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 .
DETAILED ACTION
Status of the Claims
Receipt of Remarks/Amendments filed on 07/30/2025 is acknowledged. Claims 1, 14-15, 17, 19, and 21 are amended. Claim 22 is new. Claims 1-22 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Rejection(s) not reiterated from the previous Office Action are hereby withdrawn.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 07/30/2025
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 1-4, 6-18 and 22 are rejected under 35 U.S.C. 103 as obvious over Walton et al. (US 2016/0037815 A1; Of record), hereinafter Walton, in view of Kim et al. (European Journal of Clinical Nutrition (2007) 61, 536–541; Of record), hereinafter Kim.
Regarding Claims 1 and 17-18, Walton reads on the features of i) protein, ii) stabilizing composition comprising at least one stabilizing agent, a chelator, and an emulsifier, iii) sleep-inducing composition, and iv) food additive by teaching i) milk protein concentrate as the protein, ii) cellulose gel/gum as the stabilizing agent, potassium and sodium citrate as chelator, and lecithin as emulsifier, and iv) fructose as the food additive ([0075]; p. 10, Table 3). Walton teaches its composition in a shake form ([0021], [0032]).
Regarding the sleep-inducing composition, Walton teaches the following which renders the specifically claimed limitations obvious:
casein hydrolysate - Walton teaches its nutritional composition comprises a protein source selected from the group consisting of calcium caseinate, sodium caseinate, milk protein concentrate, pea protein concentrate, whey protein hydrolysate etc. and combinations thereof (Claim 4);
Zinc – Walton teaches embodiments wherein the composition comprises additional minerals including zinc [0077];
calcium, magnesium - Walton expressly teaches compositions comprising calcium, magnesium (Table 3);
vitamins A, K, E, D, vitamin B6, C, folate, and choline- Walton teaches embodiments wherein the composition comprises vitamins inter alia A, K, E, D2 and D3, C, pyridoxine, which is the same as vitamin B6, and folic acid which encompasses folate, and choline [0076]. Walton teaches vitamins D2 and D3, which are forms of calciferol, rendering vitamin D obvious.
Walton teaches caseinate salts and other protein hydrolysate, but does not expressly teach calcium caseinate.
Kim discloses the study on the efficacy of αs1-casein hydrolysate on stress-related symptoms in women and found it may be used as an effective functional ingredient alleviating anxiety, sleep problems and general fatigue (p. 537).
Kim evaluated αs1-casein hydrolysate (lactium) and a bioactive decapeptide (αs1-casein-(f91–100), α-casozepine) and reports that supplementation of αs1-casein hydrolysate improves cardiovascular, digestive, intellectual, emotional and social symptoms/problems(p. 537, L. Col., 4th and 5th paragraph; p. 540, R. Col., 1st and 2nd paragraphs). Kim relates how cow’s milk has been long considered a tranquilizing beverage with sleep-inducing capacity, attributable to αs1-casein hydrolysate (p. 540, R. Col., 3rd and 4th paragraphs).
Walton already recognizes addition of casein, and protein hydrolysate. 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 Walton and Kim, and add casein hydrolysate, to the shake of Walton to induce sleep, and remove anxiety and other stress symptoms, particularly for female subjects.
Regarding Claim 2, Walton expressly teaches cellulose gel/gum at 3% (Table 3). However, Walton also teaches embodiments wherein the composition comprises stabilizers and gums inter alia gellan gum represent from 0.1% to 5.0% [0075].
Regarding Claims 3 and 4, because Claim 1 requires cellulose gel/gum and gellan gum in the alternative, and because the cellulose gel in Claim 1 has been rendered obvious by Walton, the requirement for the gellan gum in the dependent Claims 3-4 are also met (Table 3).
Regarding Claim 6, Walton renders obvious the claim by teaching 0.65% sodium citrate which reads on “about 0.6%” of the sodium citrate(p. 10, Table 3).
Regarding Claims 7 and 8, because Walton teaches milk protein concentrate, these claims are obvious (p. 10, Table 3).
Regarding Claim 9, Walton teaches the nutritional composition comprises a protein source inter alia pea protein hydrolysate, pea protein concentrate, soy protein concentrate, and soy protein hydrolysate (Claim 4).
Regarding Claim 10, Walton teaches soluble fiber in its compositions at an amount of 32.9 kg per 1000 kg product (Table 3). This corresponds to 32.9 g per 35.274 ounce, which is 0.9 g/oz, rendering obvious the “about 0.7 g per 1 ounce”. 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.
Regarding Claims 11-12, Walton teaches soy lecithin at 1.7 kg per 1000 kg product, which is 0.17%, and is within the claimed range.
Regarding Claim 13, Walton teaches magnesium phosphate reading on the phosphorus feature of the claim (p. 10, Table 3).
Regarding Claims 14 and 22, Walton teaches soy oil and canola oil (p. 10, Table 3).
Regarding Claim 15, Walton is silent on the decapeptide. However, Kim has described the lactium and the bioactive decapeptide (αs1-casein-(f91–100), α-casozepine) as anxiolytic agents (p. 537).
Regarding Claim 16, Walton teaches semi-liquid form of its compositions including thick shakes, liquid yogurts, and liquid gels ([0021], [0032]).
Further regarding Claim 17, Walton teaches ready-to-feed or concentrated liquid, or it can be packaged as a reconstitutable powder (e.g., spray dried, dry mixed, agglomerated) [0081].
Claims 19-21 are rejected under 35 U.S.C. 103 as obvious over Walton in view of Kim, as applied to Claims 1-2 and 6-18 above, and further in view of Pediasure (Obtained on 09/30/25 from <https://www.pediasure.com/nutrition-drinks-for-kids/grow-gain-nutrition-shakes-can), first available on Amazon in 2018, See PediaSure Grow & Gain with Immune Support Shake Mix Powder. Obtained from URL: <https://www.amazon.com/PediaSure-Powder-Nutritional-Antioxidants-Vitamins/dp/B07C9K3HXV/ref=sr_1_6?crid=1PA39U378P61T&dib= eyJ2IjoiMSJ9.zcufNDkSN2W5OUPgQpq6XPpnMBQW6lTKYVonCUWsHAyxq9P5OLrZLhnweKus8Lj4ez0OirVvTt9akuDwMsrIgKZXJ-UHYkBo1MfIEhEXkfoovJVvvpx74lI61l06vbCsCyr0i_Gx-jjcg_BPe0lbneeO8PYSdWF_4e_x7E7fsDyDG9bLXGCILK3BhK4kwqQ2t3o4zYBMQDCQmUi_o1whoz1OCU45Q-x1bjuz7NI-uIbI2cSTnfwuAo-DwQENAndUhHodsYZuCj0Sc37aA_ HXVyuqAPkX8DxcMro7H4-8CDo.8t0yVxrgtrLDGhc2kNdAzHbdE4Nq2fy3cP3Ct-Jq2bE&dib_ tag=se&keywords=pediasure%2Bgrow%2Band%2Bgain%2B8-oz%2Bcan&qid=1759262392& sprefix =pediasure%2Bgrow%2Band%%2B8-oz%2Bcan%2Caps%2C224&sr=8-6&th=1>), and as evidenced by Kim et al. (Nutrients 2019, 11, 1466), hereinafter Kim2, and Liebman, B. (Center for Science in the Public Interest, Vitamins and Minerals, explained. Obtained from URL:<https://www.cspi.org/article/vitamins-and-minerals-explained> on 09/30/25, Published Mar. 1, 2020).
The teachings of Walton and Kim have been set forth supra.
Regarding Claim 19, as above, Walton has taught the claimed features of i) protein, ii) stabilizing composition comprising at least one stabilizing agent, a chelator, and an emulsifier, iii) sleep-inducing composition, and iv) food additive by teaching i) milk protein concentrate as the protein, ii) cellulose gel/gum and gellan gum as the stabilizing agent, potassium and sodium citrate as chelator, and lecithin as emulsifier, and iv) fructose as the food additive ([0075]; p. 10, Table 3). Walton teaches its composition in a shake form ([0021], [0032]).
Regarding the sleep-inducing composition, Walton and Kim together has taught casein hydrolysate and the α-casozepine decapeptide (Vide supra). Walton teaches embodiments wherein the composition comprises additional minerals including zinc, magnesium etc., and expressly teaches calcium (Table 3; [0077]). However, Walton does not expressly teach the claimed amount of α-casozepine, zinc, calcium and magnesium, and the vitamins as claimed.
Kim teaches administration of 75 mg and 150 mg casein hydrolysate (pp. 537 and 540). Kim teaches the αs1-CH (lactium), consisting of a tryptic hydrolysate of αs1-casein enriched protein fraction, was supplied by Ingredia (Arras, France). The lactium contains 2.2% of the decapeptide as evidenced by Kim2 (Section 2.3). By Examiner’s calculation, the decapeptide is present at 1.65-3.3 mg. As such, one skilled in the art would incorporate the casein hydrolysate containing 1.65-3.3 mg amount of decapeptide into the nutritional composition of Walton as Kim has taught this amount to be effective in alleviating stress-related symptoms.
Regarding the amounts of minerals and vitamins, Pediasure teaches shake mix suitable for children with and/or at risk for undernutrition, wherein the mix comprises in daily values (DV): Zinc at 10%, magnesium at 6%, calcium at 180 mg or 15%, vitamin A at 10%, vitamin D of 3.6 mcg or 20%; vitamin B6 at 25%; vitamin C at 20%; and folate at 20%, vitamin K at 8%; vitamin E at 10%; and choline at 10%. Pediasure has been available to the public since April 17, 2018, as evidenced by Amazon. Using the DV in mg according to Liebman, the amount of components are calculated to correspond to zinc at 1.1 mg, magnesium at 25.2 mg, vitamin A at 90 mcg, vitamin B6 at 0.425 mg, vitamin C at 18 mg, and folate at 80 mcg, vitamin K at 9.6 mcg; vitamin E at 1.5 mg; and choline at 55 mg. Therefore, all the minerals and vitamins are within the claimed ranges.
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 Pediasure with Walton and Kim, and use the amounts of components based on the protein shake powder of Pediasure. Obviousness is established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so. See MPEP § 2143.01 and KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385, 1395-97 (2007).
Regarding Claims 20 and 21, Walton and Kim have already rendered phosphorous and casein hydrolysate containing decapeptide obvious (Vide supra).
Claim 5 is rejected under 35 U.S.C. 103 as obvious over Walton in view of Kim, as applied to Claim 1 above, and further in view of Zhang, J. (WO 2019/204793; Of record), hereinafter Zhang.
The teachings of Walton in view of Kim have been set forth supra.
Walton teaches inclusion of starch, but does not teach the starch in Claim 5 [0047].
Regarding Claim 5, Zhang discloses the invention relating to emulsifiers prepared flour of cereal grains, legumes, or other plant materials which contains both protein and carbohydrate, in particular starch, which shows enhanced stability against physical and chemical deteriorations as compared within those prepared using conventional emulsifiers. [0007]. The flour emulsifier is useful in protein shake [0024]. The emulsifier of Zhang can provide thickening, improve creaminess, mouthfeel, freeze-thaw stability, physical stability, chemical stability, and/or other properties to an emulsion [00129]. For example, the use of said emulsifier may lead to higher viscosity or gel strength of an emulsion-related system or product [00129].
Regarding the amount in Claim 5, Zhang gives an example of use of the flour [emulsifier in the preparation of coffee creamer, wherein 115g water and 15g flour emulsifier were mixed and homogenized, and 15g coconut oil was added to form the emulsion (Example 23). Zhang teaches that the emulsifier composition comprise about 15% to 99% carbohydrate, wherein said carbohydrate includes starch component. Therefore, the starch component can be from about 1.55-10% if the carbohydrate is all starch, or less.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to combine Zhang Walton and use an emulsifier with additional starch to include in the protein shake. One would have been motivated to do so because Zhang has taught emulsions using flour emulsifiers enhanced the stability of products compared with those prepared using conventional emulsifiers. Furthermore, the flour emulsifier of Zhang is useful in protein shake, and can creaminess, improved mouthfeel etc. With regards to the amount, merely selecting proportions and ranges is not patentable absent a showing of criticality. In re Becket, 33 USPQ 33; In re Russell, 169 USPQ 426; In re Hoeschele, 160 USPQ 809. See MPEP 2144.05. Determining the optimal or workable amounts/ratio of the components in the composition is routine experimentation. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955), the court stated that “Normally, change
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temperature, concentration, or both, is not a patentable modification; however, such changes may impart patentability to process if ranges claimed produce new and unexpected result which is different in kind and not merely in degree from results of prior art; such ranges are termed “critical” ranges, and applicant has burden of proving such criticality; even though applicant's modification results
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great improvement and utility over prior art, it may still not be patentable if modification was within capabilities of one skilled in the art; more particularly, where the general conditions of a claim are disclosed
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prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” The motivation arises from “the normal desire of scientists or artisans to improve upon what is already generally known” (Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382) through routine experimentation. (MPEP 2144.05 IIA and B).
The arts are in the same field of study, and as such, there is a high expectation of success.
Response to Remarks:
Applicant traversed the anticipatory rejection over Walton in view of the amendment. While the 102 rejection was withdrawn by the Examiner, the claims are still obvious over Walton in view of Kim. See rejection above.
Applicant traversed the 103 rejection over SelectMeal in view of Ruszkay, Zhang, and McCleary. This argument as the modified rejection supra was necessitated by the amendment.
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 JANICE Y SILVERMAN whose telephone number is (571)272-2038. The examiner can normally be reached on M-F, 10-6 EST.
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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.
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/J.Y.S./Examiner, Art Unit 1792
/ERIK KASHNIKOW/Supervisory Patent Examiner, Art Unit 1792