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 request for continued examination and amendment filed 6/15/26. As directed by the amendment, claims 1, 15, 22-23, 30, and 34 have been amended and no claims have been added nor cancelled. Claims 4-6, 10, 13, 18-20, 25, 29, 32, and 37-39 remain withdrawn as being directed towards non-elected subject matter. Claims 1-3, 7-9, 11-12, 14-17, 21-24, 26-28, 30-31, 33-36, and 40 are examined on their merits below.
Claim Objections
Claim 30 is objected to because of the following informalities: the language “wherein at least one pressurized fluid chamber” (line 1-2) is objected to as it appears Applicant unintendedly deleted the word ‘said’ in the recent amendment (claim 23 sets forth the pressurized fluid chamber); Examiner suggests amending to read –wherein said at least one pressurized fluid chamber--. Appropriate correction is required.
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 and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sullivan et al. (2005/0188985) in view of Genosar (2018/0072480) and Shahaf et al. (2016/0129205).
Note: the earliest effective filing date of the instant invention is 6/25/20, thus the Shahaf reference qualifies as prior art.
Regarding claim 1, Sullivan discloses a device for delivering one or more substances within at least one body cavity (see Fig. 1-5, abstract, and para. 0003 for example) which includes at least one pierceable vial comprising a predetermined volume Vsub of the one or more substances (see Fig. 1-2 showing pierceable vial 20, or Fig. 4 with 38 and 20 defining the pierceable vail, para. 0029 for example disclosing rupturing of the breakable membranes and thus the vial is pierceable), the at least one pierceable vial having at least one fluid discharging outlet port having a predetermined size (Fig. 1-2, outlet port covered by membrane 32, see also Fig. 4 and 6, outlet port covered by membrane 32 and the end/outlet tube 64, see para. 0029-0030, 0035; figures showing the outlet port which has a predetermined size as shown), configured for placement in proximity to the at least one body cavity (see para. 0003 and 0036-0037), the at least one pierceable vial configured to interface in a sealable manner with at least one pressurized fluid at volume VPF and predetermined pressure PPF (see Fig. 5, element 90 being a syringe with piston 94, action of which pressurizes fluid inside chamber/container 92, see para. 0035-0037; construction of the device for use provides for a predetermined volume and pressure); wherein the device, upon actuation, enables the at least one pressurized fluid to enter into the at least one pierceable vial via at least one fluid inlet port (Fig. 2, fluid inlet port covered by membrane 30, see Fig. 4 left end in this figure defining an inlet port of 58), entrains the one or more substances and delivers it through the at least one fluid discharging outlet port to within the at least one body cavity in the form of at least one selected from a group consisting of drops, droplets, stream, aerosol and any combination thereof (see para. 0013, 0029-0030, and 0036-0037 for example). Sullivan is silent as to including a cover breakably coupled to a terminal end of the vial and the fluid discharging outlet port is exposed upon removal of the cover; however, Genosar discloses a similar device which includes a cover breakably coupled to a terminal end of the vial and the fluid discharging outlet port is exposed upon removal of the cover (see Genosar Fig. 1 showing breakable cover 122 connected, para. 0078 discloses breaking cover during removal and which exposes the discharging outlet of 111). 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 Sullivan device to further include a breakably coupled cover, as taught by Genosar, in order to provide aseptic protection from the environment (see Genosar para. 0078). The modified Sullivan device is silent as to being configured to deliver the one or more substances along with the pressurized fluid within a period of time that is less than 3 seconds; however, Shahaf teaches a similar substance delivery device which teaches this delivery duration (see Shahaf para. 0279, less than about 500 ms). 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 Sullivan device to be configured to deliver the substance and fluid within 3 seconds, as taught by Shahaf, in order to provide a quick delivery time in order to ensure the user receives the full dose.
Regarding claim 22, the use of the Sullivan device includes a method for delivering one or more substances within at least one body cavity (see Fig. 1-5, abstract, and para. 0003 for example), the method including the steps of: providing a device characterized by at least one pierceable vial comprising a predetermined Vsub of the one or more substances (see Fig. 1-2 showing pierceable vial 20, or Fig. 4 with 38 and 20 defining the pierceable vial, para. 0029 for example disclosing rupturing of the breakable membranes and thus the vial is pierceable), the at least one pierceable vial having at least one fluid discharging outlet port having a predetermined orifice size (Fig. 1-2, outlet port covered by membrane 32, see also Fig. 4 and 6, outlet port covered by membrane 32 and the end/outlet tube 64, see para. 0029-0030, 0035, figures showing the outlet port which has a predetermined size as shown), configured for placement in proximity to the body cavity (see para. 0003 and 0036-0037), the at least one pierceable vial configured to interface in a sealable manner with at least one pressurized fluid at volume VPF and pressure PPF (see Fig. 5, element 90 being a syringe with piston 94, action of which pressurizes fluid inside chamber/container 92, see para. 0035-0037); placing the device in proximity to the at least one body cavity (see para. 0013 and 0036-0037); and activating the device the enable the at least one pressurized fluid to enter into the at least one pierceable vial via at least one inlet port to entrain the one or more substances and deliver through the at least one fluid discharging outlet port into the at least one body cavity in the form of at least one selected from the group consisting of drops, droplets, stream, aerosol and any combination thereof (Fig. 2, fluid inlet port covered by membrane 30, see Fig. 4 left end in this figure defining an inlet port of 58; see para. 0013, 0029-0030, and 0036-0037 for example). The Sullivan method/device is silent as to including a cover breakably coupled to a terminal end of the vial and the fluid discharging outlet port is exposed upon removal of the cover; however, Genosar discloses a similar device which includes a cover breakably coupled to a terminal end of the vial and the fluid discharging outlet port is exposed upon removal of the cover (see Genosar Fig. 1 showing breakable cover 122 connected, para. 0078 discloses breaking cover during removal and which exposes the discharging outlet of 111). 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 Sullivan method/device to further include a breakably coupled cover, as taught by Genosar, in order to provide aseptic protection from the environment (see Genosar para. 0078). The modified Sullivan method/device is silent as to being configured to deliver the one or more substances along with the pressurized fluid within a period of time that is less than 3 seconds; however, Shahaf teaches a similar substance delivery device/method of use which teaches this delivery duration (see Shahaf para. 0279, less than about 500 ms). 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 Sullivan method/device to be configured to deliver the substance and fluid within 3 seconds, as taught by Shahaf, in order to provide a quick delivery time in order to ensure the user receives the full dose.
Claim(s) 1-3, 7-9, 11-12, 14, 16-17, 21-24, 26-28, 30-31, 33, 35-36, and 40 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sullivan in view of Genosar and Nilsson et al. (2006/0067911).
Regarding claim 1, Sullivan discloses a device for delivering one or more substances within at least one body cavity (see Fig. 1-5, abstract, and para. 0003 for example) which includes at least one pierceable vial comprising a predetermined volume Vsub of the one or more substances (see Fig. 1-2 showing pierceable vial 20, or Fig. 4 with 38 and 20 defining the pierceable vail, para. 0029 for example disclosing rupturing of the breakable membranes and thus the vial is pierceable), the at least one pierceable vial having at least one fluid discharging outlet port having a predetermined size (Fig. 1-2, outlet port covered by membrane 32, see also Fig. 4 and 6, outlet port covered by membrane 32 and the end/outlet tube 64, see para. 0029-0030, 0035; figures showing the outlet port which has a predetermined size as shown), configured for placement in proximity to the at least one body cavity (see para. 0003 and 0036-0037), the at least one pierceable vial configured to interface in a sealable manner with at least one pressurized fluid at volume VPF and predetermined pressure PPF (see Fig. 5, element 90 being a syringe with piston 94, action of which pressurizes fluid inside chamber/container 92, see para. 0035-0037; construction of the device for use provides for a predetermined volume and pressure); wherein the device, upon actuation, enables the at least one pressurized fluid to enter into the at least one pierceable vial via at least one fluid inlet port (Fig. 2, fluid inlet port covered by membrane 30, see Fig. 4 left end in this figure defining an inlet port of 58), entrains the one or more substances and delivers it through the at least one fluid discharging outlet port to within the at least one body cavity in the form of at least one selected from a group consisting of drops, droplets, stream, aerosol and any combination thereof (see para. 0013, 0029-0030, and 0036-0037 for example). Sullivan is silent as to including a cover breakably coupled to a terminal end of the vial and the fluid discharging outlet port is exposed upon removal of the cover; however, Genosar discloses a similar device which includes a cover breakably coupled to a terminal end of the vial and the fluid discharging outlet port is exposed upon removal of the cover (see Genosar Fig. 1 showing breakable cover 122 connected, para. 0078 discloses breaking cover during removal and which exposes the discharging outlet of 111). 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 Sullivan device to further include a breakably coupled cover, as taught by Genosar, in order to provide aseptic protection from the environment (see Genosar para. 0078). The modified Sullivan device is silent as to being configured to deliver the one or more substances along with the pressurized fluid within a period of time that is less than 3 seconds; however, Nilsson teaches a similar substance delivery device which teaches this delivery duration (see Nilsson para. 0041, it being obvious to choose values less than 3 seconds from the range of 0.1 seconds to 5 seconds). 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 Sullivan device to be configured to deliver the substance and fluid within 3 seconds, as taught by Nilsson, in order to provide a quick delivery time in order to ensure the user receives the full dose.
Regarding claim 2, the modified Sullivan device’s at least one pressurized fluid is enclosed within at least one pressurized fluid chamber (see Sullivan para. 0036-0037, Fig. 5).
Regarding claim 8, the modified Sullivan device’s at least one vial includes at least one breakable membrane such that when pressure of the at least one pressurized fluid reaches a predetermined value the at least one membrane breaks and enables releasing of the at least one pressurized fluid from the at least one chamber (see Sullivan Fig. 5 and para. 0029, 0035-0037 and Fig. 1-2, breakable membranes 30 and 32).
Regarding claim 9, the modified Sullivan device’s at least on pressurized fluid chamber and the at least one vial includes at least one breakable membrane such that when the pressure of the fluid reaches a predetermined value the at least one membrane breaks and enable releasing of the at least one pressurized from the chamber and into the at least one vial (see Sullivan Fig. 5 and para. 0029, 0035-0037 and Fig. 1-2, breakable membranes 30 and 32).
Regarding claim 11, the modified Sullivan device’s at least one pressurized fluid chamber is a container adapted to hold the at least one pressurized fluid at the pressure for a period of time (see Sullivan Fig. 5, 92 being a container defining a chamber and is configured to hold a pressure for a period of time, see para. 0037).
Regarding claim 16, the modified Sullivan device’s at least one pressurized fluid chamber is a syringe (see Sullivan Fig. 5, 90 being a syringe, see para. 0037).
Regarding claim 17, the modified Sullivan device’s at least one pressurized fluid is compressed within the at least one chamber by at least one piston (see Sullivan Fig. 5, piston 94, see para. 0036-0037).
Regarding claim 3, the modified Sullivan device’s at least one pierceable vial is selected from the claimed group (see Sullivan Fig. 1-2, vial 20 is a pierceable vial/breakable container as membranes 30 and 32 are broken via pressure, see para. 0013, 0029, 0036 for example).
Regarding claim 7, the modified Sullivan device’s at least one pierceable vial additionally includes at least one breakable membrane such that when the pressure of the at least one pressurized fluid reaches a predetermined value the at least one membrane breaks and enables entry of the at least one pressurized fluid into the at least one vial (see Sullivan Fig. 5 and para. 0029, 0035-0037 and Fig. 1-2, breakable membranes 30 and 32).
Regarding claim 12, the modified Sullivan device’s at least one pierceable vial is made of material selected from the group consisting of high-density polyethylene and/or polypropylene and any other plastic resin (see Sullivan para. 0030).
Regarding claim 14, the modified Sullivan device’s at least one pressurized fluid is provided by external fluid pump (see Sullivan Fig. 5 and para. 0037, piston 94 reads on an ‘external pump’).
Regarding claim 21, the modified Sullivan device is such that at least one of the claimed conditions A-E set forth is held true (see Sullivan para. 0003, 0013, the body cavity being the mouth or nasal cavity).
Regarding claim 22, the use of the Sullivan device includes a method for delivering one or more substances within at least one body cavity (see Fig. 1-5, abstract, and para. 0003 for example), the method including the steps of: providing a device characterized by at least one pierceable vial comprising a predetermined Vsub of the one or more substances (see Fig. 1-2 showing pierceable vial 20, or Fig. 4 with 38 and 20 defining the pierceable vial, para. 0029 for example disclosing rupturing of the breakable membranes and thus the vial is pierceable), the at least one pierceable vial having at least one fluid discharging outlet port having a predetermined orifice size (Fig. 1-2, outlet port covered by membrane 32, see also Fig. 4 and 6, outlet port covered by membrane 32 and the end/outlet tube 64, see para. 0029-0030, 0035, figures showing the outlet port which has a predetermined size as shown), configured for placement in proximity to the body cavity (see para. 0003 and 0036-0037), the at least one pierceable vial configured to interface in a sealable manner with at least one pressurized fluid at volume VPF and pressure PPF (see Fig. 5, element 90 being a syringe with piston 94, action of which pressurizes fluid inside chamber/container 92, see para. 0035-0037); placing the device in proximity to the at least one body cavity (see para. 0013 and 0036-0037); and activating the device the enable the at least one pressurized fluid to enter into the at least one pierceable vial via at least one inlet port to entrain the one or more substances and deliver through the at least one fluid discharging outlet port into the at least one body cavity in the form of at least one selected from the group consisting of drops, droplets, stream, aerosol and any combination thereof (Fig. 2, fluid inlet port covered by membrane 30, see Fig. 4 left end in this figure defining an inlet port of 58; see para. 0013, 0029-0030, and 0036-0037 for example). The Sullivan method/device is silent as to including a cover breakably coupled to a terminal end of the vial and the fluid discharging outlet port is exposed upon removal of the cover; however, Genosar discloses a similar device which includes a cover breakably coupled to a terminal end of the vial and the fluid discharging outlet port is exposed upon removal of the cover (see Genosar Fig. 1 showing breakable cover 122 connected, para. 0078 discloses breaking cover during removal and which exposes the discharging outlet of 111). 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 Sullivan method/device to further include a breakably coupled cover, as taught by Genosar, in order to provide aseptic protection from the environment (see Genosar para. 0078). The modified Sullivan method/device is silent as to being configured to deliver the one or more substances along with the pressurized fluid within a period of time that is less than 3 seconds; however, Nilsson teaches a similar substance delivery device/method of use which teaches this delivery duration (see Nilsson para. 0041, it being obvious to choose values less than 3 seconds from the range of 0.1 seconds to 5 seconds). 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 Sullivan method/device to be configured to deliver the substance and fluid within 3 seconds, as taught by Nilsson, in order to provide a quick delivery time in order to ensure the user receives the full dose.
Regarding claim 23, the modified Sullivan method is such that the at least one pressurized fluid is enclosed within at least one pressurized fluid chamber (see Sullivan para. 0036-0037, Fig. 5).
Regarding claim 27, the modified Sullivan method includes a container that includes at least one breakable membrane such that when pressure of the at least one pressurized fluid reaches a predetermined value the at least one membrane breaks and enables the release of the at least one pressurized fluid from the at least one chamber (see Sullivan Fig. 5 and para. 0029, 0035-0037 and Fig. 1-2, breakable membranes 30 and 32).
Regarding claim 28, the modified Sullivan method’s at least one chamber and at least one vial includes at least one breakable membrane such that when the pressure of the at least one pressurized fluid reaches a predetermined value the at least one breakable membrane breaks and enables entry of the at least one pressurized fluid into the at least one pierceable vial (see Sullivan Fig. 5 and para. 0029, 0035-0037 and Fig. 1-2, breakable membranes 30 and 32).
Regarding claim 30, the modified Sullivan method’s at least one pressurized fluid chamber is a container adapted to hold the at least one pressurized fluid at the pressure for a period periods of time (see Sullivan Fig. 5, 92 being a container defining a chamber and is configured to hold a pressure for a period of time, see para. 0037).
Regarding claim 35, the modified Sullivan method’s at least one pressurized fluid chamber is a syringe (see Sullivan Fig. 5, 90 being a syringe, see para. 0037).
Regarding claim 36, the modified Sullivan method’s at least one pressurized fluid is compressed within the at least one pressurized fluid chamber by at least one piston (see Sullivan Fig. 5, piston 94, see para. 0036-0037).
Regarding claim 24, the modified Sullivan method’s at least one pierceable vial is selected from the claimed group (see Sullivan Fig. 1-2, vial 20 is a pierceable vial/breakable container as membranes 30 and 32 are broken via pressure, see para. 0013, 0029, 0036 for example).
Regarding claim 26, the modified Sullivan method’s at least one pierceable vial additionally includes at least one breakable membrane such that when the pressure of the at least one pressurized fluid reaches a predetermined value the at least one membrane breaks and enables entry of the at least one pressurized fluid into the at least one vial (see Sullivan Fig. 5 and para. 0029, 0035-0037 and Fig. 1-2, breakable membranes 30 and 32).
Regarding claim 31, the modified Sullivan method’s at least one pierceable vial is made of material selected from the group consisting of high-density polyethylene and/or polypropylene and any other plastic resin (see Sullivan para. 0030).
Regarding claim 33, the modified Sullivan method’s at least one pressurized fluid is provided by external fluid pump (see Sullivan Fig. 5 and para. 0037, piston 94 reads on an ‘external pump’).
Regarding claim 40, the modified Sullivan method is such that at least one of the claimed conditions A-E set forth is held true (see Sullivan para. 0003, 0013, the body cavity being the mouth or nasal cavity).
Claim(s) 15 and 34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sullivan, Genosar, and Nilsson as applied to claims 1 and 22 above, and further in view of Kawamura et al. (2010/0258115).
Regarding claims 15 and 34, the modified Sullivan device/method is silent as to at least one of the claimed conditions A-E being held true; however, Kawamura teaches a similar device/method which includes nasal substance delivery including a substance amount in the range of about 0.001 to about 7 ml (see Kawamura para. 0157). 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 Sullivan device/methods volume of substance to be in the range of about 0.001 to about 7 ml, as taught by Kawamura, in order to provide a desired amount of substance/medication for a patient and such an amount is suitable for such use (see Kawamura para. 0157).
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 current/above combination of references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
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/COLIN W STUART/Primary Examiner, Art Unit 3785
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