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 .
Information Disclosure Statement
The information disclosure statement(s) filed on 05/30/2023 is/are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement(s) is/are being considered by the examiner.
Claims
This office action is in response to the preliminary amendment filed on 05/23/2022. As directed by the preliminary amendments, claims 5-6, 13 and 39-45 have been amended, claims 2-4, 7-12, 14-38 have been cancelled and claims 46-54 have been added. As such, claims 1, 5-6, 13 and 39-54 are being examined in this application.
Claim Objections
Claim(s) 50 is objected to because of the following informalities:
Claim 50, line 2, recites “…wherein the inhaler…” but should recite “…wherein the metered dose inhaler…”
Appropriate correction is required.
Drawings
The drawings are objected to because Fig. 4 uses reference number 78, however, reference number 78 is not used within the specification. Furthermore, the same structure within Figs. 5-6 uses reference number 74 (valve clamp). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim(s) 1, 5-6, 13 and 39-54 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Claims 1, 5-6, 13 and 39-54 are nonenabling because one having ordinary skill in the art could not make or use the invention from the disclosure coupled with information known in the art without undue experimentation. Claim 1, 46 and 50 cites a metered dose inhaler and claims 5-6, 45, 48-49, 50 and 53 discusses the valve and valve steam seal do not comprise a spring. Claims 47 and 52 further recites “wherein the valve is urged from the actuated position to the primed position solely by a force of the pressurized formulation.” However, it is unclear how the valve is urged from the actuated position to the primed position solely by a force of the pressurized formulation and without a spring. The specification recites “Upon release of the manual force upon the canister 14, the pressure within the reservoir 37 causes the canister and valve 26 to return to their primed positions (depicted in FIG. 5 for the valve), thereby allowing the metering chamber 69 to once again fill with medicament formulation such that it is ready or subsequent use (see page 11, lines 17-21).” The specification further recites “The canister 14 is generally pressurized to between 45 and 80 bar, often to between 50 and 70 bar, and sometimes to between 50 and 60 bar. In general, the canister 14 is configured to withstand a pressure of at least 80 Bar. The pressure is selected so that at least a portion of the CO2 in the canister 14 is present as a liquid (see page 13, lines 1-4)” and “The liquid medicament formulation is pumped through the pressure fill valve 38 at a pressure of 45 to 80 bar, 45 to 70 bar, 45 to 60 bar, 45 bar, 50 bar, 55 bar, or 60 bar (see page 13, lines 14-16).” The specification further provides examples on page 17-20 wherein a canister is equipped with a filling valve and an outlet valve and is filled with carbon dioxide. However, it is not explained how the pressurized formulation including carbon dioxide, the pressurized canister and pressure fill valve is urging the valve from the actuated position to the primed position solely by a force of the pressurized formulation. An analysis of the Wands factors reveals that the following factors weigh against enablement: the level of one of ordinary skill, the amount of direction provided by the inventor, and the quantity of experimentation needed to make or use the invention based on the content of the disclosure.
Turning now to the Wands factors, the level of one of ordinary skill will not reasonably be able to understand and come to a conclusion how the valve is urged from the actuated position to the primed position solely by a force of the pressurized formulation and without a spring. Although the applicant has provided schematics drawings of the overall structure (Figs. 1-10 and specifically Figures 5 and 6), none of the drawings depict how the valve is urged from the actuated position back to the primed position by solely a force of the pressurized formulation. The drawings and specification do not depict how the pressurized formulation is able to urge the valve from the actuated position back to the primed position, thus, there is only a minimal amount of direction provided by the inventor. In re Wands, 858 F.2d 731 (Fed. Cir. 1988); MPEP § 2164.01 (a). It is noted that the determination of undue experimentation is reached by weighing all the factors and that no single factor is dispositive (MPEP 2164.01 (a)).
Upon the weight of all of these factors, one of ordinary skill in the art would not have been enabled by the originally filed disclosure to make and/or use the claimed invention without undue experimentation and therefore claims 1, 5-6, 13 and 39-54 are not enabled.
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) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived 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 nonobviousness.
Claim(s) 1, 5-6, 13, 39 and 45-54 is/are rejected under 35 U.S.C. 103 as being unpatentable over Harvey (US 20030106550 A1) in view of Brambilla (US 20090020114 A1).
Regarding claim 1, Harvey teaches a metered dose inhaler (Harvey teaches the valve of the invention to be for a metered dose inhaler as seen in Figs. 1-5 and [0073]-[0074]), comprising:
a reservoir (drug reservoir 10, see Figs. 1) containing a pressurized formulation of medicament and propellant (propellant-containing drug formulation 8, see Fig. 1), and equipped with a metering valve (Harvey teaches a valve assembly shown in Fig. 1 and [0007] and [0085] comprising valve stem 2, valve body 4, first metering chamber 22, second meter chamber 28 and seal (where reference number 30 is pointing to) as seen in Fig. 1) comprising a metering chamber (first metering chamber 22 and second metering chamber 28, see Fig. 1), a metering valve stem (valve stem 2, see Fig. 1), and a metering valve stem seal (Harvey teaches a seal present on valve body 30 (where reference number 30 is pointing to) as shown in Fig. 1, where stem 2 is inserted into) having an opening through which the metering valve stem passes to form a dynamic seal between the metering valve stem and outside atmosphere (valve stem 2 passes through the opening of the seal as seen in Fig. 1 to form a dynamic seal between valve stem 2 and the outside atmosphere (similar to applicant’s metering valve stem 24 and metering valve stem seal 59 in Fig. 5), and
wherein the metering valve stem seal has a Shore D hardness of 45 to 80 and its opening is adapted to be stretched wider by the metering valve stem passing through it than it would be absent the valve stem (Applicant’s specification recites “Exemplary materials used to form the sealing members, in particular, the metering valve stem seal member 59, include, but are not limited to, polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyethylene, particularly high-density polyethylene or linear low-density polyethylene, polyamide, such as nylon, and polypropylene.” Harvey teaches the seal/elastomers to be made out of ethylene propylene diene rubber (EPDM), such as polypropylene or polyethylene as seen in [0102]. Furthermore, the seal has an opening adapted to be stretched wider by the valve stem 2 than it would be without valve stem 2 as seen in Fig. 1).
But does not teach the reservoir containing a pressurized formulation of medicament and carbon dioxide.
However, Brambilla teaches a metered dose inhaler (Brambilla teaches a metered dose inhaler as seen in Fig. 1 and [0006] and [0040]) comprising:
reservoir containing a pressurized formulation of medicament and carbon dioxide (“The canister 1 contains a liquid formulation 10 wherein the medicament is in solution or in suspension with a low boiling point propellant.” See [0006] and Fig. 1; Brambilla teaches the propellant to be carbon dioxide or other propellants in which are gaseous at room temperature and standard atmospheric pressure may also be used as seen in [0093]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the inhaler taught by Harvey to use carbon dioxide as a propellent as taught by Brambilla as an alternative propellent known in the art that can be used with medicament as it is gaseous at room temperature and standard atmosphere pressure (see [0093]).
Regarding claim 5, Harvey in view of Brambilla teaches the inhaler of claim 1, and Harvey further teaches wherein the metering valve stem seal does not comprise a spring (the seal does not comprise a spring as seen in Fig. 1).
Regarding claim 6, Harvey in view of Brambilla teaches the inhaler of claim 1, and Harvey further teaches wherein the valve does not comprise a spring (Harvey teaches a valve without a spring as seen in Fig. 1).
Regarding claim 13, Harvey in view of Brambilla teaches the inhaler of claim 1, and Harvey further teaches wherein the metering valve stem seal is selected from polytetrafluoroethylene, ethylene tetrafluoroethylene, fluorinated ethylene propylene, polyethylene, polyamide, and polypropylene (Harvey teaches the elastomers to be made out of ethylene propylene diene rubber (EPDM), such as polypropylene or polyethylene as seen in [0102]).
Regarding claim 39, Harvey in view of Brambilla teaches the inhaler of claim 1, and Harvey further teaches wherein the metering valve further comprises:
a valve housing (valve body 4, see Fig. 1) comprising a first end, a second end, and walls defining the metering chamber (valve body 4 has a first end near reference number 30, a second end near reference number 4 and walls defining the metering chambers 22 and 28 as seen in Fig. 1); and
a reservoir seal (sealing rings 16, see Fig. 1) disposed adjacent to the second end of the valve housing (sealing rings 16 are disposed adjacent to the second end of valve body 4 as seen in Fig. 1), wherein the reservoir seal is adapted to form a dynamic seal between the metering valve stem and the reservoir (sealing rings 16 is to form a dynamic seal between valve stem 2 and drug reservoir 10 as seen in Fig. 2).
Regarding claim 45, Harvey in view of Brambilla teaches the inhaler of claim 39, and Harvey further teaches wherein the valve does not include a spring (Harvey teaches a valve without a spring as seen in Fig. 1).
Regarding claim 46, Harvey teaches a metered dose inhaler (Harvey teaches the valve of the invention to be for a metered dose inhaler as seen in Figs. 1-5 and [0073]-[0074]) having a reservoir (drug reservoir 10, see Figs. 1) containing a pressurized formulation of medicament and propellant (propellant-containing drug formulation 8, see Fig. 1), wherein the metered dose inhaler is equipped with a valve (Harvey teaches a valve assembly shown in Fig. 1 and [0007] and [0085] comprising valve stem 2, valve body 4, first metering chamber 22, second meter chamber 28 and seal (where reference number 30 is pointing to) as seen in Fig. 1) comprising:
a valve housing (valve body 4, see Fig. 1) having a first end, a second end exposed to pressurized formulation in the reservoir, and walls defining a metering chamber (first metering chamber 22 and second metering chamber 28, see Fig. 1) for receiving the formulation from the reservoir (valve body 4 has a first end near reference number 30, a second end near reference number 4 and walls defining the metering chambers 22 and 28 as seen in Fig. 1. Metering chambers 22 and 28 receives formulation 8 from drug reservoir 10 as seen in Figs. 1-5 and [0085] and [0088]),
a metering valve stem (valve stem 2, see Fig. 1) located within the metering chamber (valve stem 2 is located within first metering chamber 22 and second metering chamber 28 as seen in Fig. 1), the metering valve stem having a first end exposed to atmosphere and a second end exposed to pressurized formulation in the reservoir (valve stem 2 has a first end exposed to the atmosphere (end closer to reference number 30) and a second end exposed to drug formulation 8 in drug reservoir 10 as seen in Fig. 1), at least a portion of the metering valve stem proximate the first end having a diameter larger than the diameter of at least a portion of the metering valve stem proximate the second end (valve stem 2 comprises a piston “A” 14 and piston head “B” 18, wherein piston head “B” 18 is proximate to the first end (see Figs. 2-4) and has a diameter larger than piston head “A” 14 which is proximate to the second end as seen in Fig. 1), and
a metering valve stem seal member (Harvey teaches a seal present on valve body 30 (where reference number 30 is pointing to) as shown in Fig. 1, where stem 2 is inserted into) in contact with the first end of the valve housing and the metering valve stem (the seal is in contact with the first end of valve body 4 and valve stem 2 as seen in Fig. 1), wherein the metering valve stem seal member has a Shore D hardness of 45 to 80 (Applicant’s specification recites “Exemplary materials used to form the sealing members, in particular, the metering valve stem seal member 59, include, but are not limited to, polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyethylene, particularly high-density polyethylene or linear low-density polyethylene, polyamide, such as nylon, and polypropylene.” Harvey teaches the seal/elastomers to be made out of ethylene propylene diene rubber (EPDM), such as polypropylene or polyethylene as seen in [0102]),
the valve having a primed position wherein the formulation can freely flow between the reservoir and the metering chamber, and wherein the metering valve stem seal member seals the metering chamber from the outside atmosphere (The valve is within a primed position in Fig. 1 where drug formulation 8 flows freely between drug reservoir 10 and first metering chamber 22 and the seal seals the second metering chamber 28 from the outside atmosphere as seen in Fig. 1), and
the valve having an actuated position wherein the second end of the metering valve stem seals against the second end of the valve housing to seal the metering chamber from the reservoir (Fig. 2 shows an actuated position wherein the second end of valve stem 2 comprising piston head “A” 14 seals the metering chamber 22 from drug reservoir 10), thereby defining a metered volume of formulation within the metering chamber (a first metered dose volume 36 is captured in the first metering chamber 22 as seen in Fig. 2 and [0089]), and wherein the metering valve stem comprises a flow path (recess 24, see Figs. 3-4) allowing the formulation to freely flow between the metering chamber and the outside atmosphere (valve stem 2 comprises of recess 24 which is in communication with return channel 26 to allow drug formulation 8 to enter second metering chamber 28 as seen in Figs. 3-4 and [0090], which allows the second metering volume 40 to flow between second metering chamber 28 and the outside atmosphere as seen in Fig. 5).
but does not teach the reservoir containing a pressurized formulation of medicament and carbon dioxide.
However, Brambilla teaches a metered dose inhaler (Brambilla teaches a metered dose inhaler as seen in Fig. 1 and [0006] and [0040]) comprising:
reservoir containing a pressurized formulation of medicament and carbon dioxide (“The canister 1 contains a liquid formulation 10 wherein the medicament is in solution or in suspension with a low boiling point propellant.” See [0006] and Fig. 1; Brambilla teaches the propellant to be carbon dioxide or other propellants in which are gaseous at room temperature and standard atmospheric pressure may also be used as seen in [0093]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the inhaler taught by Harvey to use carbon dioxide as a propellent as taught by Brambilla as an alternative propellent known in the art that can be used with medicament as it is gaseous at room temperature and standard atmosphere pressure (see [0093]).
Regarding claim 47, Harvey in view of Brambilla teaches the inhaler of claim 46, and Harvey further teaches wherein the valve is urged from the actuated position to the primed position solely by a force of the pressurized formulation (the valve is urged from the actuated position to the prime position as seen in Figs. 2-5 by the force of drug formulation 8/second drug metered volume 40 as seen in Figs. 4-5 and [0063] and [0090]).
Regarding claim 48, Harvey in view of Brambilla teaches the inhaler of claim 46, and Harvey further teaches wherein the metering valve stem seal does not comprise a spring (the seal does not comprise a spring as seen in Fig. 1).
Regarding claim 49, Harvey in view of Brambilla teaches the inhaler of claim 46, and Harvey further teaches wherein the valve does not comprise a spring (Harvey teaches a valve without a spring as seen in Fig. 1).
Regarding claim 50, Harvey teaches a metered dose inhaler (Harvey teaches the valve of the invention to be for a metered dose inhaler as seen in Figs. 1-5 and [0073]-[0074]) having a reservoir (drug reservoir 10, see Figs. 1) containing a pressurized formulation of medicament and propellant (propellant-containing drug formulation 8, see Fig. 1), wherein the inhaler is equipped with a valve (Harvey teaches a valve assembly shown in Fig. 1 and [0007] and [0085] comprising valve stem 2, valve body 4, first metering chamber 22, second meter chamber 28 and seal (where reference number 30 is pointing to) as seen in Fig. 1) comprising:
a valve housing (valve body 4, see Fig. 1) having a first end, a second end with an opening exposed to pressurized formulation in the reservoir, and walls defining a metering chamber (first metering chamber 22 and second metering chamber 28, see Fig. 1) for receiving the formulation from the reservoir (valve body 4 has a first end near reference number 30, a second end near reference number 4 and walls defining the metering chambers 22 and 28 as seen in Fig. 1. Metering chambers 22 and 28 receives formulation 8 from drug reservoir 10 as seen in Figs. 1-5 and [0085] and [0088]),
a metering valve stem (valve stem 2, see Fig. 1) located within the metering chamber (valve stem 2 is located within first metering chamber 22 and second metering chamber 28 as seen in Fig. 1), the metering valve stem having a first end exposed to atmosphere and a second end exposed to pressurized formulation in the reservoir (valve stem 2 has a first end exposed to the atmosphere (end closer to reference number 30) and a second end exposed to drug formulation 8 in drug reservoir 10 as seen in Fig. 1), at least a portion of the metering valve stem proximate the first end having a diameter larger than the diameter of at least a portion of the metering valve stem proximate the second end (valve stem 2 comprises a piston “A” 14 and piston head “B” 18, wherein piston head “B” 18 is proximate to the first end (see Figs. 2-4) and has a diameter larger than piston head “A” 14 which is proximate to the second end as seen in Fig. 1), and
a metering valve stem seal member (Harvey teaches a seal present on valve body 30 (where reference number 30 is pointing to) as shown in Fig. 1, where stem 2 is inserted into) in contact with the first end of the valve housing and the metering valve stem (the seal is in contact with the first end of valve body 4 and valve stem 2 as seen in Fig. 1), wherein the metering valve stem seal member has a Shore D hardness of 45 to 80 (Applicant’s specification recites “Exemplary materials used to form the sealing members, in particular, the metering valve stem seal member 59, include, but are not limited to, polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyethylene, particularly high-density polyethylene or linear low-density polyethylene, polyamide, such as nylon, and polypropylene.” Harvey teaches the seal/elastomers to be made out of ethylene propylene diene rubber (EPDM), such as polypropylene or polyethylene as seen in [0102]) and does not comprise a spring (the seal does not comprise a spring as seen in Fig. 1),
the valve having a primed position wherein the formulation can freely flow between the reservoir and the metering chamber, and wherein the metering valve stem seal member seals the metering chamber from the outside atmosphere (The valve is within a primed position in Fig. 1 where drug formulation 8 flows freely between drug reservoir 10 and first metering chamber 22 and the seal seals the second metering chamber 28 from the outside atmosphere as seen in Fig. 1), and
the valve having an actuated position wherein the opening at the second end of the valve housing is sealed from the reservoir (Fig. 2 shows an actuated position wherein the second end of valve stem 2 comprising piston head “A” 14 seals the metering chamber 22 from drug reservoir 10), thereby defining a metered volume of formulation within the metering chamber (a first metered dose volume 36 is captured in the first metering chamber 22 as seen in Fig. 2 and [0089]), and wherein the metering valve stem comprises a flow path (recess 24, see Figs. 3-4) allowing the formulation to freely flow between the metering chamber and the outside atmosphere (valve stem 2 comprises of recess 24 which is in communication with return channel 26 to allow drug formulation 8 to enter second metering chamber 28 as seen in Figs. 3-4 and [0090], which allows the second metering volume 40 to flow between second metering chamber 28 and the outside atmosphere as seen in Fig. 5)
but does not teach the reservoir containing a pressurized formulation of medicament and carbon dioxide.
However, Brambilla teaches a metered dose inhaler (Brambilla teaches a metered dose inhaler as seen in Fig. 1 and [0006] and [0040]) comprising:
reservoir containing a pressurized formulation of medicament and carbon dioxide (“The canister 1 contains a liquid formulation 10 wherein the medicament is in solution or in suspension with a low boiling point propellant.” See [0006] and Fig. 1; Brambilla teaches the propellant to be carbon dioxide or other propellants in which are gaseous at room temperature and standard atmospheric pressure may also be used as seen in [0093]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the inhaler taught by Harvey to use carbon dioxide as a propellent as taught by Brambilla as an alternative propellent known in the art that can be used with medicament as it is gaseous at room temperature and standard atmosphere pressure (see [0093]).
Regarding claim 51, Harvey in view of Brambilla teaches the inhaler of claim 50, and Harvey further teaches wherein the second end of the metering valve stem seals against the second end of the valve housing to seal the metering chamber from the reservoir when the valve is in the actuated position (Fig. 2 shows an actuated position wherein the second end of valve stem 2 comprising piston head “A” 14 seals the metering chamber 22 from drug reservoir 10).
Regarding claim 52, Harvey in view of Brambilla teaches the inhaler of claim 50, and Harvey further teaches wherein the valve is urged from the actuated position to the primed position solely by a force of the pressurized formulation (the valve is urged from the actuated position to the prime position as seen in Figs. 2-5 by the force of drug formulation 8/second drug metered volume 40 as seen in Figs. 4-5 and [0063] and [0090]).
Regarding claim 53, Harvey in view of Brambilla teaches the inhaler of claim 50, and Harvey further teaches wherein the valve does not comprise a spring (Harvey teaches a valve without a spring as seen in Fig. 1).
Regarding claim 54, Harvey in view of Brambilla teaches the inhaler of claim 50, and Harvey further teaches wherein the metering valve stem seal is selected from polytetrafluoroethylene, ethylene tetrafluoroethylene, fluorinated ethylene propylene, polyethylene, polyamide, and polypropylene (Harvey teaches the elastomers to be made out of ethylene propylene diene rubber (EPDM), such as polypropylene or polyethylene as seen in [0102]).
Claim(s) 40-41 is/are rejected under 35 U.S.C. 103 as being unpatentable over Harvey (US 20030106550 A1) in view of Brambilla (US 20090020114 A1), as applied to claim 39 above, and further in view of Burel (US 20120160878 A1).
Regarding claim 40, Harvey in view of Brambilla teaches the inhaler of claim 39, but does not teach wherein the reservoir seal is disposed within the valve housing.
However, Burel teaches wherein the reservoir seal (lower gasket 252, see Fig. 1; lower gasket 252 is forming a seal between valve member bottom 32 and fluid from the reservoir from openings 22 as seen in Fig. 1 and [0021]-[0022]) is disposed within the valve housing (valve body 21, see Fig. 1) (lower gasket 252 is disposed within the valve body 21 as seen in Fig. 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the inhaler taught by Harvey in view of Brambilla to move the reservoir seal to be disposed within the valve housing as taught by Burel as an alternative position/rearrangement of parts which will not affect the function of the device.
Regarding claim 41, modified Harvey teaches the inhaler of claim 40, but does not teach wherein the valve housing further comprises a crimped portion that is adapted to retain the reservoir seal between the crimped portion and the second end of the valve housing.
However, Burel teaches lower gasket 252 to be retained by valve body 21 and hollow insert 255 (taken as valve housing) between the crimped portion and second end of the valve housing (taken as end where reference number 21 points to).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the inhaler taught by modified Harvey to have the valve housing comprise of a crimped portion that is adapted to retain the reservoir seal between the crimped portion and the second end of the valve housing as taught by Burel to tightly keep the seal within place (as seen in Fig. 1 of Burel).
Claim(s) 1, 39 and 42-43 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burel (US 20120160878 A1) in view of Harvey (US 20030106550 A1) and Brambilla (US 20090020114 A1)
Regarding claim 1, Burel teaches a metered dose inhaler (Burel teaches an improved aerosol metering valve 20 for use within metered dose inhalers as seen in [0024]), comprising:
a reservoir (reservoir 1, see Fig. 1) containing a pressurized formulation of medicament and propellant (“…a reservoir 1 containing the fluid to be dispensed, with only a portion of its neck being represented by dashed lines in FIG. 1. The fluid may be of the pharmaceutical type, and propellant gas…” see [0017]), and equipped with a metering valve (metering chamber 25, valve member 30 and upper gasket 251, see Fig. 1 and [0018]) comprising a metering chamber (metering chamber 25, see Fig. 1), a metering valve stem (valve member 30, see Fig. 1 and [0018]), and a metering valve stem seal (upper gasket 251, see Fig. 1) having an opening through which the metering valve stem passes to form a dynamic seal between the metering valve stem and outside atmosphere (valve member 30 passes through upper gasket 251 and upper gasket 251 forms a seal between valve member 30 and the outside atmosphere as seen in Fig. 1).
But does not teach the reservoir containing a pressurized formulation of medicament and carbon dioxide, and
wherein the metering valve stem seal has a Shore D hardness of 45 to 80 and its opening is adapted to be stretched wider by the metering valve stem passing through it than it would be absent the valve stem.
However, Harvey teaches wherein the metering valve stem seal has a Shore D hardness of 45 to 80 and its opening is adapted to be stretched wider by the metering valve stem passing through it than it would be absent the valve stem (Applicant’s specification recites “Exemplary materials used to form the sealing members, in particular, the metering valve stem seal member 59, include, but are not limited to, polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyethylene, particularly high-density polyethylene or linear low-density polyethylene, polyamide, such as nylon, and polypropylene.” Harvey teaches the seal/elastomers to be made out of ethylene propylene diene rubber (EPDM), such as polypropylene or polyethylene as seen in [0102]. Furthermore, the seal has an opening adapted to be stretched wider by the valve stem 2 than it would be without valve stem 2 as seen in Fig. 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the inhaler taught by Burel to have the metering valve stem seal be made out of polypropylene as taught by Harvey since it is a known material used for sealing rings/elastomeric material within inhalers (see [0096] and [0102]).
However, Brambilla teaches a metered dose inhaler (Brambilla teaches a metered dose inhaler as seen in Fig. 1 and [0006] and [0040]) comprising:
reservoir containing a pressurized formulation of medicament and carbon dioxide (“The canister 1 contains a liquid formulation 10 wherein the medicament is in solution or in suspension with a low boiling point propellant.” See [0006] and Fig. 1; Brambilla teaches the propellant to be carbon dioxide or other propellants in which are gaseous at room temperature and standard atmospheric pressure may also be used as seen in [0093]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the inhaler taught by Burel in view of Harvey to use carbon dioxide as a propellent as taught by Brambilla as an alternative propellent known in the art that can be used with medicament as it is gaseous at room temperature and standard atmosphere pressure (see [0093]).
Regarding claim 39, modified Burel the inhaler of claim 1, and Burel further teaches wherein the metering valve further comprises:
a valve housing (hollow insert 255, see Fig. 1) comprising a first end, a second end, and walls defining the metering chamber (hollow insert 255 has a first end near reference number 255, a second end near reference number 252 and walls defining the metering chamber 25 as seen in Fig. 1); and
a reservoir seal (lower gasket 252, see Fig. 1) disposed adjacent to the second end of the valve housing (lower gasket 252 is disposed adjacent to the second end of hollow insert 255 as seen in Fig. 1), wherein the reservoir seal is adapted to form a dynamic seal between the metering valve stem and the reservoir (lower gasket 252 forms a dynamic seal between valve member bottom 32 of valve member 30 and reservoir 1 (which fills the valve through one or more openings 22 as seen in Fig. 1 and [0021]) as seen in Fig. 1).
Regarding claim 42, modified Burel teaches the inhaler of claim 39, and further teaches
wherein the reservoir seal is disposed on an outer surface of the valve housing (lower gasket 252 is disposed on an outer surface of hollow insert 255 as seen in Fig. 1).
Regarding claim 43, modified Burel teaches the inhaler of claim 42, and Burel teaches wherein the reservoir seal is friction fit to the outer surface of the valve housing (Burel teaches the valve member to slide in a leaktight manner against the upper and lower gaskets as seen in [0007] and further teaches lower gasket 252 to be disposed on an outer surface of hollow insert 255 as seen in Fig. 1. Therefore, Burel teaches lower gasket 252 to be in a friction fit to the outer surface of hollow insert 255).
Claim(s) 44 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burel (US 20120160878 A1) in view of Harvey (US 20030106550 A1) and Brambilla (US 20090020114 A1), as applied to claim 42 above, and further in view of Boucher (US 3561444 A).
Regarding claim 44, modified Burel teaches the inhaler of claim 42, and Burel further teaches wherein the reservoir seal is retained on the outer surface of the valve housing by a valve clamp that is disposed over the reservoir seal and at least a portion of the second end of the valve housing (lower gasket 252 is retained on the outer surface of hollow insert 255 as seen in Fig. 1)
But does not teach wherein the reservoir seal is retained on the outer surface of the valve housing by a valve clamp that is disposed over the reservoir seal and at least a portion of the second end of the valve housing.
However, Boucher teaches a nebulizer unit 10 (see Fig. 2 and Col. 4, lines 63-65) with an O-ring seal 37 retained by a series of clamp screws 35 and metal clamp ring 36 as seen in Figs. 3-4 and Col. 5, lines 33-40. Furthermore, metal clamp ring 36 is disposed both over the seal and transducer base 12 as seen in Figs. 3-4 and Col. 5, lines 33-40.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the inhaler taught by modified Burel to include the clamp screws and clamp ring as taught by Boucher as an alternative method of retaining the seal within the art (see Col. 2, lines 64-68 and Col. 5, lines 33-40).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Groeger (US 20030141322 A1) teaches a valve assembly for metered dose dispensers that does not use a spring.
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/TINA ZHANG/Examiner, Art Unit 3785
/VICTORIA MURPHY/Supervisory Patent Examiner, Art Unit 4100