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 .
Election/Restrictions
Applicant's election with traverse of Group I (claims 1-18) drawn to a method for delivering an active ingredient by inhalation, comprising: atomizing a mixture of the active ingredient, an aqueous solution, and a lipid carrier into an aerosol; and administering an effective amount of the active ingredient to a subject in need thereof by inhalation of the aerosol into a respiratory system of the subject in the reply filed on April 16, 2026 is acknowledged. Applicant's election with traverse of pirfenidone as a species of an active ingredient; Lipoplus® as a species of a lipid carrier; phosphate buffered saline (PBS) as a species of a buffer; and alveoli as a species of a respiratory system in the reply filed on April 16, 2026 is also acknowledged.
The traversal is on the ground(s) that original claims 1 to 18 of the present application are directed to a method for delivering an active ingredient by inhalation and amended claims 19 and 20 of the present application are directed to a delivering system for delivering an active ingredient to a respiratory system of a subject in need thereof by inhalation, comprising the mixture of the active ingredient, the aqueous solution, and the lipid carrier of claim 1. Applicant argues that claims 1 to 20 of the present application have corresponding technical features and by conducting a search related to claimed "method for delivering an active ingredient by inhalation" (original claims 1 to 18) of the present application, there would be no serious burden to search or examine a delivering system for delivering an active ingredient to a respiratory system of a subject in need thereof by inhalation (amended claims 19 and 20), which all have corresponding special technical features over the citations.
This is not found persuasive because as detailed in the restriction requirement the inventions require a different field of search (e.g., employing different search strategies or search queries as well as searching different classes/subclasses or electronic resources) because the prior art applicable to the claimed composition may not be applicable to the method of using the composition because the composition can be used in a materially different method such as treatment of asthma. Furthermore, the Inventions are likely to raise different non-prior art issues under 35 U.S.C. 101 and/or 35 U.S.C. 112, first paragraph. As such a search for both groups would be a burden on the Office.
The requirement is still deemed proper and is therefore made FINAL.
Claims 12, 16, 19 and 20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected group or species, there being no allowable generic or linking claim.
Claims 1-11, 13-15, 17 and 18 are being examined as they read on the elected species.
Drawings Objection
Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
Specification Objection
The use of the terms Smoflipid®, Lipofundin®, Lipovenoes®, Lipovenos®, Intralipidand®, and Lipoplus®, which are trade names or marks used in commerce, has been noted in this application. The terms should be accompanied by the generic terminology; furthermore the terms should be capitalized wherever they appear or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
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 3-5 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 3-5 contain the trademarks/trade names Smoflipid®, Lipofundin®, Lipovenoes®, Lipovenos®, Intralipidand®, and Lipoplus®. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademarks/trade names are used to identify/describe lipid formulations comprising unknown components and, accordingly, the identification/description is 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, 6, 8, 9, 13-15 and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sonoke et al. U.S. 6,544,542 B1 (Provided on IDS).
Claims 1, 6, 8, 9, 13-15 and 18 of the instant application claim a method for delivering an active ingredient by inhalation comprising atomizing a mixture of the active ingredient, an aqueous solution, and a lipid carrier into an aerosol; and administering an effective amount of the active ingredient to a subject in need thereof by inhalation of the aerosol into a respiratory system of the subject.
Sonoke et al. teaches a pharmaceutical composition optimized for the administration of a drug, particularly a drug which is only sparingly soluble in water, by way of inhalation (abstract; column 1 lines 40-45). Sonoke et al. teaches a fat emulsion for inhalational administration, which is an o/w fat emulsion comprising fat emulsion particles essentially composed of an oil component, an emulsifying agent and a drug as dispersed in water, characterized in that the average particle diameter of said fat emulsion particles lies within the range of 5-100 nm (abstract; column 1 lines 46-59). Sonoke et al. teaches with the aid of a suitable inhaler, the inhalant readily yields a mist of aerosol particles fine enough to reach the alveolus (abstract). Sonoke et al. further teaches a method for administering a fat emulsion by way of inhalation, said fat emulsion being an o/w fat emulsion comprising fat emulsion particles essentially composed of an oil component, an emulsifying agent and a drug as dispersed in water and the average particle diameter of said fat emulsion particles being within the range of 5-100 nm (column 1 lines 60-66).
Sonoke et al. teaches that the oil component which can be used is not particularly restricted inasmuch as it is an oil component which can be used in pharmaceutical preparations and includes but is not limited to vegetable oil, animal oil, neutral lipid (mono-, di- or tri-substituted glyceride), synthetic lipid, and sterol derivatives (column 2 lines 2-7). Specifically, the vegetable oil includes soybean oil, cottonseed oil, rapeseedoil, sesame oil, corn oil, peanut oil, safflower oil, etc.; the animal oil includes fish oil, among others; the neutral lipid includes triolein, trilinolein, tripalmitin, tristearin, trimyristin, triarachidonin, etc.; the synthetic lipid includes azone, among others; the sterol derivative includes cholesteryl oleate, cholesteryl linoleate, cholesteryl myristate, cholesteryl palpitate, cholesteryl arachidate, and so on (column 2 lines 7-16). The preferred oil is soybean oil and highly purified soybean oil (preferably with a glyceride content of 99 weight % or more) is particularly useful (column 2 lines 17-19). Sonoke et al. teaches that the level of said oil component in the inhalant of the invention should vary with the species of oil and other components and may typically be 0.1-30 w/v %, and preferably 1-20 w/v % (column 2 lines 22-25).
Sonoke et al. teaches the preferred emulsifying agent includes egg yolk phosphatidylcholine, egg yolk lecithin and soybean lecithin, among others, and for practical purposes, egg yolk lecithin and soybean lecithin are preferred (column 2 lines 26-49). The level of said emulsifier in the inhalant of the invention should vary with the species of emulsifier and other components but may appropriately be 0.05-40 w/v %, preferably 0.1-20 w/v % (column 2 lines 50-53).
Sonoke et al. teaches the drug which can be used is not particularly restricted but is preferably a drug which is more readily lipid-soluble than water-soluble such as central nervous system drugs, peripheral nervous system drugs, sensory organ drugs, cardiovascular system drugs, respiratory system drugs, hormones, urogenital system drugs, drugs for anal diseases, vitamins, drugs for liver diseases, antigout drugs, enzymes, antidiabetics, immunosuppressants, cytoactivators, antitumoral drugs, radioactive drugs, antiallergic drugs, antibiotics, chemotherapeutic agents, biological drugs, and extracorporeal diagnostic agents (column 2 line 57-column 3 line 2). Sonoke et al. specifically teaches steroidal drugs and immunosuppressive drugs (column 3 lines 5-9, column 6 lines 25-67, column 7 lines 35-55).
Sonoke et al. teaches pharmaceutically acceptable additives such as the antioxidant, preservative, isotonizing agent, buffer, stabilizer, etc. as well as adjuvants and nutrients may also be formulated and these can be added generally in a suitable amount and need not be more than 10 w/v % (column 3 lines 57-62).
Sonoke et al. teaches that while the fat emulsion particles of the inhalant of the present invention disperse in water, the water may for example be tap water, purified water, distilled water, water for injection, an electrolyte solution such as saline or a glucose solution (column 4 lines 1-5).
Sonoke et al. further teaches that the inhalant of the invention can be administered to the human body through the nasal or oral cavity by generating aerosol particles of the inhalant with the aid of a device capable of generating an aerosol of an appropriate mist size according to the administration site (the upper respiratory tract, bronchioles, peripheral airways or alveolus) or the therapeutic objective (for the therapy of inflammation or for bronchodilation) (column 4 lines 47-54). Sonoke et al. teaches that the device for generating aerosol particles of the inhalant of the invention is not particularly restricted inasmuch as it is capable of producing aerosol particles 0.5-50 mm in diameter but is preferably a device adapted to generate an aerosol mist having a mass median aerodynamic diameter of 0.5-5 mm, particularly 1-2 mm (column 4 lines 54-59). Specific examples of such devices include pressure nebulizers and ultrasonic nebulizers (column 4 lines 59-61). Therefore, the invention encompasses a nebulizer preparation comprising the inhalant of the invention wherein the inhalant of the invention may also be provided in the form of an inhalation aerosol preparation comprising the inhalant described therein (column 4 lines 61-65). Sonoke et al. teaches that with the aid of a suitable inhaler, the inhalant is capable of delivering the drug entrapped in its fat emulsion vesicles far enough to the pulmonary alveolus to a achieve a systemic effect if desired (column 5 lines 20-25).
EXAMPLE 1 of Sonoke et al. contains 5 mg of drug, added to 500 mg of purified egg yolk lecithin, 500 mg of purified soybean oil, 9 mL of distilled water for injection and, further, 220 mg of glycerin to obtain a drug-containing fat emulsion (column 5 lines 30-42). After the emulsion was diluted with distilled water for injection to make 10 mL, it was filtered through a 0.22 mm membrane filter to give a sterilized preparation, which was then filled in injection ampules, 2.0 mL/ampule, under nitrogen gas in a clean bench to prepare the inhalant of the invention (column 5 lines 43-55). The Mass Median Aerodynamic Diameter (MMAD) and Its Distribution was also Determined wherein the drug-containing inhalant of Example 1 was used as a test sample (column 8 lines 50-57). A nebulizer body was attached to a Nissho model compressor and each sample was sprayed at a flow rate of 6 L/min. for 80 minutes to generate a mist of aerosol particles (column 9 lines 3-14). The aerosol particles thus produced were aspirated with a vacuum pump at a flow rate of 28.3 L/min and classified into multiple stages. The aerosol particles captured in each stage were washed with methanol and recovered, and its fluorescence intensity was measured to estimate the amount of the drug (column 9 lines 3-14).
Example 5 of Sonoke et al. contains 50 mg of an immunosuppressant drug (cyclosporin A) added to 500 mg of purified egg yolk lecithin (emulsifier), 500 mg of purified soybean oil (oil/lipid component), 9 ml of distilled water for injection and 220 mg of glycerin to obtain a cyclosporin A-containing fat/lipid emulsion (column 6 lines 42-52). This emulsion was diluted with distilled water for injection to make 10 mL and filtered through a 0.22 mm membrane filter and the sterile filtrate was filled into injection ampules, 2.0 mL per ampule, under nitrogen gas in a clean bench to give an inhalant of the invention (column 6 lines 52-56). Transmission electron microscopic observation revealed that these fat emulsion particles were uniform spherical nanospheres and no lipid bilayer structure like a liposome was observed (column 6 lines 59-62).
Sonoke et al. teaches that the advantages of the invention are the inhalant of the invention is low in viscosity and does not substantially produce a foam in the nebulizer or the like; it yields a mist of aerosol particles easily with the aid of a suitable inhaler such as a nebulizer; with the aid of a suitable inhaler, the inhalant of the invention readily yields a mist of aerosol particles fine enough to reach the alveolus; the inhalant is well amenable to size control of the aerosol particles; the inhalant of the invention can be used in expectation of a systemic effect by the pulmonary route, and therefore, it is not limited to topical application to the respiratory tract, bronchus, alveolus or the like; sustained action and improved bioavailability can be expected; it can be sterilized by filtration using a 0.22 mm membrane filter and therefore the invention is useful for heat-labile drugs which cannot be autoclaved for sterilization (column 12 line 63-column 13 line 15).
Claims 1-10 of Sonoke et al. claim a medical fat emulsion for inhalational administration to an individual, wherein said emulsion is an o/w fat emulsion comprising an aqueous dispersion of uniform and spherical ultrafine fat emulsion particles essentially composed of an oil component, a phospholipid and a sparingly water-soluble medical drug, wherein the average particle diameter of said fat emulsion particles is within a range of 5-100 nm, wherein the proportion of said oil component of the fat emulsion lies within the range of 0.1-30 w/v %, and is soybean oil and the phospholipid is egg yolk lecithin. Claim 12 of Sonoke et al. claims a method of administering a medical fat emulsion to an individual, wherein said fat emulsion is an o/w fat emulsion comprising an aqueous dispersion of uniform and spherical ultrafine fat emulsion particles, each composed essentially of an oil component, an emulsifying agent and a drug, wherein the average particle diameter of said fat emulsion particles is within the range of 5-100 nm, wherein said emulsion or said composition is administered by inhalation by said individual.
Thus Sonoke et al. specifically teaches a method for delivering an active ingredient such as an immunosuppressive drug or steroid by inhalation comprising atomizing a mixture of the active ingredient, an aqueous solution, and a lipid carrier which is a lipid/fat emulsion and preferably comprises soybean oil, into an aerosol; and administering an effective amount of the active ingredient to a subject in need thereof by inhalation of the aerosol into a respiratory system of the subject and thus the cited claims of the instant application are anticipated.
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.
Claims 2 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Sonoke et al. U.S. 6,544,542 B1 (Provided on IDS) as applied to claims 1, 6, 8, 9, 13-15 and 18 above.
Claims 2 and 7 of the instant application claim the aqueous solution comprises a buffer and that the soybean oil has a concentration less than 20% based on the total volume of the lipid carrier.
Said limitation as claimed in claim 2 is rendered obvious since as detailed above Sonoke et al. teaches pharmaceutically acceptable additives such as a buffer may also be added to the inhalant and these can be added generally in a suitable amount and need not be more than 10 w/v % (column 3 lines 57-62).
Said limitation as claimed in claim 7 of the instant application is rendered obvious since Sonoke et al. teaches the preferred oil is soybean oil and highly purified soybean oil is particularly useful and that the level of said oil component in the inhalant of the invention may typically be 0.1-30 w/v %, and preferably 1-20 w/v % (column 2 lines 17-19 and 22-25). Thus the amounts as taught in Sonoke et al. is within the range as claimed in claim 7.
In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (The prior art taught carbon monoxide concentrations of "about 1-5%" while the claim was limited to "more than 5%." The court held that "about 1-5%" allowed for concentrations slightly above 5% thus the ranges overlapped.); In re Geisler, 116 F.3d 1465, 1469-71, 43 USPQ2d 1362, 1365-66 (Fed. Cir. 1997) (Claim reciting thickness of a protective layer as falling within a range of "50 to 100 Angstroms" considered prima facie obvious in view of prior art reference teaching that "for suitable protection, the thickness of the protective layer should be not less than about 10 nm [i.e., 100 Angstroms]." The court stated that "by stating that ‘suitable protection’ is provided if the protective layer is ‘about’ 100 Angstroms thick, [the prior art reference] directly teaches the use of a thickness within [applicant’s] claimed range.").
Thus claims 2 and 7 of the instant application are rendered obvious over the teachings of Sonoke et al.
Claims 3-5 are rejected under 35 U.S.C. 103 as being unpatentable over Sonoke et al. U.S. 6,544,542 B1 (Provided on IDS) as applied to claims 1, 6, 8, 9, 13-15 and 18 above, and further in view of Szalay et al. U.S. Publication No. 2016/0339066 A1.
Claims 3-5 of the instant application claim the lipid emulsion comprises Lipoplus®.
Sonoke et al. is as set forth above.
Sonoke et al. does not teach Lipoplus®.
However, as detailed above Sonoke et al. teaches the use of a fat (lipid) emulsion comprising an oil component which can be one or more of a vegetable oil, animal oil, wherein specifically, the vegetable oil includes soybean oil; the animal oil includes fish oil, among others (column 2 lines 7-16). Sonoke et al. teaches that the level of said oil component in the inhalant of the invention should vary with the species of oil and other components and may typically be 0.1-30 w/v %, and preferably 1-20 w/v % (column 2 lines 22-25). Sonoke et al. teaches the preferred emulsifying agent for the fat emulsion includes egg yolk phosphatidylcholine, egg yolk lecithin and soybean lecithin, among others, and for practical purposes, egg yolk lecithin and soybean lecithin are preferred (column 2 lines 26-49). The level of said emulsifier in the inhalant of the invention should vary with the species of emulsifier and other components but may appropriately be 0.05-40 w/v %, preferably 0.1-20 w/v % (column 2 lines 50-53). As detailed above Sonoke et al. further teaches in the examples that the fat emulsion contain glycerin.
Szalay et al. teaches that prior to the effective filing date of the claimed invention lipid emulsions which meet the requirements of the lipid emulsion taught in Sonoke et al. were commercially available [0498]. For example, Lipofundin ® which contains Soybean oil (5%), coconut oil (5%), egg phospholipid (1.2%) and Glycerol (2.5 %); another Lipofundin ® which contains Soybean oil (10%), coconut oil (10%), Egg phospholipid (1.2%), and Glycerol (2.5%); SMOFlipid ® which contains Soybean oil (6%), coconut oil (6%), olive oil (5%), fish oil (3%), Egg phospholipid (1.2%), and Glycerol (2.5%); and Lipoplus ® which contains Coconut oil (10%), soybean oil (8%), fish oil (2%), Egg phospholipid (1.2%), and Glycerol (2.5%) (Table 1 page 62).
Accordingly, prior to the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to use a commercially available lipid emulsion which contains as taught by Sonoke et al. (1). an oil component which can be one or more of vegetable oil, and animal oil, wherein specifically, the vegetable oil includes soybean oil; the animal oil includes fish oil, among others wherein that the level of said oil component in may typically be 0.1-30 w/v %, and preferably 1-20 w/v %; (2). an emulsifying agent such as egg yolk phosphatidylcholine, egg yolk lecithin and soybean lecithin, among others, wherein the level of said emulsifier may appropriately be 0.05-40 w/v %, preferably 0.1-20 w/v %; and (3) glycerin (same as glycerol); such as Lipoplus ® which contains Coconut oil (10%), soybean oil (8%), fish oil (2%), Egg phospholipid (1.2%), and Glycerol (2.5%) as taught by Szalay et al. Thus since Lipoplus ® is a suitable lipid emulsion having the same components as taught by Sonoke et al. and is commercially available, an ordinary skilled artisan would have been motivated to use Lipoplus® as a lipid/fat emulsion in the inhalant of Sonoke et al. with a reasonable expectation of similar success. Thus claims 3-5 are rendered obvious in view of the cited prior art teachings.
Claims 10, 11, 15 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Sonoke et al. U.S. 6,544,542 B1 as applied to claims 1, 2, 6-9, 13-15 and 18 above, and further in view of Surber U.S. Publication No. 2013/0310424 A1.
The cited claims of the instant application claim the addition of a saline buffer such as phosphate buffered saline having a pH of about 6.0 to about 8.0; pirfenidone as the active ingredient; and the lipid carrier in an amount ranging from volume percentage about 0.5% to about 40%.
With respect to the claimed limitation that and the lipid carrier is in an amount ranging from volume percentage about 0.5% to about 40%, Sonoke et al. teaches that the lipid emulsion is comprised an oil component and an emulsifier. Sonoke et al. teaches that the level of said oil component in the inhalant of the invention should vary with the species of oil and other components and may typically be 0.1-30 w/v %, and preferably 1-20 w/v % (column 2 lines 22-25). Sonoke et al. further teaches the level of said emulsifier in the inhalant of the invention should vary with the species of emulsifier and other components but may appropriately be 0.05-40 w/v %, preferably 0.1-20 w/v % (column 2 lines 50-53). Thus combining the oil component with the emulsifier component in amounts as taught in Sonoke et al. would overlap with the range as claimed in the instant claims. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (The prior art taught carbon monoxide concentrations of "about 1-5%" while the claim was limited to "more than 5%." The court held that "about 1-5%" allowed for concentrations slightly above 5% thus the ranges overlapped.); In re Geisler, 116 F.3d 1465, 1469-71, 43 USPQ2d 1362, 1365-66 (Fed. Cir. 1997) (Claim reciting thickness of a protective layer as falling within a range of "50 to 100 Angstroms" considered prima facie obvious in view of prior art reference teaching that "for suitable protection, the thickness of the protective layer should be not less than about 10 nm [i.e., 100 Angstroms]." The court stated that "by stating that ‘suitable protection’ is provided if the protective layer is ‘about’ 100 Angstroms thick, [the prior art reference] directly teaches the use of a thickness within [applicant’s] claimed range.").
With respect to claim 15 of the instant application which recites that the active agent is pirfenidone, Sonoke et al. teaches that the drug which can be used is not particularly restricted but is preferably a drug which is more readily lipid-soluble than water-soluble such as respiratory system drugs (column 2 line 57-column 3 line 2).
Surber teaches the use of pirfenidone for the treatment of pulmonary diseases such as interstitial lung disease and further teaches delivery by inhalation [0003]-[0004]. Surber teaches that the Pirfenidone formulations can be separated into two groups; those of simple formulation and complex formulations providing taste-masking for improved tolerability, pH-optimized for stability and tolerability, immediate or sustained-release, and/or area-under-the-curve (AUC) shape-enhancing properties [0420]. Surber teaches that complex formulations may include water-based liquid formulations for nebulization which consist of pirfenidone or pyridone analog compound encapsulated or complexed with water-soluble excipients such as lipids [0420]. Surber teaches that Pirfenidone is water soluble at pH 4 to pH 8, are stable in aqueous solution and have limited to no taste [0422]. Surber teaches the use of a buffer such as a phosphate buffer that is present at a concentration sufficient to maintain, or maintain after titration with acid or base, a pH from about 4.0 to about 8.0 for a time period sufficient to enable marketable product shelf-life storage [0446]. Surber teaches the pH should be between about pH 4.0 and about pH 8.0, such as between about pH 6.0 and about pH 8.0 [0510]. A preferred buffer is a phosphate buffer [0513]. Surber teaches that pirfenidone formulations are stable at pH 6.5 with the use of a phosphate buffer [0638].
Accordingly, prior to the effective filing date of the claimed invention, it would have been prima facie obvious to prepare a fat emulsion composition suitable for inhalation based on the teachings of Sonoke et al. using pirfenidone as an active agent since Sonoke et al. teaches that the drug which can be used is not particularly restricted but is preferably a drug which is more readily lipid-soluble than water-soluble such as respiratory system drugs, and Surber et al. teaches that pirfenidone that treats respiratory illnesses and can be administered by inhalation. Thus an ordinary skilled artisan would have been motivated to formulate pirfenidone according to the teachings of Sonoke et al. with a reasonable expectation of success.
With respect to the limitations of claims 10, 11 and 17, which claim the addition of a saline solution comprising at least one pharmaceutically acceptable salt of phosphate, i.e. a phosphate buffered saline (PBS), Sonoke et al. teaches that while the fat emulsion particles of the inhalant of the present invention disperse in water, the water may for example be an electrolyte solution such as saline (column 4 lines 1-5). Thus an ordinary skilled artisan would have been motivated to disperse the fat emulsion formulation in an aqueous saline solution with a reasonable expectation of similar success as water.
In addition, based on the teachings of Surber which teaches that pirfenidone formulations for use in inhalation are stable at pH between 4.0 and 8.0, specifically pH 6.5 with the use of a phosphate buffer to maintain the pH, it would have been obvious to a person of ordinary skill in the art to modify the fat emulsion formulation in an aqueous saline solution as taught by Sonoke et al. with a phosphate buffer to maintain the pH at 6.5 when pirfenidone is used as an active ingredient with a reasonable expectation of improving the properties of the composition by improving stability of the composition.
Thus the cited claims of the instant application are rendered obvious in view of the cited prior art teachings.
Conclusion
Claims 1-11, 13-15, 17 and 18 are rejected. Claims 12, 16, 19 and 20 are withdrawn. No claims are allowed.
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/KARA R. MCMILLIAN/Primary Examiner, Art Unit 1623
KRM
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