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 .
Formal Matters
Applicant’s claim amendment and arguments in the reply filed on 29 January 2026 are acknowledged and have been fully considered. Claims 1-3 and 5-10 are pending. Claims 1-3 and 5-10 are under consideration in the instant office action. Claim 4 is cancelled. Applicant’s claim amendments in claim 1 changed the scope of the claim. Applicant’s claim amendment and argument necessitated a new ground of rejections under 35 USC 103 as set forth below.
Withdrawn Objections/Rejections
Rejections and/or objections not reiterated from the previous office actions are hereby withdrawn as are those rejections and/or objections expressly stated to be withdrawn.
Moot Arguments
Applicant’s arguments with respect to claim(s) 1-10 have been considered but are moot because the new ground of rejection addresses applicant’s main arguments as set forth below.
New Rejections-Necessitated by Amendments
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.
Claims 1-3 and 5-10 are rejected under 35 U.S.C. 103 as being unpatentable over KIM et al. (WO 2020/242132, machine English translation provided, previously provided).
Applicant Claims
Applicant claims a delayed release pharmaceutical composition of dimethyl fumarate along with one or more pharmaceutically acceptable excipients, the delayed release pharmaceutical composition consisting of: a) a core comprising dimethyl fumarate; b) a seal coating; and c) an enteric coating, wherein the core is manufactured either by extrusion spheronization or by layering method, wherein dimethyl fumarate has a particle size (D90) of less than 50 µm as measured by Malvern Laser diffraction.
Determination of the Scope and Content of the Prior Art (MPEP §2141.01)
KIM et al. teach an enteric coating tablet comprising: a core containing, as an active ingredient, dimethyl fumarate or a pharmaceutically acceptable salt thereof; and an enteric coating layer, and provides a tablet, which exhibits an effect equal to that of a capsule dosage form currently on the market, can be prepared through a simple preparation process, and is a dosage form having excellent storage stability and administration convenience, and thus can be applied to various patient groups (see abstract). One aspect of the present invention is a core comprising dimethyl fumaric acid or a pharmaceutically acceptable salt thereof as an active ingredient; and an enteric coating layer. The enteric coating layer provides an enteric-coated tablet that is included in an amount of 6 to 9 parts by weight based on 100 parts by weight of the core. On the other hand, it is made on the basis that dimethyl fumarate can be stably delivered to the absorption site and rapidly eluted to exhibit a therapeutic effect by adjusting the content of the enteric coating layer.
In particular, the enteric coating layer is typically used in an amount of 10 to 12% by weight or 10 to 13% by weight based on the total amount of the tablet core, and in this case, 100% by weight of the tablet core containing dimethyl fumaric acid or a pharmaceutically acceptable salt thereof. It is based on the fact that by using 6 to 9 parts by weight based on the fact that elution proceeds quickly at the absorption site, excellent bioavailability can be secured. In this case, the active ingredient may be included in an amount of 20 to 60% by weight based on the core, 25 to 55% by weight, 30 to 50% by weight, 35 to 45% by weight, 40 It may be included in to 45% by weight, 43 to 45% by weight, may be included in about 44% by weight.
In addition, the active ingredient may be included in the core at 50 mg to 500 mg, 60 mg to 480 mg, 100 mg to 400 mg, 50 mg to 400 mg, or 100 mg to 350 mg, 100 mg to 300 mg, 100 mg to 250 mg, 100 mg to 150 mg, 200 mg to 250 mg, or 330 mg to 400 mg, may be included as 330 mg to 480 mg, may be included as 50 mg to 100 mg, may be included as about 60 mg, may be included as about 120 mg, may be included as about 240 mg In addition, about 360 mg may be included, about 480 mg may be included, preferably 60 mg, 120 mg, 240 mg, 360 mg or 480 mg may be included. Dimethylfumaric acid or a pharmaceutically acceptable salt thereof has been demonstrated to be dose-proportional linear elimination kinetics from 120 mg to 360 mg.
The core includes one or more pharmaceutically acceptable additives selected from the group consisting of excipients, disintegrants and lubricants, and the pharmaceutically acceptable additives are not limited to the excipients, disintegrants, and lubricants, If it is an additive of a formulation commonly used pharmaceutically can be used. For example, additives such as excipients, binders, disintegrants, antioxidants, surfactants, lubricants, plasticizers, and pigments may be included.
Examples of the excipients include starch, lactose, lactose anhydride, microcrystalline cellulose, silicified microcrystalline cellulose, hypromellose, silicic acid anhydride, calcium phosphate, anhydrous calcium phosphate, calcium hydrogen phosphate, anhydrous calcium hydrogen phosphate, calcium silicate, dextrin, and deck. Straw, dextrate, mannitol, maltose, sorbitol, sucrose, polyethylene glycol, sodium chloride, and the like, and these may be used in one type or in combination of two or more. Preferably, silicified microcrystalline cellulose may be used.
Examples of the disintegrant include crospovidone, croscarmellose sodium, sodium glycolate starch, pregelatinized starch, low-substituted hydroxypropyl cellulose, grain starch, and the like, and these may be used as one or a combination of two or more. Can be used. Preferably croscarmellose sodium may be used.
Examples of the lubricant include magnesium stearate, stearic acid, talc, silicon dioxide, colloidal silicon dioxide, sodium stearyl fumarate, sodium lauryl sulfate, poloxamer, and the like, and these may be used in one or a combination of two or more. Preferably, colloidal silicon dioxide or magnesium stearate may be used, and most preferably, colloidal silicon dioxide and magnesium stearate may be used.
The plasticizer may include triethyl citrate, acetyltributyl citrate, glycerol acetic acid fatty acid ester, triacetin, dibutylphthalate, polysorbate 80, polyethylene glycol, propylene glycol, etc., and these may be one or a combination of two or more Can be used as.
Examples of the binder include povidone, copovidone, methylcellulose, hydroxymethylcellulose, hydroxypropylmethylcellulose, hydroxypropylcellulose, hydroxyethylcellulose, gelatin, guar gum, xanthan gum, and the like. It can be used in combination of two or more.
Examples of the antioxidants include dibutylhydroxytoluene, butylhydroxytoluene, butylhydroxyanisole, tertiary butylhydroquinone, propyl molar acid, vitamin C, and the like, and these may be used in one or a combination of two or more.
The surfactant may include sodium lauryl sulfate, sodium stearate, polysorbate 80, poloxamer and the like, and these may be used in one or a combination of two or more.
A seal-coating layer may be further included between the core and the enteric coating layer. In this case, the seal coating layer may be referred to as an intermediate coating layer, a primary coating layer, or a non-enteric coating layer. The seal coating layer may include a cellulose-based polymer, preferably hydroxypropylmethylcellulose, but is not limited thereto, and is not particularly limited as long as it is a non-enteric coating base, and polyvinyl alcohol (PVA) ), polyethylene glycol, polyvinyl alcohol-polyethylene glycol graft copolymer (e.g. Kollicoat-IR), ethyl cellulose, hydroxypropyl cellulose (HPC), lactose, mannitol It can be more than that. The seal coating layer may be included in an amount of 1 to 3 parts by weight based on 100 parts by weight of the core, 1 to 2 parts by weight, about 1.5 parts by weight, or about 2 parts by weight.
For specific formulations see examples 1-7. The use of ACRYL-EZE MP 93O18508 and ACRYL-EZE MP as enteric layer polymers is also demonstrated in examples 1-7. ACRYL-EZE MP, an enteric coating base, is classified into ACRYL-EZE MP 93O18508 and ACRYL-EZE MP 93O18509 according to the composition ratio of the methacrylic acid and ethyl acrylate copolymer.
The particle size distribution of the dimethyl fumaric acid or a pharmaceutically acceptable salt thereof is (a) the particle average particle size (D90) of the lower 90% of the particles is 100 μm or less; (b) the average particle size (D50) of the lower 50% of the particles is 50 μm or less; and (c) a particle average particle size (D10) of the lower 10% of the particles may satisfy one or more of the conditions of 20 μm or less, wherein (a) a particle average particle size (D90) of the lower 90% of the particles is 80 μm or less; (b) the average particle size (D50) of the lower 50% of the particles is 40 μm or less; and (c) the lower 10% of the particles may have a particle average particle size (D10) of 15 μm or less, and (a) the lower 90% of the particles may have a particle average particle size (D90) of 50 μm or less; (b) the average particle size (D50) of the lower 50% of the particles is 30 μm or less; and (c) the average particle size (D10) of the lower 10% of the particles may be 10 μm or less.
With regard to the limitation of instant claim 10, the examiner reminds Applicant that a recitation of the intended use (for the treatment of multiple sclerosis) of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
With regard to the limitation reciting in claim 1 wherein core is manufactured by either extrusion spheronization or layering method and all the process limitations recited in claims 2-3 are written in product-by-process format. "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted) (Claim was directed to a novolac color developer. The process of making the developer was allowed. The difference between the inventive process and the prior art was the addition of metal oxide and carboxylic acid as separate ingredients instead of adding the more expensive pre-reacted metal carboxylate. The product-by-process claim was rejected because the end product, in both the prior art and the allowed process, ends up containing metal carboxylate. The fact that the metal carboxylate is not directly added, but is instead produced in-situ does not change the end product.). Furthermore, "[b]ecause validity is determined based on the requirements of patentability, a patent is invalid if a product made by the process recited in a product-by-process claim is anticipated by or obvious from prior art products, even if those prior art products are made by different processes." Amgen Inc. v. F. Hoffmann-La Roche Ltd., 580 F.3d 1340, 1370 n. 14, 92 USPQ2d 1289, 1312, n. 14 (Fed. Cir. 2009). See also Biogen MA Inc. v. EMD Serono, Inc., 976 F.3d 1326, 1334, 2020 USPQ2d 11129 (Fed. Cir. 2020) ("Biogen is certainly correct that the scope of composition and method of treatment claims is generally subject to distinctly different analyses. But where, as here, the novelty of the method of administration rests wholly on the novelty of the composition administered, which in turn rests on the novelty of the source limitation, the Amgen analysis will necessarily result in the same conclusion on anticipation for both forms of claims."); United Therapeutics Corp. v Liquidia Techs., Inc., 74 F.4th 1360, 1373, 2023 USPQ2d 862 (Fed. Cir. 2023) (the court held that product-by-process claims were properly rejected as "anticipated by a disclosure of the same product irrespective of the processes by which they are made."); and Purdue Pharma v. Epic Pharma, 811 F.3d 1345, 117 USPQ2d 1733 (Fed. Cir. 2016). However, in the context of an infringement analysis, a product-by-process claim is only infringed by a product made by the process recited in the claim. Id. at 1370 ("a product in the prior art made by a different process can anticipate a product-by-process claim, but an accused product made by a different process cannot infringe a product-by-process claim").
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.012)
Kim et al. do not specifically teach the claimed invention in a specific embodiment. This addressed by the prima facie arguments set forth below.
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the instant invention to produce the instant invention by following the teachings of KIM et al. because KIM et al. teach all of the claimed elements in obvious manner. KIM et al. teach an enteric coating tablet comprising: a core containing, as an active ingredient, dimethyl fumarate or a pharmaceutically acceptable salt thereof; and an enteric coating layer, and provides a tablet, which exhibits an effect equal to that of a capsule dosage form currently on the market, can be prepared through a simple preparation process, and is a dosage form having excellent storage stability and administration convenience, and thus can be applied to various patient groups (see abstract). One aspect of the present invention is a core comprising dimethyl fumaric acid or a pharmaceutically acceptable salt thereof as an active ingredient; and an enteric coating layer. The enteric coating layer provides an enteric-coated tablet that is included in an amount of 6 to 9 parts by weight based on 100 parts by weight of the core. On the other hand, it is made on the basis that dimethyl fumarate can be stably delivered to the absorption site and rapidly eluted to exhibit a therapeutic effect by adjusting the content of the enteric coating layer. In particular, the enteric coating layer is typically used in an amount of 10 to 12% by weight or 10 to 13% by weight based on the total amount of the tablet core, and in this case, 100% by weight of the tablet core containing dimethyl fumaric acid or a pharmaceutically acceptable salt thereof. It is based on the fact that by using 6 to 9 parts by weight based on the fact that elution proceeds quickly at the absorption site, excellent bioavailability can be secured. In this case, the active ingredient may be included in an amount of 20 to 60% by weight based on the core, 25 to 55% by weight, 30 to 50% by weight, 35 to 45% by weight, 40 It may be included in to 45% by weight, 43 to 45% by weight, may be included in about 44% by weight. In addition, the active ingredient may be included in the core at 50 mg to 500 mg, 60 mg to 480 mg, 100 mg to 400 mg, 50 mg to 400 mg, or 100 mg to 350 mg, 100 mg to 300 mg, 100 mg to 250 mg, 100 mg to 150 mg, 200 mg to 250 mg, or 330 mg to 400 mg, may be included as 330 mg to 480 mg, may be included as 50 mg to 100 mg, may be included as about 60 mg, may be included as about 120 mg, may be included as about 240 mg In addition, about 360 mg may be included, about 480 mg may be included, preferably 60 mg, 120 mg, 240 mg, 360 mg or 480 mg may be included. Dimethylfumaric acid or a pharmaceutically acceptable salt thereof has been demonstrated to be dose-proportional linear elimination kinetics from 120 mg to 360 mg. The core includes one or more pharmaceutically acceptable additives selected from the group consisting of excipients, disintegrants and lubricants, and the pharmaceutically acceptable additives are not limited to the excipients, disintegrants, and lubricants, If it is an additive of a formulation commonly used pharmaceutically can be used. For example, additives such as excipients, binders, disintegrants, antioxidants, surfactants, lubricants, plasticizers, and pigments may be included. Examples of the excipients include starch, lactose, lactose anhydride, microcrystalline cellulose, silicified microcrystalline cellulose, hypromellose, silicic acid anhydride, calcium phosphate, anhydrous calcium phosphate, calcium hydrogen phosphate, anhydrous calcium hydrogen phosphate, calcium silicate, dextrin, and deck. Straw, dextrate, mannitol, maltose, sorbitol, sucrose, polyethylene glycol, sodium chloride, and the like, and these may be used in one type or in combination of two or more. Preferably, silicified microcrystalline cellulose may be used. Examples of the disintegrant include crospovidone, croscarmellose sodium, sodium glycolate starch, pregelatinized starch, low-substituted hydroxypropyl cellulose, grain starch, and the like, and these may be used as one or a combination of two or more. Can be used. Preferably croscarmellose sodium may be used. Examples of the lubricant include magnesium stearate, stearic acid, talc, silicon dioxide, colloidal silicon dioxide, sodium stearyl fumarate, sodium lauryl sulfate, poloxamer, and the like, and these may be used in one or a combination of two or more. Preferably, colloidal silicon dioxide or magnesium stearate may be used, and most preferably, colloidal silicon dioxide and magnesium stearate may be used. The plasticizer may include triethyl citrate, acetyltributyl citrate, glycerol acetic acid fatty acid ester, triacetin, dibutylphthalate, polysorbate 80, polyethylene glycol, propylene glycol, etc., and these may be one or a combination of two or more Can be used as. Examples of the binder include povidone, copovidone, methylcellulose, hydroxymethylcellulose, hydroxypropylmethylcellulose, hydroxypropylcellulose, hydroxyethylcellulose, gelatin, guar gum, xanthan gum, and the like. It can be used in combination of two or more. Examples of the antioxidants include dibutylhydroxytoluene, butylhydroxytoluene, butylhydroxyanisole, tertiary butylhydroquinone, propyl molar acid, vitamin C, and the like, and these may be used in one or a combination of two or more. The surfactant may include sodium lauryl sulfate, sodium stearate, polysorbate 80, poloxamer and the like, and these may be used in one or a combination of two or more. A seal-coating layer may be further included between the core and the enteric coating layer. In this case, the seal coating layer may be referred to as an intermediate coating layer, a primary coating layer, or a non-enteric coating layer. The seal coating layer may include a cellulose-based polymer, preferably hydroxypropylmethylcellulose, but is not limited thereto, and is not particularly limited as long as it is a non-enteric coating base, and polyvinyl alcohol (PVA) ), polyethylene glycol, polyvinyl alcohol-polyethylene glycol graft copolymer (e.g. Kollicoat-IR), ethyl cellulose, hydroxypropyl cellulose (HPC), lactose, mannitol It can be more than that. The seal coating layer may be included in an amount of 1 to 3 parts by weight based on 100 parts by weight of the core, 1 to 2 parts by weight, about 1.5 parts by weight, or about 2 parts by weight. For specific formulations see examples 1-7. The use of ACRYL-EZE MP 93O18508 and ACRYL-EZE MP as enteric layer polymers is also demonstrated in examples 1-7. ACRYL-EZE MP, an enteric coating base, is classified into ACRYL-EZE MP 93O18508 and ACRYL-EZE MP 93O18509 according to the composition ratio of the methacrylic acid and ethyl acrylate copolymer. The particle size distribution of the dimethyl fumaric acid or a pharmaceutically acceptable salt thereof is (a) the particle average particle size (D90) of the lower 90% of the particles is 100 μm or less; (b) the average particle size (D50) of the lower 50% of the particles is 50 μm or less; and (c) a particle average particle size (D10) of the lower 10% of the particles may satisfy one or more of the conditions of 20 μm or less, wherein (a) a particle average particle size (D90) of the lower 90% of the particles is 80 μm or less; (b) the average particle size (D50) of the lower 50% of the particles is 40 μm or less; and (c) the lower 10% of the particles may have a particle average particle size (D10) of 15 μm or less, and (a) the lower 90% of the particles may have a particle average particle size (D90) of 50 μm or less; (b) the average particle size (D50) of the lower 50% of the particles is 30 μm or less; and (c) the average particle size (D10) of the lower 10% of the particles may be 10 μm or less. With regard to the limitation of instant claim 10, the examiner reminds Applicant that a recitation of the intended use (for the treatment of multiple sclerosis) of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. With regard to the limitation reciting in claim 1 wherein core is manufactured by either extrusion spheronization or layering method and all the process limitations recited in claims 2-3 are written in product-by-process format. "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted) (Claim was directed to a novolac color developer. The process of making the developer was allowed. The difference between the inventive process and the prior art was the addition of metal oxide and carboxylic acid as separate ingredients instead of adding the more expensive pre-reacted metal carboxylate. The product-by-process claim was rejected because the end product, in both the prior art and the allowed process, ends up containing metal carboxylate. The fact that the metal carboxylate is not directly added, but is instead produced in-situ does not change the end product.). Furthermore, "[b]ecause validity is determined based on the requirements of patentability, a patent is invalid if a product made by the process recited in a product-by-process claim is anticipated by or obvious from prior art products, even if those prior art products are made by different processes." Amgen Inc. v. F. Hoffmann-La Roche Ltd., 580 F.3d 1340, 1370 n. 14, 92 USPQ2d 1289, 1312, n. 14 (Fed. Cir. 2009). See also Biogen MA Inc. v. EMD Serono, Inc., 976 F.3d 1326, 1334, 2020 USPQ2d 11129 (Fed. Cir. 2020) ("Biogen is certainly correct that the scope of composition and method of treatment claims is generally subject to distinctly different analyses. But where, as here, the novelty of the method of administration rests wholly on the novelty of the composition administered, which in turn rests on the novelty of the source limitation, the Amgen analysis will necessarily result in the same conclusion on anticipation for both forms of claims."); United Therapeutics Corp. v Liquidia Techs., Inc., 74 F.4th 1360, 1373, 2023 USPQ2d 862 (Fed. Cir. 2023) (the court held that product-by-process claims were properly rejected as "anticipated by a disclosure of the same product irrespective of the processes by which they are made."); and Purdue Pharma v. Epic Pharma, 811 F.3d 1345, 117 USPQ2d 1733 (Fed. Cir. 2016). However, in the context of an infringement analysis, a product-by-process claim is only infringed by a product made by the process recited in the claim. Id. at 1370 ("a product in the prior art made by a different process can anticipate a product-by-process claim, but an accused product made by a different process cannot infringe a product-by-process claim"). The examiner brings to Applicant’s attention that the concept of picking any of the ingredients and amounts from the teachings of KIM et al. The specific combination of features claimed are disclosed by KIM et al. as described above in detail. If Applicant resorts to argue the reference does not provide any motivation to select this specific ingredients, amounts, and combinations, it must be remembered that “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious.” KSR v. Teleflex, 127 S.Ct. 1727, 1740 (2007) (quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976)). One of ordinary skill in the art can easily pick an ingredient and its working amounts from the disclosed teachings of ingredients and their amounts by KIM et al. “[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious,” the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR at 1741. The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742. In the case where the claimed amounts of ingredients and actives "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). Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985). Furthermore, differences in concentration or amount will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration 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." In re Aller, 220 F.2d 454, 456, 105 USPQ 233,235 (CCPA 1955). One of ordinary skill in the art would have had a reasonable chance of success in producing the instant invention by following the teachings of KIM et al. because KIM et al. teach substantially identical or similar composition as described in detail above.
In light of the forgoing discussion, one of ordinary skill in the art would have concluded that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Conclusions
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/TIGABU KASSA/
Primary Examiner, Art Unit 1619
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