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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/26/2024 is being considered by the examiner. Many of the foreign patents only have English translations of the abstracts, therefore, only the abstracts are being considered. Please see annotated IDS form.
Claim Interpretation
In regards to claim 1, as to the limitation of ‘a blood drug concentration parameter achieved by the prolonged-release oral solid formulation when administered once a day to an individual..” it is noted that the instant claims are composition claims and future intended use, administering to an individual, is not given patentable weight. Thus any composition comprising a prolonged-release oral solid formulation of pirfenidone, comprising a sustained release formulation containing a swelling material, a shaping material, and an adhesive at the desired concentrations will meet this limitation.
In regards to claim 2, which recites “ wherein a proportion of the sustained-release formulation to a total tablet weight is 50-100%, or any value in the range; or the proportion of the sustained-release formulation to the total tablet weight is 50%, 60%, 65%, 70%, 73%, 78%, 85%, 73%, 80%, 85%, 90%, or a range formed by any two of these values”, the examiner broadly interprets this to mean any range from 50 to 100% would meet this limitation.
In regards to claim 3, which recites “ wherein an active pharmaceutical ingredient API in the sustained-release formulation accounts for 50-100% of a total API, or any value in the range; or the proportion of the total API is 50%, 60%, 65%, 70%, 73%, 78%, 85%, 73%, 80%, 85%, 90%, or a range formed by any two of these values”, the examiner broadly interprets this to mean any range from 50 to 100% would meet this limitation. Further, in regards to the API, the examiner broadly interprets this to mean an active ingredient, to include, but not limited to pirfenidone.
In regards to claims 10 and 17-20, applicant is reminded this is a composition/product claim and the prior art teaches the prolonged-release oral solid formulation of the instant claims thereby since a product is not separable from its physical properties then it necessarily teaches the tablet has an expansion growth rate. Applicants observation that it also has a specific ‘expansion growth rate’ does not give it patentable weight, since it is the same composition and same process of making, as adding a characterization to a prior art patented invention is not patentable.
In regards to claim 12, as to the limitation of ‘according to a USP standard 2 method' it is noted that the instant claims are composition claims and future intended use, such as in a USP standard 2 method, is not given patentable weight. Thus any composition meeting the limitations of the instant claim 1 from which claim 12 depends will meet this limitation.
In regards to claims 13-14, as to the limitation of ‘the prolonged-release oral solid formulation is used for the administration to an individual’ it is noted that the instant claims are composition claims and future intended use, administering to an individual, is not given patentable weight. Thus any composition meeting the limitations of claim 11 from which claims 13 and 14 depends will meet this limitation.
Claim Rejections - 35 USC § 112(b)
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 1 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 1 recites “wherein the sustained-release formulation contains a swelling material, a shaping material, and an adhesive material; a weight percentage of the swelling material in the prolonged-release oral solid formulation is 10%-25%; a weight percentage of the shaping material in the prolonged-release oral solid formulation is 10%-25%; and a weight percentage of adhesive material..” which is unclear as to what constitutes “a weight percentage”. Applicant has amended to remove “the weight percentage” which provides a definite definition for weight percentage to now say “a weight percentage” which is unclear if this is the total amount of each component within the composition or merely one of several possible weight percentages.
For the purpose of moving prosecution forward, the examiner will broadly interpret this to mean one of many weight percentage amounts. Thus, any amount of each component will teach this limitation.
Claim 2 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 2 recites “wherein a proportion of the sustained release formulation to a total tablet weight”. Claim 2 is dependent upon claim 1 which makes no mention to a tablet, therefore, it is unclear if this is part of the formulation itself or an additional added component or an intended use of the formulation in a tablet.
For the purpose of moving prosecution forward, the examiner broadly interpret the “tablet” to be intended use of the formulation of claim 1. As noted above, intended use is not given patentable weight, therefore, the examiner broadly interprets the limitations of the instant claim 1 to meet the limitations of claim 2.
Claim 6 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 6 recites “a ratio of the immediate-release formulation to the sustained-release formulation is 1-10” which is unclear if the “1-10” is 1:1 to 10:1 of the formulations or reversed, or in contrast is this is a variable calculated using the ratio. Therefore, the claim is rendered indefinite.
For the purpose of moving prosecution forward, the examiner broadly determines any ratio to satisfy this limitation.
Claim 7 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 7 recites “a ratio of an API in the immediate-release formulation is to an API in the sustained-release formulation is 0.1-0.6” which is unclear if the “0.1-0.6” is 0.1:1 to 0.6:1 of the API in the immediate-release formulation to the API in the sustained release formulation or reversed, or in contrast is this is a variable calculated using the ratio. Therefore, the claim is rendered indefinite.
For the purpose of moving prosecution forward, the examiner broadly determines any ratio to satisfy this limitation.
Claim 9 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.
Regarding claim 9, the phrase "employs" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). For instance, is this a product by process or is this further defining the swelling material or intended use of the swelling material. It is further noted that it is unclear if polyoxyethylene additionally added to the composition and/or the swelling material, in which would broaden the swelling material limitation of claim 1 from which claim 9 depends.
For the purpose of moving prosecution forward, the examiner broadly interprets any prior art teaching the limitations of the instant claim 1 from which claim 9 depends to meet this limitation.
Claim 9 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 9 contains the trademark/trade names of “K100LV”, “K4M”, “K750”, “K100”, “K200M”, and “E5LV”. 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 trademark/trade name is used to identify/describe polymer and, accordingly, the identification/description is indefinite.
Claim 9 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 9 further recites the term “model” which is undefined my instant specification. It is unclear is “model” is equivalent to “for example” or if the term means the polymer is selected the group listed and/or has a particular molecular weight, thus rendering the claim indefinite. It is further noted that “for example” is an indefinite phrase as it is unclear whether the limitation following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
For the purpose of moving prosecution forward, the examiner broadly interprets anything following “model” to not be a requirement of the claim.
Claim 13 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 13 fails to add additional structural limitations, specifically the claim recites the phrase ‘configured to’ which fails to add structure and thus does not further limit the claim rendering the claim indefinite.
As the remainder of the claim is intended use as outlined above, the examiner broadly interprets any prior art teaching the limitations of instant claim 11 from which claim 13 depends to meet these limitations.
Claim 15 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.
Regarding claim 15, the phrase "is allowed to be" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
For the purpose of moving prosecution forward, the examiner broadly interprets any tablet or capsule to meet this limitation.
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.
Claim(s) 1-9, 12, 15, and 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over Merchant et al. (CN108601839A, published 09/28/2018, Google English translation by PE2E search, hereafter Merchant) in view of Wang et al. (CN107080741A, published 08/22/2017, Google English translation, hereafter Wang), and in view of Liu et al. (CN103610658A1, published 03/05/2014, Espacenet English translation, hereafter Liu).
Merchant teaches the invention relates to mammalian such as human patients in need of therapy to treat immune or autoimmune diseases such as inflammatory diseases, fibrosis, and fibrotic lung disease (pages 18-19, paragraphs 4 and 1 respectively; according to the claim limitations of the instant claim 1). Merchant teaches the term herein “orally deliverable”, “oral administration” and “orally administered” refers to is administered orally to a subject which immediately swallowed administration of compositions (page 20, paragraph 2; according to the claim limitations of the instant claim 1). Merchant teaches the dosage form comprises a capsule shell encapsulating the dosage form, e.g. a solid dispersion, or a tablet in which the dosage form (e.g., a solid dispersion) (page 11, paragraph 3; according to the claim limitations of the instant claims 2-3, 5, 10, and 15-20). Merchant provides multiple example dosage amount from about 25 to about 1000 mg (page 11, paragraph 3 and page 13, paragraph 2; according to the claim limitations of the instant claim 11). Merchant teaches the method of invention relates to the administration of about 0.001 mg/kg to about 1000 mg/kg range of the ratio dose of pirfenidone (page 13, paragraph 3; according to the claim limitations of the instant claims 1 and 11). Further, Merchant teaches that the concentration of the drug or drug combination in the pharmaceutical formulation is about 1% to about 50% (page 14, paragraph 1 ; according to the claim limitations of the instant claims 2-3). Merchant teaches the composition has binders or adhesives and teaches suitable options are acacia gum, alone or in combination; gum tragacanth; glucose; polydextrose; starches, including pregelatinized starches; gelatin; modified celluloses including methylcellulose, sodium carboxymethylcellulose, hydroxypropyl methylcellulose (HPMC), hydroxypropyl cellulose, hydroxyethyl cellulose, and ethyl cellulose; dextrins, including maltodextrin; zein (zein); alginic acid and salts of alginic acid, such as sodium alginate; magnesium aluminum silicate; bentonite; polyethylene glycol (PEG); polyethylene oxide; guar gum; a gluconic acid; polyvinylpyrrolidones (povidone or PVP), such as povidone K-15, K-30 and K-29/32; polyacrylic acid (carbomer); polymethacrylates; and so on (page 15, paragraph 5; according to the claim limitations of the instant claim 1). Further, Merchant teaches the bonding agent and/or adhesive typically comprises from about 0.5% to about 25% by weight of the composition (page 15, paragraph 5; according to the claim limitations of the instant claims 1 and 4). Merchant teaches that from about 1 to 15% hydroxypropyl cellulose is particularly useful for tablets formulations (page 15, paragraph 6; according to the claim limitations of the instant claims 1 and 4). Further, Merchant teaches the composition comprises a disintegrating agent such as starch, powdered cellulose, microcrystalline cellulose, methyl cellulose, low-substituted hydroxypropyl cellulose, carboxymethyl cellulose, calcium carboxymethyl cellulose, sodium carboxymethyl cellulose and croscarmellose sodium; an alginate; povidone; crospovidone; potassium polacrilin; gums such as agar, guar gum, locust bean gum, karaya gum, pectin, and tragacanth gum (page 15, paragraph 3; according to the claim limitations of the instant claim 1). Further, Merchant teaches the concentration of the disintegrant is typically from about 0.2 to about 30%, such as from about 0.5% to about 20% (page 15, paragraph 3; according to the claim limitations of the instant claims 1 and 4). Further, Merchant teaches the composition comprises a lubricant and suitable lubricants include single or combination of behenic acid glyceride, stearic acid and its salts, hydrogenated vegetable oil, and wax (page 16, paragraph 3; according to the claim limitations of the instant claim 1). Merchant teaches the lubricant is present in about 0.05 to about 10% (page 16, paragraph 3, according to the claim limitations of the instant claim 1). Merchant teaches the tablets can be uncoated or may include, for example, functional film or release modifying or enteric coated core and can have a hard or soft shell capsule, which include for example, gelatin, starch, and/or HPMC (page 16, paragraph 6; according to the claim limitations of the instant claims 1, 5, and 15).
Although Merchant teaches excipients that function to release modifying, it fails to teach a prolonged release formulation as in instant claim 1. Further, although Merchant teaches the tablet may be uncoated, it does not explicitly teach the sustained release composition comprises 100% of the composition as in the instant claim 5.
Wang teaches a pirfenidone sustained release preparation wherein the pirfenidone is dispersed in the slow-release matrix material (title and abstract; according to the claim limitations of the instant claim 1). Wang claims the unit preparation of the pirfenidone sustained-release preparation of the present invention contains 200 mg of pirfenidone, and its preparation form can be tablet, pill or granule (abstract and claim 6; according to the claim limitations of the instant claims 2-3, 5, 10, and 15). Wang claims A pirfenidone sustained-release preparation, characterized in that pirfenidone is dispersed in the sustained-release matrix material (claim 1; according to the claim limitations of the instant claim 1). Wang claims pirfenidone slow-release preparation described in claim 1, it is characterized in that, described frame material is selected from one in cellulose derivative, acrylic resin, vinyl polymer and other types of frame material species or several (claim 2; according to the claim limitations of the instant claim 1). Claim 2 of Wang further claims cellulose derivative is selected from one or more of ethyl cellulose, methyl cellulose, hydroxypropyl methyl cellulose, hydroxypropyl cellulose, and sodium carboxymethyl cellulose (according to the claim limitations of the instant claim 1). Wang further claims other types of framework materials are selected from one or more of stearyl alcohol, chitin, stearic acid, polyethylene glycol, gelatin, mannitol, and sorbitol (claim 2; according to the claim limitations of the instant claim 1). Wang claims the composition of pirfenidone slow-release preparation, its mass ratio is as follows: slow-release skeleton material accounts for 12%-20% of gross weight %, pirfenidone accounts for 40%-65% of the total weight, and other auxiliary materials account for 20%-40% (claim 5; according to the claim limitations of the instant claims 1, 3, and 7). Wang teaches the recommended medication method is 200mg once, three times a day, after meals (page 2, paragraph 3; according to the claim limitations of the instant claim 11). Wang teaches after a patient tolerates it, the does can be gradually increased to 400 to 600mg once, three times a day (page 2, paragraph 3; according to the claim limitations of the instant claim 11). Further, Wang teaches the method of preparing a tablet which includes that following steps: mix the pirfenidone and the sustained-release framework material, add fillers, binders, wetting agents and soft materials in other auxiliary materials, granulate, and dry , Whole grains, adding lubricant, mixing, or further tableting (page 2, contents of invention, paragraph 16; according to the claim limitations of the instant claim 5). Wang teaches the preparation method of mix pirfenidone and hypromellose, add microcrystalline cellulose, make soft material with 70wt% ethanol aqueous solution, granulate with 16 mesh sieve, dry at 50-60 ° C, granulate with 14 mesh sieve, add magnesium stearate, mixed evenly, pressed into 1000 tablets (pages 2-3, last and first paragraph respectively).
It would be obvious to one skilled in the art before the effective filing date of the claimed invention would claim the oral tablet composition of pirfenidone with a modified release as outlined by Merchant with the ready for improvement with the known technique of utilizing the composition as a pirfenidone sustained-release preparation as outlined by Wang. Adding the forementioned components pirfenidone oral table composition as claimed by instant claim 1 would yield predictable results thus making them of obviousness as modification of a known product with a known technique is within the purview of the skilled artisan. Further, it would be obvious to one skilled in the art before the effective filing date of the claimed invention would claim the uncoated oral tablet composition of pirfenidone with a modified release as outlined by Merchant with the ready for improvement with the known technique of a sustained release formulation comprising 100% of the modified release pirfenidone as outlined by Wang. Adding the forementioned components to a pirfenidone modified release oral tablet as claimed by instant claim 5 would yield predictable results thus making them of obviousness as modification of a known product with a known technique is within the purview of the skilled artisan.
Although Merchant and Wang teach the addition and concentrations of a swelling material (i.e. HPMC), a shaping material (i.e. gelatin), and a adhesive material (i.e. carbomer), they fail to teach the viscosities of these materials as in instant claim 1. Further, although Merchant and Wang teach a modified release and sustained release formulation, they fail to teach the addition of a an immediate-release formulation with the sustained release formulation at a ratio of 1-10 or 0.1-0.6 as in instant claims 6-7.
Liu claims a immunomodulator slow-release preparation and preparation method thereof (title). Liu teaches in particular the invention is a sustained release tablet (page 1, technical field). Liu teaches the sustained release tablet comprises a binder selected from the group of one or more to include polyvinyl alcohol, gelatin, and pregelatinized starch (page 4, paragraph 4). Liu further teaches the sustained-release framework material are one or more of hydroxypropylmethylcellulose, carbomer, and polyvinyl alcohol having a viscosity of 3000 mPa·s to 120,000 mPa·s (page 4, paragraph 6). Liu teaches the lenalidomide sustained release tablet is composed of a sustained release layer and an optional immediate release layer, wherein the sustained release layer contains both the active ingredient lenalidomide and the sustained release matrix material and the immediate release layer does not contain the sustained release matrix material (page 2, paragraph 5). Liu further teaches the ratio of the amount of lenalidomide in the sustained-release layer and the immediate release layer is (5:1) to (1:2) (page 4, paragraph 7). Lastly, Liu provides example formulations wherein the sustained release layer comprises: lenalidomide 0.5-25%, sustained release matrix material 5%-60%, solubilizer 0.5%-20%, adhesive 1%-12%, filler 15%-80%, glidant 0.1%- 5%, and lubricant 0.2%-5%; and the further improvement of the immediate release layer comprises: Lenalidomide 5%-60%, solubilizer 0.5%-20%, disintegrant 1%-25%, adhesive 1%-10%, filler 5%-80%, glidant 0.1%-5%, and lubricant 0.2%-5% (pages 5-6, paragraph 4 to 2 respectively).
It would be obvious to one skilled in the art before the effective filing date of the claimed invention would to claim the oral tablet composition of pirfenidone with a modified release as outlined by Merchant in view of Wang with the ready for improvement with the known technique of adding an immediate release layer at the desired ratio to the sustained release layer and utilizing HPMC, gelatin, and carbomer that have a viscosities of 3000 mPa·s to 120,000 mPa·s as outlined by Liu. Adding the forementioned components an oral tablet composition of pirfenidone with a modified release as claimed by instant claims 1 and 6-7 would yield predictable results thus making them of obviousness as modification of a known product with a known technique is within the purview of the skilled artisan.
Claim(s) 10-11, 13-14, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Merchant et al. (CN108601839A, published 09/28/2018, Google English translation by PE2E search, hereafter Merchant) in view of Wang et al. (CN107080741A, published 08/22/2017, Google English translation, hereafter Wang), in view of Liu et al. (CN103610658A1, published 03/05/2014, Espacenet English translation, hereafter Liu), and in view of Yang et al. (CN106727393A, published 05/31/2017, PE2E search English translation, hereafter Yang).
As outlined above, Merchant in view of Wang teaches the composition of the instant claim 1 to include the formulation in the form of a tablet. Further, Merchant provides multiple example dosage amount from about 25 to about 1000 mg (page 11, paragraph 3 and page 13, paragraph 2; according to the claim limitations of the instant claim 11). Merchant teaches the method of invention relates to the administration of about 0.001 mg/kg to about 1000 mg/kg range of the ratio dose of pirfenidone (page 13, paragraph 3; according to the claim limitations of the instant claims 1 and 11).
However, both Merchant and Wang fail to teach the tablet has minimum sizes in three dimensions of a length, a width, and a height are not less than 8.0 mm as in instant claims 10 and 20.
Yang teaches an ibuprofen sustained release preparation that is a tablet (title and claim 1). Yang claims the sustained release preparation is composed of the following raw material parts by weight as follows: 10-25 parts of ibuprofen, 50-70 parts of ethyl cellulose and 5-40 parts of pore-forming agent, the sustained-release preparation is tablet or capsule with grid structure (claim 1). Further, Yang claims the diameter of the tablet is 10-14 mm, the height is 5-9mm;, the diameter of the capsule is 5-9 mm and the height is 10-18mm (claim 5).
It would be obvious to one skilled in the art before the effective filing date of the claimed invention to claim an oral tablet composition of pirfenidone with a modified release as outlined by Merchant in view of Wang with the ready for improvement with the known technique of adjusting the tablet dimensions as outlined by Yang. Adjusting the forementioned components of sustained oral release formulation as claimed by instant claims 10 and 20 would yield predictable results thus making them of obviousness as modification of a known product with a known technique is within the purview of the skilled artisan.
Claim(s) 16 is rejected under 35 U.S.C. 103 as being unpatentable over Merchant et al. (CN108601839A, published 09/28/2018, Google English translation by PE2E search, hereafter Merchant) in view of Wang et al. (CN107080741A, published 08/22/2017, Google English translation, hereafter Wang), and in view of Park et al. (US20100040681A1, published 02/18/2010, hereafter Park).
As outlined above, Merchant in view of Wang teaches the composition of the instant claim 1. Although, both references teach the composition in the form of a tablet, both Merchant and Wang fail to teach the formulation is in the form of a three layer tablet as in instant claim 16. Park renders this deviancy.
Park claims an oral sustained release triple layer tablet comprising 1) an inner immediate-release layer containing a pharmaceutically active ingredient and 2) two outer layers containing swellable polymers, wherein, upon exposure to aqueous media, the exposed lateral side of the inner immediate-release layer is surrounded by the two swollen outer layers to control the release of active ingredient (claim 1). Park claims the oral sustained-release triple layer tablet according to claim 1, wherein the inner immediate-release layer includes a pharmaceutically acceptable excipient, binder, disintegrant or lubricant (claim 2). Park teaches examples of the pharmaceutically active ingredient contained in the inner immediate-release layer may include antihypertensives (doxazosin mesylate, terazosin hydrochloride, etc.), anti-benign prostatic hyperplasia agents (tamsulosin hydrochloride, etc.), antihyperlipidemics (simvastatin, lovastatin, fluvastatin, etc.), nonsteroidal anti-inflammatory drugs (acetaminophen, zaltoprofen, etc.), analgesic drugs (tramadol hydrochloride, etc.), antidiabetes drugs, and hypnotics ([0023]). Park claims the swellable polymer is selected from the group consisting of polyethyleneoxide, hydroxypropyl methylcellulose, hydroxypropyl cellulose, carboxymethylcellulose, polyvinylalcohol and carbomer (claim 4). Park further claims the two outer layers containing swellable polymers include a pharmaceutically acceptable excipient, binder, disintegrant or lubricant (claim 5). Park claims the inner immediate-release layer is included in an amount of 5 to 60% by weight, based on the total weight of the tablet (claim 7). Further, Park claims the two outer layers containing swellable polymers are included in an amount of 40 to 95% by weight, based on the total weight of the tablet (claim 8). Park claims the swellable polymers are polyethyleneoxide, hydroxypropyl methylcellulose, or both of them (claim 9). Further, Park teaches the polyethyleneoxide has a viscosity of 400 cps or more and the hydroxypropyl methylcellulose has a viscosity of 4000 cps or more (claims 10-11). Park teaches the oral sustained-release formulation is developed to control the release of active ingredient at a designed rate and to obtain its optimal blood concentration therapeutically ([0002]). Park further teaches that in order to increase patient compliance and prevent adverse effects, variety of dosage forms have been developed ([0002-0003]). Park further teaches because of the simple compositions and ease of manufacture, many studies have been conducted on a matrix system, in which active ingredients are dispersed in polymers which control the release rate ([0003]). Park teaches the present invention acts to control the release of active ingredient from the inner immediate-release layer uniformly and reproducibly ([0012]).
It would be obvious to one skilled in the art before the effective filing date of the claimed invention would modify a sustained release oral tablet composition as outlined by Merchant in view of Wang by addition of a three layer tablet with the inner layer comprising greater than 10% and the outer third layer comprising greater than 15% of the tablet as outlined by Park under TSM, see MPEP 2143(G). As outlined by Park, three layer tablets control the release of the active ingredient uniformly and reproducibly which would motivate someone skilled in the art to advantageously combine a three layer tablet with the composition of Merchant in view of Wang as it would have a reasonable expectation of success.
Conclusion
No claims allowed.
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/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611
/A.N.I./ Examiner, Art Unit 1611
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