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 .
Formal Matters
Applicant’s claim amendments and arguments in the reply filed on 27 August 2025 are acknowledged and have been fully considered. Claims 13-15, 17-18, and 23-29 are pending. Claims 13-15, 17-18, and 23-29 are under consideration in the instant office action. Claims 1-12, 16, and 19-22 are canceled. Applicant’s claim amendments and arguments did not overcome the rejections set forth in the previous office action under 35 USC 103 for reasons set forth in the previous office action and herein below.
Withdrawn Objections/Rejections
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn as are those rejections and/or objections expressly stated to be withdrawn.
Rejections Maintained
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.
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.
Claims 13-18, 23-24, and newly added claims 25-29 are rejected under 35 U.S.C. 103 as being unpatentable over Hartle et al. (US Patent No. 6,706,904) in view of Younes et al. (EFSA Journal 2018;16(6):5292) and as evidenced by Product Data Sheet of magnesium malate from Mass Dye Chem Pvt. Ltd. Accessed May 28, 2025).
Applicants’ claims
Applicants claim a composition comprising granules of dimagnesium malate having a mole ratio of magnesium: malate of about 2:1 and a water content of at least 2.0 wt%, wherein the granules of dimagnesium malate have a particle size of about 50microns to about 1500 microns. The dependent claims thereof recite various other features.
Determination of the Scope and Content of the Prior Art
(MPEP 2141.01)
Hartle et al. teach a method of making a bioavailable divalent metal-containing complex, comprising reacting malic acid with one or more divalent metal-containing composition at a 1:2 malic acid to divalent metal-containing composition molar ratio, said divalent metal being one or more of a nutritionally relevant divalent metal (see claim 17). A method as in claim 17, wherein the step of reacting is by the following reaction scheme:
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wherein M is selected from the group consisting of copper, zinc, manganese, iron, magnesium, and calcium (see claim 19). When referring to a dimetalhydroxy malate (such as dicalciumhydroxy malate, dimagnesium malate, etc.), the “di” portion of the name refers to two +M(OH) or metalhydroxy groups, one being complexed to a first carboxyl group of the malate ion, and the other being complexed to a second carboxyl group of the malate ion. Thus, each metal is complexed to the malate ion and is also complexed to its own hydroxy group to charge balance the metal. The metals that can be used include divalent nutritionally relevant metals, and two of the same metal or two different metals can be present at each carboxyl group of the malate ion (column 2, lines 50-60). With respect to each of the compositions and methods of the present invention, once formed in an aqueous solution, the product can be dried to form a particulate composition. Desired particulate sizes can be formed using one of a number of drying methods, including spray drying, drum drying, tray drying, tunnel drying, freeze drying, compressed air drying, and oven drying, among others as is known in the art (column 5, lines 32-39). An aqueous solution of malic acid was prepared by mixing 5.859 kg of malic acid with 18.18 L of water until the solution was clear. An aqueous solution of magnesium oxide was also prepared in a separate container by thoroughly mixing 3.515 kg of magnesium oxide in 18.18 L of water. The magnesium oxide solution was then slowly added to the malic acid solution. The resulting solution was cooled, and then spray dried to produce a powdered dimagnesiumhydroxy malate (example 5). In one embodiment, this process can be carried out by first, combining the reactants, i.e., malic acid and divalent metal-containing composition, in dry form and mixing them together, such as in a Ribbon Blender or the like. The mixing device can be continuously run during this process for acceptable results. A fraction of the total amount of water needed to effectuate the reaction can then be slowly added, such as by spraying the water into the particulate mixture. The water is preferably sprayed, as dumping water onto the reactants tends to cause over reaction and clumping. In one embodiment, from 5% to 20% of the water necessary to complete the reaction can be added or sprayed on at a time, allowing reaction time to occur between each further water addition. A water jacket can be used with the reaction vessel to keep the reactants cool (column 5, lines 57-67 and column 6, lines 1-4). A method as in claim 17, wherein the reacting step is carried by
(a) dry blending the malic acid and the divalent metal-containing composition to form a particulate blend;
(b) adding water to the particulate blend in an amount that causes a partial reaction between the malic acid and the divalent metal-containing composition,
(c) allowing the particulate blend to substantially react in the presence of the amount of water; and
(d) repeating step (b) and step (c) until a granular product is formed that is substantially fully reacted (claim 24). A method as in claim 24, further comprising the step of allowing the granular product to dry (claim 25). A method as in claim 25, further comprising the step of grinding the granular product to form particulates of a predetermined particle size (claim 26). The present invention is also drawn toward a method of administering a high content of a metal in a bioavailable form to a warm-blooded animal. In one embodiment, the composition of Formula 1 above can be administered to the warm-blooded animal, such as a human. The administration can be by one of many known administration routes, including oral administration. If formulated for oral delivery or consumption, such a composition can be incorporated into many delivery vehicles, including tablets, capsules, foods, drinks, dry drink mixes, or other substances acceptable for oral consumption. Tablets may be chewable or non-chewable. A food delivery vehicle may be, for example, in the form of food bars or incorporated into dairy products. Drinks may be in the form of sports drinks, fruit drinks, citrus drinks, carbonated drinks, and other suitable drink mediums. Dry drink mixes may be in the form of a fruit mix and/or citrus mix or other particulate drink mixes. No matter what the vehicle of delivery, the compositions of the present invention are very stable, and thus, can be coadministered with many other supplements known in the art. For example, the compositions of the present invention can be coadministered with mineral salts and/or mineral amino acid chelates in drink mixes, supplement tablets or capsules, or food items (column 3, lines 19-43).
Ascertainment of the Difference Between Scope of the Prior Art and the Claims
(MPEP 2141.02)
Hartle et al. do not specifically teach wherein the granules of dimagnesium malate have a particle size ranging from about 50 microns to about 1500 microns as recited in claim 13 and from about 90 microns to about 1000 microns as recited in claim 27. Furthermore, Hartle et al. do not specifically teach wherein the granules have a bulk density of at least 0.70 g/mL as recited in claim 17 and at least 0.90 g/mL as recited in claim 28. These deficiencies are cured by the teachings of Younes et al. as evidenced by the product data sheet of magnesium malate.
Younes et al. teach the evaluation of the safety of di-magnesium malate (DMM) proposed as a novel food ingredient and as a source of magnesium for use in foods for the general population, food supplements, total diet replacement for weight control and food for special medical purposes (FSMP), and with the bioavailability of magnesium from this source. Additional information was sought from the applicant during the assessment process. However, despite several requests, the applicant did not provide the additional data. Consequently, the Panel performed this assessment on the basis of the available data and concluded that there was insufficient scientific evidence of a difference between the proposed novel food ingredient named as DMM and magnesium malate already authorised as a source of magnesium included in Annex II to Directive 2002/46/EC. Accordingly, the Panel was unable to assess the safety of DMM as a novel food ingredient. The Panel concluded that based on the data provided it was not possible to assess the dissociation of DMM into magnesium and malic acid. The Panel further concluded that if DMM dissociates, magnesium would be available following ingestion of DMM and the availability would appear similar to values reported for other sources of magnesium already permitted. Finally, the Panel noted that the proposed use levels could result in exposures to magnesium greater than its upper level (UL) (250 mg/day) for food supplements and for food for special medical purposes(see abstract). Younes et al. teach as follows:
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Finding of Prima Facie Obviousness Rational and Motivation
(MPEP 2142-2143)
It would have been prima facie obvious to a person of ordinary skill before the effective filing date of the instant invention to modify the teachings of Hartle et al. by incorporating dimagnesium malate with particle size as recited in claims 13 and 27 because Younes et al. teach the evaluation of the safety of di-magnesium malate (DMM) proposed as a novel food ingredient and as a source of magnesium for use in foods for the general population, food supplements, total diet replacement for weight control and food for special medical purposes (FSMP), and with the bioavailability of magnesium from this source. Additional information was sought from the applicant during the assessment process. However, despite several requests, the applicant did not provide the additional data. Consequently, the Panel performed this assessment on the basis of the available data and concluded that there was insufficient scientific evidence of a difference between the proposed novel food ingredient named as DMM and magnesium malate already authorised as a source of magnesium included in Annex II to Directive 2002/46/EC. Accordingly, the Panel was unable to assess the safety of DMM as a novel food ingredient. The Panel concluded that based on the data provided it was not possible to assess the dissociation of DMM into magnesium and malic acid. The Panel further concluded that if DMM dissociates, magnesium would be available following ingestion of DMM and the availability would appear similar to values reported for other sources of magnesium already permitted. Finally, the Panel noted that the proposed use levels could result in exposures to magnesium greater than its upper level (UL) (250 mg/day) for food supplements and for food for special medical purposes(see abstract). Younes et al. teach as follows:
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The particle size distribution of the granules is a result effective parameter as demonstrated by Younes et al. above and it is within the purview of one of ordinary skill in the art to tune the particle size of the granules and the bulk density of the granules. Product information sheet of magnesium malate demonstrates or evidences bulk density of greater than or equal to 0.65 g/ml. In the case where particle size and bulk density "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Similarly, 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). Furthermore, differences in concentration or particle size or density will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration 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). One of ordinary skill in the art would have had a reasonable expectation of success in combining the teachings of Hartle et al., Younes et al. because both references are drawn to granules of dimagnesium malate.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Response to Arguments
Applicant's arguments filed 27 August 2025 have been fully considered but they are not persuasive.
Applicant argues first, the Data Sheet provided by the Examiner to support the instant rejection is not prior art. Specifically, there is no evidence that this document was available as of the May 9, 2022 priority date of the application. The mere fact that it provides information related to magnesium malate is not sufficient to make it prior art. Thus, the rejection is improper for at least this reason. Second, Hartle does not teach or suggest dimagnesium malate granules at all, let alone dimagnesium granules that contain a water content of at least 2.0 wt%. The Examiner refers to Hartle's use of water in the processes, but does not discuss how much water, if any, is present in the isolated dimagnesium malate. And neither Younes nor Data Sheet provides any teaching or suggestion of the claimed water content. Thus, the rejection is improper for at least this reason. Finally, in the search for solid dimagnesium malate formulations, one would have no motivation to turn to Younes. Younes evaluates the safety of dimagnesium malate as a food ingredient, as compared to magnesium malate.
The above assertions are not found persuasive because the Product information sheet of magnesium malate is used as evidentiary reference solely to prove or evidence of bulk density of greater than or equal to 0.65 g/ml. The Product information sheet is evidentiary reference. The rejection is based on the combined teachings of Hartel et al. and Younes et al. Absent a showing of criticality the particle size distributions and bulk density of the granules are result effective and optimizable parameters. With regard to the water content Hartel et al. teach that In one embodiment, this process can be carried out by first, combining the reactants, i.e., malic acid and divalent metal-containing composition, in dry form and mixing them together, such as in a Ribbon Blender or the like. The mixing device can be continuously run during this process for acceptable results. A fraction of the total amount of water needed to effectuate the reaction can then be slowly added, such as by spraying the water into the particulate mixture. The water is preferably sprayed, as dumping water onto the reactants tends to cause over reaction and clumping. In one embodiment, from 5% to 20% of the water necessary to complete the reaction can be added or sprayed on at a time, allowing reaction time to occur between each further water addition. A water jacket can be used with the reaction vessel to keep the reactants cool. As the water is added in small amounts stepwise, the product will progress toward completion. At each stage of added water, the reactants tend to become sponge-like and raise in level within the mixer. When the reaction nears completion for a given stage, the heat lowers, the product level falls, and the density increases, returning the product to a more granular state. Next, more water is added, and a similar phenomenon reoccurs (typically to a lesser extent at each water addition step). At each stage, the product should be allowed to react until the reaction is substantially complete. Once the heat and expansion is substantially absent when water is added, the process is done. At this point, if water is continued to be added, the product will begin to change back to a powder form, which is undesirable. Therefore, care should be taken to stop adding water when desired granulation is present, and the reaction has substantially stopped. Upon completion of the process, the product can be removed from the mixing device, stored in either a cool or warm room for drying, and optionally, ground to a desired particle size. It is reasonable from the above teachings for one of ordinary skill in the art to consider the 5-20% is fully included or present in the final product based on the above teachings of Hartel et al. With regard to the arguments that Hartel et al. and Younes are not combinable the examiner reminds applicant that the reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. See, e.g., In re Kahn, 441 F.3d 977, 987, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006) (motivation question arises in the context of the general problem confronting the inventor rather than the specific problem solved by the invention); Cross Med. Prods., Inc. v. Medtronic Sofamor Danek, Inc., 424 F.3d 1293, 1323, 76 USPQ2d 1662, 1685 (Fed. Cir. 2005) ("One of ordinary skill in the art need not see the identical problem addressed in a prior art reference to be motivated to apply its teachings."); In re Lintner, 458 F.2d 1013, 173 USPQ 560 (CCPA 1972) (discussed below); In re Dillon, 919 F.2d 688, 16 USPQ2d 1897 (Fed. Cir. 1990), cert. denied, 500 U.S. 904 (1991) (discussed below). Hartel et al. teach that the present invention is also drawn toward a method of administering a high content of a metal in a bioavailable form to a warm-blooded animal. In one embodiment, the composition of Formula 1 above can be administered to the warm-blooded animal, such as a human. The administration can be by one of many known administration routes, including oral administration. If formulated for oral delivery or consumption, such a composition can be incorporated into many delivery vehicles, including tablets, capsules, foods, drinks, dry drink mixes, or other substances acceptable for oral consumption. Tablets may be chewable or non-chewable. A food delivery vehicle may be, for example, in the form of food bars or incorporated into dairy products. Drinks may be in the form of sports drinks, fruit drinks, citrus drinks, carbonated drinks, and other suitable drink mediums. Dry drink mixes may be in the form of a fruit mix and/or citrus mix or other particulate drink mixes. No matter what the vehicle of delivery, the compositions of the present invention are very stable, and thus, can be coadministered with many other supplements known in the art. For example, the compositions of the present invention can be coadministered with mineral salts and/or mineral amino acid chelates in drink mixes, supplement tablets or capsules, or food items. One of ordinary skill in the art would have had a reasonable expectation of success in combining the teachings of Hartle et al. and Younes et al. because both references are drawn to granules of dimagnesium malate in food based compositions.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TIGABU KASSA whose telephone number is (571)270-5867. The examiner can normally be reached on 8 AM-5 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Blanchard can be reached on 571-272-0827. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TIGABU KASSA/Primary Examiner, Art Unit 1619