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 1-23 have been presented for examination on the merits.
Specification
The disclosure is objected to because of the following informalities:
Some of the active substances listed in the Specification are not known compounds and do not appear to be in existence. For example, tenovir, tenovir alafenamide, tenovir disoproxil, alafenamide, alafenamide fumarate, balavir, etc. the compound vicriviroc is also misspelled. The validity of all the listed compounds have not been verified by the Examiner.
The use of the term Polysorbate 80TM, which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears 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.
Appropriate correction is required.
Claim Objections
The claims are objected to because of the following informalities: some of the active substances listed in claim 1 are not known compounds and do not appear to be in existence. For example, tenovir, tenovir alafenamide, tenovir disoproxil, alafenamide fumarate, babavir, etc. The validity of all the listed compounds have not been verified by the Examiner.
Claim 6 is objected to for reciting the tradename “Polysorbate 80TM” without using the proper form and symbol.
Claims 21-23 are objected to for reciting that the amount is between ... to ...%”. The range should be between ... and …. .
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-23 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 1 includes the recitation of “pharmaceutically acceptable derivatives thereof”. The specification does not provide any support for this recitation as there are no definition, explanation or examples of any derivatives of the said active substances. Claims 2-23 encompass this limitation.
Claim 4 recites “sugar ester”. The specification does not provide any support for this recitation as there are not sufficient examples of sugar esters.
Claim 8 recites “organic salts”. The specification does not provide any support for this recitation as there are not sufficient examples of organic salts.
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 1-23 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 1-23 are indefinite because the preamble recites a composition in dry powder form, but the body of claim 1 recites the limitation of “and suspensions thereof”. Thus, it is not clear if the claimed composition is in the form of a dry powder or suspension.
Claims 1-23 are indefinite because claim 1 recites groups of Markush species using Markush format without the proper transitional phrase "consisting of", which is indefinite. Since the Markush groups are recited without the transition phrase “consisting of”, it is unclear whether the Markush species are limited to those recited in the claims or the Markush species can include those which are not recited in the claims. Since one of ordinary skill in the art would not be reasonably apprised what the scope of these Markush species is, the claims are rendered indefinite. Proper Markush language is “selected from the group consisting of A, B, C and D”. The examiner suggests rewording the claim to include the proper Markush language. Note: MPEP § 803.02.
Similarly, claims 1, 3-9 are indefinite for reciting groups of Markush species using Markush format without the proper transitional phrase "consisting of", which is indefinite. Since the Markush groups are recited without the transition phrase “consisting of”, it is unclear whether the Markush species are limited to those recited in the claims or the Markush species can include those which are not recited in the claims. Since one of ordinary skill in the art would not be reasonably apprised what the scope of these Markush species is, the claims are rendered indefinite. Proper Markush language is “selected from the group consisting of A, B, C and D”. The examiner suggests rewording the claim to include the proper Markush language. Note: MPEP § 803.02. Specifically, claim 4 recites that said carriers are carbohydrates, …… and β-D-Mannitol. Thus, it is not clear if all species are included in the carriers or the carrier is selected from the group consisting of… . Similarly, claim 5 recite that said glidants or lubricants are calcium stearate and magnesium stearate, claim 6 recites that said additives are hydrophobic amino acids, … and bile salts, etc. Thus, it is not clear if all species are included in each category or it is selected from the group consisting of… .
Claim 1 is also indefinite for reciting, “zalcatibine and salt forms thereof, and cyclodextrin complexes thereof and pharmaceutically acceptable derivatives thereof and water-soluble forms and suspensions thereof. Thus, it is not clear if the salt form is that of zalcatibine or any of the listed active substances. Similarly, it is not clear what the said cyclodextrin complexes, derivatives, and water- soluble forms are.
Claim 1 is further indefinite for reciting, “lung diseases including COVID-19”. It is unclear if “including” means “comprising” or “form example”.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 4 recites the broad recitation carbohydrate, and the claim also recites monosaccharides, fructose, galactose, glucose, D-mannose, sorbose, disaccharides, lactose, a-lactose monohydrate, trehalose, cellobiose, mono-, di- or poly-saccharides, sucrose, maltose, raffinose, trehalose, melezitose, etc. which are the narrower statement of the range/limitation; claim 4 recites the broad recitation amino acids, and the claim also recites glycine, arginine, aspartic acid, glutamic acid, etc. which are the narrower statement of the range/limitation; claim 4 recites the broad recitation citrates, and the claim also recites sodium citrate, zinc citrate, trisodium citrate acid, etc. which are the narrower statement of the range/limitation, claim 4 recites the broad recitation organic salts, and the claim also recites sodium citrate, sodium ascorbate, zinc citrate, trisodium citrate acid, etc. which are the narrower statement of the range/limitation, claim 4 recites the broad recitation phospholipids, and the claim also recites diphospotidylcholine which are the narrower statement of the range/limitation, claim 4 recites the broad recitation cyclodextrins, and the claim also recites 2-hydroxypropyl-3-cyclodextrin, which are the narrower statement of the range/limitation; claim 6 recites the broad recitation hydrophobic amino acids, and the claim also recites leucine, tyrosine, tryptophan, which are the narrower statement of the range/limitation; claim 6 recites the broad recitation polysorbates, and the claim also recites polysorbate 80, polyoxyethylene sorbitan monooleate (Also known as Polysorbate 80TM), sorbitan esters, polysorbate esters, which are the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 10 depends on claim 4 and is indefinite for reciting that the carrier is present between 70-100% by weight with respect to the total weight of the composition. The composition comprises one or more excipients and at least one active substance. Thus, it is not clear how the carrier can be present at 100% by weight of the composition.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 13 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 13 recites that “the pharmaceutical composition according to claim 4, characterized in that the carrier is in amorphous powder form or a crystalline powder form or a combination of amorphous and crystalline powder form”. As these are the three options available, the claim fails to further limit the scope of claim 4. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements”.
Claim Interpretation
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art.
The recitations/limitations such as “used against viral diseases…” or “for use in the treatment of symptoms of viral lung diseases…” are intended use limitations and not awarded patentable weight.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 3-4, 6, 9-10, 13 and 18-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CN 111202722 (English translation provided).
CN ‘722 teaches a lopinavir inhalation dry powder pharmaceutical composition, the composition containing lopinavir as an active ingredient and pharmaceutically acceptable auxiliary materials, and is formed by shearing and mixing, and targeted lung administration can be realized through a dry powder inhalation device (See abstract).
Regarding claims 1, 3-4, 6 and 9, CN ‘722 teaches a lopinavir inhalation dry powder pharmaceutical composition comprising lopinavir and pharmaceutically acceptable auxiliary materials, including a carrier or an excipient selected from sugar and sugar alcohol compounds, such as lactose, mannitol, trehalose, sucrose, sorbitol, glucose, β -cyclodextrin and dimethyl β -cyclodextrin, erythritol, small molecular amino acids such as alanine, valine, leucine, isoleucine, phenylalanine, etc, preferably lactose monohydrate, mannitol or leucine. The disclosure provides a novel dry powder pharmaceutical composition for inhalation comprising lopinavir, a dispersion aid and a pharmaceutically acceptable carrier, which can be administered to the lung via a dry powder inhalation device (See claim 1 and page 3, 3rd para).
Regarding claim 10, CN ‘722 teaches a composition comprising 70 g of lactose monohydrate carrier and 30 g of lopinavir wherein the total weight of the composition is 100 g (that is, lactose carrier is present at 70% of the composition) (See 4th page, bottom 3rd).
Regarding claim 13, CN ‘722 teaches that lopinavir, is amorphous, and does not disclose the form of the carrier material, however it anticipates the claim as the carrier is either crystal or amorphous or a combination of both.
Regarding claims 18-20, CN ‘722 teaches that the water (moisture) content of the composition is less than 5% and preferably 2% or less (See 3rd Page, last para).
Claims 1-6, 9 and 13-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2015027848 (English translation provided).
WO ‘848 teaches a method of administering a formulation comprising peramivir and/or derivative thereof; the method can treat colds caused by an influenza virus; and the administration is performed via a dry powder inhaler (See abstract).
Regarding claims 1, 3-4, 6 and 9, WO ‘848 teaches a dry powder composition comprising peramivir and a diluent, wherein the diluent is one or more of lactose, trehalose, starch, mannitol, hydrophobic amino acids or pharmaceutical lubricants (See claims 7-8).
Regarding claim 2, WO ‘848 teach that effective dose of peramivir is 5-300 mg per day, for example, 6 mg, 28 mg, 44 mg, 100 mg, 130 mg, 160 mg, 190 mg, and the like (See 3rd page, lower part and Examples 8-16).
Regarding claim 5, WO ‘848 teach an embodiment wherein the diluent is lactose, trehalose, starch, xylitol, mannitol, hydrophobic amino acids such as valine, leucine, isoleucine, valine, phenylalanine, or a mixture of two or more or a pharmaceutically acceptable lubricant such as magnesium stearate, sodium stearyl fumarate or the like (See middle of the 4th page and example 13).
Regarding claim 13, WO ‘848 teaches that peramivir, is amorphous, and does not disclose the form of the carrier material, however it anticipates the claim as the carrier is either crystal or amorphous or a combination of both.
Regarding claims 14-17, WO ‘848 teach that the dry powder has a particle size of 1-10 microns and preferably from 2 to 3 microns (See middle of 4th page and claims 19-22).
Claims 1, 3-4, 6 and 10-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sahakijpijarn et al (Development of Remdesivir as a Dry Powder for Inhalation by Thin Film Freezing) (provided by the IDS).
Sahakijpijarn et al teach dry powder formulations comprising remdesivir and one or more suitable excipient for administration by inhalation to a subject’s lung for treating COVID-19 caused by SARS-CoV-2. The said remdesivir dry powder for inhalation was formulated using thin film freezing (TFF) (See abstract).
Regarding claims 1, 3-4 and 6, Sahakijpijarn et al teach a dry powder formulation comprising remdesivir and suitable excipients including Captisol®, mannitol, lactose and leucine (Sulfobutylether-beta-cyclodextrin (SBECD, Captisol®) (See Page 4, 2.1 and 2.2).
Regarding claims 10-12, Sahakijpijarn et al teach a formulation that comprises 5% drug (remdesivir), wherein the remaining content is Captisol®, i.e. 95% of a carrier (See Table 1, formulation F1 and page 12, 3.2).
Regarding claim 13, Sahakijpijarn et al teach that Captisol® and lactose in the compositions were amorphous after the TFF process (See page 10, Last line of the paragraph).
Regarding claims, 14-17, it is disclosed that the MMAD of these TFF remdesivir powder formulations was 3.10 ± 0.04 µm, (See Page 12, 3.2).
Claims 1 and 3-4 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rahimpour et al (Alternative carriers in dry powder inhaler formulations) (Copy provided).
Rahimpour et al teach alternative carriers in dry powder inhaler formulations (See title and abstract).
Regarding claims 1 and 3-4, Rahimpour et al teach a dry powder formulation comprising interferon β and sorbitol (See Table 1).
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.
Claims 1, 3-7, 9-23 are rejected under 35 U.S.C. 103 as being unpatentable over Yadidi (US 20190336448).
Yadidi teach a stable dry powder composition for inhalation including acetylsalicylic acid in particles having a mass median aerodynamic diameter (MMAD) in a range of about 1 μm to about 5 μm. The dry powder composition may contain a pharmaceutically acceptable excipient, such as a stearate, in an amount ranging from about 0.04% (w/w) to about 0.06% (w/w), or from about 0.4% (w/w) to about 0.6% (w/w), of the composition (See abstract).
Regarding claims 1, 3-6, Yadidi teach stable dry powder compositions comprising an active pharmaceutical ingredient (API) and a stearate (e.g., magnesium stearate (MgST) and calcium stearate), wherein the said API include, NSAIDs (e.g., ASA, ibuproxam, indomethacin, ketoprofen), antiviral drug (e.g., acyclovir), etc (See [0037]).
Regarding claims 1, 3-7, 9, Yadidi teach that the said formulations may comprise other excipients including cyclodextrins and their derivatives, polyvinylpyrrolidine, mannitol, sorbitol, calcium carbonate, calcium phosphate, lactose, arabinose, mannose, sucrose, trehalose, etc (See [0124]), phospholipids (See [0126]-[0127]) or a fatty acid (See [0122]). It is also disclosed that the said dry powder formulation may comprise one or more additional excipients including acidifiers, alkalizers, buffers, antimicrobial agents, antioxidants, etc, (See [0130]).
Regarding claims 10-12, Yadidi teach a dry powder formulation wherein the excipient may be present at levels ranging from about 0% to about 99% (w/w) (See [0129]).
Regarding claim 13, Yadidi teach a dry powder formulation wherein the components are in an amorphous phase or convert to a crystalline phase in a controlled way (See [0144]).
Regarding claims 14-17, Yadidi teach a dry powder formulations wherein the particles have an MMAD of less than 10 microns, preferably from 1 to 5 microns (See [0043], [0068] and claims 6 and 11).
Regarding claims 18-20, Yadidi teach a dry powder formulation having a water content (moisture content) of less than about 10% by weight, less than about 5% by weight, less than about 3% by weight, less than about 2% by weight, less than about 1% by weight or be anhydrous (See [0094]).
Regarding claims 21-23, Yadidi teach a dry powder formulation comprising an API and magnesium stearate, wherein the amount of MgSt is up to about 1% w/w, up to about 0.5% w/w, up to about 0.05% w/w, etc, of the composition (See [0038], and claim 2).
Yadidi does not anticipate the claims because it does not expressly disclose a dry powder formulation comprising an active agent from the listed active agents of examined claim 1, however, Yadid fully teaches and suggest the claimed dry powder to one of ordinary skill in the art. Thus, 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 followed the teachings of Yadidi to arrive at the instant invention. One of ordinary skill in the art would have been motivated to follow Yadidi’s teachings to make and use the claimed dry powder formulation because Yadidi teach a dry powder formulation comprising one or more active substances wherein the active substance may be an antiviral agent such as acyclovir, magnesium stearate (or calcium stearate) and one or more carriers/excipients including cyclodextrins, polyvinylpyrrolidine, sorbitol, lactose, sucrose, trehalose, phospholipids, etc. Yadidi also disclosed that the said dry powder formulation may comprise one or more additional excipients including acidifiers, alkalizers, buffers. The said dry powder formulations are administered to a subject via inhalation by a dry powder inhaler. The composition showed high stability.
Thus, while the main active substance of Yadidi is acetylsalicylic acid, the incorporation of antiviral agent such as acyclovir is clearly disclosed and the advantages of making such stable dry powders is also disclosed. 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, 3-4, 6 and 8-20 are rejected under 35 U.S.C. 103 as being unpatentable over Clark et al (WO 2000015262).
Clark et al teach particulate compositions and methods for delivering an active agent to the lung of a human patient. The active agent formulation is in dry powder form and exhibits (i) low moisture sorption, and (ii) a resistance to hygroscopic growth, particularly under simulated lung conditions (See abstract).
Regarding claims 1, 3-4, 6 and 9, Clark et al teach that the active agent for incorporation in the said particulate compositions include antibiotics, antiviral agents such as interferon α, interferon β, respiratory syncytial virus antibody, etc, (See pages 10-11). The said hygroscopic growth inhibitor is selected from the group consisting of phospholipids, β-cyclodextrin, hydroxypropyl-β- cyclodextrin, sulfobutylether β-cyclodextrin, dextran, maltodextrin, etc (See page and claims 2-3). In addition to the hygroscopic growth inhibitor, the active agent powders may be combined with pharmaceutical carriers or excipients which are suitable for respiratory and pulmonary administration, including proteins, peptides, amino acids, and carbohydrates (e.g., sugars, including monosaccharides, di-, tri-, terra-, and oligosaccharides; derivatized sugars), etc. Exemplified excipients include human serum albumin (HSA), gelatin, alanine, glycine, arginine, glutamic acid, aspartic acid, cysteine, leucine, phenylalanine, fructose, lactose, sucrose, trehalose, raffinose, sorbitol (glucitol), etc (See pages 13-16). The dry powder is delivered via a dry powder inhaler (See page 27).
Regarding claims 1, 3 and 8, Clark et al teach that the said compositions may also include a buffer or a pH adjusting agent including organic acid salts such as salts of citric acid, ascorbic acid, carbonic acid, tartaric acid, etc, phosphate buffers, and additional excipients including sodium citrate (See para bridging pages 16-17).
Additionally, regarding claim 8, Clark et al teach preparing a dry powder composition and disclose that salmon calcitonin was dissolved in sodium citrate buffer containing mannitol and HSA to give an aqueous solution, followed by spray drying and collecting the fine white amorphous powder (See Example 1).
Regarding claims 10-12, Clark et al disclose that sCalcitonin powders which maintain an MMAD of 3.0 microns when delivered to the alveoli are prepared by incorporating one or more HGIs into the particles in concentrations of between about 10-90%, particularly 80 or 90% by weight HGI (See Page 25, lines 14-18). It is further disclosed that the particles will generally contain anywhere from 1% by weight to about 99% by weight active agent, typically from about 2% to about 95% by weight active agent (See paragraph bridging Pages 11-12).
Regarding claim 13, it is disclosed that the said dry powder active agent formulations are preferably prepared by spray drying under conditions which result in a substantially amorphous powder (See page 17, lines 13-14 and page 18, lines 28-29).
Regarding claims 14-17, Clark et al disclose particles for delivery of an active agent to the alveoli of a human patient, comprising the active agent and a hygroscopic growth inhibitor. The hygroscopic growth inhibitor is incorporated within the particles and the particles maintain an aerosol particle size distribution below 3 microns MMAD when delivered to the alveoli (See page 3, lines 17-22, claim 15).
Regarding claims 18-20, Clark et al teach that a dry powder typically contains less than about 10% moisture, preferably less than 5% moisture, and more preferably contains less than about 3% moisture (See Page 6, lines 15-21 and page 22, lines 8-12).
Clark et al do not anticipate the claims because they do not expressly disclose a dry powder formulation comprising an active agent from the listed active agents of examined claim 1, however, Clark et al fully teach and suggest the claimed dry powder to one of ordinary skill in the art. Thus, 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 followed the teachings of Clark et al to arrive at the instant invention. One of ordinary skill in the art would have been motivated to follow Clark et al’s teachings to make and use the claimed dry powder formulation because Clark et al teach a dry powder formulation comprising one or more active substances wherein the active substance may be an antiviral agent such as interferon α, interferon β and one or more carriers/excipients including cyclodextrins, sorbitol, lactose, sucrose, trehalose, phospholipids, etc. Clark et al disclose that the said compositions may also include a buffer or a pH adjusting agent including organic acid salts such as salts of citric acid, ascorbic acid, sodium citrate phosphate buffers, etc. The said dry powder formulations are administered to a subject via inhalation by a dry powder inhaler.
Thus, while Clark et al do not expressly disclose a dry powder composition comprising an active agent as claimed, they clearly teach and suggest a dry powder composition that may comprise an antiviral agent such as interferon alpha or beta and one or more suitable excipients. 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 1-23 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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sue X. Liu can be reached at 571-272-5539. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Mina Haghighatian/
Mina Haghighatian
Primary Examiner
Art Unit 1616
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