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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 5/27/2026 has been entered.
Priority
This application is a National Stage entry of PCT/IB2021/052006, filed 03/10/2021. PCT/IB2021/052006 Claims Priority from Provisional Application 63045596, filed 06/29/2020. PCT/IB2021/052006 Claims Priority from Provisional Application 62988379, filed 03/11/2020.
Information Disclosure Statement
The IDS filed on 5/27/2026 has been considered. See the attached PTO 1449 form.
Claim Status
Receipt of Remarks filed on 5/27/2026 is acknowledged. Claims 1, 3-5, 10, 12, 14-15, 59-64, 69-90 are currently pending. Claims 70-72 have been withdrawn. Accordingly, claims 1, 3-5, 10, 12, 14-15, 59-64, 69, 73-90 are currently under examination.
Rejection(s) not reiterated from the previous Office Action are hereby withdrawn. The following rejections are either reiterated or newly applied. They constitute the complete set of rejections presently being applied to the instant application.
New/Maintained Claim(s) Objection(s)/Rejection(s)
New matter
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 81, 84, 87, 90 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 81, 84, 87, 90 recite the at least one pharmaceutically acceptable excipient does not comprise an effervescing agent. The instant specification do not provide support this limitation in the claims. Any negative limitation or exclusionary proviso must have basis in the original disclosure. If alternative elements are positively recited in the specification, they may be explicitly excluded in the claims. Any claim containing a negative limitation which does not have basis in the original disclosure should be rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, as failing to comply with the written description requirement. See MPEP 2173.05 (i) and MPEP 2163.07(b). The instant specification do not positively recite inclusion of a effervescing agent, neither do they recite that pharmaceutically acceptable excipient does not comprise an effervescing agent. As such, the claims reciting the at least one pharmaceutically acceptable excipient does not comprise an effervescing agent represent new matter.
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.
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, 3-5, 10, 12, 14-15, 59-64, 69, 77-80, 82-83, 85-86, 88-89 are rejected under 35 U.S.C. 103 as being unpatentable over Rafanelli (US2011/0142766 A1; Jun. 16, 2011) in view of Christen (Arch Intern Med., 2009) and Omenn (The New England Journal of Medicine, vol. 334, No. 18, 1150-1155; 1996).
Rafanelli teaches an effervescent dietary supplement formulation that may be beneficial to the management of symptoms related to ocular diseases (abstract). Also provided are methods of treating an ocular disease, such as macular degeneration, by administering the dietary supplement to a subject in need thereof (abstract). Rafanelli teaches the supplements slow the progression of various ocular diseases (pg. 1, para. 0012). Rafanelli teaches a supplement wherein a packet is added to water (i.e. liquid formulation, immediate release) comprising 10 mg thiamin HCL (vitamin B1), 10 mg riboflavin (vitamin B2), 20 mg niacinamide (vitamin B3), 500 mg pantothenic acid (vitamin B5), 3 mg pyridoxine (vitamin B6), 0.03 mg biotin (vitamin B7), 0.8 mg folic acid (vitamin B9), 0.1 mg cyanocobalamin (vitamin B12), 500 mg ascorbic acid (vitamin C), 400 IU dl-alpha-tocopheryl acetate (vitamin E) (which equates to about 250 mg to 400 mg), 80 mg zinc oxide, 2 mg copper oxide, 10 mg lutein and 2 mg zeaxanthin. (see e.g. pg. 7, paras. 0059-0072). Rafanelli teaches in other embodiments pantothenic acid is present in an amount of about 50 mg (pg. 2, para. 0021). Rafanelli also teaches vitamin B6 (e.g., pyridoxine) can be present in an amount of about 10 mg to 20 mg, which merely overlaps about 25 mg to about 200 mg of vitamin B6 recited in claim 1. (see e.g., claims; entire document).
Rafanelli teaches the dietary supplement can be administered daily and/or once per day, as a single dose or multiple doses (once daily, twice daily, etc.) (see e.g. pg. 1, paras. 0010-0011, pg. 6, para. 0056). Rafanelli also teaches that the dietary supplements can be prepared into orally dispersible pills or tablets or soft gel capsule (pg. 4, paras. 0039-0040). Cyanocobalamin taught by Rafanelli is synthetic form of vitamin B12. Vitamins such as biotin and ascorbic acid can be sourced naturally or can be synthetic. Further, the vitamins are identical whether natural or synthetic sourced and therefore, the vitamins taught by Rafanelli read on claims 63 and 64 as they would be identical whether they are from a synthetic or natural source. Rafanelli teaches the formulation may comprise adjuvants/excipients, including a binder wherein the binder includes gelatin (see e.g. para 0033, 0037, 0039).
Rafanelli teaches the invention provides a dietary supplement including one or more vitamins, one or more minerals, one or more antioxidants, and an effervescing agent, which facilitates delivery of the vitamins, minerals, and antioxidants contained in the dietary supplement to the subject in need of treatment (see e.g. para 0018).
The teachings of Rafanelli have been set forth above.
Rafanelli does not teach wherein pyridoxine is within 25-200 mg or wherein cyanocobalamin is within 0.25 mg to 3.0 mg.
However, Christen teaches the administration of a combination of 2.5 mg folic acid, 50 mg pyridoxine HCl, and 1 mg cyanocobalamin for the reduction of risk of developing age-related macular degeneration (abstract).
As discussed supra, Rafanelli teaches the invention provides a dietary supplement including one or more vitamins, one or more minerals, one or more antioxidants, and an effervescing agent, which facilitates delivery of the vitamins, minerals, and antioxidants contained in the dietary supplement to the subject in need of treatment. Thus, while the exemplified embodiments of Rafanelli include vitamin A, Rafanelli in the general disclosure teaches requiring one or more vitamins, one or more minerals, one or more antioxidants, and an effervescing agent. Rafanelli does not require the composition has to include vitamin A. Omenn further address this.
Omenn discusses effects of beta carotene and vitamin A on lung cancer and cardiovascular disease. Omenn teaches beta carotene and vitamin A supplementation having adverse effect on the incidence of lung cancer and cardiovascular disease. Omenn, however, still recommends the dietary intake of fruits and vegetables (i.e. not in supplement form). (see: abstract; discussion; entire document).
Taken together, it would have been prima facie obvious to modify the formulation of Rafanelli with the concentrations of vitamins of Christen. A person of ordinary skill in the art would have had the motivation to do so with a reasonable expectation of success because both Rafanelli and Christen teach pyridoxine and cyanocobalamin for treating age related macular degeneration and the art demonstrates these concentrations in formulations are effective in delaying AMD (age related macular degeneration). Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Further, as discussed supra, Rafanelli also teaches vitamin B6 (e.g., pyridoxine) can be present in an amount of about 10 mg to 20 mg, which merely overlaps about 25 mg to about 200 mg of vitamin B6 recited in claim 1. 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) (Court held as proper a rejection of a claim directed to an alloy of "having 0.8% nickel, 0.3% molybdenum, up to 0.1% iron, balance titanium" as obvious over a reference disclosing alloys of 0.75% nickel, 0.25% molybdenum, balance titanium and 0.94% nickel, 0.31% molybdenum, balance titanium. "The proportions are so close that prima facie one skilled in the art would have expected them to have the same properties."). In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%). See: MPEP 2144.05(I).
Regarding the instantly claimed recitation wherein the composition does not comprise vitamin A, as discussed supra, Rafanelli teaches the invention provides a dietary supplement including one or more vitamins, one or more minerals, one or more antioxidants, and an effervescing agent, which facilitates delivery of the vitamins, minerals, and antioxidants contained in the dietary supplement to the subject in need of treatment. Thus, while the exemplified embodiments of Rafanelli include vitamin A, Rafanelli in the general disclosure teaches requiring one or more vitamins, one or more minerals, one or more antioxidants, and an effervescing agent. Rafanelli does not require the composition has to include vitamin A. Omenn further address this wherein Omenn discusses effects of beta carotene and vitamin A on lung cancer and cardiovascular disease. Omenn teaches beta carotene and vitamin A supplementation having adverse effect on the incidence of lung cancer and cardiovascular disease. Omenn, however, still recommends the dietary intake of fruits and vegetables (i.e. not in supplement form). Therefore, one skilled in the art would have found it obvious to exclude vitamin A because Rafanelli does not require the composition having vitamin A and Omenn discloses supplementation of vitamin A having adverse effects on lung cancer and cardiovascular disease.
From the combined teaching of the cited reference, one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made.
Claims 73-76 are rejected under 35 U.S.C. 103 as being unpatentable over Rafanelli (US2011/0142766 A1; Jun. 16, 2011) in view of Christen (Arch Intern Med., 2009) (cited in IDS), Omenn (The New England Journal of Medicine, vol. 334, No. 18, 1150-1155) and Renzosvitamins (Methylated Vitamins for Kids: What You Need to Know About Folic Acid and Folate – Renzo's Vitamins; June 17, 2019).
The teachings of Rafanelli, Christen and Omenn discussed above are incorporated herein.
Rafanelli, Christen and Omenn do not teach the composition includes methyl tetrahydrofolate. However, Renzosvitamins cures this deficiency.
Renzosvitamins discloses that folic acid is a synthetic form of vitamin B9 and methylfolate or L-methylfolate (i.e., methyl tetrahydrofolate) is methylated form of synthetic folic acid and is recommended for individuals with a MTHFR gene mutation. L-methylfolate is the active form of folate in the body (see: entire document).
It would have been prima facie obvious to one or ordinary skill in the art to modify the formulation of Rafanelli and substitute the folate or folic acid form of vitamin B9 taught by Rafanelli with methylfolate. One would have been motivated to do so because Renzosvitamins teaches that methylfolate or L-methylfolate (i.e., methyl tetrahydrofolate) is methylated form of synthetic folic acid and is recommended for individuals with a MTHFR gene mutation and that L-methylfolate is the active form of folate in the body. Thus, it would have been obvious to include the readily bioactive form of vitamin B9 (methylfolate) instead of the folate or folic acid which requires conversion to methylfolate and is not suitable for individual with a MTHFR gene mutation. Thus, the use of methylfolate instead of folic acid or folate as the form of vitamin B9 would have been prima facie obvious to one of ordinary skill in the art.
Regarding the amount of methyl tetrahydrofolate recited in the claims, as discussed supra, Rafanelli teaches vitamin B9 along with other vitamins is used for treating macular degeneration and Rafanelli teaches 0.8 mg of folic acid (vitamin B9). It would have been obvious to one skilled in the art to determine an amount of the active form of folic acid (i.e. methylfolate) needed to treat macular degeneration during routine optimization. Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
From the combined teaching of the cited reference, one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made.
Response to Argument
Applicant argued the office has set forth no rationale as to why one skilled in the art would have been motivated to select from Rafanelli the specific combination of vitamins, minerals, and antioxidants presently claimed, which exclude vitamin A. It was argued that vitamin A was known in the art to be beneficial for the eyes and age related macular degeneration.
In response, as discussed supra, Rafanelli teaches the invention provides a dietary supplement including one or more vitamins, one or more minerals, one or more antioxidants, and an effervescing agent, which facilitates delivery of the vitamins, minerals, and antioxidants contained in the dietary supplement to the subject in need of treatment. Thus, while the exemplified embodiments of Rafanelli include vitamin A, Rafanelli in the general disclosure teaches requiring one or more vitamins, one or more minerals, one or more antioxidants, and an effervescing agent. Rafanelli does not require the composition has to include vitamin A. Omenn further address this wherein Omenn discusses effects of beta carotene and vitamin A on lung cancer and cardiovascular disease. Omenn teaches beta carotene and vitamin A supplementation having adverse effect on the incidence of lung cancer and cardiovascular disease. Omenn, however, still recommends the dietary intake of fruits and vegetables (i.e. not in supplement form). Therefore, one skilled in the art would have found it obvious to exclude vitamin A because Rafanelli does not require the composition having vitamin A and Omenn discloses supplementation of vitamin A having adverse effects on lung cancer and cardiovascular disease.
Applicant argued that new claims exclude an effervescing agent which is required component of Rafanelli.
In response, applicant is correct in that Rafanelli requires effervescing agent and the claims requiring the exclusion of effervescing agent are not included in the 103 rejections above. However, as discussed supra, this newly recited limitation represents new matter and is rejected under 112(a) above.
Regarding the new claims which recite the excipients consist of followed by list of several excipients, as discussed supra, Rafanelli teaches the composition comprising excipient which include binder wherein the binder is gelatin. This reads on the claimed excipients. Further, the claims recite a composition followed by the transitional phrase “comprising” which allow for additional components and all the instant claims other than claims 81, 84, 87, 90 do not require the exclusion of an effervescent agent. Thus, Rafanelli’s teachings still read on the new claims which recite the excipient consist of because the comprising language still allows for additional components such as an effervescent agent.
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 1, 3-5, 10, 12, 14-15, 59-64, 69, 73-90 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9, 19-20, 25-26, 36 of copending Application No. 17/905,913 in view of Rafanelli (US2011/0142766 A1; Jun. 16, 2011) and Omenn (The New England Journal of Medicine, vol. 334, No. 18, 1150-1155).
‘913 teaches a composition for visual health comprising 3.4 mg to 4.6 mg thiamin HCL (vitamin B1), 3.4 mg to 5.6 mg riboflavin (vitamin B2), 25 mg to 60 mg niacinamide (vitamin B3), 12-22 mg pantothenic acid (vitamin B5), 45-60 mg pyridoxine (vitamin B6), 0.05 mg to 0.75 mg biotin (vitamin B7), 0.1-50 mg folic acid and/or methyl tetrahydrofolate (vitamin B9), 0.5-1.5 mg cyanocobalamin (vitamin B12). The composition is in the form of a tablet, capsule, soft gel, liquid, or powder. The composition is in the form of an immediate release formulation or a modified release formulation. At least one vitamin is from a natural source of said vitamin. At least one vitamin is from a synthetic source of said vitamin. The composition is on a daily dosage basis.
‘913 does not teach the composition comprises ascorbic acid (vitamin C), dl-alpha-tocopheryl acetate (vitamin E), zinc oxide, copper oxide, and the amounts thereof. However, Rafanelli cures these deficiencies.
The teachings of Rafanelli and Omenn discussed above are incorporated herein.
It would have been prima facie obvious to one of ordinary skill in the art to have combined the teachings of ‘913 and Rafanellli and incorporate ascorbic acid (vitamin C), dl-alpha-tocopheryl acetate (vitamin E), zinc oxide, copper oxide, and the amounts thereof taught by Rafanelli into the composition of ‘913. One would have been motivated to do so because both ‘913 and Rafanelli are directed to compositions for ocular health and one skilled in the art would have found it obvious to combine the two compositions which are directed toward the same purpose. As a general principle it is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose, the idea of combining them flows logically from their having been individually taught in the prior art. See In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) MPEP 2144.06.
Omenn discusses effects of beta carotene and vitamin A on lung cancer and cardiovascular disease. Omenn teaches beta carotene and vitamin A supplementation having adverse effect on the incidence of lung cancer and cardiovascular disease. Omenn, however, still recommends the dietary intake of fruits and vegetables (i.e. not in supplement form). Therefore, one skilled in the art would have found it obvious to exclude vitamin A because Rafanelli does not require the composition having vitamin A and Omenn discloses supplementation of vitamin A having adverse effects on lung cancer and cardiovascular disease.
From the combined teaching of the cited reference, one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made.
This is a provisional nonstatutory double patenting rejection.
Claims 1, 3-5, 10, 12, 14-15, 59-64, 69, 73-90 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9, 16-28 of copending Application No. 17/905,930 in view of Rafanelli (US2011/0142766 A1; Jun. 16, 2011) and Christen (Arch Intern Med., 2009) (cited in IDS) and Omenn (The New England Journal of Medicine, vol. 334, No. 18, 1150-1155).
‘930 teaches a composition for visual health comprising very long chain fatty acid, 350-800 mg vitamin C, 50-550 mg vitamin E, 20-90 mg zinc, 1.5-2.5 mg copper, 5-50 mg lutein, 1-20 mg zeaxanthin, vitamin B1, vitamin B2, vitamin B3, vitamin B5, vitamin B6, vitamin B7, vitamin B9 and vitamin B12. The composition is in the form of one or more tablets, capsules, soft gels, liquid, or powder. The composition is a daily dosage. The composition is administered daily to the subject in one, two, three, or four daily doses. Further, the vitamins are identical whether natural or synthetic sourced.
‘930 does not teach the specific form of each vitamins in the composition and the amounts of the B vitamins as recited in the instant claims. However, Rafanelli and Christen cure these deficiencies.
The teachings of Rafanelli and Christen discussed above are incorporated herein.
It would have been prima facie obvious to one of ordinary skill in the art to have combined the teachings of ‘930, Rafanelli and Christen and incorporate the specific form of each vitamins in the composition and the amounts of the B vitamins as recited in the instant claims. One would have been motivated to do so because ‘930, Rafanelli and Christen are directed to compositions for ocular health and one skilled in the art would have found it obvious to combine the two compositions which are directed toward the same purpose. As a general principle it is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose, the idea of combining them flows logically from their having been individually taught in the prior art. See In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) MPEP 2144.06.
Omenn discusses effects of beta carotene and vitamin A on lung cancer and cardiovascular disease. Omenn teaches beta carotene and vitamin A supplementation having adverse effect on the incidence of lung cancer and cardiovascular disease. Omenn, however, still recommends the dietary intake of fruits and vegetables (i.e. not in supplement form). Therefore, one skilled in the art would have found it obvious to exclude vitamin A because Rafanelli does not require the composition having vitamin A and Omenn discloses supplementation of vitamin A having adverse effects on lung cancer and cardiovascular disease.
From the combined teaching of the cited reference, one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made.
This is a provisional nonstatutory double patenting rejection.
Claims 1, 3-5, 10, 12, 14-15, 59-64, 69, 73-90 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10, 21-30, 39-56, 58-62 of copending Application No. 18/402,046 in view of Rafanelli (US2011/0142766 A1; Jun. 16, 2011) and Christen (Arch Intern Med., 2009) (cited in IDS) and Omenn (The New England Journal of Medicine, vol. 334, No. 18, 1150-1155).
‘046 teaches a composition for visual health comprising 350-800 mg vitamin C (ascorbic acid), 100-550 mg vitamin E (dl-alpha tocopheryl acetate), 20-90 mg zinc oxide, 1.5-2.5 mg copper oxide, 5-50 mg lutein, and 1-20 mg zeaxanthin. The composition further comprises B vitamins. The composition is in the form of one or more tablets, capsules, soft gels, liquid, or powder. The composition is in the form of an immediate release formulation or a modified release formulation. The composition is formulated into one, two, three, or four dosage units for daily administration. The composition is formulated into one, two, three, or four tablets for daily administration. At least one vitamin is from a natural source of said vitamin. at least one vitamin is from a synthetic source of said vitamin. The composition is on a daily dosage basis.
‘046 does not teach the specific types of B vitamins and the amounts thereof in the composition as recited in the instant claims. However, Rafanelli and Christen cure these deficiencies.
The teachings of Rafanelli and Christen discussed above are incorporated herein.
It would have been prima facie obvious to one of ordinary skill in the art to have combined the teachings of ‘046, Rafanelli and Christen and incorporate the specific types of B vitamins and the amounts thereof in the composition of ‘046 as recited in the instant claims. One would have been motivated to do so because ‘046, Rafanelli and Christen are directed to compositions for ocular/visual health and one skilled in the art would have found it obvious to combine the two compositions which are directed toward the same purpose. As a general principle it is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose, the idea of combining them flows logically from their having been individually taught in the prior art. See In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) MPEP 2144.06.
Omenn discusses effects of beta carotene and vitamin A on lung cancer and cardiovascular disease. Omenn teaches beta carotene and vitamin A supplementation having adverse effect on the incidence of lung cancer and cardiovascular disease. Omenn, however, still recommends the dietary intake of fruits and vegetables (i.e. not in supplement form). Therefore, one skilled in the art would have found it obvious to exclude vitamin A because Rafanelli does not require the composition having vitamin A and Omenn discloses supplementation of vitamin A having adverse effects on lung cancer and cardiovascular disease.
From the combined teaching of the cited reference, one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant made similar argument as above regarding double patenting rejection, wherein it is argued that one skilled in the art would have not excluded vitamin A from the teachings of Rafanelli.
In response, the examiner respectfully directs applicant’s attention to examiner’s response above which also applies here.
Conclusion
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/ALI S SAEED/Examiner, Art Unit 1616
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