical ventilator);
wherein all inspiratory breathing gases pass through the nebulizer (Paragraph 0032, the entire mass of breathing gases in the inspiratory tract passes through the nebulizer when the nebulizer is active), (Paragraph 0033, all breathing gases to the patient flow through the ventilator circuit);
wherein a drug solution in the nebulizer, if present, is nebulized to administer the drug as a nebulized drug inhaled by the patient (Paragraph 0026, In an embodiment, part of the circuit is a nebulizer, which nebulizes a drug solution for inhalation of the drug by a patient. In an embodiment, the nebulizer is a jet nebulizer that nebulizes drug solutions by shear forces from a compressed air supply to the nebulizer jet);
wherein the nebulizer is not removed from the breathing circuit while the patient is breathing with the breathing circuit apparatus (Paragraph 0033, a nebulizer 101 on the inspiratory limb interposed between a T-fitting and a three-way valve such that the nebulizer can be removed from the inspiratory limb without interrupting the flow of breathing gases to the patient).
PNG
media_image1.png
908
1325
media_image1.png
Greyscale
[Smaldone, Annotated Figure 5]
Regarding Claim 6, Smaldone discloses all of the limitations of Claim 1. Smaldone further discloses: wherein an air pressure sensor (Annotated Figure 5, pressure sensor 114) is positioned on the inspiratory limb (Paragraph 0036, a pressure sensor 114 interposed between the nebulizer 101 and the ventilator 102 wherein the pressure sensor controls a pressurized air supply 117 to the nebulizer required for nebulization to occur, such that nebulization only occurs during a pressure increase on the inspiratory limb caused by an increase in air pressure from the ventilator to force an inhalation by the patient),
wherein the pressure sensor is in electronic communication with a solenoid valve that toggles compressed air to the nebulizer via air supply tube (Paragraph 0036, pressure sensor 114 is in electronic communication with solenoid valve 116 via electrical connection 115 that toggles the supply of compressed air 117 on and off. When the pressure at 114 increases, signaling an inhalation phase of the breathing cycle, pressure sensor 114 activates solenoid 116 to toggle on, supplying compressed air 117 to nebulizer 101 via nebulizer air supply line 118, which causes nebulization to start),
wherein the compressed air causes a drug solution in the nebulizer to be nebulized for administration to the patient (Paragraph 0026, the nebulizer is a jet nebulizer that nebulizes drug solutions by shear forces from a compressed air supply to the nebulizer jet), such that nebulization is toggled on and is active only when the patient is in the inhalation portion of a breathing cycle (Paragraph 0036, When the ventilator reduces the air pressure at port 103, pressure sensor 114 detects that the inhalation phase has stopped, and solenoid valve 116 toggles off stopping the compressed air to nebulizer 101 , which stops nebulization).
Regarding Claim 7, Smaldone discloses all of the limitations of Claim 1. Smaldone further discloses: wherein an air pressure sensor (Annotated Figure 5, pressure sensor 114) is positioned on the inspiratory limb, wherein the pressure sensor is interposed between the ventilator and the nebulizer input port (Paragraph 0030, the pressure sensor is placed on a tube in fluid communication with the inspiratory outlet of the mechanical ventilator. When the ventilator causes the patient to inhale by increasing the air pressure at the inspiratory outlet, the pressure sensor detects this increase and switches on a nebulizer air flow to the nebulizer, which drives the jet nebulizer and causes nebulization to occur).
Regarding Claim 8, Smaldone discloses all of the limitations of Claim ##. Smaldone further discloses: wherein the nebulizer is placed near the ventilator to reduce the effect of the duty cycle on expiratory losses (Paragraph 0009, The present invention describes a novel ventilator circuit that minimizes the influences of duty cycle or the inhalation-exhalation (l/E) ratio, bias flow, and humidification by utilizing a design that results in aerosol generation primarily during inspiration (breath enhancement) and minimizes expiratory losses (breath-actuation). The circuit facilitates control of supplemental humidification and functions independently of the brand of the ventilator).
Claim Rejections - 35 USC § 103
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.
Claims 9 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Smaldone (WO 2019236899 A1) in view of Smaldone et al. (WO 2019236896 A1, hereinafter “Inspirx”).
Regarding Claim 9, Smaldone discloses all of the limitations of Claim 1. Smaldone further discloses: wherein the jet nebulizer permanently resides in the circuit during a course of treatment (Paragraph 0033, a nebulizer 101 on the inspiratory limb interposed between a T-fitting and a three-way valve such that the nebulizer can be removed from the inspiratory limb without interrupting the flow of breathing gases to the patient)
Inspirx does disclose: and wherein an inlet port on the nebulizer allows a drug solution to be added to the nebulizer without breaking the circuit, disconnecting the nebulizer, or disassembling the nebulizer (Paragraph 0038, Also shown in Fig. 3 are liquid inlet port 210 and markings 116 on the exterior of the nebulizer that assist technicians in filing the nebulizer with the drug solution), (Paragraph 0058, a port (210 in the Figures) may be provided to allow a nebulizable drug solution to be added to the drug solution reservoir continuously. For certain drugs such as antibiotics, bronchodilators, and vasoactive drugs, this treatment mode may be desirable. The capacity of the drug reservoir is normally 6 ml and is typically charged with 3 ml or 6 ml of a drug solution. In continuous mode, about 0.5-3 ml of drug solution will be maintained in the reservoir at all times, by continuously adding drug solution through port 210).
It would have been obvious to one skilled in the art before the effective filing date to incorporate the teachings of Inspirx’s inlet port, so as to provide ease and consistency in drug administration within the ventilator and nebulizer system disclosed by Smaldone. The inlet port does not interfere with the nebulizer’s overall functionality, thus preventing any pauses or breaks in respiratory treatment for a patient.
Regarding Claim 10, Smaldone discloses all of the limitations of Claim 1. Smaldone discloses wherein the nebulizer produces aerosol particles (Paragraph 0035, nebulizer 101, as discussed herein, produces an aerosol (when active) that is shunted through a T-fitting 106 to the inspiratory line 107 and the endotracheal tube 108 positioned downstream of the inspiratory line 107), but is silent regarding the size of the aerosol particles produced by the nebulizer.
Inspirx more explicitly discloses: wherein the nebulizer produces aerosol particles with a mass median aerodynamic diameter of about 2 µm (Paragraph 0039, the nebulizer in this invention is a jet nebulizer, in which a Venturi effect from a flow of air over a liquid channel in fluid communication with a reservoir of a solution of a drug draws the solution through the tube. When the liquid from the drug solution exits the draw tube, it is atomized (also termed aerosolized or nebulized) by shear forces from the air flow. A baffle may be present to help break up large particles. Ideally, aerosol droplets for inhalation of a drug are in the 2-10 μm size range. Larger droplets tend to stick to the apparatus or mouth and throat of the patient, which is undesirable and causes drug loss)
It would have been obvious to one skilled in the art before the effective filing date to incorporate the teachings of Inspirx’s baffle arrangement with the nebulizer taught by Smaldone, so as to provide a range of aerosol sizes that are more comfortable for a user and also more effective for drug administration.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Smaldone (WO 2019236899 A1) in view of Mazela et al. (US 20140158123 A1, hereinafter “Mazela”).
Regarding Claim 11, Smaldone discloses all of the limitations of Claim 1. Smaldone further discloses: an inspiratory limb and humidifier (Paragraph 0033, The apparatus has a breathing circuit with an inspiratory limb 107 and exhalation limb 119 connected to the ventilator 102; a nebulizer 101 on the inspiratory limb interposed between a T-fitting and a three-way valve such that the nebulizer can be removed from the inspiratory limb without interrupting the flow of breathing gases to the patient; and a humidifier 121 or heat and moisture exchanger (HME) (125, Figs. 3-5) on the inspiratory limb interposed between the nebulizer and the breathing tube 108, which in turn is in fluid communication with the endotracheal tube intubated in a patient), and a breathing circuit apparatus that reduce expiratory losses (Paragraph 0009, The present invention describes a novel ventilator circuit that minimizes the influences of duty cycle or the inhalation-exhalation (l/E) ratio, bias flow, and humidification by utilizing a design that results in aerosol generation primarily during inspiration (breath enhancement) and minimizes expiratory losses (breath-actuation). The circuit facilitates control of supplemental humidification and functions independently of the brand of the ventilator).
Though Smaldone does not explicitly disclose: wherein the inspiratory limb and humidifier, if present, acts as an aerosol storage reservoir to reduce expiratory losses, the location of the nebulizer near the ventilator allows the inspiratory limb to act as a reservoir, as disclosed in the Specification of the present disclose (Paragraph 0005, Locating the nebulizer near the ventilator outflow port may increase aerosol delivery because the inspiratory limb may act as a reservoir reducing aerosol lost during exhalation). Smaldone teaches an analogous arrangement, that would thus be capable of achieving the same functionality described by the Applicant.
If the Applicant is not convinced, Mazela does disclose: an aerosol storage reservoir to reduce expiratory losses (Paragraph 0092, The aerosol tube can be equipped with an optional expandable aerosol reservoir (not shown). This reservoir is a balloon with a volume equal to or as close as possible to a patient's tidal volume and with compliance equalizing PIF. During inspiration, the patient will be breathing in aerosol without diluting it as described above, whereas during exhalation the balloon will refill with aerosol up to the volume of tidal volume or similar and thus limit the aerosol losses to the expiratory arm of the circuit).
It would have been obvious to one skilled in the art before the effective filing date to incorporate the teachings of Mazela’s aerosol reservoir to supplement the Smaldone’s breathing circuit design and assist in further reducing expiratory losses.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Wondka et al. (US 20120138050 A1) discloses a system and method for providing humidifying ventilation gas
Heidelberger (US 7934498 B1) discloses a device and method for facilitating delivery of medication and/or humidity to a patient without breaking a ventilator circuit
Dhuper et al. (US 7870857 B2) discloses a patient interface assembly for use in ventilator systems to deliver medication to a patient
Cavendish (US 8746241 B2) discloses a combination MDI and nebulizer adapter for a ventilator system
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MISHAL Z HUSSAIN whose telephone number is (703)756-1206. The examiner can normally be reached M-F, 8:30am - 5:00pm.
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) 270-7410. 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.
/MISHAL HUSSAIN/
Examiner
Art Unit 3785
/BRANDY S LEE/Supervisory Patent Examiner, Art Unit 3785
Prosecution Insights