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 .
Summary
Claims 1-2, 8-26, and 31. Claims 3-7, 27-30, and 32-35 are cancelled. All pending claims are under examination in this application.
Priority
The current application filed on January 05, 2024 is a 371 of PCT/US2022/036548 filed July 8, 2022, which in turn claims domestic priority to provisional patent application 63/220,362 filed on July 9, 2021.
Information Disclosure Statement
Receipt of the Information Disclosure Statements filed on June 2, 2025, May 17, 2024, and April 2, 2024 are acknowledged. A signed copy of the three documents are attached to this office action.
Claim Objections
Claim 25 is objected to because of the following informalities:
Claim 25 has the acronyms HFA, HFC, and HFO for pharmaceutically acceptable propellants. Please define these acronyms in full.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 2 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 2 depends on itself. The claim is, therefore, unclear and indefinite.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 8-14, 26, and 31 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Vehring et al. (WO2012/158166A1).
Vehring et al. is the closest prior art to the claimed invention as it teaches compositions, methods & systems for respiratory delivery of two or more active
agents (see title). Furthermore, Vehring et al. disclose compositions, methods and systems are provided for pulmonary or nasal delivery of two or more active agents via a
metered dose inhaler. In one embodiment, the compositions include a suspension medium, active agent particles, and suspending particles, in which the active agent particles and suspending particles form a co-suspension within the suspension medium (see abstract).
Regarding instant claim 1, Vehring et al. teach a pharmaceutical composition deliverable from a metered dose inhaler. The necessary citations within Vehring et al. that correspond to instant claim 1 are compiled within Table I.
Table I
Instant Claim 1
Vehring et al. Citations
A pharmaceutical composition deliverable from a metered dose inhaler, the pharmaceutical composition comprising:
Vehring et al. disclose a metered dose inhaler (MDI) formulation comprising a pharmaceutically acceptable co-suspension (see title and abstract within Vehring et al.).
a plurality of a first species of active agent particle;
a plurality of a second species of active agent particle;
a plurality of a third species of active agent particle;
a plurality of a fourth species of active agent particle;
a plurality of phospholipid particles comprising perforated microstructures;
Vehring et al. disclose one or more species of respirable suspending particles, wherein the
active agent particles and suspending particles associate to form a co-suspension within the suspension medium (see claim 1 within Vehring et al.).
The phospholipid particles comprise perforated microstructures (see claim 44 and paragraph [0121] within Vehring et al.).
Vehring et al. disclose the addition of multiple species within the MDI (see claims within Vehring et al.).
and a pharmaceutically acceptable propellant;
Vehring et al. disclose a suspension medium comprising a pharmaceutically acceptable propellant (see claim 1 within Vehring et al.).
wherein the first, second, third, and fourth species of active agents are each independently selected from a long-acting muscarinic antagonist (LAMA), a long-acting β2-agonists (LABA), a short-acting beta-agonists (SABA), an inhaled corticosteroid (ICS), and a non-corticosteroid anti-inflammatory agent.
Vehring et al. disclose formulations comprising providing a co-suspension comprising two or more active agents selected from short-acting beta agonist, long-acting and ultra long-acting b2 adrenergic receptor agonist (LABA), corticosteroid, anti-inflammatory, anti-tussive, bronchodilator, muscarinic antagonist, and long-acting muscarinic antagonist (LAMA) active agents, including any pharmaceutically acceptable salts, esters, isomers or solvates thereof (see claims 1-2 and 44 within Vehring et al.).
Regarding instant claims 8-12, Vehring et al. teach wherein the LAMA / LABA / ICS / anti-inflammatory agent are present at the appropriate concentration. Vehring et al. disclose that the active agent particles may be present in concentrations between about 0.01 mg/ml and about 20 mg/ml (see paragraph [0093] within Vehring et al.).
Regarding instant claim 13, Vehring et al. teach wherein the perforated microstructures comprise 1,2-Distearoyl-sn- glycero-3-phosphocholine (DSPC) and calcium chloride. Vehring et al. disclose wherein the perforated microstructures (see claim 44 within Vehring et al.) comprise 1,2-Distearoyl-sn- glycero-3-phosphocholine (DSPC) and calcium chloride (see paragraph [0168] within Vehring et al.).
Regarding instant claim 14, Vehring et al. teach wherein the phospholipid particles are present at a concentration in the range of about 0.1 mg/mL to about 10 mg/mL. Vehring et al. disclose within Example 5 the following formulation:
200 mL of a fluorocarbon-in-water emulsion of perfluorooctyl bromide (PFOB)
3.3 g of phospholipid (DSPC)
0.8 g micronized fluticasone propionate (FP)
0.3 g CaCl2
100 mL of water
If we assume a density of 1 g/mL, then all components add up to 304.4 mL. The phospholipid concentration would be (3.3 g phospholipid / 304.4 mL total volume) or ~10 mg/mL (see Example 5 paragraph [0199] within Vehring et al.).
Regarding instant claim 26, Vehring et al. teach a metered dose inhaler comprising a canister with an outlet valve including an actuator for dispensing a metered amount of the pharmaceutical composition according to instant claim 1, wherein the canister contains the pharmaceutical composition. Please see the discussion and citations within instant claim 1. Furthermore, Vehring et al. disclose the manufacture of MDIs comprising a canister (see paragraph [0171] within Vehring et al.).
Regarding instant claim 31, Vehring et al. teach a method of treating a pulmonary disease or disorder in a patient, comprising administering the pharmaceutical composition according to instant claim 1 to the patient by actuating a metered dose inhaler; wherein the metered dose inhaler contains the pharmaceutical composition. Please see the discussion and citations within instant claim 1. Additionally, Vehring et al. disclose the treatment of a pulmonary disease or disorder with the disclosed composition (see claim 1 within Vehring et al.).
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 non-obviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-2 and 15-25 are rejected under 35 U.S.C. 103 as being unpatentable over Vehring et al. in view of Lechuga-Ballesteros et al. (WO2014/190204A1), Dehaan et al. (WO2013/130767A1), and Vakkalanka et al. (US2014/0213560A1).
[The Examiner is going to introduce each new reference and then combine them in the rejection of the instant claims.]
1. Lechuga-Ballesteros et al.
Lechuga-Ballesteros et al. teach compositions, methods & systems for respiratory delivery of three or more active agents (see title). Also, Lechuga-Ballesteros et al. disclose pharmaceutical compositions, systems and methods suitable for respiratory delivery of a fixed combination of LAMA, LABA, and ICS active agents are described. The pharmaceutical compositions described herein may be formulated for respiratory delivery via a metered dose inhaler (MDI). Also described herein are MDI systems for delivery of a fixed combination of LAMA, LABA, and ICS active agents, as well as methods for preparing and using the compositions and systems described herein (see abstract).
2. Dehaan et al.
Dehaan et al. teach inhalable dry powders (see title). Additionally, Dehaan et al. disclose that the invention related to dry powders contain a therapeutic agent. The dry powders have characteristics, e.g., they are processable and/or dense in therapeutic agents that provide advantages for formulating and delivering therapeutic agents to patients (see abstract).
3. Vakkalanka et al.
Vakkalanka et al. teach methods of treating autoimmune, respiratory and inflammatory disorders by inhalation of roflumilast N-oxide (see title). In addition, Vakkalanka et al. disclose that the present disclosure relates to pharmaceutical compositions useful for (and to a method of) treating autoimmune, respiratory and/or inflammatory diseases and conditions. The method involves administering to a subject in need thereof roflumilast N-oxide by inhalation. The present disclosure particularly relates to the treatment of asthma and chronic obstructive pulmonary disease (COPD) by administering roflumilast N-oxide by inhalation (see abstract).
The teachings of Vehring et al. are presented above within the 35 U.S.C. §102 Section.
Combination of Vehring et al. and Lechuga-Ballesteros et al.
Regarding instant claim 16, Vehring et al. and Lechuga-Ballesteros et al. teach wherein the glycopyrrolate particles are in the propellant at a concentration sufficient to provide a delivered dose of glycopyrrolate per actuation of the metered dose inhaler selected from between about 5 mg and about 50 mg per actuation, between about 2 mg and about 25 mg per actuation, and between about 6 mg and about 15 mg per actuation. Vehring et al. disclose where the compositions described herein include glycopyrrolate, in certain embodiments, the compositions may include sufficient glycopyrrolate to provide a delivered dose selected from between about 10 μg and about 100 μg, about 15 μg and about 100 μg, about 15 μg and about 80 μg, and about 10 μg and about 80 μg per actuation of an MDI (see paragraph [0105] within Vehring et al.).
Regarding instant claim 17, Vehring et al. and Lechuga-Ballesteros et al. teach wherein the glycopyrrolate particles comprise micronized and crystalline glycopyrronium bromide. Lechuga-Ballesteros et al. disclose wherein the pharmaceutically acceptable salt of glycopyrronium is 3-[(cyclopentylhydroxyphenylacetyl)oxy]-1,1-dimethylpyrrolidinium bromide (see claim 8 within Lechuga-Ballesteros et al.). In addition, Lechuga-Ballesteros et al. disclose the active agent particles are provided as a micronized material (see paragraph [0063] within Lechuga-Ballesteros et al.; also see PTO-892 NPL U regarding micronized material equal to crystalline material).
Regarding instant claim 18, Vehring et al. and Lechuga-Ballesteros et al. teach wherein the formoterol particles are included in the composition at a concentration sufficient to provide a delivered dose of formoterol selected from between about 1 mg and about 30 mg, between about 0.5 mg and about 10 mg, between about 2 mg and 5 mg, between about 3 mg and about 10 mg, between about 5 mg and about 10 mg, and between 3 mg and about 30 mg per actuation of the metered dose inhaler. Vehring et al. disclose active agent particles comprising formoterol, including any pharmaceutically acceptable salts, esters, isomers or solvates thereof, suspended in the suspension medium at a concentration sufficient to provide a delivered dose of formoterol of between about 2 μg and about 10 μg per actuation of the metered dose inhaler (see paragraph [0129] within Vehring et al.).
Regarding instant claim 19, Vehring et al. and Lechuga-Ballesteros et al. teach wherein the formoterol particles comprise micronized and crystalline formoterol fumarate. Lechuga-Ballesteros et al. disclose the active agent particles are provided as a micronized material (see paragraph [0063] within Lechuga-Ballesteros et al.; also see PTO-892 NPL U regarding micronized material equal to crystalline material). Furthermore, Lechuga-Ballesteros et al. disclose formoterol can be used to treat inflammatory or obstructive pulmonary diseases and disorders such as, for example, those described herein. Formoterol has the chemical name (±)-2-hydroxy-5-[(1RS)-1-hydroxy-2-[[(1RS)-2-(4-methoxyphenyl)-1-methylethyl]-amino]ethyl] formanilide, and is commonly used in pharmaceutical compositions as the racemic fumarate dihydrate salt (see paragraph [0070] within Lechuga-Ballesteros et al.).
Regarding instant claim 20, Vehring et al. and Lechuga-Ballesteros et al. teach wherein the budesonide particles are included in the composition at a concentration sufficient to provide a delivered dose of budesonide selected from between about 50 mg and about 400 mg, between about 20 mg and about 600 mg, between about 30 mg and 100 mg, between about 50 mg and about 200 mg, and between about 150 mg and about 350 mg per actuation of the metered dose inhaler. Vehring et al. disclose active agent particles comprising budesonide, including any pharmaceutically acceptable salts, esters, isomers or solvates thereof, suspended in the suspension medium at a concentration sufficient to provide a delivered dose of budesonide of between about 30 μg and about 50 μg per actuation of the metered dose inhaler (see paragraph [0134] within Vehring et al.).
Regarding instant claim 21, Vehring et al. and Lechuga-Ballesteros et al. teach wherein the budesonide particles comprise micronized budesonide. Lechuga-Ballesteros et al. disclose saligenin- or indole- containing and adamantyl-derived b-agonists; corticosteroids, e.g., beclomethasone, budesonide, ciclesonide, flunisolide,
fluticasone, methyl-prednisolone, mometasone, prednisone and trimacinolone; anti-inflammatories are examples of specific active agents (see paragraph [0067] within Lechuga-Ballesteros et al.). Additionally, Lechuga-Ballesteros et al. disclose within the discussion and citations of instant claims 17 and 19 that active agents can be micronized.
Regarding instant claim 25, Vehring et al. and Lechuga-Ballesteros et al. teach wherein the pharmaceutically acceptable propellant is selected from HFA, HFC, HFO, and a combination thereof. Vehring et al. disclose various HFAs (see paragraph [0082] within Vehring et al.). Lechuga-Ballesteros et al. disclose HFAs, HFCs, PFCs, and CFCs (see paragraph [0082-0083] within Lechuga-Ballesteros et al.). Therefore, a skilled artisan (POSITA) could use these teachings to incorporate the appropriate pharmaceutically acceptable propellant(s).
Combination of Vehring et al. and Dehaan et al.
Regarding instant claim 2, Vehring et al. and Dehaan et al. teach the appropriate pharmaceutical composition containing the desired LAMA, LABA, SABA, ICS, and the non-corticosteriod anti-inflammatory agents. Vehring et al. disclose the appropriate active agents for LAMA (see claim 4 within Vehring et al.), LABA (see claim 4 within Vehring et al.), SABA (see paragraph [0095] within Vehring et al.), and ICS (see claim 4 within Vehring et al.). Vehring et al. does not disclose the correct non-corticosteriod anti-inflammatory agent.
However, Dehaan et al. does disclose that the respirable dry particles and dry powders can be administered to the respiratory tract of a subject in need thereof using any suitable method, such as instillation techniques, and/or an inhalation device, such as a dry powder inhaler (DPI) or metered dose inhaler (MDI) (see paragraph [000256] within Dehaan et al.). Dehann et al. also disclose the non-corticosteriod anti-inflammatory agent of choice, roflumilast (see paragraph [000127] within Dehaan et al.).
Therefore, a skilled artisan (POSITA; person of ordinary skill in the art) would combine the teachings of Dehann et al. and Vehring et al. to disclose all the elements of instant claim 2.
Regarding instant claim 15, Vehring et al. and Dehaan et al. teach the pharmaceutical composition according to instant claim 1, comprising: a plurality of glycopyrrolate particles; a plurality of formoterol particles; a plurality of budesonide particles; a plurality of roflumilast particles; and a plurality of phospholipid particles comprising perforated microstructures; and a pharmaceutically acceptable propellant. See the discussion and citations within instant claim 1 and 2 for the necessary rejection text.
Combination of Vehring et al., Dehaan et al., and Vakkalanka et al.
Regarding instant claim 22, Vehring et al., Dehaan et al., and Vakkalanka et al. teach wherein the roflumilast particles comprise micronized and crystalline roflumilast. Vakkalanka et al. disclose the roflumilast particles (pharmaceutically acceptable salt; N-oxide) comprise micronized and crystalline roflumilast (see paragraph [0019] within Vakkalanka et al.) [the Examiner has established the equivalence of micronized and crystalline forms within instant claims 17 and 19; see PTO-892 NPL U].
Regarding instant claim 23, Vehring et al., Dehaan et al., and Vakkalanka et al. teach wherein the roflumilast particles are included in the composition at a concentration sufficient to provide a delivered dose of roflumilast selected from between about 1 mg and about 100 mg, about 5 mg and about 80 mg, about 5 mg and about 50 mg, about 5 mg and about 25 mg, about 10 mg and 25 mg, about 50 mg and about 400 mg, between about 20 mg and about 600 mg, between about 30 mg and 100 mg, between about 50 mg and about 200 mg, and between about 150 mg and about 350 mg per actuation of the metered dose inhaler. Dehaan et al. has already disclosed the use of a MDI to deliver their active agents (see instant claim 2 discussion and citations). Furthermore, Vakkalanka et al. uses the pharmaceutically acceptable salt of roflumilast (N-oxide) (see the instant claim 22 discussion and citations). In addition, Vakkalanka et al. disclose that animals were anaesthetized with ketamine and lipopolysaccharide (LPS) solution was administered intratracheally one hour after roflumilast (at a dose of 0.3, 1, 3, and 10 mg/kg orally), or 30 minutes after roflumilast (at a dose of 10, 30, and 100 μg/kg i.t) or roflumilast N-oxide administration (at a dose of 10, 30 and 100 μg/kg, i.t) (see paragraph [0193] within Vakkalanka et al.).
Therefore, despite the fact that the Examiner does not have MDI data for roflumilast delivery to a subject, a skilled artisan (POSITA) could use the cited administration data to deliver suitable MDI doses that meet the instant claim 23 claim limitation.
Analogous Art
The Vehring et al., Lechuga-Ballesteros et al., Dehaan et al., and Vakkalanka et al. references are applicable to the endeavor of the instant application. Therefore, these teachings make the references relevant to instant claims 1-2, 8-23, 25-26, and 31.
Obviousness
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 modify the MDI disclosed by Vehring et al. using the teachings of Lechuga-Ballesteros et al., Dehaan et al., and Vakkalanka et al. to incorporate the necessary claim limitations.
The motivation to combine the Vehring et al., Lechuga-Ballesteros et al., Dehaan et al., and Vakkalanka et al. references relies on the fact that each citation discloses text regarding the pulmonary delivery of therapeutic agents. This overlap “links” the two references making them analogous art that would be consulted by a skilled artisan (POSITA).
Starting with Vehring et al., the skilled person only had to try the necessary claim limitations disclosed by Lechuga-Ballesteros et al., Dehaan et al., and Vakkalanka et al. The combination of Vehring et al., Lechuga-Ballesteros et al., Dehaan et al., and Vakkalanka et al. would allow one to arrive at the present application without employing inventive skill. This combination of the MDI taught by Vehring et al. along with the use of the necessary claim limitations taught by Lechuga-Ballesteros et al., Dehaan et al., and Vakkalanka et al. would allow a research and development scientist (POSITA) to develop the invention taught in the instant application. It would have only required routine experimentation to modify the MDI disclosed by Vehring et al. with the use of the necessary claim limitations taught by Lechuga-Ballesteros et al., Dehaan et al., and Vakkalanka et al. This combined modification would have led to an enhanced metered dose inhaler that would be beneficial for patients.
Allowable Subject Matter
Claim 24 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim 24 has allowable subject matter because the specific MDI data is not available within the prior art for phospholipid particles. Motivation is lacking to add this limitation to the closest prior art of Vehring et al., Lechuga-Ballesteros et al., Dehaan et al., and Vakkalanka et al.
Double Patenting
The non-statutory 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 non-statutory 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 non-statutory 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 non-statutory 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, 8-22, and 31 are provisionally rejected on the ground of non-statutory double patenting as being unpatentable over claim 1, 6-11, 30-31, 34, 37, 47, 49, 52, 54, and 59 of co-pending Application No. 18/719,343 (reference application) in view of Lechuga-Ballesteros et al.
Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant claims and that of Application ‘343 encompass a pharmaceutical composition deliverable from a MDI.
The difference between the instant claims and that of Application ‘343 is the presence of the pharmaceutically acceptable propellant 1,1-difluoroethane (HFC-152a).
However, Lechuga-Ballesteros et al. teach compositions, methods & systems for respiratory delivery of three or more active agents (see title). Also, Lechuga-Ballesteros et al. disclose pharmaceutical compositions, systems and methods suitable for respiratory delivery of a fixed combination of LAMA, LABA, and ICS active agents are described. The pharmaceutical compositions described herein may be formulated for respiratory delivery via a metered dose inhaler (MDI). Also described herein are MDI systems for delivery of a fixed combination of LAMA, LABA, and ICS active agents, as well as methods for preparing and using the compositions and systems described herein (see abstract).
It would have been prima facie obvious to provide the pharmaceutically acceptable propellant 1,1-difluoroethane (HFC-152a) for application ‘343 as suggested by Lechuga-Ballesteros et al. as Lechuga-Ballesteros et al. teach the pharmaceutically acceptable propellant 1,1-difluoroethane (see paragraph [0058] within Lechuga-Ballesteros et al.). There would have been a reasonable expectation of success in doing so, as both Lechuga-Ballesteros et al. and Application ‘343 disclose a pharmaceutical composition deliverable from a MDI.
This is a provisional non-statutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
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/JOHN W LIPPERT III/Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615