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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 30 January 2026 has been entered.
Status of the Claims
Claims 1, 8-17, 19-24, and 26-35 are pending.
Claims 22-24, 26, and 27 are withdrawn from consideration as directed to non-elected inventions.
Claims 1, 8-17, 19-21, and 28-35 are presented for examination and rejected as set forth below.
Claim Interpretation
Applicants claims are directed to compositions which combine a long-acting β-2 agonist (LABA), formoterol fumarate dihydrate, with each of a C1-4 carbon alcohol cosolvent, which in dependent claims 19, 31, and 32 is narrowed to ethanol, a propellant, which in dependent claims 20, 21, and 28-30 is narrowed to either of the hydrofluoroalkane propellants HFA134a or HFA152a, and the combination of HCl and H3PO4 in a particularly defined molar ratio. Dependent claims 8 and 9 narrow the particular molar ratio of hydrochloric to phosphoric acid, and Claims 10 and 11 specify particular concentrations of each of the hydrochloric and phosphoric acids to be present in the composition. Claims 12 and 13 add to this composition a long-acting muscarinic antagonist, which is narrowed to glycopyrronium bromide. Claims 14-16 require the inclusion of a corticosteroid, ultimately beclomethasone dipropionate. Claim 17 indicates the composition is a solution. Claims 33-35 require the inclusion of each of glycopyrronium bromide and beclomethasone dipropionate.
Response to Amendment
The Declaration of inventor Enrico Zambelli under 37 CFR 1.132 filed 30 January 2026 is insufficient to overcome the rejection of Claims 1, 8-17, 19-21, and 28-35 under 35 U.S.C. 103 as being unpatentable over Scuri as set forth in the last Office action. While the data demonstrates an improvement in the stability of each of formoterol fumarate dihydrate and glycopyrronium bromide, but not of beclomethasone, when a combination of hydrochloric and phosphoric acid is used compared to the use of phosphoric acid alone, this cannot be said to represent an unexpected result. As a threshold matter, no data concerning the stability of either formoterol fumarate or glycopyrronium bromide when 1M hydrochloric acid, the preferred acid stabilizer of the teachings of Scuri, is used. As such, applicants data fails to compare the invention claimed with the closest prior art which exists, and therefore cannot be considered persuasive evidence of unexpected results. See In re Burckel, 592 F.2d 1175, 201 USPQ 67 (CCPA 1979)(establishing that evidence of unexpected results must compare the claimed subject matter with the closest prior art to be effective to rebut a prima facie case of obviousness). More importantly, applicants are reminded that data demonstrating an achievement of expected beneficial results are evidence of obviousness of a claimed invention, just as unexpected results are evidence of unobviousness thereof. In re Gershon, 372 F.2d 535, 538, 152 USPQ 602, 604 (CCPA 1967), In re Skoner, 517 F.2d 947, 950 (CCPA 1975). Here, the art of record establishes that inorganic acids, including each of the hydrochloric and phosphoric acids applicants recite in their claims, serve to stabilize formoterol fumarate when incorporated into aerosol solutions. See Scuri [0012; 0026; 0042-43]. As was pointed out previously, a skilled artisan would expect that formulas 1 and 2, representing embodiments of the invention claimed, would demonstrate improved stability when compared to formulations 3 and 4. This is because not only is more acidic stabilizer included in the compositions, but also the additional acidic stabilizer, hydrochloric acid, is a strong monoprotic acid whereas phosphoric acid is a weak triprotic acid. Owing to the art-recognized capacity for inorganic acids incorporated into formoterol fumarate solutions to stabilize these active agents, it cannot be considered unexpected that compositions incorporating increased levels of such inorganic acid stabilizers would be more stable than comparative compositions containing less stabilizer.
For at least these reasons, the Declaration of inventor Enrico Zambelli is unpersuasive.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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, 8-17, 19-21, and 28-35 are rejected under 35 U.S.C. 103 as being unpatentable over Scuri (U.S. PGPub. 2018/0028439).
Scuri describes a solution combining glycopyrronium bromide, formoterol or a salt or hydrate thereof, and beclomethasone dipropionate dissolved in a hydrofluoroalkane propellant with a cosolvent and inorganic acids to serve as stabilizing agents for the composition. [0023-26; 0033; 0036; 0044]. Formoterol fumarate dihydrate is identified as a particularly preferred form of the formoterol for use in these compositions. [0035]. HFA134a is identified as a particularly preferred form of the hydrofluoroalkane propellant to be used in these compositions. [0037]. The cosolvent is identified in a particularly preferred embodiment as ethanol. [0038-40]. Each of the 1M HCl and phosphoric acid of the present claims are identified as suitable stability-enhancing inorganic acids to be used in these compositions, to be included in amounts of 0.1-0.6 micrograms per microliter, although Scuri indicates that acids of different molarities may be employed as stability-enhancing agents. [0042-43]. A particular embodiment of the triple combination of formoterol fumarate dihydrate, beclomethasone dipropionate, and glycopyrronium bromide is described as containing 00182% by weight of the composition. [0151]. While reciting neither the particular combination of hydrochloric acid and phosphoric acid of the claims, nor reciting the particular concentrations or molar ratios included in the claims, it must be remembered that differences in concentration between the prior art and the claims will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (indicating that where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.). Here, not only does Scuri indicate that the inorganic acids are included in these solutions to improve the stability of the compositions into which they are incorporated, but also specifically invites the skilled artisan to employ alternative concentrations of acids, or even alternative acids, from the exemplified 1M HCl. [0042-43]. Applicants are also reminded that generally 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. In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). As such, the skilled artisan would recognize that the claimed combination of hydrochloric acid and phosphoric acid, as well as the concentrations of acid and by extension their relative molar ratios, are result-effective variables suitable for optimization by little more than the routine experimentation of a person having ordinary skill in the art of pharmaceutical formulations. In the absence of evidence tending to establish some secondary indicia of nonobviousness, the inorganic acid limitations of Claims 6-11 are considered prima facie obvious over the teachings of Scuri. “The law is replete with cases in which the difference between the claimed invention and the prior art is some range or other variable within the claims. . . . In such a situation, the applicant must show that the particular range is critical, generally by showing that the claimed range achieves unexpected results relative to the prior art range.” In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
The specific combination of features claimed is disclosed within the broad generic ranges taught by the reference but such “picking and choosing” within several variables does not necessarily give rise to anticipation. Corning Glass Works v. Sumitomo Elec., 868 F.2d 1251, 1262 (Fed. Circ. 1989). Where, as here, the reference does not provide any motivation to select this specific combination of multiple inorganic acids rather than the single inorganic acid of the Scuri compositions, anticipation cannot be found.
That being said, however, it must be remembered that “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious.” KSR v. Teleflex, 127 S.Ct. 1727, 1740 (2007) (quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976)). “[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious,” the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR at 1741. The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742.
Consistent with this reasoning, it would have been prima facie obvious to have selected various combinations of formoterol fumarate dihydrate, glycopyrronium bromide, beclomethasone dipropionate, ethanol, HFA-134a and the combination of hydrochloric and phosphoric acid as stabilizers from within a prior art disclosure, to arrive at compositions “yielding no more than one would expect from such an arrangement.”
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, 8-17, 19-21, and 28-35 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 10,159,645 in view of Scuri discussed in greater detail above. While the ‘645 patent claims the instant combination of glycopyrronium bromide, formoterol fumarate, and beclomethasone dipropionate combined with HCl, ethanol and HFA134a, the ‘645 patent does not specifically include a second inorganic acid. This, however, is an obvious modification of the prior art owing to the fact that Scuri indicates that combinations of inorganic acids serve to preserve combinations of glycopyrronium bromide, formoterol fumarate, and beclomethasone dipropionate, thereby rendering the present combination prima facie obvious.
Claims 1, 8-17, 19-21, and 28-35 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 10,617,638 in view of Scuri discussed in greater detail above. While the ‘638 patent claims the instant combination of glycopyrronium bromide, formoterol fumarate dihydrate, and beclomethasone dipropionate combined with a stabilizing amount of a mineral acid, ethanol and HFA propellant, the ‘638 patent does not specifically include a combination of inorganic acid. This, however, is an obvious modification of the prior art owing to the fact that Scuri indicates that combinations of inorganic acids serve to preserve combinations of glycopyrronium bromide, formoterol fumarate, and beclomethasone dipropionate, thereby rendering the present combination prima facie obvious.
Claims 1, 8-17, 19-21, and 28-35 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. 10,596,113 in view of Scuri discussed in greater detail above. While the ‘113 patent claims the instant combination of glycopyrronium bromide, formoterol fumarate dihydrate, and beclomethasone dipropionate combined with a stabilizing amount of a mineral acid, ethanol and HFA134a propellant, the ‘113 patent does not specifically include a combination of inorganic acid. This, however, is an obvious modification of the prior art owing to the fact that Scuri indicates that combinations of inorganic acids serve to preserve combinations of glycopyrronium bromide, formoterol fumarate, and beclomethasone dipropionate, thereby rendering the present combination prima facie obvious.
Claims 1, 8-17, 19-21, and 28-35 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 10,617,669 in view of Scuri discussed in greater detail above. While the ‘669 patent claims the instant combination of glycopyrronium bromide, formoterol fumarate dihydrate, and beclomethasone dipropionate combined with a stabilizing amount of a mineral acid, ethanol and HFA134a propellant, the ‘669 patent does not specifically include a combination of inorganic acid. This, however, is an obvious modification of the prior art owing to the fact that Scuri indicates that combinations of inorganic acids serve to preserve combinations of glycopyrronium bromide, formoterol fumarate, and beclomethasone dipropionate, thereby rendering the present combination prima facie obvious.
Claims 1, 8-17, 19-21, and 28-35 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of U.S. Patent No. 10,596,146 in view of Scuri discussed in greater detail above. While the ‘149 patent claims the instant combination of glycopyrronium bromide, formoterol fumarate dihydrate, and beclomethasone dipropionate combined with a stabilizing amount of a mineral acid, ethanol and HFA134a propellant, the ‘149 patent does not specifically include a combination of inorganic acid. This, however, is an obvious modification of the prior art owing to the fact that Scuri indicates that combinations of inorganic acids serve to preserve combinations of glycopyrronium bromide, formoterol fumarate, and beclomethasone dipropionate, thereby rendering the present combination prima facie obvious.
Claims 1, 8-17, 19-21, and 28-35 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 and 12-17 of copending Application No. 17/776,168 in view of Scuri discussed in greater detail above. While the ‘168 application claims the instant combination of glycopyrronium bromide, formoterol fumarate dihydrate, and beclomethasone dipropionate combined with a stabilizing amount of a mineral acid such as HCl, ethanol and HFA134a propellant, the ‘168 application does not specifically include a combination of inorganic acids. This, however, is an obvious modification of the prior art owing to the fact that Scuri indicates that combinations of inorganic acids serve to preserve combinations of glycopyrronium bromide, formoterol fumarate, and beclomethasone dipropionate, thereby rendering the present combination prima facie obvious.
This is a provisional nonstatutory double patenting rejection.
Claims 1, 8-17, 19-21, and 28-35 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8, 11-13, and 18-32 of copending Application No. 18/959,958 in view of Scuri discussed in greater detail above. While the ‘958 application claims the instant combination of glycopyrronium bromide, formoterol fumarate dihydrate, and beclomethasone dipropionate combined with a stabilizing amount of a mineral acid such as HCl, ethanol and HFA134a propellant, the ‘958 application does not specifically include a combination of inorganic acids. This, however, is an obvious modification of the prior art owing to the fact that Scuri indicates that combinations of inorganic acids serve to preserve combinations of glycopyrronium bromide, formoterol fumarate, and beclomethasone dipropionate, thereby rendering the present combination prima facie obvious.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant's arguments filed 30 January 2026 have been fully considered but they are not persuasive.
Applicants assert that Scuri does not teach using combinations of inorganic acids. So far as this goes, it is correct; however, the Examiner has not asserted Scuri teaches using combinations of inorganic acids to stabilize formoterol fumarate solutions. The Examiner pointed out that each of the phosphoric and hydrochloric acids applicant recite in their claims were individually taught by Scuri as inorganic acids useful in stabilizing formoterol fumarate solutions, and that generally 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. In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). Because each of the claimed hydrochloric and phosphoric acids are identified by Scuri as useful inorganic acid stabilizing agents, their combination is prima facie obvious. As these are individually identified as stabilizing agents, as the Examiner previously pointed out, it must be remembered that differences in concentration between the prior art and the claims will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (indicating that where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.). Here, not only does Scuri indicate that the inorganic acids are included in these solutions to improve the stability of the compositions into which they are incorporated, but also specifically invites the skilled artisan to employ alternative concentrations of acids, or even alternative acids, from the exemplified 1M HCl. See Scuri [0042-43].
Applicants argument concerning the improvement in stability echoes those arguments set forth by the Zambelli declaration addressed above and are no more persuasive upon their repetition.
For at least these reasons, applicants arguments are unpersuasive.
Conclusion
No Claims are allowable.
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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
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