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
Filing Receipt and Priority
The filing receipt mailed 02/23/2024 states that the instant application is a 371 of PCT/US2021/036685, filed 06/09/2021 which claims benefit of provisional application 63/036,842, filed 06/09/2020.
Information Disclosure Statement
The information disclosure statement submitted 03/02/2023 has been considered.
Species Election
Applicant’s election of the following species has been acknowledged. The species elected are i) CBGA and CBDA, ii) coconut oil. Applicant has elected not to include an emulsifier.
Claims 4-9, 10-11, 15, and 17 have been withdrawn being drawn to non-elected species and formulations. Claim 18 remains withdrawn being drawn to a non-elected invention.
Drawings
Figures 1-3 have text that is difficult to interpret. Higher fidelity images are requested.
Rejections
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Written Description
Claims 1-3, 7, 12-14 and 16 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 states “A formulation comprising a combination of at least two active substances extracted from Cannabis and a carrier oil, wherein the formulation is effective in controlling head lice by disruption of at least one phase of a louse life cycle, wherein the two active substances have a synergistic effect on lice control”.
“Synergistic” is defined on p. 7, para. [0042] of the instant specification. The specification states “The use of the terms “synergistic” and “synergistically effective” are used in the present invention to mean a biological effect that is greater than the sum of the biological effects produced by the application of the individual agents.”
Discussion of combinations of ingredients are found within the Figures and starting in para. [0044]. However, this discussion amounts to simple disclosure. Para. [0044] states “Figures 1-3 provide tables of pairwise combinations of synergistic ingredients of the invention wherein the ingredients [sentence ends]. Figure 1 provides combinations wherein the synergistic ingredients are cannabinoids, flavonoids, or a cannabinoid and a flavonoid. Figure 2 provides combinations wherein the synergistic ingredients are terpenes. Figure 3 provides combinations wherein the synergistic ingredients are a terpene and a cannabinoid or a terpene and a flavonoid. For examples in some embodiments, the synergistic ingredients are CBGA and linalool (Formula 2525).”
Para. [0045]-[0048] continue with discussion of ratios of the combinations and contemplates additional ingredients.
Para. [0064]-[0071] compositions comprising a number of components that show efficacy in treating head lice. However, no data or information has been provided that indicates that these amounts are synergistic.
Nowhere in the drawings is there a comparison to a control formulation. Similarly, the instant specification does not show evidence of a synergistic effect. The specification simply states that the combinations have a synergistic effect without a comparison to a control formulation or even a medical composition used to treat head lice. One of ordinary skill in the art would recognize that applicant has formulations comprising the various components discussed, but one of ordinary skill could not objectively state that the formulations have a synergistic effect with what has been disclosed.
Essentially, claim 1 is drawn to a formulation that has a synergistic effect but a synergistic effect has not been shown.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-3, 7, 12-14 and 16 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 states “wherein the two active substances have a synergistic effect on lice control.”
“Synergistic” is defined on p. 7, para. [0042] of the instant specification. The specification states “The use of the terms “synergistic” and “synergistically effective” are used in the present invention to mean a biological effect that is greater than the sum of the biological effects produced by the application of the individual agents.”
As discussed in the written description rejection above, no data or information has been provided that indicates which specific amounts of the ingredients discussed are synergistic. Ratios of the combinations are contemplated in para. [0045]-[0048] and combinations are shown in the figures (Fig. 1-3). No doses or concentrations are discussed in these sections. As no amounts, doses, concentrations are discussed, one of ordinary skill in the art would not know the metes and bounds of claim 1.
As claims 2-3, 7, 12-14 and 16 are dependent on claim 1, they are also rejected.
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.
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.
KSR Rationales
The MPEP in section 2143, subsection I gives examples of Rationales for supporting a conclusion of obvious. These rationales are non-exhaustive and include (A) Combining prior art elements according to known methods to yield predictable results; (B) Simple substitution of one known element for another to obtain predictable results; (C) Use of known technique to improve similar devices (methods, or products) in the same way; (D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results; (E) “Obvious to try” – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success; (F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art; (G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
Claim(s) 1-3, 7, 12-14 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over King (Current Opinion in Food Science, 2019, 28:32-40) in view of Nahler (J. Altern. Complement Integr Med, 2019, 5:066) and Nordahl (US 10,597,348).
Claim 1 is drawn to a formulation comprising a combination of CBGA and CBDA (elected species) and a carrier oil (coconut oil) and further specifies that the formulation is effective in controlling head lice. The claim limitation “effective in controlling head lice” is a property of the formulation meaning any composition comprising the two active substances would also have the same property. See the written description above for discuss on the “synergistic effect” limitation.
Claim 2 species that at least one of the active substances is a cannabinoid.
Claim 3 is drawn to specific active substances (CBGA and CBDA included).
Claim 7 further comprises nerolidol, limonene, and alpha-pinene.
Claim 12 specifies coconut oil as the carrier oil.
Claim 13 specifies that the formulation has 3 active substances.
Claim 14 specifies that all active ingredients are cannabinoids.
Claim 16 is drawn to formulations which can be any of the following:
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King discuss components found in cannabis and hemp. King on p. 35, right col., full para. 1 states “The first column in Figure 3 list the target solutes (select cannabinoids and terpenes) found in cannabis or hemp…”. Figure 3, shown below, lists CBDA, pinene, and limonene as constituents of cannabis or hemp flower.
King, Figure 3
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King on p. 37, Figure 4, below, shows constituent compounds found in raw cannabis or hemp flower.
King, Figure 4
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Nahler on p. 8, right col. full para. 5 states “NF-κB is inhibited, directly or indirectly via agonists of PPARg such as CBD, CBC, CBG, THCA, THC…,endogenous compounds such as AEA, 2-AG, PEA< AA, as well as by a number of terpenes that occur in hemp such as a/β-amyrin, β-caryophyllene, a-pinene, borneal, eugenol, a-humulene, D-limonene, β-myrcene, nerolidol,…”.
The combination of King and Nahler teaches that CBGA, CBDA, nerolidol, limonene, and alpha-pinene are all compounds from extraction of raw cannabis or hemp flower. Neither King or Nahler discuss coconut oil. This is addressed by Nordahl.
Nordahl is drawn to methods of infusing raw cannabinoids into food oil (title). Nordahl in Figures 1-10 shows methods of extracting cannabinoids from raw flower and infusing said cannabinoids into food oil. Nordahl in col. 11-12 discusses methods of extracting cannabis material while preventing decarboxylation (col. 11, l.15-16) into food oil, including coconut oil (col. 11, l. 12-14)
King and Nahler teach the constituents of raw cannabis flower and hemp flower. These constituents include CBGA, CBDA, nerolidol, limonene, and alpha-pinene. Nordahl teaches a method of making a cannabis and terpene infused oil (formulation) from raw cannabis or hemp flower in a way that prevents decarboxylation. Preventing decarboxylation allows the formulation to retain the acidic forms of CBD and CBG which are CBDA and CBGA. As King and Nahler teach that nerolidol, limonene, and alpha-pinene are constituents of the flower, one of ordinary skill would know that the method in Nordahl would also extract nerolidol, limonene, and alpha-pinene.
Therefore, it would have been prima facie obvious at the time of the effective filing date for one of ordinary skill in the art to have applied the method of Nordahl to cannabis or hemp flower which comprise the CBGA, CBDA, nerolidol, limonene, and alpha-pinene as taught by King and Nahler. One of ordinary skill would be motivated to use the method in Nordahl on cannabis and/or hemp flower as the method was designed specifically for cannabis and hemp flower.
Examiner’s Comments
Formulations comprising full spectrum Hemp are well known and are easily found for sale. An example from Nature’s Alternative (Nature’s Alternative, Hemp King 1000mg Full Spectrum Topical Salve 100 mL, url= https://naturesalternative-cbd.com/product/1-cbd-salve-ointment-100-ml/, accessed 2/13/2026) is provided. No original sale date is included as companies selling these formulations do not report a “first date of sale”.
Conclusion
No claims allowed.
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/L.G./Examiner, Art Unit 1624
/SUSANNA MOORE/Primary Examiner, Art Unit 1624