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
Previous Rejections
Applicants' arguments, filed 12/12/25, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Objections:
Claim 2 is objected to under 37 CFR 1.75 as being a substantial duplicate of claim 10. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim Rejections - 35 USC § 103
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.
Claims 1-11 are rejected under 35 U.S.C. 103 as being unpatentable over Prendergast (WO 2012/095731A1, presented in IDS) in view of Gui et al. (WO 2019/001567A1) and further in view of Antony et al. (US PG Pub. 2017/0326195), Gokaraju et al. (WO 2020/079712A1), Klele et al. (US PG Pub. 2018/0339008A1), Gupta et al. (US PG Pub. 2009/0042846A1).
Prendergast discloses a composition useful for reducing stress, depression and anxiety, wherein the composition comprises olive oil supplemented by adding extra hydroxytyrosol; phosphatidylserine; lecithin from soyabean; beta carotene; and herbal extracts from Magnolia Bark, see title and abstract. Prendergast teaches a method of attenuating the cortisol awakening response (CAR) comprising administering a daily supplement consisting of the above composition, see claim 19. The reference teaches that bark of magnolia officianalis contains two active ingredients: honokiol and magnolol, see page 4, lines 15-50. The reference teaches the amount of 479.6 µmol/kg oil, see page 7, lines 28 and this amount reads on the claimed amount of about 400 to 500 µmol/kg olive oil. For to produce the effects required from this patented formulation we determined that the level of Hydroxytyrosol should be brought to a level of 450-500 µmol/kg olive oil regardless of the origin of the olive oil so as to standardize the effect on Cortisol reduction, see page 8, first paragraph. The reference further teaches that the composition further comprises an herbal extract wherein the herb is Luo Han Guo (Siraitia grosvenorii). The reference teaches sue of vitamins, calcium, Kreb’s cycle intermediates, calcium and antioxidant proanthocyanidin, see claims 1-8.
Prendergast teaches the following amount of the claimed components including phosphatidylserine and lecithin on page15:
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Several studies have demonstrated magnolia bark extract to exhibit a range of health benefits including anti-inflammatory, anti-bacterial, and anti-allergic activities (Lee, Y.K., et al. (2009), Protective effect of the ethanol extract of Magnolia officinalis and 4-0-methyl honokiol on scopolamine-induced memory impairment and the inhibition of acetylcholinesterase activity. Natural Medicines, 63, 274-282), see page 5, third paragraph. (Thus, the reference teaches anti-inflammatory effect of magnolia bark extract). Additionally, regarding honokiol and magnolol providing antiangiogenic and anti-inflammatory effect, the property would necessarily be present as the property cannot be separated from the chemistry of the compound. (MPEP 2112.02 (II)). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705,709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Since the art teaches the generic amounts of olive oil comprising hydroxytyrosol, lecithin, phosphatidylserine, it would be obvious to one of ordinary skill to have manipulated the amounts of various cited components for optimum effect of attenuating the cortisol awakening response along with anti-inflammatory and anti-allergic response by performing experimental manipulations.
Gui et al. teaches use of magnolia officianalis or magnolia bark providing synergistic anti-inflammatory efficacy in a composition, see abstract and claims.
Therefore, it would have been obvious to one of ordinary skill in the art to have utilized magnolia officianalis/magnolia bark comprising honokiol and magnolol to provide anti-inflammatory effect in a subject receiving the composition taught by Prendergast et al. because Gui et al. teaches use of magnolia bark has efficacy in anti- inflammatory properties once consumed.
Prendergast does not teach use of Ashwagandha extract.
Antony et al. teaches a randomized, double-blind, placebo-controlled study evaluating the efficacy, safety, tolerability, and pharmacological actions of an Ashwagandha (withania somnifera) extract was done in healthy, stressed adult volunteers. 60 healthy subjects with a total score between 6 to 17 on the Hamilton Rating Scale of Anxiety was given 250 mg/day of Ashwagandha extract for 60 days. There was a significant improvement in total score on Hamilton Anxiety Rating Scale (HAM-A), improvement in total score and subscale scores on the Depression and Anxiety Stress Scale (DASS-21), reduction in blood Cortisol and DHEA-s levels and improvement in testosterone levels within 30 days, see [0120]. (Thus, the reference teaches use of ashwagandha extract for reducing cortisol in a subject).
Gokaraju et al. teaches an enriched withania somnifera (Ashwagandha) extract composition comprising withanolide glycosides, withanolide aglycones and reduced levels of withaferin-A. The invention also provides to process for the preparation of these compositions and further provides to methods of improving testosterone levels, energy levels, sustained energy, vigor, stamina, and muscle mass and muscle strength using these compositions, see abstract. The invention provides withania somnifera extract composition comprising withanolide glycosides in the range of 3-15%, withanolide aglycones in the range of 2.5-8%, and withaferin-A in the range of 0.01-0.7% for reducing stress and improving testosterone levels, energy levels, sustained energy, vigor, stamina, and muscle mass and muscle strength, see page 5, first and third paragraph.
It would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have utilized ashwagandha into the cortisol reducing composition of Prendergast et. al for added benefit of reducing cortisol motivated by the teachings of Antony et al. and for reducing stress motivated by the teachings of Gokaraju et al. Additionally, it would have been obvious to one of ordinary skill in the art to combine the elements as claimed by known methods with no change in their respective functions, and the combination yielding nothing more than predictable results (MPEP 2141). "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.. [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted), see MPEP 2144.06. Manipulation of the amount of Ashwagandha extract would have been obvious given the art teaches the generic amount to be sued for reducing stress.
The references discussed above do not teach use of cannabidiol.
Klele teaches natural product compositions for treating symptoms of anxiety and depression, see title. Klele teaches use of cannabidiol, ashwagandha and withanolides for anti-stress, anti-inflammatory and cognitive enhancement, see [0048] and [0044].
It would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have utilized cannabidiol, withanolides and ashwagandha taught by Klele et al. into the Pendergast composition which also reduces anxiety as it would have been obvious to one of ordinary skill in the art to combine the elements as claimed by known methods with no change in their respective functions, and the combination yielding nothing more than predictable results (MPEP 2141). Prendergast and Klele teach anxiety reducing composition, therefore, "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose .... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCP A 1980).
The references discussed above do not teach use of carotenoid.
Gupta et al. teaches antioxidants used in delivery systems including magnolol, honokiol and carotenoids, see title, abstract and [0173] and [0163].
It would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have utilized magnolol, honokiol and carotenoid taught by Gupta et al. into the Pendergast for antioxidant properties motivated by the teachings of Gupta et al.
Applicant’s arguments are moot in view of the rejections made above wherein it is cited that Prendergast teaches the amount of 479.6 µmol/kg oil, see page 7, lines 28 and this amount reads on the claimed amount of about 400 to 500 µmol/kg olive oil, while teaching a method of attenuating the cortisol awakening response (CAR).
Action is final
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.
Correspondence
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/SNIGDHA MAEWALL/Primary Examiner, Art Unit 1612
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