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
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 18 Feb 2026 has been entered.
Response to Amendment
Status of the Claims
Receipt of Applicant’s response, filed 18 Feb 2026 has been entered.
Claims 13-32 remain pending in the application.
Claim 25 is amended.
Claims 31 and 32 are new.
Claims 1-12 are cancelled.
Claims 13-24 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Claims 25-32 are under consideration to the extent of the elected species, i.e., that the neurological disorder is chronic pain.
Rejections Withdrawn
Rejections Pursuant to 35 USC § 112
The rejections pursuant to 35 U.S.C. 112(a) set forth in the Final Office Action mailed 27 May 2025 are hereby withdrawn in light of applicants amendment of the claims.
Rejections Maintained – in modified form
Claim Rejections - 35 USC § 112
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 25-32 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.
Claims 25 and 31 contains the trademark/trade name TWEEN and SPAN. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe two different classes of surfactants and, accordingly, the identification/description is indefinite.
Claims 26-30 and 32 are included in this rejection as they depend directly, indirectly, or include all the limitations of independent claims 25 and 31.
Response to Arguments
Applicant's arguments filed 18 Feb 2026 have been fully considered but they are not persuasive. Applicant has argued that the tween and span surfactants are now identified as either polysorbate 80, 60, or 20 and either sorbitan monooleate, sorbitan monooctadecanoate, and sorbitan laurate. The examiner acknowledges the addition to the claims but maintains that the use of the trademarks names renders the claims indefinite. For instance, it is not clear if the trademark names are intended to require that the polysorbate and sorbitan compounds are derived from a specific source or supplier. The applicant has narrowed the extent of tween and span surfactants to select polysorbate and span compounds but referring to the compounds through use of the trademarks maintains the claims as indefinite.
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.
The rejection below was made previously and has been modified to address the new claims and amendments. Claims 31 and 32 have the total amount of carrier oil and CBD encompassing 0%. As the CBD and carrier oil are required components of the claims, it is thus understood that the CBD and carrier oil must be present in an amount over 0%.
Claims 25-32 are rejected under 35 U.S.C. 103 as being unpatentable over Berl et al. (US 2020/0138772, published 07 May 2020, filed 09 Jul 2018, listed on IDS filed 10 Jan 2022) as evidenced by the instant specification.
Berl teaches aqueous formulations comprising a stabilized, aqueous, purified cannabis oil emulsion (abstract, [0026], [0027]). Berl teaches that CBD exerts its effect by interacting with G protein coupled cannabinoid receptors CB1 and CB2 and that CB1 receptors have been identified to play a significant role in pain perception ([0004]). Berl teaches therapeutic methods of using the emulsion and formulations of the present application may be used effectively to treat, reduce or mitigate a variety of diseases selected from the group consisting of neurological disorders and neurological diseases such as chronic pain ([0227], [0241]). Berl teaches that the method of treating involves administering to the subject in need thereof a therapeutically effective amount of the stabilized, aqueous and purified cannabis oil emulsion ([0241]). Berl teaches the inclusion of at least one emulsifier ([0027]) (also referred to as a solubilizing agent or a surfactant ([0056])). Berl teaches a variety of exemplary emulsifiers including polysorbate 20, 60, and 80 as well as sorbitan monooleate and sorbitan monolaurate ([0084], [0088]). Berl teaches mixtures of emulsifiers such as a mixture of 2 different emulsifiers ([0233]). Berl teaches that the emulsifiers promote the formation and stabilization of an emulsion and can be described by their hydrophile-lipophile balance (HLB) value ([0054]). Berl teaches that emulsifiers with HLB values 10 or greater are hydrophilic emulsifiers while emulsifiers with HLB values less than 10 are hydrophobic emulsifiers which provides a guide for formulating compositions based on relative hydrophobicity/hydrophilicity and that a co-emulsifier is an emulsifier that acts with another emulsifier to enhance its properties and further reduce the surface tension of a liquid and thereby stabilizing the emulsion ([0054]). Berl teaches various example compositions utilizing multiple emulsifiers such as Example 6 ([0152]) which comprises 2.5 g of polysorbate 80 and 0.9 g sorbitan palmitate which would be a ratio of polysorbate 80 to sorbitan palmitate of 2.8 and example 8 ([0154]) which comprises 1.0g polysorbate 80 and 0.3 g sorbitan monostearate which is a ratio of polysorbate80 to sorbitan monostearate of 3.33:1 and other examples with different combinations of emulsifiers in varying ratios (e.g. Examples 1, 2, 5 [0146], [0147], [0151]). Berl teaches that the emulsifier to the CBD/THC is between 11.0:1.0 to 1.0:1.0 ([0237]) and teaches various examples where the emulsifier to CBD oil ratio is varied (Examples 1-10 [0146]-[0157]) indicating variable amounts of the emulsifier relative to the CBD/THC may be present. Regarding the carrier oil of claims 31 and 32, Berl teaches that vegetable oils are used to aid the solubility of cannabis oil into the oil phase of emulsions and teaches various oils such as sunflower oil and olive oil ([0099]). Berl provides examples where the vegetable oil percentage is varied (e.g. sunflower oil 3.33% example 2 [0147], canola oil 4.27% example 22 [0174], corn oil 4.17% example 24 [0176]). Example 2 of Berl has 3.33% sunflower oil and 3.38% pure CBD which is a total of 6.71% and renders obvious the 0-19% and 0-9% of carrier oil and CBD of claims 31 and 32.
Regarding the administration parameters of claims 26-30, Berl teaches dosage unit forms will generally contain between from about 1 mg to about 500 mg of the CBD/THC mixture such as 1 mg to 250 mg, 1 mg to 100 mg or 1 mg to about 80, 60, 40, 20 or 10 mg are useful ([0130]). Berl teaches that the frequency of dosage may vary depending on the compound used and the particular disease treated and that for most disorders a dosage regiment of 4 times daily or less may be used ([0130]). Thus, Berl renders obvious two dosages a day of 50 mg CBD as recited in claims 26-30. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).
Berl does not expressly teach selecting the cannabis oil emulsion comprising CBD, a polysorbate surfactant and a sorbitan surfactant in a 2.3:1 weight ratio or a carrier oil and CBD combination from 0-19% or total surfactant to carrier/CBD from 2.0-2.2:1 or the dosage regimen of CBD discussed above with sufficient specificity to rise to the level of anticipation.
However, 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 have administered a formulation comprising a stabilized, aqueous, purified cannabis oil emulsion with CBD and a vegetable oil such as sunflower or olive oil and emulsifiers such as polysorbate 20, 60, or 80 and sorbitan monooleate or sorbitan monolaurate in a method for treating chronic pain, where the CBD is in a dosage of 1 mg to 250 mg, 1 mg to 100 mg or 1 mg to about 80, 60, 40, 20 or 10 mg in a regiment of 4 times daily or less. One of ordinary skill in the art would have been motivated to do so as aqueous, stable and purified cannabis oil emulsions with a mixture of emulsifiers are taught by Berl as suitable in a method for treating chronic pain, and Berl teaches the dosing regiment described above as suitable for the compositions. One of ordinary skill in the art would have had a reasonable expectation of successfully treating chronic pain with a cannabis oil emulsion where the CBD is in a dosage of 1 mg to 250 mg, 1 mg to 100 mg or 1 mg to about 80, 60, 40, 20 or 10 mg in a regiment of 4 times daily or less as taught by Berl since the modification of the prior art represents nothing more than the predictable use of prior art elements according to their established functions.
Regarding the limitation that the “weight ratio of the Tween surfactant to the Span surfactant is 2.3:1 or the molar ratio of the Tween surfactant to the Span surfactant is 1:1.3,” in view of the teachings of Berl that the emulsions may contain a mixture of emulsifiers and that a co-emulsifier is an emulsifier that acts with another emulsifier to enhance its properties and further reduce the surface tension of a liquid and thereby stabilizing the emulsion and the wide range of emulsion concentration that may be present (Berl teaches the emulsifier to the CBD/THC is between 11.0:1.0 to 1.0:1.0), the amount of the emulsifier present in the composition is an art-recognized result effective variable such that determining that the Tween surfactant is in a weight ratio of 2.3:1 or a molar ratio of 1:1.3 to the Span surfactant would be a matter of optimization through routine experimentation. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Mixtures of emulsifiers such as polysorbate 20, 60, or 80 and sorbitan monooleate or sorbitan monolaurate are obvious from the examples and various teachings of Berl as described supra. It is known that different emulsifiers have different HLB values and that emulsifiers can be mixed together to enhance the emulsifying properties and improve the stabilization of the emulsion and the HLB values help provide a guide in formulating. Further, the range taught for the emulsifier to CBD/THC (11.0:1.0 to 1.0:1.0) further indicates that that the amount of emulsifier in the composition is a known variable. Thus, it would have been obvious to one of ordinary skill to use a mixture of emulsifiers such as polysorbate 20, 60, or 80 and sorbitan monooleate or sorbitan monolaurate and to optimize the ratio of each of the emulsifiers to best improve the emulsification properties and overall stability of the emulsion. Similarly the limitation of claim 31 that the “total amount of the Tween surfactant and the Span surfactant to a total amount of the carrier oil and CBD is 2.0-2.2:1” is obvious as a matter of routine experimentation. As described above, Berl teaches a range of emulsifier to CBD/THC (11.0:1.0 to 1.0:1.0) and teaches varying amounts of vegetable oils which are used to aid the solubility of cannabis oil into the oil phase of emulsions. Based on these teachings, it would have been obvious to one of ordinary skill in the art to vary the combination of emulsifiers relative to the CBD and vegetable oil (such as sunflower and olive oil) in order to achieve optimal solubility of the CBD and stability of the emulsion solution.
Accordingly, the instant claims are rendered prima facie obvious over the teachings of Berl.
Response to Arguments
Applicant's arguments filed 18 Feb 2026 have been fully considered but they are not persuasive. Applicant has argued for unexpected results regarding the ratio of tween and span surfactant (page 3 of remarks). Applicant addresses the examiners comments regarding the results not being persuasive. Applicant argues that the claims have been amended to specify polysorbate 80, 60, and 20 as the tween surfactant and sorbitan monoleate, sorbitan monooctadecanoate and sorbitan laurate as the span surfactant and that the claims are now commensurate in scope (page 4 of remarks). Applicant points to paragraph [0079] of the specification which says that ratios of 0:5 through 5:0 tween:span were tested and “concentrations much outside of this narrow range led to turbid or opaque solutions” as the data supporting the unexpected results (page 4 of remarks). Applicant argues that a skilled artisan would not have been motivated to adjust the amount of emulsifier through routine experimentation as Berl teaches stable, substantially clear formulations of CBD and THC and thus does not require modification (page 4 of remarks). Applicant argues that Berl only teaches one CBD emulsion with polysorbate 80 and sorbitan monoleate at a weight ratio of about 6.7:2 which is significantly different from the ratio of 2.3:1 as claimed (page 5 of remarks). Applicant further argues that the ratio of 2.3:1 was obtained from undue experimentation because different tweens, different spans and a wide range ratio of 0:5 to 5:0 was tested (page 5 of remarks). Regarding the limitation of claims 31 and 32 that the total Tween/span to the total oil/CBD is between 2.0-2.2:1, the applicant argues that the ratio was obtained from undue experimentation and points to examples 4-6 of the specification to indicate that the ratio results in unexpected stability as concentrations lower that 2.0-2.2:1 were found to be less stable with phase separation and higher concentrations led to cloudy or opaque solutions and testing was done from 0.25-5.1 (pages 5-6 of remarks).
The examiner notes that the case for obviousness may be sufficiently strong to outweigh the unexpected results such that the case for obviousness may be maintained (see MPEP 716.01(d)) and these arguments are not persuasive for overcoming the prima facie case of obviousness presented. Examples 1-6 of the specification are broad in merely stating that tween 80, 60, and 20 and span 80, 60 and 20 were examined and does not provide any clear data or even describe the formulations so that one can analyze the assertion of unexpected results. For instance, examples 3 and 4 state the following:
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It is not clear from this what specific combination of tween or span surfactants or carrier oils were used and in what amounts and other than the broad verbal description that the claimed ratios are “optimal,” there is no data presented that allows for an actual analysis. It can not be determined if the claimed ratios actually provide significantly different and unexpected results or if this is merely an example of optimization. The applicant has not shown the results are “unexpected” to an unobvious extent, and that the results are of a significant, practical advantage (see MPEP 716.02, 716.02(a) and 716.02(b)). The examiner notes that the evidence relied upon for unexpected results should establish "that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance." Ex parte Gelles, 22 USPQ2d 1318, 1319 (Bd. Pat. App. & Inter. 1992). Further, the results should demonstrate a difference in kind, rather than degree. See In re Huang, 100 F.3d 135, 139 (Fed.Cir.1996) (holding that claimed ranges must “produce a new and unexpected result which is different in kind and not merely in degree from results of the prior art”). The Court explained that a “32—43% increase in stress-rupture life, however, does not represent a ‘difference in kind’ that is required to show unexpected results.” Harris, 409 F.3d at 1344. Berl teaches the formulations as essentially clear (e.g. free of visible precipitation, cloudiness or haziness) ([0096]) and stable ([0027], [0036]) and even provides a means if a solution appears opaque cloudy or inhomogeneous for treating the solution so that it provides a “clear, homogenous solution” ([0199]). Thus, Berl teaches similar benefits and goals as the applicant of stable clear solutions and it is thus obvious to construct the formulations to reach solutions that are stable and clear. The applicant has not provided a comparison with the closest prior art (e.g. Berl) to help establish a true unexpected result (MPEP 716.02(e)). The applicant argues that one would not be motivated to modify Berl, but the modifications needed to reach the claimed invention are obvious from the teachings of Berl. The rejection was made under 35 U.S.C. 103 which requires that “a patent for a claimed invention may not be obtained… if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been prima facie 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.” “A person of ordinary skill in the art is also a person of ordinary creativity, not an automaton.” KSR, 550 U.S. at ___, 82 USPQ2d at 1397. “[I]n many cases a person of ordinary skill will be able to fit the teachings of multiple patents together like pieces of a puzzle.” Id. Office personnel may also take into account “the inferences and creative steps that a person of ordinary skill in the art would employ.” Id. At, 82 USPQ2d at 1396. While Berl may not provide a specific embodiment of the instantly claimed invention, this is not a requirement for the rejection and the examiner maintains that the invention as claimed is nonetheless made obvious over Berl for the reasons described.
Regarding the argument that the claimed ratios were obtained from undue experimentation as different tween and spans were tested and different CBD and carrier oils were tested in different amounts, the examiner is not persuaded as the applicant has not demonstrated or described anything outside of routine optimization. The fact that experimentation may be complex does not necessarily make it undue, if the art typically engages in such experimentation. Berl teaches each of the components of the claims, namely the CBD, surfactants, and oil components, and teaches that that these components may vary in the compositions and motivates finding clear and stable compositions. Adjusting the ratios to reach an optimal clarity for a set of components is not understood to be undue experimentation but instead the normal process that one of ordinary skill would engage in when combining the components to form the composition.
Conclusion
No claim is allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EDWIN C MITCHELL whose telephone number is (571)272-7007. The examiner can normally be reached Mon-Fri 8:00-5:00.
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/EDWIN COLEMAN MITCHELL/Examiner, Art Unit 1619
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