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 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.
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 1 is rejected under 35 U.S.C. 103 as being unpatentable over Batista et al. US 10,925,316 in view of Wilson et al. 2020/0147325 and Decock et al. FR3024655
Regarding claim 1, Batista discloses a droplet delivery device comprising (abstract states that “An aerosol-generating system is provided”):
a housing (Figure 1 housing 12) with an outlet configured for droplets to be ejected from the droplet delivery device (Figure 2 mouthpiece 19);
a reservoir (Figure 1, supply of aerosol forming substrate 17) configured to supply a volume of fluid and in fluid communication with the outlet (Column 8 line 20 states that “In this example the aerosol-forming substrate is a liquid and the system comprises a wick to convey the liquid to the atomizer 18.” The atomizer is in fluid communication with the outlet as seen in figure 1.);
an ejector mechanism in fluid communication with the reservoir and the outlet (Atomizer 18 in figure 1 is depicted as being in connection between reservoir 17 and the mouthpiece 19.);
an accelerometer (Figure 2 Accelerometer 20) coupled to a power source and to the housing (Figure 2 depicts the accelerometer coupled to the portion of the device that contains battery 14 seen in figure 1. Furthermore, the accelerometer is coupled to housing 12);
a microcontroller unit (Controller 15) coupled to the accelerometer (Column 8 line 49 states that “In the off state the controller 15 is responsive only to signals from the accelerometer.”);
and a feedback unit communicatively coupled to the microcontroller unit providing one or both of display and sound notification (Column 8 line 60 states that “The accelerometer produces a first input signal as a result of the shaking of the system and this first input signal is received by the controller 15 and compared to data stored in a memory of the controller. If the first input signal matches the data stored in memory, then the controller switches to a ready state 40. In the ready state some of the LEDs 28 are illuminated. In this example LEDs surrounding the fingerprint sensor 22 may be illuminated to indicated that the system in the ready state and to indicate the position of the fingerprint sensor.” The disclosed invention does contain some sort of feedback unit that has a visual indication based on the reading of the accelerometer).
Batista discloses the general concept of a feedback unit providing a display notification based on readings from an accelerometer. However, Batista fails to explicitly teach the concept of the determination on whether sufficient mixing of the fluid has occurred being the driving factor behind the display notification being provided. More specifically the limitations of the feedback unit being “programmed to communicate a confirmation of sufficient movement of the droplet delivery device to mix the volume of fluid”, and the feedback unit being “communicatively coupled to the microcontroller unit providing one or both of display and sound notification in response to receiving the confirmation of sufficient movement.”
Wilson discloses an analogous droplet delivery device in an inhaler that does teach and programmed to communicate a confirmation of sufficient movement of the droplet delivery device to mix the volume of fluid (0069 states that “The accelerometer may be configured to determine how hard and/or how long the canister 202 has been shaken by the user prior to actuation.”), and a feedback unit communicatively coupled to the microcontroller unit (0068 states that “The electronics module 230 may include a communications module capable of wirelessly communicating with the external user device and/or the data receiver 209, a battery to power its components, a memory device to store information specific to the user, as well as dosage and/or product information associated with the canister 202, and a processor (e.g., controller or microprocessor) “) providing one or both of a display and/or a sound notification in response to receiving the confirmation of the sufficient movement (0069 states that “The inhaler 200 may also include an indicator 234 that is coupled to the electronics module 230 and configured to indicate when the solution is ready for use. For example, the indicator 234 may be an externally-visible LED light that turns on when the solution is ready,”). 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 the aerosol system of Batista with the teachings of Wilson to include and programmed to communicate a confirmation of sufficient movement of the droplet delivery device to mix the volume of fluid, and a feedback unit communicatively coupled to the microcontroller unit providing one or both of display and sound notification in response to receiving the confirmation of sufficient movement as the use of an accelerometer and indicator allows for the determination on whether the solution has been properly mixed prior to dispensing, and if it has not, a multi colored LED system can be used to convey mixing status (0069).
Modified Batista in view of Wilson still fails to teach wherein the sufficient movement includes an active shake threshold of greater than 0.1 G of acceleration measured from the accelerometer. Decock teaches an analogous pharmaceutical dispensing device that does teach wherein the sufficient movement includes an active shake threshold of greater than 0.1 G of acceleration measured from the accelerometer (Page 4 of the translated application states “sufficient agitation is detected when the characteristic quantity, namely the acceleration of the distribution device recorded by the accelerometer 16, exceeds a predetermined threshold, for example 3 g (gravitational)”). 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 Batista in view of Wilson with the teachings of Decock and include wherein the sufficient movement includes an active shake threshold of greater than 0.1 G of acceleration measured from the accelerometer as this provides a threshold of activating a user warning once sufficient agitation occurs (Page 4).
Although the threshold is not at 0.1 G, it would have been obvious to one having ordinary skill in the art at the time of the invention to set the acceleration at this threshold, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art as this threshold optimizes the detection of sufficient movement to activate the device. MPEP 2144.05.
Claims 2-6 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over modified Batista, further in view of Biswas et al. 2016/0144141.
Regarding claim 2, modified Batista teaches the droplet delivery device of claim 1, but fails to explicitly teach wherein the accelerometer is configured to measure at least one of acceleration and orientation on multiple axes. Biswas discloses an analogous inhaler that does teach wherein the accelerometer is configured to measure at least one of acceleration and orientation on multiple axes (0067 states that “The accelerometer measures movement and rotation in x, y, z directions”). 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 the combination of modified Batista with the teachings of Biswas to include wherein the accelerometer is configured to measure at least one of acceleration and orientation on multiple axes as it would allow for the controller to detect the number of times and directions in which the device has been shaken before the dispensing of dosage (0067).
Regarding claim 3, modified Batista in view of Biswas teaches the droplet delivery device of claim 2. Biswas further teaches wherein the accelerometer is configured to measure the at least one of acceleration and orientation on at least three orthogonal axes (0067 states that “The accelerometer measures movement and rotation in x, y, z directions”). 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 the combination of modified Batista with the teachings of Biswas to include wherein the accelerometer is configured to measure at least one of acceleration and orientation on at least three orthogonal axes as it would allow for the controller to detect the number of times and directions in which the device has been shaken before the dispensing of dosage (0067).
Regarding claim 4, modified Batista in view of Biswas teaches the droplet delivery device of claim 3. Batista further discloses wherein the ejector mechanism includes an electromechanical actuator (Column 3 line 32 states that “The aerosol-forming element may be a piezoelectric transducer.”).
Regarding claim 5, modified Batista in view of Biswas teaches the droplet delivery device of claim 2. Batista further discloses wherein the ejector mechanism includes an electromechanical actuator (Column 3 line 32 states that “The aerosol-forming element may be a piezoelectric transducer.”).
Regarding claim 6, modified Batista teaches the droplet delivery device of claim 1. Batista further discloses wherein the ejector mechanism includes an electromechanical actuator (Column 3 line 32 states that “The aerosol-forming element may be a piezoelectric transducer.”).
Regarding claim 10, modified Batista teaches the droplet delivery device of claim 1, but fails to explicitly teach wherein the feedback unit is configured to provide a voice notification. Biswas does teach wherein the feedback unit is configured to provide a voice notification (Paragraph 0061 states that “The front view of the cap 1 as shown in FIG. 2 depicts the real-time feedback system using the multi-color LED 2, buzzer with loudspeaker system 5 and miniature linear motor 16 (shown in FIG. 5) for haptic feedback.”) 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 further modify the combination of modified Batista with the teachings of Biswas to include wherein the feedback unit is configured to provide a voice notification as this provides the user with an audible source of feedback in regards to correct inhaler usage (0061).
Claims 7-9 are rejected under 35 U.S.C. 103 as being unpatentable over modified Batista, further in view of Germinario et al. US 9,962,507
Regarding claim 7, modified Batista teaches the droplet delivery device of claim 1, but fails to explicitly teach wherein the reservoir contains a fluid including a drug. Germinario discloses an analogous droplet delivery device that does teach wherein the reservoir contains a fluid including a drug (Column 10 line 1 states that “In addition, the fluid may contain THC, CBD, or other chemicals”). 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 modified Batista with the teachings of Germinario to include wherein the reservoir contains a fluid including a drug as this would allow for the treatment of seizures and other conditions (Column 10 line 2).
Regarding claim 8, modified Batista teaches the droplet delivery device of claim 1, but fails to explicitly teach wherein the reservoir contains a fluid including nicotine or a cannabinoid. Germinario does teach wherein the reservoir contains a fluid including nicotine or a cannabinoid (Column 10 line 1 states that “In addition, the fluid may contain THC, CBD, or other chemicals”). 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 the combination of modified Batista with the teachings of Germinario to include wherein the reservoir contains a fluid including nicotine or a cannabinoid as this would allow for the treatment of seizures and other conditions (Column 10 line 2).
Regarding claim 9, modified Batista teaches the droplet delivery device of claim 1, but fails to explicitly teach wherein the reservoir contains a fluid including a therapeutic agent. Germinario does teach wherein the reservoir contains a fluid including a therapeutic agent (Column 10 line 1 states that “In addition, the fluid may contain THC, CBD, or other chemicals”). 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 the combination of modified Batista with the teachings of Germinario to include wherein the reservoir contains a fluid including a therapeutic agent as this would allow for the treatment of seizures and other conditions (Column 10 line 2).
Claims 11-14 are rejected under 35 U.S.C. 103 as being unpatentable over modified Batista, further in view of Riebe et al. CN108136144 (US family member in 2020/0086069 is also attached for convenience, paragraph 0088)
Regarding claim 11, modified Batista teaches the droplet delivery device of claim 1, but fails to teach wherein the microcontroller unit is programmed to initiate the accelerometer to determine at least one of acceleration and orientation at predetermined intervals. Riebe discloses an analogous aerosol delivery device that does teach wherein the microcontroller unit is programmed to initiate the accelerometer to determine at least one of acceleration (Page 15 of the attached translated document states that “the control system 1000 may be configured by one or more accelerometers 1026 in a certain period of time before attempting to use in sensing shake or agitate the aerosol conveying unit, and when it is determined that the shaking or agitation is not sufficiently temporarily prevent actuator 1028 activation tank 1050. control system 1000 may also provide additional indication of the shaking or agitation to the user before releasing the substance”) and orientation at predetermined intervals (“As another example, control system 1000 may be configured by one or more accelerometers 1026 in a certain period of time before attempting to use the sensed aerosol in conveying unit orientation, and the orientation is not reasonable for conveying atomized substance in the tank 1050 (e.g., aerosol conveying unit is horizontal), temporarily prevent actuator 1028 tank 1050. control system 1000 may also provide an indication to a user prior to releasing the atomized substance showing aerosol conveying unit must be redirected to a more vertical position.”). 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 further modify modified Batista include the teachings of Riebe wherein the microcontroller unit is programmed to initiate the accelerometer to determine at least one of acceleration and orientation at predetermined intervals as this ensures that protective measures can be taken to ensure compliance with the user’s dosing regimen, and to ensure a well-mixed dose is received.
Regarding claim 12, modified Batista in view of Riebe teaches the droplet delivery device of claim 11. Batista does teach wherein the microcontroller unit is programmed to wake the accelerometer (Column 8 line 49 states that “In the off state the controller 15 is responsive only to signals from the accelerometer”). Riebe further teaches to initiate the accelerometer to determine the at least one of acceleration (Page 15 of the attached translated document states that “the control system 1000 may be configured by one or more accelerometers 1026 in a certain period of time before attempting to use in sensing shake or agitate the aerosol conveying unit, and when it is determined that the shaking or agitation is not sufficiently temporarily prevent actuator 1028 activation tank 1050. control system 1000 may also provide additional indication of the shaking or agitation to the user before releasing the substance”) and orientation at predetermined intervals (“As another example, control system 1000 may be configured by one or more accelerometers 1026 in a certain period of time before attempting to use the sensed aerosol in conveying unit orientation, and the orientation is not reasonable for conveying atomized substance in the tank 1050 (e.g., aerosol conveying unit is horizontal), temporarily prevent actuator 1028 tank 1050. control system 1000 may also provide an indication to a user prior to releasing the atomized substance showing aerosol conveying unit must be redirected to a more vertical position.”). 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 further modify the combination of modified Batista to include the teachings of Riebe to initiate the accelerometer to determine at least one of acceleration and orientation at predetermined intervals as this ensures that protective measures can be taken to ensure compliance with the user’s dosing regimen, and to ensure a well-mixed dose is received.
Regarding claim 13, modified Batista in view of Riebe teaches the droplet delivery device of claim 12. Riebe further teaches wherein the microcontroller is programmed to communicate directions for moving the droplet delivery device to the feedback unit based on one or more determinations of the at least one of acceleration (Page 15 of the attached translated document states that “the control system 1000 may be configured by one or more accelerometers 1026 in a certain period of time before attempting to use in sensing shake or agitate the aerosol conveying unit, and when it is determined that the shaking or agitation is not sufficiently temporarily prevent actuator 1028 activation tank 1050. control system 1000 may also provide additional indication of the shaking or agitation to the user before releasing the substance”) and orientation (“As another example, control system 1000 may be configured by one or more accelerometers 1026 in a certain period of time before attempting to use the sensed aerosol in conveying unit orientation, and the orientation is not reasonable for conveying atomized substance in the tank 1050 (e.g., aerosol conveying unit is horizontal), temporarily prevent actuator 1028 tank 1050. control system 1000 may also provide an indication to a user prior to releasing the atomized substance showing aerosol conveying unit must be redirected to a more vertical position.”) at one or more predetermined intervals. 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 further modify the modified Batista to include the teachings of Riebe wherein the microcontroller is programmed to communicate directions for moving the droplet delivery device to the feedback unit based on one or more determinations of at least one of acceleration and orientation at one or more predetermined intervals as this ensures that protective measures can be taken to ensure compliance with the user’s dosing regimen, and to ensure a well-mixed dose is received.
Regarding claim 14, modified Batista in view of Riebe teaches the droplet delivery device of claim 11. Riebe further teaches wherein the microcontroller is programmed to communicate directions for moving the droplet delivery device to the feedback unit based on one or more determinations of the at least one of acceleration (Page 15 of the attached translated document states that “the control system 1000 may be configured by one or more accelerometers 1026 in a certain period of time before attempting to use in sensing shake or agitate the aerosol conveying unit, and when it is determined that the shaking or agitation is not sufficiently temporarily prevent actuator 1028 activation tank 1050. control system 1000 may also provide additional indication of the shaking or agitation to the user before releasing the substance”) and orientation (“As another example, control system 1000 may be configured by one or more accelerometers 1026 in a certain period of time before attempting to use the sensed aerosol in conveying unit orientation, and the orientation is not reasonable for conveying atomized substance in the tank 1050 (e.g., aerosol conveying unit is horizontal), temporarily prevent actuator 1028 tank 1050. control system 1000 may also provide an indication to a user prior to releasing the atomized substance showing aerosol conveying unit must be redirected to a more vertical position.”) at one or more predetermined intervals. 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 further modify modified Batista to include the teachings of Riebe wherein the microcontroller is programmed to communicate directions for moving the droplet delivery device to the feedback unit based on one or more determinations of at least one of acceleration and orientation at one or more predetermined intervals as this ensures that protective measures can be taken to ensure compliance with the user’s dosing regimen, and to ensure a well-mixed dose is received.
Claims 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over modified Batista, further in view of Hawes et al. 2017/0108840
Regarding claim 15, modified Batista teaches the droplet delivery device of claim 1, but fails to explicitly teach further comprising a recordable memory coupled to the microcontroller unit, wherein the microcontroller unit is programmed to store orientation data from the accelerometer relative to time in the recordable memory. Hawes discloses an analogous vaping device that does teach further comprising a recordable memory (Storage medium 2145) coupled to the microcontroller unit (Controller 2105), wherein the microcontroller unit is programmed to store orientation data (Paragraph 0154 states that “the quaternions received by, or determined by, the controller 2105 may be stored by the controller 2105 in memory from the accelerometer relative to time in the recordable memory. “The device sensors 2125 may include at least one IMU. As an example, the IMU may output movement and/or orientation measurements to the controller 2105 in the form of quaternions. As another example, the IMU may output movement and/or orientation measurements to the controller 2105 in the form of accelerometer measurements, gyroscope measurements, and/or magnetometer measurements, and quaternions may be determined by the controller 2105 based on the accelerometer measurements.” “The quaternions may be received by, or determined by, the controller 2105, for example, every 20 ms thus resulting in an update rate (or frequency) of 50 Hz.” This paragraph explains how orientation data taken from an accelerometer over an amount of time is sent to be stored within the memory of the controller.). 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 further modify modified Batista with the teachings of Hawes and include further comprising a recordable memory coupled to the microcontroller unit, wherein the microcontroller unit is programmed to store orientation data from the accelerometer relative to time in the recordable memory as this allows for historical orientation data to be used for the detection of a hand to mouth gesture (0154).
Regarding claim 16, modified Batista teaches the droplet delivery device of claim 1, but fails to teach further comprising a recordable memory coupled to the microcontroller unit, wherein the microcontroller unit is programmed to store movement data from the accelerometer to the recordable memory. Hawes does teach further comprising a recordable memory coupled to the microcontroller unit, wherein the microcontroller unit is programmed to store movement data from the accelerometer to the recordable memory (Paragraph 0154 states that “the quaternions received by, or determined by, the controller 2105 may be stored by the controller 2105 in memory from the accelerometer relative to time in the recordable memory. “The device sensors 2125 may include at least one IMU. As an example, the IMU may output movement and/or orientation measurements to the controller 2105 in the form of quaternions. As another example, the IMU may output movement and/or orientation measurements to the controller 2105 in the form of accelerometer measurements, gyroscope measurements, and/or magnetometer measurements, and quaternions may be determined by the controller 2105 based on the accelerometer measurements.” “The quaternions may be received by, or determined by, the controller 2105, for example, every 20 ms thus resulting in an update rate (or frequency) of 50 Hz.” This paragraph explains how the reference allows for movement data to be taken from the accelerometer to be stored within the memory of the controller.) 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 further modify modified Batista with the teachings of Hawes to include further comprising a recordable memory coupled to the microcontroller unit, wherein the microcontroller unit is programmed to store movement data from the accelerometer to the recordable memory as this allows for historical orientation data to be used for the detection of a hand to mouth gesture (0154).
Claims 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over modified Batista, further in view of Hunter et al. 2022/0001122
Regarding claim 17, modified Batista teaches the droplet delivery device of claim 1, but fails to explicitly teach wherein the ejector mechanism is configured to produce droplets with an average ejected droplet diameter of less than about 6 microns. Hunter discloses an analogous droplet delivery device that does teach wherein the ejector mechanism is configured to produce droplets with an average ejected droplet diameter of less than about 6 microns (Paragraph 0010 states that “the ejector mechanism is configured to generate the ejected stream of droplets wherein at least about 50% of the droplets have an average ejected droplet diameter of less than about 6 micron”). 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 further modify modified Batista with the teachings of Hunter to include wherein the ejector mechanism is configured to produce droplets with an average ejected droplet diameter of less than about 6 microns as this size allows for effective delivery of droplets deep into the lung airways (0057).
Regarding claim 18, modified Batista teaches the droplet delivery device of claim 1, but fails to explicitly teach wherein the ejector mechanism is configured to produce droplets with an average ejected droplet diameter of less than about 5 microns. Hunter does teach wherein the ejector mechanism is configured to produce droplets with an average ejected droplet diameter of less than about 5 microns (Paragraph 0010 states that “the ejector mechanism is configured to generate the ejected stream of droplets wherein at least about 50% of the droplets have an average ejected droplet diameter of less than about 6 micron”). 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 further modify modified Batista with the teachings of Hunter to include wherein the ejector mechanism is configured to produce droplets with an average ejected droplet diameter of less than about 5 microns as this size allows for effective delivery of droplets deep into the lung airways (0057).
Regarding claim 19, modified Batista teaches the droplet delivery device of claim 1, but fails to explicitly teach wherein the ejector mechanism is configured to produce droplets with an average ejected droplet diameter of more than about 1 micron to less than about 6 microns. Hunter does teach wherein the ejector mechanism is configured to produce droplets with an average ejected droplet diameter of more than about 1 micron to less than about 6 microns. Paragraph 0010 states that “the ejector mechanism is configured to generate the ejected stream of droplets wherein at least about 50% of the droplets have an average ejected droplet diameter of less than about 6 micron”. Furthermore, paragraph 0059 states possible diameter ranges including “about 1 μm to about 5 μm”. 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 further modify modified Batista with the teachings of Hunter to include wherein the ejector mechanism is configured to produce droplets with an average ejected droplet diameter of less than about 5 microns as this size allows for effective delivery of droplets deep into the lung airways (0057). Furthermore, in the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists.
Regarding claim 20, modified Batista teaches the droplet delivery device of claim 1, but fails to explicitly teach wherein the ejector mechanism is configured to produce droplets with an average ejected droplet diameter of more than about 1 micron to less than about 5 microns. Hunter does teach wherein the ejector mechanism is configured to produce droplets with an average ejected droplet diameter of more than about 1 micron to less than about 5 microns (Paragraph 0059 states a possible diameter range as being form “about 1 μm to about 5 μm”. 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 further modify modified Batista with the teachings of Hunter to include wherein the ejector mechanism is configured to produce droplets with an average ejected droplet diameter of more than about 1 micron to less than about 5 microns as this size allows for effective delivery of droplets deep into the lung airways (0057).
Response to Arguments
Applicant’s arguments with respect to claim 1 have 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
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.
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/ROHAN PATEL/Examiner, Art Unit 3785
/BRANDY S LEE/Supervisory Patent Examiner, Art Unit 3785