DETAILED ACTION
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 .
Status of the Claims
This Office Action is in response to Applicant's Restriction Requirement remarks filed on July 22, 2025. Claim(s) 1, 3, 5, 8, 9, 11, 13, 14, 16-21, 26, 27, 31, 32, 47, and 48 are pending. Claim(s) 27, 31, 32, 47, and 48 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant's election of Group I drawn to a pharmaceutical composition carrier and a pharmaceutically effective amount of a steroid and a pharmaceutically effective amount of at least one modulator selected from the group consisting of at least one transient receptor potential (TRP) channel modulator, at least one peroxisome proliferator-activated receptor (PPAR) modulator and election of species of shogaol (TRP inhibitor) and magnolol (PPAR inhibitor) of the restriction requirement in the reply is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.03(a)). The requirement is deemed proper and is therefore made FINAL. Claim(s) 1, 3, 5, 8, 9, 11, 13, 14, and 16-21 are examined herein insofar as they read on the elected invention and species. The elected species was found free of the art, therefore the search was expanded to a genus encompassing claim 1 in its entirety.
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.
Claim 16 is 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.
The recitation of the terms "hydroxy unsaturated fatty acids, alkamides, polyacetylenes” render the claim indefinite. The recitation of the broad class of compounds is not clearly defined in the specification. Hence, one of ordinary skill in the art could not ascertain and interpret the metes and bounds of the patent protection desired as to "hydroxy unsaturated fatty acids, alkamides, polyacetylenes” of compounds herein, since one of ordinary skill in the art would clearly recognize that many various groups could possibly be substituting these compounds. As a result, any significant structural variation to a compound would be reasonably expected to alter its properties, e.g., physical, chemical, physiological effects and functions. Thus, it is unclear as to what the class of compounds recited herein thereby encompass.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 1, 3, 5, 8, 9, 11, 13, 14, and 16-21 are rejected under 35 U.S.C. 103 as being unpatentable over Friedman (WO 2019/234743) of record.
Friedman teaches unexpectedly found that a combination of a cannabinoid with licorice extract (or with isolates of said extract) possesses a synergistic anti-inflammatory effect that has the potential to provide effective treatment for many inflammatory diseases and provide a safer, yet highly effective, alternative to medication with steroids. In addition, Cannabis extract and licorice extracts possess anti-infective and analgesic properties in addition to their anti-inflammatory activities [0018].
Friedman teaches anti-inflammatory composition comprising a combination of (a) at least one cannabis-related substance; and (b) at least one licorice-related substance, wherein the weight ratio of said cannabis-related substance(s) to said licorice -related substance(s) is in the range of from about 10:1 to about 1: 100 ([0111]; claim 1).
Friedman teaches the anti-inflammatory synergistic composition comprising cannabis and licorice, or isolates, fractions or components obtained therefrom, provides many benefits such as increased pharmacological efficacy, use of lower steroid or NSAID concentration, thus having the required therapeutic effect with reduced side effects, prolonged use with a lower dose or period limits or contra indications due to adverse effects [00100].
Friedman teaches many of the severe autoimmune and inflammatory diseases are well treated with steroids, these agents also possess many severe and dose-limiting unwanted side effects [0011].
Friedman teaches wherein the cannabis-related substance is selected from: cannabidiol (CBD), cannabidiolic acid (CBDA), tetrahydrocannabinol (THC), tetrahydrocannabinolic acid (THCA), cannabigerol (CBG), cannabichromene (CBC), cannabinol (CBN), cannabielsoin (CBE), iso tetrahydrocannabinol (iso-THC), cannabicyclol (CBL), cannabicitran (CBT), cannabivarin (CBV), tetrahydrocannabivarin (THCV), cannabidivarin (CBDV), cannabichromevarin (CBCV), cannabigerovarin (CBGV), cannabigerol monomethyl ether (CBGM), salts thereof, derivatives thereof and mixtures of cannabinoids ([0023]; claim 5).
Friedman teaches wherein the licorice-related substance is selected from: Glycyrrhizin/Glycyrrhetinic Acid, Glabridin, Glabrene, Licochalcone A, liquiritigenin, isoliquiritigenin, Coumarins, including licopyranocoumarin, licoarylcoumarin, and glycycoumarin, Formononetin, Glisoflavone, Hispaglabridins A and B, Rutin, Isoangustone A, Prunetin and Dehydroglyasperin C, salts thereof, derivatives thereof and mixtures of glycyrryhzanoids ([0089]; claim 7).
Friedman teaches anti-inflammatory preparations of licorice may include: Licorice extracts, triterpenes and flavonoids isolates having evident anti-inflammatory properties mainly by decreasing TNF, MMPs, PGE2 and free radicals [0089].
Friedman teaches the terpene is selected from the group consisting of bisabolol, borneol, caryophyllene, carene, camphene, cineol, citronella, eucalyptol, geraniol, guaiol, humulene, isopropyl toluene, isopulegol, linalool, limonene, methyl salicylate, menthol, myrcene, nerolidol, ocimene, pinene, phytol, pulegone, terpinene, terpinolene, thymol, salts thereof, derivatives thereof and mixtures thereof [0073].
Friedman teaches a functional inactive ingredient maybe optionally added, such as colorant or antioxidants or chelating agent or microbial preservative or viscosity modifier, pH modifying agents, buffer, or melting point modifier or anti-microbial agent or suspending agent [0087].
While Friedman does not specifically employ the terms “transient receptor potential (TRP) channel modulator)” and “peroxisome proliferator-activated receptor (PPAR)”, said terms are considered properties inherent in the disclosed active agent. "Products of identical chemical composition cannot have mutual exclusive properties." Any properties exhibited by or benefits from are not given any patentable weight over the prior art provided the composition is inherent. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the disclosed properties are necessarily present. In re Spada, 911 F.2d 705,709, 15 USPQ 1655, 1658 (Fed. Cir. 1990). See MPEP 2112.01. In the instant case, if the specific compounds in instant claims 14 and 16-18 taught as PPAR and TRP channel modulators, respectively, then the burden is shifted to the applicant to show that the prior art product does not inherently possess the same properties as the instantly claimed products.
Friedman does not specifically teach the pharmaceutical composition to contain a steroid.
As stated above, Friedman teaches the anti-inflammatory synergistic composition comprising cannabis and licorice, or isolates, fractions or components obtained therefrom, provides many benefits such as increased pharmacological efficacy, use of lower steroid or NSAID concentration, thus having the required therapeutic effect with reduced side effects, prolonged use with a lower dose or period limits or contra indications due to adverse effects [00100].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have envisioned a composition comprising an anti-inflammatory synergistic composition comprising cannabis and licorice components, among other ingredients, and also envisioned a steroid to be part of the formulation. As taught by Friedman, steroids are known to have unwanted side effects, therefore the skilled artisan would have employed the anti-inflammatory synergistic composition with a reduced amount of steroid in order to reduce the undesired adverse effects.
Regarding the specific concentrations of the PPAR and TRP modulators or the ratio of CBD to THC, as required by the limitations of claims 13 and 21, are considered parameters that can be manipulated based on the teachings provided by Friedman. Generally, mere optimization of ranges will not support the, patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "When the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimal or workable ranges by routine experimentation. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955); see also In re Peterson, 315 F. 3d at 1330, 65 USPQ 2d at 1382 "The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages." MPEP 2114.04.
Thus, based on the foregoing reasons, the instant claims are deemed unpatentable over the cited reference.
Conclusion
Claims 1, 3, 5, 8, 9, 11, 13, 14, and 16-21 are not allowed.
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to Sahar Javanmard whose telephone number is (571)270-3280. The examiner can normally be reached on Monday-Friday, 9:00-5:00 EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James Alstrum-Acevedo can be reached on 571-272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
/SAHAR JAVANMARD/
Primary Examiner, Art Unit 1627