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 .
Claims 1-20 are pending and under examination.
Priority
Acknowledge is made that this application is continuation of US patent application 18062351, filed on 12/06/2022; which is continuation of US patent application 15929953, filed on 05/29/2020; which claims priority from US provisional application 62/854925, filed on 05/30/2019.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 08/29/2024 is being considered by the examiner.
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 5-6 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.
Regarding claim 5, “desire viscosity” is a subject term, and applicant’s specification failed to provide some objective standard for measuring the scope of the term. Some objective standard must be provided in order to allow the public to determine the scope of the claim. A claim term that requires the exercise of subjective judgment without restriction may render the claim indefinite. In re Musgrave, 431 F.2d 882, 893, 167 USPQ 280, 289 (CCPA 1970). Claim scope cannot depend solely on the unrestrained, subjective opinion of a particular individual purported to be practicing the invention. Datamize LLC v. Plumtree Software, Inc., 417 F.3d 1342, 1350, 75 USPQ2d 1801, 1807 (Fed. Cir. 2005)). MPEP 2173.05 (b) IV. For compact prosecution purpose, the desired viscosity is examined as any viscosity.
Claim 6 is rejected for depending on rejected claim 5.
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 1-6 and 8-10, 12-20 are rejected under 35 U.S.C. 103 as being unpatentable over Vialpando et al. (US20200345684).
Determination of the scope and content of the prior art
(MPEP 2141.01)
Vialpando et al. teaches compositions comprising a cannabinoid or a cannabinoid mixture adsorbed onto at least one mesoporous silica wherein the cannabinoid mixture comprises a cannabinoid and a surfactant. Preferably, the composition is in the form of a free flowing powder (abstract). The cannabinoid may be selected from the group consisting of a plant extract, cannabigerolic acid (CBGA);
cannabigerolic acid monomethylether (CBGAM), cannabigerol (CBG), cannabigerol monomethylether (CBGM), cannabigerovarinic acid (CBGVA), cannabichromevarin
(CBCV), cannabichromenic acid (CBCA) cannabichromene (CBC), cannabiruolic acid (CBDA), cannabidiol (CBD), canabinolic acid (page 1, [0009]). The surfactant may be an anionic, cationic, or zwitterionic surfactant. In one embodiment the surfactant is an anionic surfactant. In a preferred embodiment, the anionic surfactant may be sodium lauryl sulfate. The composition may further comprise a terpene or terpenoid (page 1, [0011, 0013]). In some embodiments the mesoporous silica may be a mesoporous silica particle. The mesoporous silica particles have an average particle size diameter of between about 2 μm to at least about 250 μm (page 2, [0018]). In a second aspect there is provided a formulation comprising an effective amount of the composition of the first aspect and at least one carrier, diluent or excipient. The excipient may be one or more of microcrystalline cellulose, croscarmellose sodium, and magnesium stearate. In preferred embodiments the formulation is a pharmaceutically acceptable formulation. In a third aspect there is provided a process of preparing the composition of the first aspect, comprising a) heating the cannabinoid; b) mixing the cannabinoid and the mesoporous silica, wherein the cannabinoid adsorbs to the mesoporous silica. In one embodiment step b) further comprises mixing the cannabinoid with the surfactant wherein the cannabinoid and the surfactant form a cannabinoid mixture that adsorbs to the mesoporous silica (page 2, [0022-0026]). In embodiments, the cannabinoid or cannabinoid mixture is heated to a temperature that increases fluidity or decreases viscosity. For example the cannabinoid or cannabinoid mixture may be heated to a temperature up to about 100°C ([0039]). The process may further comprise the step of stirring the cannabinoid or cannabinoid mixture and the mesoporous silica (page 2, [0042]). A "carrier, diluent or excipient" includes, but is not limited to, any medium comprising a suitable water soluble organic carrier, conventional solvents, oil, hydrophobic diluent, dispersion media, fillers, solid carriers, coatings, antibacterial and antifungal agents, isotonic and absorption delaying agents. Suitable water-soluble organic carriers include, but are not limited to, saline, dextrose, com oil, dimethylsulfoxide, and gelatin or hydroxypropylmethylcellulose capsules. Other conventional additives include lactose, mannitol, com starch, potato starch, binders such as microcrystalline cellulose, cellulose derivatives such as
hydroxypropylmethylcellulose, acacia, gelatins, disintegrators such as sodium carboxymethylcellulose, and lubricants such as talc or magnesium stearate (page 3, [0058]). Plant extracts containing cannabinoids may also contain one or more terpenes and/or terpenoids. For example the plant extracts may contain a terpene selected from the group comprising t-carophyllene, myrcene, α-humulene, α-pinene, guaiol, α-terpineol, and terpinolene, linalool, fenchol, gnaiene, and 3-careen. Accordingly, "cannabinoid mixtures" as used herein may contain one or more terpenes (page 5, [0083]). The cannabinoid is heated from 30-100ºC in one embodiment (page 8, [0109]). The cannabinoid may be heated in the absence or in the presence of the surfactant. The process may further comprise the step of stirring the cannabinoid mixture and the mesoporous silica. In some embodiments the cannabinoid mixture is primarily located in the pores of the mesoporous silica, with little or no mixture outside the pores. In other embodiments, the cannabinoid mixture is located outside the pores of the mesoporous silica. Both embodiments require the cannabinoid mixture to be loaded or adsorbed onto the mesoporous silica (page 8, [0112-0113]). In some embodiments, heating is not required. In these embodiments the cannabinoid mixture and mesoporous silica are combined at room temperature and the mixture is adsorbed to the mesoporous silica at room temperature (page 8, [0119]). Another loading method utilizes the fluidized bed approach in mixing, granulation (if required), and drying are all carried out in the same equipment. First, a suspension of a given cannabinoid-to-silica ratio is formulated and thoroughly mixed. The solvent in this suspension is then evaporated by spraying the suspension with the fluidized bed equipment. Co-milling may also be used. In this solvent-free mechanical shearing process is reportedly disrupts the crystalline structure of a cannabinoid without causing significant chemical degradation through use of a low-energy jarmilling configuration. Physical mixtures of crystalline compounds (such as cannabinoids) and a mesoporous silica at suitable proportions are co-ground at room temperature. This leads to what is known as spontaneous amorphization in which the cannabinoid or cannabinoid mixture are adsorbed onto the mesoporous silica (page 9, [0122-0123]). The formulation of the composition is tablet in one embodiment by direct compression (page 9, [0129]; page 11, [[0179]). The composition is enhanced or controlled release (page 9, [0126]). Syloid 3050 XDP (50 μm median particle size) was selected as the mesoporous silica carrier and sodium lauryl sulfate (SLS) as the anionic surfactant. A delta-9-THC distillate with 85% purity, as determined by HPLC, was selected for method development and optimization purposes. To improve the ease of handling, the viscosity of the distillate was decreased by placing it in a 40° C. oven for approximately 15 minutes prior to weighing. Following removal from the oven, it was immediately added to the pre-weighed Syloid 3050 XDP and SLS to a target drug load of 35-40% (w/w) delta-9-THC (˜40-45% cannabis extract) and 4% (w/w) SLS. The mixture was blended using a standard overhead laboratory mixer until all of the distillate visually appeared to be adsorbed onto the silica. The dry powder blend was then sieved through a 60 μm sieve. The potency of the drug loaded silica/SLS mixture was then analyzed by HPLC-UV by diluting samples to ˜100 μg/mL in acetonitrile (ACN) and analyzed (n=3 replicates) at room temperature. All standard curves were linear over the concentration range of 0.7-700 μg/mL. The measured potency was evaluated against the theoretical potency with an acceptance criterion set to ≤10% (i.e., 90-100% of the theoretical maximum loading capacity). This resulting potency was then used to determine the target weight to achieve a 25 mg delta-9-THC dose in a 175 mg tablet (14.3% w/w) ([0177-0178]).
Ascertainment of the difference between the prior art and the claims
(MPEP 2141.02)
The difference between the instant application and Vialpando et al. is that Vialpando et al. is not specific enough for anticipation.
Finding of prima facie obviousness
Rational and Motivation (MPEP 2142-2143)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to produce the instant invention.
Regarding claim 1, 3, 9, 13-20, Vialpando et al. teaches the free flowing powder (free flowing powder is dry in the absence of evidence to the contrary) prepared by mixing cannabinoid (with or without heating before mixing) such as cannabigerolic acid or cannabigerol (solid cannabinoid according to applicant’s specification) with mesoporous silica (solid), Vialpando et al. teach addition of ingredients microcrystalline cellulose, croscarmellose sodium, and magnesium stearate; Vialpando et al. also teaches addition of terpenoid such as linalool (monoterpenoid) but silent about the addition of linalool is after mixing with those ingredients. MPEP 2144.04, IV. C. selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results; Selection of any order of mixing ingredients is prima facie obvious. When solid cannabigerolic acid or cannabigerol is not heating, such cannabigerolic acid or cannabigerol is still solid in the resulting free flowing powder and tablet in the absence of evidence to the contrary. Even with heating before mixing, after mixing and eventually cooling down to room temperature, the cannabigerolic acid or cannabigerol is still a solid in the absence of evidence to the contrary. Regarding the limitation of “activated”, Vialpando et al. teaches free-flowing powder that reads on activated cannabinoid controlled release compound according to applicant's specification.
Regarding claims 2 and 12, Vialpando et al. teaches HPLC analysis of purity (indication for potency) of cannabinoid before mixing and HPLC analysis of potency after mixing.
Regarding claim 4 and 6, Vialpando et al. teaches heating cannabinoid at 30-100ºC. Since Vialpando et al. cannabinoid mixed with mesoporous silica at room temperature, it is obvious that cannabinoid cools down after heating. Although Vialpando et al. is silent about duration of heating and cooling duration as well as cooling to -10ºC, those parameters are adjustable parameter, and one artisan in the art would have been motivated to optimize through routing experimentation to have claimed range, especially in the absence of evidence of showing criticality of claimed range. MPEP 2144.05.
Regarding claim 5, Vialpando et al. teaches decreased viscosity for improved fluidity.
Regarding claim 8, Vialpando et al. teaches cannabinoid mixture is primarily located in the pores of the mesoporous silica, with little or no mixture outside the pores in one embodiment; and in other embodiments, the cannabinoid mixture located outside the pores of the mesoporous silica. The cannabinoid adhered into pore or external surface results in facilitating a controlled release character of activated cannabinoid controlled release compound.
Regarding claim 10, Vialpando et al. teaches filtered with a sieve.
Regarding claim 13, Vialpando et al. teaches compressed into a tablet
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Claim 7 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Vialpando et al. (US20200345684), as applied for the above 103 rejections for claims 1-6 and 8-13, in view of De Luigi (US20180153777) and Suzuki et al. (US4835142).
Determination of the scope and content of the prior art
(MPEP 2141.01)
Vialpando et al. teaching has already been discussed in the above 103 rejection and is incorporated herein by reference.
De Luigi teaches the effervescent system in powder form (sodium bicarbonate and citric acid) was mixed in a mixing mill at about 1500 rpm for 2 minutes. At the end of the mixing, the remaining ingredients of the composition were introduced into the mixing mill. The mixing was re-started and continued for 4 minutes ([0099]). The composition comprising this powder is in the form of tablet (claims 1, 11 and 17).
Suzuki et al. teaches A powdery pharmaceutical composition (abstract). A vibratory sieve is used when the effective particle diameter of a powder is more than 37 microns, and a sonic sieve (Micro Hand Sifter SWM-2, a product of Tsutsui Rikagaku Kikai Co., Ltd.) is used when the effective particle diameter of a powder is not more than 37 microns (column 5, line 55-60).
Ascertainment of the difference between the prior art and the claims
(MPEP 2141.02)
The difference between the instant application and Vialpando et al. is that Vialpando et al. do not expressly teach 1000-30000 rpm for 1-30 minutes and vibratory sieve. This deficiency in Vialpando et al. is cured by the teachings of De Luigi and Suzuki et al.
Finding of prima facie obviousness
Rational and Motivation (MPEP 2142-2143)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Vialpando et al., as suggested by De Luigi and Suzuki et al., and produce the instant invention.
Vialpando et al. teaches procedure of mixing and stirring, and one of ordinary skill would have been motivated to mix the powder at 1000-30000 rpm for 1-30 minutes because this is optimization under prior art condition or through routing experimentation. MPEP 2144.05. Under guidance from De Luigi teaching mixing powder at about 1500 rpm for 2 minutes, it is obvious to mix the powder at 1000-30000 rpm for 1-30 minutes and produce instant claimed invention with reasonable expectation of success.
Vialpando et al. teaches procedure of filtering particle with sieve, and one of ordinary skill would have been motivated to use vibratory sieve because vibratory sieve is a suitable sieve for filtering pharmaceutical powder as suggested by Suzuki et al. MPEP 2144.07. Thus, it is obvious for one of ordinary skill in the art to use vibratory sieve and produce instant claimed invention with reasonable expectation of success.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 11596606 in view of Vialpando et al. (US20200345684) because the reference patent teaches the same cannabinoid composition prepared by applicant’s claimed process by heating and mixing cannabinoid with porous silica, in view of Vialpando et al. teaching analysis of cannabinoid potentcy before and after mixing as well as filtering, and one artisan in the art would immediately recognize the obvious claimed subject matter over reference patent.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 12076442 in view of Vialpando et al. (US20200345684) because the reference patent teaches the same cannabinoid composition prepared by applicant’s claimed process by heating and mixing cannabinoid with porous silica, in view of Vialpando et al. teaching analysis of cannabinoid potentcy before and after mixing as well as filtering, and one artisan in the art would immediately recognize the obvious claimed subject matter over reference patent.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JIANFENG SONG. Ph.D. whose telephone number is (571)270-1978. The examiner can normally be reached M-F 8-5.
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/JIANFENG SONG/Primary Examiner, Art Unit 1613
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