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 .
Status of the Application
The claims filed 19 November 2025 have been entered. Claims 1-18 are pending. The previous claim objections not repeated below have been withdrawn in view of applicant’s amendments to the claims. The previous 112(b) rejections have been withdrawn in view of applicant’s amendments to the claims. The previous 103 rejections have been modified in view of applicant’s amendments to the claims.
Terminal Disclaimer
The terminal disclaimer filed on 19 November 2025 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of 11,395,502 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Claim Objections
Claims 11 and 17 are objected to because of the following informalities:
Claim 11 (line 1) and claim 17 (line 1): insert “which” between “D-3” and “facilitates”
Appropriate correction is required.
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 1-4, 6-10, 12-16 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Mehansho (US 2004/0058034 A1) in view of Tanner-Baumgartner (US 20080214496 A1).
Regarding claims 1, 7, 8 and 13, Mehansho discloses an aqueous, liquid composition (water composition, abstract) of an iron supplement [0037]. Mehansho implies the product is capable of being taken orally because Mehansho discloses the product has “no metallic taste or aftertaste” [0016]. Mehansho discloses the aqueous composition may include a flavoring agent like monk fruit extract (luo han guo) [0067].
Mehansho discloses mineral deficiencies as a problem that needs to be addressed [0002-0003]. Mehansho discloses the iron sources including ferrous salt, a ferric salt like ferric saccharate [0042], and iron-sugar-carboxylate complexes [0043].
Mehansho does not discloses the iron source is a polysaccharide iron complex.
Tanner-Baumgartner is drawn to therapeutic uses of iron(III) complex compounds with carbohydrates (abstract). Tanner-Baumgartner discloses the iron(III) complex compounds with carbohydrates may be polysaccharide iron complexes (carbohydrates may be dextrans, maltodextrins, polymaltoses [0019], iron(III) hydroxide-polymaltose complex compound [0026], iron(III)-pullulan complex compounds, [0028]. Tanner-Baumgartner discloses the composition may be administered orally in an aqueous solution [0029]. Tanner-Baumgartner discloses the composition may treat iron deficiencies [0032]. Tanner-Baumgartner discloses the iron complex improved immune defense and/or brain performance in patients who had a normal hematological result in respect of iron status [0034].
It would have been obvious to one of ordinary skill in the art before the effective filing of the claimed invention to include a source of iron in the nutritional supplement, as taught in Mehansho, wherein the source of iron is a polysaccharide iron complex, as taught in Tanner-Baumgartner, to obtain an iron nutritional supplement comprising an iron source that is a polysaccharide iron complex. One of ordinary skill in the art at the time the invention was filed would have been motivated to use a polysaccharide iron complex because it treats iron deficiency [0032],and improves immune defense and/or brain performance in patients with normal iron status [0034].
Regarding the following claim limitations:
Claim 1: wherein the weight % of monk fruit extract is between about 1.5% to about 3.0% relative to the weight amount of a polysaccharide iron complex, the polysaccharide iron complex being present at a concentration between about 3.0% to 5.1% by weight of the aqueous composition.
Claim 7: where the ratio of monk fruit extract to polysaccharide iron complex ranges from about 1:30 parts by weight to about 1:60 parts by weight and wherein the polysaccharide iron complex being present at a concentration between about 3.0% to 5.1% by weight of the liquid formulation.
Claim 8: wherein the polysaccharide iron complex is at least about 5.0% by weight of the liquid formulation.
Claim 13: wherein the weight % of monk fruit extract is between about 1.5% to about 3.0% relative to the weight amount of a polysaccharide iron complex, the polysaccharide iron complex being present at a concentration between about 3.0% to 5.1% by weight of the aqueous composition.
The concentrations are prima facie obvious for the following reasons.
Per MPEP 2144.05 II, 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. Where 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. A change in form, proportions, or degree will not sustain a patent. It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions.
In the present case, the prior art discloses the conventional nature of an iron supplement comprising both a source of iron and a monk fruit extract (Mehansho). Mehansho discloses the amount of iron compound added to the beverage dry mix can vary widely depending upon the level of supplementation desired in the final product and the targeted consumer [0045]. Mehansho discloses at least about 1 ppm of iron compound, sufficient to deliver about 5% to about 100% USRDI of iron (based per serving) [0045]. Mehansho discloses exemplary USRDI amounts ranging from 10 mg per day to 18 mg per day [0045]. Tanner-Baumgartner discloses a daily oral dose is, for example, from 10 to 500 mg of iron/day of use [0029]. Mehansho discloses the flavoring (monk fruit extract/luo han guo) may be present in a range of about 0.01% to about 10%, preferably from about 0.02% to 8% [0067]. The prior art provides a teaching, suggestion, and motivation to select a polysaccharide iron complex as an iron source in an iron supplement. The prior art discloses the supplement has no metallic taste or after-taste (Mehansho, abstract). Based on the teachings of the prior art, the concentrations of iron and a monk fruit extract represent the mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means. As such, it is not such an invention as will sustain a patent.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have varied the quantity of polysaccharide iron complex, depending on the desired degree of iron supplementation for the composition. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have varied the quantity of monk fruit extract based on the desired degree of sweetness for the composition, and thus also vary the amount of monk fruit extract relative to the amount of polysaccharide iron complex. Absent a showing of the criticality of the claimed range, one of ordinary skill in the art would have had a reasonable expectation of success to create an iron nutritional supplement when varying the amounts of monk fruit extract and polysaccharide iron complex.
The phrases “wherein the oral dose is administered in a volume of 5 ml” (claim 1); “wherein the oral dose is administered in a volume of 5 ml or 1.0 ml” (claim 7) are statements of future intended use. A statement with regard to intended use is not further limiting in so far as the structure of the product is concerned. In order to patentably distinguish the claimed invention from the prior art, a claimed intended use must result in a structural difference between the claimed invention and the prior art. MPEP 2111.02 II. In the present case, the prior art suggests an orally administrable aqueous composition comprising a polysaccharide iron complex and monk fruit extract (luo han guo). As such there is no structural/compositional difference between the prior art and the claimed invention.
Additionally, it would have been obvious to one having ordinary skill in the art to make a size that is 1 or 5 ml because it has been held that changes in size are prima facie obvious. MPEP 2144.04 IV A. In the present case, the recited volumes represent the mere changing in size (volume) of the composition suggested in the prior art.
Regarding claims 3, 9, and 15; Mehansho in view of Tanner-Baumgartner renders obvious the claimed range of monk fruit extract of claims 1, 7 and 13 as discussed above, which also meets the claim limitations of claim 3, 9 and 15.
As to the claim language “for the flavor profile for formulations for infants and young children,” this is deemed to be an intended use in so far as the structure of the product is concerned. In article claims, a claimed intended use must result in structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. MPEP 2111.02. Given that the iron nutritional supplement of Mehansho in view of Tanner-Baumgartner is identical to that of the presently claimed in terms of structure and composition, it meets the intended use of the claimed article.
Regarding claims 2 and 14, Mehansho discloses the flavoring (monk fruit extract/luo han guo) may be present in a range of about 0.01% to about 10%, preferably from about 0.02% to 8% [0067], which overlaps with the claimed range of 0.08%-0.09%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. MPEP 2144.05 I.
Regarding claims 4, 10 and 16; Mehansho in view of Tanner-Baumgartner renders obvious the claimed range of monk fruit extract of claims 1, 7 and 13 as discussed above, which also meets the claim limitations of claims 4, 10 and 16 as interpreted in the 112(b) rejection above.
As to the claim language “for the flavor profile for adult formulations,” this is deemed to be an intended use in so far as the structure of the product is concerned. In article claims, a claimed intended use must result in structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. MPEP 2111.02. Given that the iron nutritional supplement of ‘502 is identical to that of the presently claimed in terms of structure and composition, it meets the intended use of the claimed article.
Regarding claims 6, 12 and 18; the claim language “wherein the polysaccharide iron complex provides between about 15mg elemental iron to about 50mg elemental iron”, this is merely the intended results of using the claimed composition and does not further define the scope of the invention. Since Mehansho in view of Tanner-Baumgartner discloses all of the components of the claimed composition, the composition of ‘Mehansho in view of Tanner-Baumgartner is considered to provide the claimed elemental iron. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. MPEP 2112.01 I.
Claims 5, 11 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Mehansho (US 2004/0058034 A1) in view of Tanner-Baumgartner (US 20080214496 A1) as evidenced by the National Institutes of Health (Vitamin D, https://ods.od.nih.gov/factsheets/VitaminD-HealthProfessional/, 2025).
Regarding claims 5, 11 and 17; Mehansho discloses the water composition may also include vitamins D [0063]. As evidenced by the National Institutes of Health, vitamin D has two main forms, D-2 and D-3 (p2, 2nd full para). Since there are only two main forms of vitamin D, the vitamins D of Mehansho would comprise vitamins D-2 and D-3.
Additionally, attention is invited to In re Levin, 84 USPQ 232 and the cases cited therein, which are considered in point in the fact situation of the instant case, and wherein the Court stated on page 234 as follows: This court has taken the position that new recipes or formulas for cooking food which involve the addition or elimination of common ingredients, or for treating them in ways which differ from the former practice, do not amount to invention, merely because it is not disclosed that, in the constantly developing art of preparing food, no one else ever did the particular thing upon which the applicant asserts his right to a patent. In all such cases, there is nothing patentable unless the applicant by a proper showing further establishes a coaction or cooperative relationship between the selected ingredients which produces a new, unexpected, and useful function. In re Benjamin D. White, 17 C.C.P.A (Patents) 956, 39 F.2d 974, 5 USPQ 267; In re Mason et al., 33 C.C.P.A. (Patents) 1144, 156 F.2d 189, 70 USPQ 221.
In the present case, the prior art discloses the conventional nature of a liquid composition with the claimed ingredients. The concentrations of the ingredients represent nothing patentable unless the applicant by a proper showing further establishes a coaction or cooperative relationship between the selected ingredients which produces a new, unexpected, and useful function.
Declaration Under 37 CFR 1.132
The declaration under 37 CFR 1.132 filed 19 November 2025 is insufficient to overcome the rejection of claims 1-4, 6-10, 12-16 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Mehansho (US 2004/0058034 A1) in view of Tanner-Baumgartner (US 20080214496 A1) and claim 5, 11 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Mehansho (US 2004/0058034 A1) in view of Tanner-Baumgartner (US 20080214496 A1) as evidenced by the National Institutes of Health (Vitamin D, https://ods.od.nih.gov/factsheets/VitaminD-HealthProfessional/, 2025) as set forth in the last Office action because:
The declaration argues the previous rejection does not take into account the fact that Mehansho discloses a highly dilute beverage while the instant claims are drawn to a much smaller dosage to deliver a similar amount of iron and one of ordinary skill would not look to a teaching of a beverage to develop an iron supplement in a 5 mL dose. Declaration #7-9.
This argument is not persuasive. The instant claims are not drawn to a dosage size. Instant claims 1 and 7 are drawn to an iron nutritional supplement wherein the oral dose is administered in a volume of 5mL or 1mL. However, the claims are drawn to the composition without any method steps of administering the composition. Instant claim 13 does not recite any limitations on the size of the dose of the iron nutritional supplement. Since the instant claims are drawn to the composition without any dosing method steps, arguments pertaining to the size of the dosing are moot.
The declaration argues the amount of monk fruit extract used in Mehansho to mask the flavor of the iron complex would be much greater than that recited in the instant claims. Declaration #10-11.
This argument is not persuasive. The amount of monk fruit extract recited in the instant claims, 1.5-3% by weight of the monk fruit extract relative to the amount of a polysaccharide iron complex where the polysaccharide iron complex is included in the composition at 3-5.1% by weight of the composition. This is equivalent to 0.045-0.153% monk fruit extract in the final composition (example calculation: 1.5% monk fruit extract * 3% polysaccharide iron complex * 100 = 0.045% wt monk fruit extract in the composition). Mehansho discloses the flavoring (monk fruit extract/luo han guo) may be present in a range of about 0.01% to about 10%, preferably from about 0.02% to 8% [0067]. Therefore the disclosure of Mehansho encompasses the range of monk fruit extract recited in the instant claims.
In view of the foregoing, when all of the evidence is considered, the totality of the rebuttal evidence of nonobviousness fails to outweigh the evidence of obviousness.
Response to Arguments
Applicant's arguments filed 19 November 2025 have been fully considered. To the extent they apply to the above rejections they are not persuasive.
The arguments presented by the applicant are substantially the same as those presented in the declaration dated 19 November 2025, which are addressed above. No additional argument have been presented.
Conclusion
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.
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/Michele L Jacobson/Primary Examiner, Art Unit 1793
/C.L.G./Examiner, Art Unit 1793