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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 02/17/2026 has been entered.
Response to Amendment
The amendment filed 02/17/2026 has been entered. Claims 1, 3-8, 15, 17-21, 24, 26, 28-29, 34-35 remain pending in the application, with claims 36-38 newly added.
Response to Arguments
Applicant's arguments filed 02/17/2026 (“Remarks”) have been fully considered.
The argument on page 8 of “Remarks” that Chang does not disclose the newly amended independent claims 1 and 24 is persuasive. The 102(a)(1) rejection over Chang have been withdrawn, since Chang is silent on whether the cylinder (fig. 1, 114), which generates the air flow for the breathing simulator, draws air from ambient or provides a separate air source, as now required by the claims. Examiner agrees that Chang does not disclose a liquid coating disposed in the airway.
Chang’s device uses a standard human head which is understood to comply with ISO 16900-14 respirator testing (see for example Respirator Testing Headform for RPD ISO 16900-14 | i-bodi). This standard testing fixture does not appear to replicate the human mouth and surrounding soft tissue structures.
The argument on page 9 that Watanabe does not disclose the “airway system configured to mimic mechanical properties of a human or animal respiratory tract” is not persuasive. That Watanabe only discloses a segment of the respiratory tract fulfills the broadest reasonable interpretation of this claim limitation. The applicant does not specifically claim a portion nor the entirety of the respiratory tract. Watanabe’s test fixture is specifically designed to replicate a human respiratory tract, or at least a portion of it, to determine the effects of compositions on mucosal linings ([0014]). The examiner agrees that the claimed invention differs from Watanabe according to the newly amended claims that a multiphase turbulent cloud emission into the ambient environment is not disclosed by Watanabe, since the emission cloud is enclosed into an aerosol holding chamber (fig. 1, 19). The claimed respiratory tract exit orifice, however, is disclosed by Watanabe, since the broadest reasonable interpretation is an orifice exiting the simulated respiratory tract, as the claim does not specify the structure of the orifice. The claim limitation “respiratory exit orifice” does not necessarily require the mechanical properties of the mouth and/or nose. The claimed “airway system configured to mimic mechanical properties of a human or animal respiratory tract” does not necessarily encompass the entire respiratory tract, as only a portion will fulfill the requirements under broadest reasonable interpretation. Please refer to the updated rejection below.
Claim Interpretation
Claim 1 and 24 limitation “mechanical properties of a human or animal respiratory tract” is interpreted according to its standard definition. That is, “mechanical properties” are considered to include hardness, elasticity, strength, stiffness, etc. The applicant does not include specific mechanical properties to be considered for the airway that mimics a human or animal respiratory tract. This interpretation is based upon specification [0033] which states that 3D materials for printing the pathways of the conduits of the airway system may be chosen to mimic the realistic mechanical properties of the airway.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 5-6, 8, 15, 18, 24, 26, and 35 are rejected under 35 U.S.C. 103 as unpatentable over Watanabe et al. (EP 2308469), hereafter Watanabe, in view of Chang, and Bourouiba et al (“Violent Expiratory Events: On Coughing and Sneezing”. Journal of Fluid Mechanics 745 (March 24, 2014): 537-563.), hereafter Bourouiba.
Regarding Claim 1, Watanabe discloses a system for reproducing exhalation emission events (fig. 1, [0068]), the system comprising: an air flow system (fig. 1, the assembly of elements 1-3, 5-13 [0070]) configured to have a gas flow exit therefrom ([0068]), the gas flow having a prescribed flow pattern and a prescribed momentum corresponding to one or more exhalation emission events ([0068] the simulated respiratory machine is a “cough” machine, and [0073]), the gas flow originating separately from an ambient environment (fig. 1, compressed air tank 2 [0070]); and an airway system (fig. 1, 14 model trachea, [0070]) having an airway in fluid communication with the air flow system (fig. 1, model trachea is in fluid communication with the airflow system elements to simulate breathing over the mucus layer [0068]) to receive the gas flow from the air flow system and to expel the gas flow through at least one exit orifice (fig. 1, gas exits the model trachea at the end that connects to fluid trap 16, which is an exit orifice from the model trachea [0070]), the airway system configured to mimic the mechanical properties of a human or animal respiratory tract (fig. 1, 14 is a model of the human trachea [0070] which is a portion of the human respiratory tract; the mimetic mucus layer is intended to mimic the human trachea for shearing properties [0069]), wherein at least some portion of the gas flow produced from the air flow system passes through the airway and out of the at least one exit orifice in a multiphase turbulent gas cloud emission (fig. 1 [0073] a cough event is mimicked, which is a understood to be a turbulent gas cloud), the multiphase turbulent gas cloud emission comprising at least some portion of the gas flow produced from the air flow system and one or more of a plurality of droplets, solid residues, or aerosols ([0071], fig. 1, the measurement chamber 20 at the exit of the model trachea 14 measures particles passing from the model trachea as a result of the simulated breathing passing through),
wherein the one or more of the plurality of droplets, solid residues, or aerosols are produced by the airway system due to at least one of the gas flow interacting with a liquid coating disposed in the airway (fig. 1, model trachea is lined with a mucus mimetic [0067] so that shearing caused by the simulated breathing causes particles to be released from the trachea [0069]).
Watanabe, however, is silent on the multiphase turbulent gas cloud emission into the ambient environment, airflow system having a humidifier configured to place the gas flow in a prescribed humidity range, and wherein a shape of the multiphase turbulent gas cloud emission is a function of an arrangement of the at least one exit orifice.
However, Chang teaches a simulated human breathing test device which measures a breathing mask (fig. 1, page 3, first full para.). This device expels particles into the ambient environment into a mask to test the efficacy of the mask (page 3, second full para.). The device includes a humidifier (fig. 1, saturator 140, page 4, second full para.) to place the gas flow in a prescribed humidity range (page 4, second para., the saturator is used to provide moisture to the exhalation channel).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a humidifier into Watanabe’s system to place the simulated exhaled air in the same humidity levels as human breath (Chang page 4 second para.) in order to better simulate human respiration. It further would have been obvious to one of ordinary skill in the art to expel the gas cloud into the ambient environment by replacing Watanabe’s aerosol holding chamber with Chang’s standard human head in order to test the efficacy of a face mask against the emitted droplet distribution of Watanabe, as taught by Chang.
The modified device remains silent on wherein a shape of the multiphase turbulent gas cloud emission is a function of an arrangement of the at least one exit orifice (neither reference discloses a shape of a gas cloud emitted from the exit orifice).
Bourouiba teaches that a multiphase turbulent gas cloud emission varies based on whether it is emitted from the nose (i.e., via a sneeze) or a mouth (i.e., via a cough; page 543, first full para.).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the shape of the multiphase turbulent gas could emission would be different based on the arrangement of the exit orifice.
Regarding Claim 5, Watanabe discloses a system of claim 1, wherein the air flow system further comprises: an exhalation event control system disposed between at least one of the air flow system and the airway system (fig. 1, two-way solenoid valve 8 controls the delivery of pressurized air to the through [0070] and is shown as located between the compressed air tank and the model trachea/trough), the exhalation event control system being configured to generate a pulse of air from air received from a gas containing chamber and deliver the pulse of air to the airway system at the prescribed flow pattern ([0070] the solenoid valve controls the delivery of air which mimics the cough event).
Regarding Claim 6, Watanabe discloses a system of claim 5, wherein the prescribed flow pattern comprises at least one of a velocity of air flow commensurate with a desired exhalation event from the one or more exhalation events ([0023] a range of speeds affects mucus layer in coughing).
Regarding Claim 8, Watanabe discloses a system of claim 5, wherein the exhalation event control system comprises at least one of a pulse generator or a valve (fig. 1, solenoid valve 8 [0070]).
Regarding Claim 15, Watanabe discloses a system of claim 1, wherein one or more exhalation events are human exhalation events comprising at least one of coughing (Watanabe [0068]).
Regarding Claim 18, Watanabe discloses a system of claim 1, but does not disclose wherein the air flow system is configured to achieve a prescribed buoyancy of the multiphase gas cloud a certain distance from the airway system.
However, Bourouiba teaches that a cough and sneeze cloud has a particular buoyancy (fig. 4, page 542, fig. 5, page 543, and fig. 7 page 544) that affects the trajectory of the droplets (page 552 4.1 Trajectory para.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the cough system of Watanabe have a prescribed buoyancy as taught by Bourouiba in order to more accurately replicate the breathing droplets exhaled by a person during a cough or sneeze.
Regarding Claim 24, Watanabe discloses a method for reproducing exhalation events, the method comprising: generating a flow of air at a prescribed flow pattern ([0068] and [0073] a cough pattern is applied), a prescribed momentum ([0071] the test device 20 draws an air stream at 1 CFM; [0073] the cough is applied at 3 psi; one of ordinary skill in the art would understand that pressure and flow rate are mathematically related), and one or both of a prescribed liquid or solid volume fraction ([0074] a set volume of mimetic was used in tests), for one or more exhalation events ([0074] three tests were completed), the flow of air originating separately from an ambient environment (fig. 1, compressed air tank 2 [0070]); and directing the flow of air through an airway configured to mimic mechanical properties of a human or animal respiratory tract (fig. 1, model trachea 14 [0070]) such that at least some air of the flow of air exits the airway in a multiphase turbulent gas cloud emission via at least one exit orifice (airflow exits the model trachea at end near 16 in order to be measured at 20 [0071]), the multiphase turbulent gas cloud emission comprising the at least some air of the air flow and one or more of a plurality of droplets, solid residues, or aerosols ([fig. 1, [0068], [0071]),
wherein the plurality of droplets, solid residues, or aerosols are provide by coating a portion of the airway with a fluid to become entrained with the at least some air of the flow of air (fig. 1, model trachea 14 is lined with mucus mimetic [0068-0069]).
Watanabe, however, is silent on the multiphase turbulent gas cloud emission into the ambient environment, airflow system having a humidifier configured to place the gas flow in a prescribed humidity range, and wherein a shape of the multiphase turbulent gas cloud emission is a function of an arrangement of the at least one exit orifice.
However, Chang teaches a simulated human breathing test device which measures a breathing mask (fig. 1, page 3, first full para.). This device expels particles into the ambient environment into a mask to test the efficacy of the mask (page 3, second full para.). The device includes a humidifier (fig. 1, saturator 140, page 4, second full para.) to place the gas flow in a prescribed humidity range (page 4, second para., the saturator is used to provide moisture to the exhalation channel).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a humidifier into Watanabe’s system to place the simulated exhaled air in the same humidity levels as human breath (Chang page 4 second para.) in order to better simulate human respiration. It further would have been obvious to one of ordinary skill in the art to expel the gas cloud into the ambient environment by replacing Watanabe’s aerosol holding chamber with Chang’s standard human head in order to test the efficacy of a face mask against the emitted droplet distribution of Watanabe, as taught by Chang.
The modified device remains silent on wherein a shape of the multiphase turbulent gas cloud emission is a function of an arrangement of the at least one exit orifice (neither reference discloses a shape of a gas cloud emitted from the exit orifice).
Bourouiba teaches that a multiphase turbulent gas cloud emission varies based on whether it is emitted from the nose (i.e., via a sneeze) or a mouth(i.e., via a cough; page 543, first full para.).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the shape of the multiphase turbulent gas could emission would be different based on the arrangement of the exit orifice.
Regarding Claim 26, Watanabe discloses a method of claim 24, wherein directing the flow of air through the airway further comprises shearing the fluid away from the airway to cause the liquid to become entrained with the at least some of the air of the flow of air (fig. 1, model trachea lined with mucus mimetic [0068] is sheared away during the cough simulation [0069]).
Regarding Claim 35, Watanabe discloses a system of claim 1, but is silent on the device being configured to emit predetermined ranges of droplet sizes corresponding to types of the one or more exhalation events.
However, Bourouiba teaches that droplet size affects the fall out and the velocity of the fall out, such that larger droplets fall out earlier and faster than smaller droplets (fig. 18 page 559 with caption).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Watanabe’s system to be configured to emit predetermined ranges of droplet sizes corresponding to the exhalation event (coughing) since, as taught by Bourouiba, the droplet size affects the distribution of the resulting droplet contamination range (Bourouiba page 559 fig. 18(d), the contamination range changes with the drop diameter).
Claims 3, 4, 17, 28-29, and 34 are rejected under 35 U.S.C. 103 as being unpatentable over Watanabe, Chang, and Bourouiba, further in view of Tanabe et al. (JP 2014137754), hereafter Tanabe. A machine translation is relied upon to address claims.
Regarding Claim 3, Watanabe discloses a system of claim 1, but is silent on wherein the air flow system further comprises a gas containing chamber having at least one of a temperature stabilizing unit coupled to an exterior of the gas containing chamber and configured to place the gas flow in a prescribed temperature range.
Tanabe teaches the use of a temperature control capability ([0016]) of a simulated cough generator ([0012] fig. 1) in order to maintain the simulator at a human body temperature ([0016]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a temperature stabilizing unit in Watanabe’s testing device in order to maintain the simulator at a human body temperature to further mimic human test conditions.
Regarding Claim 4, the modified Watanabe discloses a system of claim 3, wherein the air flow system further comprises at least one pressure or flow regulator configured to deliver input air into the gas containing chamber (Watanabe fig. 1, pressure regulator 1 [0070]).
Regarding Claim 17, Watanabe discloses a system of claim 1, wherein the one or more exhalation events are human exhalation events ([0004]), but is silent on whether this is based on at least one of different ages, different sizes, different shapes, or different medical conditions.
Tanabe teaches a simulated cough generator (fig. 1, [0012]) which includes inputting different medical conditions to better simulate cough frequency of a patient ([0025] and [0027]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Watanabe’s exhalation event to correspond with a medical condition of a patient to better simulate cough frequency associated with the medical condition, which would more accurately represent aerosol generation (Tanabe [0028]).
Regarding Claim 28, Watanabe discloses a method of claim 24, the method further comprising adjusting at least one of a pressure of the flow of air to fall within a respective prescribed pressure range (Watanabe [0083] the pressure is changed from 3 to 4 psi), but is silent on whether this is done based on data related to at least one of an age of the human or animal, a size of a human or animal, a shape of a human or animal, or one or more medical conditions of a human or animal.
Tanabe teaches inputting risk factors into the test system that include various medical conditions of a human patient ([0025]) that may affect the cough frequency ([0027]) and the number of droplets ([0026]) based on the patient’s health condition and any mitigating factors.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to adjust the pressure of the flow of air in Watanabe’s device by changing the flow rate in order to simulate a cough frequency based on a medical condition of a human as taught by Tanabe for the benefit of being able to test conditions related to various health concerns (Tanabe [0027]).
Regarding Claim 29, Watanabe discloses a method of claim 24, further comprising adjusting at least one of peak flow velocity of the flow of air ([0023] a range of speeds affects mucus layer in coughing), but is silent on whether the adjustment is based on data related to at least one of an age of a human or animal, a size of a human or animal, a shape of a human or animal, or one or more medical conditions of a human or animal.
Tanabe teaches inputting risk factors into the test system that include various medical conditions of a human patient ([0025]) that may affect the cough frequency ([0027]) and the number of droplets ([0026]) based on the patient’s health condition and any mitigating factors.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to adjust the flow velocity of air in Chang’s device by changing the flow rate in order to simulate a cough frequency based on a medical condition of a human as taught by Tanabe for the benefit of being able to test conditions related to various health concerns (Tanabe [0027]).
Regarding Claim 34, Watanabe discloses a system of claim 1, but is silent on the system further comprising a processor with a plurality of profiles having parameters of the air flow system or airway system for a plurality of exhalation events including two or more of coughing, sneezing, breathing, talking, panting, gagging, or singing, wherein the processor is further configured to adjust one or more parameters of the air flow system or airway system based on a selection of one of the exhalation events.
Tanabe teaches simulated cough generator (fig. 1, [0012]) having a processor ([0023] risk evaluation device 15 has a processing unit) with a plurality of profiles having parameters of the air flow system for a plurality of exhalation events including coughing and sneezing ([0025] and [0015]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a processor having a plurality of parameters for a plurality of exhalation events including coughing and sneezing, as taught by Tanabe, into Watanabe’s system for the benefit of being able to accurately demonstrate the scattering probability of droplets for each patient’s condition having the respiratory symptoms of coughing and sneezing (Tanabe [0027] and [0015]).
However, the modified device does not disclose wherein the processor is further configured to adjust the one or more parameters of the airflow system based on the selection of one of the exhalation events ([0026] the processor has a database for the occurrence probability of droplets generated with each medical condition, however, it does not differentiate between coughing and sneezing events specifically).
However, Bourouiba teaches that a droplet cloud generated by a sneeze differs from a cough in that a sneeze cloud is denser and the droplet size is larger (page 543 lines 9-10). A cough versus a sneeze has a different coefficient of entrainment (page 542 line 4 and page 543 lines 17-18) which affects the cloud buoyancy and trajectory of the droplets (page 556 first full para.)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify Watanabe’s device to adjust the parameters of the airflow system based on the selection of whether a patient coughs or sneezes, since the trajectory of a cough is different than that of a sneeze, as taught by Bourouiba.
Claim 7 is rejected under 35 U.S.C. 103 as unpatentable over Watanabe, Chang, and Bourouiba, further in view of Liu et al (WO 2020047763), hereafter Liu. A machine translation is relied upon to address claims.
Regarding Claim 7, Watanabe discloses a system of claim 5, but is silent on whether the device wherein the exhalation event control system is further configured to deliver the pulse of air to the airway system at a prescribed volume.
Liu teaches a respiration simulation device (fig. 1, 100, page 2, last para.) which can control a volume delivered (page 2, last para. lines 4-6) in order to properly simulate a particular breathing scenario.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Chang’s device to deliver the pulse of air not just by flow rate, but also by volume as taught by Liu, since a human lung has a particular capacity and this can provide a more accurate simulated breathing scenario (Liu, page 2 last para.).
Claims 19 and 36-38 are rejected under 35 U.S.C. 103 s unpatentable over Watanabe, Chang, and Bourouiba, further in view of Minskoff (US 2016/0217709 A1), hereafter Minskoff.
Regarding Claim 19, Watanabe discloses a system of claim 1, wherein the multiphase turbulent gas cloud emission is a point-source multiphase gas cloud (as modified by Chang, since the cough is emitted from a dingle opening, i.e., the mouth of the standard human head, the multiphase gas cloud originates from a point source), but is silent on wherein the at least one exit orifice is configured to replicate a shape and mechanical properties of (a) a human nose or (b) a human mouth, and surrounding soft tissue (as modified by Chang, the mouth of the standard human head is silent on replicating the shape and mechanical properties, as interpreted above).
Minskoff teaches a simulated airway system and breath simulator for the delivery of particles (abstract) which includes both inhalation and exhalation ([0044]). Minskoff teaches that particles may be affected by the oropharyngeal cavity lining as they travel, as well as shape and dimensions of the cavity ([0092]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to replicate the shape and mechanical properties of the human mouth in the modified Watanabe’s device, as taught by Minskoff, since Minskoff teaches that the oropharyngeal cavity lining, shape, and dimensions all affect the travel of particles through the oropharynx. While Minskoff’s device is targeted toward testing particle travel into the airway (abstract), one of ordinary skill in the art would have been able to understand that the mechanical properties of the mouth would similarly affect the travel of particles expelled by the airway (Minskoff [0044]).
Regarding Claim 36, Watanabe discloses a method of claim 24, emitting the turbulent gas cloud emission as a point-source multiphase gas cloud (as modified by Chang, since the cough is emitted from a dingle opening, i.e., the mouth of the standard human head, the multiphase gas cloud originates from a point source), but is silent on further comprising: arranging the least one exit orifice to replicate a shape and mechanical properties of at least one of: (a) a human nose or (b) a human mouth, and surrounding soft tissue.
Minskoff teaches a simulated airway system and breath simulator for the delivery of particles (abstract) which includes both inhalation and exhalation ([0044]). Minskoff teaches that particles may be affected by the oropharyngeal cavity lining as they travel, as well as shape and dimensions of the cavity ([0092]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to replicate the shape and mechanical properties of the human mouth in the modified Watanabe’s device, as taught by Minskoff, since Minskoff teaches that the oropharyngeal cavity lining, shape, and dimensions all affect the travel of particles through the oropharynx. While Minskoff’s device is targeted toward testing particle travel into the airway (abstract), one of ordinary skill in the art would have been able to understand that the mechanical properties of the mouth would similarly affect the travel of particles expelled by the airway (Minskoff [0044]).
Regarding Claim 37, Watanabe discloses a system for reproducing exhalation emission events, (fig. 1, [0068]), the system comprising: an air flow system (fig. 1, the assembly of elements 1-3, 5-13 [0070]) configured to output a gas flow having a predetermined flow pattern and momentum corresponding to an exhalation emission event ([0068] the gas flow pattern and momentum is intended to replicate a cough), the gas flow originating separately from an ambient environment (fig. 1, compressed air tank 2 [0070]); an airway system (fig. 1, 14 model trachea, [0070]) having an airway fluidly coupled to the air flow system via an inlet to receive the gas flow (fig. 1, model trachea is in fluid communication with the airflow system elements to simulate breathing over the mucus layer [0068]), and at least one exit orifice to output (fig. 1, gas exits the model trachea at the end that connects to fluid trap 16, which is an exit orifice from the model trachea [0070]), a point- source multiphase turbulent gas cloud emission (since there is only one exit at 16 into aerosol holding chamber 19, this is a point-source; a cough is understood to be a turbulent gas cloud emission) comprising one or more of a plurality of droplets, solid residues, or aerosols disposed in some portion of the gas flow ([0071], fig. 1, the measurement chamber 20 at the exit of the model trachea 14 measures particles passing from the model trachea as a result of the simulated breathing passing through); wherein the one or more of the plurality of droplets, solid residues, or aerosols are produced by the gas flow interacting with the liquid coating in the airway (fig. 1, model trachea is lined with a mucus mimetic [0067] so that shearing caused by the simulated breathing causes particles to be released from the trachea [0069]).
Watanabe is silent on the exit orifice outputting into the ambient environment, and at least one liquid reservoir, fluidly coupled to the airway, configured to provide a liquid coating to the airway and to inject a liquid into the gas flow, the gas flow interacting with the liquid injected into the airway, and wherein the at least one exit orifice replicates a shape and mechanical properties of at least one of: (a) a human nose or (b) a human mouth, and surrounding soft tissue.
However, Chang teaches a simulated human breathing test device which measures a breathing mask (fig. 1, page 3, first full para.). This device expels particles into the ambient environment into a mask to test the efficacy of the mask (page 3, second full para.). The device includes a liquid reservoir fluidly coupled to the airway (fig. 1, saturator 140, page 4, second full para.) that injects liquid into the gas flow (page 4, second para., the saturator is used to provide moisture to the exhalation channel).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a humidifier into Watanabe’s system to place the simulated exhaled air in the same humidity levels as human breath (Chang page 4 second para.) in order to better simulate human respiration. It further would have been obvious to one of ordinary skill in the art to expel the gas cloud into the ambient environment by replacing Watanabe’s aerosol holding chamber with Chang’s standard human head in order to test the efficacy of a face mask against the emitted droplet distribution of Watanabe, as taught by Chang.
The modified device remains silent on wherein the at least one exit orifice replicates a shape and mechanical properties of at least one of: (a) a human nose or (b) a human mouth, and surrounding soft tissue (as modified by Chang, the standard human head does not have the shape and mechanical properties of the human mouth).
Minskoff teaches a simulated airway system and breath simulator for the delivery of particles (abstract) which includes both inhalation and exhalation ([0044]). Minskoff teaches that particles may be affected by the oropharyngeal cavity lining as they travel, as well as shape and dimensions of the cavity ([0092]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to replicate the shape and mechanical properties of the human mouth in the modified Watanabe’s device, as taught by Minskoff, since Minskoff teaches that the oropharyngeal cavity lining, shape, and dimensions all affect the travel of particles through the oropharynx. While Minskoff’s device is targeted toward testing particle travel into the airway (abstract), one of ordinary skill in the art would have been able to understand that the mechanical properties of the mouth would similarly affect the travel of particles expelled by the airway (Minskoff [0044]).
Regarding Claim 38, Watanabe as modified discloses a system of claim 37, but does not disclose wherein the airway system comprises a plurality of conduits, each of the plurality of conduits sized and shaped to form a scaled portion of a human or animal respiratory tract, and wherein the airway system is configured to mimic mechanical properties of the human or the animal respiratory tract.
However, Minskoff teaches that both the nasal cavities and oropharyngeal cavity affect the flow of particles in the respiratory tract ([0044]) as well as teaching a nose simulator in addition to a mouth simulator (fig. 7B [0095]) in order to test the flow of particles through the respiratory tract ([0093]). The nose and mouth cavities may be coated with a cavity lining ([0102]) which affects the flow of particles ([0092]).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add a nose simulator in addition to the mouth of the modified Watanabe and Chang, as taught by Minskoff, since the nose also affects the flow of air and particles through the respiratory tract (Minskoff [0092] and [0044]), as well as obvious to ensure that the airway system is configured to mimic mechanical properties of the human airway system, since the flow of particles is affected by the shape, size, and cavity lining of these structures.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Zhang et al. “Design and characterization of a cough simulator”. J. Breath Res. 11 (2017) 016014. 23 February 2017.
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/SARA K TOICH/Examiner, Art Unit 3785
/BRANDY S LEE/Supervisory Patent Examiner, Art Unit 3785
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