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 1-23 are pending.
Claims 1, 13-14 and 16 are currently amended.
Claims 1-12 and 18-20 are withdrawn.
Claims 21-23 were added.
Claims 13-17 and 21-23 have been examined.
Claims 13-17 and 21-23 are rejected.
**It is noted that the instant claim set is non-compliant with CFR 1.121(c)(1), CFR 1.121(c)(2), and/or CFR 1.121(c)(4) since at least instant claim 6 does not show the proper status identifier to indicate that it has been amended. Howbeit, for clarity of the record and to comply with CFR 1.121(c)(1)-(5), applicants should indicate claim 6 as withdrawn, and ensure that future responses properly indicate the status of all claims. See MPEP 1893.01(a)(4).
Acknowledgement of Receipt
This Office Action is in response to the Applicants' amendments and remarks filed 11/28/2025.
Information Disclosure Statement
The Information Disclosure Statements (IDSs) submitted on 11/14/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDS is considered by the Examiner.
Withdrawn Objections/Rejections
The objection to claim 13 is withdrawn.
In light of the new amendments, the rejections of claims 14 and 16 under 35 U.S.C. § 112(b) are withdrawn.
New Rejections
Applicant' s amendments have necessitated the following grounds of rejection:
Claim Rejections - 35 USC § 102
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 13 and 15-16 are rejected under 35 USC § 102(a)(2) as being anticipated by Fisher et al. (US 7744930 B2, pub. 06/29/2010) herein referenced Fisher.
Fisher anticipates the claimed methods comprising administering to the subject by disclosing combinations of soy protein, chromium and free leucine in amounts effective to inhibit the loss of lean body mass of a subject under conditions of caloric restriction and are useful in the improvement of lipid profiles (reducing cholesterol levels) (abstract). Fisher discloses that in certain embodiments the method is used to treat a subject having the Metabolic Syndrome (col. 14, line 27). Fisher teaches that the combination can be administered as a powder that is mixable into a liquid beverage and as a nutritional supplement (abstract). The composition is particularly suitable for use by overweight, but otherwise healthy, adults (col. 17, lines 42-44). Fisher teaches administering dosages in the form of a beverage from a powdered beverage mix (col. 3 line 35; col. 4, lines 15-30).
Fisher discloses a mineral mix component that includes iron (col. 12, line 57; col. 20, line 50, Table 1, Example 6). Example 1 shows acacia gum, lecithin (i.e., phospholipid), mixed tocopherol concentrate (i.e., Vitamin E), vitamin B12, and vitamin D3 (col. 11, lines 35, 39, 43). Fisher discloses that the weight of acacia gum is about 8% to about 16% of the total weight of the composition and that the amount of lecithin (such as soy lecithin) is about 0.5 to about 2% by weight of the composition to anticipate the first agent to phospholipid 50:1 – 10:1 limitation.
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.
Applicant Claims
The instant claims are directed to a method comprising administering a formulation that comprises: a nutrient, wherein said nutrient is a mineral (Mg, Ca, Fe, Zn, I, Se, Cr, Cu(II), salt, complex or oxide) or/and a vitamin (B12, C, D3, E); and a first agent (carrageenan or an acacia gum) wherein said first agent to said phospholipid weight ratio is from 50:1 to 10:1 (instant claims 13-14); wherein the administering is performed to obtain at least one of: preventive/ curative/adjuvant treatment of a deficiency of said mineral/vitamin (instant claim 14). Applicants further claim that the formulation does not comprise sucrester, wherein the first agent consists of said acacia gum, and further comprises a gelatinized or pre-gelatinized starch of plant origin.
Claims 13-17 and 21-23 are rejected under 35 U.S.C. 103 as being unpatentable over Gomez-Ramirez et al. (Pharmaceuticals, 11, 97, pg. 1-23, pub. 10/04/2018, cited on IDS) in view of Kamal et al. International Journal of Rheumatology Volume 2018, pub. 07/05/2018), Lacorte (US 2015/0250885 A1, pub. 09/10/2015, equivalent cited on IDS submitted 11/14/2025) and Fang et al. (CN 109012520 A, pub. 12/18/2018, MT) herein Gomez, Kamal, Lacorte and Fang. Citations from Fang are taken from the translation provided.
Gomez discloses Sucrosomial® Iron, as oral iron formulation in which ferric pyrophosphate (i.e., iron mineral salt) is protected by a phospholipid bilayer membrane, mainly from sunflower lecithin, plus a sucrester matrix (sucrosome) (abstract, pg. 5, section 4.1, para. 3). Sucrosomial® Iron is taught as a valid option for iron deficiency (i.e., anemia) treatment and in treating subjects with intolerance to iron salts or those for whom iron salts are inefficacious and has a high iron bioavailability and a low gastrointestinal toxicity (pg. 17, section 6., para. 2).
Regarding the carrageenan or acacia gum limitation, looking to the instant disclosure, Applicants describe acacia gum or gum arabic as stabilizers (see Spec., pg. 29, lines 11, 23). While Gomez teaches that further stability is obtained by adding tricalcium phosphate, starch in Section 4.1 (pg. 5, para. 3), Gomez does not teach carrageenan or acacia gum.
Kamal teaches that acacia gum (gum arabic) has anti-inflammatory activity through its derivative butyrate (abstract, pg. 1, col. 2, para. 1) and that it is a Ca2+-, Mg2+-, and K+-rich dietary fiber that can modulate immunity (pg. 2, col. 1, para. 2).
It would have been prima facie obvious to person of ordinary skill in the art to replace the tricalcium phosphate of Gomez with the gum arabic (acacia) taught by Kamal because not only would a broader range of health benefits provide additional support during treatment of a subject with iron deficiency but more pointedly as Gomez teaches that inflammatory bowel disease causes malabsorption of iron, anti-inflammatory medications increase the loss of iron (pg. 2, Table 1) and that oral iron supplementation results in oxidative stress and microbiota alterations (pg. 11, section 5.4., para. 2), acacia gum would clearly be the stabilizer associated with better health outcomes.
Regarding the first agent to phospholipid (50:1-10:1) limitation, Gomez and Kamal do not mentioned ratios. Lacorte and Fang are provided to show obviousness of the claimed range.
Lacorte discloses a solid composition for use in the treatment of disorders or diseases related to or derived from an iron deficiency (abstract). Lacorte teaches a method for treating a subject, the method comprising administering to the subject a solid composition comprising iron pyrophosphate, sunflower lecithin, sucrose esters or sucresters and guar gum (claim 1) wherein said sucrose esters or sucresters E473 are in an amount from 10 to 30% by weight (claim 4), lecithin is in an amount from 0.1 to 1.5 by weight (claim 5), and said lecithin are in the composition in a weight ratio from 25:1 to 20:1 (claim 6). The guar gum is in said liquid composition of the present invention in an amount comprised from 0.1 to 5% relative to the weight of the liquid composition ([0124]). Here the prior art of Lacorte teaches and suggests the use of more guar gum than lecithin in the composition.
Fang discloses a method for preparing core-shell structure microcapsules characterized by comprising the following steps: the core body material in the preparation method is any one of sodium alginate, agar and k-carrageenan, the shell layer material is zein, and the preparation method comprises the following steps: to include mixing the k-carrageenan solution and a medium chain triglyceride (MCT) solution containing 2% w/w of lecithin according to a mass ratio of 1:4 (abstract, claim 1). Fang teaches a ratio that suggests employing considerably less lecithin compared carrageenan (consider 1:4; 25:100; where 25 to 2% of 100, or 25:2).
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 the teachings of Lacorte and Fang to adjust the phospholipid bilayer membrane of Gomez in view of Kamal in terms of acacia gum being more than the lecithin component with expected results. One would be motivated to do so because Fang teaches carrageenan as hydrophilic and provides a microcapsule with hydrophilic material (i.e., core body) and hydrophobic material (i.e., shell layer). Fang explains that when said materials have common characteristics, the slow release effect improves and so does the protection effect on substances (i.e., Vitamin B6) (Fang, pg. 3, para. 2). Additionally, the teachings of Fang are suited with Lacorte’s demonstration of improved stability over time ([0141]). Besides, MPEP 2144.05 states that 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. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) there was no evidence of the criticality of the claimed ranges. Upon a thorough search of the instant disclosure, criticality of these ratios has yet to be provided and shown.
Claims 14-17 are intended use claims and a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art is capable of performing the intended use, then it meets the claim. The cited references teach the structural components and as such make obvious that the capability of performing these intended uses would have been met. Furthermore, MPEP 2114(I.) states that the prior art structure inherently possesses the functionally defined limitations of the claimed apparatus.
Regarding claim 21, Fang does not mention sucrester or sucrose esters.
Regarding claim 22, as mentioned above, Kamal teaches acacia gum.
Regarding claim 23, Lacorte teaches that the composition further comprises a gelatinized or pregelatinized starch (claim 2) wherein said gelatinized or pregelatinized starch is selected from the group comprising rice starch or maize starch; said starch is in an amount from 15 to 40% by weight (claim 7).
Response to Arguments
Applicants' arguments have been fully considered but they are not persuasive.
Applicants argue that acacia gum would have an unpredictable impact on the performance of the resulting combination and that impermissible hindsight was applied (Remarks, pg. 13, para. 1).
Gomez teaches that inflammatory bowel disease causes malabsorption of iron, anti-inflammatory medications increase the loss of iron (pg. 2, Table 1) and that oral iron supplementation results in oxidative stress and microbiota alterations (pg. 11, section 5.4., para. 2), acacia gum would clearly be the stabilizer associated with better health outcomes.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
With respect to Applicants’ arguments citing the instant specification page 62, first paragraph, Figure 3 (e.g., increase in average size with increasing carrageenan) the adjustment of particular conventional working conditions (e.g., determining result effective amounts of the ingredients beneficially taught by the cited references, especially within the broad ranges instantly claimed) is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan. Accordingly, this type of modification would have been well within the purview of the skilled artisan and no more than an effort to optimize results. Examiner respectfully submits that Applicant is required to present a comparison with the closest prior art of record.
Regarding the newly amended claims to include the recitation of a 50:1 to 10:1 ratio, Applicants' arguments are based on newly amended limitations which have been addressed by the new grounds of rejection above (see Remarks, bridging pgs. 13-14).
For these reasons, Applicants' arguments are found unpersuasive.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Karen Ketcham whose telephone number is (571)270-5896. The examiner can normally be reached 900-500 ET.
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/Karen Ketcham/Examiner, Art Unit 1614
/ALI SOROUSH/Supervisory Patent Examiner, Art Unit 1614