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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 06/09/2026 has been entered.
Response to Amendment
The present office action is in response to the Arguments/Remarks filed 06/09/2026. As directed by the amendment, claims 18-20, and 27 have been amended. Thus, claims 1-5, 7-8, 10-20, and 25-30 are presenting pending in this application.
Applicant has amended claims 18-20 and 27 to address minor informalities. Therefore, the previously held claim objection is hereby withdrawn.
Response to Arguments
Applicant’s arguments, see section under “Rejection Under 35 U.S.C. § 103” in PG 6-12, filed 06/09/2026, have been fully considered and are not persuasive.
Applicant argues that the modification of Kulkarni et al. (WO 2021033081 A1) based on the teachings of Lewis et al. (US 20060257324 A1), Scuri et al. (US 20180028439 A1), Jacuk et al. (US 20130000636 A1), and Jinks (US 20140109900 A1) does not result in specific invention set forth as experimental results highlighted below shows superior stability of the formulation is an unexpected result.
MODIFYING KULKARNI BY FOLLOWING THE COMBINED TEACHINGS OF LEWIS,SCURI, JACUK, AND JINKS DOES NOT RESULT IN THE SPECIFIC INVENTION SET FORTH IN APPLICANT'S CLAIMS.
Following the Teachings in Lewis Results in Using HFA 132a or HFA 227.
Applicant argues that Lewis features the superiority of HFA 134a and HFA 227. In contract, Applicant’s claim 1 requires a different propellant HFA-152 propellent. Hence the result of following combined teaching is a formulation not encompassed by Applicant’s claim 1.
Examiner respectfully disagree with Applicant’s argument. As discussed in preceding Office action, Kulkarni et al. discloses, at least a corticosteroid (abstract, “ a corticosteroid selected from fluticasone, budesonide, beclomethasone”; PG 11, ln 5-30), a long acting beta-2 agonist (LABA) agent selected from formoterol fumarate and formoterol fumarate dihydrate (abstract, “ formoterol fumarate dihydrate”; PG 11, ln 5-30) , a long acting muscarinic receptor antagonist (LAMA) agent (abstract, “glycopyrronium bromide”; PG 11, ln 5-30), and HFA 152a propellant (abstract; PG 15, ln 27-30, “An HFA propellant can be selected from HFA- 134a, HFA-227a, HFA- 32, HFC-143a, HFC-134, HFC-152a and mixture thereof”) and recognize the need to develop a stable improved aerosol composition for inhalation which is stable for at least three months (PG 4, ln 21-24). While Kulkarni et al. is silent on the pH level of the said formulation, Lewis et al. which is analogous art to the claimed invention for the recognizing stability problems (¶0005) and improving of the stability (¶0039-0043) of the formulation consisting similar composition of Kulkarni et al., teaches an aerosol composition which consists of as active ingredient formoterol fumarate in combination with beclomethasone diproprionate in a solution of a liquefied HFA 134a propellant has an apparent pH between 3.0 and 3.5 (claim 1; ¶0045).
Examiner notes that the purpose of HFA propellant is a gas inside the pressurized canister that pushes the medication/formulation out upon valve actuation. Further, HFA-134a is not soluble in water(as evidenced by PubChem - https://pubchem.ncbi.nlm.nih.gov/compound/13129 #section=Solubility), so it would not have impact on pH of the formulation. Thus, Examiner notes that the teaching of the Lewies et al. implies that the apparent pH of the composition is determined by the active ingredients, co-solvents, and acids and the choice of a specific HFA propellant would not impact or interfere with the stabilization mechanism achieved by the 2.5-5 pH range. Since both references expressly discloses that the formulations need to be stable and the can is required to prevent leakage, one of the ordinary skills in the art would have recognize the benefit from the teaching of Lewis et al. and motivated to modify the formulation in order to make and use an effect formulation for inhalation by improving stability as discussed in the preceding Office action without unexpected results. Further, Kulkarni et al. comes more than 14 years after Lewis et al. One of ordinary skills in the art would have obviously recognized that HFA 152a (a newer, environmentally preferable propellant option as evidenced by Corr et al. US 20192047339 which was cited in preceding Office action dated 10/01/2025) was a newer propellant relative to the teaching of Lewis et al., so the teaching of Lewis et al. could have been obviously applied to the teachings of Kulkarni et al. when desiring to specify a stable acidic buffering of the solution of Kulkarni et al.
Following the Teachings in Jacuk Results in Making Any Gasket in the Valve Out of COC.
Applicant argues that Jacuk explains that a gasket made of COC provides numerous advantages over the other types of material, such as a gasket made of EPDM, and that COC provides the benefit that very few particles leach out of a gasket made of COC. The person of ordinary in the art without engaging in inventive activity would make any gasket in the valve out of COC. Hence, the result is a combination where any gasket in the valve is made of COC, so the combination is not encompassed by Applicant’s claim 1.
Examiner concurs with Applicant’s argument.
Kulkarni et al. explicitly discloses the aerosol valve assembly can comprise at least a butyl rubber or EPDM or a cyclic olefin co-polymer gasket and/or at least one pre-ring to prevent degradation of the product and/or to prevent the leakage of product contained in the canister during storage or transportation (PG 25 ln 6-13). This implies that the valve can be comprised of various combinations of materials. Jacuk et al. as discussed in preceding Office action, teaches that the sealing elements are made out of material of the ethylene-propylene terpolymer rubber (EPDM), or chloroprene rubber type. All of those materials perform well to a greater or lesser extent depending on the properties under consideration (Jacuk et al.: ¶0003, “the valve itself includes one or more sealing gaskets …two gaskets known as "internal gaskets" against which the valve member slides in leaktight manner during actuation…They are also in contact with the propellant gas. Generally, the sealing elements are made out of material of the ethylene-propylene terpolymer rubber (EPDM), nitrile rubber, or chloroprene rubber, etc. type. All of those materials perform well to a greater or lesser extent depending on the properties under consideration, and they all present certain drawback). Jacuk et al also teach a valve comprising three gaskets, a neck gasket, an upper internal gasket, and a lower internal gasket comprising COC elastomer. It is stated that COC elastomer also presents significant barrier properties against water vapor, and mechanical properties that are entirely suitable for making valve gaskets, and sealing performances (static leakage of propellant, moisture ingress) similar to TPE (thermoplastic elastomer) materials, and better performances than elastomers, e.g. EPDM.
However, Jacuk et al. does not specifically suggest or teach wherein said can is provided with a valve selected from a valve with a gasket made of cycloolefin copolymer (COC).
Since independent claim 1 recites, “wherein said can is provided with a valve selected from the group consisting of”, Examiner notes that the claims rejections 1-5, 7-8, 10-18, 20, and 25-30 from preceding Office action as it would not necessarily require the limitation of (i) of claim 1.
Following the Teachings in Kulkarni Results in a Valve With a Pre-Ring.
Applicant argues that Kulkarni teaches the benefits of a “pre-ring” which is made from “polyamide, polystyrene & polyethylene polymer”. The result of the combined teaches of cited reference is a valve that is outside the scope and results in a combination not encompassed by Applicant’s claim 1. Hence, it may engage in hindsight or not engage inventive activity would results in a combination not encompassed by Applicant’s claim 1.
Examiner respectfully disagree with Applicant’s arguments. First, in response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Second, Kulkarni et al., as discussed above, explicitly discloses the aerosol valve assembly can comprise at least a butyl rubber or EPDM or a cyclic olefin co-polymer gasket and/or at least one pre-ring to prevent degradation of the product and/or to prevent the leakage of product contained in the canister during storage or transportation (PG 25 ln 6-13). This implies that the valve can be comprised of various combinations of materials. Further, instant claim 1 utilizes the open-ended transition term “comprising” when describing the valve assembly. Examiner notes that a claim that uses “comprising” is not closed; it permits the inclusion of additional, unrecited elements. See MPEP 2111.03.
While the prior art does not expressly teach the specific valve systems as claimed, they clearly point one of ordinary skill in the art to the said systems. For example, Kulkarni et al. discloses teach that the gasket used is rubber or polymer gasket, preferably, of EPDM or cyclic olefin co-polymer. Jacuk et al teach a device comprising three gaskets wherein they may be made of COC or a combination of elastomers including EPDM and teach that COC performs better than EPDM. Scuri et al teaches a system comprising gaskets all made of chlorobutyl polymer. Therefore, the combination of references would have guided one of ordinary skill to one of the valve systems as claimed with a reasonable expectation of success.
EXPERIMENTAL RESULTS SHOWING SUPERIOR STABILITY OF THE CLAIMED FORMULATION IS AN UNXPECTED RESULT THAT FURTHER SUPPORTS A FINDING THAT THE PENDING CLAIMS COMPLY WITH THE REQUIREMENTS OF 35 U.S.C. § 103.
Applicant argues that the achieve a stable of formulation of formoterol has been reported to a difficult challenge as evidenced by US Pub 2019/0247339 by Corr et al. and the instant application provides experimental data demonstrating “superior stability” of the formulation according to parameter of apparent pH as shown in Examples 1 and 2 (demonstrate a stable pH for the formulation over an extended duration of storage for the HFA 152a propellant in comparison between two examples). The experimental results shows “superior stability” is a ”unexpected result” that further supports a finding that claim 1 complies with the requirement of 35 U.S.C. §103. Applicant notes that it should not be overlooked that none of the Cited References provide working example of an HFA 152 formulation containing formoterol fumarate, let alone provide stability date for an HFA 152a formulation containing formoterol fumarate when stored in the particular type of can with one of the particular valves set forth in claim 1. In view of different application (US 2023/0347080) further provide experimental results in Table 1 demonstrate a stable pH for the formulation over an extended duration of storage for the HFA 152a propellant and FEP-coated can while Table 2 demonstrates inferior stability with a substantial increase in the pH value over storage. Therefore, modification of Cited References does not result in the specific invention.
Examiner respectfully concurs partially with Applicant’s arguments.
The closest prior art is Lewis et al. which teaches the apparent pH of the formulation of the formoterol fumarate and HFA propellent. Without a comparative test showing the instant application performs in a manner completely different to what Lewis et al. already teaches, a mere showing of stability in the specification is insufficient.
Said examples of the instant application indicates a residual percentage and an apparent PH level over the duration in months while the differences between said examples is a coating of the can with valves A, B, or V which are known valves from known manufacturers, Aptar, Vari, and Bespak (as evidenced by Bonelli et al. US 20150182459; cited in Office action filed 10/01/2025). However, Tables of the different application US 2023/0347080 provides more information in comparison between the propellant HFA 152a and HFA 134a.
Regarding Table A, the remaining amount of FF at 6 months, it is noted that this modest increase appears to fall well within the standard deviation of the three tested formulations. That is, the highest difference between A valve and B valve comprising HFA 152a at 6 months is about 4% points. Taking standard deviation into account, the difference between V valve and B valve is 0.15% and between A valve and B valve is 3.1%. These differences cannot support an argument of superiority. Additionally, the Specification only refers to this data in Tables 1 and 2 with regard to the benefit of an internally coated can compared to a non-coated can.
Regarding Table B, it is noted that three test points are disclosed. That is, there is no standard deviation.
However, Jacuk et al. and a valve of Apak (NPL 5; IDS filed 02/03/2023) do not specifically teach or suggest wherein said can is provided with a valve selected from a valve with a gasket made of cycloolefin copolymer (COC).
Since independent claim 1 recites, “wherein said can is provided with a valve selected from the group consisting of”, Examiner maintains the rejection 1-5, 7-8, 10-18, 20, and 25-30 from preceding Office action as it would not necessarily require the limitation of (i) of claim 1.
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 nonobviousness.
Claims 1-5, 7-8, 10-18, 20, and 25-30 are rejected under 35 U.S.C. 103 as being unpatentable over Kulkarni et al. (WO 2021033081 A1) in view of Lewis et al. (US 20060257324 A1), Scuri et al. (US 20180028439 A1), and Jinks (US 20140109900 A1).
Examiner notes that the following combination of the prior arts were applied to each valve type of claim 1:
For limitation (ii), Kulkarni et al. (WO 2021033081 A1) in view of Lewis et al. (US 20060257324 A1), and Jinks (US 20140109900 A1)
For limitation (iii), Kulkarni et al. (WO 2021033081 A1) in view of Lewis et al. (US 20060257324 A1), and Scuri et al. (US 20180028439 A1)
Regarding claim 1, Kulkarni et al. discloses, a can for use in a pMDI device (PG 5, ln 1-2, “wherein the composition is to be delivered using pressurized MDI suitable for aerosol administration”; PG 24, ln 9-15, “The composition of the present invention can be delivered using conventional metered-dose inhalers. The drug delivery device comprises a suitable aerosol canister with a metering valve”), said can containing a formulation comprising at least a corticosteroid (abstract, “ a corticosteroid selected from fluticasone, budesonide, beclomethasone”; PG 11, ln 5-30), a long acting beta-2 agonist (LABA) agent selected from formoterol fumarate and formoterol fumarate dihydrate (abstract, “ formoterol fumarate dihydrate”; PG 11, ln 5-30) , a long acting muscarinic receptor antagonist (LAMA) agent (abstract, “glycopyrronium bromide”; PG 11, ln 5-30), and HFA 152a propellant (abstract; PG 15, ln 27-30, “An HFA propellant can be selected from HFA- 134a, HFA-227a, HFA- 32, HFC-143a, HFC-134, HFC-152a and mixture thereof”), wherein said can is internally coated by a coating comprising fluorinated-ethylene- propylene polymer (FEP) (PG 24, ln 16-27, “fluorinated ethylene propylene and polyethersulphone”)
While Kulkarni et al. recognize the need to develop a stable improved aerosol composition for inhalation which is stable for at least three months (PG 4, ln 21-24), Kulkarni et al. is silent on the formulation comprising an apparent pH buffered between 2.5 and 5.
However, Lewis et al. which is analogous art to the claimed invention for the recognizing stability problems (¶0005) and improving of the stability (¶0039-0043) of the formulation consisting similar composition of Kulkarni et al., teaches an aerosol composition which consists of as active ingredient formoterol fumarate in combination with beclomethasone diproprionate in a solution of a liquefied HFA 134a propellant has an apparent pH between 3.0 and 3.5 (claim 1; ¶0045). The said formulations are contained in cans having part of all of the internal surfaces made of anodised aluminium, stainless steel or lined with an inert organic coating. Examples of preferred coatings are epoxy-phenol resins, perfluoroalkoxyalkane, perfluoroalkoxyalkylene, perfluoroalkylenes such as polytetrafluoroethylene, fluorinated-ethylene-propylene, polyether sulfone and a copolymer fluorinated-ethylene-propylene polyether sulfone. Other suitable coatings could be polyamide, polyimide, polyamideimide, polyphenylene sulfide or their combinations. The formulation is actuated by a metering valve (¶0037-0039).
It would have been prima facie obvious to a person of ordinary skilled in the art at the time the invention was made to have combined the teachings of Lewis et al. with that of Kulkarni et al. to arrive at the instant invention. Therefore, it would have been obvious to do so because Scuri et al. teach the similar compositions as claimed but is silent with regard to the pH of the formulation. Thus, one of ordinary skill in the art wishing to follow Scuri et al.'s teachings to make and use an effective formulation for inhalation by improving stability (¶0039-0046, “HFA formulations turned out to much more stable below pH' 5.5… the apparent pH of said solution having been adjusted to between 3.0 and 5.0 by addition of small amounts of a mineral acid”; ¶0075-0077, “The apparent pH range is advantageously comprised between 2.5 and 5.0, preferably between 3.0 and 5.0… hydrochloric acid should be added to obtain an apparent pH between 3.0 and 3.5”), would be interested in finding guidance on the suitable pH range for this formulation. Lewis et al. teach the same formulation and provide that guidance one of ordinary skill in the art would be looking for.
In other words, the claims would have been obvious because the technique for improving a particular formulation was part of the ordinary capabilities of a person of ordinary skill in the art, in view of the teaching of the technique for improvement in other situations.
From the combined teaching of the cited references, one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made.
While Kulkarni et al. discloses, the metering valve with a gasket made of rubber, polymer gasket, EPDM, or COC (PG 25, ln 6-13), Kulkarni et al. does not specifically discloses a valve selected from group of a valve with three gaskets that are each made of a polymer of EPDM.
However, Scuri et al. which is analogous art to the claimed invention given a similar composition of Kulkarni et al. (abstract) and the canister fitting with a metering valve (¶0055), teaches a valve with three gaskets (¶0062, “an inner- and an outer-seal around the metering chamber… and a gasket to prevent leakage of propellant through the valve”; Examiner interprets gasket(s) as to any gasket and/or valve seals in BRI as ¶0061 of the instant application. Examiner notes: one skilled in the art would readily recognize that the gasket is used as valve seal where the gasket is defined as a material such as rubber or a part used to make a joint fluid tight as defined by Merriam-Webster) comprising of EPDM (¶0063, “The gasket seal and the seals around the metering valve may comprise elastomeric material such as EPDM, chlorobutyl rubber, bromobutyl rubber, butyl rubber, or neoprene. EPDM rubbers are particularly preferred”)
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the can of Kulkarni et al. to include a valve with three gaskets that are each made of a polymer of EPDM as taught by Scuri et al. in order to prevent leakage of propellant through the valve (¶0063).
While Kulkarni et al. discloses, the metering valve with a gasket made of rubber, polymer gasket, EPDM, or COC (PG 25, ln 6-13), Kulkarni et al. does not specifically discloses a valve with two gaskets that are each made of chlorobutyl polymer.
However, Jinks which is analogous art to the claimed invention for medicinal inhalation devices, metered dose valves and valve components (¶0001), teaches a metered dose valve (10, Fig 3-5) with two gaskets (an inner seal 16 and outer diaphragm seal 17, Fig 3-5; Examiner interprets gasket(s) as to any gasket and/or valve seals in BRI as ¶0061 of the instant application. Examiner notes: one skilled in the art would readily recognize that the gasket is used as valve seal where the gasket is defined as a material such as rubber or a part used to make a joint fluid tight as defined by Merriam-Webster) which are well-known valve from WO2004/022142, Bespak, Bergen Way, and Valois SAS (¶0044-0046) that are each made of chlorobutyl polymer (¶0048, “Seals are typically elastomeric… Chlorobutyl”)
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to substitute the valve of Kulkarni et al. with a valve with two gaskets that are each made of chlorobutyl polymer as taught by Jinks et al. for a substitution of known metered dose valves in the art without unexpected results. See MPEP 2144.04.
Regarding claim 2, Kulkarni et al. in view of Lewis et al., Scuri et al. and Jinks discloses the can of claim 1 as discussed above.
Kulkarni et al. further discloses, wherein said corticosteroid is selected from the group consisting of: budesonide, and fluticasone, (abstract, “ a corticosteroid selected from fluticasone, budesonide, beclomethasone”)
Regarding claim 3, Kulkarni et al. in view of Lewis et al., Scuri et al. and Jinks discloses the can of claim 2 as discussed above.
Kulkarni et al. further discloses, wherein herein said corticosteroid is beclomethasone dipropionate or budesonide (abstract).
Regarding claim 4, Kulkarni et al. in view of Lewis et al., Scuri et al. and Jinks discloses the can of claim 1 as discussed above.
Kulkarni et al. further discloses, wherein the LABA agent is selected from the group consisting of: formoterol fumarate (PG 2, ln 24-30, “Formoterol fumarate… with budesonide, mometasone furoate and glycopyrrolate respectively for the treatment of asthma and/or COPD”).
Regarding claim 5, Kulkarni et al. in view of Lewis et al., Scuri et al. and Jinks discloses the can of claim 1 as discussed above.
Kulkarni et al. further discloses, wherein said LABA agent is formoterol fumarate dihydrate (abstract).
Regarding claim 7, Kulkarni et al. in view of Lewis et al., Scuri et al. and Jinks discloses the can of claim 1 as discussed above.
Kulkarni et al. further discloses, wherein the LAMA agent is selected from the group consisting of glycopyrronium, methscopolamine, ipratropium, oxitropium, trospium, tiotropium, aclidinium and umeclidinium or pharmaceutically acceptable salts thereof (abstract).
Regarding claim 8, Kulkarni et al. in view of Lewis et al., Scuri et al. and Jinks discloses the can of claim 7 as discussed above.
Kulkarni et al. further discloses, wherein said LAMA agent is glycopyrronium bromide (abstract).
Regarding claim 10, Kulkarni et al. in view of Lewis et al., Scuri et al. and Jinks discloses the can of claim 7 as discussed above.
Kulkarni et al. further discloses, wherein the coating is a fluorinated-ethylene-propylene (FEP) polymer (PG 24, ln 16-27, “fluorinated ethylene propylene and polyethersulphone”).
Regarding claim 11, Kulkarni et al. in view of Lewis et al., Scuri et al. and Jinks discloses the can of claim 1 as discussed above.
Scuri et al. further discloses, wherein the formulation further comprising one or more excipients, co-solvents, and acids (abstract, “co-solvent, optionally a stabilizer”).
Regarding claim 12, Kulkarni et al. in view of Lewis et al., Scuri et al. and Jinks discloses the can of claim 11 as discussed above.
Kulkarni et al. further discloses, wherein said co-solvent is an aliphatic alcohol having from 1 to 4 carbon atoms (PG 16, ln 4-11, “the co-solvent comprises one or more of C2- C6 aliphatic alcohols (such as, but not limited to, ethyl alcohol and isopropyl alcohol), glycerol, polyoxyethylene alcohols, polyoxyethylene fatty acid esters, hydrocarbons (such as, but not limited to, n-propane, n-butane, isobutane, n-pentane, iso-pentane, neo-pentane, and n-hexane), ethers (such as but not limited to diethyl ether) and mixture thereof. The alcoholic co-solvent in the present invention comprises one or more of C2- C6 aliphatic alcohols, glycerol, polyoxyethylene alcohols and mixture thereof, wherein co-solvent may further comprise water. Preferably, the co-solvent is anhydrous ethanol.”).
Regarding claim 13, Kulkarni et al. in view of Lewis et al., Scuri et al. and Jinks discloses the can of claim 12 as discussed above.
Kulkarni et al. further discloses, herein said aliphatic alcohol is ethanol (PG 16, ln 4-11).
Regarding claim 14, Kulkarni et al. in view of Lewis et al., Scuri et al. and Jinks discloses the can of claim 1 as discussed above.
Modified Kulkarni et al. further discloses, wherein said acid is a mineral or organic acid selected from the group consisting of: hydrochloric acid, hydrobromic acid, nitric acid, fumaric acid, phosphoric acid and citric acid, maleic acid, acetic acid, xinafoic acid, oxalic acid, lactic acid, 2-methyl propionic acid, malic acid, butanoic acid, tartaric acid, propionic acid, pentanoic acid, succinic acid, glycolic acid, hexanoic acid, malonic acid, glutaric acid, formic acid, adipic acid, ascorbic acid, benzoic acid and glucuronic acid. (Lewis et al.:¶0039-0043; ¶0075-0077, “the apparent pH range is advantageously comprised between 2.5 and 5.0, preferably between 3.0 and 5.0. Strong mineral acids such as hydrochloric, nitric, sulphuric or phosphoric are preferably used to adjust the apparent pH”).
Regarding claim 15, Kulkarni et al. in view of Lewis et al., Scuri et al. and Jinks discloses the can of claim 14 as discussed above.
Modified Kulkarni et al. further discloses, wherein said acid is hydrochloric acid (Lewis et al.:¶0039-0043; ¶0075-0077).
Regarding claim 16, Kulkarni et al. in view of Lewis et al., Scuri et al. and Jinks discloses the can of claim 1 as discussed above.
Kulkarni et al. further discloses, the formulation further comprising a low volatility component selected from the group consisting of: glycols, and propylene glycol (PG 17, ln 3-11, “A low volatility component may be selected from glycerol, glycols (eg. propylene glycol) etc. Preferably glycerol is used as low volatility component”).
Regarding claim 17, Kulkarni et al. in view of Lewis et al., Scuri et al. and Jinks discloses the can of claim 1 as discussed above.
Scuri et al. further discloses, the formulation is in the form of a solution (PG 5, ln 18-19, “…is either in suspension form or in solution form”).
Regarding claim 18, Kulkarni et al. in view of Lewis et al., Scuri et al. and Jinks discloses the can of claim 1 as discussed above.
Modified Kulkarni et al. further discloses, wherein the valve is the valve with the three gaskets that are each made of the polymer of EPDM (Scuri et al.: ¶0063-0064).
Regarding claim 20, Kulkarni et al. in view of Lewis et al., Scuri et al. and Jinks discloses the can of claim 1 as discussed above.
Modified Kulkarni et al. further discloses, wherein the valve is the valve with the two gaskets that are each made of chlorobutyl polymer (Jinks: ¶0001,0044-0046,0048; Fig 3-5).
Regarding claim 25, Kulkarni et al. in view of Lewis et al., Scuri et al. and Jinks discloses the can of claim 1 as discussed above.
Modified Kulkarni et al. further discloses, the formulation further comprising the apparent pH buffered between 3 and 4.5 (Lewis et al.:¶0039-0043; ¶0075-0077).
Regarding claim 26, Kulkarni et al. discloses a pMDI device (claim 9; PG 5, ln 1-2, “wherein the composition is to be delivered using pressurized MDI suitable for aerosol administration”; PG 24, ln 9-15, “The composition of the present invention can be delivered using conventional metered-dose inhalers. The drug delivery device comprises a suitable aerosol canister with a metering valve”) comprising the can according to claim 1 (Kulkarni et al. in view of Lewis et al., Scuri et al. and Jinks in claim 1 as discussed above).
Regarding claim 27, Kulkarni et al. further discloses a method of treating asthma or chronic obstructive pulmonary disease (COPD) (PG 1, ln 10- 23, “the present invention also relates to a process for preparing such composition and its use for the treatment of respiratory disorders such as asthma and/or chronic obstructive pulmonary disease in a subject in need thereof.”) comprising administering to a subject in need thereof using the pMDI device according to claim 26 (as discussed above in claim 26 having the can of claim 1), the formulation having an apparent pH buffered between 2.5 and 5 that comprises comprising at least a corticosteroid, a LABA agent selected from formoterol fumarate and formoterol fumarate dihydrate, a LAMA agent, and HFA 152a er HFO propellant (Kulkarni et al. in view of Lewis et al., Scuri et al. and Jinks in claim 1 as discussed above)
Regarding claim 28, Kulkarni et al. in view of Lewis et al., Scuri et al. and Jinks discloses the can of claim 5 as discussed above.
While Kulkarni et al. discloses, the composition comprising a corticosteroid selected from fluticasone, budesonide, beclomethasone, and glycopyrronium bromide, formoterol fumarate dihydrate and fluticasone propionate, co-solvent, optionally a stabilizer and HFA propellant (abstract), Kulkarni et al. does not specifically discloses, wherein the corticosteroid is beclomethasone dipropionate.
However, Scuri et al. teaches, beclometasone dipropionate which are useful for the prevention or treatment of moderate/severe chronic obstructive pulmonary disease in combination of glycopyrronium bromide, formoterol.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify can of Kulkarni et al. to include beclometasone dipropionate for treating moderate/severe chronic obstructive pulmonary disease (abstract).
Regarding claim 29, Kulkarni et al. in view of Lewis et al., Scuri et al. and Jinks discloses the can of claim 5 as discussed above.
Kulkarni et al. further discloses, wherein the LAMA agent is glycopyrronium bromide (abstract).
Regarding claim 30, Kulkarni et al. in view of Lewis et al., Scuri et al. and Jinks discloses the can of claim 28 as discussed above.
Kulkarni et al. further discloses, wherein the LAMA agent is glycopyrronium bromide (abstract).
Allowable Subject Matter
Claim 19 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Reasons for Indication of Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter:
Regarding the subject matters of claim 19, the closest identified prior art document of record is Jacuk et al. (US 20130000636 A1).
Jacuk et al. discloses, the valves are commonly used with ethylene-propylene terpolymer rubber (EPDM), nitrile rubber, or chloroprene rubber, etc. type (¶0003) while COC was commonly used in hoses, tubes etc, but material has never been used in devices of the inhaler type (¶0004). Jacuk further teaches that COC has better performance than EPDM (¶0033), but the prior art does not specifically teach or suggest wherein the valve with a gasket made of cycloolefin copolymer (COC), along with two gaskets made of a polymer of EPDM.
Conclusion
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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.
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/J.J./Examiner, Art Unit 3785 /JOSEPH D. BOECKER/Primary Examiner, Art Unit 3785
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