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 .
This office action is in response to the amendment filed 3/2/26. As directed by the amendment: claims 1, 3, 5, 7, 9, 11, 13, 15, 17-19, 21, 24, 27, 32, 37, 39, 41-42, 44, 46-47, 49, 53, 55, 57-59, 61, 63, 65, 67, 71, 73, and 75-76 have been amended, claims 40, 45, 56, and 74 have been cancelled, and no claims have been added. As such, claims 1-39, 41-44, 46-55, 57-73, and 75-84 are pending in the instant application.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 14/733143, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The parent application does not support the predetermined volume Vgas being in a range of 0.1-21 ml (see claim 2, 8, 14, 20, 50, and 64). The parent application sets forth a range of 1-21 ml for this parameter, not 0.1-21 ml.
Claim Objections
Claims 1, 13, 15, 19, 21, 49, 63 are objected to because of the following informalities:
Regarding claim 1, the language “configured to contain predetermined volume” (line 20) is objected to for a grammatical/typographical error; Examiner suggests amending to read –configured to contain a predetermined volume--.
Regarding claim 13, the language “configured to contain predetermined volume” (line 21-22) is objected to for a grammatical/typographical error; Examiner suggests amending to read –configured to contain a predetermined volume--.
Regarding claim 15, the claim sets forth that the method additionally comprises at least one of steps a)-i); however, step e) includes language/limitations already found in claim 13; Examiner suggests deleting step e).
Regarding claim 19, the language “adapted to contain predetermined volume” (line 21-22) is objected to for a grammatical/typographical error; Examiner suggests amending to read –adapted to contain a predetermined volume--.
Regarding claim 21, the claim sets forth that the method additionally comprises at least one of steps a)-i); however, step e) includes language/limitations already found in claim 19; Examiner suggests deleting step e).
Regarding claim 49, the language “configured to contain predetermined volume” (line 20) is objected to for a grammatical/typographical error; Examiner suggests amending to read –configured to contain a predetermined volume--.
Regarding claim 63, the language “configured to contain predetermined volume” (line 21) is objected to for a grammatical/typographical error; Examiner suggests amending to read –configured to contain a predetermined volume--.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 63-73 and 75-76 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 63 recites the limitation "said predetermined volume Vsub" in line 4-5. There is insufficient antecedent basis for this limitation in the claim. Note that the amendment in line 1-2 changed the claims to have a predetermined mass Msub having a volume Vsub, but not a predetermined volume Vsub.
Regarding claim 63, the claim sets forth a “predetermined mass Msub” of the substance (see line 5-6) but also sets forth this parameter as being in a range of 0.01-7 ml; however, milliliters is a measure of volume not mass and thus the metes and bounds of the claim are unclear.
Regarding claim 75, the language “The device of claim 763” (line 1) is unclear as this refers to a claim that has not been set forth and thus the metes and bounds of the claim cannot be ascertained. It appears that this claim should be dependent on claim 63 and for purposes of examination this claim will be treated as such.
Claims 64-73 and 76 are rejected based on dependency on a rejected claim.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-5, 22-23, 39, 41, 43, 78, 13-17, 28-31, 82, 63-67, 69-70, 73, and 75 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shahaf et al. (WO 2013/128447) in view of Price et al. (2006/0213514), Addington et al. (2013/0267864), Wilkerson et al. (2013/0299607), and Yeates (2011/0011398).
Regarding claim 1, Shahaf shows a device for delivering a predetermined volume Vsub [ml] of at least one substance within at least one body cavity of a subject (see Fig. 3A-18 for example, abstract) which includes at least one capsule sized and shaped for containing the predetermined volume Vsub of said at least one substance (see Fig. 6C showing capsule 25, see pg. 73 ln. 24 through pg. 74 ln. 4), said at least one substance including a plurality of particles (see pg. 13-14 which discloses various types of substances that can be delivered, the substance delivered in aerosol form and thus having a plurality of particles); a nozzle configured for placement in proximity to the body cavity and being in fluid communication with the capsule, the nozzle including at least one orifice with a diameter D (see Fig. 3B, 6B-C showing nozzle 20 with at least one orifice which inherently has a diameter, see pg. 32 ln. 15 disclosing outlet opening having a diameter; pg. 73 ln. 24 through pg. 74 ln. 4 which discloses the outlet as a bore which also has a diameter and the operation of the device which shows the fluid communication of the nozzle with the capsule and placement in proximity to the body cavity, see also Fig. 19); at least one valve mechanically connectable to the capsule and characterized by at least two configurations: (i) an active configuration in which the valve enables delivery of predetermined volume Vsub of the substance from the capsule to the body cavity via the nozzle and (ii) an inactive configuration in which the valve prevents delivery of the predetermined volume Vsub of the substance form the capsule to the body cavity (see Fig. 4C showing valve 10 in the INACTIVE CONFIGURATION, see Fig. 5C and D showing valve in the ACTIVE CONFIGURATION; see also pg. 73); the valve reconfigurable from the inactive configuration to the active configuration with in a predetermined period of time, dT, in response to activation of the valve (see pg. 73 and Fig. 4C, the valve is spring loaded and in response to inhalation by the user, will actuate/reconfigure within a predetermined period of time dT); a fluid tight chamber configured to contain predetermined volume Vgas [ml] of pressurized gas at a predetermined pressure Pgas [barg] (see Fig. 4C showing the fluid tight chamber as the space between piston seal 8 and element 40, see also Fig. 11 which is the same figure disclosed by the instant application, the gas in this chamber is pressurized per pg. 71 ln. 27 through pg. 74 ln. 4, see pg. 6 ln. 3-5 discloses volume and pressure values for the compressed gas in the fluid tight chamber); the pressurized gas, once the valve is reconfigured from the inactive to the active configuration, is configured to entrain the substance and deliver it via the orifice in the nozzle within the body cavity (see pg. 71 ln. 27 through pg. 74 ln. 4 which discloses the operation of the device for delivery of the substance entrained by the pressurized gas from the fluid tight chamber, the delivery of such includes pressure, volume (gas) and volume (substance) rates during the delivery time period); wherein the device is configured to deliver the predetermined volume Vsub of the substance and the predetermined volume Vgas of the pressurized gas through the orifice into the body cavity (see pg. 71 ln. 27 through pg. 74 ln. 4 which discloses the operation of the device for delivery of the substance entrained by the pressurized gas to the user). The Shahaf device discloses that the Pgas is in a range of about 1-10 bar (see pg. 6 ln. 3-5). The Shahaf device is silent as to also having a diameter of the orifice D being in a range of 0.2-6 mm (Shahaf discloses on pg. 76-77 varying parameters of the device); however, Price teaches a similar delivery device including an outlet orifice having a diameter D in the claimed range (see Price para. 0143, 0.5 to 2.5 mm). Thus 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 Shahaf device’s orifice diameter to be in the claimed range, such as the values taught by Price, in order to provide a diameter to best accommodate the physical/chemical characteristics of the particular medicament to be aerosolized (see Price para. 0143). The now modified Shahaf device is silent as to the predetermined volume Vsub explicitly being in a range of 0.01-7 ml; however, the amount of substance to be delivered to the user would have been an obvious matter of design choice and would be obvious to choose such values depending on the needs of the user. Furthermore, Addington teaches a drug delivery device which provides a volume of substance to be delivered being in the range of 0.01-7 ml (see Addington para. 0101). Thus 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 modified Shahaf device’s capsule to contain substance with a predetermined volume being in the range of 0.01-7 ml, as taught by Addington, in order to provide a desired amount of substance to the user depending on the user’s needs (i.e. dosing amount). The now modified Shahaf device is silent as to the release time of the volume Vsub of the substance and the pressurized gas, dTdelivery being less than 500 ms and is silent as to the a viscosity η of the at least one substance being in a range of 1x10-3 poise to 1 poise; however, Wilkerson teaches a similar drug delivery device (see Wilkerson para. 0002 & 0007) which teaches a delivery time of less than 500 ms (see para. 0268) and delivery of a substance having a viscosity η of the at least one substance being in a range of 1x10-3 poise to 1 poise (see Wilkerson para. 0269 and TABLE 15, 0.3 to 100 cP which is encompassed by the claimed range). Thus 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 modified Shahaf device’s drug delivery time to be less than 500 ms and to deliver a substance with a viscosity level, as taught by Wilkerson, in order to deliver a particular/desired type of substance to the user, and to provide an optimized/desired drug delivery time and furthermore, it has been held true that where the general conditions of the claim are disclosed in the prior art, discovering optimum or workable ranges involve only routine skill in the art. In re Aller, 200 F. 2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The now modified Shahaf device delivers the at least one substance by forming a mixture of the predetermined volume of the pressurized gas and volume of the at least one substance to entrain within the device to form a plume of aerosol for delivery to the user (see Shahaf pg. 71 ln. 27 through pg. 74 ln. 4 which discloses the operation of the device for delivery of the substance entrained by the pressurized gas to the user, see also Fig. 10 and pg. 7 last 3 lines), but is silent as to the plume of aerosol having an angle subtending a full width of the plume at an angle of less than 25°; however, Yeates teaches an aerosol delivery device which discloses such a shaped aerosol plume for delivery (Yeates para. 0003, and 0090 which discloses subtending angles including the claimed range of less than 25°, it being obvious to choose such values in Yeates). Thus 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 modified Shahaf device to be configured to deliver a plume of aerosol having an angle subtending a full width of the plume at an angle of less than 25°, as taught by Yeates, for “optimal function” of the aerosol plume (see Yeates para. 0090).
Regarding claim 2, the modified Shahaf device is silent as to the predetermined volume Vgas being in a range of 0.1-21 ml; however, Shahaf discloses that the Vgas is in a range of about 5-50 mL (see Shahaf pg. 6 ln. 3-5). Thus 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 modified Shahaf device to choose the Vgas in a range of about 0.1-21 mL as these particular values/ranges would have been obvious to try and in order to further optimize the substance delivery to the user (see MPEP 2144.05 I and II).
Regarding claim 3, the modified Shahaf device includes all the same structural elements as claimed such that it would provide for the claimed conditions and further includes that the body orifice is one of the ones claimed in condition a (see Fig. 19 and pg. 73 ln. 24-27, nasal cavity, note the device, such as in Fig. 11, is the same figure disclose and also is capable of delivery substance to the other body orifices).
Regarding claim 4, the modified Shahaf device’s includes a capsule having a main longitudinal axis and forming at least one compartment arranged about the main longitudinal axis (see Shahaf Fig. 6C and pg. 73 ln. 24-32). The modified Shahaf also discloses that the container can including plural compartments (see pg. 77 ln. 8-11 and pg. 80 ln. 21-23).
Regarding claim 5, the modified Shahaf device’s capsule includes a port fluidly connectable to an exterior of the device and configured such that the substance is insertable into the chamber via the port (see annotated Fig. 6D below).
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Regarding claim 22, the modified Shahaf device’s dTdeliver is maintained less than 500 ms independent of how the user operates the device (see Shahaf pg. 32 ln. 11-13, pg. 77 ln. 3-7 and pg. 71 ln. 27 through pg. 74 ln. 4 which discloses the operation of the device; the actuation time is dependent on the spring strength and thus independent the user).
Regarding claim 23, the modified Shahaf device’s dTdeliver is maintained less than 500 ms independent of at least one of the of the claimed group (see Shahaf pg. 32 ln. 11-13, pg. 77 ln. 3-7 and pg. 71 ln. 27 through pg. 74 ln. 4 which discloses the operation of the device; the actuation time is dependent on the spring strength and thus independent of at least one of the claimed group).
Regarding claim 39, the modified Shahaf device is such that a velocity of the plurality of particles of the at least one substance, after exiting the device, is maintained in a range of about 5 m/s to 50 m/s, independent of at least one of the predetermined volume Vgas [ml], the predetermined volume Vsub [ml], and the predetermined pressure Pgas [barg] (the modified Shahaf device includes each structural and functional limitation as claimed such that it would also provide the same performance parameters claimed).
Regarding claim 41, the modified Shahaf device’s full width of the plume is maintained at the angle less than 25 degrees independent of the Vgas, Vsub, and Pgas (see above explanation in claim 40, the modified Shahaf includes each structural and functional limitation as claimed such that it would also provide the same performance limitation).
Regarding claim 43, the modified Shahaf device includes a delivery time dTdeliver of less than 500 ms (see Wilkerson para. 0268), inherently has an internal diameter of the valve and includes the same Vgas, Vsub, and Pgas limitations such that its delivery time would also be independent thereof. The modified Shahaf device is silent as to the internal diameter being above 0.22 mm; however, this would have been an obvious matter of design choice to one of ordinary skill in the art before the effective filing date of the claimed invention and one would expect the modified Shahaf device to perform equally as well.
Regarding claim 78, the modified Shahaf device teaches a delivery time dTdeliver of less than 500 ms (see Wilkerson para. 0268) and includes the same Vgas, Vsub, and Pgas limitations such that its delivery time would also be independent thereof.
Regarding claim 13, the use of the Shahaf device includes a method of delivering a predetermined volume Vsub [ml] of at least one substance within at least one body cavity of a subject (see Fig. 3A-18 for example, abstract) which includes providing a device including at least one capsule sized and shaped for containing the predetermined volume Vsub of said at least one substance (see Fig. 6C showing capsule 25, see pg. 73 ln. 24 through pg. 74 ln. 4), said at least one substance including a plurality of particles (see pg. 13-14 which discloses various types of substances that can be delivered, the substance delivered in aerosol form and thus having a plurality of particles); a nozzle configured for placement in proximity to the body cavity and being in fluid communication with the capsule, the nozzle including at least one orifice with a diameter D (see Fig. 3B, 6B-C showing nozzle 20 with at least one orifice which inherently has a diameter, see pg. 32 ln. 15 disclosing outlet opening having a diameter; pg. 73 ln. 24 through pg. 74 ln. 4 which discloses the outlet as a bore which also has a diameter and the operation of the device which shows the fluid communication of the nozzle with the capsule and placement in proximity to the body cavity, see also Fig. 19); at least one valve mechanically connectable to the capsule and characterized by at least two configurations: (i) an active configuration in which the valve enables delivery of predetermined volume Vsub of the substance from the capsule to the body cavity via the nozzle and (ii) an inactive configuration in which the valve prevents delivery of the predetermined volume Vsub of the substance form the capsule to the body cavity (see Fig. 4C showing valve 10 in the INACTIVE CONFIGURATION, see Fig. 5C and D showing valve in the ACTIVE CONFIGURATION; see also pg. 73); the valve reconfigurable from the inactive configuration to the active configuration with in a predetermined period of time, dT, in response to activation of the valve (see pg. 73 and Fig. 4C, the valve is spring loaded and in response to inhalation by the user, will actuate/reconfigure within a predetermined period of time dT); a fluid-tight chamber configured to contain predetermined volume Vgas [ml] of pressurized gas at a predetermined pressure Pgas [barg] (see Fig. 4C showing the fluid tight chamber as the space between piston seal 8 and element 40, see also Fig. 11 which is the same figure disclosed by the instant application, the gas in this chamber is pressurized per pg. 71 ln. 27 through pg. 74 ln. 4, see pg. 6 ln. 3-5 discloses volume and pressure values for the compressed gas in the fluid tight chamber); the pressurized gas, once the valve is reconfigured from the inactive to the active configuration, is configured to entrain the substance and deliver it via the orifice in the nozzle within the body cavity (see pg. 71 ln. 27 through pg. 74 ln. 4 which discloses the operation of the device for delivery of the substance entrained by the pressurized gas from the fluid tight chamber, the delivery of such includes pressure, volume (gas) and volume (substance) rates during the delivery time period); wherein the device is configured to deliver the predetermined volume Vsub of the substance and the predetermined volume Vgas of the pressurized gas through the orifice into the body cavity (see pg. 71 ln. 27 through pg. 74 ln. 4 which discloses the operation of the device for delivery of the substance entrained by the pressurized gas to the user); placing the delivery end in proximity to the body cavity and reconfiguring the valve from the INACTIVE CONFIGURATION to the ACTIVE CONFIGURATION thereby entraining the substance in the predetermined volume of gas and thereby delivering the predetermined volume of the substance, predetermined volume of gas through the orifice of diameter D in a pressure rate of dPgas/dT, volume rate dVgas/dT, and volume rate dVsub/dT, wherein the volume/pressure of pressurized gas is released from the chamber upon activation of the valve entrains the substance and erupts via the orifice into the body cavity (see Fig. 3A-11 and 19 and see pg. 71 ln. 27 through pg. 74 ln. 4 which discloses the operation of the device for delivery of the substance entrained by the pressurized gas from the fluid tight chamber during activation of the valve, the delivery of such includes a pressure/volume rates during the delivery time period). The Shahaf method/device’s predetermined pressure Pgas being in a range 1-10 barg (see pg. 6 ln. 3-5). The Shahaf method/device is silent as to also having a diameter of the orifice D being in a range of 0.2-6 mm (Shahaf discloses on pg. 76-77 varying parameters of the device); however, Price teaches a similar delivery device including an outlet orifice having a diameter D in the claimed range (see Price para. 0143, 0.5 to 2.5 mm). Thus 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 Shahaf method/device’s orifice diameter to be in the claimed range, such as the values taught by Price, in order to provide a diameter to best accommodate the physical/chemical characteristics of the particular medicament to be aerosolized (see Price para. 0143). The now modified Shahaf method/device is silent as to the predetermined volume Vsub explicitly being in a range of 0.01-7 ml; however, the amount of substance to be delivered to the user would have been an obvious matter of design choice and would be obvious to choose such values depending on the needs of the user. Furthermore, Addington teaches a drug delivery device which provides a volume of substance to be delivered being in the range of 0.01-7 ml (see Addington para. 0101). Thus 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 modified Shahaf method/device’s capsule to contain substance with a predetermined volume being in the range of 0.01-7 ml, as taught by Addington, in order to provide a desired amount of substance to the user depending on the user’s needs (i.e. dosing amount). The now modified Shahaf method/device is silent as to the release time of the volume Vsub of the substance and the pressurized gas, dTdelivery being less than 500 ms and is silent as to the a viscosity η of the at least one substance being in a range of 1x10-3 poise to 1 poise; however, Wilkerson teaches a similar drug delivery device (see Wilkerson para. 0002 & 0007) which teaches a delivery time of less than 500 ms (see para. 0268) and delivery of a substance having a viscosity η of the at least one substance being in a range of 1x10-3 poise to 1 poise (see Wilkerson para. 0269 and TABLE 15, 0.3 to 100 cP which is encompassed by the claimed range). Thus 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 modified Shahaf method/device’s drug delivery time to be less than 500 ms and to deliver a substance with a viscosity level, as taught by Wilkerson, in order to deliver a particular/desired type of substance to the user, and to provide an optimized/desired drug delivery time and furthermore, it has been held true that where the general conditions of the claim are disclosed in the prior art, discovering optimum or workable ranges involve only routine skill in the art. In re Aller, 200 F. 2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The now modified Shahaf method/device delivers the at least one substance by forming a mixture of the predetermined volume of the pressurized gas and volume of the at least one substance to entrain within the device to form a plume of aerosol for delivery to the user (see Shahaf pg. 71 ln. 27 through pg. 74 ln. 4 which discloses the operation of the device for delivery of the substance entrained by the pressurized gas to the user, see also Fig. 10 and pg. 7 last 3 lines), but is silent as to the plume of aerosol having an angle subtending a full width of the plume at an angle of less than 25°; however, Yeates teaches an aerosol delivery device which discloses such a shaped aerosol plume for delivery (Yeates para. 0003, and 0090 which discloses subtending angles including the claimed range of less than 25°, it being obvious to choose such values in Yeates). Thus 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 modified Shahaf method/device to be configured to deliver a plume of aerosol having an angle subtending a full width of the plume at an angle of less than 25°, as taught by Yeates, for “optimal function” of the aerosol plume (see Yeates para. 0090).
Regarding claim 14, the modified Shahaf method is silent as to the predetermined volume Vgas being in a range of 0.1-21 ml; however, Shahaf discloses that the Vgas is in a range of about 5-50 mL (see pg. 6 ln. 3-5). Thus 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 modified Shahaf device to choose the Vgas in a range of about 0.1-21 mL as these particular values/ranges would have been obvious to try and in order to further optimize the substance delivery to the user (see MPEP 2144.05 I and II).
Regarding claim 15, the modified Shahaf method includes all the same structural elements as claimed such that it would provide for the claimed conditions and further includes that the body orifice is one of the ones claimed in condition a) (see Fig. 19 and pg. 73 ln. 24-27, nasal cavity, note the device, such as in Fig. 11, is the same figure disclose and also is capable of delivery substance to the other body orifices).
Regarding claim 16, the modified Shahaf method’s includes a capsule having a main longitudinal axis and forming at least one compartment arranged about the main longitudinal axis (see Shahaf Fig. 6C and pg. 73 ln. 24-32). The modified Shahaf also discloses that the container can including plural compartments (see pg. 77 ln. 8-11 and pg. 80 ln. 21-23).
Regarding claim 17, the modified Shahaf method’s capsule includes a port fluidly connectable to an exterior of the device and configured such that the substance is insertable into the chamber via the port (see annotated Fig. 6D above).
Regarding claim 28, the modified Shahaf method includes the step of pre-pressurizing the chamber with the gas to the pressure or pressurizing the chamber before reconfiguring the valve from the inactive configuration to the active configuration (see pg. 71 ln. 27 through pg. 74 ln. 4 which discloses the operation of the device for delivery of the substance entrained by the pressurized gas to the user; Fig. 5A-C show the device with the chamber pressurized and then the user inhales to reconfigure the valve to discharge the pressurized gas and receive the dose of substance).
Regarding claim 29, the modified Shahaf method includes the step of either pre-emplacing the substance in the capsule or emplacing the substance in the capsule before reconfiguring the valve from the inactive to active configuration (see pg. 71 ln. 27 through pg. 74 ln. 4 which discloses the operation of the device for delivery of the substance entrained by the pressurized gas to the user; the substance is placed in the capsule which is placed in the device before reconfiguring the valve from inactive to active configuration in order for the user to receive the dose of the substance).
Regarding claim 30, the modified Shahaf method’s dTdeliver is maintained less than 500 ms independent of how the user operates the device (see Shahaf pg. 32 ln. 11-13, pg. 77 ln. 3-7 and pg. 71 ln. 27 through pg. 74 ln. 4 which discloses the operation of the device; the actuation time is dependent on the spring strength and thus independent the user).
Regarding claim 31, the modified Shahaf method’s dTdeliver is maintained less than 500 ms independent of at least one of the of the claimed group (see Shahaf pg. 32 ln. 11-13, pg. 77 ln. 3-7 and pg. 71 ln. 27 through pg. 74 ln. 4 which discloses the operation of the device; the actuation time is dependent on the spring strength and thus independent of at least one of the claimed group).
Regarding claim 82, the modified Shahaf method teaches a delivery time dTdeliver of less than 500 ms (see Wilkerson para. 0268) and includes the same Vgas, Vsub, and Pgas limitations such that its delivery time would also be independent thereof.
Regarding claim 63, Shahaf shows a device for delivering a predetermined mass Msub [mg] and volume Vsub [ml] of at least one substance within at least one body cavity of a subject (see Fig. 3A-18 for example, abstract) which includes at least one capsule sized and shaped for containing the predetermined volume Vsub of said at least one substance (see Fig. 6C showing capsule 25, see pg. 73 ln. 24 through pg. 74 ln. 4), said at least one substance including a plurality of particles (see pg. 13-14 which discloses various types of substances that can be delivered, the substance delivered in aerosol form and thus having a plurality of particles); a nozzle configured for placement in proximity to the body cavity and being in fluid communication with the capsule, the nozzle including at least one orifice with a diameter D (see Fig. 3B, 6B-C showing nozzle 20 with at least one orifice which inherently has a diameter, see pg. 32 ln. 15 disclosing outlet opening having a diameter; pg. 73 ln. 24 through pg. 74 ln. 4 which discloses the outlet as a bore which also has a diameter and the operation of the device which shows the fluid communication of the nozzle with the capsule and placement in proximity to the body cavity, see also Fig. 19); at least one valve mechanically connectable to the capsule and characterized by at least two configurations: (i) an active configuration in which the valve enables delivery of predetermined volume Vsub of the substance from the capsule to the body cavity via the nozzle and (ii) an inactive configuration in which the valve prevents delivery of the predetermined volume Vsub of the substance form the capsule to the body cavity (see Fig. 4C showing valve 10 in the INACTIVE CONFIGURATION, see Fig. 5C and D showing valve in the ACTIVE CONFIGURATION; see also pg. 73); the valve reconfigurable from the inactive configuration to the active configuration with in a predetermined period of time, dT, in response to activation of the valve (see pg. 73 and Fig. 4C, the valve is spring loaded and in response to inhalation by the user, will actuate/reconfigure within a predetermined period of time dT); a fluid-tight chamber configured to contain predetermined volume Vgas [ml] of pressurized gas at a predetermined pressure Pgas [barg] (see Fig. 4C showing the fluid tight chamber as the space between piston seal 8 and element 40, see also Fig. 11 which is the same figure disclosed by the instant application, the gas in this chamber is pressurized per pg. 71 ln. 27 through pg. 74 ln. 4, see pg. 6 ln. 3-5 discloses volume and pressure values for the compressed gas in the fluid tight chamber); the pressurized gas, once the valve is reconfigured from the inactive to the active configuration, is configured to entrain the substance and deliver it via the orifice in the nozzle within the body cavity (see pg. 71 ln. 27 through pg. 74 ln. 4 which discloses the operation of the device for delivery of the substance entrained by the pressurized gas from the fluid tight chamber, the delivery of such includes pressure, volume (gas) and volume (substance) rates during the delivery time period); wherein the device is configured to deliver the predetermined volume Vsub of the substance and the predetermined volume Vgas of the pressurized gas through the orifice into the body cavity (see pg. 71 ln. 27 through pg. 74 ln. 4 which discloses the operation of the device for delivery of the substance entrained by the pressurized gas to the user). The Shahaf device discloses that the Pgas is in a range of about 1-10 bar (see pg. 6 ln. 3-5). The Shahaf device is silent as to also having a diameter of the orifice D being in a range of 0.2-6 mm (Shahaf discloses on pg. 76-77 varying parameters of the device); however, Price teaches a similar delivery device including an outlet orifice having a diameter D in the claimed range (see Price para. 0143, 0.5 to 2.5 mm). Thus 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 Shahaf device’s orifice diameter to be in the claimed range, such as the values taught by Price, in order to provide a diameter to best accommodate the physical/chemical characteristics of the particular medicament to be aerosolized (see Price para. 0143). The now modified Shahaf device is silent as to the predetermined mass Msub explicitly being in a range of 0.01-7 ml; however, the amount of substance to be delivered to the user would have been an obvious matter of design choice and would be obvious to choose such values depending on the needs of the user. Furthermore, Addington teaches a drug delivery device which provides a mass/volume of substance to be delivered being in the range of 0.01-7 ml (see Addington para. 0101). Thus 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 modified Shahaf device’s capsule to contain substance with a predetermined mass/volume being in the range of 0.01-7 ml, as taught by Addington, in order to provide a desired amount of substance to the user depending on the user’s needs (i.e. dosing amount). The now modified Shahaf device is silent as to the release time of the volume Vsub of the substance and the pressurized gas, dTdelivery being less than 500 ms, and is silent as to the a viscosity η of the at least one substance being in a range of 1x10-3 poise to 1 poise; however, Wilkerson teaches a similar drug delivery device (see Wilkerson para. 0002 & 0007) which teaches a delivery time of less than 500 ms (see para. 0268) and delivery of a substance having a viscosity η of the at least one substance being in a range of 1x10-3 poise to 1 poise (see Wilkerson para. 0269 and TABLE 15, 0.3 to 100 cP which is encompassed by the claimed range). Thus 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 modified Shahaf device’s drug delivery time to be less than 500 ms and to deliver a substance with a viscosity level, as taught by Wilkerson, in order to deliver a particular/desired type of substance to the user, and to provide an optimized/desired drug delivery time and furthermore, it has been held true that where the general conditions of the claim are disclosed in the prior art, discovering optimum or workable ranges involve only routine skill in the art. In re Aller, 200 F. 2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The modified Shahaf device is silent as to the internal diameter being above 0.22 mm; however, this would have been an obvious matter of design choice to one of ordinary skill in the art before the effective filing date of the claimed invention and one would expect the modified Shahaf device to perform equally as well. The modified Shahaf device further includes that the body orifice is one of the claimed list (see Fig. 19 and pg. 73 ln. 24-27, nasal cavity, note the device, such as in Fig. 11, is the same figure disclose and also is capable of delivery substance to the other body orifices). The now modified Shahaf device delivers the at least one substance by forming a mixture of the predetermined volume of the pressurized gas and volume of the at least one substance to entrain within the device to form a plume of aerosol for delivery to the user (see Shahaf pg. 71 ln. 27 through pg. 74 ln. 4 which discloses the operation of the device for delivery of the substance entrained by the pressurized gas to the user, see also Fig. 10 and pg. 7 last 3 lines), but is silent as to the plume of aerosol having an angle subtending a full width of the plume at an angle of less than 25°; however, Yeates teaches an aerosol delivery device which discloses such a shaped aerosol plume for delivery (Yeates para. 0003, and 0090 which discloses subtending angles including the claimed range of less than 25°, it being obvious to choose such values in Yeates). Thus 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 modified Shahaf device to be configured to deliver a plume of aerosol having an angle subtending a full width of the plume at an angle of less than 25°, as taught by Yeates, for “optimal function” of the aerosol plume (see Yeates para. 0090).
Regarding claim 64, the Shahaf device is silent as to the predetermined volume Vgas being in a range of 0.1-21 ml; however, Shahaf discloses that the Vgas is in a range of about 5-50 mL (see pg. 6 ln. 3-5). Thus 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 Shahaf device to choose the Vgas in a range of about 0.1-21 mL as these particular values/ranges would have been obvious to try and in order to further optimize the substance delivery to the user (see MPEP 2144.05 I and II).
Regarding claim 65, the modified Shahaf device includes all the same structural elements as claimed such that it would provide for at least one of the claimed conditions (Fig. 4C showing air-tight chamber which holds air, see also relevant written description).
Regarding claim 66, the modified Shahaf device’s includes a capsule having a main longitudinal axis and forming at least one compartment arranged about the main longitudinal axis (see Shahaf Fig. 6C and pg. 73 ln. 24-32). The modified Shahaf also discloses that the container can including plural compartments (see pg. 77 ln. 8-11 and pg. 80 ln. 21-23).
Regarding claim 67, the modified Shahaf device’s capsule includes a port fluidly connectable to an exterior of the device and configured such that the substance is insertable into the chamber via the port (see annotated Fig. 6D above).
Regarding claim 69, the modified Shahaf device’s dTdeliver is maintained less than 500 ms independent of how the user operates the device (see Shahaf pg. 32 ln. 11-13, pg. 77 ln. 3-7 and pg. 71 ln. 27 through pg. 74 ln. 4 which discloses the operation of the device; the actuation time is dependent on the spring strength and thus independent the user).
Regarding claim 70, the modified Shahaf device’s dTdeliver is maintained less than 500 ms independent of at least one of the of the claimed group (see Shahaf pg. 32 ln. 11-13, pg. 77 ln. 3-7 and pg. 71 ln. 27 through pg. 74 ln. 4 which discloses the operation of the device; the actuation time is dependent on the spring strength and thus independent of at least one of the claimed group).
Regarding claim 73, the modified Shahaf device is such that the velocity of the particles of the at least one substance, after the exit from the device, is maintained in the range of about 5 m/s to 50 m/s, independent of at least one of the predetermined volume Vgas [ml], the predetermined volume Vsub [ml], and the predetermined pressure Pgas [barg] (the modified Shahaf device includes each structural and functional limitation as claimed such that it would also provide the same performance parameters claimed).
Regarding claim 75, the modified Shahaf device includes an aerosol plume of the mixture of the substance and pressurized gas and a full width of the plume subtends an angle of less than 25 degrees. See Fig. 1C, 10; since a subtended angle is arbitrarily defined at an arbitrary vertex per the definition of this term, the figures noted show this angle, furthermore, this would have been an obvious matter of design choice to one of ordinary skill in the art before the effective filing date of the claimed invention and one would expect the modified Shahaf device to perform equally as well. The modified Shahaf device’s full width of the plume is maintained at the angle less than 25 degrees independent of the Vgas, Vsub, and Pgas (see above explanation, the modified Shahaf includes each structural and functional limitation as claimed such that it would also provide the same performance limitation).
Claim(s) 6, 18, 68 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shahaf, Price, Addington, Wilkerson, and Yeates as applied to claims 5, 17, and 67 above, and further in view of Peters et al. (2007/0154407).
Regarding claims 6, 18, and 68, the modified Shahaf device/method includes a port cover to provide a closure for the port, the cover being one of slidable along the device, rotatable around the device, rotatable around a hinge of the device and any combination thereof (see Shahaf annotated Fig. 6D above and Fig. 6C, cover 24, pg. 74 ln. 5-9; see also Fig. 13, cover/closure 20, pg. 78 ln. 8-10 for example). The modified Shahaf device/method is silent as to the cover explicitly providing an air-tight closure for the port; however, Peters teaches a similar device/method which includes a container/capsule for containing a substance therein with a cover/closure that provides an air-tight seal (see Peters para. 0020, 0059, and 0073). Thus 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 modified Shahaf device/method’s cover/closure to be air-tight, as taught by Peters, in order to ensure that no substance is lost before dispensing and that the user receives the proper dose amount.
Claim(s) 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shahaf, Price, Addington, Wilkerson, Yeates, and Peters as applied to claim 6 above, and further in view of Muellinger et al. (2015/0174343).
Regarding claim 27, the modified Shahaf method is silent as to explicitly disclosing at least one of the pressure velocity and volume rates holding true (Shahaf discloses on pg. 76-77 varying parameters of the device); however, Muellinger teaches a similar delivery device including volume rates (see Muellinger para. 0027 and 0078). Thus 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 modified Shahaf device’s rate to be values, such as taught by Muellinger, in order to provide a desired rate of flow for the patient.
Claim(s) 24, 32, and 71 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shahaf, Price, Addington, Wilkerson, and Yeates as applied to claims 1, 13, and 63 above, and further in view of Muellinger.
Regarding claim 24, the modified Shahaf device is silent as to explicitly disclosing at least one of the pressure velocity and volume rates holding true (Shahaf discloses on pg. 76-77 varying parameters of the device); however, Muellinger teaches a similar delivery device including volume rates (see Muellinger para. 0027 and 0078). Thus 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 modified Shahaf device’s rate to be values, such as taught by Muellinger, in order to provide a desired rate of flow for the patient.
Regarding claim 32, the modified Shahaf method is silent as to explicitly disclosing at least one of the pressure velocity and volume rates holding true (Shahaf discloses on pg. 76-77 varying parameters of the device); however, Muellinger teaches a similar delivery device including volume rates (see Muellinger para. 0027 and 0078). Thus 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 modified Shahaf method’s rate to be values, such as taught by Muellinger, in order to provide a desired rate of flow for the patient.
Regarding claim 71, the modified Shahaf device is silent as to explicitly disclosing at least one of the pressure velocity and volume rates holding true (Shahaf discloses on pg. 76-77 varying parameters of the device); however, Muellinger teaches a similar delivery device including volume rates (see Muellinger para. 0027 and 0078). Thus 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 modified Shahaf device’s rate to be values, such as taught by Muellinger, in order to provide a desired rate of flow for the patient.
Claim(s) 38 and 72 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shahaf, Price, Addington, Wilkerson, and Yeates as applied to claims 1 and 63 above, and further in view of Denton et al. (2005/0131357) and Galgon et al. (2015/0165136).
Regarding claim 38, the modified Shahaf device is silent as to the nozzle including a nozzle tip portion and tip extension that surrounds and has a larger diameter than the tip portion, the tip portion defining the at least one orifice and the extension defining at least one hole through which substance exits laterally; however, Denton teaches a similar substance delivery device which includes a nozzle tip portion and tip extension that surrounds and has a larger diameter than the tip portion (see Denton Fig. 5, tip portion 262 tip extension portion 264, see para. 0040) and Galgon teaches a similar substance delivery device which include holes providing lateral delivery (see Galgon Fig. 1A-B, lateral holes 21, para. 0045). Thus 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 modified Shahaf device to include nozzle tip and extension portion and lateral delivery holes, as taught by Denton and Galgon, in order to provide a nostril guide (Denton para. 0040) and a greater spray pattern (Galgon para. 0045).
Regarding claim 72, the modified Shahaf device is silent as to the nozzle including a nozzle tip portion and tip extension that surrounds and has a larger diameter than the tip portion, the tip portion defining the at least one orifice and the extension defining at least one hole through which substance exits laterally; however, Denton teaches a similar substance delivery device which includes a nozzle tip portion and tip extension that surrounds and has a larger diameter than the tip portion (see Denton Fig. 5, tip portion 262 tip extension portion 264, see para. 0040) and Galgon teaches a similar substance delivery device which include holes providing lateral delivery (see Galgon Fig. 1A-B, lateral holes 21, para. 0045). Thus 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 modified Shahaf device to include nozzle tip and extension portion and lateral delivery holes, as taught by Denton and Galgon, in order to provide a nostril guide (Denton para. 0040) and a greater spray pattern (Galgon para. 0045).
Claim(s) 42 and 76 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shahaf, Price, Addington, Wilkerson, and Yeates as applied to claims 1 and 63 above, and further in view of Sullivan et al. (2008/0177246).
Regarding claims 42 and 76, the modified Shahaf device is silent as to the full width of the plume measured at 6 cm from the nozzle is 21 mm or less (see Shahaf Fig. 1C, 10; the modified Shahaf device includes each structural and functional limitation as claimed such that it would also provide the same performance limitation, see Yeates para. 0090). Furthermore, Sullivan teaches a similar device which discloses that shape/size/surface texture of components of the delivery device can be varied to form optimum spray plume geometry (see Sullivan para. 0019). 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 modified Shahaf device to be configured to optimize the spray plume geometry, as taught by Sullivan, and to provide a desired sized spray plume (Sullivan para. 0019). Additionally, it has been held true that where the general conditions of the claim are disclosed in the prior art, discovering optimum or workable ranges involve only routine skill in the art. In re Aller, 200 F. 2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Claim(s) 77 and 81 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shahaf, Price, Addington, Wilkerson, and Yeates as applied to claim 1 above, and further in view of Winkler et al. (2015/0122257).
Regarding claim 77, the modified Shahaf device is silent as to the predetermined period of time dT for reconfiguration being less than or equal to 200 ms; however, Shahaf discloses the ability to vary parameters including spring strength of the valve for optimization (see pg. 32 ln. 11-13, pg. 77 ln. 3-7) and discloses having the open/reconfiguration time being low (see pg. 75 ln. 22-27) and furthermore, Winkler teaches a similar drug delivery device which includes a valve with an actuation/reconfiguration time being less than or equal to 200 ms (see Winkler para. 0027). Thus 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 modified Shahaf device’s valve actuation/reconfiguration time to be less than or equal to 200 ms, as taught by Winkler, in order to provide quick actuation to ensure the user receives the dose immediately during their inhalation effort to optimize drug delivery and furthermore, it has been held true that where the general conditions of the claim are disclosed in the prior art, discovering optimum or workable ranges involve only routine skill in the art. In re Aller, 200 F. 2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 81, the modified Shahaf method/device is silent as to the predetermined period of time dT for reconfiguration being less than or equal to 200 ms; however, Shahaf discloses the ability to vary parameters including spring strength of the valve for optimization (see pg. 32 ln. 11-13, pg. 77 ln. 3-7) and discloses having the open/reconfiguration time being low (see pg. 75 ln. 22-27) and furthermore, Winkler teaches a similar drug delivery device which includes a valve with an actuation/reconfiguration time being less than or equal to 200 ms (see Winkler para. 0027). Thus 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 modified Shahaf method/device’s valve actuation/reconfiguration time to be less than or equal to 200 ms, as taught by Winkler, in order to provide quick actuation to ensure the user receives the dose immediately during their inhalation effort to optimize drug delivery and furthermore, it has been held true that where the general conditions of the claim are disclosed in the prior art, discovering optimum or workable ranges involve only routine skill in the art. In re Aller, 200 F. 2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Claim(s) 7-11, 25-26, 44, 46, 48, 80, 19-21, 33-36, 84, 49-52, 55, 57, and 59-61 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shahaf in view of Price, Haartsen et al. (2012/0291779), Wilkerson, and Yeates.
Regarding claim 7, Shahaf shows a device for delivering a predetermined mass Msub [mg] of at least one substance within at least one body cavity of a subject (see Fig. 3A-18 for example, abstract) which includes at least one capsule sized and shaped for containing the mass Msub of the substance (see Fig. 6C showing capsule 25, see pg. 73 ln. 24 through pg. 74 ln. 4) having a predetermined volume Vsub and a plurality of particles (see pg. 13-14 which discloses various types of substances that can be delivered, the substance delivered in aerosol form and thus having a plurality of particles and which has a predetermined volume of that loaded into the capsule); a nozzle configured for placement in proximity to the body cavity and being in fluid communication with the capsule, the nozzle including at least one orifice with a diameter D (see Fig. 3B, 6B-C showing nozzle 20 with at least one orifice which inherently has a diameter, see pg. 32 ln. 15 disclosing outlet opening having a diameter; pg. 73 ln. 24 through pg. 74 ln. 4 which discloses the outlet as a bore which also has a diameter and the operation of the device which shows the fluid communication of the nozzle with the capsule and placement in proximity to the body cavity, see also Fig. 19); at least one valve mechanically connectable to the capsule and characterized by at least two configurations: (i) an active configuration in which the valve enables delivery of predetermined mass Msub of the substance from the capsule to the body cavity via the nozzle and (ii) an inactive configuration in which the valve prevents delivery of the predetermined mass Msub of the substance from the capsule to the body cavity (see Fig. 4C showing valve 10 in the INACTIVE CONFIGURATION, see Fig. 5C and D showing valve in the ACTIVE CONFIGURATION; see also pg. 73); the valve reconfigurable from the inactive configuration to the active configuration with in a predetermined period of time, dT, in response to activation of the valve (see pg. 73 and Fig. 4C, the valve is spring loaded and in response to inhalation by the user, will actuate/reconfigure within a predetermined period of time dT); a fluid tight chamber configured to contain predetermined volume Vgas [ml] of pressurized gas at a predetermined pressure Pgas [barg] (see Fig. 4C showing the fluid tight chamber as the space between piston seal 8 and element 40, see also Fig. 11 which is the same figure disclosed by the instant application, the gas in this chamber is pressurized per pg. 71 ln. 27 through pg. 74 ln. 4, see pg. 6 ln. 3-5 discloses volume and pressure values for the compressed gas in the fluid tight chamber); the pressurized gas, once the valve is reconfigured from the inactive to the active configuration, is configured to entrain the substance and deliver it via the orifice in the nozzle within the body cavity (see pg. 71 ln. 27 through pg. 74 ln. 4 which discloses the operation of the device for delivery of the substance entrained by the pressurized gas from the fluid tight chamber, the delivery of such includes pressure, volume (gas) and volume (substance) rates during the delivery time period); wherein the device is configured to deliver the predetermined mass Msub of the substance and the predetermined volume Vgas of the pressurized gas through the orifice into the body cavity (see pg. 71 ln. 27 through pg. 74 ln. 4 which discloses the operation of the device for delivery of the substance entrained by the pressurized gas to the user). The Shahaf device’s Pgas is in a range 1-10 barg (see pg. 6 ln. 3-5). The Shahaf device is silent as to also having a diameter of the orifice D being in a range of 0.2-6 mm (Shahaf discloses on pg. 76-77 varying parameters of the device); however, Price teaches a similar delivery device including an outlet orifice having a diameter D in the claimed range (see Price para. 0143, 0.5 to 2.5 mm). Thus 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 modified Shahaf device’s orifice diameter to be in the claimed range, such as the values taught by Price, in order to provide a diameter to best accommodate the physical/chemical characteristics of the particular medicament to be aerosolized (see Price para. 0143). The now modified Shahaf device is silent as to the predetermined mass Msub explicitly being in a range of 1-1000 mg; however, the amount of substance to be delivered to the user would have been an obvious matter of design choice and would be obvious to choose such values depending on the needs of the user. Furthermore, Haartsen teaches a drug delivery device which provides an amount of substance to be delivered being in the range of 1-1000 mg (see Haartsen para. 0003). Thus 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 modified Shahaf device’s capsule to contain substance with a predetermined mass being in the range of 1-1000 mg, as taught by Haartsen, in order to provide a desired amount of substance to the user depending on the user’s needs (i.e. dosing amount). The now modified Shahaf device is silent as to the release time of the mass Msub of the substance and the pressurized gas, dTdelivery being less than 500 ms, and is silent as to the a viscosity η of the at least one substance being in a range of 1x10-3 poise to 1 poise; however, Wilkerson teaches a similar drug delivery device (see Wilkerson para. 0002 & 0007) which teaches a delivery time of less than 500 ms (see para. 0268), and delivery of a substance having a viscosity η of the at least one substance being in a range of 1x10-3 poise to 1 poise (see Wilkerson para. 0269 and TABLE 15, 0.3 to 100 cP which is encompassed by the claimed range). Thus 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 modified Shahaf device’s drug delivery time to be less than 500 ms and to deliver a substance with a viscosity level, as taught by Wilkerson, in order to deliver a particular/desired type of substance to the user, and to provide an optimized/desired drug delivery time and furthermore, it has been held true that where the general conditions of the claim are disclosed in the prior art, discovering optimum or workable ranges involve only routine skill in the art. In re Aller, 200 F. 2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The now modified Shahaf device delivers the at least one substance by forming a mixture of the predetermined volume of the pressurized gas and volume of the at least one substance to entrain within the device to form a plume of aerosol for delivery to the user (see Shahaf pg. 71 ln. 27 through pg. 74 ln. 4 which discloses the operation of the device for delivery of the substance entrained by the pressurized gas to the user, see also Fig. 10 and pg. 7 last 3 lines), but is silent as to the plume of aerosol having an angle subtending a full width of the plume at an angle of less than 25°; however, Yeates teaches an aerosol delivery device which discloses such a shaped aerosol plume for delivery (Yeates para. 0003, and 0090 which discloses subtending angles including the claimed range of less than 25°, it being obvious to choose such values in Yeates). Thus 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 modified Shahaf device to be configured to deliver a plume of aerosol having an angle subtending a full width of the plume at an angle of less than 25°, as taught by Yeates, for “optimal function” of the aerosol plume (see Yeates para. 0090).
Regarding claim 8, the Shahaf device is silent as to the predetermined volume Vgas being in a range of 0.1-21 ml; however, Shahaf discloses that the Vgas is in a range of about 5-50 mL (see pg. 6 ln. 3-5). Thus 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 Shahaf device to choose the Vgas in a range of about 0.1-21 mL as these particular values/ranges would have been obvious to try and in order to further optimize the substance delivery to the user (see MPEP 2144.05 I and II).
Regarding claim 9, the modified Shahaf device includes all the same structural elements as claimed such that it would provide for the claimed a-h conditions and further includes that the body orifice is one of the ones claimed in condition a (see Fig. 19 and pg. 73 ln. 24-27, nasal cavity, note the device, such as in Fig. 11, is the same figure disclose and also is capable of delivery substance to the other body orifices).
Regarding claim 10, the modified Shahaf device’s includes a capsule having a main longitudinal axis and forming at least one compartment arranged about the main longitudinal axis (see Shahaf Fig. 6C and pg. 73 ln. 24-32). The modified Shahaf also discloses that the container can including plural compartments (see pg. 77 ln. 8-11 and pg. 80 ln. 21-23).
Regarding claim 11, the modified Shahaf device’s capsule includes a port fluidly connectable to an exterior of the device and configured such that the substance is insertable into the chamber via the port (see annotated Fig. 6D above).
Regarding claim 25, the modified Shahaf method’s dTdeliver is maintained less than 500 ms independent of how the user operates the device (see Shahaf pg. 32 ln. 11-13, pg. 77 ln. 3-7 and pg. 71 ln. 27 through pg. 74 ln. 4 which discloses the operation of the device; the actuation time is dependent on the spring strength and thus independent the user).
Regarding claim 26, the modified Shahaf method’s dTdeliver is maintained less than 500 ms independent of at least one of the of the claimed group (see Shahaf pg. 32 ln. 11-13, pg. 77 ln. 3-7 and pg. 71 ln. 27 through pg. 74 ln. 4 which discloses the operation of the device; the actuation time is dependent on the spring strength and thus independent of at least one of the claimed group).
Regarding claim 44, the modified Shahaf device is such that a velocity of the plurality of particles of the at least one substance, after exiting the device, is maintained in the range of about 5 m/s to 50 m/s, independent of at least one of the predetermined volume Vgas [ml], the predetermined volume Vsub [ml], and the predetermined pressure Pgas [barg] (the modified Shahaf device includes each structural and functional limitation as claimed such that it would also provide the same performance parameters claimed).
Regarding claim 46, the modified Shahaf device’s full width of the plume is maintained at the angle less than 25 degrees independent of the Vgas, Vsub, and Pgas (see above explanation in claim 45, the modified Shahaf includes each structural and functional limitation as claimed such that it would also provide the same performance limitation).
Regarding claim 48, the modified Shahaf device includes a delivery time dTdeliver of less than 500 ms (see Wilkerson para. 0268), inherently has an internal diameter of the valve and includes the same Vgas, Vsub, and Pgas limitations such that its delivery time would also be independent thereof. The modified Shahaf device is silent as to the internal diameter being above 0.22 mm; however, this would have been an obvious matter of design choice to one of ordinary skill in the art before the effective filing date of the claimed invention and one would expect the modified Shahaf device to perform equally as well.
Regarding claim 80, the modified Shahaf device teaches a delivery time dTdeliver of less than 500 ms (see Wilkerson para. 0268) and includes the same Vgas, Vsub, and Pgas limitations such that its delivery time would also be independent thereof.
Regarding claim 19, the use of the Shahaf device includes a method of delivering a predetermined mass Msub [mg] of at least one substance within at least one body cavity of a subject (see Fig. 3A-18 for example, abstract) which includes providing a device including at least one capsule sized and shaped for containing the predetermined mass Msub of said at least one substance (see Fig. 6C showing capsule 25, see pg. 73 ln. 24 through pg. 74 ln. 4) having a predetermined volume Vsub and a plurality of particles (see pg. 13-14 which discloses various types of substances that can be delivered, the substance delivered in aerosol form and thus having a plurality of particles and which has a predetermined volume of that loaded into the capsule); a nozzle configured for placement in proximity to the body cavity and being in fluid communication with the capsule, the nozzle including at least one orifice with a diameter D (see Fig. 3B, 6B-C showing nozzle 20 with at least one orifice which inherently has a diameter, see pg. 32 ln. 15 disclosing outlet opening having a diameter; pg. 73 ln. 24 through pg. 74 ln. 4 which discloses the outlet as a bore which also has a diameter and the operation of the device which shows the fluid communication of the nozzle with the capsule and placement in proximity to the body cavity, see also Fig. 19); at least one valve mechanically connectable to the capsule and characterized by at least two configurations: (i) an active configuration in which the valve enables delivery of predetermined mass Msub of the substance from the capsule to the body cavity via the nozzle and (ii) an inactive configuration in which the valve prevents delivery of the predetermined mass Msub of the substance from the capsule to the body cavity (see Fig. 4C showing valve 10 in the INACTIVE CONFIGURATION, see Fig. 5C and D showing valve in the ACTIVE CONFIGURATION; see also pg. 73); the valve reconfigurable from the inactive configuration to the active configuration with in a predetermined period of time, dT, in response to activation of the valve (see pg. 73 and Fig. 4C, the valve is spring loaded and in response to inhalation by the user, will actuate/reconfigure within a predetermined period of time dT); a fluid-tight chamber configured to contain predetermined volume Vgas [ml] of pressurized gas at a predetermined pressure Pgas [barg] (see Fig. 4C showing the fluid tight chamber as the space between piston seal 8 and element 40, see also Fig. 11 which is the same figure disclosed by the instant application, the gas in this chamber is pressurized per pg. 71 ln. 27 through pg. 74 ln. 4, see pg. 6 ln. 3-5 discloses volume and pressure values for the compressed gas in the fluid tight chamber); the pressurized gas, once the valve is reconfigured from the inactive to the active configuration, is configured to entrain the substance and deliver it via the orifice in the nozzle within the body cavity (see pg. 71 ln. 27 through pg. 74 ln. 4 which discloses the operation of the device for delivery of the substance entrained by the pressurized gas from the fluid tight chamber, the delivery of such includes pressure, volume (gas) and volume (substance) rates during the delivery time period); wherein the device is configured to deliver the predetermined mass Msub of the substance and the predetermined volume Vgas of the pressurized gas through the orifice into the body cavity (see pg. 71 ln. 27 through pg. 74 ln. 4 which discloses the operation of the device for delivery of the substance entrained by the pressurized gas to the user); placing the delivery end in proximity to the body cavity and reconfiguring the valve from the INACTIVE CONFIGURATION to the ACTIVE CONFIGURATION thereby entraining the substance in the predetermined volume of gas and thereby delivering the predetermined mass of the substance, predetermined volume of gas through the orifice of diameter D in a pressure rate of dPgas/dT, volume rate dVgas/dT, and volume rate dVsub/dT, wherein the volume/pressure of pressurized gas is released from the chamber upon activation of the valve entrains the substance and erupts via the orifice into the body cavity (see Fig. 3A-11 and 19 and see pg. 71 ln. 27 through pg. 74 ln. 4 which discloses the operation of the device for delivery of the substance entrained by the pressurized gas from the fluid tight chamber during activation of the valve, the delivery of such includes a pressure/volume rates during the delivery time period). The Shahaf method/device the predetermined pressure Pgas being in a range 1-10 barg (see pg. 6 ln. 3-5). The now modified Shahaf method/device is silent as to also having a diameter of the orifice D being in a range of 0.2-6 mm (Shahaf discloses on pg. 76-77 varying parameters of the device); however, Price teaches a similar delivery device including an outlet orifice having a diameter D in the claimed range (see Price para. 0143, 0.5 to 2.5 mm). Thus 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 modified Shahaf method/device’s orifice diameter to be in the claimed range, such as the values taught by Price, in order to provide a diameter to best accommodate the physical/chemical characteristics of the particular medicament to be aerosolized (see Price para. 0143). The now modified Shahaf device is silent as to the predetermined mass Msub explicitly being in a range of 1-1000 mg; however, the amount of substance to be delivered to the user would have been an obvious matter of design choice and would be obvious to choose such values depending on the needs of the user. Furthermore, Haartsen teaches a drug delivery device which provides an amount of substance to be delivered being in the range of 1-1000 mg (see Haartsen para. 0003). Thus 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 modified Shahaf device’s capsule to contain substance with a predetermined mass being in the range of 1-1000 mg, as taught by Haartsen, in order to provide a desired amount of substance to the user depending on the user’s needs (i.e. dosing amount). The now modified Shahaf method/device is silent as to the release time of the mass Msub of the substance and the pressurized gas, dTdelivery being less than 500 ms and is silent as to the a viscosity η of the at least one substance being in a range of 1x10-3 poise to 1 poise; however, Wilkerson teaches a similar drug delivery device (see Wilkerson para. 0002 & 0007) which teaches a delivery time of less than 500 ms (see para. 0268), and delivery of a substance having a viscosity η of the at least one substance being in a range of 1x10-3 poise to 1 poise (see Wilkerson para. 0269 and TABLE 15, 0.3 to 100 cP which is encompassed by the claimed range). Thus 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 modified Shahaf method/device’s drug delivery time to be less than 500 ms and to deliver a substance with a viscosity level, as taught by Wilkerson, in order to deliver a particular/desired type of substance to the user, and to provide an optimized/desired drug delivery time and furthermore, it has been held true that where the general conditions of the claim are disclosed in the prior art, discovering optimum or workable ranges involve only routine skill in the art. In re Aller, 200 F. 2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The now modified Shahaf method/device delivers the at least one substance by forming a mixture of the predetermined volume of the pressurized gas and volume of the at least one substance to entrain within the device to form a plume of aerosol for delivery to the user (see Shahaf pg. 71 ln. 27 through pg. 74 ln. 4 which discloses the operation of the device for delivery of the substance entrained by the pressurized gas to the user, see also Fig. 10 and pg. 7 last 3 lines), but is silent as to the plume of aerosol having an angle subtending a full width of the plume at an angle of less than 25°; however, Yeates teaches an aerosol delivery device which discloses such a shaped aerosol plume for delivery (Yeates para. 0003, and 0090 which discloses subtending angles including the claimed range of less than 25°, it being obvious to choose such values in Yeates). Thus 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 modified Shahaf method/device to be configured to deliver a plume of aerosol having an angle subtending a full width of the plume at an angle of less than 25°, as taught by Yeates, for “optimal function” of the aerosol plume (see Yeates para. 0090).
Regarding claim 20, the Shahaf method is silent as to the predetermined volume Vgas being in a range of 0.1-21 ml; however, Shahaf discloses that the Vgas is in a range of about 5-50 mL (see pg. 6 ln. 3-5). Thus 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 Shahaf device to choose the Vgas in a range of about 0.1-21 mL as these particular values/ranges would have been obvious to try and in order to further optimize the substance delivery to the user (see MPEP 2144.05 I and II).
Regarding claim 21, the modified Shahaf method includes all the same structural elements as claimed such that it would provide for the claimed conditions and further includes that the body orifice is one of the ones claimed in condition a (see Fig. 19 and pg. 73 ln. 24-27, nasal cavity, note the device, such as in Fig. 11, is the same figure disclose and also is capable of delivery substance to the other body orifices).
Regarding claim 33, the modified Shahaf method includes the step of pre-pressurizing the chamber with the gas to the pressure or pressurizing the chamber before reconfiguring the valve from the inactive configuration to the active configuration (see pg. 71 ln. 27 through pg. 74 ln. 4 which discloses the operation of the device for delivery of the substance entrained by the pressurized gas to the user; Fig. 5A-C show the device with the chamber pressurized and then the user inhales to reconfigure the valve to discharge the pressurized gas and receive the dose of substance).
Regarding claim 34, the modified Shahaf method includes the step of either pre-emplacing the substance in the capsule or emplacing the substance in the capsule before reconfiguring the valve from the inactive to active configuration (see pg. 71 ln. 27 through pg. 74 ln. 4 which discloses the operation of the device for delivery of the substance entrained by the pressurized gas to the user; the substance is placed in the capsule which is placed in the device before reconfiguring the valve from inactive to active configuration in order for the user to receive the dose of the substance).
Regarding claim 35, the modified Shahaf method’s dTdeliver is maintained less than 500 ms independent of how the user operates the device (see Shahaf pg. 32 ln. 11-13, pg. 77 ln. 3-7 and pg. 71 ln. 27 through pg. 74 ln. 4 which discloses the operation of the device; the actuation time is dependent on the spring strength and thus independent the user).
Regarding claim 36, the modified Shahaf method’s dTdeliver is maintained less than 500 ms independent of at least one of the of the claimed group (see Shahaf pg. 32 ln. 11-13, pg. 77 ln. 3-7 and pg. 71 ln. 27 through pg. 74 ln. 4 which discloses the operation of the device; the actuation time is dependent on the spring strength and thus independent of at least one of the claimed group).
Regarding claim 84, the modified Shahaf method teaches a delivery time dTdeliver of less than 500 ms (see Wilkerson para. 0268) and includes the same Vgas, Vsub, and Pgas limitations such that its delivery time would also be independent thereof.
Regarding claim 49, Shahaf shows a device for delivering a predetermined mass Msub [mg] of at least one substance within at least one body cavity of a subject (see Fig. 3A-18 for example, abstract) which includes at least one capsule sized and shaped for containing the mass Msub of the substance (see Fig. 6C showing capsule 25, see pg. 73 ln. 24 through pg. 74 ln. 4) having a predetermined volume Vsub and a plurality of particles (see pg. 13-14 which discloses various types of substances that can be delivered, the substance delivered in aerosol form and thus having a plurality of particles and which has a predetermined volume of that loaded into the capsule); a nozzle configured for placement in proximity to the body cavity and being in fluid communication with the capsule, the nozzle including at least one orifice with a diameter D (see Fig. 3B, 6B-C showing nozzle 20 with at least one orifice which inherently has a diameter, see pg. 32 ln. 15 disclosing outlet opening having a diameter; pg. 73 ln. 24 through pg. 74 ln. 4 which discloses the outlet as a bore which also has a diameter and the operation of the device which shows the fluid communication of the nozzle with the capsule and placement in proximity to the body cavity, see also Fig. 19); at least one valve mechanically connectable to the capsule and characterized by at least two configurations: (i) an active configuration in which the valve enables delivery of predetermined mass Msub of the substance from the capsule to the body cavity via the nozzle and (ii) an inactive configuration in which the valve prevents delivery of the predetermined mass Msub of the substance from the capsule to the body cavity (see Fig. 4C showing valve 10 in the INACTIVE CONFIGURATION, see Fig. 5C and D showing valve in the ACTIVE CONFIGURATION; see also pg. 73); the valve reconfigurable from the inactive configuration to the active configuration with in a predetermined period of time, dT, in response to activation of the valve (see pg. 73 and Fig. 4C, the valve is spring loaded and in response to inhalation by the user, will actuate/reconfigure within a predetermined period of time dT); a fluid tight chamber configured to contain predetermined volume Vgas [ml] of pressurized gas at a predetermined pressure Pgas [barg] (see Fig. 4C showing the fluid tight chamber as the space between piston seal 8 and element 40, see also Fig. 11 which is the same figure disclosed by the instant application, the gas in this chamber is pressurized per pg. 71 ln. 27 through pg. 74 ln. 4, see pg. 6 ln. 3-5 discloses volume and pressure values for the compressed gas in the fluid tight chamber); the pressurized gas, once the valve is reconfigured from the inactive to the active configuration, is configured to entrain the substance and deliver it via the orifice in the nozzle within the body cavity (see pg. 71 ln. 27 through pg. 74 ln. 4 which discloses the operation of the device for delivery of the substance entrained by the pressurized gas from the fluid tight chamber, the delivery of such includes pressure, volume (gas) and volume (substance) rates during the delivery time period); wherein the device is configured to deliver the predetermined mass Msub of the substance and the predetermined volume Vgas of the pressurized gas through the orifice into the body cavity (see pg. 71 ln. 27 through pg. 74 ln. 4 which discloses the operation of the device for delivery of the substance entrained by the pressurized gas to the user). The Shahaf device’s Pgas is in a range 1-10 barg (see pg. 6 ln. 3-5). The Shahaf device is silent as to also having a diameter of the orifice D being in a range of 0.2-6 mm (Shahaf discloses on pg. 76-77 varying parameters of the device); however, Price teaches a similar delivery device including an outlet orifice having a diameter D in the claimed range (see Price para. 0143, 0.5 to 2.5 mm). Thus 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 modified Shahaf device’s orifice diameter to be in the claimed range, such as the values taught by Price, in order to provide a diameter to best accommodate the physical/chemical characteristics of the particular medicament to be aerosolized (see Price para. 0143). The now modified Shahaf device is silent as to the predetermined mass Msub explicitly being in a range of 1-1000 mg; however, the amount of substance to be delivered to the user would have been an obvious matter of design choice and would be obvious to choose such values depending on the needs of the user. Furthermore, Haartsen teaches a drug delivery device which provides an amount of substance to be delivered being in the range of 1-1000 mg (see Haartsen para. 0003). Thus 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 modified Shahaf device’s capsule to contain substance with a predetermined mass being in the range of 1-1000 mg, as taught by Haartsen, in order to provide a desired amount of substance to the user depending on the user’s needs (i.e. dosing amount). The now modified Shahaf device is silent as to the release time of the mass Msub of the substance and the pressurized gas, dTdelivery being less than 500 ms and is silent as to the a viscosity η of the at least one substance being in a range of 1x10-3 poise to 1 poise; however, Wilkerson teaches a similar drug delivery device (see Wilkerson para. 0002 & 0007) which teaches a delivery time of less than 500 ms (see para. 0268) and delivery of a substance having a viscosity η of the at least one substance being in a range of 1x10-3 poise to 1 poise (see Wilkerson para. 0269 and TABLE 15, 0.3 to 100 cP which is encompassed by the claimed range). Thus 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 modified Shahaf device’s drug delivery time to be less than 500 ms and to deliver a substance with a viscosity level, as taught by Wilkerson, in order to deliver a particular/desired type of substance to the user, and to provide an optimized/desired drug delivery time and furthermore, it has been held true that where the general conditions of the claim are disclosed in the prior art, discovering optimum or workable ranges involve only routine skill in the art. In re Aller, 200 F. 2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The modified Shahaf device includes a delivery time dTdeliver of less than 500 ms (see Wilkerson para. 0268), inherently has an internal diameter of the valve and includes the same Vgas, Vsub, and Pgas limitations such that its delivery time would also be independent thereof. The modified Shahaf device is silent as to the internal diameter being above 0.22 mm; however, this would have been an obvious matter of design choice to one of ordinary skill in the art before the effective filing date of the claimed invention and one would expect the modified Shahaf device to perform equally as well. The now modified Shahaf device delivers the at least one substance by forming a mixture of the predetermined volume of the pressurized gas and volume of the at least one substance to entrain within the device to form a plume of aerosol for delivery to the user (see Shahaf pg. 71 ln. 27 through pg. 74 ln. 4 which discloses the operation of the device for delivery of the substance entrained by the pressurized gas to the user, see also Fig. 10 and pg. 7 last 3 lines), but is silent as to the plume of aerosol having an angle subtending a full width of the plume at an angle of less than 25°; however, Yeates teaches an aerosol delivery device which discloses such a shaped aerosol plume for delivery (Yeates para. 0003, and 0090 which discloses subtending angles including the claimed range of less than 25°, it being obvious to choose such values in Yeates). Thus 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 modified Shahaf device to be configured to deliver a plume of aerosol having an angle subtending a full width of the plume at an angle of less than 25°, as taught by Yeates, for “optimal function” of the aerosol plume (see Yeates para. 0090).
Regarding claim 50, the Shahaf device is silent as to the predetermined volume Vgas being in a range of 0.1-21 ml; however, Shahaf discloses that the Vgas is in a range of about 5-50 mL (see pg. 6 ln. 3-5). Thus 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 Shahaf device to choose the Vgas in a range of about 0.1-21 mL as these particular values/ranges would have been obvious to try and in order to further optimize the substance delivery to the user (see MPEP 2144.05 I and II).
Regarding claim 51, the modified Shahaf device’s dTdeliver is maintained less than 500 ms independent of how the user operates the device (see Shahaf pg. 32 ln. 11-13, pg. 77 ln. 3-7 and pg. 71 ln. 27 through pg. 74 ln. 4 which discloses the operation of the device; the actuation time is dependent on the spring strength and thus independent the user).
Regarding claim 52, the modified Shahaf device’s dTdeliver is maintained less than 500 ms independent of at least one of the of the claimed group (see Shahaf pg. 32 ln. 11-13, pg. 77 ln. 3-7 and pg. 71 ln. 27 through pg. 74 ln. 4 which discloses the operation of the device; the actuation time is dependent on the spring strength and thus independent of at least one of the claimed group).
Regarding claim 55, the modified Shahaf device is such that a velocity of the plurality of particles of the at least one substance, after exiting the device, is maintained in the range of about 5 m/s to 50 m/s, independent of at least one of the predetermined volume Vgas [ml], the predetermined volume Vsub [ml], and the predetermined pressure Pgas [barg] (the modified Shahaf device includes each structural and functional limitation as claimed such that it would also provide the same performance parameters claimed).
Regarding claim 57, the modified Shahaf device’s full width of the plume is maintained at the angle less than 25 degrees independent of the Vgas, Vsub, and Pgas (see above explanation in claim 56, the modified Shahaf includes each structural and functional limitation as claimed such that it would also provide the same performance limitation).
Regarding claim 59, the modified Shahaf device includes all the same structural elements as claimed such that it would provide for the claimed conditions and further includes that the body orifice is one of the ones claimed in condition a (see Fig. 19 and pg. 73 ln. 24-27, nasal cavity, note the device, such as in Fig. 11, is the same figure disclose and also is capable of delivery substance to the other body orifices).
Regarding claim 60, the modified Shahaf device’s includes a capsule having a main longitudinal axis and forming at least one compartment arranged about the main longitudinal axis (see Shahaf Fig. 6C and pg. 73 ln. 24-32). The modified Shahaf also discloses that the container can including plural compartments (see pg. 77 ln. 8-11 and pg. 80 ln. 21-23).
Regarding claim 61, the modified Shahaf device’s capsule includes a port fluidly connectable to an exterior of the device and configured such that the substance is insertable into the chamber via the port (see annotated Fig. 6D above).
Claim(s) 12 and 62 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shahaf, Price, Haartsen, Wilkerson, and Yeates as applied to claims 11 and 61 above, and further in view of Peters.
Regarding claims 12 and 62, the modified Shahaf device/method includes a port cover to provide a closure for the port, the cover being one of slidable along the device, rotatable around the device, rotatable around a hinge of the device and any combination thereof (see Shahaf annotated Fig. 6D above and Fig. 6C, cover 24, pg. 74 ln. 5-9; see also Fig. 13, cover/closure 20, pg. 78 ln. 8-10 for example). The modified Shahaf device/method is silent as to the cover explicitly providing an air-tight closure for the port; however, Peters teaches a similar device/method which includes a container/capsule for containing a substance therein with a cover/closure that provides an air-tight seal (see Peters para. 0020, 0059, and 0073). Thus 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 modified Shahaf device/method’s cover/closure to be air-tight, as taught by Peters, in order to ensure that no substance is lost before dispensing and that the user receives the proper dose amount.
Claim(s) 47 and 58 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shahaf, Price, Haartsen, Wilkerson, and Yeates as applied to claims 7 and 49 above, and further in view of Sullivan.
Regarding claims 47 and 58, the modified Shahaf device is silent as to the full width of the plume measured at 6 cm from the nozzle is 21 mm or less (see Shahaf Fig. 1C, 10; the modified Shahaf device includes each structural and functional limitation as claimed such that it would also provide the same performance limitation, see Yeates para. 0090). Furthermore, Sullivan teaches a similar device which discloses that shape/size/surface texture of components of the delivery device can be varied to form optimum spray plume geometry (see Sullivan para. 0019). 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 modified Shahaf device to be configured to optimize the spray plume geometry, as taught by Sullivan, and to provide a desired sized spray plume (Sullivan para. 0019). Additionally, it has been held true that where the general conditions of the claim are disclosed in the prior art, discovering optimum or workable ranges involve only routine skill in the art. In re Aller, 200 F. 2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Claim(s) 37 and 53 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shahaf, Price, Haartsen, Wilkerson, and Yeates as applied to claims 19 and 49 above, and further in view of Muellinger.
Regarding claim 37, the modified Shahaf method is silent as to explicitly disclosing at least one of the pressure velocity and volume rates holding true (Shahaf discloses on pg. 76-77 varying parameters of the device); however, Muellinger teaches a similar delivery device including volume rates (see Muellinger para. 0027 and 0078). Thus 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 modified Shahaf device’s rate to be values, such as taught by Muellinger, in order to provide a desired rate of flow for the patient.
Regarding claim 53, the modified Shahaf device is silent as to explicitly disclosing at least one of the pressure velocity and volume rates holding true (Shahaf discloses on pg. 76-77 varying parameters of the device); however, Muellinger teaches a similar delivery device including volume rates (see Muellinger para. 0027 and 0078). Thus 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 modified Shahaf device’s rate to be values, such as taught by Muellinger, in order to provide a desired rate of flow for the patient.
Claim(s) 79 and 83 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shahaf, Price, Haartsen, Wilkerson, and Yeates as applied to claims 7 and 19 above, and further in view of Winkler.
Regarding claim 79, the modified Shahaf device is silent as to the predetermined period of time dT for reconfiguration being less than or equal to 200 ms; however, Shahaf discloses the ability to vary parameters including spring strength of the valve for optimization (see pg. 32 ln. 11-13, pg. 77 ln. 3-7) and discloses having the open/reconfiguration time being low (see pg. 75 ln. 22-27) and furthermore, Winkler teaches a similar drug delivery device which includes a valve with an actuation/reconfiguration time being less than or equal to 200 ms (see Winkler para. 0027). Thus 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 modified Shahaf device’s valve actuation/reconfiguration time to be less than or equal to 200 ms, as taught by Winkler, in order to provide quick actuation to ensure the user receives the dose immediately during their inhalation effort to optimize drug delivery and furthermore, it has been held true that where the general conditions of the claim are disclosed in the prior art, discovering optimum or workable ranges involve only routine skill in the art. In re Aller, 200 F. 2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 83, the modified Shahaf method/device is silent as to the predetermined period of time dT for reconfiguration being less than or equal to 200 ms; however, Shahaf discloses the ability to vary parameters including spring strength of the valve for optimization (see pg. 32 ln. 11-13, pg. 77 ln. 3-7) and discloses having the open/reconfiguration time being low (see pg. 75 ln. 22-27) and furthermore, Winkler teaches a similar drug delivery device which includes a valve with an actuation/reconfiguration time being less than or equal to 200 ms (see Winkler para. 0027). Thus 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 modified Shahaf method/device’s valve actuation/reconfiguration time to be less than or equal to 200 ms, as taught by Winkler, in order to provide quick actuation to ensure the user receives the dose immediately during their inhalation effort to optimize drug delivery and furthermore, it has been held true that where the general conditions of the claim are disclosed in the prior art, discovering optimum or workable ranges involve only routine skill in the art. In re Aller, 200 F. 2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Claim(s) 54 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shahaf, Price, Haartsen, Wilkerson, and Yeates as applied to claim 49 above, and further in view of Denton and Galgon.
Regarding claim 54, the modified Shahaf device is silent as to the nozzle including a nozzle tip portion and tip extension that surrounds and has a larger diameter than the tip portion, the tip portion defining the at least one orifice and the extension defining at least one hole through which substance exits laterally; however, Denton teaches a similar substance delivery device which includes a nozzle tip portion and tip extension that surrounds and has a larger diameter than the tip portion (see Denton Fig. 5, tip portion 262 tip extension portion 264, see para. 0040) and Galgon teaches a similar substance delivery device which include holes providing lateral delivery (see Galgon Fig. 1A-B, lateral holes 21, para. 0045). Thus 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 modified Shahaf device to include nozzle tip and extension portion and lateral delivery holes, as taught by Denton and Galgon, in order to provide a nostril guide (Denton para. 0040) and a greater spray pattern (Galgon para. 0045).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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Claims 1-39, 41-44, 46-55, 57-73, and 75-84 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims (see below claim-to-claim comparison for list) of U.S. Patent No. 11,116,914.
Although the claims at issue are not identical, they are not patentably distinct from each other because they include each structural and functional limitation as claimed (see patent claims, claim-to-claim comparison below) but include additional limitations (such as the Tdeliver maintained less than 500 ms independent of the Vgas,sub Pgas and the particle velocity) such that the patent claims are narrower versions of the instant claims. As such, any infringement on the patent claims would result in infringement on the instant claims. Functional limitations not specifically addressed in the patent claims are able to be performed by the patent claims as they include the same structural and functional limitations as claimed, including Vsub/Msub, Vgas, and Pgas values and other dimensional limitations (same explanations above regarding prior art applies below).
Instant claim 1-2 corresponds to patent claim 1. Instant claim 3 corresponds to patent claim 2. Instant claim 4 corresponds to patent claim 3. Instant claim 5-6 corresponds to patent claim 4-5. Instant claim 7-8 corresponds to patent claim 14. Instant claim 9 corresponds to patent claim 15. Instant claim 10 corresponds to patent claim 16. Instant claim 11-12 corresponds to patent claim 17-18. Instant claim 1 corresponds to patent claim 1. Instant claim 13-14 corresponds to patent claim 22. Instant claim 15 corresponds to patent claim 23. Instant claim 16 corresponds to patent claim 24. Instant claim 17-18 corresponds to patent claim 25-26. Instant claim 19-20 corresponds to patent claim 32. Instant claim 21 corresponds to patent claim 33. Instant claim 22-24 corresponds to patent claim 1. Instant claim 25 corresponds to patent claim 20. Instant claim 26 corresponds to patent claim 14. Instant claim 27 corresponds to patent claim 5. Instant claim 28 corresponds to patent claim 28. Instant claim 29 corresponds to patent claim 29. Instant claim 30 corresponds to patent claim 30. Instant claim 31 corresponds to patent claim 22. Instant claim 32 corresponds to patent claim 17. Instant claim 33 corresponds to patent claim 34. Instant claim 34 corresponds to patent claim 35. Instant claim 35-37 corresponds to patent claim 32. Instant claim 38 corresponds to patent claim 7. Instant claim 39 corresponds to patent claim 1. Instant claim 41-43 corresponds to patent claim 10-13. Instant claim 44 corresponds to patent claim 14. Instant claim 46-48 corresponds to patent claim 14. Instant claim 49-55, 57-62 corresponds to patent claim 14. Instant claim 63-73, 75-76 corresponds to patent claim 10-13.
Response to Arguments
Applicant’s arguments with respect to the claims have been considered but are moot because the new ground of rejection does not rely on the same combination of references 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to COLIN W STUART whose telephone number is (571)270-7490. The examiner can normally be reached M-F: 9-5.
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/COLIN W STUART/Primary Examiner, Art Unit 3785
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