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 1-30 are pending, presented for examination, and rejected as set forth in greater detail below.
Claim Interpretation
Applicants’ claims are directed to compositions combining a glycopyrrolate salt, beclomethasone dipropionate, and formoterol or a salt thereof with a propellant component including at least 90% 1,1-difluoroethane. 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.
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. 11,826,348. The ‘348 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, unsaturated impurities present, and incorporating the instantly claimed ethanol.
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.
Claims 1-30 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent Application 18/489,133. The ‘133 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 which in dependent claims is identified as formoterol fumarate dihydrate, with HFA-152a and optionally ethanol. Dependent claims limit the amount of propellant, water, oxygen, impurities present, and incorporating the instantly claimed ethanol. As a result, the limitations of the ‘133 application define inventions overlapping the scope of, and therefore render obvious, the claims of the instant application.
This is a provisional nonstatutory double patenting rejection.
Response to Argument
Applicants arguments filed 18 June 2026 have been fully considered.
Applicants arguments concerning the rejection of Claims 1-30 over the combination of Pieper and Keller have been fully considered and are persuasive. The rejection of Claims 1-30 as being rendered obvious by the combined teachings of Pieper and Keller are therefore WITHDRAWN.
However, applicants arguments concerning the Obviousness-type Double Patenting rejections have been considered and are NOT persuasive.
Applicants assert that the teachings of Pieper are not directed to the use of “any” anticholinergic, and that the lack of a generic teaching of employing alternative anticholinergic agents within the text of Pieper itself precludes the Examiner, or any other person in possession of ordinary skills in the medical arts, to exchange an alternative anticholinergic agent for the specific anticholinergic agent identified by Pieper. With this argument, applicants adopt an overly restrictive view to the question of obviousness and what the art, properly considered as a whole, teaches. Applicants arguments require that the teachings of Pieper not only be considered in a vacuum, but that Pieper is limited to conveying to the skilled artisan that only the single "new" anticholinergic agent may be combined with a corticosteroid and betamimetic. While the invention of Pieper may be limited to such a combination, a position the Examiner does not concede, by establishing that a corticosteroid combined with a long-acting betamimetic and an anticholinergic agent provides effective treatment of respiratory diseases, this provides the skilled artisan a jumping-off point for the consideration of alternatives. This is because it is well settled that it is a matter of obviousness for one of ordinary skill in the art to select a particular component from among many disclosed by the prior art as long as it is taught that the selection will result in the disclosed effect, even when the possible selections number 1200 or in the thousands. Merck & Co., Inc. v. Biocraft Labs., Inc., 874 F.2d 804, 807 (Fed. Cir. 1989); In re Corkill, 771 F.2d 1496, 1500 (Fed. Cir. 1985), and that an express suggestion to substitute one equivalent component (e.g., an equivalent viscosity modifier) for another is not necessary to render such substitution obvious. In re Fout, 675 F.2d 297 (CCPA 1982). A compound described by the art as possessing anticholinergic properties incorporated into a composition described as desirably containing an anticholinergic is not limited to structurally similar compounds. Art describing the desirability of the activity of the compound in such a composition provides the needed rationale for a skilled artisan to substitute alternative compounds possessing that activity. See Fout, supra. Keller, in the instant case, is relied upon solely to establish that the glycopyrronium bromide, budesonide, and formoterol represent known alternative anticholinergic, corticosteroid, and long-acting betamimetic agents suitable for use in the compositions of Pieper which combine a long-acting betamimetic, corticosteroid, and anticholinergic agent. Teachings concerning the invention of Keller, such as the use of dinitrogen monoxide to alter properties of such compositions, are not relevant to the obviousness analysis undertaken by the Examiner. The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981), In re Kotzab, 217 F.3d 1365, 1370 (Fed. Cir. 2000).
As nothing but the teachings of Pieper and Keller are relied on to conclude the issued patent claims and copending application claims are obvious modifications of the instant claims, applicants assertion that impermissible hindsight has been employed are unpersuasive. To be sure, "[a]ny judgment on obviousness is in a sense necessarily a reconstruction based on hindsight reasoning, but so long as it takes into account only knowledge which was within the level of ordinary skill in the art at the time the claimed invention was made and does not include knowledge gleaned only from applicant’s disclosure, such a reconstruction is proper." In re McLaughlin, 443 F.2d 1392, 1395, 170 USPQ 209, 212 (CCPA 1971).
Applicants assertion that the holdings of Kerkhoven and Sinclair are distinguishable from the present claims likewise fails to persuade. Applicants own arguments underscore this point, as nothing of the instant claims requires anything more than the physical combination of anticholinergic, corticosteroid, and long acting betamimetic agents, which is what Pieper and Keller, combined, convey to the skilled artisan. Applicants are welcome to provide evidence tending to establish a degree of unpredictability in the pharmaceutical formulation arts; However, as the record at present is devoid of such a showing, these arguments remain unpersuasive. In re Rinehart, 531 F.2d 1048, 189 USPQ 143 (CCPA 1976) (indicating that evidence showing there was no reasonable expectation of success may support a conclusion of nonobviousness), In re Geisler, 116 F.3d 1465, 1470, 43 USPQ2d 1362 (Fed. Cir. 1997) ("An assertion of what seems to follow from common experience is just attorney argument and not the kind of factual evidence that is required to rebut a prima facie case of obviousness.").
As such, the instant claims cannot be said to be patentably distinguishable from those recited by each of the ‘568, '569, '256, '546, '366, '480, '502, '330, '823, '348, and '349 patents as well as the claims of copending applications ‘150 and '133.
Conclusion
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, 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
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