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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 02/20/26 has been entered.
Receipt is acknowledged of Amendments, Remarks and a Declaration filed on 01/26/26, one IDS filed on 03/09/26 and a second IDS filed on 03/09/26. Claims 1, 4-5, 29, 33-34, 37-45 have been amended, no new claims have been added and claims 7, 9-10 and 36 have been canceled. Accordingly, claims 1-5, 13-18, 26-29, 33-34 and 37-45 are pending and under examination on the merits.
Rejections and/or objections not reiterated from the previous Office Action are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set of rejections and/or objections presently being applied to the instant application.
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 nonobviousness.
Claims 1-5, 13-18, 28-29, 33-34 and 37-39 are rejected under 35 U.S.C. 103 as being unpatentable over Kulkarni et al (WO 2021033081) in view of Scuri et al (US 20180028439), Jacuk et al (US 20180079587) and Corr et al (US 20190247339).
Kulkarni et al teach a stable aerosol composition for inhalation administration using metered dose inhaler (MDI) comprising glycopyrronium or its pharmaceutically acceptable salt, formoterol or its pharmaceutically acceptable salt, a corticosteroid selected from fluticasone, budesonide, beclomethasone and its pharmaceutically acceptable salt or esters thereof, HFA propellant and one or more other pharmaceutically acceptable excipients, including a co-solvent. The formoterol is preferably formoterol fumarate dihydrate (See abstract, claims 1 and 4).
Regarding claims 1-5 and 37 in part, Kulkarni et al teach the pMDI device, containing a can comprising the formulation comprising budesonide or beclomethasone propionate (i.e. dipropionate) and formoterol fumarate dihydrate and wherein the can comprises a valve. It is disclosed that the inner surface of the container is coated with a suitable polymer including fluorocarbon copolymers such as FEP-PES (fluorinated ethylene propylene and polyethersulphone). The canister is fitted with a valve, preferably a metering valve. Metering valves suitable to deliver a specific amount of the composition each time the device is actuated. A gasket may also be used between the valve and the canister to prevent leakage of the composition. Preferably, the gasket used is rubber or polymer gasket, more preferably, the gasket used is ethylene propylene diene monomer (EPDM) or cyclic olefin co-polymer with and/or at least one pre-ring made up of polyamide, polystyrene or polyethylene polymer which prevent degradation and leakage of composition during storage or transportation (See pages 14, 24-25 and claim 16).
Further regarding claim 1, it is disclosed that the said HFA propellant may be HFA 152 (See page lines and claim 1).
Regarding claims 13-14, and 17-18, it is disclosed that the said formulations also comprise a co-solvent including ethanol and a low volatility component including glycerol. The formulations are in the form of a solution or suspension (See page 5, page, 17, lines 3-10, page 18, lines 16-21, page 19 and claims 6, 9 and 18).
Regarding claim 15, Kulkarni et al teach the addition of a stabilizer including an organic acid such as citric acid, acetic acid, oleic acid, etc, (See paragraph bridging pages 16-17 and claim 7).
Regarding claims 28-29, Kulkarni et al teach a pMDI device containing the said formulation and wherein the formulation is administered via inhalation to a subject to teat respiratory diseases including asthma and COPD (See page 13, lines 19-30).
Kulkarni et al teach a pMDI device comprising a valve and gaskets made of cyclo olefine copolymer (COC), EDPM or rubber butyl polymer. However, they do not expressly disclose the valve with three gaskets or two gaskets as claimed or a valve with two gaskets made of chlorobutyl polymer. These are taught by Scuri et al, Jacuk et al and Corr et al.
Scuri et al teach aerosol formulations comprising glycopyrronium bromide, formoterol or a salt thereof, and beclometasone dipropionate are useful for the prevention or treatment of moderate/severe chronic obstructive pulmonary disease (COPD) (See abstract).
Regarding the limitations pertaining to the formulation in claims 1-5, 13-18 and device and method of claims 28-29, Scuri et al teach that the formoterol salt (a LABA) is preferably formoterol fumarate dihydrate (See [0035] claims 4 and 6). The formulations comprise a propellant which may be any pressure-liquefied propellant and is preferably a hydrofluoroalkane (HFA) or a mixture of different HFAs, (See [0037] and claim 6).
Scuri et al also disclose that the said solution formulation may comprise other pharmaceutical excipients or additives known in the art. In particular, the compositions may comprise one or more low volatility components. Examples of low-volatility components are isopropyl myristate, tocopherol esters; glycols such as propylene glycol, polyethylene glycol, glycerol; and surface active agents such as saturated organic carboxylic acids (e.g. lauric, myristic, stearic acid) or unsaturated carboxylic acids (e.g. oleic or ascorbic acid) (See [0045]-[0046]).
Regarding claims 1-5 and 13-18, Scuri et al teach a method for reducing the moderate/severe COPD exacerbation rate by administering an inhaled pharmaceutical composition consisting of a fixed combination of beclometasone dipropionate (BDP) 100 μg per actuation, formoterol fumarate (FF) dihydrate 6 μg per actuation and glycopyrronium bromide (GB) 12.5 μg per actuation completely dissolved in HFA 134a, anhydrous ethanol and 1M HCl per actuation, administered for reducing the moderate/severe COPD (See claim 6 and [0067]).
Regarding the device, the valve and gaskets in claim 1, Scuri et al teach that the said pharmaceutical formulation is filled into pMDI devices known in the art. Said devices comprise a canister fitted with a metering valve (See [0055]). The metal canisters may have part or all of their internal surfaces lined with an inert organic coating. Examples of preferred coatings are fluorinated-ethylene-propylene (FEP), or fluorinated-ethylene-propylene polyether sulfone (FEP-PES) mixtures (See [0057]-[0059]). The container is closed with a metering valve for delivering a daily therapeutically effective dose of the active ingredient. Generally, the metering valve assembly comprises a gasket to prevent leakage of propellant through the valve. 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. The metering valve comprises at least a butyl rubber gasket. Among the butyl rubber, chlorobutyl rubber is particularly preferred. The most preferred metering valve has all the seals made with the same elastomeric material including a chlorobutyl rubber (See [0062]-[0064]).
Jacuk et al teach a fluid dispenser device comprising: a body provided with a dispenser orifice; a reservoir containing fluid and a propellant gas; and a metering valve assembled on said reservoir wherein the said metering valve includes a valve member and comprises at least one sealing element (40, 41, 42) so as to form a leaktight seal, at least one sealing element (40, 41, 42) of said device comprising COC elastomer (See abstract and Figs. 1-2).
Regarding the valve system i) in claim 1, Jacuk et al teach that 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. Jacuk et al also teach a valve wherein the at least one of the sealing elements, i.e. at least one of the neck gasket 40, the upper internal gasket 41, and the lower internal gasket 42, comprise COC elastomer. 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 (See [0003], [0024] and [0032).
Corr et al, with regard to claims 1-5, teach a pharmaceutical composition comprising: (i) at least one formoterol compound including salts or solvates of formoterol, (ii) at least one corticosteroid; (iii) a surfactant component comprising at least one surfactant compound; and (iv) a propellant component which is 1,1-difluoroethane (R-152a) (i.e HFA 152) (See abstract and claim 1). It is further stated that the propellant component in the said pharmaceutical composition comprises 1,1-difluoroethane (R-152a) (See [0044]).
Regarding the canister and the valve system, Corr et al teach that the said pharmaceutical composition is suitable for delivery to the respiratory tract using a metered dose inhaler (MDI) (See [0033]). The metered dose inhaler typically comprises a nozzle and valve assembly that is crimped to a container holding the pharmaceutical composition to be dispensed. An elastomeric gasket is used to provide a seal between the container and the nozzle/valve assembly. Preferred elastomeric gasket materials are EPDM, chlorobutyl, bromobutyl and cycloolefin copolymer rubbers as these can exhibit good compatibility with HFA-152a and also provide a good barrier to prevent or limit HFA-152a permeating from the container (See [0079]).
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 Jacuk et al Scuri et al and Corr et al with that of Kulkarni et al to arrive at the instant invention. While no one reference anticipates the claimed canister and formulation, the combination of references would have led one of ordinary skill in the art to the same claimed invention. That is. it would have been obvious to do combine the teachings of the references because all references are teaching and disclosing features of an effective aerosol system including the composition and the internal coating of the can. Kulkarni et al teach a composition in solution form comprising beclomethasone or budesonide and formoterol fumarate, HFA 152, ethanol, glycerol and an acid for delivery to a subject for treating asthma and COPD wherein the device contains a valve comprising gaskets made of cyclic olefin co-polymer and/or EPDM.
Scuri et al teach the same compositions as claimed and teach that the internal surface of the said aerosol can is preferably coated with an inert material. Scuri et al also disclose that the device with a valve assembly comprising a gasket to prevent leakage of propellant through the valve, the gasket seal and the seals around the metering valve may comprise elastomeric material such as EPDM, chlorobutyl rubber, or butyl rubber with EPDM rubbers being particularly preferred. The metering valve comprises at least a chlorobutyl rubber gasket. Corr et al teach the advantages of using HFA 152a as the propellant in an inhalation system because of at least its effect on the environment having a lower GWP. Corr et al also disclose that elastomeric gasket materials include EPDM, chlorobutyl, bromobutyl and cycloolefin copolymer rubbers as these can exhibit good compatibility with HFA-152a and also provide a good barrier to prevent or limit HFA-152a permeating from the container.
Thus, one of ordinary skill in the art having possession of the references would have deduced that incorporating HFA 152a in an inhalation formulation and making a device with a valve system comprising gaskets made of EPDM, chlorobutyl and cycloolefin copolymer rubbers would be beneficial both to the stability of the formulation in terms of leakage and to the environment.
That is, it is generally considered to be prima facie obvious to substitute components which are taught by the prior art to be well known and useful for the same purpose in order to form a composition that is to be used for an identical purpose. The motivation for substituting them flows from their having been used in the prior art, and from their being recognized in the prior art as useful for the same purpose. As shown by the recited teachings, instant claims are no more than the substituting conventional gasket polymers and aerosol propellants as taught by the prior art. It therefore follows that the instant claims define prima facie obvious subject matter. Cf. In re Ruff, 256 F.2d 590, 118 USPQ 340 (CCPA 1958).
Furthermore, one of ordinary skill in the art having possession of the references would have deduced that an effective aerosol system may have one or more gaskets and they can be made of the same or different inert materials known in the art as suitable and effective such as COC, EPDM and/or chlorobutyl polymers with a reasonable expectation of success.
The claims would have been obvious because a person of ordinary skill has good reasons to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense.
Claims 1-5, 13-18, 26-29, 33-34 and 37-45 are rejected under 35 U.S.C. 103 as being unpatentable over Kulkarni et al (WO 2021033081) in view of Scuri et al (US 20180028439), Jacuk et al (US 20180079587), Corr et al (US 20190247339) and Lewis et al (EP 2223682).
Kulkarni et al, Scuri et al, Jacuk et al and Corr et al’s teachings are delineated above and incorporated herein.
The combined references lack a disclosure on the pH of the formulations, However, Lewis et al teach the same formulation and disclose its pH.
Lewis et al teach stable aerosol compositions which consist of as active ingredient formoterol fumarate in combination with beclomethasone diproprionate in a solution of a liquefied HFA 134a propellant and 12% w/w ethanol as a co-solvent, and hydrochloric acid in an amount such that the solution has an apparent pH between 3.0 and 3.5 (See claim 1, [0015] and [0045]).
The formulations may also comprise a low volatility component including isopropyl myristate or glycerol (See [0043]).
The said formulations are contained in cans having part of all of the internal surfaces lined with an inert organic coating. Examples of preferred coatings include fluorinated-ethylene-propylene (FEP), etc. The formulation is actuated by a metering valve (See [0037]-[0039]).
Metering valves fitted with gaskets made of chloroprene-based rubbers can preferably be used to reduce the ingress of moisture which can adversely affect the stability of the drug during storage (See [0040]).
Regarding the stability and pH of the formulation, Lewis et al disclose that “overall consideration of the pH and formoterol content data implies that the stability of a solution formulation of the drug in HFA can be improved by the addition of mineral acid to provide a formulation with pH between 2.5-5.0” (See [0055]).
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 Jacuk et al Scuri et al, Corr et al and Lewis et al with that of Kulkarni et al to arrive at the instant invention. While no one reference anticipates the claimed canister and formulation, the combination of references would have led one of ordinary skill in the art to the same claimed invention. The reasons for combining the references statement for Jacuk et al Scuri et al and Corr et al with that of Kulkarni et al is delineated above and incorporated herein.
It further would have been obvious to have incorporated the teachings of Lewis et al because Kulkarni et al and Scuri et al teach the same compositions as claimed but are silent with regard to the pH of the formulation. Thus, one of ordinary skill in the art wishing to follow Kulkarni et al and/or Scuri et al’s teachings to make and use an effective formulation for inhalation, 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.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Bonelli et al (US 20150182459).
Bonelli et al teach stable pressurized aerosol solutions, comprising glycopyrronium bromide and formoterol, or a salt thereof or a solvate of said salt, optionally in combination with an inhalation corticosteroid (ICS), stabilized by a mineral acid, and an HFA propellant which are contained in an aerosol can, with a metering valve having at least a butyl rubber gasket (See abstract, claim 1, [0027] and [0029]).
The said corticosteroid is preferably beclomethasone dipropionate, budesonide, etc (See [0041] and claim 6).
Also disclosed is that the said aerosol can is provided with a metering valve having at least a butyl rubber gasket which may be selected from a chlorobutyl or bromobutyl rubber gasket and in particular with a metering valve wherein all the gaskets are made with a butyl rubber, because the amounts of degradation products during their shelf-life, particularly of DP3 may be minimized even below the detection threshold as determined after storage under severe conditions of temperature and humidity (See [0028]-[0029]).
Bonelli et al teach aerosol solution compositions intended for use with a pressurized metered dose inhaler (pMDI), comprising glycopyrronium bromide and formoterol, or a salt thereof or a solvate of said salt, optionally in combination with an inhalation corticosteroid (ICS), stabilized by a selected amount of a mineral acid, the said composition being contained in an aerosol can provided with a metering valve having at least a butyl rubber gasket. The said aerosol solution compositions are effective in the prevention and therapy of airway diseases, particularly of obstructive respiratory disorders such as asthma and COPD (See [0030] and [0032]).
The said solution formulations further comprise a co-solvent such as ethanol and a mineral acid including HCl, and a one or more HFA propellants including HFA 134a (1,1,1,2-tetrafluoroethane), HFA 227 (1,1,1,2,3,3,3-heptafluoropropane), and mixtures thereof (See [0082], [0085], [0087]-[0088]).
Aptar Pharma (DF30 Technology).
Aptar Pharma discloses that DF30 metering valve platform has been the industry gold standard for more than 25 years. The metering valve is a key sub-system of pMDI which enables an accurate and repeatable dose of drug to be delivered. Elastomeric seals for valves are critical component that must maintain their function and chemical integrity with benefits including a selection of ultra clean, highly inert elastomer gaskets, including EPDM, TPE and COCe (See 2nd page).
Aptar Pharma also disclose a DF30 product range which states that DF30 comprises materials including PBT, EPDM or COCe, etc; (See Table on 3rd page).
Response to Arguments
Applicant’s amendments to the claims, filed on 01/26/26 have necessitated modified grounds of rejections. Applicant’s arguments so far as they pertain to the maintained references and rejections are discussed below.
Applicant’s arguments are mainly that the references do not teach or render obvious the claims as amended. For example, Applicant argues that Scuri et al do not teach HFA152 and Corr et al do not teach the valve configuration containing more than one gasket. Applicant also points to the Declaration of Enrico Zambelli arguing surprising and remarkable results achieved with the two specific configurations in terms of performance in reducing average leak rate (See Remarks, pages 7-8).
The above arguments are not persuasive. Firstly, the arguments are moot as the above rejections have been modified to better relate to the claims as amended. Secondly, as shown by the rejections, all recited limitations of the claims and features of the can are taught by the prior art with a clear reason for combining them. That is simply by following the teachings of the prior art one of ordinary skill in the art would have arrived at the claimed invention. Additionally, all references expressly disclose that the formulations need to be stable and the can is required to prevent leakages. One of ordinary skill in the art would have been motivated to have selected the coating material for internal coating of the can, the gasket polymers, and the propellant from the references because the references provide the advantages of such components. For example, Kulkarni et al teach the same composition comprising HFA 152. Additionally, it is clearly disclosed by Corr et al that not only the HFA 152a propellants have less detrimental effect on the environment but that elastomeric gasket materials, EPDM, chlorobutyl, and cycloolefin copolymer rubbers can exhibit good compatibility with HFA-152a and also provide a good barrier to prevent or limit HFA-152a permeating from the container. Thus, Corr et al in addition to Kulkarni et al provide sufficient motivation for one of ordinary skill in the art to select HFA 152a and incorporate a gasket made of EPDM, chlorobutyl, and/or cycloolefin copolymer rubbers and expect advantages including stability, lass permeation from the can and less adverse effect on the environment.
Regarding the argument that the references do not teach the claimed valve configuration contains more than one gasket, it is noted that Jacuk et al teach that generally, 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 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.
Thus, Jacuk et al teach that while both COC and EPDM perform well, gaskets made of COC show better performance. This would have motivated one of ordinary skill in the art to make a valve system with COC and EPDM, as claimed. On the other hand, Scuri et al teach that the most preferred metering valve has all the seals made with the same elastomeric material including a chlorobutyl rubber, which is also recommended by other references as a suitable material for gaskets, such as Corr et al.
The remaining arguments relate to the unexpected and superior results, as stated in the Declaration which will be addressed below.
Response to the Declaration under Rule 132
Enrico Zambelli, the named inventor of this Application has provided a Declaration under Rule 132 that is dated 01/26/26. The Declaration meets the formal requirements. In the most relevant part, the Declaration details the unexpected results of the claimed valve system, specifically with regard to weight percent of formoterol fumarate at 6 months and average leak rate of the three valve systems tested.
A Declaration is due full consideration and weight for all that it discloses. Declarations are reviewed for the following considerations: 1) whether the Declaration presents a nexus such as a side-by-side or single-variable comparison (In re Huang, 40 USPQ2d 1685, 1689 (Fed. Cir. 1996)), 2) whether the Declaration presents a comparison to the closest art, 3) whether the Declaration is commensurate in scope with the scope of the claims (In re Kulling, 14 USPQ2d 1056, 1058 (Fed. Cir. 1990)), 4) whether the Declaration shows a difference in kind rather than merely a difference in degree (In re Waymouth, 182 USPQ 290, 293 (C.C.P.A. 1974)), and 5) whether the prima facie case is sufficiently strong that allegedly superior results are insufficient to overcome the case for obviousness (Pfizer Inc. v. Apotex, Inc., 82 USPQ2d 1321, 1339 (Fed. Cir. 2007)).
The relevant criterion here are Nos. 1) whether the Declaration presents a nexus such as a side-by-side or single-variable comparison, 2) whether the Declaration presents a comparison to the closest art, and 5) whether the prima facie case is sufficiently strong that allegedly superior results are insufficient to overcome the case for obviousness.
The examiner has carefully reviewed the Declaration, including the data presented in the Declaration. The data show that A valve and V valve result in slightly more FF remain at 6 months and the average leak rate in mg/tear is lower than B valve.
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.
The data and the Declaration are also insufficient to overcome the rejections because, as stated above, one of ordinary skill in the art would have expected superior results from the claimed arrangements because the references teach the said benefits and advantages including stability, leakage prevention and performance. That is, the claims would have been obvious because a person of ordinary skill has good reasons to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense.
Additionally, even if the claimed combination of features provides better results in stability, leakage prevention or performance, the prior art motivates one of ordinary skill in the art to make the same combination which would have provided the same results to one of ordinary skill in the art. In this regard the courts have held that “The fact that applicant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
Furthermore, it has been held that “In determining obviousness, neither the particular motivation to make the claimed invention nor the problem the inventor is solving controls. The proper analysis is whether the claimed invention would have been obvious to one of ordinary skill in the art after consideration of all the facts.” See MPEP § 2141. As shown by the rejections, each component or feature of the claimed invention has been clearly disclosed by the prior art and reasons for substitution or modifications are provided. For example, one of ordinary skill in the art is given a clear reason to select HFA 152a as the propellant and it is known in the art that HFA 152 is beneficial in leak prevention with a valve system and gaskets comprising elastomeric material and that COC is better than EPDM. The coating material for the internal coating of the can is taught, and the suitable and compatible material for valve gaskets are also disclosed.
Thus, regarding criterion No. 1) whether the Declaration presents a nexus such as a side-by-side or single-variable comparison, the answer is no. Applicants have selectively compared two valve systems as claimed to one other valve system, V valve. However, the prior art provides teachings on other valve systems that are said to be effective against leakage and perform well. For Example, Jacuk et al provide a teaching where all three gaskets may be made of COC,
regarding criterion No. 2) whether the Declaration presents a comparison to the closest art, the answer is no. As stated above the prior art teaches valve and gaskets that are taught as effective and have not been tested,
and regarding criterion No. 5) whether the prima facie case is sufficiently strong that allegedly superior results are insufficient to overcome the case for obviousness, the answer is no. 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 and Corr et al teach incorporating HFA 152 and disclose its advantages. Kulkarni et al also 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 the two valve systems as claimed with a reasonable expectation of success.
The provisional Obviousness type double patenting rejection of instant claims over claims of the co-pending Application No. 17/801,067 is withdrawn since Applicants have submitted a Terminal Disclaimer in the said Application over this Application.
Claims 1-5, 13-18, 26-29, 33-34 and 37-45 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Mina Haghighatian whose telephone number is (571)272-0615. The examiner can normally be reached M-F, 7-5 EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sue X. Liu can be reached at 571-272-5539. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Mina Haghighatian/
Mina Haghighatian
Primary Examiner
Art Unit 1616