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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 6/16/2026 has been entered.
Status of Action/Claims
Receipt of Remarks/Amendments filed on 6/16/2026 is acknowledged. Claims 28 and 30-42 are currently pending and presented for examination on the merits for patentability.
Rejection(s) not reiterated from the previous Office Action are hereby withdrawn. The following rejections are either reiterated or newly applied. They constitute the complete set of rejections presently being applied to the instant application.
Withdrawn Rejections/Objections
Applicant’s argument regarding the 103 rejections have been fully considered and are persuasive. The 103 rejections have been withdrawn because the prior art does not teach or render obvious the composition contains dissolved oxygen and water in the amounts recited in the instant claims.
New/Maintained Claim Rejection(s)
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 28, 30-42 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 25-57 of copending Application No. 16/582,710 (USPGPUB No. 20200016174) in view of Malhotra et al. (US 2015/0250713 A1; Sep. 10, 2015).
The ‘710 application recites a pharmaceutical composition comprising beclomethasone dipropionate and formoterol fumarate dehydrate as the drug component and 1,1- difluoroethane as the propellant component. The chemically stable pharmaceutical composition is within a sealed and pressurized container that is operatively coupled with a metered dose inhaler. The drug component comprises from 0.01 to 2.5 weight%. The composition is in the form of suspension. ‘710 recites the composition contains less 500 ppm of water and also oxygen in the amount instantly claimed. ‘710 recite the drug component additionally comprises long-acting muscarinic antagonists including tiotropium and glycopyrronium bromide which the salt of glycopyrrolate. ‘710 recite that at least 90, 95 and 99 weight % of the propellant component is 1,1-difluoroethane which read on instant claims. ‘710 recites propellant component contains from 0.5 to 10 ppm of unsaturated impurities. ‘710 recites the composition is free of surfactants and perforated microstructures which read on instant claims. ‘710 recite the weight of total impurities which read on instant claims. ‘710 recite the composition in the form of suspension. ‘710 recites the composition is free of acid stabilizers.
Regarding claim 40, ‘710 application teaches the 1,1-difluoroethan (R-152a) propellant added to the composition and therefore it would necessarily be stabilized compared to HFA-134a or HFA-227ea.
The ‘710 application does not teach the composition further comprises a surfactant. However, this deficiency is cured by Malhotra.
Malhotra also teach metered dose inhaler formulations for treating respiratory diseases wherein the formulations comprise the active drug and propellant component, including HFA-152a. (Abstract; Summary of Invention; Para 0051). Malhotra teaches that one or more surfactants may be employed to stabilize the composition and to also provide lubrication to the valve system of the metered dose inhaler (Para 0059).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the teachings of Malhotra and further comprise a surfactant in the formulation of ‘710. One would have been motivated to do so because Malhotra also teach metered dose inhaler formulations for treating respiratory diseases wherein the formulations comprise the active drug and propellant component, including HFA-152a and Malhotra provides the motivation that one or more surfactants may be employed to stabilize the composition and to also provide lubrication to the valve system of the metered dose inhaler.
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.
Even though the claims in the instant invention are directed towards a method and ‘710 application is directed towards a composition, the instant claims still read on ‘710 application claims because the instant claims recite the same composition.
This is a provisional nonstatutory double patenting rejection.
Claims 28, 30-42 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4, 7-9, 13-16, 20, 22-23, 26 and 39-40 of copending Application No. 16/334,156 (USPGPUB No. 20190388436) in view of Malhotra et al. (US 2015/0250713 A1; Sep. 10, 2015).
The ‘156 application in claim 1 recites a pharmaceutical composition comprising glycerol, beclomethasone dipropionate and formoterol fumarate dihydrate as the drug component and 1,1- difluoroethane as the propellant component. ‘156 recite amounts of water and oxygen which read on instant claims. Claims 7-9 of ‘156 recite the drug component additionally comprises long acting muscarinic antagonists including tiotropium and salt of glycopyrrolate. Claims 13 and 14 of ‘156 recite weight % of the propellant component that reads on instant claims. Claim 15 of ‘156 recites propellant component contains 0.5 to 10 ppm of unsaturated impurities which reads on instant claims. Claims 20 and 26 of ‘156 recite the composition is free of surfactants, perforated microstructures and acid stabilizers which read on instant claims. Claims 22 and 23 recite the weight of total impurities which read on instant claims. Claims 24 and 25 of ‘156 recite the composition in the form of suspension and solution which reads on instant claims.
Regarding claim 20 and 40, ‘156 application teaches the 1,1-difluoroethane (R-152a) propellant added to the composition and therefore it would necessarily be stabilized compared to HFA-134a or HFA-227ea.
The ‘156 application does not teach the composition further comprises a surfactant. However, this deficiency is cured by Malhotra.
Malhotra also teach metered dose inhaler formulations for treating respiratory diseases wherein the formulations comprise the active drug and propellant component, including HFA-152a. (Abstract; Summary of Invention; Para 0051). Malhotra teaches that one or more surfactants may be employed to stabilize the composition and to also provide lubrication to the valve system of the metered dose inhaler (Para 0059).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the teachings of Malhotra and further comprise a surfactant in the formulation of ‘156. One would have been motivated to do so because Malhotra also teach metered dose inhaler formulations for treating respiratory diseases wherein the formulations comprise the active drug and propellant component, including HFA-152a and Malhotra provides the motivation that one or more surfactants may be employed to stabilize the composition and to also provide lubrication to the valve system of the metered dose inhaler.
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.
Even though the claims in the instant invention are directed towards a method and ‘156 application is directed towards a composition, the instant claims still read on ‘156 application claims because the instant claims recite the same composition.
This is a provisional nonstatutory double patenting rejection.
Claims 28, 30-42 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4-18, 20, 22-30 of copending Application No. 17/460,585 (USPGPUB No. 20210386717) in view of Gaetano (WO 2007/121913 A2; Nov. 1, 2007).
The ‘585 application claims a pharmaceutical composition comprising a propellant component at least 90 weight % of which is 1,1-difluoroethane, a drug component comprising tiotropium bromide and the composition is free of acid stabilizers. The composition is in the form of suspension. The composition is within a sealed and pressurized container that is operatively coupled with a metered dose inhaler (claim 1, 13, 22, 24, 25, 26). ‘585 claims the composition further comprises formoterol fumarate dihydrate or beclomethasone dipropionate along with tiotropium (claims 6-9). ‘585 claims the composition comprising water and oxygen in the amount recited in instant claims. ‘585 claims the weight percent of the propellant component (claim 10, 11, 24) in the amount that reads on instant claims. ‘585 recites propellant contains 0.5 to 10 ppm of unsaturated impurities (claims 12 and 14). ‘585 recites the composition is free of perforated microstructures and other components (claim 15). ‘585 also teach the composition in a metered dose inhaler. (claims 1, 13, 22, 24, 25, 26).
While ‘585 teaches the composition comprises formoterol fumarate dihydrate or beclomethasone dipropionate along with tiotropium, ‘585 does not teach wherein the composition comprising glycopyrrolate and specifically glycopyrronium bromide. However, this deficiency is cured by Gaetano.
As discussed supra, Gaetano teaches the composition can comprise anticholinergic atropine-like derivatives which include ipratropium bromide, oxitropium bromide, tiotropium bromide and glycopyrronium bromide (i.e. salt of glycopyrrolate) (see Page 7, line 11-25). Further, the reference teaches that long acting beta agonist such as formoterol and antimuscarinic agents in combination with inhaled corticosteroids have been proposed for the prevention and/or treatment of diseases (see Page 2, line 4-7). Therefore, it would have been obvious to one of ordinary skill in the art to comprise the salt of glycopyrrolate in the formulation because the combination of the different drugs was known to be beneficial in preventing or treating disease. Further, it would have been obvious to one of ordinary skill in the art to try and substitute one antimuscarinic agent already taught by ‘585 application for another as a person with ordinary skill has good reason to pursue known options within his or her technical grasp. see MPEP 2141 KSR International CO. v. Teleflex Inc. 82 USPQ 2d 1385 (Supreme Court 2007).
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.
Even though the claims in the instant invention are directed towards a method and ‘585 application is directed towards a composition, the instant claims still read on ‘585 application claims because the instant claims recite the same composition.
This is a provisional nonstatutory double patenting rejection.
Claims 28, 30-42 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of US11826349B2 in view of Gaetano (WO 2007/121913 A2; Nov. 1, 2007).
The ‘349 patent claims a pharmaceutical composition comprising a propellant component at least 90 weight % of which is 1,1-difluoroethane, a drug component comprising glycopyrrolate, budesonide and formoterol and the composition is free of acid stabilizers (claims 1-9, 11). ‘349 claims the composition comprising water and oxygen (claim 2) in the amount recited in instant claims. ‘349 claims the weight percent of the propellant component (claim 7-8) in the amount that reads on instant claims. ‘349 recites propellant contains 0.5 to 10 ppm of unsaturated impurities (claim 8). ‘349 recites the composition is free of perforated microstructures and other components (claim 11). ‘349 also teaches the composition in a metered dose inhaler and in the form of suspension (claim 1-2, 16).
While ‘349 teaches the composition comprises formoterol fumarate dihydrate, budesonide and glycopyrrolate, ‘349 does not teach wherein the composition comprising beclomethasone and tiotropium. However, this deficiency is cured by Gaetano.
As discussed supra, Gaetano teaches the composition can comprise anticholinergic atropine-like derivatives which include ipratropium bromide, oxitropium bromide, tiotropium bromide and glycopyrronium bromide (i.e. salt of glycopyrrolate) (see Page 7, line 11-25). Further, the reference teaches that long acting beta agonist such as formoterol and antimuscarinic agents in combination with inhaled corticosteroids (e.g., beclomethasone) have been proposed for the prevention and/or treatment of diseases (see Page 2, line 4-7). Therefore, it would have been obvious to one of ordinary skill in the art to comprise beclomethasone and/or tiotropium in the formulation because the combination of the different drugs was known to be beneficial in preventing or treating disease. Further, it would have been obvious to one of ordinary skill in the art to try and substitute one antimuscarinic agent/inhaled corticosteroid for another as a person with ordinary skill has good reason to pursue known options within his or her technical grasp. see MPEP 2141 KSR International CO. v. Teleflex Inc. 82 USPQ 2d 1385 (Supreme Court 2007).
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.
Even though the claims in the instant invention are directed towards a method and ‘349 application is directed towards a composition, the instant claims still read on ‘349 application claims because the instant claims recite the same composition.
Claims 28, 30-42 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of US11826348B2 in view of Gaetano (WO 2007/121913 A2; Nov. 1, 2007) and Noakes (WO 2012/156711 A1; Nov. 22, 2012).
The ‘348 claims a pharmaceutical composition comprising a propellant component at least 90 weight % of which is 1,1-difluoroethane, a drug component comprising glycopyrrolate, beclomethasone and formoterol and the composition is free of acid stabilizers (claim 1, 2, 8). ‘348 claims the composition comprising water and oxygen in the amount (claim 2) recited in instant claims. ‘348 claims the weight percent of the propellant component in the amount (claim 6, 7) that reads on instant claims. ‘348 recites propellant contains 0.5 to 10 ppm of unsaturated impurities (claim 8). ‘348 recites the composition is free of perforated microstructures and other components (claim 11). ‘348 also teach the composition in the form of solution and a metered dose inhaler (claim 1, 2, 8, 16).
The ‘348 does not claim the composition is in the form of suspension as recited in instant claims. However, Noakes cures this deficiency.
As discussed supra, Noakes teaches that incorporation of 1,1-difluoroethane as the propellant allows for a metered dose inhaler with low GWP in comparison with HFA-134a, reduced irritancy and forms stable suspensions or solutions.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified ‘348 to incorporate the teachings of Noakes and make the composition in the form of a suspension. One would have been motivated to do so because Noakes discusses problems related to HFA-134a propellant in solutions and suspensions and as discussed above, Noakes teaches that incorporation of 1,1-difluoroethane as the propellant allows for a metered dose inhaler with low GWP in comparison with HFA-134a, reduced irritancy and forms stable suspensions or solutions. Noakes teachings suggest that it was well known in the art that metered dosed inhalers can be made in the form of solution and suspension and it further provides motivation of achieving stable solution and suspension with the use of 1,1-difluoroethane as the propellant and therefore it would have been obvious to one of ordinary skill in the art to make the formulation in the form of a suspension.
‘348 does not teach wherein the composition comprises tiotropium. However, this deficiency is cured by Gaetano.
As discussed supra, Gaetano teaches the composition can comprise anticholinergic atropine-like derivatives which include ipratropium bromide, oxitropium bromide, tiotropium bromide and glycopyrronium bromide (i.e. salt of glycopyrrolate) (see Page 7, line 11-25). Further, the reference teaches that long acting beta agonist such as formoterol and antimuscarinic agents in combination with inhaled corticosteroids (e.g., beclomethasone) have been proposed for the prevention and/or treatment of diseases (see Page 2, line 4-7). Therefore, it would have been obvious to one of ordinary skill in the art to comprise tiotropium in the formulation because the combination of the different drugs was known to be beneficial in preventing or treating disease. Further, it would have been obvious to one of ordinary skill in the art to try and substitute one antimuscarinic agent for another as a person with ordinary skill has good reason to pursue known options within his or her technical grasp. see MPEP 2141 KSR International CO. v. Teleflex Inc. 82 USPQ 2d 1385 (Supreme Court 2007).
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.
Even though the claims in the instant invention are directed towards a method and ‘348 application is directed towards a composition, the instant claims still read on ‘348 application claims because the instant claims recite the same composition.
Claims 28, 30-42 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims of U.S. Patent No. 11,690,823; 11,179,366; 11,077,076; 11,103,480; 11,260,052; 11,559,507; 11,559,505; 10,792,256; 10,888,546 in view of Gaetano (WO 2007/121913 A2; Nov. 1, 2007).
The obviousness Double Patenting rejection is appropriate because while the conflicting claims are not identical, they are not patentably distinct from the reference claims. The instant claims would have been obvious over the reference claims in view of Gaetano.
Examined claims are drawn to a method of improving chemical stability of composition, composition comprising beclomethasone and formoterol compound and adding a propellant comprising 1,1-difluoroethane (R-152a) to the composition in the form of suspension.
Reference claims are drawn to a composition comprising at least one active agent, adding to the composition a propellant R-152a in the form of suspension wherein ethanol is optional and composition is free of polar excipient. Water and oxygen in the claimed amount is also recited.
Specifically, the difference is that the examined claims require beclomethasone and formoterol, while reference claims require other active agents. This however is obvious in view of Gaetano.
As discussed supra, Gaetano teaches that long-acting beta agonist such as formoterol and antimuscarinic agents in combination with inhaled corticosteroids such as beclomethasone have been proposed for the prevention and/or treatment of diseases (see: Page 2, line 4-7; Claim 7). As taught by Gaetano et al, the disclosed active agents are alternatively usable species in compositions treating respiratory diseases and specially in inhalation formulations. The factual underpinning is that different active agents are considered alternatively usable species and as such one of ordinary skill in the art is more than capable of substituting one species / active agent for another with a reasonable expectation of success.
The courts have held that “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 components of pharmaceutical active agents. 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).
As the number of patents applied under obviousness type double patenting is very large, they are rejected collectively and based on similar analysis as stated above.
Claims 28, 30-42 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims of copending Application No. 17/944,637; 17/944,666; 17/969,250 in view of Gaetano (WO 2007/121913 A2; Nov. 1, 2007) and Keller et al. (US 6,585,958 B1; Jul. 1, 2003) as evidenced by Watson et al. (US 2010/0008997 A1; Jan. 14, 2010).
The obviousness Double Patenting rejection is appropriate because while the conflicting claims are not identical, they are not patentably distinct from the reference claims. The instant claims would have been obvious over the reference claims in view of in view of Gaetano and Keller et al. as evidenced by Watson et al.
Examined claims are drawn to a method of improving chemical stability of composition, composition comprising beclomethasone and formoterol compound and adding a propellant comprising 1,1-difluoroethane (R-152a) to the composition in the form of suspension.
Reference claims are drawn to a composition comprising at least one active agent, adding to the composition a propellant R-152a and ethanol. Water and Oxygen in the claimed amounts is also taught.
Specifically, the difference is that the examined claims require beclomethasone and formoterol, while reference claims require other active agents and ethanol. This however is obvious in view of Gaetano and Keller et al. as evidenced by Watson et al.
As discussed supra, Gaetano teaches that long-acting beta agonist such as formoterol and antimuscarinic agents in combination with inhaled corticosteroids such as beclomethasone have been proposed for the prevention and/or treatment of diseases (see: Page 2, line 4-7; Claim 7). As taught by Gaetano et al, the disclosed active agents are alternatively usable species in compositions treating respiratory diseases and specially in inhalation formulations. The factual underpinning is that different active agents are considered alternatively usable species and as such one of ordinary skill in the art is more than capable of substituting one species / active agent for another with a reasonable expectation of success.
The courts have held that “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 components of pharmaceutical active agents. 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).
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.
Claims 28, 30-42 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims of copending Application No. 18/489,133 in view of Gaetano (WO 2007/121913 A2; Nov. 1, 2007) and Keller et al. (US 6,585,958 B1; Jul. 1, 2003) as evidenced by Watson et al. (US 2010/0008997 A1; Jan. 14, 2010).
The obviousness Double Patenting rejection is appropriate because while the conflicting claims are not identical, they are not patentably distinct from the reference claims. The instant claims would have been obvious over the reference claims in view of in view of Gaetano and Keller et al. as evidenced by Watson et al.
Examined claims are drawn to a method of improving chemical stability of composition, composition comprising beclomethasone and formoterol compound and adding a propellant comprising 1,1-difluoroethane (R-152a) to the composition in the form of suspension.
Reference claims are drawn to a composition comprising at least one active agent, adding to the composition a propellant R-152a and optionally ethanol.
Specifically, the difference is that the examined claims require beclomethasone and formoterol, while reference claims require other active agents. This however is obvious in view of Gaetano and Keller et al. as evidenced by Watson et al.
As discussed supra, Keller teaches that glycerol can also be added in place of ethanol in metered dose aerosols . Keller also provides a motivation that by addition of glycerol, suspension or solution aerosols having improved properties can often be obtained. Therefore, it would have been obvious to one of ordinary skill in the art to try and substitute the different cosolvents as a person with ordinary skill has good reason to pursue known options within his or her technical grasp. see MPEP 2141 KSR International CO. v. Teleflex Inc. 82 USPQ 2d 1385 (Supreme Court 2007).
As discussed supra, Gaetano teaches that long-acting beta agonist such as formoterol and antimuscarinic agents in combination with inhaled corticosteroids such as beclomethasone have been proposed for the prevention and/or treatment of diseases (see: Page 2, line 4-7; Claim 7). As taught by Gaetano et al, the disclosed active agents are alternatively usable species in compositions treating respiratory diseases and specially in inhalation formulations. The factual underpinning is that different active agents are considered alternatively usable species and as such one of ordinary skill in the art is more than capable of substituting one species / active agent for another with a reasonable expectation of success.
The courts have held that “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 components of pharmaceutical active agents. 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).
The other difference is that the reference claims do not teach that the formulation is a suspension. However, as discussed supra, Keller provides a motivation that by addition of glycerol, suspension or solution aerosols having improved properties can often be obtained. Thus, it would have been obvious to formulate the composition in the form of a suspension or solution as both types of forms are taught to be used in metered dose inhalers.
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.
Claims 28, 30-42 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims of copending Application No. 18/489,150 in view of Gaetano (WO 2007/121913 A2; Nov. 1, 2007).
The obviousness Double Patenting rejection is appropriate because while the conflicting claims are not identical, they are not patentably distinct from the reference claims. The instant claims would have been obvious over the reference claims in view of in view of Gaetano and Keller et al. as evidenced by Watson et al.
Examined claims are drawn to a method of improving chemical stability of composition, composition comprising beclomethasone and formoterol compound and adding a propellant comprising 1,1-difluoroethane (R-152a) to the composition in the form of suspension.
Reference claims are drawn to a composition comprising at least one active agent, adding to the composition a propellant R-152a and optionally ethanol.
Specifically, the difference is that the examined claims require beclomethasone and formoterol, while reference claims require other active agents. This however is obvious in view of Gaetano.
As discussed supra, Gaetano teaches that long-acting beta agonist such as formoterol and antimuscarinic agents in combination with inhaled corticosteroids such as beclomethasone have been proposed for the prevention and/or treatment of diseases (see: Page 2, line 4-7; Claim 7). As taught by Gaetano et al, the disclosed active agents are alternatively usable species in compositions treating respiratory diseases and specially in inhalation formulations. The factual underpinning is that different active agents are considered alternatively usable species and as such one of ordinary skill in the art is more than capable of substituting one species / active agent for another with a reasonable expectation of success.
The courts have held that “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 components of pharmaceutical active agents. 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).
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.
Response to Arguments
Applicant requested the rejections be reconsidered in view of the amended claims. Also argued that the rejections be held in abeyance until there is indication of allowably subject matter.
In response, the amended claims do not overcome the double patenting rejections discussed above. Since applicant’s arguments regarding the double patenting rejections are not found persuasive, the rejections are maintained at this time.
Regarding US11,642,330, Applicant argued that ‘330 teaches glycopyrrolate and formoterol is the sole drug component and teach away from including beclomethasone.
In response, the rejection over ‘330 patent has been withdrawn since the ‘330 patent does not teach water and dissolved oxygen.
Regarding the collective double patenting rejections because the number of patents applied under obviousness type double patenting being very large and based on similar analysis, Applicant argued that examiner’s collective rejection of all examination claims over the unspecified reference claims constitutes legal error. Applicant appear to argue that a double patenting rejection of an instant claim should be over a specific single reference claim and not over all the claims. Applicant pointed to MPEP 804 II.B.2.
In response, as disclosed in the remarks by applicants, the MPEP states: Any nonstatutory double patenting rejection made under the obviousness analysis should make clear:
(A) The differences between the inventions defined by the conflicting claims — a claim in the patent compared to a claim in the application; and
(B) The reasons why a person of ordinary skill in the art would conclude that the invention defined in the claim at issue would have been an obvious variation of the invention defined in a claim in the patent.
In the collective rejections made above (for example over claims of U.S. Patent No. 11,690,823; 11,179,366; 11,077,076; 11,311,502; 11,103,480; 11,260,052; 11,559,507; 10,792,256; 10,888,546), the examiner states that the examined claims are drawn to a composition comprising beclomethasone and formoterol compound, glycerol and a propellant comprising 1,1-difluoroethane (R-152a).
Then the examiner states that the reference claims are drawn to a composition comprising at least one active agent, propellant R-152a and ethanol.
Then the examiner states the differences between the inventions defined by the conflicting claims, specifically, the difference is that the examined claims require beclomethasone and formoterol, while reference claims require other active agents. Also, the examined claims require glycerol, while reference claims do not teach this.
The reasons why a person of ordinary skill in the art would conclude that the invention defined in the claim at issue would have been an obvious variation of the invention defined in a claim in the patent is also discussed in the rejection. Specifically, the examiner discusses how the difference is obvious in view of Gaetano and Keller et al. as evidenced by Watson et al.
Further, the rejections state “over the claims of” which include all the claims of the patents/copending applications. Applicant also argued that the examiner does not specify the active ingredients in the reference claims. In response, it is argued that the examiner points out the reference claims are drawn to a composition comprising at least one active ingredient and the difference between the actives of the examined claims verses the reference claims.
Further, regarding the argument that a double patenting rejection of an instant claim should be over a specific single reference claim and not over all the claims, the examiner argues that no where in the MPEP is it stated and required that an instant claim should be over a specific single reference claim. For example, claim A can be rejected over claims A and B (e.g. B depends from A) when the limitations of claim A are recited in the combined claims A and B. For example, in the double patenting rejections above, the instant claims are rejected over claims of US 11,690,823 where ‘823 recites claims 1-20 and claims 2-20 depend from claim 1. Thus, limitations of the instant claims taught in either claim 1 or any dependent claim 2-20 of ‘823 would constitute a proper rejection because the MPEP does not require that all the limitations of one instant claims should be taught in a single reference claim. Therefore, applicant’s arguments regarding the grouping together of reference claims are not found persuasive at this time.
Conclusion
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/ALI S SAEED/Examiner, Art Unit 1616
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