DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 55-63 and the species of asthma and chronic obstructive pulmonary disease (COPD) in the reply filed on September 30, 2025 is acknowledged.
Claims 64-75 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on September 30, 2025.
Claim Objections
Claim 56 is objected to because of the following informalities: in line 3, the “and” before “3 µg and…”. 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 55 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 1 recites “particles comprising a corticosteroid or a pharmaceutically acceptable salt thereof, budesonide or a pharmaceutical acceptable salt thereof, and formoterol or a pharmaceutically acceptable salt thereof”. Budesonide is a corticosteroid. Therefore it is unclear whether (i) the claim requires a first corticosteroid that is not budesonide (i.e., budesonide is a second corticosteroid), or (ii) budesonide suffices as “a corticosteroid” in the above claim phrase.
For the purposes of examination now this claim is construed as either of (i) or (ii) above.
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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 under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 55-59 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Tarara (US 2006/0159629) in view of Ekstrom (US 2001/0049396).
Tarara teaches administering bioactive agents “to at least a portion of the pulmonary air passages of a patient in need thereof” (para.0018), wherein the bioactive agents include formoterol, budesonide, and corticosteroids such as prednisone and dexamethasone (para.0043) “for use in the treatment of respiratory disorders such as asthma by inhalation therapy” (para.0040). Tarara teaches using two or more active agents, specifically including formoterol, budesonide, and anticholinergics, which may be crystalline (paras.0042-43, 0045, 0056; claims 10, 18).
The pulmonary medicament particulates are in a metered dose inhaler (paras.0020, 0087, 0140), in a “suspension medium (i.e., propellant)” (para.0121; see para.0118; title; abstract). Tarara teaches that "each particulate" has "a perforated microstructure comprising a phospholipid structural matrix and active agent” (abstract). Each particulate is made up of:
(i) micronized particles of one or more active agent, e.g., spray dried active agent particles (paras. 0045-46; see paras. 0040-44); and
(ii) a phospholipid structural matrix, i.e., “perforated microstructures [comprising] a structural matrix that exhibits, defines or comprises voids, pores, defects, hollows, spaces, interstitial spaces, apertures, perforations or holes” (para. 0018; see paras. 0021, 0027-30, 0034-35). The microstructures are formed using a phospholipid such as disteroylphosphatidylcholine, in solid or dry particulate form (see, e.g., para.0175 discussing a dispersion, i.e., discrete solids in liquid, of hydrogenated egg phosphatidylcholine in water), rigidifying excipients such as calcium chloride (paras. 0038, 0078), and insoluble in suspension medium such as the hydrofluoroalkanes (HFAs) including HFA-134a (paras. 0016, 0143, 0152).
Tarara further teaches as follows:
“it should be appreciated that the particulate or perforated microstructure may be coated, linked or otherwise associated with an agent or bioactive agent in a non-integral manner” (para.0022);
“the selected active or bioactive agent(s) may be associated with, or incorporated in, the perforated microstructures in any form that provides the desired efficacy and is compatible with the chosen production techniques. As used herein, the terms "associate" or "associating" mean that the structural matrix or perforated microstructure may comprise, incorporate, adsorb, absorb, be coated with or be formed by the active or bioactive agent.” (para.0044).
Thus Tarara teaches two distinct populations within the medicament particles: the perforated microstructures comprising a phospholipid structural matrix, and micronized active agent particles.
Regarding the weight ratio of the suspending particles to the active agent particles, Tarara teaches that “in selected embodiments the perforated microstructures may incorporate much less bioactive agent depending on the activity thereof. … as little as 0.001% by weight although a concentration of greater than about 0.1% w/w is preferred… greater than about 5%, 10%, 15%, 20%, 25%, 30% or even 40% w/w active or bioactive agent…” (para.0041). Thus Tarara discloses a wide range of the weight ratio of the total mass of suspending particles to active agent particles, e.g. 70:30, 75:25, etc. which are within the range in claim 55.
Tarara does not specifically teach the combination of formoterol and budesonide in claim 55.
Ekstrom teaches “treatment of an acute condition of asthma and/or intermittent asthma and/or episodes in chronic asthma by administering [ ] by inhalation” a mixture containing “(a) a first active ingredient which is formoterol, a pharmaceutically acceptable salt or solvate thereof or a solvate of such a salt; and (b) a second active ingredient which is budesonide” (abstract; see title; paras.0040-41; claims 1, 2, 5-11, 13-23). The “active ingredients (a) or (b) are in the form of an ordered mixture with diluent, additive or carrier” (para.0031) including as a suspension in a propellant to be used in a metered dose inhaler (paras.0032-33). Formoterol dose is preferably 2-24 µg and budesonide dose is preferably 100-200 µg (paras.0027-28).
It would have been prima facie obvious for one having ordinary skill in the art before the effective filing date to combine the teachings of Tarara and Ekstrom and devise Tarara’s method using the combination of formoterol and budesonide as recited in the instant claim(s). The skilled person would have been motivated to do so because both are drawn to treating asthma using an inhaled combination of drugs including formoterol and budesonide, and Ekstrom teaches that the combination of formoterol and budesonide specifically in the doses recited here can surprisingly provide treatment of an acute condition of asthma, as a rescue medication, as well as intermittent asthma and/or episodes in chronic asthma (paras.0018, 0021, 0023).
Claims 55-63 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Tarara (US 2006/0159629) in view of Ekstrom (US 2001/0049396) and Weers (US 7442388).
Tarara and Ekstrom do not specifically teach using 1,2-distearoyl-sn-glycero-3-phosphocholine in claim 60; however Tarara teaches using phosphatidylcholine to form suspending particles (para.0066).
Weers teaches using distearoylphosphatidylcholine, DSPC, or 1,2-distearoyl-sn-glycero-3-phosphocholine to form dry lung surfactant particles (title; abstract; col.16 ll.57-59).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to combine the teachings of Tarara and Ekstrom with that of Weers. One of ordinary skill in the art at the time the invention was made would have been motivated to do so because (i) all are drawn to inhalable pharmaceutical compositions, (ii) Tarara teaches using phosphatidylcholine to form suspending particles, and (iii) Weers teaches that 1,2-distearoyl-sn-glycero-3-phosphocholine of DSPC can be used successfully to form diverse embodiments of inhalable powders for pulmonary delivery (abstract; Tables I-III, Example VIII).
Regarding the volume median optical diameter between 0.2 and 50 microns in claim 60, Tarara teaches mean geometric diameter of “the perforated microstructures will comprise a powder of dry, hollow, porous microspherical shells of approximately 1 to 10 μm or 1 to 5 μm in diameter” (para.0088; see claim 1). While Tarara does not specifically disclose the volume median optical diameter, without some evidence to the contrary the volume median would not differ significantly from the mean geometric diameter. Also Applicant describes MMAD of the suspending particles of about 500 nm to about 10 µm (para.0111, US 2025/0009652). Applicant also states, to “achieve respirable suspending particles within the MMAD [mean mass aerodynamic diameter] ranges described, the suspending particles will typically exhibit a volume median optical diameter between about 0.2 µm and about 50 µm” (para.0112, pre-grant publication). Tarara teaches MMAD within this range, e.g., 3.4 µm, 2.4 µm, 2.2 µm for the particulates comprising the active agent associated with the suspending particles or perforated microstructures (Tables IV-VI; see claim 1). Thus Tarara indicates a volume median optical diameter of the suspending particles within the range of claim 60. Furthermore since the particulates comprise the active agent associated with the perforated microstructure, at least 90% of the active agent particles by volume would have an optical diameter of 7 µm or less as further recited in claim 60.
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 55-63 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 29 of U.S. Patent No. 8324266.
Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets are drawn to a method for treating a pulmonary disease or disorder in a patient, comprising: providing a metered dose inhaler comprising a pharmaceutical composition, wherein the pharmaceutical composition comprises: a suspension medium comprising a pharmaceutically acceptable propellant; a plurality of respirable active agent particles comprising a corticosteroid or a pharmaceutically acceptable salt thereof, budesonide or a pharmaceutically acceptable salt thereof, and formoterol or a pharmaceutically acceptable salt thereof; and a plurality of respirable suspending particles comprising phospholipid particles, wherein the phospholipid particles comprise perforated microstructures; and wherein the plurality of suspending particles and the plurality of active agent particles are co-suspended in the suspension medium at a weight ratio of total mass of suspending particles to total mass of active agent particles that ranges from above 1:1; and administering the pharmaceutical composition to the patient by actuating the metered dose inhaler, wherein the administration comprises delivering a therapeutically effective amount of the active agents to the patient. The ’266 patent claims recite further limitations and therefore anticipate the current claims.
Claims 55-63 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 34 and 44 of U.S. Patent No. 8703806.
Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets are drawn to a method for treating a pulmonary disease or disorder in a patient, comprising: providing a metered dose inhaler comprising a pharmaceutical composition, wherein the pharmaceutical composition comprises: a suspension medium comprising a pharmaceutically acceptable propellant; a plurality of respirable active agent particles comprising a corticosteroid or a pharmaceutically acceptable salt thereof, budesonide or a pharmaceutically acceptable salt thereof, and formoterol or a pharmaceutically acceptable salt thereof; and a plurality of respirable suspending particles comprising phospholipid particles, wherein the phospholipid particles comprise perforated microstructures; and wherein the plurality of suspending particles and the plurality of active agent particles are co-suspended in the suspension medium; and administering the pharmaceutical composition to the patient by actuating the metered dose inhaler, wherein the administration comprises delivering a therapeutically effective amount of the active agents to the patient. The ’806 patent claims recite further limitations and therefore anticipate the current claims. The present claims recite a weight ratio of total mass of suspending particles to total mass of active agent particles that ranges from above 1:1 which appears at least in claim 45 of the ’806 patent.
Claims 55-63 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 3 and 4 of U.S. Patent No. 8815258.
Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets are drawn to a method for treating a pulmonary disease or disorder in a patient, comprising: providing a metered dose inhaler comprising a pharmaceutical composition, wherein the pharmaceutical composition comprises: a suspension medium comprising a pharmaceutically acceptable propellant; a plurality of respirable active agent particles comprising a corticosteroid or a pharmaceutically acceptable salt thereof, budesonide or a pharmaceutically acceptable salt thereof, and formoterol or a pharmaceutically acceptable salt thereof; and a plurality of respirable suspending particles comprising phospholipid particles, wherein the phospholipid particles comprise perforated microstructures; and wherein the plurality of suspending particles and the plurality of active agent particles are co-suspended in the suspension medium at a weight ratio of total mass of suspending particles to total mass of active agent particles that ranges from above 1:1; and administering the pharmaceutical composition to the patient by actuating the metered dose inhaler, wherein the administration comprises delivering a therapeutically effective amount of the active agents to the patient. The ’258 patent claims recite further limitations and therefore anticipate the current claims.
Claims 55-63 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 4, 5, 8, and 9 of U.S. Patent No. 9415009.
Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets are drawn to a method for treating a pulmonary disease or disorder in a patient, comprising: providing a metered dose inhaler comprising a pharmaceutical composition, wherein the pharmaceutical composition comprises: a suspension medium comprising a pharmaceutically acceptable propellant; a plurality of respirable active agent particles comprising a corticosteroid or a pharmaceutically acceptable salt thereof, budesonide or a pharmaceutically acceptable salt thereof, and formoterol or a pharmaceutically acceptable salt thereof; and a plurality of respirable suspending particles comprising phospholipid particles, wherein the phospholipid particles comprise perforated microstructures; and wherein the plurality of suspending particles and the plurality of active agent particles are co-suspended in the suspension medium at a weight ratio of total mass of suspending particles to total mass of active agent particles that ranges from above 1:1; and administering the pharmaceutical composition to the patient by actuating the metered dose inhaler, wherein the administration comprises delivering a therapeutically effective amount of the active agents to the patient. The ’009 patent claims recite further limitations and therefore anticipate the current claims.
Claims 55-63 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 26 of copending Application No. 18/577168 (sharing a common inventor).
Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets are drawn to a method for treating a pulmonary disease or disorder in a patient, comprising: providing a metered dose inhaler comprising a pharmaceutical composition, wherein the pharmaceutical composition comprises: a propellant; a plurality of respirable active agent particles comprising an inhaled corticosteroid (ICS) that includes budesonide and a long-acting β2-agonist (LABA) that includes formoterol (see claims 4, 5); and a plurality of respirable suspending particles comprising phospholipid particles, wherein the phospholipid particles comprise perforated microstructures; and administering the pharmaceutical composition to the patient by actuating the metered dose inhaler, wherein the administration comprises delivering a therapeutically effective amount of the active agents to the patient. The present claims recite at a weight ratio of total mass of suspending particles to total mass of active agent particles that ranges from above 1:1 up to 200:1; however the ’168 application’s claims recite phospholipid particle concentration of about 0.1 mg/mL to about 10 mg/mL, LABA at 0.01 mg/mL to about 1 mg/mL, and ICS at about 0.1 mg/mL to about 20 mg/mL (see claims 7-10). Therefore the weight ratio of the phospholipid particle to the sum of LABA and ICS ranges substantially overlaps that in the present claims.
This is a provisional nonstatutory double patenting rejection.
Claims 55-63 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 26 and 27 of copending Application No. 18/590826 (sharing a common inventor).
Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets are drawn to a method for treating a pulmonary disease or disorder in a patient, comprising: providing a metered dose inhaler comprising a pharmaceutical composition, wherein the pharmaceutical composition comprises: a propellant; a plurality of respirable active agent particles comprising budesonide and formoterol; and a plurality of respirable suspending particles comprising phospholipid particles, wherein the phospholipid particles comprise perforated microstructures; and administering the pharmaceutical composition to the patient by actuating the metered dose inhaler, wherein the administration comprises delivering a therapeutically effective amount of the active agents to the patient. The present claims recite at a weight ratio of total mass of suspending particles to total mass of active agent particles that ranges from above 1:1 up to 200:1; however the ’826 application’s claims recite phospholipid particle concentration of 0.1 mg/mL to 10 mg/mL, formoterol at 0.01 mg/mL to 1 mg/mL, and budesonide at 0.1 mg/mL to about 20 mg/mL (see claims 6, 9, 10). Therefore the weight ratio of the phospholipid particle to the sum of LABA and ICS ranges substantially overlaps that in the present claims.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to H. S. PARK whose telephone number is (571)270-5258. The examiner can normally be reached on weekdays.
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/H. SARAH PARK/Primary Examiner, Art Unit 1614