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 .
Detailed Action
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.
Claims 1, 10-12, 19 and 21-33 are rejected under 35 U.S.C. 103 as being unpatentable over Perrin et al. (USP 8,183,227 or US PG pub. 2017/0112178A1) in view of White et al. (US PG pub. 2018/0368458A1) and further in view of Evenstad et al. (US PG pub. 2015/0050261A) and Jouni et al. (US PG pub. 2013/0095189), Toothman (USP 10,617,700) and Bortz et al. (US PG Pub. 2014/0364491A1).
Perrin et al. discloses compositions and methods of administering compositions for both prophylactic and therapeutic nutritional supplementation. Specifically, for example, the present invention relates to novel compositions of vitamins, minerals, and omega-3 fatty acids that can be used to supplement the nutritional deficiencies observed in patients throughout physiologically stressful states, see column 3, lines 20-26. Perrin teaches that patient comprises any and all organisms and includes the term subjects and patient may refer to human or any other animal, see column 8, lines 21-24. Example 1 discloses composition comprising vitamins and minerals, see column 36, example 1. Perrin teaches that the term “patient,” as used herein, comprises any and all organisms and includes the term “subject.” “Patient” may refer to a human or any other animal. “Patient” may also refer to a fetus, see [0030] and see [0035] wherein it is stated that the phrase “pharmaceutically acceptable,” as used herein, refers to those compounds, materials, compositions and/or dosage forms which are, within the scope of sound pharmaceutical/medical judgment, suitable for use in contact with the tissues of human beings and animals without excessive toxicity, irritation, allergic response, or other problem or complication, commensurate with a reasonable benefit/risk ratio.
Perrin discloses that the pharmaceutical composition consists of vitamin D, iodine, vitamin B1, vitamin B6, vitamin B12, vitamin B2, vitamin B9, vitamin B3, vitamin E, vitamin A, vitamin C, iron, zinc, copper, magnesium, omega-3 fatty acids and one or more pharmaceutically acceptable carriers, see abstract. Perrin teaches use of folate and iron in the form of ferrous bisglycinate and folates are selected from D-glucosamine folate, tetrahydrofolate, D-glucosamine -5-methyl tetrahydrofolate and D-glactosamine -methyl tetrahydrofolate, see description. Perrin teaches that zinc can be used as zinc picolinate or gluconate, see column 5, lines 25-30. Perrin teaches vitamin D in an amount of about 500I.U. Vitamin B1 in an amount of 0.8mg to about 2.4mg, vitamin B6 in an amount of about 1.2mg to about 3.8mg, vitamin B12 in an amount of about between 0.9mg to about 2.7mg, vitamin B9 in an amount of about 6 to 18 micrograms, see column 5, lines 55-65. Perrin teaches use of DHA and EPA, see column 5, lines 40-45. Perrin teaches the composition can be in powder, gel, oily, gritty, or tablet form, see column 6, lines 40-47. Vitamin B3 is niacin, see column 13, lines 37-40. Use of pyridoxine is taught in column, 13, lines 55-58. Vitamin B12 as methyl cobalamin, see column 13, lines 58-62. Perrin teaches that the compositions, kits and methods of the present invention may be used or utilized in one or more dosage forms. In a specific embodiment, the dosage form more be a capsule, tablet, caplet, gel caplet (gelcap), syrup, a liquid composition, a concentrated powder, and a concentrated powder admixed with a liquid. The kits may comprise multiple compositions utilizing multiple dosage forms, see [0139]. Perrin teaches use of kits and inserts, see [0139] and [0132]. Perrin teaches that the dissolution of the compositions may be facilitated by including relatively small particles sizes of the ingredients used, see [0153].
While Perrin teaches the composition can be in powder, gel, oily, gritty, or tablet form, Perrin does not teach use of beadlets or boron in a dietary supplement.
White et al. teaches time-release vitamins and minerals in edible oils, see title. White et al. teaches a nutrition enhancing composition comprising (a) an oil phase comprising one or more fish oils and optionally one or more oil soluble vitamins and/or minerals, (b) controlled release beads comprising one or more vitamins and/or minerals, wherein the controlled release beads are incorporated into said one or more edible oils and optionally (c) an immediate release component comprising at least one performance enhancing component, see abstract. White et al. teaches that in certain aspects, the (a) immediate release oil phase comprises one or more edible oils and optionally one or more oil soluble vitamins and/or minerals. The (b) controlled release component comprises one or more vitamins, one or minerals, or a combination thereof, formulated for timed release. In certain aspects, the (b) controlled release component or immediate release component comprises one or more vitamins, one or more minerals, or a combination thereof formulated for sustained release, delayed release, or a combination of both sustained release and delayed release, such that the extended release component provides a sustained nutrition and/or performance, a latter nutrition and/or performance burst, or combinations thereof, see [0017]. White et al. teaches that the nutrition and/or performance enhancing immediate and extended release composition is mixed and contained within a capsule, optionally forming a two-piece liquid capsule, or in a soft gel, see [0076]. While also teaches use of nutritional enhancing composition comprising boron and water soluble minerals, see claim 17.
It would have been obvious to one of ordinary skill to have utilized the oral nutritional supplement of Perrin et al. into a beadlet form and oil form based on the teachings of White et al. One of ordinary skill would have been motivated to do so because Perrin teaches powder or tablet or capsule form of dosage formulation while teaching a pharmaceutical composition in a single oral dosage form for administration to human wherein the pharmaceutical composition consists of vitamin D, iodine, vitamin B1, vitamin B6, vitamin B12, vitamin B2, vitamin B9, vitamin B3, vitamin E, vitamin A, vitamin C, iron, zinc, copper, magnesium, omega-3 fatty acids and White et al. provide a nutritional composition comprising oil phase and controlled release beads which can comprise vitamins, minerals and oil soluble components in a liquid capsule. Utilization of the known nutrition enhancing composition comprising oil phase and controlled release beads was known in the art by White et al. and utilization of such as formulation would have provided a predictable result of forming a known nutritional dosage formulation. Additionally, it would have been obvious to one of ordinary skill to have utilized mineral like boron into the nutritional composition of Perrin et al. for nutrition purposes motivated by the teachings of White et al.
While Perrin teaches use of zein, Evenstad et al. teaches various coating materials as discussed below:
Evenstad et al. discloses dietary and nutritional supplements containing an omega-3 fatty acid, see title. The reference teaches use of the supplements that include vitamins, minerals, nutrients and omega-3 fatty acids, see abstract. The reference teaches use of coating that can be used including zein, gelatin, shellac etc. as disclosed in [0072]. Evenstad teaches use of dietary and nutritional supplements to humans, see [0003].
It would have been obvious to one of ordinary skill to have utilized the zein comprising coating to oral nutritional supplements as taught by Evenstad et al. because Perrin et al. and Evenstad et al. both are directed to nutritional supplements and utilization of known coatings to be applied to nutrients would have provided predictable results. Since Perrin et al. teaches the known nutritional supplementation comprising vitamins and minerals and White provides use of beadlets comprising time-release vitamins and minerals in edible oils, it would have been obvious to one of ordinary skill to have utilized the known coatings comprising natural material zein along with vitamins and minerals as taught by Evanstad et al. for time-delivered nutritional supplementation.
Generally, it is prima facie obvious to combine two compositions, each of which is taught by the prior art to be useful for same purpose, in order to form a third composition to be used for the very same purpose. The idea for combining them flows logically from their having been individually taught in the prior art. See MPEP 2144.06. Regarding the release of the capsule components after passing through the stomach, it is pointed out that since Perrin suggests use of coatings and Evenstad teaches zein as naturally known coating materials, it would flow implicitly that the release of capsule will be after passing through the stomach of the user.
The references discussed above do not teach use of vitamin K as menaquinone-7. The references discussed above do not teach use of calcium fructoborate and dimagnesium malate.
Jouni et al. disclose nutritional supplements comprising vitamins, nutrients and menaquinone-7, see [0017] and [0082]. It would have been obvious to one of ordinary skill to have utilized menaquinone-7 as taught by Jouni into the nutritional supplement of Perrin et al. Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07.
Toothman teaches vitamin supplements with enhanced bioavailability and women’s multivitamin comprising boron as calcium fructoboarate, see [Table 0007]. It would have been obvious to one of ordinary skill to have utilized boron as calcium fructoboarate as taught by Toothman into the nutritional supplement of Perrin et al. Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. Since Toothman teaches use of boron as calcium fructoborate in a women’s multivitamin, it would be obvious to one of ordinary skill to have utilized a specific one into the boron teaching nutritional supplement of Perrin et al. for its nutritional purposes. Bortz teaches iron supplement for prenatal pregnancy and as pre-natal vitamin which can be administered before, during or after pregnancy wherein the composition can comprise salts and mineral including dimagnesium malate, see title, [0076] and [0055]. Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. It would be obvious to one of ordinary skill to have utilized a specific dimagnesium malate as mineral and salt for nutritional purposes to prenatal pregnant women motivated by the teachings of Bortz et al.
Nonstatutory double patenting rejection
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1, 10-12, 19 and 21-33 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11,083,738.
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims recite a daily women's health dietary supplement comprising a plurality of beadlets and oil, wherein: the beadlets are solid, and comprise one or more nutrients miscible in aqueous solution selected from the group consisting of vitamin B12, boron, magnesium, iron, and folate; and the oil is liquid, and comprises one or more fat-soluble nutrients selected from the group consisting of vitamin K, vitamin D, vitamin E, and omega-3 fatty acids. A daily women's pre-natal or post-natal supplement comprising a first capsule and a second capsule, wherein: the first and second capsules are essentially free of components derived from animals; the first capsule comprises one or more nutrients miscible in aqueous solution selected from the group consisting of vitamin B12, biotin, choline, iron, iodine, boron, magnesium, zinc, vitamin C, and folate; and the second capsule comprises one or more fat-soluble nutrients selected from the group consisting of vitamin D, vitamin E, vitamin K, and omega-3 fatty acids.
The patented claims recite a daily women's health dietary supplement comprising a plurality of beadlets and oil contained in an extended release capsule, the capsule being essentially free of components derived from animals, wherein: the beadlets are solid, and comprise one or more nutrients miscible in aqueous solution selected from the group consisting of vitamin B12, boron, magnesium, iron, and between about 500 mcg to about 800 mcg of folate, and the beadlets further comprising an outer coating layer comprising zein; the oil is liquid, and comprises vitamin K as menaquinone-7, and one or more fat-soluble nutrients selected from the group consisting of between about 1800 IU to about 2500 IU of vitamin D, vitamin E, and between about 290 mg to about 400 mg of one or more omega-3 fatty acids; and wherein the extended release capsule releases a majority of the plurality of beadlets and oil after passing through a user's stomach. Dependent claims recite, wherein the daily women's health dietary supplement is packaged in a transparent bottle, wherein the bottle comprises a scented insert, wherein the scented insert comprises a polymer and a scented oil, wherein the scented insert consists essentially of ethylene vinyl acetate and peppermint oil. The patented dietary composition comprising beads, oils, vitamins and omega-3-fatty acids in a capsule and packaged in a bottle with scented insert reads on the instant claims and the use of the dietary supplement for men or women is an intended use of the known nutritional supplement.
Claims 1, 10-12, 19 and 21-33 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-33 of USP 12,128,057. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims recite a daily women's health dietary supplement comprising a plurality of beadlets and oil, wherein: the beadlets are solid, and comprise one or more nutrients miscible in aqueous solution selected from the group consisting of vitamin B12, boron, magnesium, iron, and folate; and the oil is liquid, and comprises one or more fat-soluble nutrients selected from the group consisting of vitamin K, vitamin D, vitamin E, and omega-3 fatty acids. A daily women's pre-natal or post-natal supplement comprising a first capsule and a second capsule, wherein: the first and second capsules are essentially free of components derived from animals; the first capsule comprises one or more nutrients miscible in aqueous solution selected from the group consisting of vitamin B12, biotin, choline, iron, iodine, boron, magnesium, zinc, vitamin C, and folate; and the second capsule comprises one or more fat-soluble nutrients selected from the group consisting of vitamin D, vitamin E, vitamin K, and omega-3 fatty acids.
The patented claims recite a daily women’s pre-natal supplement comprising a first capsule and a second capsule, wherein: the first and second capsules are essentially free of components derived from animals; the first capsule comprises one or more nutrients miscible in aqueous solution selected from the group consisting of vitamin B12, biotin, choline, iron, iodine, boron, magnesium, and folate; and the second capsule comprises one or more fat-soluble nutrients selected from the group consisting of vitamin D, vitamin E, vitamin K, and omega-3 fatty acids. The dependent claims recite, wherein the daily women’s pre-natal supplement is packaged in a transparent bottle, wherein the bottle comprises a scented insert, wherein the scented insert comprises a polymer and a scented oil, wherein the scented insert consists essentially of ethylene vinyl acetate and at least one citrus oil selected from the group consisting of grapefruit oil, lemon oil, and orange oil. The patented dietary composition comprising beads, oils in a capsule and packaged in a bottle with scented insert reads on the instant claims and the use of the dietary supplement for men or women is an intended use of the known nutritional supplement.
Claims 1, 10-12, 19 and 21-33 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of USP 12,128,056. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims recite a daily women's health dietary supplement comprising a plurality of beadlets and oil, wherein: the beadlets are solid, and comprise one or more nutrients miscible in aqueous solution selected from the group consisting of vitamin B12, boron, magnesium, iron, and folate; and the oil is liquid, and comprises one or more fat-soluble nutrients selected from the group consisting of vitamin K, vitamin D, vitamin E, and omega-3 fatty acids. A daily women's pre-natal or post-natal supplement comprising a first capsule and a second capsule, wherein: the first and second capsules are essentially free of components derived from animals; the first capsule comprises one or more nutrients miscible in aqueous solution selected from the group consisting of vitamin B12, biotin, choline, iron, iodine, boron, magnesium, zinc, vitamin C, and folate; and the second capsule comprises one or more fat-soluble nutrients selected from the group consisting of vitamin D, vitamin E, vitamin K, and omega-3 fatty acids.
The patented claims recite a dietary supplement comprising a plurality of beadlets and oil, contained in an extended release capsule, wherein: the dietary supplement is formulated as a men's daily formulation; the extended release capsule is vegetarian; the beadlets comprise aqueous-soluble nutrients in a solid and the oil comprises fat-soluble nutrients in a liquid, wherein the aqueous-soluble nutrients consist of vitamin B12, magnesium, zinc, boron, and folate; the beadlets further comprise an outer coating layer comprising zein; the fat-soluble nutrients consist of vitamin D3, vitamin E, vitamin A, vitamin K, and omega-3 fatty acids; and the extended release capsule releases a majority of the plurality of beadlets and oil after passing through a user's stomach. The dependent claims recite, wherein the daily women’s pre-natal supplement is packaged in a transparent bottle, wherein the bottle comprises a scented insert, wherein the scented insert comprises a polymer and a scented oil, wherein the scented insert consists essentially of ethylene vinyl acetate and at least one citrus oil selected from the group consisting of grapefruit oil, lemon oil, and orange oil. The patented dietary composition comprising beads, oils in a capsule and packaged in a bottle with scented insert reads on the instant claims and the use of the dietary supplement for men or women is an intended use of the known nutritional supplement.
Correspondence
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/SNIGDHA MAEWALL/
Primary Examiner, Art Unit 1612
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