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 .
Claims 1-4 and 6-8 have been presented for examination on the merits.
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 4 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 4 is indefinite for reciting -at least one or more-. This is indefinite because the term -at least- implies or more. Thus, it is not clear what is meant by at least one or more.
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.
Claim 1: A container comprising: (a) a capsule containing a respirable, dry powder particle surfactant formulation for pulmonary delivery comprising: i) at least 30% DPPC by weight of the particle; ii) about 2% NaCl by weight of the particle; iii) about 1% to about 10% by weight of the particle of excipient selected from leucine, trehalose; lactose or hydrogenated starch hydrolysate (HSH); and iv) about 1 to about 10% by weight of the particles of a surfactant protein, wherein all components of the dry powder particles amount to 100 weight percent; and (b) a desiccant.
Claim 1, 3-4 and 6-8 are rejected under 35 U.S.C. 103 as being unpatentable over Schmitke et al (US 20080226730) in view of Johnson et al (WO 2006055532) and Lipp et al (WO 2012030664).
Schmitke et al teach formulations having particles comprising phospholipids, bioactive agent and excipients and the pulmonary delivery thereof, dry powder inhaled insulin and improved formulations comprising DPPC, insulin and sodium citrate (See abstract).
Schmitke et al disclose one embodiment wherein the formulations have particles comprising, by weight, approximately 40% to approximately 60% DPPC, approximately 30% to approximately 50% insulin and approximately 10% sodium citrate, and embodiments wherein the particles comprise, by weight, approximately 75% to approximately 80% DPPC, approximately 10% to approximately 15% insulin and approximately 10% sodium citrate (See [0009]-[0010] and [0014]).
Schmitke et al also disclose methods for treating a human patient in need of insulin comprising administering pulmonarily to the respiratory tract of a patient in need of treatment, an effective amount of particles comprising by weight, approximately 40% to approximately 60% DPPC, approximately 30% to approximately 50% insulin and approximately 10% sodium citrate (See [0011]).
Disclosed is also a kit comprising two or more receptacles comprising an amount of dry powder in unit dosages selected from the said insulin formulations. For example, the formulation can be particles comprising, by weight, approximately 60% DPPC, approximately 30% insulin and approximately 10% sodium citrate for inhalation (See [0015]-[0016]). The receptacles are capsules (See [0114] and [0130]).
Schmitke et al further disclose that the powder was filled at approximately 8.7-mg quantities into size 2 hydroxypropylmethyl cellulose (HPMC) capsules and then packaged in Aclar-foil blister cards. The blister cards were sealed in aluminum foil bags, containing a small, food-grade desiccant bag for additional moisture protection (See [0152] and [0155]).
Additionally, it is disclosed that the combinations of one or more phospholipids with other materials also can be employed to achieve a desired matrix transition temperature. Examples include polymers, cholesterol, surfactants, etc. The said phospholipids include DPPC and DPPG (See [0053]-[0055]).
Schmitke et al further disclose particles including other materials such as, for example, buffer salts, polysaccharides, lactose, trehalose, cyclodextrins, proteins, peptides, polypeptides, etc (See [0079]). The said dry powder may also comprise an amino acid such as leucine which may be present at a concentration of from 5 to 30% by weight (See [0077]-[0078]).
Schmitke et al lack a disclosure on the surfactant being surfactant proteins, especially sinapultide. This is taught by Johnson et al. Schmitke et al also lack a specific disclosure on the presence of sodium chloride or its amount. This is taught by Lipp et al.
Johnson et al teach methods of producing lung surfactant formulations through solvent dissolution and lyophilization as well as surfactant formulations derived therefrom and methods of treating respiratory distress dysfunction (See abstract).
It is stated that natural lung surfactants are protein/lipid compositions that are produced naturally in the lungs and are critical to the lungs' ability to absorb oxygen. Human surfactants primarily contain phospholipids, the major one being dipalmitoyl phosphatidyl-choline (DPPC), and four surfactant polypepides, A, B, C and D with surfactant protein B (SP-B) being essential for respiratory function (See [0038]).
A preferred SP-B mimetic is KL4 peptide (also known as sinapultide), which is a cationic peptide containing repeating lysine and leucine residues (See [0042]).
Examples of phospholipids useful in the said compositions include native and/or synthetic phospholipids, including dipalmitoyl phosphatidylcholine (DPPC), dioleoyl phosphatidylcholine (DOPC), palmitoyloleoyl phosphatidylglycerol (POPG), palmitoyloleoyl phosphatidylcholine (POPC), etc (See [0049]).
Johnson et al further disclose excipients that can be combined with the lung surfactant polypeptide, one or more lipids, and organic solvent system before lyophilization including, including various sugars such as dextrose, fructose, lactose, maltose, mannitol, sucrose, sorbitol, trehalose, and the like, salts such as NaCl, CaCl2 and the like, alcohols, such as cetyl alcohol, and buffers (See [0054]). Preferably, the lung surfactant peptide is combined with phospholipids and free fatty acids or fatty alcohols, e.g., DPPC (dipalmitoyl phosphatidylcholine), POPG (palmitoyl- oleyl phosphatidylglycerol) and palmitic acid (PA) (See [0055]).
It is further disclosed that in certain preferred embodiments, the lung surfactant composition is lucinactant or another lung surfactant formulation comprising the synthetic surfactant protein KLLLLKLLLLKLLLLKLLLL (KL4; SEQ ID NO:1). Lucinactant, is a combination of DPPC, POPG, palmitic acid (PA) and the KL4 peptide (weight ratio of approximately 7.5 : 2.5 : 1.35 : 0.267) (See [0056]).
Specifically, the dry lung surfactant compositions can be further processed and administered, for example, as a dry powder of an aerosol (See [0095]).
In one example, lipids and peptide were weighed and combined dry in a 20 ml scintillation vial (450 mg DPPC, 150 mg POPG, 81 mg PA, and 15.9 mg KL4 (purity adjusted)) (See [0113]).
Also, disclosed is that lyophilization vials (20 ml) were filled with 2 ml of 30 mg/ml KL4 lung surfactant containing DPPC (45 mg), POPG (15 mg), PA (8.1 mg) and KL4 (1.6 mg), dissolved in t-butanol. Lyophilized cakes were assayed by time of hydration with Tris-NaCl at room temperature (See [0118]).
Lipp et al teach respirable dry particles for delivery of divalent metal cation salts and/or monovalent cation salts to the respiratory tract (See abstract).
Lipp et al teach a formulation wherein the said monovalent metal cation salt is a sodium salt selected from the group consisting of sodium chloride (See [0012]).
Lipp et al disclose an embodiment wherein the respirable dry particles comprise a sodium salt, such as sodium chloride, in an amount between about 2% and about 20%, or between about 3.5% and about 10%> by weight of dry particle (See [00144]).
The said respirable dry particles can contain the amino acid leucine in an amount of about 5% to about 30% by weight or about 10% to about 20% by weight (See [00141]).
The said respirable dry particles can contain one or more surfactants, wherein suitable surfactants include L-alpha-phosphatidylcholine dipalmitoyl ("DPPC"), diphosphatidyl glycerol (DPPG), etc (See [00158]).
Lipp et al further disclose that the said respirable dry powder can comprise one or more excipients chosen from sugars (e.g., lactose, trehalose), amino acids (e.g., leucine, isoleucine), a phospholipid, e.g. dipalmitoylphosphosphatidylcholine (DPPC), diphosphatidyl glycerol (DPPG), etc, (See 00216]-[00217]).
It would have been prima facie obvious to a person of ordinary skilled in the art at the time the invention was made to have combined the teachings of Johnson et al and Lipp et al with that of Schmitke et al to arrive at the instant invention. It would have been obvious to do so because Schmitke et al teach inhalable powder formulations comprising phospholipids such as DPPC and a salt including sodium citrate as well as an active agent such as insulin for administration to the pulmonary system. Schmitke et al disclose that the concentration of DPPC in the formulation may be from about 40 to 80%. It is disclosed that the selection of the phospholipid affects the release rate of the active agent. Johnson et al also disclose inhalable formulations comprising a combination of phospholipids and in addition a surfactant protein for improved delivery and absorption of the active agent. Johnson et al teach that the surfactant proteins include KL4 (sinapultide). The dry powder formulations also may comprise excipients such as lactose and NaCl. Lipp et al teach respirable dry particles comprising a divalent and monovalent cation salt, wherein the monovalent salt is sodium chloride and is present at about 2% by weight of the particles. The particles also comprise excipients including lactose and leucine and surfactants including DPPC and DPPG.
As such it would have been obvious to one of ordinary kill in the art to have incorporated Johnson et al and Lipp et al’s components into the formulations of Schmitke et al with a reasonable expectation of success. Johnson et al’s sodium chloride and surfactant protein such as KL4 are disclosed as effective components in making dry powder formulations for inhalation. Lipp et al also teach similar compositions comprising 2% sodium chloride and phospholipids for effective delivery of active agents into the respiratory system.
Additionally, one of ordinary skill in the art would have been more than motivated to combine a phospholipid and a surfactant protein in a formulation to improve drug delivery and lung health in a patient in need thereof.
In other words, all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention.
Claims 1-4 and 6-8 are rejected under 35 U.S.C. 103 as being unpatentable over Hafner et al (US 20030091509) in combination with Blizzard et al (WO 2009026434) and Poutiatine et al (US 20130131586).
Hafner et al teach the use of pulmonary surfactant preparations for the prophylaxis or treatment of chronic pulmonary diseases in mammals (See abstract).
Hafner et al disclose the use of a powdered surfactant preparation comprising at least one phospholipid, pulmonary surfactant proteins SP-B and/or SP-C and/or modified derivatives thereof and excipients for the production of a medicament for the treatment of respiratory conditions. Particularly, powdered surfactant preparations obtainable by spray-drying are preferred. The preferred "phospholipids" are dipalmitoylphosphatidylcholine (DPPC), palmitoyloleylphosphatidylglycerol (POPG) and/or phosphatidylglycerol (PG). Particularly preferably, the phospholipids are mixtures of various phospholipids, in particular mixtures of dipalmitoyl-phosphatidylcholine (DPPC) and palmitoyloleylphosphatidylglycerol (POPG), preferably in the ratio from 7 to 3 to 3 to 7 (See [0011] and [0013]).
It is disclosed that the pulmonary surfactant preparations can also contain electrolytes such as calcium, magnesium and/or sodium salts (for example calcium chloride, sodium chloride) to establish an advantageous viscosity. Preferred preparations according to the invention contain 80 to 95% by weight of phospholipids, 0.5 to 3.0% by weight of pulmonary surfactant proteins, 3 to 15% by weight of fatty acid, preferably palmitic acid, and 0 to 3% by weight of calcium chloride (See [0012]).
Hafner et al disclose means of administration for the atomization of active compound powder. Preferably, the primary packaging is a glass bottle which can be sealed, for example, by a commercially available rubber stopper or a septum. A suitable secondary packaging which may be mentioned by way of example is a folding box (See [0016]).
Hafner et al teach production of powdered pulmonary surfactant preparations in Example 1, comprising mixing 7.0 g of 1,2-dipalmitoyl-3-sn-phosphatidylcholine, 2.5 g of 1-palmitoyl-2-oleoyl-3-sn-phosphatidylglycerol sodium, 205 mg of calcium chloride dihydrate, 250 mg of palmitic acid and 350 ml of a solution of rSP-C (FF/l) and spray dried. A relatively loose powder is obtained (See [0020]).
In Example 5, 0.5 g of KL4 (INN: sinapultide), 7.125 g of 1,2-dipalmitoyl-3-sn-phosphatidylcholine (DPPC) and 2.43 g of 1-palmitoyl-2-oleoyl-3sn-phosphatidylglycerol ammonium were mixed and a colorless powder is obtained (See [0024]).
Hafner et al lack a specific disclosure on the excipient being leucine or HSH. This would have been obvious to incorporate based on the teachings of Blizzard et al.
Hafner et al lack a specific disclosure on the presence of a desiccant. This well known in the art as taught by Poutiatine et al.
Blizzard et al teaches improved pharmaceutical formulations for pulmonary delivery having improved chemical and physical stability of the therapeutic, prophylactic or diagnostic agent as compared to formulations known in the art. The said formulations comprise a mass of biocompatible particles comprising an active agent, and a hydrogenated starch hydrosylate (HSH), preferably polyalditol. The improvement over the prior art comprises the presence of HSH in the pharmaceutical formulation. (See abstract).
The said composition is in the form of a dry powder (See claims 2 and 10 and Page 3, lines 20-24).
The said HSH is present in the said biocompatible particles is in an amount of at least 5% by weight (See Page 5, lines 15-29).
The composition also comprises an amino acid, preferably leucine which is present in an amount of from about 5 % to about 60%, preferably in an amount ranging from about 5 to about 30 wt% (See page 5, line 30 page 6, line 11 and claims 18-20)
It is disclosed that the particles can also include other materials such as buffer salts, polysaccharides, lactose, trehalose, cyclodextrins, proteins, polypeptides, fatty acids, inorganic compounds, and phosphates (See Page 6, lines 12-15).
Blizzard et al disclose that at least 80% of the mass of the biocompatible particles stored in the inhaler receptacle is delivered to a subject's respiratory system in a single, breath-activated step. The term "receptacle" includes a capsule, blister, film covered container well, chamber and other suitable means of storing a powder in an inhalation device known to those skilled in the art (See page 9, lines 29-33).
Blizzard et al exemplify preparation of spray-dried formulations comprising polyalditol / Citrate / Teriparatide (80/15.5/4.5), DPPC / Citrate / Teriparatide (80/15.5/4.5), DPPC / CaCl2 / Citrate / Teriparatide (70/10/15.5/4.5) (See pages 26-29).
Poutiatine et al teach drug storage and dispensing devices for dispensing a drug dosage form to a patient (See abstract and [0016]). Dosage form may be capsule (See [0081]).
It is disclosed that to protect the drug dosage forms from exposure to moisture either from humidity, saliva ingress, or accidental exposure to other water-based liquids, the dispensing device and the container or cartridge which houses the dosage form within the device may contain a desiccant. A mechanism to prevent saliva ingress includes inclusion of a desiccant, seals, absorbents, adsorbents wipers, and sensors. A desiccant is a sorbant, in the form of a solid, liquid, or gel that has an affinity for water, and absorbs or adsorbs moisture from the surrounding, thus controlling the moisture in the immediate environment. Any commercial desiccant which typically take the form of pellets, canisters, packets, capsules, powders, solid materials, papers, etc. There are many types of solid desiccants, including silica gel, alumino-silicate, zeolite, etc. (See [0183]).
It would have been prima facie obvious to a person of ordinary skilled in the art at the time the invention was made to have combined the teachings of Blizzard et al with that of Hafner et al to arrive at the instant invention. It would have been obvious to do so because Hafner et al teach powder formulations comprising surfactant proteins such as sinapultide, a combination of phospholipids, and excipients including NaCl and a sugar such as lactose for pulmonary delivery. Blizzard et al is in the same field of endeavor and teach powder formulations for inhalation comprising phospholipids, salts and respiratory active agents. Blizzard et al especially teach that HSH is a superior excipient and provides for an improved and stable formulation. Blizzard et al further teach that the said compositions may comprise an amino acid such as leucine which may be present at an amount of up to 30% by weight.
As such it would have been obvious to one of ordinary kill in the art to substitute Hafner et al’s lactose with Blizzard et al’s HSH with a reasonable expectation of success as Blizzard et al teach that HSH is superior to lactose and makes a better stable formulation for pulmonary delivery having improved chemical and physical stability of the therapeutic, prophylactic or diagnostic agent as compared to formulations known in the art.
That is, the claims would have been obvious because the substitution of one known element for another would have yielded predictable results to one of ordinary skill in the art at the time of the invention.
Additionally, the claims would have been obvious because the technique for improving a particular formulation was part of the ordinary capabilities of a person of ordinary skill in the art, in view of the teaching of the technique for improvement in other situations.
It also would have been prima facie obvious to a person of ordinary skilled in the art at the time the invention was made given the teaching of Hafner et al and Blizzard et al to have looked in the art for specific desiccants suitable for drug storage and degradation control as taught by Poutiatine et al with a reasonable expectation of success.
Specifically, Hafner et al teach dry powder formulations for inhalation comprising DPPC, a salt and excipients, wherein the powder formulation is placed in a capsule and stored in a container. Poutiatine et al teach drug storage and dispensing devices for dispensing a drug dosage form such as a capsule to a patient. To protect the drug dosage forms from exposure to moisture the dispensing device and the container contain a desiccant, such as silica gel, alumino-silicate, etc.
Accordingly, one of ordinary kill in the art would have been motivated to have looked in the art for suggestions on suitable method to prevent degradation of the formulations and to maintain stability such as desiccant material such as silica gel as taught by Poutiantine et al with a reasonable expectation of success.
That is, the claims would have been obvious because a person of ordinary skill has good reasons to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense.
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 1-4 and 6-8 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 and 5-6 of copending Application No. 17/892,436 (US 20240016823) in view of Hafner et al (US 20030091509) and Poutiatine et al (US 20130131586).
An obviousness-type double patenting rejection is appropriate because while the conflicting claims are not identical, the examined claims are not patentably distinct from the reference claims because the examined claims would have been obvious over the reference claims in view of Hafner et al and Poutiatine et al.
Specifically, the examined claims 1-4 are drawn to a container comprising: (a) a capsule containing a respirable, dry powder particle surfactant formulation for pulmonary delivery comprising: i) at least about 30% DPPC by weight of the particle; ii) about 2% NaCl by weight of the particle; and iii) an excipient selected from the group consisting of lactose, trehalose, leucine and hydrogenated starch hydrolysate (HSH); and iv) about 1 to about 10% by weight of the particles of a surfactant protein; wherein all components of the dry powder particles amount to 100 weight percent; and (b) a desiccant.
The reference claims are drawn to a method of treating a patient in need of lung surfactant therapy comprising administering a respirable, dry powder particle surfactant formulation for pulmonary delivery comprising: i) at least about 30% DPPC by weight of the particle; ii) 0.1% to 3% NaCl by weight of the particle; and iii) 10% to 30% by weight of the particle of an excipient selected from the group consisting of any one or more of leucine, magnesium lactate, trehalose, lactose, mannitol, albumin, or a hydrogenated starch hydrolysate (HSH); and iv) 1% to 10% by weight of the particle of SP-B surfactant protein or any active fragment, derivative, or modification thereof, wherein all components of the dry powder particles amount to 100 weight percent and wherein the surfactant protein is selected from the group consisting of SEQ ID Nos 1-16 pr an amino acid sequence homologues thereto with at least 90% identity at the amino acid level. The said powder further comprises at least one or more of DOPC, POPC, DPPE, DPPG or POPG.
The differences are minor and obvious. Particularly, the reference claims are drawn to a method of treating a patient by administering the said composition to the patient. Also, the reference claims do not recite the presence of the surfactant protein, sinapultide, while examined claims do. However, the said differences are obvious over the teachings of Hafner et al which teach a composition comprising one or more surfactant proteins including SP-B or KL4 (sinapultide) in addition to a combination of phospholipids, specifically DPPC. Hafner et al teach the administration of the said pulmonary surfactant preparation for the treatment of chronic pulmonary diseases including (COPD), asthma, cystic fibrosis, pulmonary fibrosis, pulmonary degeneration, chronic bronchitis or pulmonary emphysema. Thus, it would have been obvious to one of ordinary skill in the art to have treated lung surfactant conditions with the formulations as claimed based on the teachings of Hafner et al. The other minor difference is that examined claims recite the presence of a desiccant in the container, while reference claims do not. However as taught by Poutiatine et al, it would have been obvious to one of ordinary skill in the art to add a desiccant to a container to prevent degradation and increase shelf life of the formulation.
This is a provisional nonstatutory double patenting rejection.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Lipp (US 20160317503).
Lipp teach powder formulations containing zolmitriptan for pulmonary administration to the respiratory tract of a patient for the treatment of disease (See abstract and [0006]). Disclosed is a dry powder formulation comprising zolmitriptan, dipalmitoylphosphatidylcholine (DPPC), sodium chloride or sodium citrate and L-leucine or polyglycitol (See [0012]).
Lipp disclose a dry powder formulation comprising zolmitriptan, a phospholipid, a salt and an additional excipient which is an amino acid, a sugar or a sugar alcohol. (See [0011]).
The salts suitable for use in said powders and particles include sodium and potassium salts, such as sodium chloride (NaCl), sodium citrate, sodium lactate, calcium chloride, etc. A preferred salt is sodium chloride. Examples of amino acids include leucine, isoleucine, alanine, etc,. A preferred amino acid is L-leucine. Examples of sugars and sugar alcohols include maltodextrin, polyglycitol, lactose, trehalose and mannitol (See [0034]-[0036]).
Lipp disclose that the particles may comprise about 5 to about 50% zolmitriptan, about 5 to about 20% phospholipid, and about 1 to about 10% salt as measured by weight percent of dry solids in the powder (See 0041]).
The said inhalable powder is contained in a capsule (See [0061], [0063] and [0064]). The said zolmitriptan formulations are prepared and packaged in a manner that prevents or minimizes the degradation of the active ingredient due to oxidation of zolmitriptan. Zolmitriptan powders are produced and packaged in an environment in which the oxygen is minimized or excluded, such as under an atmosphere of an inert gas, in a final packaging (See [0074]).
Claims 1-4 and 6-8 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Mina Haghighatian whose telephone number is (571)272-0615. The examiner can normally be reached M-F, 7-5 EST.
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/Mina Haghighatian/
Mina Haghighatian
Primary Examiner
Art Unit 1616
Prosecution Insights