DETAILED ACTION
Applicant’s arguments, filed 22 December 2025, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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.
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 .
Claim Rejections - 35 USC § 103 (maintained)
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.
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 1-3, 9-13, 16 and 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Ross et al. (WO 2018/089863 A1, 05/17/2018) (hereinafter Ross).
Ross discloses a formulation comprising cannabinoid extracts (CBD) embedded in a matrix comprising hydrophilic polymers, including ethylcellulose, for oral administration in a dosage form such as a lozenge ([0015]), which may be removed by the user ([0050]). The hydrophilic polymers may comprising ethylcellulose and adhesive polymers including polyethylene glycol ([0036]). The dosage form may typically comprise approx. 25-49.5 wt. % each of cannabinoids and hydrophilic polymers, and optional additives, e.g., added beneficial agents, and excipients typically represent about 1-50 wt. % of the formulation ([0037]); exemplary additives includes mineral oils and vegetable oils ([0046]). The ethylcellulose should have a solution viscosity of about 1-120 cP (or mPa·s), examples include Ethocel® 4 (approx. 3-5.5 cP), Ethocel® 7 (approx. 6-8 cP), Ethocel® 10 (approx. 9-11 cP), Ethocel® 20 (approx. 18-22 cP), and Ethocel® 45 (approx. 41-49 cP), with all solution viscosities determined using an Ubbelohde viscometer and a solvent mixture of 80% toluene and 20% alcohol ([0041]). Varying the molecular weight or viscosity of the hydrophilic polymer can impart certain properties to the dosage form, such as release rate and time to disintegration in the mouth, as well as adjust the tackiness and hardness of the dosage form ([0039]). The cannabinoid extracts comprise cannabinoid (CBD) and a lipophilic solvent or suspension carrier, including medium chain triglycerides and polyethylene glycols ([0027]-[0028]).
Accordingly, Ross discloses a formulation comprising ethylcellulose, CBD as the first non-volatile oil which is an active ingredient, and mineral oil as the second oil. The prior art is not anticipatory insofar as this combination must be selected from various lists/locations in the reference. It would have been obvious, however, to make the combination since all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. See MPEP § 2143 (I)(A).
Regarding the claim reciting an oleogel composition, as noted by p.4, lines 8-11 of the instant Specification, “oleogel” refers to a mixture that contains one or more oils and one or more ethylcellulose polymers forming a network throughout the oil continuous phase, being solid at 25°C. Thus the formulation of Ross, comprising a mixture of oils such as medium chain triglycerides and mineral oil, and ethylcellulose matrix, meets the limitation of an oleogel as instantly claimed.
Regarding claims 1 and 19 reciting amounts of ethylcellulose, although Ross does not explicitly disclose an amount of ethylcellulose, it would have been obvious to one of ordinary skill in the art to have selected an amount of ethyl cellulose and an amount of polyethylene glycol, such that the total amount is within the disclosed range of about 25-49.5 wt.%. The claimed ranges of ethylcellulose (i.e. 12-20% or 12-17% by weight, respectively) would have been obvious to one of ordinary skill in the art from selecting from this range. Moreover, in any case, the selection of appropriate weight percentages would appear to require no more than routine testing on the part of the skilled artisan, and so alternatively it would have been obvious to determine workable ranges to arrive at the claimed amounts. "[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." See MPEP § 2144.05(II)(A).
Regarding claim 10 reciting amounts of CBND (cannabinoid) oil, the claimed ranges (i.e. 51-85% by total weight) would have been obvious to one of ordinary skill in the art since they are close to the ranges of the prior art (i.e. about 25-49.5 wt. %). Generally, a prima facie case of obviousness exists where the claimed ranges or amounts overlaps with the range of the prior art, or alternatively, do not overlap with the prior art but are merely close. See MPEP § 2144.05(I).
Regarding claim 11 reciting a ratio of the CBND oil to the second oil, as discussed above, Ross discloses wherein amount of additives may be about 1-50 wt. % of the composition. Accordingly, it would have been obvious to one of ordinary skill in the art to have selected an amount of additive (e.g. mineral oil) and an amount of CBD from the disclosed ranges. Such amounts selected would have equated to a ratio that overlaps with the claimed ratio (i.e. 65:35 to 50:50) thus making the claimed range obvious. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP § 2144.05(I).
Regarding claims 12-13, as discussed above, Ross discloses wherein the composition comprises polyethylene glycol (i.e. claimed plasticizer).
Regarding claim 18, Ross further discloses wherein the mixture of the components may be compressed in a mold ([0053]).
Response to Arguments
Applicant mainly asserts Ross fails to provide the ethylcellulose polymer percentages recited in the currently amended claims. Applicant has demonstrated that a 40:60 ratio of simethicone:sunflower oil with EC20 ethylcellulose present at 17% forms a solid stable gel. See Specification at Table 2. However, the same ratio of simethicone:sunflower oil with EC20 ethylcellulose present at 9% resulted in a "flowable gel formed, phase separation."
The Examiner does not find the Applicant’s assertion to be persuasive. A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments. See MPEP 2123(I). Ross discloses wherein the matrix comprises hydrophilic polymers including ethylcellulose and additional polymers. Therefore Ross teaches or at least suggests selecting an amount of ethylcellulose and an amount of additional polymers, such that the total amounts is within the disclosed range of about 25-49.5 wt.%. As such, Ross does not limit the amount of ethylcellulose specifically to the disclosed range of hydrophilic polymers and Applicant’s assertion is unpersuasive.
Regarding allegations of unexpected results, Applicant has the burden of explaining the data in any declaration they proffer as evidence of non-obviousness. See MPEP § 716.02(b)(II). Applicant has explained that various statements referenced in the specification support their position, but these cannot take the place of evidence in the record. See MPEP § 716.01(c)(II). Moreover, any differences between the claimed invention and the prior art may be expected to result in some difference in properties. The issue is whether the properties differ to such an extent that the difference is really unexpected. The burden is on applicant to establish that the results are in fact really unexpected and of statistical and practical significance. Ex parte Gelles, 22 USPQ2d 1318 (Bd. Pat. App. & Inter. 1992). See also MPEP § 716.02.
In this instant case, Applicant has made reference to some of the data of Table 2, but Applicant does not appear to have discussed same with respect to objective data specifically. For example, it is unclear to the Examiner how the criticality of the ethylcellulose range of 12-20 wt. %, or 12-17 wt. % has been established, since various other examples of 17% of ethylcellulose polymer did not show solid, stable gel formation (see rows 1-3, 5, and 7-8).
Finally, assuming purely arguendo that the unexpectedness of the results have been established, the probative value of the evidence as compared to the invention as claimed must then be determined, i.e., the claims must be “commensurate in scope” with the showing. MPEP § 716.02(d). See also MPEP § 2145. The examples of Table 2 employ specific components in specific percentages, ratios, and viscosities, and even if Applicant were to show unexpected results, they would be have been obtained, for example, not with the broad class of “ethylcellulose polymer,” “a first, non-volatile oil,” or “triglyceride oils and mineral oils” generally, but instead with specific species. Note for example, Table 2 at page 10 of the instant specification uses simethicone, sunflower oil, and specifically EC 10 or EC 20 in combination. Applicant would need to explain how these specific species are “reasonably representative” of the more broadly claimed subject matter of the claims.
Claims 5-8, 14-15 and 20-21 are rejected under 35 U.S.C. 103 as being unpatentable over Ross et al. (WO 2018/089863 A1, 05/17/2018) (hereinafter Ross) in view of Yucel et al. (US 2020/0246404 A1, 08/06/2020) (hereinafter Yucel).
The disclosure of Ross has been discussed above. Ross further discloses wherein the formulation is useful for the treatment and prevention of wide range of disorders including gastrointestinal tract distress ([0061]).
Ross differs from the instant claims insofar as not explicitly disclosing wherein the formulation comprises safflower oil (claim 5) or simethicone (claim 6).
However, Yucel discloses compositions comprising one or more actives including cannabinoids, surfactants, co-solvents, and mono-, di-, or triglycerides or fatty acids, suitable for oral unit dose dosage forms ([0017]-[0022]). The mono-, di-, or triglycerides or fatty acids may include an oil such as safflower oil ([0149]); the triglycerides include medium chain triglycerides (MCT) ([0158]) from oils including sunflower oil and sesame oil ([0204]). The one or more actives includes simethicone ([0113]). Suitable dosage forms include lozenges, chewing gum, and buccal unit dosage forms, including in the form of semi-solid ([0265]-[0267]). The composition may comprise a semi-sold inducer including colloidal silicon dioxide (i.e. claimed silicone surfactant) ([0256]).
Ross discloses wherein the formulation may comprise oils and excipients. Accordingly, it would have been obvious to one of ordinary skill in the art to have included safflower oil, sunflower oil, sesame oil, and/or colloidal silicone dioxide in the formulation of Ross, since each is a known and effective oil and/or semi-solid inducer as an excipient, suitable for cannabinoid oral formulations as taught by Yucel.
Regarding claims 6-8, since Ross discloses wherein the formulation may treat gastrointestinal distress, it would have been obvious to one of ordinary skill in the art to have included simethicone since it is a known and effective active suitable for cannabinoid oral formulations as taught by Yucel.
Regarding the claimed amounts of simethicone, and ratios thereof to the second oil, since simethicone is an active exerting an effect on the gastrointestinal tract, it would have taken no more than the relative skill of one of ordinary skill in the art to have arrived at the claimed amount of simethicone (i.e. about 1-36% by total weight) through routine experimentation based on the level of gastrointestinal effect desired. As such, deriving the claimed ratio would have also been obvious. "[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." See MPEP § 2144.05(II)(A).
Regarding claims 20-21 reciting a viscosity of ethylcellulose polymer, as discussed above, Ross discloses ethyl cellulose polymers having viscosities of approx. 9-11 cP/mPa·s (Ethocel® 10), approx. 18-22 cP/mPa·s (Ethocel® 20), and approx. 41-49 cP/mPa·s (Ethocel® 45), with all solution viscosities determined using an Ubbelohde viscometer and a solvent mixture of 80% toluene and 20% alcohol.
Regarding claims 20-21 reciting amounts of ethylcellulose polymer, such limitations have been addressed when addressing the limitations of claims 1 and 19 as discussed above.
Response to Arguments
Applicant mainly asserts Yucel does not cure the deficiencies of Ross.
Since the Examiner has discussed Ross above, this rejection is maintained.
Claims 1, 5 and 16-17 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Morley et al. (US 2011/0158920 A1, 06/30/2011) (hereinafter Morley).
Morley discloses an oleogel (also referred to as oily phase or oily gel ([0026])) comprising an oily agent including triglyceride oils such as palm oil ([0028]) and gelled with about 0.1-10% by weight of ethylcellulose ([0032]). The oleogel may further comprising at least one active pharmaceutical ingredient ([0106]) or cosmetically active ingredient including sesame oil ([0132]). The amount of active agent may be from about 0.01-10% by weight ([0134]). The oleogel is also suitable for incorporation into a bigel, which may be coated by a capsule (i.e. unit dosage form) ([0125]). The viscosity of the bigel may be adjusted to appropriate value for the intended route of administration, including by adapting the proportions of gelling agents in the oleogel phase ([0108]). Morley further discloses a specific embodiment comprising an oleogel comprising ethylcellulose and a mixture of capric/caprylic triglycerides ([0035]),
The prior art is not anticipatory insofar as this combination must be selected from various lists/locations in the reference. It would have been obvious, however, to make the combination since all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. See MPEP § 2143 (I)(A).
Regarding the claimed amounts of ethylcellulose, the claimed ranges (i.e. 12-20%, or 12-17% by total weight, respectively) would have been obvious to one of ordinary skill in the art since they are close to the ranges of the prior art (i.e. about 0.1-10 wt. %). In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP § 2144.05(I). Moreover, in any case, the selection of appropriate weight percentages would appear to require no more than routine testing on the part of the skilled artisan, and so alternatively, consistent with the disclosure of Morley, it would have been obvious to determine workable ranges to arrive at the claimed amounts in % by weight. "[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." See MPEP § 2144.05(II)(A).
Response to Arguments
Applicant mainly asserts Morley fails to provide the ethylcellulose polymer percentages recited in the currently amended claims. None of the ranges recited in the currently amended claims overlap with the range (0.1 to 10 wt. %) allegedly provided by Morley. Additionally, as demonstrated by Applicant, using ethylcellulose polymer at 9 wt. % (e.g., within the range allegedly provided by Morley) was unsuitable, as it resulted in a "[f]lowable gel formed, phase separation." Specification at Table 2. Thus, one of ordinary skill in the art would have been unable to arrive at the claimed subject matter by following Morley.
The Examiner does not find the Applicant’s assertion to be persuasive. A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments. See MPEP 2123(I). Therefore the teachings of Morley are not limited to preferred ranges and working examples. In this instant case, the amount of ethylcellulose disclosed by Morley (e.g. about 10%) teaches or at least suggests amounts above 10% by weight such that one of ordinary skill in the art would have reasonably expected about 10% and 12% of ethyl cellulose to have the same properties. Similarly, Morley discloses in para. [0108] that the viscosity of may be adjusted to appropriate value for the intended route of administration, including by adapting the proportions of gelling agents in the oleogel phase. Therefore, Morley does not require that the amount of ethylcellulose be limited to less than 10% by weight. As such, it would have been obvious to one of ordinary skill in the art to have incorporated more than 10% wt. ethyl cellulose with a reasonable expectation of success.
Regarding allegations of unexpected results, such assertion has been addressed when addressing Ross above, and similarly applies here.
Citation of Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Cavazutti et al. (US 2013/0280198 A1, 10/24/2013) is directed to compositions comprising dimethicone (para. 0102}, octyldodecanol as a second non-volatile oil and ethylcellulose as gelling polymer.
Murty et al. (US 2014/0357708 A1, 12/04/2014) is directed to an oral dosage form comprising cannabinoids and 1-70% wt. of viscosity modifying agents including ethylcellulose, triglycerides including soybean oil and mixed glycerides such as glyceryl stearate, and silica semi-solid inducer including silicates.
Segal et al. (US 2020/0146984 A1, 05/14/2020) is directed to a cannabis gel for oral administration, comprising cannabis extract, polyoxyl castor oil, and ethylcellulose.
Garabagi et al. (US 2021/0236575 A1, 08/05/2021, priority 08/26/2019) is directed to cannabinoid capsules and lozenges, further comprising ethylcellulose, mineral oil, and polyethylene glycol.
Marangoni (US 2012/0183663 A1, 07/19/2012) is directed to an edible oleogel comprising an oil including sunflower oil, ethylcellulose, and a surfactant including glyceryl monostearate.
Ergun et al. (US 2015/0157038 A1, 06/11/2015) is directed to an edible oleogel comprising ethylcellulose and triacylglycerol oil (e.g. flaxseed oil).
Le Maire et al. (US 2019/0380934 A1, 12/19/2019) is directed to compositions for stabilizing taste of food products comprising oils (e.g. sunflower oil) and emulsifiers such as glycerol monoesters of saturated fatty acids (e.g. glycerol monostearate), and ethylcellulose.
Ergun et al. (US 2020/0015493 A1, 01/06/2020) is directed to an oleogel comprising ethycellulose polymers, triglycerides, and stearic acid.
Ergun et al. (US 2019/0307145 A1, 10/10/2019) is directed to an oleogel comprising ethylcellulose polymers, stearic acid, unsaturated oils such as sunflower oil, and monoglycerides.
Conclusion
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LUCY TIEN whose telephone number is (571)272-8267. The examiner can normally be reached Monday - Thursday 8:30 AM - 6:30 PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, SAHANA KAUP can be reached at (571) 272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LUCY M TIEN/Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612