DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
This action is responsive to the amendment filed 01/20/2026. Claims 13 and 20 have been canceled and claims 21-22 have been added thus claims 1-12, 14-19 and 21-22 are currently pending.
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 1-8 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 1 calls to a cross-sectional area of the metering valve. It is unclear if the cross sectional area of the metering valve is the internal area of the metering valve that the medicament passes through or if the cross sectional area includes the structure of the metering valve and thus relies on the outer diameter of the valve. For the purposes of examination, the cross-sectional area of the metering valve is being interpreted as referring the internal dimensions/area of the valve. Claims 7-8 are rejected by dependency upon claim 1.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by King (US 2006/0118107 A1).
Regarding claim 1, King discloses a device for delivery of a medicament to at least one of the olfactory region, the turbinates region or the nasopharynx of a nasal cavity (abstract, fig 26, par 0101 “intranasal inhaler”), the device comprising: a canister (#540 fig 26) comprising: a container containing a pressurised propellant and the medicament (par 0101 “pharmaceutical aerosol”); and a metering valve (#550 fig 26, par 0004 disclosing metered dose inhalers, par 0101 “valve stem”) configured to release a predetermined amount of the pressurised propellant and the medicament (par 0004 disclosing mdi); and an actuator (#570/640 fig 26) comprising: a housing receiving the canister (#570 fig 26); a valve block (portion of #570 fig 26 surrounding #590 and supporting #550) receiving the metering valve (see fig 26), the valve block defining an expansion chamber for passage of propellant and medicament expelled from the canister (#590 fig 10); and a nosepiece for insertion into a user's nostril (#660 fig 26), the nosepiece comprising a fluid passage (#680/630 fig 26) and a delivery opening (#700 fig 26) for expulsion of the propellant and medicament into the user's nostril (par 0102); wherein a flow path is defined through the actuator for passage of propellant and medicament from the canister (predominantly #10 fig 26, par 0101-0102), the flow path including the expansion chamber, the fluid passage and the delivery opening, and wherein the cross-sectional area of the flow path is greater than the lowest cross-sectional area of the metering valve at all points along the flow path (see fig 10 showing a tubular nozzle embodiment that has a greater cross-sectional area than the internal portion of the valve stem, par 0084 disclosing a larger inner diameter, par 0082 disclosing the tubing of fig 9-19 can be utilized on the intranasal inhalers).
Regarding claim 2, King discloses the device of claim 1. King further discloses the metering valve comprises a valve stem (#550 fig 26) having a valve stem inlet (portion of valve stem communicating with the canister) and a valve stem outlet (portion of valve stem communicating with tubing #10/590 fig 26), wherein the valve stem defines the lowest cross-sectional area of the metering valve (fig 10, par 0084).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 4 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over King as applied to claim 1 above and further in view of Jinks (US 2010/0247932 A1).
Regarding claim 4, King discloses the device of claim 2. King does not expressly disclose teaches the valve stem inlet comprises a plurality of openings defined in a sidewall of the valve stem.
Jinks teaches a similar inhaler device utilizing a canister with a valve stem on a valve block (see fig 1a), wherein the metering valve comprises a valve stem (#14 fig 3) having a valve stem inlet (#19 fig 3) and a valve stem outlet (#24 fig 3), the valve stem inlet comprises a plurality of openings defined in a sidewall of the valve stem (#19 fig 3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize a typical valve stem as taught by Jinks for the valve stem of King as the valve stem is of a typical/known type (Jinks: par 0190) and therefore can reduce manufacturing costs by outsourcing the valve stem.
Regarding claim 8, King discloses the device of claim 1. King is silent to the pressurised propellant comprises at least 25%CO2.
Jinks teaches utilizing a pressurized propellant of CO2 (par 0183).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize CO2 as the propellant for King as taught by Jinks as CO2 is a common propellant used for aerosol inhaler (Jinks par 0183) and is a relatively cheap propellant option. It would have further been obvious to utilize at least 25% CO2 in order to have a sufficient amount of propellant to act on the medicament.
Claims 3 and 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over King/modified King as applied to claims 2 and 4 above and further in view of Warby (GB 2413498 A).
Regarding claim 3, King discloses the device of claim 2. King is silent to the valve stem inlet has a cross- sectional area of at least 0.4 mm2.
Warby discloses that the size of the valve stem inlet effects the amount/dosage dispensed through the valve stem upon actuation (pg 12 ln 26-30, see inlet #20 fig 1-3). Therefore, the inlet size is a result effective variable.
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 inlet of King to have the claimed size in order to control the dosage amount since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 5, King discloses the device of claim 4. King is silent to the plurality of openings define a total cross-sectional area of at least 0.4 mm2.
Warby discloses that the size of the valve stem inlet effects the amount/dosage dispensed through the valve stem upon actuation (pg 12 ln 26-30, see inlet #20 fig 1-3). Therefore, the inlet size is a result effective variable.
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 inlet of modified King to have the claimed size in order to control the dosage amount since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 6, King discloses the device of claim 2. King is silent to the valve stem inlet comprises a non-circular opening.
Warby discloses that the size and thus shape of the valve stem inlet effects the amount/dosage dispensed through the valve stem upon actuation (pg 12 ln 26-30, see inlet #20 fig 1-3). Therefore, the inlet size/shape is a result effective variable.
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 inlet of King to have the claimed non-circular shape in order to control the dosage amount since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). It would have further been obvious as a matter of design choice to utilize a non-circular opening. (MPEP 2144.04).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over King as applied to claim 1 above and further in view of Rubin (CA 2,808,836 A1) and Schneider (US 2019/0029318 A1).
Regarding claim 7, King discloses the device of claim 1. King is silent to at least part of the flow path is constructed from a conductive material having at least one of: a thermal conductivity greater than or equal to 1W/mK; or an electrical resistivity less than or equal to 1x1010Q-m.
Rubin teaches a similar inhaler device that utilizes at least part of the flow path is constructed from a conductive material (pg 58 claim 35 discloses metal or plastic-coated metal along the walls of the device/flow path).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize a conductive material like metal as taught by Rubin for the flow path of King as doing so helps to prevent deposition of the medicament (Rubin pg 58 cl 35).
Modified King is further silent to the conductive material/metal having at least one of: a thermal conductivity greater than or equal to 1W/mK; or an electrical resistivity less than or equal to 1x1010Q-m.
Schneider teaches a vaporization device that utilizes metals such as aluminum (par 0125), aluminum being a metal with a thermal conductivity of 237 W/mK.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use aluminum as taught by Schneider for the metal of modified King as aluminum can be a cost saving material (Schneider par 0125).
Claims 9-12 and 14-16 are rejected under 35 U.S.C. 103 as being unpatentable over Gisle (WO 00/51672) in view of Rubin and Schneider.
Regarding claim 9, Gisle discloses a device for delivery of a medicament to at least one of the olfactory region, the turbinates region or the nasopharynx of a nasal cavity (abstract “nasal airway”, “nostril”), the device comprising: a canister (#120 fig 9) comprising: a container (#121 fig 9) containing a pressurised propellant and the medicament (pg 29 ln 22-24); and a metering valve (#122 fig 9) configured to release a predetermined amount of the pressurised propellant and the medicament (pg 29 ln 24-30); and an actuator (#110 fig 9) comprising: a housing receiving the canister (see annotated Gisle fig 9 below); a valve block (#116/117 fig 9) receiving the metering valve (pg 29 ln 19-20), the valve block defining an expansion chamber for passage of propellant and medicament expelled from the canister (pg 30 ln 2-4); and a nosepiece for insertion into a user's nostril (#132 fig 9, pg 30 ln 10-12), the nosepiece comprising a fluid passage and a delivery opening for expulsion of the propellant and medicament into the user's nostril (see annotated Gisle fig 9 below); wherein a flow path is defined through the actuator for passage of propellant and medicament from the canister (pg 30 ln 30 – pg 31 ln 2), the flow path including the expansion chamber, the fluid passage and the delivery opening; wherein a single uninterrupted flow path is defined through the nosepiece from the valve block body (see fig 9, the flow path being between 117 and the delivery opening, see also response to arguments below).
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Gisle annotated fig 9
Gisle is silent to at least part of the flow path is constructed from a conductive material having at least one of: a thermal conductivity greater than or equal to 1W/mK; or an electrical resistivity less than or equal to 1x1010Q-m.
Rubin teaches a similar inhaler device that utilizes at least part of the flow path is constructed from a conductive material (pg 58 claim 35 discloses metal or plastic-coated metal along the walls of the device/flow path).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize a conductive material like metal as taught by Rubin for the flow path of Gisle as doing so helps to prevent deposition of the medicament (Rubin pg 58 cl 35).
Modified Gisle is further silent to the conductive material/metal having at least one of: a thermal conductivity greater than or equal to 1W/mK; or an electrical resistivity less than or equal to 1x1010Q-m.
Schneider teaches a vaporization device that utilizes metals such as aluminum (par 0125), aluminum being a metal with a thermal conductivity of 237 W/mK.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use aluminum as taught by Schneider for the metal of modified Gisle as aluminum can be a cost saving material (Schneider par 0125).
Regarding claim 10, modified Gisle discloses the device of claim 9. Modified Gisle does not expressly disclose the at least part of the flow path constructed from a conductive material includes a portion of the flow path defined in the valve block. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the conductive material on the valve block as doing so prevents deposition in the valve block (Rubin pg 58 cl 35).
Regarding claim 11, modified Gisle discloses the device of claim 9. Modified Gisle does not expressly disclose the at least part of the flow path constructed from a conductive material includes at least part of the expansion chamber. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the conductive material on the expansion chamber as doing so prevents deposition in the expansion chamber (Rubin pg 58 cl 35).
Regarding claim 12, modified Gisle discloses the device of claim 10. Modified Gisle does not expressly disclose the valve block further comprises an insert defining at least part of the flow path defined in the valve block, wherein the insert is constructed from the conductive material, and wherein the valve block body is constructed from a material having at least one of a lower thermal conductivity or higher electrical resistivity than the insert.
However, Rubin discloses the use of plastic coated with metal (pg 58 cl 35), it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use plastic coated with metal for the valve block of Gisle as doing so prevents deposition within the valve block and reduces cost due to the low cost of plastic materials. Utilizing metal coated plastic for the valve block is seen as disclosing a plastic valve block with a metal/conductive insert (coating), where the plastic valve block has a lower thermal conductivity that the metal insert.
Regarding claim 14, modified Gisle discloses the device of claim 9. Gisle further discloses the single uninterrupted flow path is defined through a single delivery tube extending from the valve block body, through the nosepiece to the delivery opening (see fig 9).
Regarding claim 15, modified Gisle discloses the device of claim 9. Modified Gisle discloses the conductive material comprises a metal (Rubin pg 58 cl 35).
Regarding claim 16, modified Gisle discloses the device of claim 15. Modified Gisle discloses the conductive material comprises aluminium (Schneider par 0125).
Claims 17-19 and 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Gisle in view of Mezzoli (US 2003/0101992 A1) and Goodall (ES 2280386 T3).
Regarding claim 17, Gisle discloses a device for delivery of a medicament to at least one of the olfactory region, the turbinates region or the nasopharynx of a nasal cavity (abstract “nasal airway”, “nostril”), the device comprising: a canister (#120 fig 9) comprising: a container (#121 fig 9) containing a pressurised propellant and the medicament (pg 29 ln 22-24); and a metering valve (#122 fig 9) configured to release a predetermined amount of the pressurised propellant and the medicament (pg 29 ln 24-30); and an actuator (#110 fig 9) comprising: a housing receiving the canister (see annotated Gisle fig 9 below); a valve block (#116/117 fig 9) receiving the metering valve (pg 29 ln 19-20), the valve block defining an expansion chamber for passage of propellant and medicament expelled from the canister (pg 30 ln 2-4); and a nosepiece for insertion into a user's nostril (#132 fig 9, pg 30 ln 10-12), the nosepiece comprising a fluid passage and a delivery opening for expulsion of the propellant and medicament into the user's nostril (see annotated Gisle fig 9 below); wherein a flow path is defined through the actuator for passage of propellant and medicament from the canister to the delivery opening (pg 30 ln 30 – pg 31 ln 2).
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Gisle annotated fig 9
Gisle is silent to the delivery opening has a profile with a first dimension in a first direction and a second dimension in a second direction, wherein the first dimension is larger than the second dimension.
Mezzoli discloses a nozzle for nasal spray, wherein the delivery opening has a profile with a first dimension in a first direction and a second dimension in a second direction, wherein the first dimension is larger than the second dimension (fig 2, 4, par 0011 disclose an elliptical shape thus disclosing a width dimension being greater than a height dimension).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize an elliptical delivery opening as taught by Mezzoli for the delivery opening of Gisle as doing so helps to obtain a more uniform distribution of the medicament on the nasal cavity (Mezzoli abstract).
Modified Gisle does not expressly disclose the cross-sectional area of the flow path transitions from a circular profile to the profile of the delivery opening.
Goodall teaches an aerosol device where the cross-sectional area of the flow path transitions from a circular profile to the profile of the delivery opening (#200 fig 2, pg 5 par 3 “In one embodiment, the end of nozzle inlet has a circular cross profile, while the outlet end of the nozzle has a profile elliptical cross section in relation to a horizontal axis similar to the shape of the user's mouth (for example, a major axis which is substantially collinear with the "line" formed by upper and lower lips of the user when joined)”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to transition the flow path of modified Gisle from a circular to elliptical flow path as taught by Goodall, as the starting circular flow path aligns with how the aerosol is ejected from the canister while the elliptical profile better meets the needs of medicament distribution in the nose (see Mezzoli above).
Regarding claim 18, modified Gisle discloses the device of claim 17. Modified Gisle further discloses the delivery opening has a curved profile (Mezzoli par 0011 oval/elliptical are curved profiles).
Regarding claim 19, modified Gisle discloses the device of claim 17. Modified Gisle further discloses the delivery opening is elliptical (Mezzoli par 0011).
Regarding claim 21, modified Gisle discloses the device of claim 17. Modified Gisle of fig 9 is silent to the fluid passage of the nosepiece has a first flow axis proximate the valve block, and a second flow axis proximate the delivery opening, wherein the first and second flow axes are at an angle to each other.
However, Gisle discloses additional embodiments wherein the fluid passage of the nosepiece has a first flow axis proximate the valve block, and a second flow axis proximate the delivery opening, wherein the first and second flow axes are at an angle to each other (see #34 fig 2-3 and annotated Gisle fig 2 below).
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Gisle annotated fig 2
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize a bend nose piece as taught by Gisle fig 2-3 for the nose piece of Gisle fig 9 as the bend allows for ease of insertion of the nose piece tip inside a user’s upward facing nostrils.
Regarding claim 22, modified Gisle discloses the device of claim 17. Modified Gisle further discloses a single uninterrupted flow path is defined through the nosepiece from a valve block body of the valve block (see fig 9).
Response to Arguments
Applicant’s arguments with respect to claim 1 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant's arguments filed 01/20/20226 have been fully considered but they are not persuasive.
Applicant asserts that the flow path of claim 9 is interrupted by the exhaled air flow from the mouthpiece (see pg 12 of the response filed 01/20/2026). Interrupt is defined by Merriam-Webster as “to stop or hinder by breaking in” or “to break the uniformity or continuity of. As the flow from the mouth piece is present for the entirety of the fluid passage between the valve block and the delivery opening it is not seen that the presence of this additional fluid flow causes a break in uniformity or continuity of the flow. Further the flow does not act as an obstacle the stops or ceases the flow from the valve block and therefore it is not seen that the presence of the flow from the mouth piece interrupts the flow path. Therefore, applicant’s arguments are not persuasive and the examiner upholds the rejection. See conclusion showing additional prior art containing a single flow path similar to applicant’s.
Applicant further asserts that Goodall is non-analogous art as it pertains to an inhaler for inhaling through the mouth rather than inhaling through the nose (see pg 14 of response filed 01/20/2026). However, it is seen that the delivery of inhalant to a user constitutes the same field of endeavor whether the delivery be through the mouth or nose. Further it is seen that the reference of Goodall is solving the same problem as it is for providing a smooth delivery of inhalant to the user. Therefore, applicant’s arguments are not persuasive and the examiner upholds the rejection.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 2016/0101245 A1 discloses a single flow path nasal inhaler
US 6,092,522 discloses an inhaler with anti-static walls
GB 2397025 A discloses a nasal inhaler with two flow axis for the delivery of the inhalant (see fig 6(e)-6(h))
US 4046146 A discloses a nasal inhaler with a similar shape to applicant (see fig 10) (not breath actuated
US 20050268915 A1 discloses a nasal adapter for an inhaler (not breath actuated)
US 20120085345 A1 discloses a nasal spray device
US 20190151576 A1 discloses a nasal inhaler
CN 104755122 A discloses a metering valve coated in aluminum for reduced drug deposition
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KIRA B DAHER whose telephone number is (571)270-0190. The examiner can normally be reached M-F 8am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brandy Lee can be reached at (571) 270-7410. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KIRA B DAHER/Examiner, Art Unit 3785
/BRADLEY H PHILIPS/Primary Examiner, Art Unit 3799