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 .
All previous claim rejections made under 35 U.S.C. 103, which were indicated in the Office action dated October 1, 2026, have been withdrawn in view of applicant’s amendment made to claim 1 which requires a complex of ץ-cyclodextrin and coenzyme Q10.
New rejections have been made to address the amended claim.
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 1-4, 7-9 and 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Bromley et al. (US 20120016026 A1, published on June 3, 2014, cited in IDS) (“Bromley” hereunder) in view of Yurko-Mauro (us 20130172412 A1, published on July 4, 2013), Seo et al. (WO 2017209397 A1, published on December 7, 2017) (“Seo” hereunder) and Sorg et al (EP3345495 A1, published on July 11, 2018) (“Sorg” hereunder).
Bromley teaches a spray-dried powder composition provided from a liquid emulsion concentrate; the concentrate provides at least at least 500 mg or about 500 mg of non-polar active ingredient when dissolved in a serving of a food or beverage. See [0069].
The reference teaches a food or beverage containing the concentrate providing a single dosage of the non-polar active ingredient; more specifically, the composition contains one or more of 30-220 mg omega-3 docosahexaenoic acid (DHA)/eicosapentaenoic acid (EPA) or 220-mg DHA/EPA, 50-200 mg CoQ10, 100-500 mg phytosterols and 1-200 mg carotenoids per serving. See [0052]. The example of the paragraph [0052] also contains 400-800 IU vitamin D3 (10 -20 mcg), 40-400 mcg vitamin A palmitate, and optionally 1.5-3g omega-6 CLA. The total amount of the non-polar active ingredients can range from 1681.05 mg – 4120.12 mg.
Although Bromley fails to specifically disclose the proportion of the non-polar active ingredients, the reference teaches that the amounts are based in one single serving, which includes 8 ounces of a beverage. See [308]. Since applicant describes the claimed composition, weighing 100 g, is dissolved in a drinkable solution, it is viewed that the amounts of the non-polar active ingredients as provided in a concentrated or in a powder composition to make one serving are comparable to the presently claimed amounts of the actives in the total amount of the powder weighing 100 g, unless shown otherwise. It is also noted that the reference teaches that the formulation is made so that at least 500 mg or about 500 mg of the non-polar active ingredient is added and diluted in an 8 oz of the drink. See [0045-0048]. As the reference teaches that the amount of the non-polar compounds can be adjusted according to the judgment by a physician, pharmaceutical scientist, etc., one of ordinary skill in the art would have been obviously motivated to adjust the amount of the active ingredients to achieve targeted health benefits. See [0312, 0524].
Bromley further teaches that the liquid emulsion concentrate is freeze-dried or spray-dried to powder which also comprises at least one excipient. See [0523]. Bromley teaches that the powder forms of the composition can further include at least one excipient, such as diluents or fillers including starch, maltodextrin, gaur gum, etc. See [0523]. The reference further teaches that the concentration of the excipients is within a concentration range of between 50-85 % of the free-flowing powder. See [0525]. Thus, preparing a powder composition comprising the non-polar active ingredients in excipients including fillers/diluent in the amount of about 50-85 % of the total weight of the powder composition to make a single serving would have been prima facie obvious.
Bromley teaches that Lutein and Zeaxanthin are carotenoids and are antioxidants enhances the vertebrate immune system, according to the reference. See [0416]. The reference also teaches that carotenoid-containing compounds are used in the provided composition within a concentration range up to 15 %. See [0417]. The reference also suggests using a commercially available carotenoids comprising in the amount of 80% lutein and 4.5% zeaxanthin. See [0419]. Thus, for a composition comprising 200 mg of carotenoids, lutein can be present at the amount of 160 mg and zeaxanthin 9 mg, which are well within range of the present limitation. See the present claims 1 and 12.
Regarding the amount of DHA, Bromley teaches that the non-polar actives can comprise DHA in the amount of up to about 90%. See [0033]. The reference further teaches an embodiment in which the non-polar active ingredients contain EPA at an amount between 5 or about 5and 20% or about 20%. The reference suggests that fish oil or algae oil can be used as the source of DHA and EPA. The reference fails to teach the weight amount of DHA in the composition.
Yurko-Mauro teaches a daily dose of 2 grams or about 520 mg – 4 grams of DHA is effective in treating mild cognitive decline, aging-related cognitive defect of subjects. See translation, [0043].
Given the teachings of administering to subjects non-polar active ingredients for improving health in Bromley, one of ordinary skill in the art before the effective filing date of the present application would have been obviously motivated to look to prior arts such as Yurko-Mauro for further disclosure on the specific dose. Since the latter teaches that a daily dose of 2 grams or about 520 mg -4 grams of DHA is useful in treating cognitive decline, the skilled artisan would have been obviously motivated to modify the teachings of Bromley and incorporate such amount of DHA to make a composition which provide such therapeutic effects. See the present claims 1and 12.
The amended claim 1 further requires coenzyme Q10 complexed with ץ-cyclodextrin. Bromley teaches that coenzyme Q10 is a potent antioxidant and typically provided in an amount of up to 15 % of the concentrate. See [0403 - 0408]. As discussed above, the reference suggests an embodiment which provides 50-200 mg of CoQ10 per serving. See the present claims 1 and 12. Although Bromley fails to teach the coenzyme Q10/ץ-cyclodextrin complex, Sorg teaches using such complex, provided with a lecithin component and commercially available as Cavawax W8 CoQ10, which has a higher water solubility and high uptake efficiency. See translation, p. 3, 3rd full paragraph – p. 4, 1st full paragraph.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present application to modify the teachings of Bromley and use the coenzyme Q10/ץ-cyclodextrin complex of Sorg, as the latter teaches the complex has a higher water solubility and high uptake efficiency. As both references teach dietary supplements and Sorg teaches that the coenzyme Q10/ץ-cyclodextrin complex is commercially available, the skilled artisan would have had a reasonable expectation of successfully combining the teachings of the references and producing a stable and safe dietary supplement with improved bioavailability of coenzyme Q10.
The amended claim 1 further requires 1-10g of sugar and 0.01 g-1 g of at least one steviol glycoside. Bromley teaches and suggests adding flavoring additives to improve the taste of the concentrate and/or beverages containing the concentrate, but fails to specifically teach sugar or steviol glycerides. See [0634].
Seo teaches sweeteners such as white sugar and steviol glycoside are commonly used to mask better taste of nutritional supplement. See translation, p. 13, 5th full paragraph.
Given the teachings in Bromley to use flavoring agents to improve the taste of the composition, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present application to look to prior art such as Seo for ways for organoleptic improvement, and incorporate to the Bromley composition sweeteners to mask unpleasant or bitter taste. Since Seo teaches that sugar and steviol glycosides are commonly used for such purposes in nutritional supplement art, adding such in an optimal amount for flavor masking and enhancing sweetness would have been well within the skill of ordinary skill in the art.
Regarding claim 2, Bromley the reference teaches that the at least one excipient can be diluents or fillers including starch, maltodextrin, guar gum, etc. See [0523].
Regarding claim 3, Bromley teaches that the concentration of the excipients is within a concentration range of between 50-85 % of the free-flowing powder, wherein the excipients are selected from maltodextrin and gum acacia, which is gum Arabic. See [0356, 0523-0525]. The reference particularly teaches that gum Arabic is used as the emulsion stabilizer in the concentrate; the spray-dried powder obtained from such liquid emulsion concentration inherently contains gum Arabic.
Regarding claim 4, the reference teaches that the powder is “dissolved” in a serving of a food or beverage, which suggests that the powder is water soluble. See [0069].
Regarding claim 7, Bromley teaches citric acid can be used as a pH adjusting agent in the amount ranging from 0.1-3.5 % of the concentrate. See [0517].
Regarding claim 8, as discussed above, Bromley teaches that EPA can be present in the composition in the amount ranging from 25-220 mg per serving.
Regarding claim 9, Bromley teaches that phytochemical-containing compounds such as isoflavones are used in the provided composition within a concentration range of up to 15 % of the concentrate. See [0409-0410]. As discussed above, the reference discloses an embodiment which provides 100-500 mg of phytosterols per serving.
Regarding claim 13, Yurko-Mauro teaches that the dry powders can be provided in individual or multiple use packages for reconstituted suspensions or sprinkles. See [0522]. Since the purpose of the powder is to be dissolved or dispersed in a food or beverage providing packaged powders with food or beverage products together for convenience would have been prima facie obvious. See [0069].
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Bromley, Yurko-Mauro, Seo and Sorg as applied to claims 1-4, 7-9, 12 and 13 above, and further in view of Tuttle (US 6193973 B1, published on August 22, 1997).
Although Bromley teaches that ginseng extract can be used to provide micronutrients, see [0026], the reference fails to suggest any amount or the type of ginseng to be used in the invention.
Tuttle teaches that ginseng builds stamina and endurance by enhancing the body’s ability to adapt to stress. See col. 3, lines 33-63. The reference teaches that Panax ginseng additionally strengthens the heart muscle and stimulates the immune system, increases cerebral circulation. The reference teaches that the dietary supplement for an adult would be 3-6 capsules, each capsule comprising about 100-600 mg of ginseng (0.3-3.6 g). See col. 2, lines 31-36; col. 2, lines 51 – 55.
Given the teachings of Bromley to use ginseng extract as a source of micronutrients, one of ordinary skill in the art would have been obviously motivated to look to prior art such as Tuttle for further teachings on the source of ginseng to be used and its effective amounts in a nutritional supplement. Since the latter teaches Panax ginseng builds stamina and endurance, strengthens the heart muscle, stimulates the immune system, and increases cerebral circulation, and also suggests the effective daily dose and the amount of a single dose, the skilled artisan would have been motivated to incorporate Panax ginseng in the Bromley composition in the amount suggested by Tuttle; the skilled artisan would have had a reasonable expectation of successfully fortifying the Bromley composition which also impart the health benefits of Panax ginseng.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Bromley, Yurko-Mauro, Seo and Sorg as applied to as applied to claims 1-4, 7-9, 12 and 13 above, and further in view of Yuan et al. (US 20200046712 A1, filed on August 10, 2018).
Bromley teaches using fish oil to provide DHA and EPA, and further teaches that a minor about of saturated fatty acids (e.g., palmitic acid, stearic acid) can be present. [0390]. Although the reference does not specifically suggest the amount of such saturated fatty acid, formulating a pharmaceutical composition in the form of powder that contain a minor amount of a saturated fatty acid such as stearic acid as a lubricant an antiadherent is well-known. See [0523]. Yuan also teaches that lubricants are conventionally used in palatable nutritional supplements, foods or pharmaceutical composition; the reference teaches that 0.1-10 wt % of stearic acid can be used as a lubricant. See [0089].
Given the teachings in Bromley to use stearic acid as a lubricant/antiadherent in the free-flowing powder composition, one of ordinary skill in the art before the effective filing date of the present application would have been obviously motivated to look to prior art such as Yuan for teachings on further teachings on the lubricant/adherent, and incorporated to the Bromley composition an appropriate amount of stearic acid to maintain free flow during processing and handling.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-4, 6-9 and 11-13 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.
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/GINA C JUSTICE/Primary Examiner, Art Unit 1617