DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. This office action is written in response to the Applicants Remarks filed 9/8/25. Claims 1-6, 8-18 are pending. Claim 7 was cancelled. Claims 14-16 were withdrawn. Claims 1-6, 8-13 have been examined on the merits.
Withdrawn Rejections
3. The 112(b) rejection of claim 5 has been withdrawn due to the amendment to claim 5.
4. The 102 (a)(1) rejections of claims 1, 7, 9, 10, 11, 12, 13, and 17 by Clarke (US 2020/0113220) have been withdrawn due to the amendment to claim 1.
5. The 103(a) rejections of claims 2-5 over Clarke (US 2020/0113220) and Kataoka et al. (US 2019/ 0021359) have been withdrawn due to the amendment to claim 1.
6. The 103(a) rejections of claims 6 and 8 over Clarke (US 2020/0113220) in view of Liu et al. CN 108308598 Machine Translation July 2018 have been withdrawn due to the amendment to claim 1.
Claim Rejections - 35 USC § 103
7. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
8. Claims 1, 9, 10, 11, 12, 13, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Clarke (US 2020/0113220) in view of Sakuma (US 7,141,265).
Regarding Claim 1: Clarke discloses a composition containing 3-hydroxybutyrate (a salt of 3-hydroxybutyric acid), an edible fat and protein [abstract; 0023; 0025; 0083; 0094]. Clarke discloses including a protein in the form of gelatin [0094-0097].
Clarke does not disclose that the protein is whey, or casein, or soy protein.
Sakuma discloses an oil composition containing protein [abstract; col. 2, lines 19-30]. Sakuma discloses that the protein may be casein, whey, or soy [col. 5, lines 21-28; claim 1, 13, 15].
At the effective filing date of the invention it would have been obvious to one of ordinary skill in the art to modify the protein of Clarke to be derived from casein, whey or soy as disclosed in Sakuma since an edible fat composition in combination with protein is also disclosed in Sakuma and the selection of the source or type of protein is based on the desire of one of ordinary skill in the art. For example, one wanting to provide a vegan or vegetarian composition would opt for including soy protein as opposed to an animal source of protein i.e. casein or whey.
Regarding Claim 9: Clarke discloses 3-hydroxybutyrate (a salt of 3-hydroxybutyric acid), as discussed above in claim 1. Clarke discloses that the composition may be present as pharmaceutically acceptable salts and discloses alkali metals and alkali earth metal [0110].
Regarding Claim 10: Clarke discloses as discussed above in claim 1. Clarke discloses that the 3-hydroxybutyrate has an R configuration [abstract; 0037].
Regarding Claim 11: Clarke discloses as discussed above in claim 1. Clarke discloses that the composition is for oral intake [0118].
Regarding Claim 12: Clarke discloses as discussed above in claim 1. Clarke discloses that the composition can be in liquid form which is equivalent to an aqueous dispersion [0089; 0105].
Regarding Claim 13: Clarke discloses as discussed above in claim 1. Clarke discloses that the composition can be in solid form [0089; 0093].
Regarding Claim 17: Clarke discloses as discussed above in claim 1. Clarke discloses that the composition can be a nutraceutical, food supplement, nutritional composition/dietary supplement [0025; 0083; 0089; 0091; 0092].
9. Claims 2-5 are rejected under 35 U.S.C. 103 as being unpatentable over Clarke (US 2020/0113220) and Sakuma (US 7,141,265) as applied to claim 1 above, and further in view of Kataoka et al. (US 2019/ 0021359).
Regarding Claims 2-5: Clarke discloses as discussed above in claim 1. Clarke does not disclose that the edible fat or oil is wherein the edible fat and/or oil is a fat and/or oil particle containing a fat and/or oil component comprising at least one type of XXX triglyceride having a fatty acid residue X at positions 1 to 3 of glycerin (claim 2); wherein the fat and/or oil component comprises β-form fat and/or oil (claim 3); wherein the number of carbon atoms of the fatty acid residue is an integer of 10 to 22 (claim 4); wherein the fat and/or oil particle has a plate-like shape (claim 5).
Kataoka discloses an edible fat and/or oil ingredient containing an XXX triglyceride fat having fatty acid residues X, each with x carbon atoms, at positions 1 to 3 of glycerin, characterized in that x number of carbon atoms is an integer selected from 10 to 22, and the fat/or oil ingredient is a β-form fat and/or oil, and particles of the powdered fat and/or oil composition have a plate-like shape [abstract; 0015-0017; 0019-0021]. Kataoka discloses that the edible fat composition can also contain protein by its disclosure of skim milk powder, gelatin, casein [0073; 0136; 0148; 0163]. Kataoka discloses that the composition is useful for dietary supplements, balanced nutritional foods and other types of food [0232]. Kataoka generally discloses the powered fat/oil composition for foods and/or beverages, quasi drugs, pharmaceutical drugs, household goods, feeds, general goods [0043].
At the effective filing date of the invention it would have been obvious to one of ordinary skill in the art to modify the composition of Clarke to include the powdered fat or oil of Kataoka as its edible fat since Clarke incorporate fat/oil in its composition and since the powdered fat or oil of Kataoka is able to improve the functionality and the stability of products [Kataoka 0004; 0044;0045] and since as discussed above it is useful in food, beverage, quasi drug and pharmaceutical compositions. The 3-hydroxybutyrate of Clarke is used in food for health benefits and therefore the combination of the 3-hydroxybutyrate with the protective fat of Kataoka would have improved the stability and administration of the 3-hydroxybutyrate.
10. Claims 6 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Clarke (US 2020/0113220) and Sakuma (US 7,141,265) as applied to claim 1 above, and further in view of Liu et al. CN 108308598 Machine Translation July 2018.
Regarding Claims 6 and 8: Clarke discloses 3-hydroxybutyrate (a salt of 3-hydroxybutyric acid), as discussed above in claim 1. Clarke does not explicitly disclose wherein the edible fat and/or oil is present in an amount of 0.5 to 200 parts by mass per 100 parts by mass of the 3-hydroxybutyric acid and/or salt of 3-hydroxybutyric acid (claim 6); wherein the protein product is present in an amount of 30 to 2000 parts by mass per 100 parts by mass of the 3-hydroxybutyric acid and/or salt of 3-hydroxybutyric acid (claim 8).
Liu discloses a meal replacement bar containing protein, fat and an active ingredient. Liu discloses 28 to 50 parts protein powder, 6 to 16 parts oil, 2 to 8 parts medicinal and edible extract [abstract].
At the effective filing date of the invention it would have been obvious to one of ordinary skill in the art to include the ingredients of Clarke at amounts as in Liu in order to provide a composition that is stable with good mouthfeel [Liu abstract].
Although Liu does not disclose the amounts recited in the claims, it would have been obvious to one having ordinary skill in the art at the time of the invention to adjust the amount of protein, fat, and active ingredient for providing a health benefit in a food supplement, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272.
Response to Arguments
11. The 112(b) rejection of claim 5 has been withdrawn due to the amendment to claim 5.
12. The 102 (a)(1) rejections of claims 1, 7, 9, 10, 11, 12, 13, and 17 by Clarke (US 2020/0113220) have been withdrawn due to the amendment to claim 1.
13. The 103(a) rejections of claims 2-5 over Clarke (US 2020/0113220) and Kataoka et al. (US 2019/ 0021359) have been withdrawn due to the amendment to claim 1.
14. The 103(a) rejections of claims 6 and 8 over Clarke (US 2020/0113220) in view of Liu et al. CN 108308598 Machine Translation July 2018 have been withdrawn due to the amendment to claim 1.
15. The rejections have been modified to reflect the source of protein as now recited in amended claim 1 and its dependent claims.
Conclusion
15. 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.
16. Any inquiry concerning this communication or earlier communications from the examiner should be directed to FELICIA C TURNER whose telephone number is (571)270-3733. The examiner can normally be reached Mon-Thu 8:00-4:00 pm.
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/Felicia C Turner/Primary Examiner, Art Unit 1793