Prosecution Insights
Last updated: July 17, 2026
Application No. 17/341,945

THERMAL MODULATION OF AN INHALABLE MEDICAMENT

Non-Final OA §103
Filed
Jun 08, 2021
Priority
Aug 26, 2014 — provisional 62/042,224 +6 more
Examiner
ZIEGLER, MATTHEW D
Art Unit
3785
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
Michael Edward Breede
OA Round
6 (Non-Final)
48%
Grant Probability
Moderate
6-7
OA Rounds
0m
Est. Remaining
99%
With Interview

Examiner Intelligence

Grants 48% of resolved cases
48%
Career Allowance Rate
109 granted / 228 resolved
-22.2% vs TC avg
Strong +54% interview lift
Without
With
+54.0%
Interview Lift
resolved cases with interview
Typical timeline
3y 5m
Avg Prosecution
25 currently pending
Career history
279
Total Applications
across all art units

Statute-Specific Performance

§101
0.6%
-39.4% vs TC avg
§103
83.1%
+43.1% vs TC avg
§102
3.6%
-36.4% vs TC avg
§112
5.0%
-35.0% vs TC avg
Black line = Tech Center average estimate • Based on career data from 228 resolved cases

Office Action

§103
DETAILED ACTION This Office Action is in response to the filing of a Request for Continued Examination (RCE) and amendments therein filed 5/04/2026. As per the amendments, claims 1, 10, 13, 14, and 17-18 have been amended, and no claims have been added or cancelled. Thus, claims 1-20 are pending in the application. 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 5/04/2026 has been entered. 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 1-2, 5-7, and 9-13 are rejected under 35 U.S.C. 103 as being unpatentable over Lloyd et al. (US Pat. 5,957,124) in view of Takei (US Pub. 2010/0043792) in view of Schuster et al. (US Pat. 6,131,570). Regarding claim 1, Lloyd discloses a delivery system that delivers an inhalable medicament (drug delivery device 40 of Fig. 4), comprising: a delivery device including; an aspiration tube (see tubular channel 11 in Fig. 4, through which flow path 29 travels through); at least one heater adjacent to the aspiration tube (see Fig. 4 where there is both a formulation heating mechanism 45 and a heater 14, both of which are adjacent to the tubular channel 11) to selectively heat any of a plurality of discrete locations along a length of the aspiration tube (see Fig. 4 and Col. 11 lines 11-23 where the heat from heater 14 heats air going into the tubular channel 11 to heat the aerosol along the length of the channel, thus heating the aerosol at a plurality of locations axially along the length of the tube as it interacts with the heated air); and a controller that modulates a temperature of the at least one heater (see Fig. 4 and Col. 11 lines 11-23 where the heat from both the heater 14 (air heating mechanism 14, mislabeled as “5” at one point of the referenced section) and the formulation heating mechanism 45 are able to be controlled by a microprocessor 26), a location of the aspiration tube heated by the at least one heater (see Fig. 4 and Col. 11 lines 11-23 where heater 14 applied heat to incoming air that is entering tubular channel 11, and is thus adjacent to the tubular channel, and where formulation heating mechanism 45 heats the formulation before entering the tubular channel 11 and thus is adjacent to it, both of which apply heat to a location of the aspiration tube), and a temperature of an aerosol of the inhalable medicament traveling through the location of the aspiration tube adjacent to which the at least one heater is positioned to impart the aerosol with the target particle size (see Col. 10 lines 35-41 and Col. 11 lines 11-23 where the heater 14 imparts heat to the aerosol in the tubular channel 11, the drug being an aerosol once forced out of pores in membrane 3 (see Col. 11 lines 11-13) and the heat imparting a predetermined/ target particle size (see Col. 3 lines 12-16, and Col. 20 lines 56-67)); and a cartridge containing the inhalable medicament and connectable to the housing to selectively communicate the inhalable medicament to the aspiration tube (see Figs. 4 and 8-9 where disposable package 46 has containers 1 (cartridges) for holding the formulation 5, which are selectively communicable with the drug delivery device 40, as seen in Col. 1 lines 55-67, as the device transports a next container 1 into position and acts on the container with wall 2 and spring 22 during actuation (see Col. 1 lines 29-39)). Lloyd lacks a detailed description of the delivery device including a housing, and the aspiration tube carried by the housing. However, Takei teaches an inhaler device where there is a housing (see the inhaler of Fig. 2, having a housing case 17 that holds the inhaler components within), and the aspiration tube carried by the housing (see Fig. 2 where an aspiration tube is within cartridge 10 (see Figs. 4A-4B an aspiration tube formed by hollow needle 38) which resides with the housing case 17). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the inhaler system of Lloyd to be held within of a housing as taught by Takei, as it would provide an outer structure to hold the components together in a singular device, as well as protect the components from damage or contamination. The modified Lloyd device lacks a detailed description of the controller that: receives an input for a location within an airway of an individual to which the inhalable medicament is to be delivered; determines a target particle size that will enable the inhalable medicament to be delivered to the location within the airway of the individual. It is noted that the modified Lloyd device does have the use of heat for creating a target and uniform particle size (Lloyd; see Col. 3 lines 12-16, and Col. 20 lines 56-67), and does at least make note of the fact that the adjustment of particle size affects the location of the airway which the particles can reach (Lloyd; see Col. 1 lines 46-57). However, Schuster teaches a similar temperature controlled aerosol delivery device, where a controller receives an input for a location within an airway of an individual to which the inhalable medicament is to be delivered (see Col. 3 lines 44-47, Col. 4 lines 38-45 and lines 56-60, and Col. 16 lines 16-34 where the controller for the heating system is set based on a desired particle size, which is understood to alter the targeted region of the airway tract which the particles reach, and adjusts the amount of energy to be delivered based on the desired particle size and location); determines a target particle size that will enable the inhalable medicament to be delivered to the location within the airway of the individual (see Col. 3 lines 44-47, Col. 4 lines 38-45 and lines 56-60, and Col. 16 lines 16-34 where the controller adjusts the amount of energy to be delivered based on the desired particle size and location, the desired particle size being chosen based on the desired location for particle delivery). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the controller and heat system of the modified Lloyd device to adjust the outputted temperature based on a selected particle size which is based on a desired particle delivery site as taught by Schuster, as it would allow for the control over particle size independent of ambient conditions to more precisely target particular areas of the respiratory tract (Schuster; see abstract). Regarding claim 2, the modified Lloyd device wherein the at least one heater comprises a plurality of heaters positioned at different locations along a length of the aspiration tube (Lloyd; see Fig. 4 and Col. 11 lines 11-23 where the heat from both the heater 14 and the formulation heating mechanism 45 are located at different parts of the tubular channel 11). Regarding claim 5, the modified Lloyd device has the aspiration tube, and communication of the aerosol of the inhalable medicament from the cartridge to the aspiration tube (Lloyd; see Fig. 4 where tubular channel 11 connects to the containers 1, which hold the formulation 3 which is communicated to the channel by wall 2 and spring 22). The modified Lloyd device lacks a detailed description of a reservoir tap in communication with the aspiration tube, the reservoir tap including a conduit that selectively communicates with the cartridge to enable selective communication of the aerosol of the inhalable medicament from the cartridge to the aspiration tube. However, Takei further teaches a device for inhalation, with a reservoir tap in communication with the aspiration tube (see Figs. 4A-4B, where hollow needle 38 communicates with the tube at numeral 32), the reservoir tap including a conduit that selectively communicates with the cartridge to enable selective communication of the aerosol of the inhalable medicament from the cartridge to the aspiration tube (see Figs. 4A-4B where hollow needle 38 connects reservoir 2 with ejection head 8 having a heater (see [0038]) via the tube between them). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the cartridge/ spring actuation system of the modified Lloyd device to be a hollow needle for penetrating the membrane of the container that also has a heater as further taught by Takei, as it would be a simple substitution of one means for receiving liquid from a reservoir for another, with the benefit of the reservoir being fully sealed until pierced to prevent contamination. Regarding claim 6, the modified Lloyd device has a tap heater adjacent to the reservoir tap (Takei; see [0038] where a heater is placed adjacent to the aspiration conduit and hollow needle 38, for heating the liquid that leaves the reservoir, and thus modifying heater 45 in Fig. 4 of Lloyd). Regarding claim 7, the modified Lloyd device has wherein a position of the tap heater within the housing is stationary (Takei; see [0038] where a heater is placed adjacent to the aspiration conduit and hollow needle 38, and remains there unmoving). Regarding claim 9, the modified Lloyd device has wherein the controller controls the tap heater (Takei; see [0038] where the heater is part of the system of Lloyd, and the microprocessor 26 in Fig. 4 of Lloyd controls the outputted heat of the heaters as seen in Col. 11 lines 11-23). Regarding claim 10, the modified Lloyd device has wherein the predetermined particle size of the aerosol of the inhalable medicament (Lloyd; see Col. 3 lines 12-16, and Col. 20 lines 56-67) enables the aerosol to reach a predetermined destination within an airway of an individual who uses the delivery device (Lloyd; see Col. 20 lines 56-67). Regarding claim 11, the modified Lloyd device has wherein the predetermined destination comprises a lung of the individual (Lloyd; see Col. 20 lines 56-67). Regarding claim 12, the modified Lloyd device has wherein the predetermined destination comprises a particular lobe of a lung of the individual (Lloyd; see Col. 20 lines 56-67 where the lungs are made of lobes, and thus the medicament can reach a particular lobe. Further, Lloyd discloses particle sizes within the same range as the claimed invention, and are thus equally as capable of reaching a particular lobe of the lungs (see Col. 25 lines 5-12)). Regarding claim 13, the modified Lloyd device has wherein the predetermined destination comprises a trachea, a bronchus, a bronchiole, an alveolus, and pulmonary vasculature (Lloyd; see Col. 20 lines 56-67 where the medicament reaches the lung, and thus passes through and at least partially deposits in a trachea, a bronchus, a bronchiole, an alveoli, and pulmonary vasculature. Further, Lloyd discloses particle sizes within the same range as the claimed invention, and are thus equally as capable of reaching the same parts of the respiratory tract (see Col. 25 lines 5-12)). Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Lloyd in view of Takei in view of Schuster as applied to claim 2 above, and further in view of Counts et al. (US Pat. 5,338,594). Regarding claim 3, the modified Lloyd device has wherein the controller modulates a temperature of each heater of the plurality of heaters (Lloyd; see Col. 11 lines 11-23 where each of heater 14 and 45 are controlled by microprocessor 26). The modified Lloyd device lacks a detailed description of wherein the controller modulates a temperature of each heater of the plurality of heaters individually from every other heater of the plurality of heaters. However, Counts teaches a device for inhaling, where the controller modulates a temperature of each heater of the plurality of heaters individually from every other heater of the plurality of heaters (see Fig. 6 and Col. 5 lines 42-60 and Col. 12 lines 47-65 where a plurality of heaters in assembly 89 are individually modulated by control circuitry 41 for individual selection of the heaters). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the control over the heaters of the modified Lloyd device to include means for selecting between the heaters and independently controlling them as taught by Counts, as it would allow for a user to cycle the heater between a plurality of heat levels for better control over the applied heat. Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Lloyd in view of Takei in view of Schuster as applied to claim 2 above, and further in view of Nichols et al. (US Pub. 2003/0230303). Regarding claim 4, the modified Lloyd device has the at least one heater is positioned adjacent the location of the aspiration tube (Lloyd; Fig. 4 where heaters 14 and 45 are adjacent to the tubular channel 11). The modified Lloyd device lacks a detailed description of wherein the at least one heater is positioned around an entirety of an outer periphery of the location of the aspiration tube. However, Nichols teaches a drug aerosolizing and heating device wherein the at least one heater is positioned around an entirety of an outer periphery of the location of the aspiration tube (Nichols; see [0051] and [0060] where the heater can be a tube or coil around the passage 102). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the position of the heater (Fig. 4, heater 14) of the modified Lloyd device to be around the entire periphery of the channel as taught by Nichols, as it would be a simple substitution of one location for a heater for another location, to yield the predictable result of still applying heat to the air entering the channel. Further, it is noted that placing the heater 14 in Fig. 4 of Lloyd to be around the proximal end of the channel 11 closest to the air intakes at desiccator 41/ opening 38 would have no functional difference on the Lloyd device. Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Lloyd in view of Takei in view of Schuster as applied to claim 6 above, and further in view of Counts et al. (US Pat. 5,060,671). Regarding claim 8, the modified Lloyd device has the tap heater (Takei; see [0038]). The modified Lloyd device lacks a detailed description of wherein the tap heater moves with the reservoir tap. However, Counts teaches a inhalation device, where a heater is moved over a tube structure (see Figs. 7G-H and Col. 7 lines 23-46 where the heaters 760/771 move along the tube structure 76/77, either manually or automatically). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the reservoir tap heater of the modified Lloyd device to be moveable along the tap as taught by Counts, as it would allow for the heater to be adjusted to alter the location of the heating, for better control over the heat output of the tap heater. Claims 14 and 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Lloyd in view of Takei in view of Schuster in view of Counts et al. (US Pat. 5,338,594). Regarding claim 14, Lloyd discloses a delivery device that delivers an inhalable medicament (drug delivery device 40 of Fig. 4), comprising: a delivery device including; an aspiration tube (see tubular channel 11 in Fig. 4, through which flow path 29 travels through); a plurality of heaters that heat discrete locations of the aspiration tube (see Fig. 4 where there is both a formulation heating mechanism 45 and a heater 14, both of which are adjacent to the tubular channel 11; see Fig. 4 and Col. 11 lines 11-23 where the heat from heater 14 and heating mechanism 45 heats air going into the tubular channel 11/ a section of the tubular channel 11, to heat the aerosol along the length of the channel, thus heating the aerosol at a plurality of locations axially along the length of the tube as it interacts with the heated air); and a controller that modulates a temperature of each heater of the plurality of heaters (see Fig. 4 and Col. 11 lines 11-23 where the heat from both the heater 14 (air heating mechanism 14, mislabeled as “5” at one point of the referenced section) and the formulation heating mechanism 45 are able to be controlled by a microprocessor 26), locations of the aspiration tube heated by the plurality of heaters (see Fig. 4 and Col. 11 lines 11-23 where heater 14 applied heat to incoming air that is entering tubular channel 11, and is thus adjacent to the tubular channel, and where formulation heating mechanism 45 heats the formulation before entering the tubular channel 11 and thus is adjacent to it), and a temperature of an aerosol of the inhalable medicament traveling through the locations of the aspiration tube heated by the plurality of heaters (see Col. 10 lines 35-41 and Col. 11 lines 11-23 where the heater 14 imparts heat to the aerosol in the tubular channel 11, the drug being an aerosol once forced out of pores in membrane 3 (see Col. 11 lines 11-13)) to impart the vapor exiting the aspiration tube with the target particle size to enable the aerosol to reach the location within the airway of the individual (see Col. 3 lines 12-16, and Col. 20 lines 56-67 where the heat makes the aerosol have a predetermined particle size, and see Col. 25 lines 5-12 where the size allows for lung delivery, thus allowing the particles to reach the lung location); and a cartridge containing the inhalable medicament and connectable to the housing to selectively communicate the inhalable medicament to the aspiration tube (see Figs. 4 and 8-9 where disposable package 46 has containers 1 (cartridges) for holding the formulation 5, which are selectively communicable with the drug delivery device 40, as seen in Col. 1 lines 55-67, as the device transports a next container 1 into position and acts on the container with wall 2 and spring 22 during actuation (see Col. 1 lines 29-39)). Lloyd lacks a detailed description of the delivery device including a housing, and the aspiration tube carried by the housing. However, Takei teaches an inhaler device where there is a housing (see the inhaler of Fig. 2, having a housing case 17 that holds the inhaler components within), and the aspiration tube carried by the housing (see Fig. 2 where an aspiration tube is within cartridge 10 (see Figs. 4A-4B an aspiration tube formed by hollow needle 38) which resides with the housing case 17). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the inhaler system of Lloyd to be held within of a housing as taught by Takei, as it would provide an outer structure to hold the components together in a singular device, as well as protect the components from damage or contamination. The modified Lloyd device lacks a detailed description of the controller that: receives an input for a location within an airway of an individual to which the inhalable medicament is to be delivered; determines a target particle size that will enable the inhalable medicament to be delivered to the location within the airway of the individual who uses the delivery device. It is noted that the modified Lloyd device does have the use of heat for creating a target and uniform particle size (Lloyd; see Col. 3 lines 12-16, and Col. 20 lines 56-67), and does at least make note of the fact that the adjustment of particle size affects the location of the airway which the particles can reach (Lloyd; see Col. 1 lines 46-57). However, Schuster teaches a similar temperature controlled aerosol delivery device, where a controller receives an input for a location within an airway of an individual to which the inhalable medicament is to be delivered (see Col. 3 lines 44-47, Col. 4 lines 38-45 and lines 56-60, and Col. 16 lines 16-34 where the controller for the heating system is set based on a desired particle size, which is understood to alter the targeted region of the airway tract which the particles reach, and adjusts the amount of energy to be delivered based on the desired particle size and location); determines a target particle size that will enable the inhalable medicament to be delivered to the location within the airway of the individual (see Col. 3 lines 44-47, Col. 4 lines 38-45 and lines 56-60, and Col. 16 lines 16-34 where the controller adjusts the amount of energy to be delivered based on the desired particle size and location, the desired particle size being chosen based on the desired location for particle delivery). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the controller and heat system of the modified Lloyd device to adjust the outputted temperature based on a selected particle size which is based on a desired particle delivery site as taught by Schuster, as it would allow for the control over particle size independent of ambient conditions to more precisely target particular areas of the respiratory tract (Schuster; see abstract). The modified Lloyd device lacks a detailed description of wherein the controller modulates a temperature of each heater of the plurality of heaters separately from every other heater of the plurality of heaters. However, Counts teaches a device for inhaling, where the controller modulates a temperature of each heater of the plurality of heaters individually from every other heater of the plurality of heaters (see Fig. 6 and Col. 5 lines 42-60 and Col. 12 lines 47-65 where a plurality of heaters in assembly 89 are individually modulated by control circuitry 41 for individual selection of the heaters). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the control over the heaters of the modified Lloyd device to include means for selecting between the heaters and independently controlling them as taught by Counts, as it would allow for a user to cycle the heater between a plurality of heat levels for better control over the applied heat. Regarding claim 16, the modified Lloyd device has wherein the plurality of heaters are spaced apart from each other along a length of the aspiration tube (Lloyd; see Fig. 4 and Col. 11 lines 11-23 where the heat from both the heater 14 and the formulation heating mechanism 45 are located at different parts of the tubular channel 11). Regarding claim 17, the modified Lloyd device has wherein the target particle size is about 0.1 μm to about 15 μm (Lloyd; see Col. 25 lines 5-12). Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Lloyd in view of Takei in view of Schuster in view of Counts et al. as applied to claim 14 above, and further in view of Thorens et al. (US Pub. 2011/0094523). Regarding claim 15, the modified Lloyd device has the plurality of heaters are positioned around the aspiration tube. The modified Lloyd device lacks a detailed description of wherein each heater of the plurality of heaters is positioned around an entirety of an outer periphery of the aspiration tube. However, Thorens teaches an inhalation device, where heating elements are arranged around the periphery of a tube (see Fig. 1 where heating coil 119 is arranged around the capillary wick 117). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the plurality of heater elements of the modified Lloyd device to be arranged around the channel as taught by Thorens, as it would be a simple substitution of one location of a heating element for another, with the benefit of surrounding the tube to deliver a more even and complete heating of aerosol in the tube. Claims 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Lloyd in view of Schuster. Regarding claim 18, Lloyd discloses a method for modulating a particle size of an inhalable medicament (see Col. 3 lines 12-16, and Col. 20 lines 56-67 where applied heat modulates a particle size of the aerosol), comprising: controllably heating an aerosol of the inhalable medicament traveling through an aspiration tube of an inhaled medicament delivery device (see Fig. 4 where heater 14 applied heat to tubular channel 11, which contains the aerosol, and see Col. 11 lines 11-23 where the heat from the heater 14 is controlled by a microprocessor 26 to heat an aerosol forced out of pores 3) to a temperature that will reduce a particle size of the inhalable medicament to the target particle size upon exiting the aspiration tube to enable the inhalable medicament to flow to the location within the airway of the individual (see Col. 3 lines 12-16, and Col. 20 lines 56-67 where the applied heat from heater 14 is controlled to apply a predetermined particle size to the inhalable medicament, to flow to the airway of the individual (see Col. 25 lines 5-12)). Lloyd lacks a detailed description of determining a location within an airway of an individual to which the inhalable medicament is to be delivered; determining a target particle size that will enable the inhalable medicament to be delivered to the location within the airway of the individual. It is noted that Lloyd does have the use of heat for creating a target and uniform particle size (Lloyd; see Col. 3 lines 12-16, and Col. 20 lines 56-67), and does at least make note of the fact that the adjustment of particle size affects the location of the airway which the particles can reach (Lloyd; see Col. 1 lines 46-57). However, Schuster teaches a similar temperature controlled aerosol delivery device, where a controller receives an input for a location within an airway of an individual to which the inhalable medicament is to be delivered (see Col. 3 lines 44-47, Col. 4 lines 38-45 and lines 56-60, and Col. 16 lines 16-34 where the controller for the heating system is set based on a desired particle size, which is understood to alter the targeted region of the airway tract which the particles reach, and adjusts the amount of energy to be delivered based on the desired particle size and location); determines a target particle size that will enable the inhalable medicament to be delivered to the location within the airway of the individual (see Col. 3 lines 44-47, Col. 4 lines 38-45 and lines 56-60, and Col. 16 lines 16-34 where the controller adjusts the amount of energy to be delivered based on the desired particle size and location, the desired particle size being chosen based on the desired location for particle delivery). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the controller and heat system of Lloyd to adjust the outputted temperature based on a selected particle size which is based on a desired particle delivery site as taught by Schuster, as it would allow for the control over particle size independent of ambient conditions to more precisely target particular areas of the respiratory tract (Schuster; see abstract). Regarding claim 19, the modified Lloyd device has wherein controllably heating the aerosol comprises controllably heating the aerosol at a plurality of different discrete locations along a length of the aspiration tube (Lloyd; see Fig. 4 and Col. 11 lines 11-23 where the heat from heater 14 heats air going into the tubular channel 11 to heat the aerosol along the length of the channel, thus heating the aerosol at a plurality of locations axially along the length of the tube as it interacts with the heated air). Regarding claim 20, the modified Lloyd device has wherein controllably heating the aerosol comprises controllably heating the aerosol to different temperatures at the plurality of different discrete locations along the length of the aspiration tube (Lloyd; see Fig. 4 and Col. 11 lines 11-23 where the heat from heater 14 heats air going into the tubular channel 11 to heat the aerosol along the length of the channel, thus creating a heating gradient along the length of the channel, such that aerosol closest to heater 14 is initially heated to a first temperature, and as the aerosol travels along channel 11 to mouthpiece 30 it continues to be heated towards the target temperature based on the temperature gradient, which is a constantly changing temperature based on the axial location in channel 11). Response to Arguments Applicant’s arguments with respect to claims 1-20 have been considered but are moot because the new ground of rejection does not rely on the combination of references applied in the prior rejection of record. Specifically, the newly applied Schuster teaching reference teaches a controller and heater system for an inhalable aerosol which adjusts the heat energy to alter the particle size, in order to specifically target particular areas of the airway. For the reasons above, the rejections hold. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW D ZIEGLER whose telephone number is (571)272-3349. The examiner can normally be reached Mon-Fri 10:00-6:00. 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, Timothy Stanis can be reached at (571)272-5139. 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. /MATTHEW D ZIEGLER/Examiner, Art Unit 3785 /TIMOTHY A STANIS/Supervisory Patent Examiner, Art Unit 3785
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Prosecution Timeline

Show 9 earlier events
Apr 15, 2025
Response after Non-Final Action
Aug 13, 2025
Non-Final Rejection mailed — §103
Nov 13, 2025
Response Filed
Jan 02, 2026
Final Rejection mailed — §103
Mar 04, 2026
Response after Non-Final Action
May 04, 2026
Request for Continued Examination
May 08, 2026
Response after Non-Final Action
May 29, 2026
Non-Final Rejection mailed — §103 (current)

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Prosecution Projections

6-7
Expected OA Rounds
48%
Grant Probability
99%
With Interview (+54.0%)
3y 5m (~0m remaining)
Median Time to Grant
High
PTA Risk
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