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 .
Priority
The instant application, filed 12/17/2021, is a National Stage entry of PCT/IB2020/051791, filed 03/03/2020, which claims domestic benefit to U.S. provisional
application 62/873,397, filed 07/12/2019.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 10/14/2025 has been entered.
Status of Application and Claims
The amendment filed 10/14/2025 is acknowledged. Claim 1 is amended. Claims 2, 3, 5, 9-11, 21-33, and 35 are cancelled. Claims 1, 4, 6-8, 12-20 and 34, 36, and 37 are currently pending and are examined on the merits herein.
Withdrawn Rejections and Objections
In the final office action dated 07/17/2025:
Objection to Claim 35 is withdrawn.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.-The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AlA), second paragraph: The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 34 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 34 recites “pressurized canister of any of preceding claims” which refers back to claims that are drawn to method (e.g., claims 19 and 20) which lacks antecedent basis for product of “pressurized canister”. Thus, the metes and bounds of the claim is not clear. Claim 34 also recites “the propellant comprises a hydrofluorocarbon propellant.” There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or non-obviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 4, 6-8, 12-14, 34, and 36-37 are rejected under 35 U.S.C. 103 as being unpatentable over US 2017/0119744 A1 (Malhotra, G.; Raut, P.) 4 MAY 2017 (IDS 01/05/2023).
US’744 teaches pharmaceutical compositions for inhalation comprising one or more bronchodilators (abstract). Said one or more bronchodilators comprises anticholinergic agents preferably umeclidinium or daroptropium and β-agonists ([0037]). US’744 teaches that the use of long-acting β2-agonists reduces the frequency of drug administration ([0010]). US'744 teaches currently-known long acting β-agonists (LABAs) include abediterol and vilanterol ([0011]). US'744 teaches the combination of umeclidinium and vilanterol exhibits significant bronchodilation effects ([0016]). US’744 teaches a method of treating a respiratory disease or disorder that comprises administering the pharmaceutical compositions to a patient in need thereof (claim 26). US'744 teaches that the pharmaceutical compositions can be in a form suitable for administration by a metered dose inhaler (MDI), for example, in the form of an aerosol composition; such compositions may comprise pharmaceutically acceptable propellants (such as HFC or HFA) and co-solvents for use in pressurized MDls ([0073]). US’744 teaches propellant may comprise HFC-152a ([0074]. US’744 teaches co-solvents function to increase the solubility of the medicament and the excipients in the formulation ([0075]). Examples of co-solvents can be aliphatic alcohols such as ethanol ([0076]) which reads on trace amount of alcohol recited in instant claim 13. US'744 teaches that surfactants can also be employed in the aerosol composition to stabilize the solution formulation and improve the performance of valve systems of the MDI; suitable surfactants include polyvinylpyrrolidone (PVP) ([0077]). US’744 teaches that the aerosol composition for administration using an MDI may be packed in any cans suitable for MDI delivery ([0096] sentence 1). US’744 exemplifies a pharmaceutical composition that includes the following ingredients and their respective amounts (Example 3, [0115]):
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Note that the PVP in the formulation of Example 3 has a K value of 25. Also note that, besides the active pharmaceuticals, propellant, and PVP, the only other component present in the composition is a low concentration of the co-solvent PEG. US’744 exemplifies the method of formulating this pharmaceutical composition and incorporating it into a pre-crimped aluminum can (Example 3, [0116]). Because the composition is in aerosol form, and pre-crimped in an aluminum can, this exemplified formulation reads on the pressurized canister comprising the formulation which comprises umeclidinium bromide, propellants (HFA-134A or HFA-227), and PVP with the corresponding K value as recited in claims 1 and 4. US'744 also exemplifies multiple comparable pharmaceutical composition formulations without co-solvent (Example 1) and with an alternative co-solvent (ethanol) at low concentrations (Examples 5-7).
It would have been prima facie obvious before the effective filing date of the claimed invention for a person having ordinary skill in the art to use umeclidinium and vilanterol together in the exemplified formulations because US’744 teaches that the combination of aforementioned drugs exhibits significant bronchodilation effects ([0016]).
US’744 teaches that the pharmaceutical composition formulated for use in an MDI comprises a propellant (Claim 17). As is shown in Example 3 above, US'744 exemplifies the use of HFA134A or HFA227 in its formulation (see Example 3 table above) which satisfies the limitations of the hydrofluorocarbon propellant recited in instant claim 34.
US’744 differs from the claimed invention in that it does not exemplify the pharmaceutical composition in a pressurized canister that is coated with either a poly(fluoroalkylene) polymer or a copolymer of polyfluoroalkylenes, more particularly where the copolymer of poly(fluoroalkylenes) is a copolymer of a C2-C4 fluoroalkylene and a C3-C6 fluoroalkylene, or a copolymer of hexafluoropropylene and tetrafluoroethylene, as is recited in instant claims 1, 6-8 and 36. US'744 also doesn’t exemplify an inhaler comprising said pressurized canister, as is recited by claim 14. US’744 does not teach the PVP in the pharmaceutical composition is present at about 0.005%-0.05% by weight of the formulation, more narrowly 0.0075% to 0.02% PVP by weight of the formulation, as is recited in claims 1 and 37 respectively. US'744 also does not exemplify the presence of a trace amount of any other component (particularly water and/or alcohol) in the formulation, other than the active pharmaceutical ingredients, propellants, and PVP, as recited in claims 12 and 13.
US’744 does, however, teach some aerosol drugs tend to adhere to the inner surfaces, i.e. the walls of the cans and valves of the MDI, which can lead to the patient getting less than the prescribed amount of the active agent when using the MDI ([0096] sentences 2-3). US'744 teaches that this adhesion problem can be remedied by coating the inner surface of the container with a suitable coating such as fluorocarbon copolymers e.g. fluorinated ethylene propylene and polyethersulphone (FEP-PES); this coating technique is known in the art ([0096] sentences 4-5). According to the instant specification, FEP is a copolymer of hexafluoropropylene and tetrafluoroethylene (page 5, paragraph 2, final sentence). Because FEP is a copolymer of hexafluoropropylene and tetrafluoroethylene, it also reads on a copolymer of “a C2-C4 fluoroalkylene” (i.e. tetrafluoroethylene) and “a C3-C6 fluoroalkylene” (i.e. hexafluoropropylene) as recited in instant claims 7 and 36.
It would have been prima facie obvious before the effective filing date of the claimed invention for a person having ordinary skill in the art to incorporate an aerosol form of US'744’s pharmaceutical composition into a suitable can coated with fluorocarbon copolymers such as FEP-PES, and then to use said can in an MDI, because US’744 (1) teaches its composition is applicable for administration via MDI, and (2) teaches remediation of the issues surrounding adherence of the pharmaceutical composition to walls of cans and valves of the MDI by coating the can’s inner surface with fluorocarbon copolymers comprising FEP. One of ordinary skill in the art would have a reasonable expectation of success because US’744 teaches the suitability of its pharmaceutical composition for use in an MDI. US'744 also teaches that the use of fluorocarbon copolymer-coated cans is well-known in MDI art.
Regarding the amount range of PVP recited in claims 1 and 37, it would have been prima facie obvious to perform routine optimization on the concentration of the surfactant PVP present in the pharmaceutical composition taught by US’744 with the goal of improving the stability of the solution formulation and improving the function of valve systems in any MDI used to administer said pharmaceutical formulation. US’744 teaches that surfactants can be employed in the aerosol composition to stabilize the solution formulation and improve the performance of valve systems of the MDI; suitable surfactants include polyvinylpyrrolidone. US’744 establishes a baseline concentration upon which an ordinarily skilled artisan can perform routine optimization with reasonable expectation of success. Furthermore, regarding the instantly claimed amounts, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close (MPEP 2144.05 (1)). See Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985). In this case, the claimed PVP concentration range of 0.005%-0.05% by weight of the formulation, more narrowly 0.0075% to 0.02% PVP by weight of the formulation, is so close to US’744’s PVP concentration of 0.001% of the pharmaceutical composition that one skilled in the art would expect no change in properties in the overall formulation.
Regarding the trace amount of any other components, particularly alcohol, recited in claims 12 and 13, it would be prima facie obvious for a person having ordinary skill in the art to perform routine optimization with the co-solvents taught by US’744 to determine whether or not a co-solvent is necessary in the pharmaceutical composition because US’744 teaches cosolvents may be incorporated and provides examples of co-solvents including PEG and ethanol. In this case, an “obvious to try” line of reasoning is applicable (MPEP 2143 (E)). An ordinarily skilled artisan would note the variety in ingredients present in the pharmaceutical compositions exemplified by US’744, and would particularly note the absence of a co-solvent in one particular embodiment (example 1). The ordinarily skilled artisan would have been motivated to perform routine optimization on the co-solvent used during formulation of US’744 in order to minimize the use of ingredients that aren't strictly necessary for administration of the active pharmaceuticals via MDI. Since US’744 teaches the purpose of the co-solvent is only to improve solubility of other excipients in the formulation, and also suggests a finite number of alternative co-solvents including ethanol, the ordinarily skilled artisan would have a reasonable expectation of success in optimizing the use of a co-solvent (or lack thereof) in the formulation because US'744 teaches (1) the exchange of PEG with ethanol as an alternative co-solvent, and (2) the lack of necessity of a co-solvent in the pharmaceutical composition.
Claims 1-4, 6-8, 12-14, 15-20, and 34-37 are rejected under 35 U.S.C. 103 as being unpatentable over US 2017/0119744 A1 (Malhotra, G.; Raut, P.) 4 MAY 2017 (IDS 01/05/2023) as applied to claims 1-4, 6-8, 12-14 and 34-37 above, and further in view of US 2017/0152396 A1 (Jinks. P. A.; Audenaert, F. A.) 1 JUNE 2017 (IDS 01/05/2023).
The teachings of US'744 are as stated above.
US’744 fails to teach individual components present in the MDI, and fails to teach that the metering valve in the MDI is coated with a co-polymer of poly(fluoroalkylenes), as is recited in claims 15-17. US’744 also fails to teach steps of administering its pharmaceutical composition for inhalation via actuating an MDI, as is recited by claims 18-20.
US’396 teaches that, in medicinal inhalation devices such as pressurized inhalers, potentially undesirable interactions between a component of the device and the medicinal formulation may include enhanced medicament degradation or permeation of a formulation constituent or extraction of chemicals from materials ([0004]-[0005]). As a solution to this problem, US’396 teaches two methods of making a component for medicinal delivery device (claims 1 and 6). US’396 teaches these methods provide components which, when assembled and in use, significantly reduce dose-to-dose and unit-to-unit variability of medicinal delivery devices ([0015]).
US’396 teaches one of these methods includes washing of the surface of the component of the medicinal delivery device with a solvent prior to applying a coating that comprises an at least partially fluorinated compound (Claim 6). US’396 teaches the component to be coated is a component of a pressurized MDI selected from an actuator, aerosol container, valve body, valve stem, and compression spring ([0064]; Claims 9 and 10). Figure 1 of US’396 depicts the components of the metered dose inhaler 100 including an aerosol container 1 fitted with a metered dose valve 10 in communication with an actuator 5 (Fig. 1; [0212] and [0213]). US’396 teaches that, in order to actuate the valve, the valve stem 14 is pressed inward and the formulation from the aerosol container passes through the metering chamber to the actuator nozzle, and then out to the patient (Figs 1a and 1b; [0215]). US’396 exemplifies the success of the coating methods by demonstrating low dose to dose variability of medicament administered via pressurized MDI containing coated components (Example 3; Results Table 3; [0267]).
It would have been prima facie obvious for a person having ordinary skill in the art to combine the method of coating components of pressurized metered dose inhalers taught by US’396 with the pharmaceutical formulation and coating of an MDI canister taught by US’744 to arrive at the instantly claimed invention. An ordinarily skilled artisan would have been motivated to use the coating method of US’396 to coat the interior canister and metered valve of a pressurized MDI with any of the coatings discussed in either US’396 or US’744 (which includes FEP-PES, as taught by US'744) because US’744 teaches that the interior canister and valves are locations where pharmaceutical active agents adhere, causing the patient to receive less medicament upon actuation of the inhaler, and US’396 teaches methods of coating components of the MDI (including valve components) to combat this problem and provide a decrease in variability in units and their doses. An ordinarily skilled artisan would have a reasonable expectation of success because US’396 teaches this coating method is successful for components of pressurized metered dose inhalers, and US’744’s pharmaceutical composition is taught for use in metered dose inhalers.
It would have then been prima facie obvious for an ordinarily skilled artisan to utilize the teachings of US’396 to actuate the pressurized MDI containing the pharmaceutical composition of US'744 and release the formulation from the canister into a patient via inhalation, because US’396 teaches this method for actuating the inhaler and releasing the formulation for the patient to inhale, and US’744 teaches its formulation to be administered via inhalation from MDI. There is a reasonable expectation of success based on the fact that the MDI of US’396 successfully releases medicament from its aerosol units with low dose-to-dose variability.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 4, 6-8, 12-20, 34, and 36-37 are provisionally rejected on the ground of non-statutory double patenting as being unpatentable over claims 1, 9-11, and 13-18 of co-pending Application No. 17/624,433 in view of US 2017/0119744 A1 (Malhotra, G.; Raut, P.) 4 MAY 2017 (IDS 01/05/2023).
App ‘433 claims a pressurized canister comprising a formulation which comprises: an active pharmaceutical ingredient comprising umeclidinium or a salt thereof, vilanterol or a salt thereof, or a combination of two or more of the foregoing; one or more propellants, wherein propellant comprises HFC-227, HFC-152a, HFC-134a, or any combination; and poly(ethylene glycol), wherein the interior of the pressurized canister is coated with copolymer of a C2-C4 fluoroalkylene and a C3-C6 fluoroalkylene (claim 1). App’433 claims the copolymer of poly(fluoroalkylenes) is a copolymer of hexafluoropropylene and tetrafluoroethylene (Claim 9). App’433 further claims the formulation contains no more than a trace amount of any component other than the active pharmaceutical ingredient(s), propellant(s), and PEG; additionally, the container comprises a trace amount of water, alcohol, or water and alcohol (Claims 10-11). App’433 claims an inhaler comprising the pressurized canister of its claim 1, further comprising a valve and actuator in communication with the valve, furthermore wherein the valve is a metering valve (Claims 13-15). App’433 claims at least portion of the metering valve is coated with the poly(fluoroalkylene) polymer or copolymer of poly(fluoroalkylenes) (Claim 16). App’433 claims a method of actuating the inhaler for a sufficient time to release at least a portion of the formulation from the inhaler, and a method for administering a formulation via the inhaler actuation and inhaling at least a portion of the formulation released (Claims 17-18).
App’433 differs from the instantly claimed invention in that its formulation does not comprise PVP as recited in claim 1. Therefore, App'433 doesn’t claim PVP with a K-value in the range of 10-95 as recited in instant claim 4, and a concentration of about 0.005% to about 0.05% and 0.0075% to about 0.02% by weight of the formulation as recited in instant claims 1 and 37 respectively. App’433 also fails to claim the trace amount of any other components in the formulation, particularly alcohol, besides the pharmaceutical active ingredient(s), propellant(s), and PVP as recited in instant claims 12-13.
The teachings of US'744 are as disclosed above. US’744 also teaches its formulation contains suitable propellants which, when mixed with solvents, form a homogeneous propellant system in which a therapeutically effective amount of the medicament can be dissolved, in order to form an aerosol composition which is suitable for administration via MDI ([0072]-[0073]).
It would have been prima facie obvious for an ordinarily skilled artisan to add US'744’s PVP with a K value of 25 to the formulation of App’433 because the formulation is used in an inhaler, and US’744 teaches a similar pharmaceutical composition for use in an inhaler that includes PVP with a K value of 25. US'744 also teaches the benefit of using surfactant and propellant in aerosol formulations for use in MDIs. An ordinarily skilled artisan would have been motivated to add the taught PVP to the formulation taught by App’433 based on US’744’s teaching that PVP is a surfactant used in aerosol compositions to stabilize the solution formulation and improve the performance of valve systems of MDIs. An ordinarily skilled artisan would have a reasonable expectation of success because the formulation of US'744 is similar to App’433, with the only discernable difference being the added PVP, and this formulation is successful as a bronchodilator for inhalation via inhaler.
Regarding the concentration range of PVP recited in instant claims 1 and 37, it would have been prima facie obvious to perform routine optimization on the concentration of the surfactant PVP added to the pharmaceutical composition of App’433 with the goal of improving the stability of the solution formulation and improving the function of valve systems in any MDI used to administer said pharmaceutical formulation. US'744 teaches that surfactants can be employed in the aerosol composition to stabilize the solution formulation and improve the performance of valve systems of the MDI; suitable surfactants include polyvinylpyrrolidone. In the similar formulation taught by US’744, a baseline concentration of PVP is established, upon which an ordinarily skilled artisan would obviously perform routine optimization when adding a concentration of PVP to the formulation claimed by App’433, with reasonable expectation of success due to the similar makeup and application of the formulations of App’433 and US'744.
Regarding the trace amount of any other components, particularly alcohol, recited in instant claims 12 and 13, it would have been prima facie obvious for a person having ordinary skill in the art to perform routine optimization on the PEG present in App’433’s claimed invention (upon addition of PVP) to determine whether or not a co-solvent is necessary in the pharmaceutical composition of App’433 because US’'744 teaches similar pharmaceutical compositions where co-solvents may be incorporated. In this case, an “obvious to try” line of reasoning is applicable (MPEP 2143 (E)). An ordinarily skilled artisan would note the variety in ingredients present in the similar pharmaceutical compositions exemplified by US'744, and would particularly note the absence of a co-solvent in one particular embodiment (example 1). The ordinarily skilled artisan would have been motivated to perform routine optimization on App’433’s claimed formulation’s co-solvent in order to minimize the use of ingredients that aren't strictly necessary for administration of the active pharmaceuticals via MDI. Since US'744 teaches the purpose of co-solvent is only to improve solubility of other excipients in the formulation, and also suggests a finite number of alternative co-solvents including ethanol, the ordinarily skilled artisan would have a reasonable expectation of success in optimizing the use of a co-solvent (or lack thereof) in the formulation because US’744 teaches (1) the exchange of PEG with ethanol as an alternative co-solvent, and (2) the lack of necessity of a co-solvent in its pharmaceutical composition.
This is a provisional non-statutory double patenting rejection.
Claims 1, 4, 6-8, 12-20, 34, and 36-37 are provisionally rejected on the ground of non-statutory double patenting as being unpatentable over claims 1, 19, 20 and 22 of co-pending Application No. 17/059,617 in view of WO 2012/110770 A2 (Malhotra, G.; Purandare, S. M.) 23 AUGUST 2012 (IDS 09/06/2023) and US 2017/0152396 Al (Jinks. P. A.; Audenaert. F. A.) 1 JUNE 2017 (IDS 01/05/2023).
App’617 claims an aerosol canister comprising a composition that comprises particulate vilanterol or a pharmaceutically acceptable salt thereof; and a propellant consisting of HFA-152a; wherein the canister comprises at least one surface having a primer composition applied to at least a portion of the surface, the primer composition comprising a silane having two or more reactive silane groups separated by an organic linker group disposed thereon, and a coating composition comprising an at least partially fluorinated compound disposed on the primer coating (Claims 19 and 20). App’617 claims the aerosol canister wherein the at least one surface is a portion of a valve surface (claim 22). It is noted that there are no other components claimed in the composition besides the pharmaceutically active ingredients and propellant. Therefore, there are no more than trace amounts of any other components besides these in the claimed composition. It is also noted that HFC-152a is hydrofluorocarbon propellant as recited in instant claim 34.
App’ 617 differs from the instantly claimed invention in that its composition does not comprise PVP as recited in instant claim 1; furthermore, this PVP doesn’t have a K-value in the range of 10-95, and isn’t present in the formulation at a concentration of about 0.005% to about 0.05% or 0.0075% to 0.02% by weight of the formulation as recited in instant claims 1, 4 and 37. App’617 doesn’t claim a coating on the interior of the aerosol canister that comprises a copolymer of poly(fluoroalkylenes) as recited in instant claims 6-8. App'617 doesn’t claim the presence of a trace amount of alcohol in the formulation as recited in claim 13. App’617 doesn’t claim incorporation of the aerosol canister of claims 19 and 20 into an inhaler, nor does it claim components of the inhaler that are present, as well as coating a metering valve in the inhaler with a co-polymer of poly(fluoroalkylenes), as is recited in claims 14-17. Finally, App'617 doesn’t claim steps of administering its pharmaceutical composition for inhalation via actuating the actuator of the inhaler and inhaling, as is recited by claims 18-20.
WO’770 teaches pharmaceutical compositions for inhalation comprising glycopyrrolate and vilanterol (Claim 1). WO’770 teaches these compositions to be successful at treating diseases of the respiratory tract, and they facilitate the treatment of an obstructive and inflammatory airway disease with a single medicament as opposed to multiple inhalers (Page 10). WO’770 teaches an embodiment where said pharmaceutical compositions are in a form suitable for administration by MDI, particularly aerosol form (Page 15 bottom paragraph). Such aerosol compositions may comprise acceptable excipients, in particular HCA or HFA propellants and co-solvents, such as C2-C6 aliphatic alcohols or PEG (Page 16 paragraphs 2, 3 and 6). WO’770 teaches the inclusion of surfactants, in particular PVP, for the purpose of stabilizing the solution formulation and improving the performance of valve systems of the metered dose inhaler (Page 17 paragraph 2). WO’770 teaches that the aerosol composition for administration using an MDI may be packed in any cans suitable for MDI delivery (Page 21 paragraph 1).
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WO'770 exemplifies this pharmaceutical composition that includes the following ingredients and their respective amounts (Example 25, Page 39):
Note that the PVP in the formulation of Example 25 has a K value of 25. Also note that, besides the active pharmaceuticals, propellant, and PVP, the only other component present in the composition is a low concentration of the co-solvent PEG. WO’770 exemplifies the method of formulating this pharmaceutical composition and incorporating it into a pre-crimped aluminum can (Example 25, Page 39). WO’770 also exemplifies comparable pharmaceutical composition formulations without co-solvent (Example 23) and with the co-solvent ethanol instead of PEG at low concentrations (Examples 26-29).
WO'770 teaches some aerosol drugs tend to adhere to the inner surfaces, i.e. the walls of the cans and valves of the MDI, which can lead to the patient getting less than the prescribed amount of the active agent when using the MDI; this adhesion problem can be remedied by coating the inner surface of the container with a coating technique known in the art utilizing known coatings such as the fluorocarbon copolymers containing fluorinated ethylene propylene (FEP) (Page 21 first paragraph).
The teachings of US’396 are as disclosed above.
It would have been prima facie obvious for an ordinarily skilled artisan to add PVP with a K value of 25 to the formulation of App’617 and incorporate the aerosol canister containing the resulting formulation into an MDI with all of the relevant components as taught by US’396 because WO'770 teaches a similar pharmaceutical composition for use in an MDI that includes the surfactant PVP. WO’770 also teaches the benefit of using surfactant in aerosol formulations for use in MDlIs. An ordinarily skilled artisan would have been motivated to add PVP to the formulation taught by App’617 based on WO’770’s teaching that PVP is a surfactant used to stabilize formulations and aid in valve functioning of an MDI comprising the formulation. An ordinarily skilled artisan would have a reasonable expectation of success adding PVP to the formulation in the aerosol canister of App’617 for use in an inhaler because the formulation in Example 25 of WO’770 is similar to the composition of App’617 in regards to the common use of fluticasone, vilanterol and an HFA propellant, and the formulation is taught to be a medicament for treatment of respiratory diseases via inhaler.
Regarding the concentration range of PVP recited in instant claims 1 and 37, it would have been prima facie obvious to perform routine optimization on the concentration of the surfactant PVP added to the pharmaceutical composition of App’617 with the goal of improving the stability of the solution formulation and improving the function of valve systems in any MDI used to administer said pharmaceutical formulation. In the similar formulation taught by WO’770 (example 25), a baseline concentration of PVP is established, upon which an ordinarily skilled artisan would obviously perform routine optimization when adding a concentration of PVP to the formulation claimed by App’617, with reasonable expectation of success due to the similar makeup and application of the formulations of App’617 and WO'770.
Regarding the coating on the interior of the aerosol canister and metered valve comprising a copolymer of poly(fluoroalkylenes) as defined in instant claims 6-8,17 and 36, it would have been prima facie obvious for a person having ordinary skill in the art to coat the canister interior and valve surface claimed by App'617 with the FEP taught by WO’770, using the method taught by US’396, to arrive at the instantly claimed invention. An ordinarily skilled artisan would have been motivated to do so because WO’770 teaches that coating the interior canister and valves of an inhaler with a copolymer comprising FEP can remediate issues regarding adherence of pharmaceutical active agents resulting in the patient receiving less medicament upon actuation of the inhaler, and US’396 teaches its methods of coating components (including valve components) also combat this problem and provide a decrease in variability in unit doses. An ordinarily skilled artisan would have a reasonable expectation of success because both WO’770 and US’396 teach these coating methods are successful for use on components of pressurized metered dose inhalers, therefore they would be successful in the inhaler claimed by App’617.
Regarding the trace amount of alcohol recited in claim 13, it would have been prima facie obvious for a person having ordinary skill in the art to perform routine optimization on the composition of App’617 with the co-solvents taught by WO’770 to determine whether or not a co-solvent is necessary in composition of App’617 because WO’770 teaches similar compositions where co-solvents such as ethanol may be incorporated. In this case, an “obvious to try” line of reasoning is applicable (MPEP 2143 (E)). The ordinarily skilled artisan would have been motivated to perform routine optimization by experimenting with the addition of co-solvent to the composition of App’617 in the case that a co-solvent would help aid dissolution of the other excipients in the composition. Since WO’770 teaches the purpose of the co-solvent is to improve solubility of other excipients in the formulation, and also suggests a finite number of suitable co-solvents including ethanol, the ordinarily skilled artisan would have a reasonable expectation of success in optimizing the use of a co-solvent (or lack thereof) in the formulation because WO’770 teaches many examples of formulations for use in inhalers with similar excipients to that of App’617 which contain the co-solvent ethanol.
It would have then been prima facie obvious for an ordinarily skilled artisan to utilize the teachings of US’396 to actuate an inhaler incorporating the aerosol canister of App'617 (containing its PVP-modified composition and inner surface coatings) and release the formulation from the canister into a patient via inhalation, because US’396 teaches this method for actuating the inhaler and releasing the formulation for the patient to inhale and WO’770 teaches its comparable PVP-containing formulation is administered via inhalation from MDI. There is a reasonable expectation of success based on the fact that the MDI of US’396 successfully releases medicament from its aerosol units with low dose-to-dose variability thanks to its coatings, and the inhaler containing the canister of App’617 would obviously have the same suitable coatings.
This is a provisional non-statutory double patenting rejection.
Response to Arguments
Malhotra
Applicant’s arguments filed on 10/14/2025 regarding the obviousness rejection of claim 1 over Malhotra, have been fully considered but they are not persuasive.
Applicant asserts that claim 1 is amended to include features of claims 3 and 35 and further claim 1 is amended to recite, "formulation comprising...umeclidinium or a pharmaceutically acceptable salt thereof and vilanterol or a pharmaceutically acceptable salt thereof; HFC-152a..."
The rejection of claim 1 is maintained over Malhotra.
Applicant asserts that examiner plucks the claimed features from Malhotra without considering Malhotra as whole. Applicant further asserts that Malhotra does not provide objective teaching for selecting the features of the pressurized canister and formulation of the independent claim.
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
In this case, Malhotra clearly points out use of combination of umeclidinium and vilanterol in the cited references WO2013153146 and WO2011067212 (para. [0021] and [0022]). Malhotra also clearly points out that combination of umeclidinium and vilanterol exhibit significant bronchodilation effect (Malhotra, para. [0045]). Thus, use of combination of umeclidinium and vilanterol in the pharmaceutical composition is known in the art for treating/preventing respiratory, inflammatory or obstructive airway disease (para. [0045]). A skilled artisan would have been motivated to use the combination of umeclidinium and vilanterol known in the art and formulate according to teachings of Malhotra.
In contrary to applicant’s assertion, Malhotra provides guidance of formulating pharmaceutical drugs or combination drugs for inhalation by selecting propellant from the finite choices of routinely used propellants including HFC-152a ([0074]), using suitable surfactant from choice of finite surfactants ([0077] commonly used in pharmaceutical formulations and known in the art as and also teaches using PVP in its exemplary formulation ([0115], example 3). Malhotra also teaches administering pharmaceutical composition in form of aerosol in a pressurized container. Malhotra discloses the known problem in the art of adherence of pharmaceutical drugs to the inner surfaces of cans and suggests using suitable coatings from finite choice of fluorocarbon co-polymers known in the art to prevent adherence of pharmaceutical drugs (0096]).
Malhotra in view of Jinks
Applicant’s arguments filed on 10/14/2025 regarding the obviousness rejection of claims 15-20 over Malhotra in view of Jinks, have been fully considered but they are not persuasive for the above reasons.
Rejection of claims 15-20 is maintained over Malhotra in view of Jinks.
Conclusion
No claims are allowed.
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/VIJAY D PATEL/ Examiner, Art Unit 1616
/SUE X LIU/ Supervisory Patent Examiner, Art Unit 1616