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
The Amendments filed on 10/6/2025 has been received and entered.
Currently, Claims 10, 12, and 14-20 are pending. Claims 10, 12, and 14-20 are examined on the merits.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 2/29/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Election/Restrictions
Applicant’s election without traverse of Group II (Claims 10-20), the species, a cannabinoid, bioenhancer, a pharmaceutically acceptable carrier, excipient, piperidine, tamarind, in the reply filed on April 29, 2022 is acknowledged.
Claims 1-9 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group and species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on April 29, 2022.
Response to Amendment
Claim Rejections - 35 USC § 103
Claim(s) 10, 12, 14-15, and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Guy et al. (WO 2009093018 A1) in view of Singh et al. (2016, AYU 37:3-10) for the reasons set forth in the previous Office Action, which is set forth below. All of Applicant's arguments regarding this ground of rejection have been fully considered but are not persuasive. This is not a new rejection.
Guy et al. teaches a method of treating obesity (Claim 16) with cannabinoid between 0.1 mg/kg and 5.0 mg/kg (Claim 12) as a nutraceutical for humans (page 7, lines 12-16). Obesity is a subject in need of reduction of body weight.
However, Guy et al. does not teach a cannabinoid having a concentration of about 20-1%, a bioenhancer having a concentration of about 0.05-20%, piperine.
Singh et al. teaches a method of using bioavailability enhancer when co-administered with principal drug at low doses, such as Piper longum (Abstract). Piperine, an active principle of Pippali, has been extensively studied for its bio-enhancing effect. Piperine has the following proposed mechanisms of action. It acts on enzymes that are responsible for drug metabolism and degradation. Piperine also inhibits other enzymes, lowers the endogenous UDP-glucuronic acid content and also inhibits the transferase activity. It increases the absorption of drug molecule in the gastrointestinal region because it vasodilates the tissues that results in a greater extent of perfusion in the area. Its stimulation enhances the uptake of amino acids which ultimately enhance the absorption of drugs that conjugates with amino acid. It is assumed that piperine acts as a receptor for certain molecules or enhances the sensitivity of receptors. It also modulates cell transduction pathways, hence decreasing the efflux signals. Modulation of dynamics of cell barrier or blood–brain barrier ultimately ends in the enhancement of transportation of drugs (page 4, bottom left column, top right column).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to make a composition comprising a cannabinoid having a concentration of about 20-1%, a bioenhancer having a concentration of about 0.05-20% of the active agent combination for the following reasons. The reference does teach the composition for treating obesity. Guy et al. teaches a method of treating obesity (Claim 16) with cannabinoid between 0.1 mg/kg and 5.0 mg/kg (Claim 12) as a nutraceutical for humans (page 7, lines 12-16). Singh et al. teaches a method of using bioavailability enhancer when co-administered with principal drug at low doses, such as Piper longum (Abstract). Thus, it would have been obvious to make a concentrated composition containing cannabinoids and piperidine. Additionally, the amount of a specific ingredient in a composition that is used for a particular purpose (the composition itself or that particular ingredient) is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. "[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). Thus, optimization of general conditions is a routine practice that would be obvious for a person of ordinary skill in the art to employ. It would have been customary for an artisan of ordinary skill to determine the optimal amount of each ingredient to add in order to best achieve the desired results, especially within the ranges taught by the reference. Thus, absent some demonstration of unexpected results from the claimed parameters, this optimization of ingredient amount would have been obvious at the time of applicant’s invention.
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to add piperine because Singh et al. teaches a method of increases the absorption of drug molecule in the gastrointestinal region because piperine vasodilates the tissues that results in a greater extent of perfusion in the area (see above). One would have been motivated to use piperine for the expected benefit of treating obesity by enhancing delivery of cannabinoids as taught by Guy et al. and Singh et al. Absent evidence to the contrary, there would have been a reasonable expectation of success in making the claimed invention from the combined teachings of the cited references.
Claim(s) 10, 12, and 14-20 are rejected under 35 U.S.C. 103 as being unpatentable over Guy et al. (WO 2009093018 A1) in view of Singh et al. (2016, AYU 37:3-10) as applied to claims 10, 12, 14-15, and 19-20 above, and further in view of Arsiwala et al. (IN 201400887) for the reasons set forth in the previous Office Action, which is set forth below. All of Applicant's arguments regarding this ground of rejection have been fully considered but are not persuasive.
This is not a new rejection.
The teachings of Guy et al. and Singh et al. are set forth above and applied as before.
The combination of Guy et al. and Singh et al. do not specifically teach the tamarind and concentration 0.05-20%.
Arsiwala et al. teaches a method of improving obesity with 2-80% w/w tamarind seed extract (Abstract).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to add tamarind because Arsiwala et al. teaches a method of improving obesity with 2-80% w/w tamarind seed extract (Abstract). One would have been motivated to use tamarind for the expected benefit of treating obesity as taught by Guy et al. and Singh et al. Absent evidence to the contrary, there would have been a reasonable expectation of success in making the claimed invention from the combined teachings of the cited references.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to make a composition comprising about 0.05-20% of the active agent combination for the following reasons. The reference does teach the composition for treating obesity. Arsiwala et al. teaches a method of improving obesity with 2-80% w/w tamarind seed extract (Abstract). Thus, it would have been obvious to make a concentrated composition containing both flavonoids and tocotrienols for use as a supplement to the diet. Additionally, the amount of a specific ingredient in a composition that is used for a particular purpose (the composition itself or that particular ingredient) is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. "[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). Thus, optimization of general conditions is a routine practice that would be obvious for a person of ordinary skill in the art to employ. It would have been customary for an artisan of ordinary skill to determine the optimal amount of each ingredient to add in order to best achieve the desired results, especially within the ranges taught by the reference. Thus, absent some demonstration of unexpected results from the claimed parameters, this optimization of ingredient amount would have been obvious at the time of applicant’s invention.
Response to Arguments
Applicant argues that the reference teaches other ingredients combined for weight loss.
In response to Applicant’s argument, the claims are drawn toward “comprising” which is opened end language. The claims are not excluding other ingredients for the treatment. Guy et al. teaches CBD alone or in combination with another cannabinoid for controlling obesity, metabolic disease and cardiovascular disease (Abstract). Obesity control would involve weight loss. Thus, the reference teaches the claimed ingredients and for the same use.
Applicant argues that there is no reason to combine the references.
In response to Applicant’s argument, Guy et al. teaches a method of treating obesity (Claim 16) with cannabinoid between 0.1 mg/kg and 5.0 mg/kg (Claim 12) as a nutraceutical for humans (page 7, lines 12-16). Arsiwala et al. teaches a method of improving obesity with 2-80% w/w tamarind seed extract (Abstract). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to add tamarind with cannabinoid because Arsiwala et al. teaches a method of improving obesity with 2-80% w/w tamarind seed extract (Abstract). One would have been motivated to use tamarind for the expected benefit of treating obesity as taught by Guy et al. Singh et al. teaches a method of using bioavailability enhancer when co-administered with principal drug at low doses, such as Piper longum (Abstract). One would have been motivated to use piperine for the expected benefit of enhancing bioavailability in treating obesity as taught by Guy et al. Absent evidence to the contrary, there would have been a reasonable expectation of success in making the claimed invention from the combined teachings of the cited references.
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.
Catheryne Chen Examiner Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655