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 .
This office action is in response to the application filed on June 14, 2023. The earliest effective filing date of the application is December 15, 2020.
Priority
The present application is a 371 National Stage Application of PCT/EP2021/067549 which has a filing date of June 25, 2021.
Status of Application
The amendment filed January 21, 2026 with the Remarks has been entered. The status of the claims upon entry of the present amendment stands as follows:
Pending claims: 16 – 18, 20 – 26, and 28 – 31
Withdrawn claims: 29 – 31
Amended claims: 16 and 24
Previously cancelled claims: 1 – 15
Newly cancelled claims: 19 and 27
Claims currently under consideration: 16 – 18, 20 – 26, and 28
By not repeating the previously presented objection/rejection(s), it is sufficiently clear that said objection/rejection(s) are withdrawn.
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.
Claim 20 is 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.
Claim 20 depends on a cancelled claim, rendering them incomplete. It is unclear what limitations are included in claim 20. It appears to be the applicant’s intention, given the presented claims, for the claims that are dependent on the cancelled claim 19 to depend on claim 16. For the purpose of examination, claim 20 is interpreted to reference claim 16 instead of claim 19. It is noted that under this interpretation, claim 20 has the same scope as claim 28.
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 16 – 18, 20, 21, 23 – 26, and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Diosady et al. (WO 2017054084 A1) in view of Armstrong et al. (Improving Adhesion of Seasonings to Crackers with Hydrocolloid Solutions. Journal of Food Science. Vol 78, Iss 11. Pp. 1704 – 1712. (2013)), and Tian et al. (Dissolution behaviour of ferric pyrophosphate and its mixtures with soluble pyrophosphates: Potential strategy for increasing iron bioavailability. Food Chemistry. Vol 208. Pp. 97 – 102. (2016)).
Regarding claim 16, Diosady teaches an iron-fortified tea preparation comprising dried tea (i.e., a leaf tea product); and a mixture of a chelator and iron (i.e., a micronized iron compound) adhered to the dried tea (Abstract). Diosady teaches the mixture of the chelator and the iron is adhered to dried tea with an adhesive to yield the iron-fortified tea preparation (i.e., the micronized iron compound and polysaccharides form a coating on the leaf tea product – [0017]). Diosady teaches the adhesive comprises a modified dextrin or a gum (i.e., polysaccharides – [0018]).
Regarding the amount of dried tea (i.e., leaf tea product) in the iron-fortified tea preparation, Diosady teaches the amount of iron present in the tea preparation may be from about 0.1 (0.001g) mg iron per g of dried tea to about 20 mg (0.02g) iron per g of dried tea ([0020]). The range disclosed by Diosady corresponds to the iron-fortified tea preparation comprising 98.0 – 99.9 wt% dried tea (i.e., leaf tea product).
The range of dried tea (i.e., leaf tea product) content in the iron-fortified tea preparation, 98.0 – 99.9 wt%, as disclosed by Diosady, overlaps with the claimed range of 85 – 98.5 wt%. MPEP § 2114.05 teaches that it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have selected the overlapping portion of the ranges disclosed by the reference because selection of overlapping portion of ranges has been held to be a prima facie case of obviousness.
Diosady does not explicitly state the adhesive comprises maltodextrin or gum arabic.
Armstrong teaches adhesive hydrocolloids for adhering flavor powder to crackers (i.e., a dry food surface). Armstrong teaches both maltodextrin and gum arabic are effective food adhesives for adhering edible powders to dry food surfaces (p. 1705, paragraphs 3 and 7; p. 1708, Figure 4).
Diosady and Armstrong are combinable because they are concerned with the same field of endeavor, namely, adhering edible powders to dry food surfaces. It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have selected maltodextrin or gum arabic to include in the adhesive of Diosady, as taught by Armstrong, Armstrong provides that it was known for maltodextrin and gum arabic to be successfully used as food adhesives and published at the time of filing, which means it was within the general skill of a worker in the art to select maltodextrin or gum arabic as adhesives in the composition of Diosady, because it would be obvious to one of skill in the art to do such a thing on the basis of its suitability for a similar intended use. See MPEP § 2144.07.
While Diosady does not explicitly state the adhesive comprises both maltodextrin and gum arabic, MPEP 2144.06.I states “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.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). Therefore it would have been obvious to one of ordinary skill in the art to have combined maltodextrin and gum arabic to form the adhesive in the composition of Diosady.
Diosady does not teach the particle size of the micronized iron. Diosady teaches the iron source may be ferric pyrophosphate ([0049]). Diosady teaches inclusion of ascorbic acid in the mixture may incrementally improve absorption of the iron, particularly in cases where the iron source has low bioavailability, such as ferric pyrophosphate ([0061]).
Tian investigates the impact of pH on the solubility of ferric pyrophosphate by adjusting pH (Abstract). Tian utilizes ferric pyrophosphate powder with a particle size of 2.5 µm (microns – p. 98, paragraph 5). Tian teaches adjusting the pH significantly alters the solubility of the ferric pyrophosphate (p. 99, Figure 1).
Diosady and Tian are combinable because they are concerned with the same field of endeavor, namely, iron-fortified tea. It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have selected ferric pyrophosphate with a particle size of 2.5 µm (microns), as taught by Tian in the composition of Diosady because Tian shows ferric pyrophosphate with a particle size of 2.5 µm (microns) was susceptible to solubility (i.e., bioavailability) adjustment by pH, as discussed in the disclosure of Diosady. Therefore, it would be obvious to one of skill in the art to select ferric pyrophosphate with a particle size of 2.5 µm (microns) on the basis of its suitability for a similar intended use. See MPEP § 2144.07.
While Diosady does not explicitly teach the moisture content of the dried tea (i.e., leaf tea product), Diosady teaches the dried tea is dried. Furthermore, Diosady clarifies that once the chelator/iron mixture is adhered to the dried tea, the treated tea may then be further dried to remove residual moisture that may remain from the adhesion process ([0094]). Diosady insists the dried tea is dry, therefore, while Diosady is not explicit about the exact moisture content of the dried tea (i.e., leaf tea product), the implicit disclosure teaches a dried tea (i.e., leaf tea product) with a moisture content of 10% moisture by weight or less by weight of the dried tea (i.e., leaf tea product).
Regarding claim 17, Diosady teaches for non-chelated iron sources, water solubility of the iron source tends to correlate with bioavailability of the iron ([0050]). Diosady teaches inclusion of ascorbic acid in the mixture may incrementally improve absorption of the iron, particularly in cases where the iron source has low bioavailability, such as ferric pyrophosphate ([0061]).
Furthermore, Tian teaches ferric pyrophosphate is insoluble (p. 97, paragraph 1).
Therefore, the prior art concurs ferric pyrophosphate is insoluble in water at 25 °C.
Regarding claims 18 and 21, Diosady teaches the iron source may be ferric pyrophosphate ([0049]).
Regarding claims 20 and 28, Diosady teaches the mixture may further comprise a flavouring, a colouring, a perfume, an essential oil, or ascorbic acid (i.e., additional nutrients – [0021]).
Regarding claim 23, Diosady teaches the adhesive may be added to the mixture of chelator and iron at a concentration of about 0.5 % (w/v) to about 25 % (w/v) ([0026]). Diosady teaches the amount of iron present in the tea preparation may be from about 0.1 (0.001g) mg iron per g of dried tea to about 20 mg (0.02g) iron per g of dried tea ([0020]). Diosady teaches the present invention includes a chelator with the iron, in a molar ratio of about 2:1 chelator:iron or greater ([0012]). Diosady teaches the chelator is EDTA ([0016]).
Given the molar mass of EDTA is 292.24 g/mol and the molar mass of ferric pyrophosphate is 745.224 g/mol, a 2:1 chelator:iron ratio would result in a mixture comprising 28.2 wt% chelator and 71.8 wt% ferric pyrophosphate. Assuming a 1 g/ml density for the chelator:iron mixture, the addition of 0.5 % (w/v) to about 25 % (w/v) of adhesive would result in an adhesive mixture of 0.5 – 25 wt% adhesive, 15.67 – 27.92 wt% chelator, and 59.33 – 71.58 wt% ferric pyrophosphate, while maintaining a molar ratio of about 2:1 chelator:iron or greater. Finally, the amount of iron present in the tea preparation may be from about 0.1 (0.001g) mg iron (i.e., ferric pyrophosphate) per g of dried tea to about 20 mg (0.02g) iron (i.e., ferric pyrophosphate) per g of dried tea, as taught by Diosady ([0020]). Therefore, the range disclosed by Diosady corresponds to the iron-fortified tea preparation comprising 0.0007 – 0.82 wt% adhesive.
While Diosady does not teach the iron-fortified tea preparation comprises 0.5 – 5 wt% maltodextrin, Armstrong teaches combining adhesives does not provide greater adhesion than the best individual adhesives (p. 1709, paragraph 4). Given each adhesive is suitable for its intended use, and no unique adhesive ability is garnered from the combined use of maltodextrin and gum arabic, any ratio of maltodextrin and gum arabic would have been obvious to one of ordinary skill in the art.
Therefore, the range of maltodextrin content in the iron-fortified tea preparation, 0.0007 – 0.82 wt%, as disclosed by Diosady, overlaps with the claimed range of 0.5 – 5 wt%. MPEP § 2114.05 teaches that it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have selected the overlapping portion of the ranges disclosed by the reference because selection of overlapping portion of ranges has been held to be a prima facie case of obviousness.
Regarding claim 24, Diosady teaches the adhesive may be added to the mixture of chelator and iron at a concentration of about 0.5 % (w/v) to about 25 % (w/v) ([0026]). Diosady teaches the amount of iron present in the tea preparation may be from about 0.1 (0.001g) mg iron per g of dried tea to about 20 mg (0.02g) iron per g of dried tea ([0020]). Diosady teaches the present invention includes a chelator with the iron, in a molar ratio of about 2:1 chelator:iron or greater ([0012]). Diosady teaches the chelator is EDTA ([0016]).
Given the molar mass of EDTA is 292.24 g/mol and the molar mass of ferric pyrophosphate is 745.224 g/mol, a 2:1 chelator:iron ratio would result in a mixture comprising 28.2 wt% chelator and 71.8 wt% ferric pyrophosphate. Assuming a 1 g/ml density for the chelator:iron mixture, the addition of 0.5 % (w/v) to about 25 % (w/v) of adhesive would result in an adhesive mixture of 0.5 – 25 wt% adhesive, 15.67 – 27.92 wt% chelator, and 59.33 – 71.58 wt% ferric pyrophosphate, while maintaining a molar ratio of about 2:1 chelator:iron or greater. Finally, the amount of iron present in the tea preparation may be from about 0.1 (0.001g) mg iron (i.e., ferric pyrophosphate) per g of dried tea to about 20 mg (0.02g) iron (i.e., ferric pyrophosphate) per g of dried tea, as taught by Diosady ([0020]). Therefore, the range disclosed by Diosady corresponds to the iron-fortified tea preparation comprising 0.0007 – 0.82 wt% adhesive.
While Diosady does not teach the iron-fortified tea preparation comprises 0.5 – 5 wt% maltodextrin, Armstrong teaches combining adhesives does not provide greater adhesion than the best individual adhesives (p. 1709, paragraph 4). Given each adhesive is suitable for its intended use, and no unique adhesive ability is garnered from the combined use of maltodextrin and gum arabic, any ratio of maltodextrin and gum arabic would have been obvious to one of ordinary skill in the art.
Therefore, the range of gum arabic content in the iron-fortified tea preparation, 0.0007 – 0.82 wt%, as disclosed by Diosady, overlaps with the claimed range of 0.05 – 6 wt%. MPEP § 2114.05 teaches that it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have selected the overlapping portion of the ranges disclosed by the reference because selection of overlapping portion of ranges has been held to be a prima facie case of obviousness.
Regarding claim 25, Diosady teaches the tea may be white tea, green tea, oolong tea or black tea ([0043]).
Regarding claim 26, Diosady teaches the tea may be black tea ([0043]).
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Diosady et al. (WO 2017054084 A1) in view of Armstrong et al. (Improving Adhesion of Seasonings to Crackers with Hydrocolloid Solutions. Journal of Food Science. Vol 78, Iss 11. Pp. 1704 – 1712. (2013)), and Tian et al. (Dissolution behaviour of ferric pyrophosphate and its mixtures with soluble pyrophosphates: Potential strategy for increasing iron bioavailability. Food Chemistry. Vol 208. Pp. 97 – 102. (2016)), as applied to claim 16 above, and further in view of Marshman et al. (US 20090061068 A1 – IDS Filed on August 9, 2023).
Regarding claim 22, Diosady teaches the iron source may be ferric pyrophosphate ([0049]).
Diosady does not explicitly state the iron source may also be iron oxide.
Marshman teaches a food product fortified with biopolymer-stabilized iron-containing nanoparticles (Abstract). Marshman teaches the food product may be a beverage such as tea ([0007]; [0035]). Marshman teaches the advantages of using the biopolymer-stabilized iron-containing nanoparticles the excellent chemical stability in respect to interaction with other elements, oxidation, complexion activity, color change, and, due to the presence of stabilizing biopolymer, these particles are compatible with many products containing other biopolymers ([0028]). Marshman teaches the iron in the biopolymer-stabilized iron-containing nanoparticles is ferric oxide (i.e., iron oxide – [0038]).
Diosady and Marshman are combinable because they are concerned with the same field of endeavor, namely, beverages comprising iron supplements. It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to include biopolymer-stabilized iron oxide-containing nanoparticles, as taught by Marshman in the product of Diosady, in addition to the chelated ferrous pyrophosphate, because biopolymer-stabilized iron oxide-containing nanoparticles have excellent chemical stability in respect to interaction with other elements, oxidation, complexion activity, and color change.
Response to Arguments
Applicant's arguments filed January 21, 2026 have been fully considered but they are not persuasive.
Applicant argues the supplemental data shows the combination of features in the claimed tea composition give rise to the surprising and unexpected technical effect of significantly improved iron delivery, without any detriment to infusion color (p. 8, paragraph 3).
Applicant’s argument has been carefully considered however the argument is not persuasive. Applicant has not filed an affidavit or declaration accompanying the supplemental data. MPEP § 716.01(c)(II) states "Arguments presented by the applicant cannot take the place of evidence in the record. In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965) and In re De Blauwe, 736 F.2d 699, 705, 222 USPQ 191, 196 (Fed. Cir. 1984). Examples of statements which are not evidence and which must be supported by an appropriate affidavit or declaration include statements regarding unexpected results, commercial success, solution of a long-felt need, inoperability of the prior art, invention before the date of the reference, and allegations that the author(s) of the prior art derived the disclosed subject matter from the inventor or at least one joint inventor." Furthermore, 37 C.F.R. 1.132 states “When any claim of an application or a patent under reexamination is rejected or objected to, any evidence submitted to traverse the rejection or objection on a basis not otherwise provided for must be by way of an oath or declaration.” In this case, because no affidavit or declaration was filed accompanying the supplemental data relied upon to traverse the rejection by way of unexpected results, the supplemental data has not been considered.
Applicant argues Patel does not teach or render obvious the invention of claims 16 – 18, 20 – 26, and 28 as amended (p. 8 – 11).
Applicant’s argument has been carefully considered and it is persuasive. Therefore, the rejections in view of Patel have been withdrawn. However, upon further consideration, a new ground(s) of rejection, necessitated by applicant’s amendments, is made in view of Diosady.
Applicant argues there was not motivation for a person of ordinary skill in the art to have combined Patel with Fooduzzi to arrive at claims 19, 20, and 27 (p. 9, paragraphs 3 and 4; p. 10).
Applicant’s arguments with respect to claims 19, 20, and 27 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
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 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 LARK JULIA MORENO whose telephone number is (571)272-2337. The examiner can normally be reached 6:30 - 4:30 M - F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Emily Le can be reached at (571) 272-0903. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/L.J.M./
Examiner, Art Unit 1793
/EMILY M LE/Supervisory Patent Examiner, Art Unit 1793
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