DETAILED ACTION
This Office Action is in response to the filing of a Request for Continued Examination (RCE) filed 1/06/2026. As per the amendment, claims 1, 13, and 22 have been amended, and no claims have been added or cancelled. Thus, claims 1-3, 5-19, and 21-27 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 1/06/2026 has been entered.
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1 recites the term “wherein-the” in line 12. Examiner suggests changing to read --wherein the-- in order to remove an erroneous hyphenation.
Appropriate correction is required.
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 1-3, 5, 9, 22-24 are rejected under 35 U.S.C. 103 as being unpatentable over McFarland, Jr. (US Pat. 6,729,327; hereinafter ‘McFarland’) in view of Oldfield et al. (US Pub. 2018/007,1469) in view of Siegel et al. (US Pat. 10,279,155).
Regarding claim 1, McFarland discloses a spray device for the oral administration of a therapeutic, active agent (see system of Fig. 1), comprising a liquid container for holding an amount of a liquid to be nebulized that comprises the active agent (medication module 71 in Fig. 6) and comprising an inhalation member (the system of mouthpiece 68, aerosol nozzle 69, and nebulizing shroud 70 in Fig. 6 (mouthpiece 7 of Fig. 1)), comprising a mouthpiece that is intended and adapted to be received orally by a user (mouthpiece 68 in Fig. 6), wherein said inhalation member is spatially separated from the container and is coupled to the container via a flexible fluid line (see Fig. 6 where medication module 71 and the mouthpiece 68 are spatially separate from one another, being connected by tube 8 (which appears to be mislabeled and should be fluid supply tube 67 as seen in Col. 5 lines 8-10)), wherein said inhalation member comprises a spray nozzle unit (aerosol nozzle 69 in Fig. 6) which is configured and adapted to receive a pressurized liquid under an elevated operating pressure, containing the active agent, and to create a mist from said pressurized liquid containing the active agent (see Col. 14 lines 43-47 and 55-62 where the mouthpiece 68 receives medication from tubing 8, and pressurized gas from oxygen gas supply 66, when then combine at mouthpiece 68 to form a liquid that is under an elevated operating pressure, and thus pressurized, before reaching nozzle 69 where it atomizes; see also Col. 6 lines 32-34, Col. 8 lines 20-29, and Col. 13 lines 5-17 where the oxygen gas is understood to be some low gauge pressure (less than 50 psi above atmosphere) which makes it pressurized, and is sent from the regulator to the environmental control unit, then to the nebulizer), wherein said spray nozzle unit is fixated in said inhalation member (see Fig. 1 and 6, where the mouthpiece 7 is the inhalation member, and the aerosol nozzle 69 is placed within it so as to be fixed to the dispensing cup 68 by ultrasonic welding; see also Col. 14 line 65 to Col. 15 line 3), wherein the mouthpiece comprises a spray cavity (shroud 70 in Fig. 6) which, during use, opens into the oral cavity of the user (see Col. 14 line 38 to Col. 15 line 10 where the nebulizing shroud 70 dispenses the aerosol to the mouth of the user), wherein the spray nozzle unit opens into the spray cavity to deliver the mist via said spray cavity to the oral cavity of the user (see Col. 14 line 38 to Col. 15 line 10 where nebulizing shroud 70 has some cavity that receives the aerosol formed by aerosol nozzle 69, and directs it to the mouth of the user), wherein the inhalation member comprises at least one air inlet which enables the user to inhale through the mouthpiece and directs an inhaled air stream via an airflow path to the spray cavity (see Col. 14 lines 54-64 where the nebulizing shroud 70 has at least one air inlet from aerosol nozzle 69 and mouthpiece 68, from which the gas flow from gas line 66 flows from).
McFarland lacks a detailed description of wherein the mouthpiece is intended and arranged to be received between the lips of the user, comprising a base member that holds said mouthpiece, wherein the inhalation member comprises an edge on a circumference of the inhalation member between said base member and said mouthpiece for receiving a dental element of the user. It is understood that McFarland does disclose a mouthpiece, and that a mouthpiece is understood to be placed into the mouth, and thus between the lips of the user.
However, Oldfield teaches a similar respiratory device with a mouthpiece, wherein the mouthpiece is intended and arranged to be received between the lips of the user (see Figs. 13A-13B where mouthpiece 1017 is placed into the mouth so that teeth are on biting portion 1019; see [0406]), comprising a base member that holds said mouthpiece (see Figs. 13A-13B and [0406] where flange 1018 is a base member for the mouthpiece 1017), wherein the inhalation member comprises an edge on a perimeter of the inhalation member between said base member and said mouthpiece for receiving a dental element of the user (see Figs. 13A-13B and [0406] where the intersection of biting portion 1019 and flange 1018 creates an edge surface around the perimeter of the mouthpiece 1017, that sits between the base of flange 1018 and the mouthpiece entrance at seal 1022). It is understood that McFarland does disclose a mouthpiece, and that a mouthpiece is understood to be placed into the mouth, and thus between the lips of the user.
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 mouthpiece of McFarland to go between the lips and have an edge and base as taught by Oldfield, as it would ensure that all of the aerosol is received into the mouth of the user, while providing a means for the user’s mouth to hold onto and retain the proper placement of the mouthpiece within the mouth.
In the alternative that the modified McFarland device does not have a pressurized liquid under an elevated operating pressure, then it is taught by Siegel.
Siegel teaches a device for delivering an air and liquid mixture to an orifice of a patient, where the liquid is pressurized under an elevated operating pressure (see Figs. 3-3C and Col. 4 lines 6-16 and Col. 20 line 64 to Col. 21 line 12 where the liquid can be held under pressure by a pressurizing liquid supply means (e.g. a syringe 360)).
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 liquid medicament source of the modified McFarland device to be a syringe as taught by Siegel, as it would be a simple substitution of one means for expelling the liquid for another (Siegel; Col. 20 line 64 to Col. 21 line 12), with the benefit of providing more precise control over the amount of liquid being delivered (Siegel; see Col. 4 lines 6-16).
Regarding claim 2, the modified McFarland device has wherein the liquid line maintains a substantially fixed connection with the spray nozzle unit at a first end (McFarland; see Fig. 6 where tube 8 (67) maintains connection with mouthpiece 68; see also Col. 15 lines 5-10), wherein the liquid container is manually detachably coupled to a second end of the liquid line (McFarland; see Col. 8 lines 15-16 where the medicine chamber 9 (analogous to module 71 in Fig. 6) is disposable, and thus able to be detached from the system, including the tube 8 (67)).
Regarding claim 3, the modified McFarland device has wherein the edge comprises a shoulder on a circumference of the inhalation member (Oldfield; see Figs. 13A-13B flange 1018 being a shoulder off of biting portion 1019).
Regarding claim 5, the modified McFarland device has wherein said airflow path crosses an airflow resistance member (McFarland; see Col. 14 lines 54-64 where the front end of the shroud 70 has a geometric shape hole, such that the front end of the shroud 70 has airflow resisting members that surround the hole to give it its shape).
Regarding claim 9, the modified McFarland device has wherein the liquid line comprises a flexible tube (McFarland; tube 8 (67) in Col. 5 lines 8-10 which is understood to have some amount of flexibility as it is worn on the head of a person which is mobile).
Regarding claim 22, the modified McFarland device has wherein the spray nozzle unit opens into the spray cavity to deliver the mist via said spray cavity to the oral cavity of the user, targeting a pharyngeal region (McFarland; see Col. 1 lines 24-27, and Col. 2 lines 1-5 and lines 24-25).
Regarding claim 23, the modified McFarland device has wherein the liquid container is manually detachably coupled to a second end of the liquid line (McFarland; see Col. 8 lines 15-16 where the medicine chamber 9 (analogous to module 71 in Fig. 6) is disposable, and thus able to be detached from the system, including the tube 8 (67)).
The modified McFarland device lacks a detailed description of means of a manually detachable coupling.
However, Siegel further teaches a similar system for attaching a source of fluid to a tube to be delivered to a user, where the liquid container connects to the fluid line by a luer coupling (see Figs. 3B-3C where luer connector 365 attaches the syringe 360 to the tubular body 325 of the tubing line 380).
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 connection of the liquid container to the fluid line of the modified McFarland device to be a luer connector as taught by Siegel, as it would be a simple substitution of one means for detaching the liquid container for another, to yield the predictable result of allowing detaching and replacement of the liquid container.
Regarding claim 24, the modified McFarland device has wherein the manually detachable coupling comprises a Luer coupling (Siegel; see Figs. 3B-3C luer connections 365 and 330).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over McFarland in view of Oldfield in view of Siegel as applied to claim 1 above, and further in view of Piper (US Pat. 8,596,263).
Regarding claim 6, the modified McFarland device has said airflow path.
The modified McFarland device lacks a detailed description of wherein that said airflow path crosses a filter member.
However, Piper teaches a similar nebulizer device, where the nebulizer has a post-nebulization filter (see Fig. 15 post nebulization filter 70 made of filter membrane 80 before reaching mouthpiece 82).
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 nebulizer of the modified McFarland device to have a post-nebulization filter as taught by Piper, as it would reduce the amount of residual medicament (Piper; see Col. 11 lines 30-35).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over McFarland in view of Oldfield in view of Siegel as applied to claim 1 above, and further in view of Yeates (US Pat. 8,616,532).
Regarding claim 7, the modified McFarland device has at least one air inlet and an outlet of the spray nozzle unit.
The modified McFarland device lacks a detailed description of wherein the at least one air inlet is in open communication with a number of air channels that are distributed radially around an outlet of the spray nozzle unit and open in pairs toward one another.
However, Yeates teaches a similar aerosol generator, where the at least one air inlet is in open communication with a number of air channels that are distributed radially around an outlet of the spray nozzle unit and open in pairs toward one another (see Figs. 7A-7F where an aerosol concentrator has a flow path through 5100, leading to a plurality of acceleration nozzles 7002, 7102, 7202 located towards the outlet at 7032, formed as radially opposite pairs which are aligned with one another).
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 outlet of the nebulizer of the modified McFarland device to include a plurality of radially located air channels as an aerosol concentrator as taught by Yeates, as it would accelerate the flow of aerosol to ensure a better jet stream of concentrated particles (Yeates; see Col. 26 line 63 to Col. 26 line 4).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over McFarland in view of Oldfield in view of Siegel as applied to claim 1 above, and further in view of Srinivasan et al. (US Pat. 8,251,055).
Regarding claim 8, the modified McFarland device has said container.
The modified McFarland device lacks a detailed description of wherein said container is a disposable medicinal syringe.
However, Srinivasan teaches a delivery system for an aerosol to a patient, where a disposable syringe can be used (see Figs. 11-12 and Col. 17 lines 17-37).
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 liquid container of the modified McFarland device to be a disposable syringe as taught by Srinivasan, as it would allow for the rest of the nebulization system to be reusable, while allowing for the liquid to be replaced or changed for different patients and/or different medicaments.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over McFarland in view of Oldfield in view of Siegel as applied to claim 1 above, and further in view of Leonard (US Pat. 4,820,287).
Regarding claim 10, the modified McFarland device has wherein the container with an outlet to the liquid line.
The modified McFarland device lacks a detailed description of wherein the container comprises a movable plunger member on a side remote from an outlet to the liquid line that transmits said elevated operating pressure to the liquid.
However, Leonard teaches a similar device for expelling a fluid from a fluid holder (device of Fig. 1), where a plunger member which is sealingly displaceable therein separate from the outlet (Fig. 1 plunger head 20 within the body of the device, separate from the outlet at 2), said plunger being configured and adapted to expel liquid from said reservoir towards said nozzle under an elevated operating pressure (see Col. 3 lines 25-32 and out of the nozzle at needle holder 2 in Fig. 1).
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 medicament module of McFarland to be operated by a lever-actuated plunger system as taught by Leonard, as it would be a simple substitution of one type of fluid expelling module for another, to yield the predictable result of being able to provide fluid to the spray nozzle. Further, it would provide the user with a manual means of expelling the liquid (for better control over when nebulization occurs), and providing set values for the expelled fluid to have consistent volume nebulization (via the ratchet and tooth mechanism of Leonard).
Claims 11-12 and 25-26 are rejected under 35 U.S.C. 103 as being unpatentable over McFarland in view of Oldfield in view of Siegel as applied to claim 1 above, and further in view of Dunne et al. (US Pub. 2021/0228822).
Regarding claim 11, the modified McFarland device has said spray nozzle.
The modified McFarland device lacks a detailed description of wherein said spray nozzle comprises a nozzle plate having a number of substantially identical nozzle orifices that receive said liquid and nebulize said liquid into droplets of approximately equal size, wherein said orifices have an effective diameter of at least 3.5 micrometre.
However, Dunne teaches a similar nebulizer device, where a spray nozzle comprises a nozzle plate having a number of substantially identical nozzle orifices that receive said liquid (see nozzle 12 in Figs. 2-3, having a plurality of channels 12d that expel the liquid; see [0102]-[0103]) and nebulize said liquid into droplets of approximately equal size, wherein said orifices have an effective diameter of at least 3.5 micrometre (see [0102]-[0103] where the channels 12d expel the liquid, and the outputted droplets have a diameter of 3-20 microns, as seen in [0046] and [0122]).
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 nebulizer of the modified McFarland device to have a channel that outputs between 3 to 10 microns, such as 4 microns, as it would be a simple matter of design choice for one of ordinary skill in the art to choose the size of the particles they wish to nebulize, such as 4 microns.
Regarding claim 12, the modified McFarland device has said spray nozzle.
The modified McFarland device lacks a detailed description of wherein said spray nozzle comprises a nozzle plate having a number of substantially identical nozzle orifices that receive said liquid and nebulize said liquid into droplets of approximately equal size, wherein said orifices have an effective diameter of below 3.5 micrometre.
However, Dunne teaches a similar nebulizer device, where a spray nozzle comprises a nozzle plate having a number of substantially identical nozzle orifices that receive said liquid (see nozzle 12 in Figs. 2-3, having a plurality of channels 12d that expel the liquid; see [0102]-[0103]) and nebulize said liquid into droplets of approximately equal size, wherein said orifices have an effective diameter of below 3.5 micrometre (see [0102]-[0103] where the channels 12d expel the liquid, and the outputted droplets have a diameter of 3-20 microns, as seen in [0046] and [0122]).
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 nebulizer of the modified McFarland device to have a channel that outputs between 3 to 10 microns, such as 3 microns, as it would be a simple matter of design choice for one of ordinary skill in the art to choose the size of the particles they wish to nebulize, such as 3 microns.
Regarding claim 25, the modified McFarland device has wherein said orifices have an effective diameter between 3.5 micrometre and 10 micrometre (Dunne; see [0102]-[0103] where channels 12d expel fluid and are 3-20 microns, as seen in [0046] and [0122], as modifying the orifices of McFarland).
Regarding claim 26, the modified McFarland device has wherein said orifices have an effective diameter between 1 micrometre and 3.5 micrometre (Dunne; see [0102]-[0103] where channels 12d expel fluid and are 3-20 microns, as seen in [0046] and [0122], as modifying the orifices of McFarland).
Claims 13-14, 16-19, 21 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over McFarland in view of Srinivasan in view of Leonard in view of Oldfield.
Regarding claim 13, McFarland discloses force control system (system of Figs. 1 and 6), comprising a holder (medication module holder 72 in Fig. 6) a disposable product container (see Col. 8 lines 15-16 where the medicine chamber 9 (analogous to module 71 in Fig. 6) is disposable, and thus can be exchanged), which product container comprises a reservoir holding a liquid to be nebulized that contains a therapeutic (see Col. 1 lines 24-27, and Col. 2 lines 1-5 and lines 24-25), active agent for oral administration (medication module 71 in Fig. 6); - a mouthpiece spatially separated from the product container (mouthpiece 68 in Fig. 6 which is separate from medication module 71), which is intended and adapted to be orally received between lips by a user (mouthpiece 68 goes into the mouth in Fig. 6), said mouthpiece comprising a spray nozzle (aerosol nozzle 69 in Fig. 6) which is configured and adapted to receive said liquid to be nebulized under an elevated operating pressure and to dispense a mist therefrom containing the active agent (see Col. 14 lines 43-47 and 55-62); and - a liquid line between the product container and the mouthpiece connecting said reservoir to said spray nozzle for a supply of said liquid (see Fig. 6 where medication module 71 and the mouthpiece 68 are spatially separate from one another, being connected by tube 8 (which appears to be mislabeled and should be fluid supply tube 67 as seen in Col. 5 lines 8-10)); wherein the liquid reservoir debouches on a first side into said liquid line and an opposite side (see Fig. 6 where fluid line 8 (67) connects to the medication module 71 on a first end, and the medication module 71 has an opposing end), wherein the mouthpiece comprises a spray cavity (shroud 70 in Fig. 6) which, during use, opens into the oral cavity of the user (see Col. 14 line 38 to Col. 15 line 10 where the nebulizing shroud 70 dispenses the aerosol to the mouth of the user), wherein the spray nozzle opens into the spray cavity to deliver the mist via said spray cavity to the oral cavity of the user (see Col. 14 line 38 to Col. 15 line 10 where nebulizing shroud 70 has some cavity that receives the aerosol formed by aerosol nozzle 69, and directs it to the mouth of the user), and wherein the inhalation member comprises at least one air inlet which enables the user to inhale through the mouthpiece and directs and inhaled air stream via an airflow path to the spray cavity (see Col. 14 lines 54-64 where the nebulizing shroud 70 has at least one air inlet from aerosol nozzle 69 and mouthpiece 68, from which the gas flow from gas line 66 flows from).
McFarland lacks a detailed description of wherein the holder is for a disposable medicinal syringe.
However, Srinivasan teaches a delivery system for an aerosol to a patient, where a disposable syringe can be used (see Figs. 11-12 and Col. 17 lines 17-37).
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 liquid product container of McFarland to be a disposable syringe as taught by Srinivasan, as it would allow for the rest of the nebulization system to be reusable, while allowing for the liquid to be replaced or changed for different patients and/or different medicaments.
The modified McFarland device lacks a detailed description of an opposite side of the liquid reservoir comprises a plunger member being sealingly displaceable therein, said plunger member being configured and adapted to expel liquid from said reservoir towards said spray nozzle under an elevated operating pressure; wherein said holder comprises a push member that engages directly or indirectly said plunger member, said push member being configured and adapted to impose said elevated operating pressure on said plunger; wherein said holder comprises at least one manipulator member that is configured and intended to transmit a manual force by the user to said push member; and wherein said manipulator member is coupled to the push member via a power transmission that provides a force-increasing power transmission.
However, Leonard teaches a similar device for expelling a fluid from a fluid holder (device of Fig. 1), where a plunger member which is sealingly displaceable therein (see Fig. 1 plunger head 20 within the body of the device), said plunger being configured and adapted to expel liquid from said reservoir towards said nozzle under an elevated operating pressure (see Col. 3 lines 25-32 and out of the nozzle at needle holder 2 in Fig. 1); wherein said holder comprises a push member that engages directly or indirectly said plunger member (plunger 6 which engages with plunger head 20 in Fig. 1), said push member being configured and adapted to impose said elevated operating pressure on said plunger (see Col. 4 lines 34-43); wherein said holder comprises at least one manipulator member that is configured and intended to transmit a manual force by the user to said push member (ratchet 8 in Fig. 1 which transmits manual force to the toothed rack 7 to then transmit force to the plunger 6); and wherein said manipulator member is coupled to the push member via a power transmission that provides a force-increasing power transmission (lever 9 in Fig. 1 which moves ratchet 8 to interact with toothed rack 7, providing a power transmission due to the leverage of the lever).
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 medicament module of the modified McFarland device to be operated by a lever-actuated plunger system as taught by Leonard, as it would be a simple substitution of one type of fluid expelling module for another, to yield the predictable result of being able to provide fluid to the spray nozzle. Further, it would provide the user with a manual means of expelling the liquid (for better control over when nebulization occurs), and providing set values for the expelled fluid to have consistent volume nebulization (via the ratchet and tooth mechanism of Leonard).
The modified McFarland device lacks a detailed description of wherein the mouthpiece is intended and adapted to be orally received between lips by a user, and wherein said mouthpiece connects to a base member of an inhalation member that comprises an edge of a circumference of said inhalation member between said base member and said mouthpiece for receiving a dental element of the user. It is understood that the modified McFarland device does disclose a mouthpiece, and that a mouthpiece is understood to be placed into the mouth, and thus between the lips of the user.
However, Oldfield teaches a similar respiratory device with a mouthpiece, wherein the mouthpiece is intended and arranged to be received between the lips of the user (see Figs. 13A-13B where mouthpiece 1017 is placed into the mouth so that teeth are on biting portion 1019; see [0406]), comprising a base member that holds said mouthpiece (see Figs. 13A-13B and [0406] where flange 1018 is a base member for the mouthpiece 1017), wherein the inhalation member comprises an edge on a perimeter of the inhalation member between said base member and said mouthpiece for receiving a dental element of the user (see Figs. 13A-13B and [0406] where the intersection of biting portion 1019 and flange 1018 creates an edge surface around the perimeter of the mouthpiece 1017, that sits between the base of flange 1018 and the mouthpiece entrance at seal 1022). It is understood that McFarland does disclose a mouthpiece, and that a mouthpiece is understood to be placed into the mouth, and thus between the lips of the user.
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 mouthpiece of the modified McFarland device to go between the lips and have an edge and base as taught by Oldfield, as it would ensure that all of the aerosol is received into the mouth of the user, while providing a means for the user’s mouth to hold onto and retain the proper placement of the mouthpiece within the mouth.
Regarding claim 14, the modified McFarland device has wherein said power transmission comprises a lever (Leonard; see lever 9 in Fig. 1) which is configured to allow first displacement that axially displaces the push member over a second displacement (Leonard; see Fig. 1 and Col. 4 lines 34-43 where the motion of the lever causes a first displacement of the ratchet 8, which results in a second displacement of the plunger 6), wherein the first displacement is greater than the second displacement (Leonard; see Fig. 1 where the displacement that arced ratchet 8 undergoes when actuated by lever 7 is greater than the displacement of the linear plunger 6, which has its displacement reduced by the button 11 and spring 15 as seen in Figs. 1 and 3).
Regarding claim 16, the modified McFarland device has wherein the transmission comprises an intermediate device which is resiliently coupled to the push member (Leonard; see Fig. 1 and 6 where button 11 is resiliently coupled to the toothed rack 7 and thus to plunger 6) and connects to the at least one manipulator member (Leonard; see Fig. 1 where button 11 is coupled to the same system as lever 9, and moves in relation to the lever 9 when pressed).
Regarding claim 17, the modified McFarland device has herein the holder comprises a housing with an axial body cavity that accommodates the intermediate device and the push member (Leonard; see Fig. 1 where the body of the device is axial, and accommodates the button 11 and toothed rack 7), and wherein the manipulator member successively engages a shoulder of an axial series of shoulders extending from the intermediate device (Leonard; where the notches of toothed rack 7 extend out from button 11 to form a ratchet and pawl system, having a series of shoulders), wherein said shoulders mutually have a substantially fixed pitch that defines an incremental axial stroke by the push member (Leonard; see Figs. 1 and 3 where the teeth of toothed rack 7 are fixed to define a set push stroke from ratchet 8).
Regarding claim 18, the modified McFarland device has wherein the push member engages the plunger member against a resilient spring tension in order to deliver a substantially constant actuating force (Leonard; see Col. 4 lines 50-57 and Col. 5 line 50 to Col 6 line 7 where ratchet 8 loads the helical spring 15 in Fig. 1, which is limited by the movement of the toothed rack 7), substantially independent of a manual force imposed by the user (Leonard; see Col. 4 lines 50-57 and Col. 5 line 50 to Col 6 line 7 where the amount of force loaded onto the spring is limited by the guideshoes 13 and toothed rack 7, thus making it at least substantially independent from the applied force of the lever 9).
Regarding claim 19, the modified McFarland device has wherein said spring tension is delivered by a coil spring that is compressed over a predefined distance within said transmission (Leonard; see Col. 4 lines 50-57 and Col. 5 line 50 to Col 6 line 7 where the helical spring 15 only moves a predefined distance due to the force transference through guideshoes 13 and toothed rack 7).
Regarding claim 21, the modified McFarland device has a spray device for the oral administration of at least one of a therapeutic active agent and a pharmaceutical active agent (McFarland; see system of Figs. 1 and 6), wherein said spray device comprises a container (McFarland; see medicament module 71 in Fig. 6, as modified to be the system of Leonard) and an inhalation member(McFarland; the system of mouthpiece 68, aerosol nozzle 69, and nebulizing shroud 70 in Fig. 6), wherein said container is configured to hold an amount of a liquid that is to be nebulized, said liquid comprising said active agent (McFarland; the modified medicament module 71 in Fig. 6), wherein a flexible fluid line couples said container to said inhalation member and also spatially separates said container from said inhalation member (McFarland; see Fig. 6 where medication module 71 and the mouthpiece 68 are spatially separate from one another, being connected by tube 8 (which appears to be mislabeled and should be fluid supply tube 67 as seen in Col. 5 lines 8-10)), wherein said inhalation member comprises a mouthpiece and a stop, wherein said mouthpiece is adapted to be received between lips of a user (McFarland; mouthpiece 68 in Fig. 6 as modified by Oldfield (see Figs. 13A-13B where mouthpiece 1017 is placed into the mouth so that teeth are on biting portion 1019 with flange 1018 acting as a stop; see [0406])), wherein said mouthpiece comprises a spray nozzle (McFarland; aerosol nozzle 69 in Fig. 6) unit and a spray cavity (McFarland; shroud 70 in Fig. 6), wherein said spray nozzle unit is configured and adapted to receive said liquid under an elevated operating pressure and to create a mist therefrom, said mist containing said active agent (McFarland; see Col. 14 lines 43-47 and 55-62), wherein said spray cavity, during use, opens into said user's oral cavity (McFarland; see Col. 14 line 38 to Col. 15 line 10 where nebulizing shroud 70 has some cavity that receives the aerosol formed by aerosol nozzle 69, and directs it to the mouth of the user), wherein said stop receives a dental element of said user (Oldfield; see Figs. 13A-13B and [0406] where the intersection of biting portion 1019 and flange 1018 creates an edge surface around the perimeter of the mouthpiece 1017), wherein said spray unit opens into said spray cavity to deliver said mist, via said spray cavity, to said oral cavity (McFarland; see Col. 14 line 38 to Col. 15 line 10 where nebulizing shroud 70 has some cavity that receives the aerosol formed by aerosol nozzle 69, and directs it to the mouth of the user) and to target a pharyngeal region thereof (McFarland; see Col. 1 lines 24-27, and Col. 2 lines 1-5 and lines 24-25).
Regarding claim 27, the modified McFarland device has wherein the liquid to be nebulized contains a pharmaceutical agent for pharyngeal or pulmonary administration (McFarland; see Col. 1 lines 24-27, and Col. 2 lines 1-5 and lines 24-25).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over McFarland in view of Srinivasan in view of Leonard in view of Oldfield as applied to claim 14 above, and further in view of Walker et al. (US Pat. 8,628,536).
Regarding claim 15, the modified McFarland device has the manipulator member, a spring tension, and first displacement of the lever.
The modified McFarland device lacks a detailed description of wherein the manipulator member comprises a squeeze handle extending from a housing of the holder, wherein the squeeze handle is configured to allow a stroke against a spring tension relative to the housing that imposes said first displacement on the lever.
However, Walker teaches a similar plunger delivery system, where a squeeze handle extends from a housing of the holder (handle 206 in Fig. 2), wherein the squeeze handle is configured to allow a stroke against a spring tension relative to the housing that imposes said first displacement on the lever (see Col. 4 lines 35-67 where the handle 206 is biased by the spring 218 so as to be against the spring tension, and is in hinged connection to the lever 214 so as to allow displacement of the lever).
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 lever plunger system of the modified McFarland device to have a squeeze handle connected to the spring and lever system as taught by Walker, as it would an actuator that is independent on the pumping mechanism, preventing accidental actuation of the plunger pump without an additional handle member.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-3, 5-19, and 21-27 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, Siegel has now been applied to claim 1, and Oldfield has been applied to claim 13 to accommodate the claim amendments.
Applicant argues on page 8 of the remarks that McFarland does not have the liquid operate under an elevated operating pressure. The argument is not well-taken. Firstly, it is understood that McFarland teaches a mouthpiece area that mixes a pressurized gas with a liquid, forming a pressurizing combination of the two that is to be nebulized. Hence, the liquid, when reaching this “mixing chamber” part of the mouthpiece and before the nozzle end, is understood to be at some elevated operating pressure due to the pressurized gas. However, even if this were not the case, then the newly applied to claim 1 reference of Siegel does teach this limitation.
Applicant further argues on pages 8-9 of the remarks that the Oldfield does not have the spray unit nozzle being fixated in the inhalation member. The argument is not well-taken. The above rejection looks to the McFarland reference for this limitation, where the spray unit nozzle is the whole mouthpiece area (Fig. 1, mouthpiece 7) which has the shroud, nozzle, mouthpiece, and so on (Fig. 6). As seen in the rejection, the aerosol nozzle 69 is welded to the dispensing cup 68, such that it is fixated in place. Hence, the amendments are taught by McFarland.
Thus, the claim rejections hold.
Conclusion
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/MATTHEW D ZIEGLER/Examiner, Art Unit 3785
/TIMOTHY A STANIS/Supervisory Patent Examiner, Art Unit 3785