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 .
DETAILED ACTION
The office acknowledges Applicants filing of the claim amendments on 7/19/2024. Claims 3, 5, 7, 9, 11, 13-15 has been amended and claims 17-18 have been added new. Claims 1-18 are pending. For the sake of compact prosecution the attorney of record, Luke Kilyk was contacted on 5/13/2026. Attorney Kilyk on 5/15/2026 elected Group I, claims 1-12, 15-18 with traverse. However Applicants’ have not put forth any arguments. Applicants have further elected the species, formoterol (beta-2-agonist), beclomethasone (steroid) and iptratropium bromide (muscarinic antagonist) for examination. The restriction requirement is made final. Claims 13-14 are withdrawn from further consideration pursuant to 37 C.F.R. 1.142(b), as being drawn to non-elected subject matter. Claims 1-12, 15-18 read on Group I and elected species and are examined based on the merits herein.
Application Priority
This application filed 07/19/2024 is a National Stage entry of PCT/GB2023/ 050117, International Filing Date: 01/20/2023, claims foreign priority to 2200809.8, filed 01/21/2022.
Information Disclosure Statement
The information disclosure statement(s) (IDS) filed on 7/19/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDS is being considered by the Examiner.
Election/Restrictions
REQUIREMENT FOR UNITY OF INVENTION
As provided in 37 CFR 1.475(a), a national stage application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept (“requirement of unity of invention”). Where a group of inventions is claimed in a national stage application, the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression “special technical features” shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art.
The determination whether a group of inventions is so linked as to form a single general inventive concept shall be made without regard to whether the inventions are claimed in separate claims or as alternatives within a single claim. See 37 CFR 1.475(e).
When Claims Are Directed to Multiple Categories of Inventions:
As provided in 37 CFR 1.475 (b), a national stage application containing claims to different categories of invention will be considered to have unity of invention if the claims are drawn only to one of the following combinations of categories:
(1) A product and a process specially adapted for the manufacture of said product; or
(2) A product and a process of use of said product; or
(3) A product, a process specially adapted for the manufacture of the said product, and a use of the said product; or
(4) A process and an apparatus or means specifically designed for carrying out the said process; or
(5) A product, a process specially adapted for the manufacture of the said product, and an apparatus or means specifically designed for carrying out the said process.
Otherwise, unity of invention might not be present. See 37 CFR 1.475 (c).
Restriction is required under 35 U.S.C. 121 and 372.
This application contains the following inventions or groups of inventions which are not so linked as to form a single general inventive concept under PCT Rule 13.1.
In accordance with 37 CFR 1.499, applicant is required, in reply to this action, to elect a single invention to which the claims must be restricted.
Group I, claim(s) 1-12, 15-18 are drawn to an inhalable formulation comprising at least one amino acid, at least one beta2-agonist comprising a benzylic hydroxyl moiety and a propellant; wherein the inhalable formulation is a solution formulation in which the at least one beta2-agonist is dissolved in solution.
Group II, claims 13-14 are drawn to a method of prevention or treatment of a disease of the lungs and/or respiratory tracts, said method comprising administering the inhalable formulation according to claim 1 to a person in need thereof.
The groups of inventions listed above do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons:
Groups I-II lack unity of invention because even though the inventions of these groups require the technical feature of the inhalable formulation comprising amino acid, a beta-agonist and a propellent. WO 0016814 teach aerosol formulation comprising an active ingredient, e.g. formoterol, an amino acid, e.g. leucine and a propellent (See claims 1-8). The formulations can be prepared in solution form in order to avoid the concern for proper particle size in the formulation for dispensing (See p 1, lines 18-21).
Unity of invention links the various inventions together by sharing a common special technical feature in each invention. However, when the special technical feature is not a contribution over the prior art, the various inventions may be restricted from each other.
Applicant is advised that the reply to this requirement to be complete must include (i) an election of invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To preserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144.
Applicants are required to elect a single group for examination, e.g. Group I.
Election of Species
This application contains claims directed to more than one species of the generic invention. These species are deemed to lack unity of invention because they are not so linked as to form a single general inventive concept under PCT Rule 13.1.
The species are as follows:
Beta-agonist
Steroid
Muscarinic agonist
Disease of the lungs/respiratory to be treated or prevented.
The species listed above do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, the species lack the same or corresponding special technical features for the following reasons:
The species lack unity because the shared common technical feature is not a contribution over the prior art. Beta-agonist, steroids, muscarinic agonist are known in the prior art. The solution comprising beta-agonist and an amino acid can be arrived from the prior art and hence it cannot be considered a special technical feature.
As to the disease to be treated the disease of the lungs and/or respiratory tract include different and distinct etiology and pathophysiological manifestations, and that each is differently treated, for e.g. lung cancer, asthma etc. Disease states herein claimed do not flow from a single biochemical lesion, but form a range of physiological activities. Therefore the species election is proper, as they do not share a contribution over prior art. See MPEP 1850 and 37 CFR 1.475. Because the inventions lack unity for the reasons given above restriction for examination purpose as indicated is proper.
Applicant is required, in reply to this action, to elect a single species to which the claims shall be restricted if no generic claim is finally held to be allowable. The reply must also identify the claims readable on the elected species, including any claims subsequently added. An argument that a claim is allowable or that all claims are generic is considered non-responsive unless accompanied by an election.
Applicant is required to elect a single species of beta-agonist, steroid, muscarinic agonist and disease of the lungs/respiratory to be treated or prevented.
During a telephone conversation with attorney Kilyk on 5/15/2026 a provisional election was made with traverse to prosecute the invention of Group I, claims 1-12, 15-18 and species, formoterol (beta-2-agonist), beclomethasone (steroid) and iptratropium bromide (muscarinic antagonist). Affirmation of this election must be made by applicant in replying to this Office action. Claims 13-14 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention. It is noted that Applicants elected Group I and species as above but did not elect any species for the disease as Group II was not elected.
Upon the allowance of a generic claim, applicant will be entitled to consideration of claims to additional species which are written in dependent form or otherwise require all the limitations of an allowed generic claim. Currently, the following claim(s) are generic: 1-2, 5-7, 9, 11-12, 15-18.
The election of species may be made with or without traverse. To preserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable on the elected invention or species.
Should applicant traverse on the ground that the inventions or species have unity of invention (37 CFR 1.475(a)), applicant must provide reasons in support thereof. Applicant may submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. Where such evidence or admission is provided by applicant, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 of the other invention.
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/ apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
Claim Rejections - 35 USC § 103
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 1-12, 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Adjei et al. (IDS: WO 00/16814).
Adjei teach medicinal aerosol formulation comprising a therapeutically effective amount of a particulate medicament, e.g. formoterol, beclomethasone, ipratropium bromide etc., propellant, e.g. 1,1,1, 2-tetrafluoroethane, 1,1,1,2,3,3,3- heptafluoro propane or a mixture thereof and a stabilizer selected from an amino acid, e.g. leucine, valine, alanine etc. and a cosolvent, ethanol (See claims 1-8). Non-CFC propellants such as 1,1,1 ,2-tetrafluoroethane (Propellant 134a), 1,1,1 ,2,3,3,3-heptafluoropropane (Propellant 227) or mixtures thereof are preferred (See p 5, lines 9-11). Further taught is that a metered dose inhaler containing a medicinal aerosol formulation, the formulation comprising the medicament, amino acid and propellent (claim 14). Once prepared an aerosol formulation is filled into an aerosol canister equipped with a metered dose valve (See p 1, lines 22-23). It is taught that the formulation is for delivery of drugs to the lung by way of inhalation for treating a variety of conditions, e.g. bronchial asthma, COPD (p 1, lines 9-12, claim 11).
From the teachings of Adjei a person skilled in the art before the effective filing date of the invention would have found it obvious to arrive at the claimed inhalable solution formulation comprising a beta-agonist, formoterol, amino acid, leucine, and a propellent, e.g. HFA134A, a co-solvent, e.g. ethanol and the beta-agonist is dissolved in solution. A person skilled in the art would have been motivated to arrive at the inhalable formulation as claimed from Adjei with a reasonable expectation of success and to use it in treating conditions like asthma. Thus claims 1-6, 11-12, 18 are addressed. As to claims 7-10, 17, Adjei teach corticosteroid, beclomethasone, muscarinic agonist, ipratropium bromides are used as a medicament in the formulation and its use in treating lung conditions like asthma. A person skilled in the art would have found it obvious to combine two or more active agents that are known to be useful for the same utility in a formulation in expectation of additive or synergistic benefits. One of ordinary skill in the art would have been motivated to incorporate the agents herein in a single combination pharmaceutical composition because combining the agents herein each of which is known to be useful to treat a respiratory condition like asthma individually into a single composition useful for the very same purpose is prima facie obvious. See In re Kerkhoven 205 USPQ 1069.
Claims 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Adjei et al. (IDS: WO 00/16814) in view of Kaplan (Canadian Respiratory Journal, 2018, p 1-9).
Adjei teachings as discussed above. The above rejection is incorporated herein.
Adjei is not explicit in teaching the pressurized metered dose inhaler or the pressurized canister.
Kaplan teaches pressurized metered-dose inhalers (pMDIs) as one of the inhalation devices for delivery of drugs and pressurized canister of drug in solution or suspension, a chamber for producing an aerosol and a mouthpiece for inhalation (See p 2, col. 2, last para). Kaplan teach asthma and chronic obstructive pulmonary disease (COPD) are chronic inflammatory pulmonary diseases. Both disorders cause airflow limitation, and inhaled medications—including inhaled corticosteroids, short- and long-acting β2 agonists, and antimuscarinic drugs are central to their management. Inhaled therapy ensures rapid and direct delivery to the site of pathology and can be provided to patients via a range of devices, including nebulizers, pressurized metered-dose inhalers (pMDIs) (See p 1, 1. Introduction, col. 1, para 1).
From Kaplan a person skilled in the art before the effective filing date of the invention would have found it obvious to arrive at the pressurized metered dose inhaler and the pressurized canister for use in a pressurized metered dose inhaler. A person skilled in the art would have been motivated to arrive at claims 15-16 with a reasonable expectation of success and use the pressurized meter dose inhaler comprising the pressurized canister for inhalation therapy in pulmonary conditions.
Claims 1-12, 15-18 are rejected under 35 U.S.C. 103 as being unpatentable over Lewis et al. (IDS: WO 2007/121913) and Kaplan (Canadian Respiratory Journal, 2018, p 1-9) in view of Zhang et al. (IDS: WO 2021/068961) and Tong et al. (IDS: WO 2022/148418, priority date: 8/1/2021, 18/01/2021, see English translation).
Lewis et al. teach pharmaceutical solution formulations comprising wo or more active drug substances to the lung selected from beta2-agonist is formoterol, corticosteroid is selected from the group consisting of beclomethasone dipropionate, budesonide, antimuscarinic inhibitor, e.g. ipratropium bromide, the active dissolved in an HFA propellant (HFA 134a, HFA 227 and mixtures thereof) and ethanol as a co-solvent for pressurized metered dose inhalers able of providing therapeutical doses for the treatment of asthma or COPD (See abstract, claims, 1-14, p 3, lines 11-20, p 9, lines 9-10, p 10, lines 5-10, p 1, 11-14).
Kaplan teachings discussed as above.
The above prior art is not explicit in teaching amino acid in the formulation.
Zhang teach an inhalation solution pharmaceutical composition comprising indacaterol or a pharmaceutically acceptable salt thereof and amino acid, a pH adjusting agent (abstract, see claim 1) and HFA propellent (e.g. HFA 134A, HFA 227) (claim 36) for treating asthma or COPD (claim 47).
Tong teach pharmaceutical composition comprising active ingredient, formoterol, corticosteroid such as budesonide, tiotropium etc. and a hydrophobic amino acid selected from leucine, isoleucine, valine etc. (Abstract, p 4, para 7, 15). The respirable suspended particles are prepared by spray-drying a carrier solution, and the components contained in the suspended particles are pre-dissolved in the carrier solution (claim 40).
From Zhang and Tong a skilled artisan would have found it obvious to add amino acid to a solution formulation of Lewis that comprises a beta-agonist, a propellent and a co-solvent, e.g. ethanol. A skilled artisan would have been motivated to arrive at the claimed formulation by adding a carrier such as leucine, an amino acid with a reasonable expectation of success and to use the formulation in treating asthma or COPD. Thus claims 1-12, 17-18 are addressed. As to claims 15-16 from Lewis and Kaplan a person skilled in the art before the effective filing date of the invention would have found it obvious to arrive at the pressurized metered dose inhaler and the pressurized canister for use in a pressurized metered dose inhaler. A person skilled in the art would have been motivated to arrive at those claims with a reasonable expectation of success and use the pressurized meter dose inhaler comprising the pressurized canister for inhalation therapy in pulmonary conditions.
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.
Claims 3, 4, 8, 10 are 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.
Claims 3, 4, 8, 10 include a limitation of ‘derivative’ or ‘derivatives’. The term "derivative" is a relative term which renders the claims indefinite. In particular, "derivative" does not particularly point out the degree or type of derivation that a given compound may have in relation to the parent compound and still be considered a "derivative". According to Hackh's chemical dictionary, "derivative" is defined as a compound, usually organic obtained from another compound by a simple chemical process or an organic compound containing a structural radical similar to that from which it is derived (Hackh's chemical dictionary, 1972). The term ‘derivative’ includes salts, isomers, analogs, metabolites, prodrugs, crystals, polymorphs, solvates, hydrates etc. The claim does not set forth any metes and bounds for the terms and presents uncertainty with respect to the scope of the claims.
The primary purpose of this requirement of definiteness of claim language is to ensure that the scope of the claims is clear so the public is informed of the boundaries of what constitutes infringement of the patent. A secondary purpose is to provide a clear measure of what applicants regard as the invention so that it can be determined whether the claimed invention meets all the criteria for patentability and whether the specification meets the criteria of 35 U.S.C. 112, first paragraph with respect to the claimed invention.", (see MPEP § 2173).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to UMAMAHESWARI RAMACHANDRAN whose telephone number is (571)272-9926. The examiner can normally be reached M-F- 8:30-5:00 PM (PST).
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, Kortney Klinkel can be reached on 5712705239. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Umamaheswari Ramachandran/Primary Examiner, Art Unit 1627
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