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 .
Claim Status
Claims 1-7 and 9-19 are pending.
Claim 8 has been canceled.
Claims 5 is withdrawn.
Claims 1-7 and 9-16 are currently amended.
Claims 17-19 have been added.
Claims 1-4, 6-7 and 9-19 are currently under consideration.
Claims 1-4, 6-7 and 9-19 are rejected.
Acknowledgement of Receipt
This Office Action is in response to the Applicants’ amendments and remarks filed 11/26/2025.
Withdrawn Objections and Rejections
The objection to the specification is withdrawn.
In light of the new amendments, the rejection of claims 1-4 and 7 rejected under 35 U.S.C. § 102 as being anticipated by De Paoli evidenced by Kurtz is withdrawn.
In light of the new amendments, the rejection of claims 1-4, 6-7 and 9-16 rejected under 35 U.S.C. § 103 as being unpatentable over Jackson and Lee evidenced by Lee, G.A. and MicroMesh is withdrawn.
New Rejections
Applicant’s amendments have necessitated the following grounds of rejection:
Claim Rejections - 35 USC § 102
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-4 and 6 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Akahoshi et al. (WO 1998/035565 A1, pub. 08/20/1998) herein referenced Akahoshi. Citations for Akahoshi are taken from the machine translated document provided.
Akahoshi discloses fermented milk enriched with iron and a method for producing the same in which iron content is fortified, has good dispersibility, and has no unpleasant taste of iron (abstract). Akahoshi teaches a ferric pyrophosphate emulsifier coating composition obtained by coating ferric pyrophosphate with a specific emulsifying component was used in lactic acid-enzyme acid milk. It is stable and stable, and the unique unpleasant taste of iron is extremely unlikely to develop (bridging pgs. 1-2 of the document provided).
Regarding claims 1-2, Akahoshi provides a ferric pyrophosphate emulsifier coating composition and teaches that a stable adsorptive interphase is formed on the surface of the water-insoluble mineral particles. Regarding the encapsulating agent being present in a range of 5-99% w/w, Akahoshi discloses a 10% enzymatically decomposed lecithin coated ferric pyrophosphate slurry (pg. 4, para. 4, see Reference Example 1).
Regarding claims 3-4, Akahoshi teaches that the food emulsifier used for the production of the coated ferric pyrophosphate is not particularly limited, and general food emulsifiers such as sucrose fatty acid ester, dalyserine fatty acid ester, propylene dalycol fatty acid ester and sorbitan fatty acid esters and the like can be used alone or in combination of two or more, but it is preferable to use enzymatically degraded lecithin (i.e., hydrolyzed lecithin, a phospholipid) which is a polar lipid having a high covering effect (pg. 2, para. 6).
Regarding claim 6, Akahoshi describes ferric pyrophosphate-enzyme-decomposed lecithin complex in the solid phase 8.2 kg (in terms of dry weight) of the powder (coated ferric pyrophosphate) being recovered and resuspended in ion-exchanged water to prepare a 10% coated ferric pyrophosphate slurry (pg. 4, para. 4).
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 (a) are summarized as follows:
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue.
Resolving the level of ordinary skill in the pertinent art.
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. Applicants are 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.
Applicant Claims
The claims are directed to a composition comprising dry encapsulated particles, the dry encapsulated particles including: i) carbonyl iron salt particles having a density in the range of 0.1 - 10 g/mL, the carbonyl iron salt particles being present in the composition in a range of 1-95% w/w; and ii) an encapsulating agent encapsulating the carbonyl iron salt particles to form the dry encapsulated particles, the encapsulating agent being present in the composition in a range of 5-99% w/w (claim 1);
wherein the dry encapsulated particles are in the form of granules (claim 7);
wherein the carbonyl iron salt particles are selected from carbonyl iron, ferrous fumarate, ferrous succinate, ferrous gluconate, ferric pyrophosphate, ferric saccharate, ferric orthophosphate, ferrous ascorbate, ferrous sulfate and mixtures thereof (claim 2); and have a size before encapsulation permitting passage through a 40# mesh (claim 12), a 60# mesh (claim 13), a 80# mesh (claim 14), and a 20# mesh (claim 15);
wherein the encapsulating agent is selected from lipids, emulsifiers and mixtures thereof (claim 3); wherein the lipid is selected from hydrogenated fats, phospholipids, natural waxes, gums, polyethylene glycols, and oligosaccharides, either alone or mixtures thereof (claim 4).
Said composition has a dissolution profile in which iron is released from the composition, wherein the % of iron released into 900 mL of water after 180 minutes in a USP Type II paddle apparatus operating at 50 RPM for three hours is about 92%, based on titration analysis of iron in the water (claim 9); a dissolution profile in which iron is released from the composition, wherein the % of iron released into 900 mL of 0.1 N HCl after 180 minutes in a USP Type II paddle apparatus operating at 50 RPM for three hours is about 40%, based on titration analysis of iron in the 0.1 N HCl (claim 10); and a dissolution profile in which iron is released from the composition, wherein the % of iron released into 900 mL of 6.8 pH buffer after 180 minutes in a USP Type II paddle apparatus operating at 50 RPM for three hours is about 70%, based on titration analysis of iron in the buffer (claim 11).
The claims are further directed to a method of using the composition, comprising including the composition in sprinkles, micronutrient premixes, tablets, capsules, powders, pellets, salt, rice or wheat flour (claim 6).
The claims are further directed to a method of making a composition of dry encapsulated particles, comprising: i) transferring carbonyl iron salt particles having a density in the range of 0.1- 10 g/mL to a fluid bed processor; ii) spraying a molten encapsulating agent onto the carbonyl iron salt particles on the fluid bed processor to form dry encapsulated particles, the dry encapsulated particles comprising the carbonyl iron salt particles in a range of 1-95% w/w of the dry encapsulated particles and the encapsulating agent in a range of 5-99% w/w of the particles (claim 17); wherein the encapsulating agent is selected from lipids, emulsifiers and mixtures thereof (claim 18), comprising melting the encapsulating agent to form the molten encapsulating agent (claim 19).
Claim(s) 1-4, 6-7 and 9-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zlotkin (US-20040224032-A1, pub. 11/11/2004) evidenced by Michael B. Zimmermann (Int. J. Vitam. Nutr. Res., 74 (6), 2004, 453–461) herein referenced Zlotkin and Zimmermann.
Zlotkin discloses a composition useful in the prevention of iron deficiency anemia comprising micro-encapsulated iron granules with a lipid (abstract, [0009]). The iron granules may comprise any bioavailable solid form of iron capable of providing iron to include iron salts, such as ferrous sulphate, ferrous fumarate, ferrous succinate, ferrous gluconate, ferric pyrophosphate, ferric saccharate, ferric orthophosphate ([0017]). Zltokin discloses that the granulated iron compound is provided as a fine free flowing powder ([0018]). In the composition, granules are prepared having a diameter of no more than about 850 microns and granules of this size range can be obtained, for example, using a U.S. No. 20 Sieve ([0018]).
Zltokin provides examples in which the iron fumarate is encapsulated in a matrix of hydrogenated soybean oil as evidenced by Zimmermann (pg. 459, Table IX, no. 7; see producer Watson) and discloses that the encapsulated ferrous fumarate 60% (1 gram delivers 600 mg ferrous fumarate), having a particle size of no more that about 850 microns in which about 99% of the particles pass through a U.S. No. 20 Sieve ([0028]). Ferrous Sulfate (Fe SO4 7H2O) is the reference compound in the study which found that the mean hemoglobin response of the high iron control and high iron diet groups (in rats) was 31 g/L and 33 g/L, respectively ([0034]).
Methods of using involve administering iron-containing sachets (i.e., powders) to infants ([0036], claim 30). Making the composition is disclosed in Examples 1-3 and in claims 1 and 28.
Regarding density and percentage w/w, as mentioned above, Zlotkin prepares the composition with encapsulated ferrous fumarate 60% (Example 1). As Zlotkin teaches a species recited in dependent instant claim 2, Zlotkin meets the density limitation.
Zlotkin explicitly states that 10 mg of elemental iron is present in the form of micro-encapsulated granules in the study ([0033-0034]) wherein the ferrous fumarate is at 60%, the encapsulant as mentioned above, evidenced by Zimmerman is hydrogenated soybean oil, thereby reading on the hydrogenated fat species of instant claim 4; present in an amount that falls within the claimed range. Zlotkin explicitly states that the granulated iron is a powder ([0018]) to meet the limitations of both instant claims 6 and 7.
Regarding mesh sizes, as mentioned above Zlotkin provides a size limit of 850 microns and suggests that a skilled artisan would readily obtain this with a number 20 sieve ([0018]). Here the prior art makes it obvious that carbonyl ion salt particle recited in the claims would be able to meet the different mesh sizes. These specifications are commonly known and widely used in sieves wherein the mesh size disclosed by Zlotkin would fall within the claimed mesh numbers (i.e., 20, 30, 40, 60, 80).
Regarding dissolution profiles, these claims recite certain properties of the composition. MPEP § 2112.01 states that if a composition is physically the same, it must have the same properties. Given that the teachings of Zlotkin meet the structural limitations of claim 1, the property of having a dissolution profile as instantly described, and as such are presumed to be present in any composition that meets the structural requirements of the claims.
It would have been prima facie obvious to a person of ordinary skill in the art, ahead of the effective filing date of the claimed invention, to the taught by in the taught by with expected results. One would be motivated to do so with a reasonable expectation of success because Zlotkin provides a composition that can readily be admixed with the semi-solid foods that the 6 and 24 months age group consumes (abstract, [0008]). Zlotkin teaches that lipids and the iron granules interact in chemically stable manner in which no adverse interaction occurs such as undesirable aesthetic changes or undesirable changes to the taste of the product ([0016]).
Claim(s) 17-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zlotkin evidenced by Zimmermann as applied to claim(s) 1-4, 6-7 and 9-16 above, and further in view of, Jouni et al. (WO-2013055439-A1, pub. 04/18/2013) and Hong et al. (KR-20080049224-A, pub. 06/04/2008, Espacenet MT), herein referenced Jouni and Hong. Hong is cited from the machine translation provided.
The teachings of Zlotkin and Zimmermann above are incorporated herein.
Jouni discloses milk-based nutritional compositions for pediatric subjects and the corresponding methods of using the nutritional compositions to promote health and development (abstract). Jouni discloses methods for eliminating or reducing the formation of a color complex, such as an iron phytonutrient color complex, in a nutritional composition comprising an iron source wherein the source of iron comprises encapsulated ferrous fumarate (claim 12, 19, 38, 48, 58, 68); encapsulated ferrous sulfate (claim 13, 20, 39, 49, 59, 69) and at least one phytonutrient ([0010]). Jouni teaches that the encapsulation can extend shelf life, provide protection from environmental factors, and prevent or minimize iron-catalyzed lipid oxidation ([0142-0145], [0163]). Formulations thereof are provided in Table 1 where iron is present at 0.7 and 2.8 mg/100 kcal ([0121])
Encapsulation involves first providing a mixture in which particles of active ingredient(s), such as phytonutrients, are surrounded by a coating or are embedded in a polymeric matrix ([0144]). Next, the mixture is immediately dried (e.g. spray-drying, freeze drying, fluid bed drying, etc.) to form a tridimensional network of the polymer as a wall system encapsulating the active ingredient ([0144]). The mixture for encapsulation can be based on single emulsion, double emulsion, micelle, or liposome structure ([0144]). Alternatively, an electrostatic layer by layer deposition technique can be applied in order to enhance the barrier ([0144]). Jouni teaches that wall material include lipids such as plant oil dairy fat, medium chain triglycerides, and other lipids known in the art ([0146]). Jouni teaches that in addition to the wall materials, emulsifiers, such as phospholipids and lecithin, and other emulsifiers known in the art, and surfactants are typically added to improve the stability of the emulsion ([0146]). Jouni discloses ferrous sulfate, ferrous fumarate, ferrous carbonate, ferric pyrophosphate, ferric chloride, iron amino acid chelates (e.g. ferrous bisglycinate chelate, ferrous glycine), etc. as examples of irons that could be encapsulated with vegetable fats and are used in the nutritional composition ([0156]). Other matrices comprised of combinations of carbohydrate, protein, alginate and lipid may also be used to encapsulate phytonutrients and iron ([0157]).
Jouni teaches the encapsulation of iron; spray drying and fluid bed drying.
Jouni does not explicitly teach iron salt particles in the claimed ranges.
Hong discloses a complex iron preparation manufactured by a process of coating iron, folic acid, and vitamin B12 with a lipid layer, and a method for manufacturing the same characterized in that 0.1-5 parts by weight of the lipid is coated on 1 part by weight of a mixed powder of iron, folic acid, and vitamin B12 (pg. 4, claim 2). The lipid may be at least one selected from the group consisting of waxes and fatty acid esters; glyceryl palmitostearate is preferred (pg. 4, claim 3, 5). The wax may be hydrogenated oil (abstract). Examples of iron components used for the purpose of supplying iron which may include carbonyl iron, iron sulfate, iron fumarate, wherein an iron polysaccharide complex salt is preferred (bridging pg.4-5). As mentioned above, carbonyl iron is taught as an iron supply (pg. 2, 4), to read on the carbonyl iron salt of the instant claims and thus meets the density limitation.
Hong provides a mixing ratio then according to the ratio measures out 326.1 g of polysaccharide iron complex, 1.3 g of folic acid, 37.5 g of 0.1% cyanocobalamin, and 17.605 g of glyceryl palmitostearate, mixes, melts, cools to room temp and then passes the prepared lipid coating through a no. 18 sieve and fills 382.505 mg of the coating in one capsule or manufacturing them in the form of a conventional tablet (pg. 3, para. 1) disclose an iron powder at about 85% and a lipid at about 5% (pg. 7, claim 6) to read on the claimed percentages. further, it would have been prima facie obvious to a person of ordinary skill in the art, ahead of the effective filing date of the claimed invention, to substitute one known iron source, i.e., polysaccharide iron complex with the specific carbonyl iron (salt) for a similar purpose of providing an iron source in a composition to address nutritional deficiency (see Jouni [0117], Hong pg. 2). Simple substitution of one for another is within the purview of the skilled artisan and would have yielded predictable results.
Hong describes using general wet manufacturing methods, high-speed mixing to obtain wet granules that are dried and passed through a No. 18 sieve to obtain a sieved product (pg. 8). Hong describes using general dry manufacturing methods (pg. 9) and conducting general dissolution test methods (i.e., 500 mL purified water, paddle at 50 rpm, 60 min.) (pg. 10). Hong’s teaching of the mixed powder being mixed and melted, cooled and sieved reads on the claim limitation steps of transferring particles to a fluid bed processor and spraying the molten encapsulating agent on the processor (i.e., sieve) and then drying to obtain the granule (bridging pgs. 6-7).
It would have been prima facie obvious to a person of ordinary skill in the art, ahead of the effective filing date of the claimed invention, to apply methods taught by Hong to the methods taught by Jouni with expected results. One would be motivated to do so with a reasonable expectation of success because Hong provides a composite iron preparation that has enhanced stability, such as non-hygroscopicity, compared to existing composite iron preparations, and improved shelf life even when stored for a long period of time (pg. 5, para. 2). In addition, the composite iron preparation manufactured by the manufacturing method of Hong exhibits an excellent dissolution rate similar to that of existing composite iron preparations, despite using lipid as a coating material (bridging pgs. 11-12). The method for manufacturing a composite iron powder taught by Hong reduces the manufacturing time and simplifies the process, thereby increasing the convenience and efficiency of manufacturing (pgs. 11-12).
Response to Arguments
Applicants' arguments are based on newly amended limitations which have been addressed by the new grounds of rejection above.
Conclusion
All claims under consideration remain rejected; no claims are allowed. Applicant’s amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee 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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/Karen Ketcham/Examiner, Art Unit 1614
/ALI SOROUSH/Supervisory Patent Examiner, Art Unit 1614