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 .
Status of Claims
The present Office action is responsive to the Request for Continued Examination filed on 04-02-2026. As directed, claims 1, 12-16, 23, 25, 28, and 30 have been amended, claims 2-7 and 17-22 have been canceled, and new claims 32-35 have been added. Thus, claims 1, 8-16, and 23-35 are currently pending examination.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 04-02-2026 has been entered.
Terminal Disclaimer
The terminal disclaimer filed against US patent 11,511,054 is received and acknowledged. The double patenting rejections previously made of record are obviated.
Response to Arguments
Applicant argues that the double patenting rejections of record should be withdrawn owing to the filing of the terminal disclaimer on 03-24-206. As a result of the filing of the terminal disclaimer, the double patenting rejections of record are hereby withdrawn.
Applicant argues, see Remarks as filed pages 9-10, that claims 1, 16, and 25 have been amended to overcome previous reliance on the combination of Hale and Rubin. Insofar as Applicant has amended these claims to include the antistatic plastics limitations, Steelman and/or Snyder will be used to read on those limitations as previously applied in the prior Office action of record. The additional amendments made to further limit the structure of the device will be newly rejected using additional disclosure and teachings from Hale.
Applicant further argues, see Remarks as filed pages 10-11, that the Notice of Allowance issued with respect to the parent application previously indicated that charging of alprazolam was not a known issue, and thus the claimed device was found to be patentable.
Examiner notes that the Board decision levied 12-10-2025, and the Final rejections of 05-21-2024 and 02-25-2026 in the instant case have already extensively addressed the propriety of reliance on Rubin for establishing that electrostatic charging of vapor and subsequent aerosol deposition is a known issue in delivering vapor via condensation aerosolization. Notably, the Board upheld the Office’s decision to reject the instant claims on those grounds. Thus, following this affirmation, Examiner maintains the same arguments as set forth in the previous rejections of record and in accordance with the Board decision: Rubin teaches the skilled artisan that aerosol deposition of vapor under the condition of delivering medicament or other inhalable via condensation aerosolization is a known problem, and a known solution is to construct the airways of the device from antistatic material in order to solve this issue (Rubin: page 38, lines 20-33; page 43, lines 13-24; page 44, lines 22-29). On this issue, Rubin will be maintained in the rejections of record below.
Applicant additionally points to the use and discussion of Rubin’s electrostatic charger, which is conceded in Rubin itself to produce electrostatic charge, as a reason the Office and the Board have erred in their interpretation and reliance on Rubin. Applicant specifically argues that the charger is an intentional technical element that Rubin relies on, and that element is what creates the electrostatic charge of vapor.
Examiner once again disagrees for reasons that have been extensively outlined on the record. In Applicant’s own provision of Rubin’s disclosure at page 12 of the remarks, Rubin expressly concedes that the heating element may serve as an electrostatic charger. The term may plainly sets forth that this arrangement is an option, but does not limit all embodiments of Rubin’s device to require such an element. Still further, the previously cited and relied on sections of Rubin in the rejections of record, in particular at page 44, quite explicitly state “The airflow conduit 441 may be made of anti-static materials, or have an anti-static coating, so that the conduit, itself, does not readily experience aerosol deposition”. Rubin thus purports that the conduit 441 may be made from anti-statics for the express purpose of avoiding aerosol particle deposition. This therefore indicates that static/charge-based aerosol deposition was a known problem before the effective filing date of the instant invention, and one that Rubin provides clear instruction and teaching on how to solve.
Further, with respect to Applicant’s arguments that Rubin thus requires electrical energy due to the presence of the electrostatic charger, which stands at odds with claims 32-35 which invoke an exothermic reaction for heating the chemical compound, Examiner also disagrees with Applicant’s overall interpretation of the prior art rejections, and thus the premise of this argument. In the rejections made of record, and further set forth below, the electrostatic charger of Rubin is not imported by modification into the Hale device. Hale expressly refers to use of exothermic reaction for aerosolization (paragraphs 278-279 and 286-287). Rubin is only relied on for the teaching of anti-static coating in an airway to avoid particle deposition thereon. Further, as has been stated above, Rubin does not necessitate the electrostatic charger to be contained it its device in order to also justify use of anti-static airway materials. Thus, Hale’s device is not modified to include Rubin’s electrostatic charger. Therefore, Applicant’s arguments here are also unpersuasive.
Claim Objections
Claims 8, 11, and 34 are objected to because of the following informalities:
At claim 8, line 1, it is suggested that “further” be added before “comprising”.
At claim 11, line 2, it is suggested that a comma be added following “pure drug”.
At claim 34, line 2, it is suggested that “msec” be replaced with “milliseconds” for clarity.
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
A “breath-actuation element” in claim 26 which is interpreted relative to paragraph 71 of the Specification to include devices capable of controlling the timing of aerosol delivery relative to user inhalation.
A “dose counting/logging device” in claim 27 which is interpreted relative to paragraphs 71 and 122 of the Specification to include elements capable of tracking inhaled doses.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or non-obviousness.
Claims 1, 8-16, 23-27, and 32-35 are rejected under 35 U.S.C. 103 as being unpatentable over Hale (US 2007/0122353) in view of Rubin (WO 2012/026963) and Steelman (US 2013/0276781).
Regarding claim 1, Hale discloses a device (30) for delivering a condensation aerosol comprising alprazolam (paragraph 290, lines 1-6; paragraph 315, lines 1-4; Fig. 2A), comprising:
an inlet (36) (paragraph 290, lines 8-11; Fig. 2A);
an outlet (34) (paragraph 290, lines 7-11; Fig. 2A);
a drug layer (40) comprising alprazolam and configured to be heated to form a vaporized drug (paragraph 290, lines 11-15; paragraph 291, lines 1-4; paragraph 315, lines 1-4; Fig. 2A);
a condensation space configured to condense the vaporized drug to form the condensation aerosol comprising alprazolam (paragraph 289, lines 1-7, see “inert passageway”; paragraph 290, lines 1-6; Fig. 2A); and
a housing (32) defining an airway extending from the inlet (36) to the outlet (34) (paragraph 290, lines 7-11; paragraph 291, lines 1-5; Fig. 2A).
Hale fails to disclose wherein the housing comprises an antistatic material, the antistatic material being an antistatic plastic or antistatic plastics applied as airway materials.
However, Rubin teaches a device (410) for delivering a condensation aerosol comprising a housing (see Fig. 11 which illustrates a two-part shell of inhaler 410 housing internal components) wherein the housing comprises antistatic material (page 38, lines 20-33; page 43, lines 13-24; page 44, lines 22-29; Figs. 9-11). Rubin further teaches that the anti-static material serves to shield the conduit itself and internal components of the device from aerosol deposition (page 44, lines 22-29). Additionally, Rubin teaches that the inhaler can be used to deliver alprazolam (see claim 55).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed by Hale to further construct the housing to include an anti-static material, as taught by Rubin, in order to shield the airway and internal components of the device from aerosol deposition.
Presently modified Hale fails to disclose wherein the antistatic material is comprised of an antistatic plastic or antistatic plastics applied as airway materials.
However, Steelman teaches an inhalation device (abstract, lines 1-3; Fig. 1) wherein the antistatic material is comprised of antistatic plastics applied as airway materials (paragraph 13, lines 1-5; paragraph 82, lines 1-8).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute an antistatic plastic for the device airway of the device disclosed by modified Hale, as taught by Steelman, in order to achieve the same result as indicated by Rubin to reduce particle deposition on the interior of the device via an anti-static material (see MPEP 2143 I B).
Regarding claim 8, Hale in view of Rubin and Steelman disclose the device of claim 1, as discussed above.
Hale further discloses wherein the device (30) comprises an alprazolam film (42) that is coated on a solid support (40) (paragraph 274, lines 1-4; paragraph 290, lines 1-6; paragraph 291, lines 1-6; paragraph 315, lines 1-4).
Regarding claim 9, Hale in view of Rubin and Steelman disclose the device of claim 8, as discussed above.
Hale further discloses wherein the solid support (40) is selected from metal foils, smooth metal surfaces and non-porous ceramics (paragraph 269, lines 5-7).
Regarding claim 10, Hale in view of Rubin and Steelman disclose the device of claim 1, as discussed above.
Hale further discloses wherein the condensation aerosol comprising alprazolam is free of solvents and propellants (paragraph 54, lines 1-4; paragraph 106, lines 1-5; paragraph 255, lines 1-10).
Regarding claim 11, Hale in view of Rubin and Steelman disclose the device of claim 10, as discussed above.
Hale further discloses wherein the alprazolam aerosol is pure drug free of any solvents, propellants or excipients (paragraph 54, lines 1-4; paragraph 106, lines 1-5; paragraph 255, lines 1-10; paragraph 315, lines 1-4).
Regarding claim 12, Hale in view of Rubin and Steelman disclose the device of claim 1, as discussed above.
Modified Hale further discloses wherein the surface resistivity of the antistatic plastic is between 1E9 ohm/sq and 1E12 ohm/sq (Steelman: paragraph 13, lines 1-5; paragraph 82, lines 1-8).
The range disclosed by Steelman of 1E9 ohm/sq and 1E12 ohm/sq overlaps the claimed range of 1E9 ohm/sq and 1E11 ohm/sq. In the case where the range in the prior art overlaps the claimed range, a prima facie case of obviousness exists (see MPEP 2144.05 I).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select an antistatic plastic with a surface resistivity in the range of 1E9 ohm/sq and 1E12 ohm/sq, as taught by Steelman, in order to achieve the desired anti-static properties, such a range overlapping the claimed range.
Regarding claim 13, Hale in view of Rubin disclose the device of claim 11, as discussed above.
Modified Hale further discloses wherein the surface resistivity of the antistatic plastic is between 1E9 ohm/sq and 1E12 ohm/sq (Steelman: paragraph 13, lines 1-5; paragraph 82, lines 1-8).
The range disclosed by Steelman of 1E9 ohm/sq and 1E12 ohm/sq overlaps the claimed range of 1E9 ohm/sq and 1E11 ohm/sq. In the case where the range in the prior art overlaps the claimed range, a prima facie case of obviousness exists (see MPEP 2144.05 I).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select an antistatic plastic with a surface resistivity in the range of 1E9 ohm/sq and 1E12 ohm/sq, as taught by Steelman, in order to achieve the desired anti-static properties, such a range overlapping the claimed range.
Regarding claim 14, Hale in view of Rubin and Steelman disclose the device of claim 1, as discussed above.
Modified Hale further discloses wherein the antistatic material is an antistatic plastic with a surface resistivity between 1E9 ohm/sq and 1E12 ohm/sq (Steelman: paragraph 13, lines 1-5; paragraph 82, lines 1-8).
The range disclosed by Steelman of 1E9 ohm/sq and 1E12 ohm/sq the claimed value of 1E11 ohm/sq lies within the range disclosed by the prior art. In the case where the range in the prior art includes the claimed value, a prima facie case of obviousness exists (see MPEP 2144.05 I).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select an antistatic plastic with a surface resistivity in the range of 1E9 ohm/sq and 1E12 ohm/sq, as taught by Steelman, in order to achieve the desired anti-static properties, such a range encompassing the claimed value.
Regarding claim 15, Hale in view of Rubin disclose the device of claim 11, as discussed above.
Modified Hale further discloses wherein the surface resistivity of the antistatic plastic is between 1E9 ohm/sq and 1E12 ohm/sq (Steelman: paragraph 13, lines 1-5; paragraph 82, lines 1-8).
The range disclosed by Steelman of 1E9 ohm/sq and 1E12 ohm/sq the claimed value of 1E11 ohm/sq lies within the range disclosed by the prior art. In the case where the range in the prior art includes the claimed value, a prima facie case of obviousness exists (see MPEP 2144.05 I).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select an antistatic plastic with a surface resistivity in the range of 1E9 ohm/sq and 1E12 ohm/sq, as taught by Steelman, in order to achieve the desired anti-static properties, such a range encompassing the claimed value.
Regarding claim 16, Hale discloses a method for producing drug condensation aerosol comprising alprazolam for delivery to a patient by inhalation in a drug delivery device (30) (paragraph 290, lines 1-6; Fig. 2A; paragraph 315, lines 1-4) comprising an inlet (36), an outlet (34), and a housing (32) defining an airway extending between the inlet (36), and the outlet (34) (paragraph 290, lines 7-11; paragraph 291, lines 1-5; Fig. 2A),
wherein the drug condensation aerosol is formed by heating a thin layer containing alprazolam, on a solid support (40), to produce a vapor of the alprazolam (paragraph 274, lines 1-4; paragraph 290, lines 1-6; paragraph 291, lines 1-6; paragraph 315, lines 1-4), and condensing the vapor to form the drug condensation aerosol characterized by less than 10% drug degradation products of alprazolam by weight, and a mass median aerodynamic diameter (MMAD) of less than 5 microns (paragraph 255, lines 1-12; paragraph 284, lines 1-9; paragraph 290, lines 1-6; paragraph 291, lines 1-6).
Hale fails to disclose wherein the housing in the drug delivery device comprises an antistatic material, wherein the antistatic material is an antistatic plastic or antistatic plastics applied as airway materials.
However, Rubin teaches a device (410) for delivering a condensation aerosol comprising a housing (see Fig. 11 which illustrates a two-part shell of inhaler 410 housing internal components) wherein the airway housing comprises antistatic material (page 38, lines 20-33; page 43, lines 13-24; page 44, lines 22-29; Figs. 9-11). Rubin further teaches that the anti-static material serves to shield the conduit itself and internal components of the device from aerosol deposition (page 44, lines 22-29). Additionally, Rubin teaches that the inhaler can be used to deliver alprazolam (see claim 55).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed by Hale to further construct the housing to include an anti-static material, as taught by Rubin, in order to shield the airway and internal components of the device from aerosol deposition.
Presently modified Hale fails to disclose wherein the antistatic material is comprised of an antistatic plastic or antistatic plastics applied as airway materials.
However, Steelman teaches an inhalation device (abstract, lines 1-3; Fig. 1) wherein the antistatic material is comprised of antistatic plastics applied as airway materials (paragraph 13, lines 1-5; paragraph 82, lines 1-8).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute an antistatic plastic for the device airway of the device disclosed by modified Hale, as taught by Steelman, in order to achieve the same result as indicated by Rubin to reduce particle deposition on the interior of the device via an anti-static material (see MPEP 2143 I B).
Regarding claim 23, Hale in view of Rubin and Steelman disclose the method of claim 16, as discussed above.
Modified Hale further discloses wherein the surface resistivity of the antistatic plastic is between 1E9 ohm/sq and 1E12 ohm/sq (Steelman: paragraph 13, lines 1-5; paragraph 82, lines 1-8).
The range disclosed by Steelman of 1E9 ohm/sq and 1E12 ohm/sq overlaps the claimed range of 1E9 ohm/sq and 1E11 ohm/sq. In the case where the range in the prior art overlaps the claimed range, a prima facie case of obviousness exists (see MPEP 2144.05 I).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select an antistatic plastic with a surface resistivity in the range of 1E9 ohm/sq and 1E12 ohm/sq, as taught by Steelman, in order to achieve the desired anti-static properties, such a range overlapping the claimed range.
Regarding claim 24, Hale in view of Rubin and Steelman disclose the method of claim 16, as discussed above.
Hale further discloses wherein the condensation aerosol is formed by heating said solid support (40) on which the thin layer of alprazolam is placed to a temperature of at least about 300°C (paragraph 279, lines 1-12; paragraph 315, lines 1-4).
Regarding claim 25, Hale discloses a kit comprising a hand-held device (30) for delivering a condensation aerosol comprising at least one dose of alprazolam wherein the device (30) comprises
an inlet (36) (paragraph 290, lines 8-11; Fig. 2A);
an outlet (34) (paragraph 290, lines 7-11; Fig. 2A);
a drug layer (40) comprising alprazolam and configured to be heated to form a vaporized drug (paragraph 290, lines 11-15; paragraph 291, lines 1-4; paragraph 315, lines 1-4; Fig. 2A);
a condensation space configured to condense the vaporized drug to form the condensation aerosol comprising alprazolam (paragraph 289, lines 1-7, see “inert passageway”; paragraph 290, lines 1-6; Fig. 2A); and
a housing (32) defining an airway extending from the inlet (36) to the outlet (34) (paragraph 290, lines 7-11; paragraph 291, lines 1-5; Fig. 2A).
Hale fails to disclose wherein the housing comprises an antistatic material, the at least one antistatic material being an antistatic plastic or antistatic plastics applied as airway materials.
However, Rubin teaches a device (410) for delivering a condensation aerosol comprising a housing (see Fig. 11 which illustrates a two-part shell of inhaler 410 housing internal components) wherein the housing comprises antistatic material (page 38, lines 20-33; page 43, lines 13-24; page 44, lines 22-29; Figs. 9-11). Rubin further teaches that the anti-static material serves to shield the conduit itself and internal components of the device from aerosol deposition (page 44, lines 22-29). Additionally, Rubin teaches that the inhaler can be used to deliver alprazolam (see claim 55).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed by Hale to further construct the housing to include an anti-static material, as taught by Rubin, in order to shield the airway and internal components of the device from aerosol deposition.
Presently modified Hale fails to disclose wherein the antistatic material is comprised of an antistatic plastic or antistatic plastics applied as airway materials.
However, Steelman teaches an inhalation device (abstract, lines 1-3; Fig. 1) wherein the antistatic material is comprised of antistatic plastics applied as airway materials (paragraph 13, lines 1-5; paragraph 82, lines 1-8).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute an antistatic plastic for the device airway of the device disclosed by modified Hale, as taught by Steelman, in order to achieve the same result as indicated by Rubin to reduce particle deposition on the interior of the device via an anti-static material (see MPEP 2143 I B).
Regarding claim 26, Hale in view of Rubin and Steelman disclose the kit of claim 25, as discussed above.
Hale further discloses wherein the device (30) further comprises a breath-actuation element (paragraph 288, lines 1-6; paragraph 347, lines 12-15).
Regarding claim 27, Hale in view of Rubin and Steelman disclose the kit of claim 25, as discussed above.
Currently modified Hale fails to disclose wherein the device further comprises a dose counting/logging device.
However, Rubin further teaches the inhaler device (410) further comprising a dose counting/logging device in order to store information related to the usage of the device (page 41, lines 16-19).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed by Hale to further include a dose counting/logging device, as taught by Rubin, in order to store information related to the usage of the device.
Regarding claim 32, Hale in view of Rubin and Steelman disclose the device of claim 1, as discussed above.
Hale further discloses wherein the drug layer (40) is configured to further comprise a chemically reactive material to be heated by an exothermic reaction upon actuation for producing the heat to vaporize the alprazolam (paragraph 278, lines 1-8, see “exothermic chemical reactions”; paragraph 279, lines 12-20; paragraph 290, lines 11-15; paragraph 291, lines 1-10; paragraph 315, lines 1-4; Fig. 2A).
Regarding claim 33, Hale in view of Rubin and Steelman disclose the method of claim 16, as discussed above.
Hale further discloses wherein the heating is accomplished by an exothermic chemical reaction (paragraph 278, lines 1-8, see “exothermic chemical reactions”; paragraph 279, lines 12-20; paragraph 290, lines 11-15; paragraph 291, lines 1-4; paragraph 315, lines 1-4; Fig. 2A).
Regarding claim 34, Hale in view of Rubin and Steelman disclose the method of claim 33, as discussed above.
Hale further discloses wherein the exothermic reaction is based on a chemical material, wherein the chemical material is consumed in a period of between 50-500 msec after actuation (paragraph 278, lines 1-8, see “exothermic chemical reactions”; paragraph 279, lines 12-20; paragraph 290, lines 11-15; paragraph 291, lines 1-4; paragraph 315, lines 1-4; Fig. 2A).
Regarding claim 35, Hale in view of Rubin and Steelman disclose the kit of claim 25, as discussed above.
Hale further discloses wherein the drug layer (40) is configured to further comprise a chemically reactive material to be heated by an exothermic reaction upon actuation for producing the heat to vaporize the alprazolam (paragraph 278, lines 1-8, see “exothermic chemical reactions”; paragraph 279, lines 12-20; paragraph 290, lines 11-15; paragraph 291, lines 1-10; paragraph 315, lines 1-4; Fig. 2A).
Claims 28-31 are rejected under 35 U.S.C. 103 as being unpatentable over Hale (US 2007/0122353) in view of Rubin (WO 2012/026963) and Steelman (US 2013/0276781), as applied to claims 1, 12, 23, and 25 above, in further view of Snyder (US 2008/0257345).
Regarding claim 28, Hale in view of Rubin and Steelman disclose the device of claim 1, as discussed above.
Modified Hale fails to disclose wherein the antistatic plastic is an antistatic polycarbonate.
However, Snyder teaches a device wherein an antistatic material is comprised of antistatic plastics applied as airway housing materials (chamber housing 4 is comprised of antistatic plastic; paragraph 39, lines 1-3), specifically an antistatic polycarbonate (paragraph 40, lines 1-4). Snyder further teaches that the use of an antistatic material for the housing improves the consistency of the medicament delivery because the aerosol generated by the device is less likely to be attracted to the interior surface of the housing during delivery (paragraph 10, lines 6-12).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute an antistatic polycarbonate for the device airway of the device disclosed by modified Hale, as taught by Snyder, to achieve the same result as indicated by Rubin and Steelman to reduce particle deposition on the interior of the device, and improve consistency of the delivered medicament.
Regarding claim 29, Hale in view of Rubin and Steelman disclose the device of claim 12, as discussed above.
Modified Hale fails to disclose wherein the antistatic plastic is polycarbonate.
However, Snyder teaches a device wherein an antistatic material is comprised of antistatic plastics applied as airway housing materials (chamber housing 4 is comprised of antistatic plastic; paragraph 39, lines 1-3), specifically polycarbonate (paragraph 40, lines 1-4). Snyder further teaches that the use of an antistatic material for the housing improves the consistency of the medicament delivery because the aerosol generated by the device is less likely to be attracted to the interior surface of the housing during delivery (paragraph 10, lines 6-12).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute an antistatic polycarbonate for the device airway of the device disclosed by modified Hale, as taught by Snyder, to achieve the same result as indicated by Rubin and Steelman to reduce particle deposition on the interior of the device, and improve consistency of the delivered medicament.
Regarding claim 30, Hale in view of Rubin and Steelman disclose the method of claim 23, as discussed above.
Modified Hale fails to disclose wherein the antistatic plastic is an antistatic polycarbonate.
However, Snyder teaches a device wherein an antistatic material is comprised of antistatic plastics applied as airway housing materials (chamber housing 4 is comprised of antistatic plastic; paragraph 39, lines 1-3), specifically an antistatic polycarbonate (paragraph 40, lines 1-4). Snyder further teaches that the use of an antistatic material for the housing improves the consistency of the medicament delivery because the aerosol generated by the device is less likely to be attracted to the interior surface of the housing during delivery (paragraph 10, lines 6-12).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute an antistatic polycarbonate for the device airway of the device disclosed by modified Hale, as taught by Snyder, to achieve the same result as indicated by Rubin and Steelman to reduce particle deposition on the interior of the device, and improve consistency of the delivered medicament.
Regarding claim 31, Hale in view of Rubin and Steelman disclose the kit of claim 25, as discussed above.
Modified Hale fails to disclose wherein the antistatic plastic is an antistatic polycarbonate.
However, Snyder teaches a device wherein an antistatic material is comprised of antistatic plastics applied as airway housing materials (chamber housing 4 is comprised of antistatic plastic; paragraph 39, lines 1-3), specifically an antistatic polycarbonate (paragraph 40, lines 1-4). Snyder further teaches that the use of an antistatic material for the housing improves the consistency of the medicament delivery because the aerosol generated by the device is less likely to be attracted to the interior surface of the housing during delivery (paragraph 10, lines 6-12).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute an antistatic polycarbonate for the device airway of the device disclosed by modified Hale, as taught by Snyder, to achieve the same result as indicated by Rubin and Steelman to reduce particle deposition on the interior of the device, and improve consistency of the delivered medicament.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAIGE BUGG whose telephone number is (571)272-8053. The examiner can normally be reached Monday-Friday 9-5.
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/PAIGE KATHLEEN BUGG/Primary Examiner, Art Unit 3785
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