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 .
Status of the Claims
Claims 1-21 are pending, presented for examination, and rejected as set forth below.
Claim Interpretation
Applicants’ claims are directed to compositions combining a glycopyrrolate salt, beclomethasone dipropionate, and formoterol or a salt thereof with 1,1-difluoroethane as a propellant. Dependent claims specify the presence of various additional components, or narrow the salts of the active agents to be present, or define concentrations of propellant, define the composition as a suspension or solution, contain the composition in a sealed and pressurized aerosol container, recite properties that the compositions are to possess, or methods of administering the compositions to treat respiratory disease. Concerning these properties; applicants are reminded that the U.S. Patent office is not equipped with analytical instruments to test prior art compositions for the infinite number of ways that a subsequent applicant may present previously unmeasured characteristics. When the prior art appears to contain the exact same ingredients and applicant’s own disclosure supports the suitability of the prior art composition as the inventive composition component, the burden is properly shifted to applicant to show otherwise.
Terminal Disclaimer
The terminal disclaimer filed on 12 February 2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of U.S. Patent 11,826,348 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Response to Arguments
Applicant’s arguments with respect to the rejection of Claims 1, 3-7, and 9-17 as obvious under 35 U.S.C. 103 have been fully considered and are persuasive. Specifically, the Examiner agrees with applicants position that the Keller reference, relied on for the teaching concerning replacing the Pieper propellant with the HFA-152a of the instant claims, requires the combination of HFA-152a with dinitrogen monoxide, a composition excluded from the propellant of the instant claims.
The rejection of Claims 1, 3-7, and 9-17 has been WITHDRAWN.
However, Applicant's arguments filed 12 February 2026 concerning the remaining double patenting rejections of record have been fully considered but are not persuasive. This is because in the context of the remaining double patenting rejections, Pieper and Keller are not relied on to provide guidance for the selection of the propellant component which rendered the obviousness rejection entered under 35 U.S.C. 103 untenable. Pieper and Keller are relied on rather to establish that the remaining double patenting rejections are based on previously issued or copending claims which differ from the present claims in the identity of either the anticholinergic agent, corticosteroid, or betamimetic present, or not, from these compositions. Col.2, L.41 – Col.4, L.10. Pieper indicates that combinations of anticholinergic agent, corticosteroid, and betamimetic provide particularly effective compositions for use in the treatment of inflammatory or obstructive diseases of the respiratory tract. (Col.1, L.20-46). On this basis the instantly claimed combination of glycopyrrolate (a known anticholinergic agent), beclomethasone (corticosteroid), and formoterol (betamimetic) represents an obvious modification, as set forth previously and again below, of the issued patents and copending applications combinations of steroid and betamimetic, anticholinergic agent and betamimetic, or combination of anticholinergic agent, corticosteroid, and betamimetic present. This is because of the art-based recognition of the different anticholinergic agent, corticosteroid, or betamimetic as equivalent in the treatment of respiratory diseases. See Keller, Col.8, L.19-30; see also In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980)(it is prima facie obvious to combine two compositions, each of which is taught by the prior art to be useful for same purpose, in order to form a third composition to be used for the very same purpose. The idea for combining them flows logically from their having been individually taught in the prior art); See Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945)(it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use).
For at least these reasons, in the absence of a properly filed terminal disclaimer, the double patenting rejections are MAINTAINED.
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 1, 3-7, and 9-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 6-12 of U.S. Patent No. 10,258,568 in view of Pieper and Keller, discussed in greater detail above. The claims of the ‘568 patent combine the beclomethasone dipropionate and HFA-152a propellant of the instant claims with ethanol; the instant claims requirement of the additional glycopyrrolate salt and formoterol fumarate dihydrate amount to little more than combinations of therapeutic agents useful for the same purpose rendering the instant claims an obvious modification of the subject matter encompassed by the ‘568 patent.
Claims 1, 3-7, and 9-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 and 11-13 of U.S. Patent No. 10,258,569 in view of Pieper and Keller, discussed in greater detail above. The claims of the ‘569 patent combine the beclomethasone dipropionate and HFA-152a propellant of the instant claims with ethanol; the instant claims requirement of the additional glycopyrrolate salt and formoterol fumarate dihydrate amount to little more than combinations of therapeutic agents useful for the same purpose rendering the instant claims an obvious modification of the subject matter encompassed by the ‘569 patent.
Claims 1-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-22 of U.S. Patent No. 10,792,256 in view of Pieper and Keller, discussed in greater detail above. The ‘256 patent combines the instantly claimed steroids including the instantly claimed beclomethasone with each of salmeterol, a LAMA which in dependent claims is a glycopyrronium bromide, and HFA-152a, with dependent claims limiting the amount of water, oxygen, impurities present, and incorporating the instantly claimed ethanol, and surfactants. Pieper and Keller indicate the salmeterol of the ‘256 patent is equivalent to the instantly claimed formoterol salts useful for the same purpose of treating respiratory diseases, which renders the instant claims an obvious modification of the subject matter encompassed by the ‘502 patent.
Claims 1-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of U.S. Patent No. 10,888,546 in view of Pieper and Keller, discussed in greater detail above. The claims of the ‘546 patent combine glycopyrronium bromide with the corticoid fluticasone and a beta-2-agonist and HFA-152a propellant of the instant claims with a defined range of water, oxygen, impurities, and ethanol; the instant claims requirement of the beclomethasone amount to little more than the substitution of a therapeutic agent useful for the same purpose, specifically the fluticasone, and a selection of a component, the and formoterol as a beta-2 agonist known to be useful for that purpose, rendering the instant claims an obvious modification of the subject matter encompassed by the ‘546 patent.
Claims 1-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 11,179,366 in view of Pieper and Keller, discussed in greater detail above. The claims of the ‘366 patent combine a glycopyrrolate, which in dependent claims is glycopyrronium bromide with a corticoid and a long-acting beta-2-agonist and HFA-152a propellant of the instant claims with a defined range of water, oxygen, impurities, and ethanol; the instant claims requirement of the beclomethasone amount to little more than the selection of a therapeutic agent useful for the purpose, and a selection of a component, the and formoterol as a beta-2 agonist known to be useful for that purpose, rendering the instant claims an obvious modification of the subject matter encompassed by the ‘366 patent per the teachings of Pieper and Keller.
Claims 1-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-16 of U.S. Patent No. 11,103,480 in view of Pieper and Keller, discussed in greater detail above. The ‘480 patent combines steroids including the instantly claimed beclomethasone dipropionate with a glycopyrrolate which in dependent claims is a glycopyrronium bromide, formoterol, and HFA-152a, with dependent claims limiting the amount of water, oxygen, impurities present, and incorporating the instantly claimed ethanol, and surfactants. Pieper and Keller indicate the formoterol salts of the ‘480 patent include the instantly claimed formoterol fumarate dihydrate useful for the same purpose of treating respiratory diseases, which renders the instant claims an obvious modification of the subject matter encompassed by the ‘480 patent.
Claims 1-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-22 of U.S. Patent No. 11,311,502 in view of Pieper and Keller, discussed in greater detail above. The ‘502 patent combines the instantly claimed steroids including the instantly claimed beclomethasone with each of salmeterol, a LAMA which in dependent claims is a glycopyrronium bromide, and HFA-152a, with dependent claims limiting the amount of water, oxygen, impurities present, and incorporating the instantly claimed ethanol, and surfactants. Pieper and Keller indicate the salmeterol of the ‘502 patent is equivalent to the instantly claimed formoterol salts useful for the same purpose of treating respiratory diseases, which renders the instant claims an obvious modification of the subject matter encompassed by the ‘502 patent.
Claims 1, 3-7, and 9-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 11,642,330 in view of Pieper and Keller, discussed in greater detail above. The claims of the ‘330 patent combine the formoterol fumarate dihydrate and glycopyrronium salts, which in dependent claims is the glycopyrronium bromide of the instant claims and HFA-152a propellant of the instant claims with ethanol; the instant claims requirement of the additional beclomethasone dipropionate amount to little more than combinations of therapeutic agents useful for the same purpose rendering the instant claims an obvious modification of the subject matter encompassed by the ‘330 patent per the guidance of Pieper and Keller.
Claims 1-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-20 of U.S. Patent No. 11,690,823 in view of Pieper and Keller, discussed in greater detail above. The ‘823 patent combines the instantly claimed glycopyrronium salt which in dependent claims is a glycopyrronium bromide and HFA-152a, with dependent claims incorporating a LABA and a corticosteroid, as well as limiting the amount of water, oxygen, impurities present, and incorporating the instantly claimed ethanol, and surfactants. Pieper and Keller indicate the instant claims requirement of the beclomethasone amount to little more than the selection of a therapeutic agent useful for the purpose, and a selection of a component, the and formoterol as a beta-2 agonist known to be useful for that purpose, rendering the instant claims an obvious modification of the subject matter encompassed by the ‘823 patent.
Claims 1-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-16 of U.S. Patent No. 11,826,349. The ‘349 patent combines the instantly claimed glycopyrronium salt which in dependent claims is a glycopyrronium bromide with beclomethasone dipropionate and a formoterol salt with HFA-152a and optionally ethanol, but which is free of additional polar excipients, rather than the instant claims exclusion of simply polar solvents. Dependent claims specify the formoterol is formoterol fumarate dihydrate, and the glycopyrronium is glycopyrronium bromide, as well as limiting the amount of water, oxygen, impurities present, and incorporating the instantly claimed ethanol.
Claims 1-21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-21 of U.S. Patent Application 18/489,150 in view of Pieper and Keller, discussed in greater detail above. The ‘150 application combines the instantly claimed glycopyrronium salt which in dependent claims is a glycopyrronium bromide, with beclomethasone which in dependent claims is the dipropionate, and a formoterol salt with HFA-152a and optionally ethanol, but which is free of additional polar excipients, rather than the instant claims exclusion of simply polar solvents. Dependent claims specify the formoterol is formoterol fumarate dihydrate, and the glycopyrronium is glycopyrronium bromine, as well as limiting the amount of water, oxygen, impurities present, and incorporating the instantly claimed ethanol. Pieper and Keller indicate the instant claims requirement of the beclomethasone amount to little more than the selection of a therapeutic agent useful for the purpose, and a selection of a component, the and formoterol as a beta-2 agonist known to be useful for that purpose, rendering the instant claims an obvious modification of the subject matter encompassed by the ‘150 application.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No Claims are allowable.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN M BASQUILL whose telephone number is (571)270-5862. The examiner can normally be reached Monday through Thursday, 5:30 AM to 4 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached at (571) 272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SEAN M BASQUILL/Primary Examiner, Art Unit 1614