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 .
Summary
Claims 1-3, 10-11, 13, 15-16, 18, 20-21, 23-27, 29-30 and 67-68 are pending in this office action. Claims 67-68 are new. Claims 4-9, 12, 14, 17, 19, 22, 28, and 31-66 have been cancelled. All pending claims are under examination in this application.
Priority
The current application filed on June 30, 2022 is a 371 of PCT/US2020/067521 filed December 30, 2020, which in turn claims domestic priority to provisional patent application 62/955,283 filed on December 30, 2019.
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 non-obviousness.
Claims 1-3, 10-11, 13, 15-16, 18, 20-21, 23-27, 29-30 and 67-68 are rejected under 35 U.S.C. 103 as being unpatentable over Elzinga et al. (WO2015/042232A1) in view of Geiling et al. (US2019/0321330A1), Kleidon et al. (US2019/0076355A1), and Piorkowski (US2016/0255870A1).
[The Examiner is going to introduce each reference and then combine them where appropriate to reject the instant claims.]
1. Elzinga et al.
Elzinga et al. is regarded as being the prior art closest to the subject-matter of the present application as it teaches improved terpene-based compositions, processes, methodologies for creation and products thereby (see title). In addition, Elzinga et al. disclose compositions which are fragrant and contain at least a member set culled
from a library of compositions, each being comprised of sub-combinations of selected
terpenes. Fragrances that mimic that of various states of organic and synthetic aromatics including products, processes and those from non-combusted plant products, among other things, uniquitous products, processes, medicinals, and related moieties leverage databases of all known terpene groupings are offered for consideration, and have been provided, according to the instant teachings (see abstract).
2. Geiling et al.
Geiling et al. teach cannabis placebo compositions, delivery vehicles and a method for colour matching/neutralization of cannabis products (see title). Furthermore, Geiling et al. disclose cannabis placebo compositions having an appearance, odor and flavour to match that of an active cannabis product, as well as methods for colour matching and colour neutralization of cannabis products. The compositions include a colourant to provide a colour match between the cannabis placebo composition and the active cannabis product; and a terpene, an ester, a flavonoid, or any combination thereof to provide an odor and flavour (see abstract).
3. Kleidon et al.
Kleidon et al. teach methods and systems for forming stable droplets (see title). Additionally, Kleidon et al. disclose methods and systems for forming stable droplets as part of an emulsion. The emulsion may be, for example, formed by bringing an aqueous phase in contact with an oil phase at a droplet generation junction of a droplet generator. Droplets of the present disclosure may be used for holding compositions for various uses (see abstract).
4. Piorkowski
Piorkowski teaches encapsulated weighting agents for beverage emulsions (see title). Also, Piorkowski discloses emulsions including an aqueous phase with an
emulsifier dissolved in the aqueous phase, an oil phase including oil droplets, and a solid weighting agent encapsulated in the oil droplets. The ratio of the solid weighting agent to the oil phase in the emulsion may be from about 1:5 to about 1 :2000. The emulsions may be used with ready-to-drink and liquid concentrate beverages. Methods for making such emulsions are also disclosed (see abstract).
Combination of Elzinga et al., Geiling et al., and Kleidon et al.
Regarding instant claim 1, Elzinga et al., Geiling et al., and Kleidon et al. teach a composition comprising a terpene mixture. The necessary citations within Elzinga et al., Geiling et al., and Kleidon et al. that correspond to instant claim 1 are compiled within Table I.
Table I
Instant Claim 1
Elzinga et al., Geiling et al., and Kleidon et al. Citations
A composition, comprising a first mixture including beta caryophyllene, myrcene, limonene, alpha humulene, linalool, and alpha terpineol wherein:
Elzinga et al. disclose a composition, comprising a first mixture including beta caryophyllene, myrcene, limonene, alpha humulene, linalool, and alpha terpineol, and wherein the first mixture optionally includes one or more of beta pinene, alpha pinene, alpha bisabolol, valencene, terpinolene, trans ocimene, delta 3 carene, or xanthohumol [see claim 6 (prepared blend of terpenes by a process comprising the steps of: measuring a baseline endocannabinoid level of a patient; obtaining a terpene composition); and see claim 12 (The prepared blend of terpenes of claim 6, wherein the blend comprises one or more terpene compounds selected from a list comprising the following: beta -caryophyllene, alpha-humulene, limonene, linalool, myrcene, and alpha-terpineol; both claims are in Elzinga et al.)].
Additionally, Geiling et al. disclose the use of numerous terpenes including b eta-Myrcene, Linalool, Alpha-Pinene, Beta-Pinene, Beta-Caryophyllene, Caryophyllene oxide, Alpha-Humulene, Nerolidol, D-Limonene, L-Limonene, Para-Cymene, Eugenol, Farnesol, Geraniol, Phytol, Menthol, Terpineol, Alpha-Terpineol, Benzaldehyde, Hexyl acetate, Methyl Salicylate, Eucalyptol, Ocimene, Terpinolene, Alpha-Terpinene, Isopulegol, Guaicol, Alpha-Bisabolol, or any combination thereof (see paragraph [0114] within Geiling et al.).
beta caryophyllene is present in the first mixture in a concentration of about 20 % to about 40 % v/v; myrcene is present in the first mixture in a concentration of about 5 % to about 40 % v/v; limonene is present in the first mixture in a concentration of about 2 % to about 15 % v/v;
Elzinga et al. disclose the use of beta-caryophyllene (see PTO-892 NPL U) at about 10-30 wt% (see paragraphs [0013-0014] within Elzinga et al.); Elzinga et al. disclose the use of myrcene at about 5-30 wt% (see paragraphs [0013-0014] within Elzinga et al.); Elzinga et al. disclose the use of limonene at about 5-45 wt% (see paragraphs [0013-0014] within Elzinga et al.)
Although the claim limitation is in terms of volume, and alternatively the Elzinga et al. reference is in terms of weight, there still should be overlap of the ranges based on the considerable overlap. The Examiner is confident of this especially as the density of each component approaches 1.00 g/mL.
alpha humulene is present in the first mixture in a concentration of less than 1 % to about 15 % v/v; linalool is present in the first mixture in a concentration of less than 1 % to about 5 % v/v; alpha terpineol is present in the first mixture in a concentration of less than 1 % to about 5 % v/v;
Elzinga et al. disclose the use of alpha humulene, linalool, and alpha terpineol at 0-20 wt% (see paragraphs [0010] and [0013-0014] where the combination of terpenes beta caryophyllene, myrcene, and limonene is between 20-100 wt% within Elzinga et al.); Please see the argument above regarding the comparison of volume and weight percentages.
xanthohumol is present in the first mixture in a concentration of not more than about 20% v/v;
Kleidon et al. disclose that the one or more compositions comprise at least one agent selected from the group consisting of an herb, an essential oil, a therapeutic compound, a food product, a mushroom, pregnenolone, fulvic acid, L-Theanine, Fish Oil, phenyl ethyl amine (PEA), tulsi, lemon balm, passion flower, blue lotus, cacao, maca, schizandra, Siberian ginseng, kava, skullcap, valerian, hops, California poppy, catuba, epidmedium, pao d'arco, ashwaganda, ginko, albiza, reishi, lion's mane, maitake, chaga, vitamin C, turmeric, cannabidiol (CBD), tetrahydrocannabinol (THC), bioperine, and xanthohumol (see paragraph [0011] within Kleidon et al.). Furthermore, for example Kleidon et al. disclose the use of 10% to 40% CBD compounds by weight (see Examples 3-6 within Kleidon et al.; since CBD and xanthohumol are similar agents within paragraph [0011] within Kleidon et al. the Examiner is relying on the this overlapping concentration.).
and the first mixture optionally includes one or more of beta pinene, alpha pinene, alpha bisabolol, valencene, terpinolene, trans ocimene, or delta 3 carene.
Furthermore, Elzinga et al. disclose the use of beta pinene, alpha pinene, alpha bisabolol, valencene, terpinolene, trans ocimene, and/or delta 3 carene (see paragraphs [0010] and [0012] within Elzinga et al.).
[The remainder of the instant claims that are either directly or indirectly dependent on instant claim 1 are taught in full by the combination of Elzinga et al., Geiling et al., and Kleidon et al.]
Regarding instant claims 2 and 3, Elzinga et al., Geiling et al., and Kleidon et al. teach wherein the first mixture is present in the composition in a concentration of about 10 to 15 mg/mL or 13.3 g/mL. Elzinga et al. does not disclose wherein the first mixture is present in the composition in a concentration of about 10 to 15 mg/ml or 13.3 mg/ml. Elzinga et al. disclose concentrations of specific agents [claim 15 (The prepared blend of terpenes of claim 6, wherein beta-caryophyllene is present at about 1 0-30 wt%; limonene is present at about 5-45 wt%; and myrcene is present at about 5-30 wt% …)]. It would have been obvious to one skilled in the art to optimize the concentrations using routine experimentation.
Regarding instant claim 10, Elzinga et al., Geiling et al., and Kleidon et al. teach wherein the desired terpenes are obtained in a mixture. Elzinga et al. disclose support for the terpene mixture (see paragraphs [0010] and [0012-0015]; both within Elzinga et al.). Also, please see the discussion and citations within instant claim 1.
Regarding instant claim 11, Elzinga et al., Geiling et al., and Kleidon et al. teach further comprising one or more of L-theanine, caffeine, quercetin, green tea extract, vitamin B12 or vitamin D. Geiling et al. disclose the use of one or more vitamins such as vitamin B12 and vitamin D (see paragraph [0080] within Geiling et al.).
Regarding instant claim 13, Elzinga et al., Geiling et al., and Kleidon et al. teach further comprising one or more of curcumin, cocoa, dark chocolate, galangal, ashwagandha, an adaptogen, or maca root. Geiling et al. disclose the use of one or more additives such as curcumin (see claim 6 within Geiling et al.) or cocoa (see paragraphs [0120-0121] within Geiling et al.).
Regarding instant claim 15, Elzinga et al., Geiling et al., and Kleidon et al. teach wherein the first mixture is encapsulated within a vesicle. Geiling et al. disclose the use encapsulation of lipophilic substances in a hydrophilic matrix (see paragraphs [0072-0073] within Geiling et al.).
Regarding instant claim 16, Elzinga et al., Geiling et al., and Kleidon et al. teach further comprising one or more of vitamin A, vitamin B6, vitamin C, vitamin D, vitamin E, vitamin K, thiamin, riboflavin, niacin, pantothenic acid, pyridoxal, cobalamin, biotin, folate, folic acid, and other elements and minerals. Geiling et al. disclose the use the use of one or more vitamins such as vitamins A, B6, C, D, E, and K (see paragraph [0080] within Geiling et al.).
Regarding instant claim 18, Elzinga et al., Geiling et al., and Kleidon et al. teach further comprising vitamin C, vitamin E, selenium, carotene, lycopene, lutein, zeaxanthin, or a combination thereof. Please see the discussion and citations within instant claims 16 and 17 for the necessary rejection text.
Regarding instant claim 20, Elzinga et al., Geiling et al., and Kleidon et al.teach wherein the composition is further comprising quercetin (see paragraph [0153] within Geiling et al.).
Regarding instant claim 21, Elzinga et al., Geiling et al., and Kleidon et al. teach wherein the composition further includes selenium, a flavonoid, and an antioxidant (see paragraphs [0080], [0104], and [0081] respectively within Geiling et al.).
Regarding instant claim 23, Elzinga et al., Geiling et al., and Kleidon et al. teach a nutritive ingestible food or beverage or food or beverage additive, comprising the composition of claim 1. Geiling et al. disclose a beverage which can comprise the above vitamins, minerals, flavonoids, antioxidants, and other additives (see paragraph [0392] within Geiling et al.; and the above instant claims). Also, please see the discussion and citations within instant claim 1.
Regarding instant claim 24, Elzinga et al., Geiling et al., and Kleidon et al. teach a non-nutritive ingestible food or beverage or food or beverage additive, comprising the composition of claim 1. By not adding any of the additional components (see instant claim 23) a non-nutritive beverage can be formulated within Geiling et al. (Geiling et al. uses cannabis products for their beverage). Please see the discussion and citations within instant claim 23.
Regarding instant claims 25 and 26, Elzinga et al., Geiling et al., and Kleidon et al. teach said particles including the composition of claim 1, encapsulated within a vesicle. Please see the discussion and citations within instant claims 15, 23, and 24 for the necessary rejection text.
Regarding instant claim 27, Elzinga et al., Geiling et al., and Kleidon et al. teach an emulsion, comprising: 1) about 2 wt % CBD oil or the composition of claim 1, about 2 wt % polysorbate 80, about 1 wt % lecithin, and about 95 wt % water; or 2) about 5 wt % CBD oil or the composition of claim 1, about 3.3 wt % polysorbate 80, about 1.7 wt % lecithin, and about 90 wt % water. Please see the discussion and citations within instant claim 1. Geiling et al. disclose the use of CBD oil (see paragraph [0262] within Geiling et al.), a surfactant (see paragraph [0076] within Geiling et al.), an emulsifier (see paragraphs [0079] and [0081] within Geiling et al.), lecithin (see paragraph [0066] within Geiling et al.), and water in stable emulsions (see paragraphs [0072-0073] within Geiling et al.). Although, Geiling et al. does not disclose a specific formulation example, a skilled artisan (POSITA; person having ordinary skill in the art) would use a common surfactant or emulsifier, like polysorbate 80. Routine experimentation and optimization would produce a beverage using the claim limitations of instant claim 27.
Regarding instant claim 29, Elzinga et al., Geiling et al., and Kleidon et al. teach a kit, comprising the composition of claim 1, and instructions for use thereof. Please see the discussion and citations within instant claims 1, 23, and 24. It would be obvious based on the teachings of Elzinga et al., Geiling et al., and Kleidon et al. to construct a kit-of-parts with instructions to afford a nutritive or non-nutritive beverage containing terpenes.
Regarding instant claim 30, Elzinga et al., Geiling et al., and Kleidon et al. teach a method comprising ingesting the composition of claim 1. Please see the discussion and citations within instant claims 1, 23, and 24. Formulation of a beverage would be for the purpose of ingestion of a nutritive or non-nutritive beverage containing terpenes.
Combination of Elzinga et al., Geiling et al., Kleidon et al., and Piorkowski
Regarding instant claim 67, Elzinga et al., Geiling et al., Kleidon et al., and Piorkowski teach wherein the composition is encapsulated within a vesicle having a droplet diameter of about 170 nm to about 300 nm. Piorkowski discloses a droplet size of greater than 100 nm (see paragraph [0030] within Piorkowski). Emulsions consisting of oil droplets within an aqueous phase would be within the range of 170 nm to 300 nm based on the number of organic materials required by the beverage.
Therefore, a skilled artisan would generate emulsions having oil droplet diameters within 170 nm to 300 nm based on the Piorkowski disclosure.
Regarding instant claim 68, Elzinga et al., Geiling et al., Kleidon et al., and Piorkowski teach a composition, comprising: a first mixture including beta caryophyllene, myrcene, limonene, alpha humulene, linalool, alpha terpineol and xanthohumol; and wherein the composition is encapsulated within a vesicle having a droplet diameter of about 170 nm to about 300 nm. Please see the citations and discussion with instant claims 1 and 67 for the necessary rejection text.
In the context of instant method claim 30, the desired purpose defines an effect that arises from, and is implicit in the method step(s). Thus, where the purpose is limited to stating a technical effect that inevitably occurs during the performance of the claimed method step(s), and is therefore inherent in that/those step(s), that technical effect is not limiting to the subject-matter of the claim. Thus, the present method claim, defining the application/use of the composition according to the prior art and defining its purpose as "use", is anticipated by any document of the state of the art describing a method of application/use although not mentioning this specific use.
Analogous Art
The Elzinga et al., Geiling et al., Kleidon et al., and Piorkowski disclosures are all relevant for the rejection of instant claims 1-3, 10-11, 13, 15-16, 18, 20-21, 23-27, 29-30 and 67-68 due to their direct application to the present invention.
Obviousness
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the terpene composition disclosed by Elzinga et al., using the teachings of Geiling et al., Kleidon et al., and Piorkowski to incorporate the necessary claim limitations. A skilled artisan (POSITA) would be motivated to combine the primary and secondary references due to the fact that all of the references are within the terpene beverage arts.
Starting with Elzinga et al., the skilled person only had to try the addition of the necessary claim limitations disclosed by Geiling et al., Kleidon et al., and Piorkowski. The combination of Elzinga et al., Geiling et al., Kleidon et al., and Piorkowski would allow one to arrive at the present application without employing inventive skill. This combination of the terpene composition taught by Elzinga et al. along with the use of the necessary claim limitations taught by Geiling et al., Kleidon et al., and Piorkowski would allow a research and development scientist (POSITA) to develop the invention taught in the instant application. It would have only required routine experimentation to modify the terpene composition disclosed by Elzinga et al. with the use of the claim limitations taught by Geiling et al., Kleidon et al., and Piorkowski. This combined modification would have led to an enhanced terpene composition that would be beneficial for patients and consumers.
Response to Arguments
Applicant's arguments filed September 11, 2025 have been fully considered but they are not persuasive.
The Applicant’s claim amendments were sufficient to address the 35 U.S.C. 112(b) rejection and claim objection. Therefore, the 35 U.S.C. 112(b) rejection and claim objection from the Non-Final office action dated March 11, 2025 is withdrawn.
The Applicant’s claim amendments did necessitate a new ground of rejection.
Applicant Argument: The Applicant argues that the addition of xanthohumol into instant claim 1 is not taught by Elzinga et al. or Geiling et al.
Examiner’s Rebuttal: The argument is now moot. The Examiner has added the Kleidon et al. reference to the record. This reference addresses the xanthohumol amendment to instant claim 1.
Applicant Argument: The Applicant argues that the addition of new instant claims 67 and 68 are not taught by Elzinga et al. or Geiling et al.
Examiner’s Rebuttal: The argument is now moot. The Examiner has added the Kleidon et al. and Piorkowski references to the record. These references address all of the instant claim limitations of both new claims.
Applicant Argument: The Applicant argues that the Examiner has not established a prima facie case of obviousness.
Examiner’s Rebuttal: The Examiner respectfully disagrees. All of the references are within the terpene beverage arts. These analogous art references (Elzinga et al., Geiling et al., Kleidon et al., and Piorkowski) would be consulted by a skilled artisan (POSITA). Routine experimentation would afford the present invention.
Thus, the Examiner has established a strong 35 U.S.C. § 103 rejection.
Therefore, the 35 U.S.C. § 103 rejection is maintained for instant claims 1-3, 10-11, 13, 15-16, 18, 20-21, 23-27, 29-30 and 67-68.
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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/JOHN W LIPPERT III/Examiner, Art Unit 1615 /Robert A Wax/Supervisory Patent Examiner, Art Unit 1615