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 Claims
Receipt of Remarks/Amendments filed on 06/24/2025 is acknowledged. Claims 7-9 are cancelled. Claims 1-6 and 10 have been amended and are presented for examination on the merits for patentability.
Rejection(s) not reiterated from the previous Office Action are hereby withdrawn. The following rejections are either reiterated or newly applied. They constitute the complete set of rejections presently being applied to the instant application.
Modified Rejection As Necessitated by the Amendment Filed 06/24/2025
Claim Objections
Claim 10 is objected to because of the following informalities:
In Claim 10, there should be no spaces before and after the colon in “NaPP : FeNaEDTA”.
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.
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 1-6 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Diosady et al. (US 2018/0279638 A1, Of record) ), hereinafter Diosady, and in view of Kudo et al. (JP 2018-88901 A), hereinafter Kudo.
Diosady teaches iron fortification of tea products as an inexpensive source of bioavailable dietary iron [0007]. The iron used may be from any bioavailable iron source that contains an iron atom or iron ion that is available for coordination with the chelator to form a chelate, such as ferric sodium EDTA [0048].
Regarding Claim 1, Diosady expressly teaches a mixed fortified tea preparation containing 2 mg iron/g tea leaves, which the Examiner calculates to be 0.2% of iron in the product, which is within the claimed range (Example 1). Diosady teaches that the iron and sodium EDTA were attached onto tea leaves by spraying in a solution of HPMC comprising the iron and sodium EDTA, and freeze dried (Example 1). The fortification procedure was carried out by preparing a premixed iron fortified tea preparation containing using either ferric EDTA or ferrous sulphate as iron source at different molar ratios of total EDTA:iron (1:1, 1:1.5, 1:1.75 and 1:2), and the mixture sprayed in a solution with 10% pharmaceutical grade HPMC. With the iron at 0.2% and the solution having a maximum of 10% sprayed HPMC, and assuming that nearly 100% of the solid HPMC stick to the tea leaves, the tea product comprises close to 90% tea component, which is near the minimum of the claimed range. A prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. See MPEP 2144.05.
Diosady relates that for iron fortification of food, iron needs to be bioavailable, without making the fortified food unpalatable, however, the process is associated with undesirable flavor and colour changes which are off-putting for consumers [0008].
Diosady does not teach the dibasic sodium pyrophosphate.
Kudo is in the same field of research, and relates that teeth staining caused by tea has become a major aesthetic issue, and relates the invention of suppressing stain adhesion from drinking tea by blending a condensed phosphate and ascorbic acids with a tea beverage (p. 2). While the phosphate serves to remove stain adhesion, the ascorbic acid provides flavoring (p. 2). The condensed phosphate is one or more selected from the group consisting of sodium metaphosphate, sodium tripolyphosphate, and sodium dihydrogen pyrophosphate, which is the same as dibasic sodium pyrophosphate (p. 2). Kudo teaches preparing the tea beverage from a tea extract produced using a method used for the preparation of a normal tea extract, concentrated or diluted solution, for example, by mixing and contacting tea leaves and water, or mixing or dissolving a concentrate or purified tea extract or tea powder in water (p. 2).
Regarding the amount of phosphate, Kudo teaches the concentration of the condensed phosphate in the tea beverage is 0.01% - 0.1% (p. 3). Kudo expressly teaches the preparation of a tea beverage comprising 4000 g water, 100 g of black tea leaf, and sodium metaphosphate concentration of 0.05% (Example 1 in translation; Table 1, Original). By calculation, this means that at 0.05% phosphate concentration in the tea beverage, the phosphate is 2g; and 2% with respect to the tea leaf.
Diosady welcomes additional component for adhesion to the dried tea by dissolving the mixture in the solvent and spraying the resulting solution containing the mixture onto the dried tea [0073]. Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to combine the teachings of Kudo with that of Diosady and add condensed phosphate in the form of sodium metaphosphate, sodium tripolyphosphate, and/or sodium dihydrogen pyrophosphate in the mixture of tea leaves and FeNaEDTA, and spray the solution containing the mixture, and drying to adhere the mixture to the dried tea. One would try any of the phosphates taught by Kudo as a person with ordinary skill has good reason to pursue known options within his or her technical grasp and therefore also try dibasic sodium pyrophosphate. One would have been motivated to add the phosphate of Kudo in order to address the issue of staining from drinking tea. Kudo’s solution addresses the discoloration issue raised by Diosady regarding undesirable flavor and colour changes which are off-putting for consumers. Where there are a finite number of identified, predictable solutions and there is no evidence of unexpected results, an obvious to try inquiry may properly lead to a legal conclusion of obviousness. See MPEP 2143. Herein,
Regarding Claim 2, Diosady teaches brewing tea comprising its tea leaves preparation (Example 1).
Regarding Claim 3-6, Diosady teaches that fortification may be performed on any tea that is suitable for preparing a brewed tea beverage or suitable for other consumption, and may comprise buds and/or leaves of the plant Camellia sinensis, and may be dried tea from green tea, black tea etc. ([0043]; Example 1).
Regarding Claim 10, Diosady teaches preparing a premixed iron fortified tea preparation containing 10 mg iron per gram of tea leaves, which is 1% iron [0111]. Kudo teaches 2% phosphate component with respect to the tea leaf. As such, the ratio of phosphate component to iron component is 2:1, which is within the claimed range.
Response to Arguments:
Applicant traversed the rejection over Viteri in view of Nestel and Smith; Applicant traversed the rejection over Viteri in view of Nestel and Diosady.
The modified rejection supra was necessitated by the amendment and no longer relies on Viteri, Nestel, and Smith. Specifically, the amendment now recites a “tea product”.
Applicant argued that the tea component in Diosady is less than 89% of the tea product.
The Examiner noted in the above rejection that a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close.
Applicant alleges surprising and unexpected coloration properties of its recited compositions.
The Examiner has reviewed the disclosure and the argument, but was not persuaded. Firstly, an unexpected property or result must actually be unexpected and of statistical and practical significance. The burden is on the applicant to establish the results are in fact unexpected, unobvious and of statistical and practical significance. See MPEP 716.02. Herein, Applicant studies are based on single concentrations for FeNaEDTA and NaPP (See p. 12 of Specification), which is not commensurate in scope of the claim, and studies appear to have only been conducted without replicates. It is therefore difficult to ascertain the statistical and practical significance of the claimed invention.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
McGee et al. LWT - Food Science and Technology 89 (2018) 756–762.
Cercamondi et al. British Journal of Nutrition (2016), 116, 496–503.
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 JANICE Y SILVERMAN whose telephone number is (571)272-2038. The examiner can normally be reached M-F, 10-6 EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Erik Kashnikow can be reached on (571) 270-3475. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/J.Y.S./Examiner, Art Unit 1792
/ERIK KASHNIKOW/Supervisory Patent Examiner, Art Unit 1792