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 .
Applicant’s amendments filed 2/3/2025 have been entered.
Claims 56-75 are pending.
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.
Claim(s) 56-67, 69-70, 72-75 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US2014/0051755 (‘755).
‘755 teaches a method of treating neurological diseases, such as Parkinson’s disease, by continuously administering to said patient a composition of 1-6% of carbidopa/ 4-12% of levodopa, and arginine, wherein the composition is administered subcutaneously and orally administration of levodopa and/or carbidopa (see claims 1, 3, 4, 27, 31, 34). ‘755 teaches the extended oral administration can be 2-5 times daily at discrete intervals (see [0037], [0054], [0078]). ‘755 teaches the dosage of levodopa/carbidopa used as 100/25mg or in the ratio of 10:1 to 4:1 (see for example [0031], [0032], [0067]). ’755 teaches the pH of the composition as 9.1-9.8 (see [0005], [0039], [0040]). ‘755 teaches antioxidants including Na-ascorbate, L-cysteine, N-acetylcysteine (NAC), glutathione (GSH), Na2-EDTA, Na2-EDTA-Ca, or any combinations, can be incorporated into the liquid composition (see claims 10-11). ‘755 teaches the subcutaneous administration can be for 24 hours (see for example [0080]). ‘755 teaches the dosage of the liquid carbidopa/levodopa composition for subcutaneous infusion at an average rate of about 10-250 μl/hour, or about 160±40 μl/hour continuously for 24 hours (see [0080]). ‘755 teaches oral dosage of 100/25 (levodopa/carbidopa) produce comparable plasma level of LD (see Example 6, Fig. 5B). ‘755 teaches the oral composition can be formulated as pills, tablets or, the like (see [0067]). The examiner notes that at 250 μl/hour x 24 hours, it would be equivalent to 83.33mg to 720mg of levodopa (4-12%) and 60-360mg of carbidopa (1-6%). ‘755 also teaches the composition comprising about 2.5 to 7% of levodopa (see claim 35).
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.
Claim(s) 68, 71 is/are rejected under 35 U.S.C. 103 as being unpatentable over ‘755.
‘755 teaches a method of treating neurological diseases, such as Parkinson’s disease, by continuously administering to said patient a composition of 1-6% of carbidopa/ 4-12% of levodopa, and arginine, wherein the composition is administered subcutaneously and orally administration of levodopa and/or carbidopa (see claims 1, 3, 4, 27, 31, 34). ‘755 teaches the extended oral administration can be 2-5 times daily at discrete intervals (see [0037], [0054], [0078]). ‘755 teaches the dosage of levodopa/carbidopa used as 100/25mg or in the ratio of 10:1 to 4:1 (see for example [0031], [0032], [0067]). ’755 teaches the pH of the composition as 9.1-9.8 (see [0005], [0039], [0040]). ‘755 teaches antioxidants including Na-ascorbate, L-cysteine, N-acetylcysteine (NAC), glutathione (GSH), Na2-EDTA, Na2-EDTA-Ca, or any combinations, can be incorporated into the liquid composition (see claims 10-11). ‘755 teaches the subcutaneous administration can be for 24 hours (see for example [0080]). ‘755 teaches the dosage of the liquid carbidopa/levodopa composition for subcutaneous infusion at an average rate of about 10-250 μl/hour, or about 160±40 μl/hour continuously for 24 hours (see [0080]). ‘755 teaches oral dosage of 100/25 (levodopa/carbidopa) produce comparable plasma level of LD (see Example 6, Fig. 5B). ‘755 teaches the oral composition can be formulated as pills, tablets or, the like (see [0067]). The examiner notes that at 250 μl/hour x 24 hours, it would be equivalent to 83.33mg to 720mg of levodopa (4-12%) and 60-360mg of carbidopa (1-6%). ‘755 also teaches the composition comprising about 2.5 to 7% of levodopa (see claim 35).
‘755 does not expressly teach the dosing regimen and the reason for administering the oral levodopa composition.
It would have been obvious to one of ordinary skill in the art at the time of filing to employ the amount of the oral composition for ensure the serum level of levodopa as being in the therapeutic level to treat any symptoms of Parkinson’s disease.
One of ordinary skill in the art would have been motivated to employ the amount of the oral composition for ensure the serum level of levodopa as being in the therapeutic level to treat any symptoms of Parkinson’s disease. The optimization of result effect parameters (dosage range, dosing regimens) is obvious as being within the skill of the artisan. The optimization of known effective amounts of known active agents to be administered, is considered well in the competence level of an ordinary skilled artisan in pharmaceutical science, involving merely routine skill in the art. It has been held that it is within the skill in the art to select optimal parameters, such as amounts of ingredients, in a composition in order to achieve a beneficial effect. See In re Boesch, 205 USPQ 215 (CCPA 1980). It is also noted that “[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). Since the amount of levodopa will affect the therapeutic level of levodopa, adjusting the amount to be administered would be obvious.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 56-75 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 11,213,502 (‘502) in view of ‘755. ‘502 teaches a method of treating Parkinson’s disease using subcutaneous administration of levodopa/carbidopa and oral administration of levodopa/carbidopa, in the dosages within the herein claimed dosages (see claims 1-8).
‘502 does not expressly teach pH and the dosing regimen of the composition. ‘502 does not expressly teach arginine to be incorporated into the composition. ‘502 does not expressly teach the incorporation of anti-oxidants.
‘755 teaches a method of treating neurological diseases, such as Parkinson’s disease, by continuously administering to said patient a composition of 1-6% of carbidopa/ 4-12% of levodopa, and arginine, wherein the composition is administered subcutaneously and orally administration of levodopa and/or carbidopa (see claims 1, 3, 4, 27, 31, 34). ‘755 teaches the extended oral administration can be 2-5 times daily at discrete intervals (see [0037], [0054], [0078]). ‘755 teaches the dosage of levodopa/carbidopa used as 100/25mg or in the ratio of 10:1 to 4:1 (see for example [0031], [0032], [0067]). ’755 teaches the pH of the composition as 9.1-9.8 (see [0005], [0039], [0040]). ‘755 teaches antioxidants including Na-ascorbate, L-cysteine, N-acetylcysteine (NAC), glutathione (GSH), Na2-EDTA, Na2-EDTA-Ca, or any combinations, can be incorporated into the liquid composition (see claims 10-11). ‘755 teaches the subcutaneous administration can be for 24 hours (see for example [0080]). ‘755 teaches the dosage of the liquid carbidopa/levodopa composition for subcutaneous infusion at an average rate of about 10-250 μl/hour, or about 160±40 μl/hour continuously for 24 hours (see [0080]). ‘755 teaches oral dosage of 100/25 (levodopa/carbidopa) produce comparable plasma level of LD (see Example 6, Fig. 5B). ‘755 teaches the oral composition can be formulated as pills, tablets or, the like (see [0067]). The examiner notes that at 250 μl/hour x 24 hours, it would be equivalent to 83.33mg to 720mg of levodopa (4-12%) and 60-360mg of carbidopa (1-6%). ‘755 also teaches the composition comprising about 2.5 to 7% of levodopa (see claim 35). ‘755 teaches arginine can form a salt of carbidopa, and/or levodopa to give rise a stable composition (see [0026]).
It would have been obvious to one of ordinary skill in the art at the time of filing to employ the pH and dosing regimen in the method of treating Parkinson’s disease. It would have been obvious to one of ordinary skill in the art at the time of filing to incorporate antioxidants and arginine into the levodopa/carbidopa composition in a method of treating Parkinson’s disease.
One of ordinary skill in the art would have been motivated to employ the pH and dosing regimen in the method of treating Parkinson’s disease. Adjusting the pH to maximize stability of the composition would be seen to be obvious as being within the purview of skilled artisan. The optimization of known effective amounts of known active agents to be administered, is considered well in the competence level of an ordinary skilled artisan in pharmaceutical science, involving merely routine skill in the art. It has been held that it is within the skill in the art to select optimal parameters, such as amounts of ingredients, in a composition in order to achieve a beneficial effect. See In re Boesch, 205 USPQ 215 (CCPA 1980). It is also noted that “[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). Since the amount of levodopa will affect the therapeutic level of levodopa, adjusting the amount to be administered would be obvious.
One of ordinary skill in the art would have been motivated to incorporate antioxidants arginine into the levodopa/carbidopa composition in a method of treating Parkinson’s disease because anti-oxidants can slow down the degradation of the composition while arginine can form a salt of carbidopa, and/or levodopa to give rise a stable composition.
Claims 56-75 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 11,331,293 (‘293) in view of ‘755. ‘293 teaches a method of treating Parkinson’s disease using subcutaneous administration of levodopa/carbidopa/arginine and oral administration of levodopa/carbidopa, in the dosages within the herein claimed dosages (see claims 1-15).
‘293 does not expressly teach pH and the dosing regimen of the composition. ‘293 does not expressly teach the incorporation of anti-oxidants.
‘755 teaches a method of treating neurological diseases, such as Parkinson’s disease, by continuously administering to said patient a composition of 1-6% of carbidopa/ 4-12% of levodopa, and arginine, wherein the composition is administered subcutaneously and orally administration of levodopa and/or carbidopa (see claims 1, 3, 4, 27, 31, 34). ‘755 teaches the extended oral administration can be 2-5 times daily at discrete intervals (see [0037], [0054], [0078]). ‘755 teaches the dosage of levodopa/carbidopa used as 100/25mg or in the ratio of 10:1 to 4:1 (see for example [0031], [0032], [0067]). ’755 teaches the pH of the composition as 9.1-9.8 (see [0005], [0039], [0040]). ‘755 teaches antioxidants including Na-ascorbate, L-cysteine, N-acetylcysteine (NAC), glutathione (GSH), Na2-EDTA, Na2-EDTA-Ca, or any combinations, can be incorporated into the liquid composition (see claims 10-11). ‘755 teaches the subcutaneous administration can be for 24 hours (see for example [0080]). ‘755 teaches the dosage of the liquid carbidopa/levodopa composition for subcutaneous infusion at an average rate of about 10-250 μl/hour, or about 160±40 μl/hour continuously for 24 hours (see [0080]). ‘755 teaches oral dosage of 100/25 (levodopa/carbidopa) produce comparable plasma level of LD (see Example 6, Fig. 5B). ‘755 teaches the oral composition can be formulated as pills, tablets or, the like (see [0067]). The examiner notes that at 250 μl/hour x 24 hours, it would be equivalent to 83.33mg to 720mg of levodopa (4-12%) and 60-360mg of carbidopa (1-6%). ‘755 also teaches the composition comprising about 2.5 to 7% of levodopa (see claim 35).
It would have been obvious to one of ordinary skill in the art at the time of filing to employ the pH and dosing regimen in the method of treating Parkinson’s disease. It would have been obvious to one of ordinary skill in the art at the time of filing to incorporate antioxidants into the composition.
One of ordinary skill in the art would have been motivated to employ the pH and dosing regimen in the method of treating Parkinson’s disease. Adjusting the pH to maximize stability of the composition would be seen to be obvious as being within the purview of skilled artisan. The optimization of known effective amounts of known active agents to be administered, is considered well in the competence level of an ordinary skilled artisan in pharmaceutical science, involving merely routine skill in the art. It has been held that it is within the skill in the art to select optimal parameters, such as amounts of ingredients, in a composition in order to achieve a beneficial effect. See In re Boesch, 205 USPQ 215 (CCPA 1980). It is also noted that “[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). Since the amount of levodopa will affect the therapeutic level of levodopa, adjusting the amount to be administered would be obvious.
One of ordinary skill in the art would have been motivated to incorporate antioxidants into the composition because anti-oxidants can slow down the degradation of the composition.
Claims 56-75 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 11,458,115 (‘115) in view of ‘755. ‘115 teaches a method of treating Parkinson’s disease using subcutaneous administration of levodopa/carbidopa and oral administration of levodopa/carbidopa, in the dosages within the herein claimed dosages (see claims 1-30).
‘115 does not expressly teach pH and the dosing regimen of the composition. ‘115 does not expressly teach arginine to be incorporated into the composition. ‘115 does not expressly teach the incorporation of anti-oxidants.
‘755 teaches a method of treating neurological diseases, such as Parkinson’s disease, by continuously administering to said patient a composition of 1-6% of carbidopa/ 4-12% of levodopa, and arginine, wherein the composition is administered subcutaneously and orally administration of levodopa and/or carbidopa (see claims 1, 3, 4, 27, 31, 34). ‘755 teaches the extended oral administration can be 2-5 times daily at discrete intervals (see [0037], [0054], [0078]). ‘755 teaches the dosage of levodopa/carbidopa used as 100/25mg or in the ratio of 10:1 to 4:1 (see for example [0031], [0032], [0067]). ’755 teaches the pH of the composition as 9.1-9.8 (see [0005], [0039], [0040]). ‘755 teaches antioxidants including Na-ascorbate, L-cysteine, N-acetylcysteine (NAC), glutathione (GSH), Na2-EDTA, Na2-EDTA-Ca, or any combinations, can be incorporated into the liquid composition (see claims 10-11). ‘755 teaches the subcutaneous administration can be for 24 hours (see for example [0080]). ‘755 teaches the dosage of the liquid carbidopa/levodopa composition for subcutaneous infusion at an average rate of about 10-250 μl/hour, or about 160±40 μl/hour continuously for 24 hours (see [0080]). ‘755 teaches oral dosage of 100/25 (levodopa/carbidopa) produce comparable plasma level of LD (see Example 6, Fig. 5B). ‘755 teaches the oral composition can be formulated as pills, tablets or, the like (see [0067]). The examiner notes that at 250 μl/hour x 24 hours, it would be equivalent to 83.33mg to 720mg of levodopa (4-12%) and 60-360mg of carbidopa (1-6%). ‘755 also teaches the composition comprising about 2.5 to 7% of levodopa (see claim 35). ‘755 teaches arginine can form a salt of carbidopa, and/or levodopa to give rise a stable composition (see [0026]).
It would have been obvious to one of ordinary skill in the art at the time of filing to employ the pH and dosing regimen in the method of treating Parkinson’s disease. It would have been obvious to one of ordinary skill in the art at the time of filing to incorporate antioxidants and arginine into the levodopa/carbidopa composition in a method of treating Parkinson’s disease.
One of ordinary skill in the art would have been motivated to employ the pH and dosing regimen in the method of treating Parkinson’s disease. Adjusting the pH to maximize stability of the composition would be seen to be obvious as being within the purview of skilled artisan. The optimization of known effective amounts of known active agents to be administered, is considered well in the competence level of an ordinary skilled artisan in pharmaceutical science, involving merely routine skill in the art. It has been held that it is within the skill in the art to select optimal parameters, such as amounts of ingredients, in a composition in order to achieve a beneficial effect. See In re Boesch, 205 USPQ 215 (CCPA 1980). It is also noted that “[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). Since the amount of levodopa will affect the therapeutic level of levodopa, adjusting the amount to be administered would be obvious.
One of ordinary skill in the art would have been motivated to incorporate anti-oxidants and arginine into the levodopa/carbidopa composition in a method of treating Parkinson’s disease because anti-oxidants can slow down the degradation of the composition while arginine can form a salt of carbidopa, and/or levodopa to give rise a stable composition.
Claims 56-75 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-29 of U.S. Patent No. 11,844,754 (‘754) in view of ‘755. ‘754 teaches a method of treating Parkinson’s disease using subcutaneous administration of levodopa/carbidopa and oral administration of levodopa/carbidopa, in the dosages within the herein claimed dosages (see claims 1-29).
‘754 does not expressly teach pH and the dosing regimen of the composition. ‘754 does not expressly teach arginine to be incorporated into the composition. ‘754 does not expressly teach the incorporation of anti-oxidants.
‘755 teaches a method of treating neurological diseases, such as Parkinson’s disease, by continuously administering to said patient a composition of 1-6% of carbidopa/ 4-12% of levodopa, and arginine, wherein the composition is administered subcutaneously and orally administration of levodopa and/or carbidopa (see claims 1, 3, 4, 27, 31, 34). ‘755 teaches the extended oral administration can be 2-5 times daily at discrete intervals (see [0037], [0054], [0078]). ‘755 teaches the dosage of levodopa/carbidopa used as 100/25mg or in the ratio of 10:1 to 4:1 (see for example [0031], [0032], [0067]). ’755 teaches the pH of the composition as 9.1-9.8 (see [0005], [0039], [0040]). ‘755 teaches antioxidants including Na-ascorbate, L-cysteine, N-acetylcysteine (NAC), glutathione (GSH), Na2-EDTA, Na2-EDTA-Ca, or any combinations, can be incorporated into the liquid composition (see claims 10-11). ‘755 teaches the subcutaneous administration can be for 24 hours (see for example [0080]). ‘755 teaches the dosage of the liquid carbidopa/levodopa composition for subcutaneous infusion at an average rate of about 10-250 μl/hour, or about 160±40 μl/hour continuously for 24 hours (see [0080]). ‘755 teaches oral dosage of 100/25 (levodopa/carbidopa) produce comparable plasma level of LD (see Example 6, Fig. 5B). ‘755 teaches the oral composition can be formulated as pills, tablets or, the like (see [0067]). The examiner notes that at 250 μl/hour x 24 hours, it would be equivalent to 83.33mg to 720mg of levodopa (4-12%) and 60-360mg of carbidopa (1-6%). ‘755 also teaches the composition comprising about 2.5 to 7% of levodopa (see claim 35). ‘755 teaches arginine can form a salt of carbidopa, and/or levodopa to give rise a stable composition (see [0026]).
It would have been obvious to one of ordinary skill in the art at the time of filing to employ the pH and dosing regimen in the method of treating Parkinson’s disease. It would have been obvious to one of ordinary skill in the art at the time of filing to incorporate antioxidants and arginine into the levodopa/carbidopa composition in a method of treating Parkinson’s disease.
One of ordinary skill in the art would have been motivated to employ the pH and dosing regimen in the method of treating Parkinson’s disease. Adjusting the pH to maximize stability of the composition would be seen to be obvious as being within the purview of skilled artisan. The optimization of known effective amounts of known active agents to be administered, is considered well in the competence level of an ordinary skilled artisan in pharmaceutical science, involving merely routine skill in the art. It has been held that it is within the skill in the art to select optimal parameters, such as amounts of ingredients, in a composition in order to achieve a beneficial effect. See In re Boesch, 205 USPQ 215 (CCPA 1980). It is also noted that “[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). Since the amount of levodopa will affect the therapeutic level of levodopa, adjusting the amount to be administered would be obvious.
One of ordinary skill in the art would have been motivated to incorporate antiocidants arginine into the levodopa/carbidopa composition in a method of treating Parkinson’s disease because anti-oxidants can slow down the degradation of the composition while arginine can form a salt of carbidopa, and/or levodopa to give rise a stable composition.
Claims 56-75 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of copending Application No. 18/969,590 (‘590) in view of ‘755.
‘590 teaches a method of treating Parkinson’s disease using subcutaneous administration of levodopa/carbidopa/arginine and oral administration of levodopa/carbidopa, in the dosages within the herein claimed dosages (see claims 1, 2, 8, 9, 13).
‘590 does not expressly teach pH and the dosing regimen of the composition. ‘590 does not expressly teach the incorporation of anti-oxidants.
‘755 teaches a method of treating neurological diseases, such as Parkinson’s disease, by continuously administering to said patient a composition of 1-6% of carbidopa/ 4-12% of levodopa, and arginine, wherein the composition is administered subcutaneously and orally administration of levodopa and/or carbidopa (see claims 1, 3, 4, 27, 31, 34). ‘755 teaches the extended oral administration can be 2-5 times daily at discrete intervals (see [0037], [0054], [0078]). ‘755 teaches the dosage of levodopa/carbidopa used as 100/25mg or in the ratio of 10:1 to 4:1 (see for example [0031], [0032], [0067]). ’755 teaches the pH of the composition as 9.1-9.8 (see [0005], [0039], [0040]). ‘755 teaches antioxidants including Na-ascorbate, L-cysteine, N-acetylcysteine (NAC), glutathione (GSH), Na2-EDTA, Na2-EDTA-Ca, or any combinations, can be incorporated into the liquid composition (see claims 10-11). ‘755 teaches the subcutaneous administration can be for 24 hours (see for example [0080]). ‘755 teaches the dosage of the liquid carbidopa/levodopa composition for subcutaneous infusion at an average rate of about 10-250 μl/hour, or about 160±40 μl/hour continuously for 24 hours (see [0080]). ‘755 teaches oral dosage of 100/25 (levodopa/carbidopa) produce comparable plasma level of LD (see Example 6, Fig. 5B). ‘755 teaches the oral composition can be formulated as pills, tablets or, the like (see [0067]). The examiner notes that at 250 μl/hour x 24 hours, it would be equivalent to 83.33mg to 720mg of levodopa (4-12%) and 60-360mg of carbidopa (1-6%). ‘755 also teaches the composition comprising about 2.5 to 7% of levodopa (see claim 35).
It would have been obvious to one of ordinary skill in the art at the time of filing to employ the pH and dosing regimen in the method of treating Parkinson’s disease. It would have been obvious to one of ordinary skill in the art at the time of filing to incorporate antioxidants into the composition.
One of ordinary skill in the art would have been motivated to employ the pH and dosing regimen in the method of treating Parkinson’s disease. Adjusting the pH to maximize stability of the composition would be seen to be obvious as being within the purview of skilled artisan. The optimization of known effective amounts of known active agents to be administered, is considered well in the competence level of an ordinary skilled artisan in pharmaceutical science, involving merely routine skill in the art. It has been held that it is within the skill in the art to select optimal parameters, such as amounts of ingredients, in a composition in order to achieve a beneficial effect. See In re Boesch, 205 USPQ 215 (CCPA 1980). It is also noted that “[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). Since the amount of levodopa will affect the therapeutic level of levodopa, adjusting the amount to be administered would be obvious.
One of ordinary skill in the art would have been motivated to incorporate antioxidants into the composition because anti-oxidants can slow down the degradation of the composition.
This is a provisional nonstatutory double patenting rejection.
Claims 56-75 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 5, 6, 8-11, 17, 23, 24, 32-35, 40-44 of copending Application No. 18/725,986 (‘986) in view of ‘755.
‘986 teaches a method of treating Parkinson’s disease using subcutaneous administration of levodopa/carbidopa and oral administration of levodopa/carbidopa, in the dosages within the herein claimed dosages (see claims 1, 10, 17, 32-35, 40-41).
‘986 does not expressly teach pH and the dosing regimen of the composition. ‘986 does not expressly teach arginine to be incorporated into the composition. ‘986 does not expressly teach the incorporation of anti-oxidants.
‘755 teaches a method of treating neurological diseases, such as Parkinson’s disease, by continuously administering to said patient a composition of 1-6% of carbidopa/ 4-12% of levodopa, and arginine, wherein the composition is administered subcutaneously and orally administration of levodopa and/or carbidopa (see claims 1, 3, 4, 27, 31, 34). ‘755 teaches the extended oral administration can be 2-5 times daily at discrete intervals (see [0037], [0054], [0078]). ‘755 teaches the dosage of levodopa/carbidopa used as 100/25mg or in the ratio of 10:1 to 4:1 (see for example [0031], [0032], [0067]). ’755 teaches the pH of the composition as 9.1-9.8 (see [0005], [0039], [0040]). ‘755 teaches antioxidants including Na-ascorbate, L-cysteine, N-acetylcysteine (NAC), glutathione (GSH), Na2-EDTA, Na2-EDTA-Ca, or any combinations, can be incorporated into the liquid composition (see claims 10-11). ‘755 teaches the subcutaneous administration can be for 24 hours (see for example [0080]). ‘755 teaches the dosage of the liquid carbidopa/levodopa composition for subcutaneous infusion at an average rate of about 10-250 μl/hour, or about 160±40 μl/hour continuously for 24 hours (see [0080]). ‘755 teaches oral dosage of 100/25 (levodopa/carbidopa) produce comparable plasma level of LD (see Example 6, Fig. 5B). ‘755 teaches the oral composition can be formulated as pills, tablets or, the like (see [0067]). The examiner notes that at 250 μl/hour x 24 hours, it would be equivalent to 83.33mg to 720mg of levodopa (4-12%) and 60-360mg of carbidopa (1-6%). ‘755 also teaches the composition comprising about 2.5 to 7% of levodopa (see claim 35).
It would have been obvious to one of ordinary skill in the art at the time of filing to employ the pH and dosing regimen in the method of treating Parkinson’s disease. It would have been obvious to one of ordinary skill in the art at the time of filing to incorporate antioxidants and arginine into the levodopa/carbidopa composition in a method of treating Parkinson’s disease.
One of ordinary skill in the art would have been motivated to employ the pH and dosing regimen in the method of treating Parkinson’s disease. Adjusting the pH to maximize stability of the composition would be seen to be obvious as being within the purview of skilled artisan. The optimization of known effective amounts of known active agents to be administered, is considered well in the competence level of an ordinary skilled artisan in pharmaceutical science, involving merely routine skill in the art. It has been held that it is within the skill in the art to select optimal parameters, such as amounts of ingredients, in a composition in order to achieve a beneficial effect. See In re Boesch, 205 USPQ 215 (CCPA 1980). It is also noted that “[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). Since the amount of levodopa will affect the therapeutic level of levodopa, adjusting the amount to be administered would be obvious.
One of ordinary skill in the art would have been motivated to incorporate arginine and antioxidants into the levodopa/carbidopa composition in a method of treating Parkinson’s disease because anti-oxidants can slow down the degradation of the composition while arginine can form a salt of carbidopa, and/or levodopa to give rise a stable composition.
This is a provisional nonstatutory double patenting rejection.
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/SAN MING R HUI/Primary Examiner, Art Unit 1627
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