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 1-20 are presented for examination.
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.
Claim(s) 1, 4, 5, 6, 7, 8, 10, 14, 15 and 18-20 is/are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Holm et al. (US 20080249076).
The claims are drawn to an excipient granulation comprising a plurality of excipient granules, wherein the excipient granules comprise:
a viscosifying agent;
a disintegrant; and
one or more additional excipients.
Regarding claim 1, Holm teaches a solid pharmaceutical composition comprising danazol dissolved in a solid carrier formulated for oral administration. See Para [0002]. The use of one or more excipients is taught in Para [0018]. Holm teaches that examples of suitable excipients for use in a composition or solid dosage form according to the invention include fillers, diluents, disintegrants, binders, lubricants etc. or mixture thereof. As the composition or solid dosage form according to the invention may be used for different purposes, the choice of excipients is normally taken into consideration. Other pharmaceutically acceptable excipients for suitable use are e.g. acidifying agents, alkalizing agents, preservatives, antioxidants, buffering agents, chelating agents, coloring agents, complexing agents, emulsifying and/or solubilizing agents, flavors and perfumes, humectants, sweetening agents, wetting agents etc. See Para [0078]. The use of disintegrants is taught in para [0081]. The use of xanthan gum as viscosifying agent is taught in Para [0157]. The use of granules is taught in Paras [0142] and [0211]. Holm makes clear that the composition of claim 1 is old and well known.
Regarding claim 4, Holm teaches the use of xanthan gum in Para [0157].
Regarding claim 5, Holm teaches the use of crospovidone in Para [0081].
Regarding claim 6, Holm teaches that examples of suitable excipients for use in a composition or solid dosage form according to the invention include fillers, diluents, disintegrants, binders, lubricants etc. or mixture thereof. As the composition or solid dosage form according to the invention may be used for different purposes, the choice of excipients is normally made taken such different uses into considerations. Other pharmaceutically acceptable excipients for suitable use are e.g. acidifying agents, alkalizing agents, preservatives, antioxidants, buffering agents, chelating agents, coloring agents, complexing agents, emulsifying and/or solubilizing agents, flavors and perfumes, humectants, sweetening agents, wetting agents etc. See Para [0078].
Regarding claim 8, Holm teaches a solid pharmaceutical composition comprising danazol dissolved in a solid carrier formulated for oral administration. see Para [0002]. The use of one or more excipients is taught in Para [0018]. Holm teaches that examples of suitable excipients for use in a composition or solid dosage form according to the invention include fillers, diluents, disintegrants, binders, lubricants etc. or mixture thereof. As the composition or solid dosage form according to the invention may be used for different purposes, the choice of excipients is normally taken such different uses into considerations. Other pharmaceutically acceptable excipients for suitable use are e.g. acidifying agents, alkalizing agents, preservatives, antioxidants, buffering agents, chelating agents, coloring agents, complexing agents, emulsifying and/or solubilizing agents, flavors and perfumes, humectants, sweetening agents, wetting agents etc. See Para [0078]. The use of disintegrants is taught in para [0081]. The use of xanthan gum as viscosifying agent is taught in Para [0157]. The use of granules is taught in Paras [0142] and [0211].
Regarding claim 10, Holm teaches the use of danazole in combination with excipient in a pharmaceutical formulation. See Paras {0022] and [0018].
Regarding claim 13, Holm teaches a solid pharmaceutical composition comprising danazol dissolved in a solid carrier formulated for oral administration. see Para [0002]. The use of one or more excipients is taught in Para [0018]. Holm teaches that examples of suitable excipients for use in a composition or solid dosage form according to the invention include fillers, diluents, disintegrants, binders, lubricants etc. or mixture thereof. As the composition or solid dosage form according to the invention may be used for different purposes, the choice of excipients is normally taken into considerations. Other pharmaceutically acceptable excipients for suitable use are e.g. acidifying agents, alkalizing agents, preservatives, antioxidants, buffering agents, chelating agents, coloring agents, complexing agents, emulsifying and/or solubilizing agents, flavors and perfumes, humectants, sweetening agents, wetting agents etc. See Para [0078]. The use of disintegrants is taught in para [0081]. The use of xanthan gum as viscosifying agent is taught in Para [0157]. The use of granules is taught in Paras [0142] and [0211]. The composition taught by Holm reads on a product.
Regarding claim 14, Holm teaches that the excipients or the composition comprising an active ingredient and an excipient can be in the form of granules. See Paras [0142] and [0211].
Regarding claim 15, Holm teaches that the pharmaceutical formulation can be placed in a sachet. See Para [0130].
Regarding Claims 19 and 20, Holm teaches Solid dispersions (solvent method) are prepared by dissolving a physical mixture of the active substance (e.g. a drug substance) and the carrier in a common organic solvent, followed by evaporation of the solvent. The carrier is often a hydrophilic polymer. Suitable organic solvents include pharmaceutical acceptable solvent in which the active substance is soluble such as methanol, ethanol, methylene chloride, chloroform, ethylacetate, acetone or mixtures thereof. See Para [0133].
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Holm et al. (US 20080249076).
The claims are drawn to an excipient granulation comprising a plurality of excipient granules, wherein the excipient granules comprise:
a viscosifying agent;
a disintegrant; and
one or more additional excipients.
Regarding claim 1, Holm teaches a solid pharmaceutical composition comprising danazol dissolved in a solid carrier formulated for oral administration. see Para [0002]. The use of one or more excipients is taught in Para [0018]. Holm teaches that examples of suitable excipients for use in a composition or solid dosage form according to the invention include fillers, diluents, disintegrants, binders, lubricants etc. or mixture thereof. As the composition or solid dosage form according to the invention may be used for different purposes, the choice of excipients is normally taken into considerations. Other pharmaceutically acceptable excipients for suitable use are e.g. acidifying agents, alkalizing agents, preservatives, antioxidants, buffering agents, chelating agents, coloring agents, complexing agents, emulsifying and/or solubilizing agents, flavors and perfumes, humectants, sweetening agents, wetting agents etc. See Para [0078]. The use of disintegrants is taught in para [0081]. The use of xanthan gum as viscosifying agent is taught in Para [0157]. The use of granules is taught in Paras [0142] and [0211]. Holm makes clear that the composition of claim 1 is old and well known.
Regarding claim 2, Holm in Para [0195] teaches the use of viscosity agents, disintegrants and other excipients at the concentrations within the scope of the claimed invention.
Regarding claim 3, Holm in Para [0076] teaches the particulate material of a pharmaceutical composition has a mean diameterfrom about 100 to about 1500 .mu.m, from about 100 to about 1000 .mu.m or from about 100 to about 700 .mu.m, or at the most about 400 .mu.m or at the most 300 .mu.m such as, e.g., from about 50 to about 400 .mu.m such as, e.g., from about 50 to about 350 .mu.m, from about 50 to about 300 .mu.m, from about 50 to about 250 .mu.m or from about 100 to about 300 .mu.m.
Regarding claim 4, Holm teaches the use of xanthan gum in Para [0157].
Regarding claim 5, Holm teaches the use of crospovidone in Para [0081].
Regarding claim 6, Holm teaches that examples of suitable excipients for use in a composition or solid dosage form according to the invention include fillers, diluents, disintegrants, binders, lubricants etc. or mixture thereof. As the composition or solid dosage form according to the invention may be used for different purposes, the choice of excipients is normally taken such different uses into considerations. Other pharmaceutically acceptable excipients for suitable use are e.g. acidifying agents, alkalizing agents, preservatives, antioxidants, buffering agents, chelating agents, coloring agents, complexing agents, emulsifying and/or solubilizing agents, flavors and perfumes, humectants, sweetening agents, wetting agents etc. See Para [0078].
Regarding claim 7, Holm teaches the viscosity Brookfield of from 200-4000 CPS. Holm does not teach the viscosity within 40cP to 100 cP. However, the determination of optimum viscosity is considered to be within the skill of artisan in the absence of evidence to the contrary. The process of mixing the excipients with water at specific temperature is part of the process of making and not the composition as claimed in claim 1. Using a specific viscometer does not create a patentably distinct composition.
Regarding claim 8, Holm teaches a solid pharmaceutical composition comprising danazol dissolved in a solid carrier formulated for oral administration. see Para [0002]. The use of one or more excipients is taught in Para [0018]. Holm teaches that examples of suitable excipients for use in a composition or solid dosage form according to the invention include fillers, diluents, disintegrants, binders, lubricants etc. or mixture thereof. As the composition or solid dosage form according to the invention may be used for different purposes, the choice of excipients is normally taken such different uses into considerations. Other pharmaceutically acceptable excipients for suitable use are e.g. acidifying agents, alkalizing agents, preservatives, antioxidants, buffering agents, chelating agents, coloring agents, complexing agents, emulsifying and/or solubilizing agents, flavors and perfumes, humectants, sweetening agents, wetting agents etc. See Para [0078]. The use of disintegrants is taught in para [0081]. The use of xanthan gum as viscosifying agent is taught in Para [0157]. The use of granules is taught in Paras [0142] and [0211].
Regarding claim 9, Holm does not teach the wt.% of the excipients in the pharmaceutical composition. However, the determination of optimum proportions or amounts are considered to be within the skill of artisan in the absence of evidence to the contrary. Applicant’s attention is drawn to In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955), wherein the court states “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation”.
Regarding claim 10, Holm teaches the use of danazole in combination with excipient in a pharmaceutical formulation. See Paras {0022] and [0018].
Regarding claim 11, Holm does not teach the wt.% of excipient granulation and pharmaceutical granulation. However, the determination of optimum proportions or amounts are considered to be within the skill of artisan in the absence of evidence to the contrary. Applicant’s attention is drawn to In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955), wherein the court states “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation”.
Regarding claim 12, Holm teaches the granulation of pharmaceutical formulation comprising an active ingredient and excipients. See Paras [0142] and [0211]. Having different bulk density and proportion of excipients and pharmaceutical active agent is considered to be within the skill of artisan In the absence of evidence to the contrary.
Regarding claim 13, Holm teaches a solid pharmaceutical composition comprising danazol dissolved in a solid carrier formulated for oral administration. see Para [0002]. The use of one or more excipients is taught in Para [0018]. Holm teaches that examples of suitable excipients for use in a composition or solid dosage form according to the invention include fillers, diluents, disintegrants, binders, lubricants etc. or mixture thereof. As the composition or solid dosage form according to the invention may be used for different purposes, the choice of excipients is normally taken such different uses into considerations. Other pharmaceutically acceptable excipients for suitable use are e.g. acidifying agents, alkalizing agents, preservatives, antioxidants, buffering agents, chelating agents, coloring agents, complexing agents, emulsifying and/or solubilizing agents, flavors and perfumes, humectants, sweetening agents, wetting agents etc. See Para [0078]. The use of disintegrants is taught in para [0081]. The use of xanthan gum as viscosifying agent is taught in Para [0157]. The use of granules is taught in Paras [0142] and [0211]. The composition taught by Holm reads on a product.
Regarding claim 14, Holm teaches that the excipients or the composition comprising an active ingredient and an excipient can be in the form of granules. See Paras [0142] and [0211].
Regarding claim 15, Holm teaches that the pharmaceutical formulation can be placed in a sachet. See Para [0130].
Regarding claim 16, Holms teaches the use of excipient granulation and pharmaceutical active ingredient granulation, which can be housed in a sachet and other forms of packaging. See Paras [0142], [0130] and claim 46.
Regarding claim 17, Holm teaches the use of different types of packaging. See Para [0130], [0142] and claim 46. To store the excipients and the pharmaceutical active ingredients in a different packaging does not create a patentably distinct composition and it is considered to be within the skill of artisan in the absence of evidence to the contrary.
Regarding claim 18, Holm teaches the viscosity Brookfield of from 200-4000 CPS. The claimed viscosity of 50cP to 1000 cP overlaps with the claimed viscosity. Furthermore, the determination of optimum viscosity is considered to be within the skill of artisan in the absence of evidence to the contrary. The process of mixing the excipients with water at specific temperature is part of the process of making and not the composition as claimed in claim 1. Using a specific viscometer does not create a patentably distinct composition.
Regarding Claims 19 and 20, Holm teaches Solid dispersions (solvent method) are prepared by dissolving a physical mixture of the active substance (e.g. a drug substance) and the carrier in a common organic solvent, followed by evaporation of the solvent. The carrier is often a hydrophilic polymer. Suitable organic solvents include pharmaceutical acceptable solvents in which the active substance is soluble such as methanol, ethanol, methylene chloride, chloroform, ethylacetate, acetone or mixtures thereof. See Para [0133].
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZOHREH A FAY whose telephone number is (703)756-1800. The examiner can normally be reached Monday-Friday 9:30AM-6:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sue 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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/ZOHREH A FAY/Primary Examiner, Art Unit 1617
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