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 .
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.
Claim Status
Receipt of Remarks filed on 11/21/2025 is acknowledged. Claims 1, 3-5, 10, 12, 14-15, 59-64, 69-78 are currently pending. Claims 70-72 have been withdrawn. Accordingly, claims 1, 3-5, 10, 12, 14-15, 59-64, 69, 73-78 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Rejection(s) not reiterated from the previous Office Action are hereby withdrawn.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.
Withdrawn Rejections
The double patenting rejections over copending applications 17/905,930 and 18/402,046 have been withdrawn due to the amended claims use of consisting of language which excludes the ingredients recited in ‘930 and ‘046 copending applications.
New/Maintained Claim(s) Objection(s)/Rejection(s)
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 75-78 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 75 and 77 recite “about 500 of ascorbic acid”. The recitation does not specify the units of the amount of ascorbic acid which makes it unclear as to what exact amount of ascorbic acid is required in the composition.
Claims 76 and 78 are included in the rejection as they depend on a rejected base claim and do not clarify the issues discussed above.
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, 77-78 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).
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 (see e.g. para 0033).
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 (excipient), 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).
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 consists of only the component recited in the claims, while Rafanelli does not exemplify a composition which consists of only the components recited in the instant claims, 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 (excipient), which facilitates delivery of the vitamins, minerals, and antioxidants contained in the dietary supplement to the subject in need of treatment. The one or more vitamins, one or more minerals, one or more antioxidants, and an effervescing agent (excipient) are the required component of Rafanelli and these required components fall within the consisting of language recited in the instant claims. Therefore, all of the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention. Note: MPEP 2141 KSR International CO. v. Teleflex Inc. 82 USPQ 2d 1385 (Supreme Court 2007).
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) 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 and Christen discussed above are incorporated herein.
Rafanelli and Christen 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 that the amended claims recite composition consisting of the recited vitamins, minerals, and antioxidants, along with at least one pharmaceutically acceptable excipient. Applicant argued that Rafanelli teaches compositions comprising additional active ingredients which are excluded from the claimed composition.
In response, as discussed supra, while Rafanelli does not exemplify a composition which consists of only the components recited in the instant claims, 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 (excipient), which facilitates delivery of the vitamins, minerals, and antioxidants contained in the dietary supplement to the subject in need of treatment. The one or more vitamins, one or more minerals, one or more antioxidants, and an effervescing agent (excipient) are the required component of Rafanelli and these required components fall within the consisting of language recited in the instant claims. Therefore, all of the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention. Note: MPEP 2141 KSR International CO. v. Teleflex Inc. 82 USPQ 2d 1385 (Supreme Court 2007). “Disclosed examples and preferred embodiments do not constitute a teaching away from the broader disclosure or non-preferred embodiment.” In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971). MPEP 2123.
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, 73-78 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-25 of copending Application No. 17/905,913 in view of Rafanelli (US2011/0142766 A1; Jun. 16, 2011).
‘905 teaches a composition for visual health comprising 0.1 mg to 25.0 mg thiamin HCL (vitamin B1), 0.1 mg to 25.0 mg riboflavin (vitamin B2), 1.0 mg to 300 mg niacinamide (vitamin B3), 1.0 mg to 250.0 mg pantothenic acid (vitamin B5), 25.0 mg to 200.0 mg pyridoxine (vitamin B6), 0.01 mg to 1.0 mg biotin (vitamin B7), 0.1 mg to 50.0 mg folic acid and/or methyl tetrahydrofolate (vitamin B9), 0.25 mg to 3.0 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.
‘905 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 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 ‘905 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 ‘905. One would have been motivated to do so because both ‘905 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.
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 Argument
Applicant argued that the present application and the copending application ‘913 have the same filing date and their patent terms are equal. Thus, the granting of one would not create an unjustified extension of the other’s term.
In response, applicant’s attention is respectfully drawn to MPEP 804 which state: If both the application under examination and the reference application have the same patent term filing date, the provisional nonstatutory double patenting rejection made in each application should be maintained until it is overcome. Provisional nonstatutory double patenting rejections are subject to the requirements of 37 CFR 1.111(b). Thus, applicant can overcome a provisional nonstatutory double patenting rejection by filing a reply that either shows that the claims subject to the rejection are patentably distinct from the claims of the reference application, or includes a compliant terminal disclaimer under 37 CFR 1.321 that obviates the rejection. If the reply is sufficient, the examiner will withdraw the nonstatutory double patenting rejection in the application in which it was submitted.
Conclusion
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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/A.S/ Examiner, Art Unit 1616
/SUE X LIU/ Supervisory Patent Examiner, Art Unit 1616