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 Remarks and Amendments filed on 09-08-2026. As directed, claims 1, 8, 11,16, 25, and 34 have been amended, claims 28-31 are newly canceled, no new claims have been added, and claims 2-7 and 17-22 were previously canceled. Thus, claims 1, 8-16, 23-27, and 32-35 are currently pending examination.
Response to Amendment
Applicant has amended each of claims 8, 11, and 34 to overcome minor informalities within these claims. The previously held claim objections are hereby withdrawn.
Response to Arguments
Applicant argues, see Remarks as filed at page 8, that Hale merely discloses that the airway is inert, which is at odds with the selection of an antistatic material for charge dissipation, as required by the instant claim. Applicant further argues that Hale has not identified that it was known that alprazolam would experience an electrostatic charge and thus does not recognize the problem that the claimed invention attempts to solve.
Examiner respectfully submits that Hale has not been relied on for the antistatic feature, rendering any arguments against those particularly claimed materials moot. Further, as has been addressed in several Office actions and echoed by the Patent Trial and Appeal Board, simply because Hale did not expressly identify that alprazolam would experience a charge does not make Applicant’s claims novel, as identification of such a charge is merely an indication of a latent property present, but not necessarily identified by the prior art. Per MPEP 2145 II, this by itself does not rebut a prima facie case of obviousness.
Applicant argues, see Remarks as filed at page 8, that the Office action then proposes modifying Hale in view of Rubin to construct the housing from an anti-static material. Applicant contends that Rubin does not support the modification for three reasons outlined throughout pages 8-9. Applicant alleges that Rubin’s electrostatic shielding is of hardware components as opposed to a housing, that the anti-static coating may or may not be present, that there is no reason to include the Rubin anti-static without the electrostatic charger Rubin discusses, that Rubin’s anti-statics do not include an anti-static polycarbonate, and that Rubin provides other examples of reducing or eliminating electrostatic charge besides reconstructing the airway housing material, and also does not indicate that alprazolam would experience a charge upon aerosol condensation.
None of these arguments are persuasive. As has been extensively argued, and once again affirmed by the Patent Trial and Appeal Board, Rubin expressly teaches that the airway housing can be made from anti-static material so that the conduit itself does not experience aerosol deposition (page 44, lines 24-29). This is a clear teaching to an ordinarily skilled artisan that aerosol deposition on an airway is a known issue regardless of drug. Thus, one of ordinary skill would indeed be motivated to construct the airway housing from an anti-static material in order to reduce or eliminate aerosol deposition. Thus, it is not understood to be singularly hardware components nor an electrostatic charger that Rubin insinuates causes a charge, specifically given that these components need not be included in the Rubin device. It has already been conceded that Rubin does not teach an anti-static polycarbonate; such a teaching has come from Snyder. Thus, this point is moot.
Applicant argues, see pages 9-10, that Steelman’s anti-static material is not polycarbonate, rendering the rejections of claims 11-15 and 23 improper in light of the amendments to the independent claims.
Examiner concedes this point, as the combination of the surface resistivity and the anti-static being polycarbonate was not previously analyzed together by virtue of the previously claimed dependency chain. In the foregoing, Bruce (EP 2314337) will be relied on to evidence that polycarbonate ahs the relevant, claimed surface resistivities (Bruce:“ all being permanently anti-static and having a surface resistivity between about 10E10 and about 10E11 ohms/sq”). Thus, this argument is rendered moot.
Applicant argues, see Remarks as filed page 10, that Snyder is directed to a spacer for an inhaler device as opposed to a device that produces a condensation aerosol, and does not identify the problem indicated in claim 1, making the material selection unrelated to any particular active ingredient.
This argument is unpersuasive. It is Rubin that clearly establishes the need or possibility for an airway to be anti-static within the field of aerosol condensation (page 38, lines 20-33; page 43, lines 13-24; page 44, lines 22-29; Figs. 9-11). While it is true that Rubin does not list polycarbonate as an anti-static, Snyder provides an additional teaching of other known anti-static components. Thus, Applicant has mischaracterized the previous rejection by attacking the references individually. While Snyder is related to a pMDI device, Rubin has already provided the ordinarily skilled artisan with enough requisite information to arrive at the conclusion that there is a benefit to using an anti-static airway material. Snyder simply provides additional, known options in that arena. The rejections will be maintained.
Applicant alleges that the overlapping ranges rationale for the surface resistivity are rebutted because the claimed range produces an unexpected result.
This argument is unpersuasive. As detailed above, Bruce will be relied on to show that polycarbonate includes a surface resistivity within the claimed ranges (Bruce:“ all being permanently anti-static and having a surface resistivity between about 10E10 and about 10E11 ohms/sq”). Bruce explicitly gives an example that is within each claimed range, and in the case of claims 14-15, is equal to the claimed value. This is anticipatory evidence (see MPEP 2131.03 I), and despite any alleged unexpected result or criticality, examples of exact values in the claims are present in the prior art. These rejections are therefore, not rebutted by the alleged unexpected results nor alleged criticality, as these surface resistivities are expressly known in the prior art. In addition, the surface resistivity is not an unexpected result, as it strictly relates to a material property of a known material used for the express purpose of discouraging aerosol deposition. Further, it is the combination of references that has proven a prima facie case of obviousness regarding the use of an anti-static material. Rubin links condensation aerosolization to a need for anti-static conduits. Hale and Rubin each provide disclosure of condensation aerosolizing alprazolam. Snyder provides a different anti-static material known in the art. Bruce shows that polycarbonate can have the claimed surface resistivity. Thus, Applicant has not persuasively argued that the rejections of record are improper, nor overcome the rejections via amendment. The rejections, to each of the independent and dependent claims, will be updated and maintained below.
Claim Objections
Claim 15 is objected to because of the following informalities:
At claim 15, line 1, it is suggested that “the” be added before “antistatic plastic” 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
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, 8-11, 16, 24-27, 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 Snyder (US 2008/0257345).
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, specifically wherein the antistatic plastic is an antistatic polycarbonate.
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, specifically 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 to reduce particle deposition on the interior of the device, and to additionally improve consistency of the delivered medicament.
Regarding claim 8, Hale in view of Rubin and Snyder disclose the device of claim 1, as discussed above.
Hale further discloses wherein the device (30) further 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 Snyder 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 Snyder 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 Snyder 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 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, specifically wherein the antistatic plastic is an antistatic polycarbonate.
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, specifically 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 to reduce particle deposition on the interior of the device, and to additionally improve consistency of the delivered medicament.
Regarding claim 24, Hale in view of Rubin and Snyder 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, specifically wherein the antistatic plastic is an antistatic polycarbonate.
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, specifically 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 to reduce particle deposition on the interior of the device, and to additionally improve consistency of the delivered medicament.
Regarding claim 26, Hale in view of Rubin and Snyder 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 Snyder 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 Snyder 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 Snyder 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 Snyder 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 milliseconds 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 Snyder 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 12-15 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Hale (US 2007/0122353) in view of Rubin (WO 2012/026963) and Snyder (US 2008/0257345), as applied to claims 1, 11, and 16 above, in further view of Bruce (EP 2314337).
Regarding claim 12, Hale in view of Rubin and Snyder disclose the device of claim 1, as discussed above.
While presently modified Hale indicates that the antistatic plastic is polycarbonate (Snyder: chamber housing 4 is comprised of antistatic plastic; paragraph 39, lines 1-3 and paragraph 40, lines 1-4), modified Hale fails to explicitly disclose wherein a surface resistivity of the antistatic plastic is between about 1E9 ohm/sq and about 1E11 ohm/sq.
However, Bruce further teaches a chamber housing that can be made from a PermaStat® 300 series polycarbonate material that are all described as being both anti-static and having a surface resistivity between about 1E10 ohms/sq and 1E11 ohms/sq (see paragraph 26 and note anticipation of ranges discussion at MPEP 2131.03).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have selected the polycarbonate of modified Hale to be PermaStat® 300 series polycarbonate material, as taught by Bruce, as a known chamber housing material for imbuing a medication delivery device with antistatic properties, which results in a material with a surface resistivity within the claimed range.
Regarding claim 13, Hale in view of Rubin and Snyder disclose the device of claim 11, as discussed above.
While presently modified Hale indicates that the antistatic plastic is polycarbonate (Snyder: chamber housing 4 is comprised of antistatic plastic; paragraph 39, lines 1-3 and paragraph 40, lines 1-4), modified Hale fails to explicitly disclose wherein a surface resistivity of the antistatic plastic is between about 1E9 ohm/sq and about 1E11 ohm/sq.
However, Bruce further teaches a chamber housing that can be made from a PermaStat® 300 series polycarbonate material that are all described as being both anti-static and having a surface resistivity between about 1E10 ohms/sq and 1E11 ohms/sq (see paragraph 26 and note anticipation of ranges discussion at MPEP 2131.03).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have selected the polycarbonate of modified Hale to be PermaStat® 300 series polycarbonate material, as taught by Bruce, as a known chamber housing material for imbuing a medication delivery device with antistatic properties, which results in a material with a surface resistivity within the claimed range.
Regarding claim 14, Hale in view of Rubin and Snyder disclose the device of claim 1, as discussed above.
While presently modified Hale indicates that the antistatic plastic is polycarbonate (Snyder: chamber housing 4 is comprised of antistatic plastic; paragraph 39, lines 1-3 and paragraph 40, lines 1-4), modified Hale fails to explicitly disclose wherein a surface resistivity of the antistatic plastic is about 1E11 ohm/sq.
However, Bruce further teaches a chamber housing that can be made from a PermaStat® 300 series polycarbonate material that are all described as being both anti-static and having a surface resistivity of about 1E11 ohms/sq (see paragraph 26 and note disclosure of 1E11 ohms/sq as a disclosed value for the surface resistivity).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have selected the polycarbonate of modified Hale to be PermaStat® 300 series polycarbonate material, as taught by Bruce, as a known chamber housing material for imbuing a medication delivery device with antistatic properties, which results in a material with a surface resistivity of the claimed value.
Regarding claim 15, Hale in view of Rubin and Snyder disclose the device of claim 11, as discussed above.
While presently modified Hale indicates that the antistatic plastic is polycarbonate (Snyder: chamber housing 4 is comprised of antistatic plastic; paragraph 39, lines 1-3 and paragraph 40, lines 1-4), modified Hale fails to explicitly disclose wherein a surface resistivity of the antistatic plastic is about 1E11 ohm/sq.
However, Bruce further teaches a chamber housing that can be made from a PermaStat® 300 series polycarbonate material that are all described as being both anti-static and having a surface resistivity of about 1E11 ohms/sq (see paragraph 26 and note disclosure of 1E11 ohms/sq as a disclosed value for the surface resistivity).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have selected the polycarbonate of modified Hale to be PermaStat® 300 series polycarbonate material, as taught by Bruce, as a known chamber housing material for imbuing a medication delivery device with antistatic properties, which results in a material with a surface resistivity of the claimed value.
Regarding claim 23, Hale in view of Rubin and Snyder disclose the method of claim 16, as discussed above.
While presently modified Hale indicates that the antistatic plastic is polycarbonate (Snyder: chamber housing 4 is comprised of antistatic plastic; paragraph 39, lines 1-3 and paragraph 40, lines 1-4), modified Hale fails to explicitly disclose wherein a surface resistivity of the antistatic plastic is between about 1E9 ohm/sq and about 1E11 ohm/sq.
However, Bruce further teaches a chamber housing that can be made from a PermaStat® 300 series polycarbonate material that are all described as being both anti-static and having a surface resistivity between about 1E10 ohms/sq and 1E11 ohms/sq (see paragraph 26 and note anticipation of ranges discussion at MPEP 2131.03).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have selected the polycarbonate of modified Hale to be PermaStat® 300 series polycarbonate material, as taught by Bruce, as a known chamber housing material for imbuing a medication delivery device with antistatic properties, which results in a material with a surface resistivity within the claimed range.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to 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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