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
Information Disclosure Statement
As of the date of this action, no information disclosure statements (IDS) have been submitted.
Election/Restrictions
Applicant’s election without traverse of Group II, claims 9-17, was acknowledged.
Claims 1-8 and 18-20 were withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 10/07/2024.
Applicant elected the following species without traverse:
-psilocybin as a compound for treating drug addiction,
-undecylenic acid methyl ester as a menthol stabilizer,
-method of treating drug addiction,
-carrageenan as a second biocompatible polymer,
-calcium chloride as a cross-linking agent,
-coconut oil as a pharmaceutically acceptable suitable solvent.
Response to Amendments
The amendments made to the claims 01/09/2026 have been entered.
Claims 16 and 17 have been canceled by applicant.
Withdrawn Rejection
In view of the amendments made, the 112(d) rejection made in the prior office action has been withdrawn.
Modified Rejection
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) 9-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ghalil (US 2020/0315986) in view of Amin (Scientific Research and Essay, Vol. 3, 11, 2009), Lohani (Journal of Drug Delivery Science and Technology, 31, 2016, 53-64), Kumash (Journal of Solution Chemistry, Vol. 5, No. 11, 1976), Proniuk (Pharmaceutical Development and Technology, 7:2, 249-255, 2002), Harris (Journal of Pharmaceutical Sciences, 1992, Vol. 81, No. 1) Prud’homme (Substance Abuse: Research and Treatment, 2015:9) Inserra (Pharmacol Rev 73:202-277, 2021) and Nichols (Clinical Pharmacology & Therapeutics, Vol. 101, No. 2, 2017).
In regards to claims 9, 13, and 14, Ghalil in para. [0086]-[0088] teaches patches comprising a composition comprising glycerin, menthol, and full spectrum hemp oil.
Ghalil on p 7, para. [0060] contemplates sodium carboxymethyl cellulose and carrageenan as a suitable biocompatible polymers for its invention. Ghalil in the same paragraph states that “Suitable biocompatible polymers that act as gelling, thickening, and/or stabilizing agents…” indicating that the biocompatible polymers act to stabilize the composition.
Ghalil in para. [0061] teaches glycerin as a suitable polyalcohol for its invention.
Ghalil in para. [0062] contemplates full spectrum cannabidiol (CBD) in embodiments of its invention.
Ghalil in para. [0011] contemplates menthol included within a stabilized menthol composition and also including undecylenic acid methyl ester as a menthol stabilizer. Ghalil in para [0050] contemplates amounts and ratios of menthol to menthol stabilizer that read on the instant claim 9.
In regards to claim 13, Ghalil in para. [0060] contemplates carrageenan as a suitable biocompatible polymer.
In regards to claim 14, Ghalil in para. [0052] contemplates coconut oil as a pharmaceutically acceptable solvent.
In regards to claims 9 and 12, Ghalil in para. [0053] contemplates oral administration.
Ghalil in para. [0012] contemplates glycerin in amounts between 1 wt% to about 5 wt%
In regards to claims 11 and 15, Ghalil in para. [0013] contemplates dose amounts of menthol from 2 mg to 400 mg. Additionally, Ghalil in para. [0012] contemplates amounts of menthol between 1 wt% to about 10 wt%.
In regards to claims 10 and 15, Ghalil in para. [0040] contemplates amounts of CBD which read on the instant claims.
Regarding the claim limitation “including minimal residual water of about 0.5 wt% or less”, Ghalil in para. [0059] teaches water content and includes residual water where it states “Total water content (including residual water present in other ingredients) can be in an amount of about 70%...”.
Ghalil discusses salts, glycerin, oral administration but does not explicitly discuss calcium chloride, anhydrous glycerin, and buccal administration. This is addressed by the combination of Amin and Lohani, Proniuk, and Harris.
Ghalil does not discuss a method of treating opioid addiction or the addition of psilocybin. The combination of Prud’homme, Inserra, and Nichols address this.
In regards to claims 9 and 13, specifically the claim limitation calcium chloride, Amin on p. 1176, sec. Use of cross linkers states “Since hydrogels are the polymers which swell in presence of water and they entrap drug within their pores; therefore, to impart sufficient mechanical strength to these polymers, cross linkers are incorporated like glutaraldehyde, calcium chloride and oxidized konjac glucomannan (DAK). These cross linkers prevent burst release of the medicaments.”
Further, Lohani discusses the effect of a polymer combination with sodium carboxymethylcellulose, carrageenan, and calcium chloride. Lohani in sec. 2.2 teaches methods to create a interpenetrating polymer network (IPN) with carrageenan (κ-CG), and sodium carboxy methylcellulose (SCMC) cross-linked with metallic ions sourced from barium chloride, zinc chloride, ferric chloride, calcium chloride, and aluminum chloride. Lohani sec. 2.3 teaches a how to load the polymer combination with the drug ibuprofen. Lohani in sec. 3.1 states “κ-CG is a water soluble anionic polysaccharide and its gelling ability with divalent positively charged ions (e.g. potassium or calcium) is well-recognized for the formulation of drug-loaded beads.” Lohani, therefore, indicates that cross-linking carrageenan with another polymer using metal ions is well known within the art and would give a predictable effect.
In regards to claim 9, specifically the claim limitation regarding the amount of residual water in carboxymethylcellulose (CMC), Kumash on p. 805, Table I teaches several CMC types and the amount of unfreezing water (residual water) contained within said CMC types. Kumash on p. 805, para. 1 states “Values of n decrease with decreasing molecular weight of the sample and are an indication of how the amount of bound water will vary with concentration.” While this teaching is broadly to how water content in CMC changes, it is relied upon as it indicates that CMC would always have some amount of residual water content. Note that Kumash in Fig. 1 indicates CMC samples with lower particle size bind lower amounts of water (<0.5 concentration).
Kumash Table 1
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502
852
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Greyscale
In regards to claim 9, Proniuk is drawn to a anhydrous glycerin-based Carbopol gel (abstract). Proniuk on p. 250, sec. Introduction states “The use of a purely anhydrous formulation may be a promising approach to prevent or prolong the degradation of the drug.” Proniuk on p. 250, sec. Materials and Methods indicates that a 99.5% (anhydrous glycerin) was used.
Therefore, it would be obvious for one of ordinary skill in the art to modify the composition of Ghalil by replacing the glycerin with anhydrous glycerin. One of ordinary skill would find motivation in order to create an anhydrous formulation that would prolong the shelf life of a drug.
In regards to claim 12, Harris is drawn to drug delivery of the oral cavity (title). Harris on p. 1, Abstract states “The buccal mucosa, by comparison, is considerably less permeable, but is probably better suited to the development of sustained-delivery systems.” Harris on p. 1, right col., para. 1 identifies the “buccal mucosa” as the lining of the cheek.
Therefore, not only would one of ordinary skill find it obvious to orally administer the composition as taught by Ghalil, one of ordinary skill would also find it obvious to administer the composition to the buccal lining of the mouth in order to maximize sustained-release potential.
In regards to claims and 9, Prud’homme discusses Cannabidiol as a potential drug intervention for Addictive Behaviors (title).
Prud’homme in its abstract states “A limited number of preclinical studies suggest that CBD may have therapeutic properties on opioid, cocaine, and psychostimulant addiction…”. Prud’homme on p. 34-35, section Included Animal Studies. Effects of CBD on opioid-related addictive behaviors discusses testing designed to study the effect of CBD on opioid (morphine) withdrawal. Prud’homme on. 35 of the same section also states “Overall, CBD was found to have an impact on the intoxication and relapse phase of opioid addiction.”
In regards to claims 9, Inserra, drawn Psychedelic use in psychiatry (title), on p. 217, Table 2 lists a study that examined psilocybin as a treatment for opioid use disorder (OUD). Additionally, Inserra reports dose amounts for treating alcohol use disorder (0.3-0.4 mg/kg or 25 mg), tobacco use disorder (20 or 30 mg/70kg) and cocaine use disorder (0.36 mg/kg).
This is further supported by Nichols on p. 211, sec. Addiction, para. 1-2 where Nichols teaches of a study where participants were given 20 mg/kg and 30 mg/70kg psilocybin.
Nichols additionally states “The promising results from both the opioid and alcoholic populations suggest the exciting possibility that psychedelic treatment might be broadly applicable to psychologic and/or biological processes in common across addictions, in contrast to typical addiction medications that target specific drug classes by acting at the primary receptor mediating drug effect…”
Regarding the claim limitation of “a second biocompatible polymer” in claim 9, a similar limitation was included in previous claim 13 (see claim set of 02/05/2025) which stated “The method of claim 9, further including a second biocompatible polymer and a cross-linking agent.” Claim 13 now reads “The method of claim 9, wherein the second biocompatible polymer is carrageenan and the cross-linking agent is calcium chloride.” Ghalil does not explicitly mention combining a second biocompatible polymer, however, as discussed below, it would be prima facie obvious to combine two ingredients that are known to share a similar purpose.
Regarding the claim limitation in claim 9 which states “psilocybin in an amount ranging from about 0.01 wt% to about 0.10 wt%...”, the art teaches dose amounts. While these amounts are drawn to doses to treat different use disorders, considering the teaching of Nichols above, one of ordinary skill in the art would find it obvious to use similar amounts to treat opioid use disorder. Further, the MPEP section 2144.05, subsection II states:
“The adjustment of particular conventional working conditions (e.g., determining result effective amounts of the ingredients beneficially taught by the cited references), is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan. Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical.
“[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). Accordingly, this type of modification would have been well within the purview of the skilled artisan and no more than an effort to optimize results.”
One of ordinary skill in the art would find it obvious to modify the doses to arrive at the weight percentage in the instant claims.
Prud’homme and Inserra teach CBD and psilocybin as compounds used to treat opioid addiction (opioid use disorder).
The MPEP section 2144.06 states:
““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)”
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 combined the teachings of Ghalil, Amin and Lohani, Kumash, Proniuk, Harris, Prud’homme, Inserra, and Nichols to arrive at the instant claims.
One of ordinary skill would have been motivated to combine the teachings as discussed above and because the combination of CBD and psilocybin would be obvious via In re Kerkhoven.
Response to Arguments
Applicant’s arguments regarding the inclusion of divalent metal ions to crosslink sodium carboxymethylcellulose with the second biocompatible polymer, carrageenan, is addressed by the addition of Lohani.
Not only does Lohani teach how to make the polymer combination comprising the sodium carboxymethyl cellulose, carrageenan, and calcium chloride, Lohani teaches that combining carrageenan with another polymer using a metal divalent ion sourced from calcium chloride is well known within the art. While Lohani teaches to the efficacy of aluminum trichloride in defusing ibuprofen, calcium chloride is listed as an alternative. Therefore, one of ordinary skill in the art would assume that the use of calcium-linked polymers would be comparably as effective.
Applicant argues that the Examiner must ‘identify a reason that would have prompted a person of ordinary skill in the art in the relevant field to combine the elements in the new the way the new invention does”. Applicant then states that “Amin does not teach or suggest the different properties of sodium carboxy methylcellulose and only relates to cross-linking single polymer or single co-polymers. Kumash merely refers to the different properties of sodium carboxy methylcellulose ad does not teach or suggest cross-linking agents whatsoever. Furthermore, Ghalil does not teach or suggest a combination of two different biocompatible polymers…”.
Lohani also addresses these arguments. Lohani teaches a combination of sodium carboxymethylcellulose, carrageenan, and calcium chloride. The polymer combination, the general combination of carrageenan with other polymer using metal ions, and the enhanced diffusion of properties of the polymer combination were well known within the art at the time of the effective filing date. Therefore, one of ordinary skill in the art would have found the instant claims obvious.
Conclusion
No claims 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LUISALBERTO GONZALEZ whose telephone number is (571)272-1154. The examiner can normally be reached M-F 8:30-5:30.
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/L.G./Examiner, Art Unit 1624
/SUSANNA MOORE/Primary Examiner, Art Unit 1624
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