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 07/14/2026. The previous 112 rejections have been withdrawn in response to applicant’s amendment. Claims 1-12, 14-19 and 21-22 are currently pending.
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.
Claims 1-2 are 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 pressurized 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 pressurized 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, at all points along the flow path, is greater than a lowest internal cross-sectional area of the metering valve through which the propellant and medicament pass (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; note also general teaching in par 0071 that the flow path may exclude all tapered sections throughout its length, par 0037 disclosing throats/constrictions being only in some embodiments thus disclosing embodiments where the flow path does not have a constriction, as well as fig 20 – 25 illustrating the constant diameter).
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 pressurized 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 pressurized propellant and the medicament (pg 29 ln 22-24); and a metering valve (#122 fig 9) configured to release a predetermined amount of the pressurized 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 of the valve block, wherein 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, the flow path/single delivery tube 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 delivery tube provides a single channel extending from the expansion chamber to the delivery opening without flow disruption (see fig 9, 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 and therefore the flow is without disruption).
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 22 are rejected under 35 U.S.C. 103 as being unpatentable over King in view of Mezzoli (US 2003/0101992 A1) and Goodall (ES 2280386 T3).
Regarding claim 17, King discloses a device for delivery of a medicament to at least one of the olfactory region, the turbinates region and 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 pressurized 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 pressurized 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 (predominantly #10 fig 26, par 0101-0102) is defined through the actuator for passage of the propellant and the medicament from the canister to the delivery opening (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, at all points along the flow path, is greater than a lowest internal cross-sectional area of the metering valve through which the propellant and medicament pass (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 inhaler).
King 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; examiner notes that the delivery opening is larger in cross section than the upstream fluid passage, see Figs. 7a and 7b).
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 King as doing so helps to obtain a more uniform distribution of the medicament on the nasal cavity (Mezzoli abstract).
Modified King 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 King 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 King discloses the device of claim 17. Modified King further discloses the delivery opening has a curved profile (Mezzoli par 0011 oval/elliptical are curved profiles).
Regarding claim 19, modified King discloses the device of claim 17. Modified King further discloses the delivery opening is elliptical (Mezzoli par 0011).
Regarding claim 22, modified King discloses the device of claim 17. Modified King further discloses a single uninterrupted flow path is defined through the nosepiece from a valve block body of the valve block (fig 26).
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over modified King as applied to claim 17 above, and further in view of Gisle.
Regarding claim 21, modified King discloses the device of claim 17. Modified King 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.
Gisle discloses a nasal inhaler 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 for the nose piece of modified King as the bend allows for ease of insertion of the nose piece tip inside a user’s upward facing nostrils
Response to Arguments
Applicant’s arguments with respect to claim 17 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 07/14/2026 have been fully considered but they are not persuasive.
Applicant asserts that the King does not teach the claimed differing diameters “at all points along the flow path” (see pg 10 of the response filed 07/14/2026). However, King expressly discloses “the tubular nozzle 10 has a larger inner diameter than the dispensing passage 480” (see par 0084 of King). Absent express disclosure that this embodiment of Kin includes a constriction within the tubing, it is seen that disclosure that the tubing is larger than the dispensing passage is sufficient to disclose that the tubing exhibits this larger diameter along its entire length. Applicant’s arguments are not persuasive and the examiner maintains the rejection.
Applicant further asserts that the flow path of claim 9 is not a single delivery tube/single flow path but is instead a tubular section of the breath actuated tubing (see pg 13 of the response filed 07/14/2026). It is unclear how the scope of a single delivery tube excludes a portion of a tubing. As there are not multiple flow paths or tubing existing between the valve block/expansion chamber and the delivery opening it is seen that this tubing satisfies the claim. 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
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 KIRA B DAHER whose telephone number is (571)270-0190. The examiner can normally be reached M-F 8am-5pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, 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
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