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 .
This action is in response to the amendment filed on July 6th, 2026.
Any objections or rejections not reiterated below are hereby withdrawn.
Claims 1, 3, 5, 7-13, 15, 18, 21, and 25 are pending and were examined on the merits.
Withdrawal of Objections and Rejections
Applicant’s arguments, filed July 6th, 2026, with respect to the objections to the specification have been fully considered and are persuasive. The applicant has amended the specification to correct the informalities pointed out by the examiner, and to correctly recite trademarks and tradenames. Furthermore, the trademark “ICN” pointed out by the examiner in the previous office action is cancelled and belonged to ICN Pharmaceuticals, Inc., an entity with a different name than that recited in the specification ICN Biochemicals, Inc. (page 26 line 24). If the applicant finds that ICN Pharmaceuticals, Inc. and the entity recited as “ICN Biochemicals, Inc.” are the same entity, then the applicant is requested to correct the recitation of the term “ICN” according to the guidelines provided in the previous office action for trademarks and tradenames. The objection to the specification has been withdrawn.
Applicant’s arguments, filed July 6th, 2026, with respect to the objection to claim 11 have been fully considered and are persuasive. The applicant has amended claim 11 to recite the term “gastrointestinal system” in place of the term “gastric system”, clarifying the scope of the claim. The objection to claim 11 has been withdrawn.
Applicant’s arguments, filed July 6th, 2026, with respect to the rejection of claims 3, 5, 7, and 10 under 35 U.S.C have been fully considered and are persuasive. The applicant has amended claims 3 and 5 to remove the phrase “such as” and has amended claims 7 and 10 to remove the term “about”. The applicant has also amended claim 5 to remove trademarks and tradenames. The rejection of claims 3, 5, 7, and 10 under 35 U.S.C. 112(b) has been withdrawn.
Applicant’s arguments, filed July 6th, 2026, with respect to the rejection of claims 1, 3, 5, 7-11, 15, 18, 21, and 25 under 35 U.S.C. 102 have been fully considered and are persuasive. The applicant has amended instant independent claim 1, from which claims 3, 5, 7-11, 15, 18, 21, and 25 depend, to recite “one or more components increasing intestinal lymphatic transport of the one or more constituent, derivative, or extract of cannabis”, which is subject matter not taught by the prior art reference Heller (US 20200054702 A1). The rejection of claims 1, 3, 5, 7-11, 15, 18, 21, and 25 under 35 U.S.C. 102 has been withdrawn.
Pending Objections and Rejections
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, 3, 5, 7-13, 15, 18, 21, and 25 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 5, 7, 8, 10, 13, 16, 18-22, 28, and 32 of copending Application No. 18/580005 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because of the following similarities.
Response to Arguments
Applicant's arguments filed July 6th, 2026 have been fully considered but they are not persuasive. The applicant alleges that no. Even if the phrase “one of more” does not contain a typographical error, reference claim 19 still discloses a component increasing intestinal lymphatic transport of the one or more constituent, derivative or extract of cannabis, which reads on the "one or more components increasing intestinal lymphatic transport of the one or more constituent, derivative, or extract of cannabis" of instant claim 1.
Pending Rejection
Each claim mentioned in the rejection below is a dependent claim unless stated otherwise for
that particular claim.
Both applications recite a composition comprising one or more constituent, derivative or extract of cannabis, a means for solubilising the one or more constituent, derivative or extract of cannabis in an aqueous environment, and an additive which slows or inhibits crystallization of the one or more constituent, derivative or extract of cannabis, and one [or] more components increasing intestinal lymphatic transport of the one or more constituent, derivative or extract of cannabis (instant independent claims 1 and dependent claims 3, 5, 7-13, 15, 18, 21, and 25; reference claims 1 (independent), 8, 16, and 19). One [or] more components increasing intestinal lymphatic transport of the one or more constituent, derivative or extract of cannabis reads on enhanced bioavailability properties in the gastrointestinal system (instant claim 11; reference claim 20).
Both applications recite a composition wherein the means for solubilising the one or more
constituent, derivative, or extract of cannabis in an aqueous environment comprises encapsulation of
the one or more constituent, derivative or extract of cannabis, optionally wherein the encapsulation is
by a molecular encapsulant (instant claim 3; reference claim 10), or by a micelle comprising a surfactant (instant claims 5 and 7; reference claims 10 and 13), where the weight percent range of surfactant encompasses 0.5-10% based on the total weight of the composition (instant claim 7; reference claim 13). It is within the knowledge of one of skill in the art that a composition comprising micelles in an aqueous environment is reasonably a colloidal dispersion (instant claim 21; reference claims 10 and 13).
Both applications recite the additive which slows or inhibits crystallization of the one or more
constituent, derivative or extract of cannabis in an aqueous environment wherein the additive is
selected from the group consisting of at least polyvinylpyrrolidone (PVP), hydroxypropyl cellulose (HPC)
and mixtures (or a combination) thereof (instant claim 8; reference claim 16).
Both applications recite a composition wherein the one or more constituent, derivative or
extract of cannabis is selected from the group consisting of: cannabigerol (CBG), cannabichromene
(CBC), cannabidiol (CBD), tetrahydrocannabinol (THC), cannabinol (CBN), cannabinodiol (CBDL),
cannabicyclol (CBL), cannabivarin (CBV), tetrahydrocannabivarin (THCV), cannabidivarin (CBDV),
cannabichromevarin (CBCV), cannabigerovarin (CBGV), cannabigerol monomethyl ether (CBGM),
cannabinerolic acid, cannabidiolic acid (CBDA), cannabinol propyl variant (CBNV), cannabitriol (CBO), tetrahydrocannabmolic acid (THCA), and tetrahydrocannabivarinic acid (THCV A) (instant claim 9;
reference claim 5).
Both applications recite a composition wherein the constituent, derivative or extract of cannabis
is present in an amount of from 0.1 to 30% by weight, based on the total weight of the
composition (instant claim 10; reference claim 7). Both applications recite a composition comprising one
[or] more components enhancing enterocyte intestinal absorption of the one or more constituent,
derivative or extract of cannabis (instant claim 12; reference claim 18).
Both applications recite a composition comprising a terpene, a grapefruit extract, or a black pepper extract (instant claim 13; reference claim 19).
Both applications recite a composition comprising either a pH modifier or buffer (which reasonably overlap) and a flavor or sensate (instant claim 15; reference claims 21 and 22).
Both applications recite a composition that is at least partially soluble in an aqueous
environment (instant claim 18; reference claim 8).
Both applications recite an invention encompassing a beverage for providing gastric delivery of
one or more constituent, derivative or extract of cannabis (instant claim 25; reference claims 1
(independent), 4, 28, and 32).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 3, 5, 7-13, 15, 18, 21, and 25 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-5, 7, 9, 11, 14, 16, 17, 19, 20, and 22 of copending Application No. 18/580022 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because of the following similarities.
Response to Arguments
Applicant's arguments filed July 6th, 2026 have been fully considered but they are not persuasive. The applicant alleges that no. Even if the phrase “one of more” does not contain a typographical error, reference claim 20 still discloses a component increasing intestinal lymphatic transport of the one or more constituent, derivative or extract of cannabis, which reads on the "one or more components increasing intestinal lymphatic transport of the one or more constituent, derivative, or extract of cannabis" of instant claim 1.
Pending Rejection
Each claim mentioned in the rejection below is a dependent claim unless stated otherwise for
that particular claim.
Both applications recite a composition comprising one or more constituent, derivative, or
extract of cannabis, a means for solubilising the one or more constituent, derivative or extract of
cannabis in an aqueous environment, and an additive which slows or inhibits crystallization of the one or
more constituent, derivative or extract of cannabis, and one [or] more components increasing intestinal lymphatic transport of the one or more constituent, derivative or extract of cannabis (instant independent claim 1 and dependent claims 3, 5, 7-13, 15, 18, 21, and 25; reference claims 1 (independent), 9, 16, and 20). One [or] more components increasing intestinal lymphatic transport of the one or more constituent, derivative or extract of cannabis reads on enhanced bioavailability properties in the gastrointestinal system (instant claim 11; reference claim 20).
Both applications recite a composition wherein the means for solubilising the one or more
constituent, derivative, or extract of cannabis in an aqueous environment comprises encapsulation of
the one or more constituent, derivative or extract of cannabis, optionally wherein the encapsulation is
by a molecular encapsulant (instant claim 3; reference claim 11) or by a micelle comprising a surfactant (instant claims 5 and 7; reference claims 11 and 14). It is within the knowledge of one of skill in the art that a composition comprising micelles in an aqueous environment is reasonably a colloidal dispersion (instant claim 21; reference claims 11 and 14). The weight percent of a surfactant (instant claim 7) is obvious over routine optimization, through adjustment using a laboratory scale, and monitoring the resulting compositions, at fixed time intervals, for phase separation.
Both applications recite the additive which slows or inhibits crystallization of the one or more
constituent, derivative or extract of cannabis in an aqueous environment wherein the additive is (at
least optionally) selected from the group consisting of at least polyvinylpyrrolidone (PVP), hydroxypropyl
cellulose (HPC) and mixtures (or a combination) thereof (instant claim 8; reference claim 17).
Both applications recite a composition wherein a constituent, derivative, or extract of cannabis
is selected from the group consisting of: cannabigerol (CBG), cannabichromene (CBC), cannabidiol (CBD),
tetrahydrocannabinol (THC), cannabinol (CBN), cannabinodiol (CBDL), cannabicyclol (CBL), cannabivarin
(CBV), tetrahydrocannabivarin (THCV), cannabidivarin (CBDV), cannabichromevarin (CBCV), cannabigerovarin (CBGV), cannabigerol monomethyl ether (CBGM), cannabinerolic acid, cannabidiolic
acid (CBDA), cannabinol propyl variant (CBNV), cannabitriol (CBO), tetrahydrocannabmolic acid (THCA),
and tetrahydrocannabivarinic acid (THCV A) (instant claim 9; reference claim 3).
Both applications recite a composition wherein the constituent, derivative, or extract of
cannabis is present in an amount of from 0.1 to 30% by weight, based on the total weight
of the composition (instant claim 10; reference claim 4).
Both applications recite a composition comprising one [or] more components enhancing
enterocyte intestinal absorption of the one or more constituent, derivative, or extract of cannabis
(instant claim 12; reference claim 19).
Both applications recite a composition comprising a terpene, a grapefruit extract, or a black pepper extract (instant claim 13; reference claim 20).
Both applications recite a composition comprising either a pH modifier or buffer (which reasonably overlap) and a flavor or sensate (instant claim 15; reference claims 5, 7, and 22).
Both applications recite a composition that is at least partially soluble in an aqueous
environment (instant claim 18; reference claim 9).
Both applications recite an invention encompassing a composition for providing gastric delivery
of one or more constituent, derivative or extract of cannabis (instant claim 25; reference claim 1 (independent)).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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.
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, 5, 7-13, 15, 18, 21, and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Heller (US 20200054702 A1); and further in view of Ahn and Park (Biomaterials Research 2016, 20 (1), s40824-016-0083-1), abbreviated below as "Ahn".
Response to Arguments
Applicant's arguments filed July 6th, 2026 have been fully considered but they are not persuasive. The applicant has pointed out that the maltodextrin embedding of cannabinoids. The use of maltodextrin would not be required to slow or inhibit crystallization of one or more constituent, derivative or extract of cannabis. Inhibiting the crystallization of cannabinoids could be achieved by emulsifying cannabinoids using a surfactant, limiting the scale of the aggregation of cannabinoid molecules, and therefore, inhibiting their crystallization. Furthermore, the teachings of Heller are not limited to compositions that are dehydrated as Heller recites compositions as a gel or colloidal solution (paragraph [0010]).
Pending Rejection
Claim 1 recites “A composition comprising one or more constituent, derivative, or extract of cannabis, a means for solubilising the one or more constituent, derivative, or extract of cannabis in an aqueous environment, an additive which slows or inhibits crystallisation of the one or more constituent, derivative, or extract of cannabis, and one or more components increasing intestinal lymphatic transport of the one or more constituent, derivative, or extract of cannabis”. Claim 3 recites “A composition as claimed in claim 1, wherein the means for solubilising the one or more constituent, derivative, or extract of cannabis in an aqueous environment comprises encapsulation of the one or more constituent, derivative, or extract of cannabis, optionally wherein the encapsulation is by a molecular encapsulant, such as a cyclodextrin”. Claim 5 recites “A composition as claimed in claim 3, wherein the encapsulation is by a micelle comprising a surfactant, optionally wherein the surfactant is selected from the group consisting of long chain triglycerides, linoleic acid, glyceryl monooleate; and sodium lauryl sulfate (sodium dodecyl sulfate, SLS, or SDS), docusate sodium, lecithins, polyoxyethylene sorbitan fatty acid esters, polyoxyethylene 15 hydroxy stearate, polyoxyethylene castor oil derivative, polyoxyethylene stearates, sorbitan fatty acid esters, polyoxyethylene alkyl ethers, and polyoxyethylene nonylphenol ether and sugar esters”. Claim 7 recites “A composition as claimed in claim 5, wherein the composition comprises surfactant in an amount of from 0.5 to 20% by weight, based on the total weight of the composition”. Claim 8 recites “A composition as claimed in claim 1, wherein the additive is selected from the group consisting of polyvinylpyrrolidone (PVP), hydroxypropyl cellulose (HPC), methyl cellulose (MC), hydroxypropyl methyl cellulose (HPMC), poloxamer (F68), polyvidon, Hydroxypropyl methylcellulose acetate succinate (HPMC-AS), or a combination thereof”. Claim 9 recites “A composition as claimed in claim 1, wherein the one or more constituent, derivative, or extract of cannabis is selected from the group consisting of: cannabigerol (CBG), cannabichromene (CBC), cannabidiol (CBD), tetrahydrocannabinol (THC), cannabinol (CBN), cannabinodiol (CBDL), cannabicyclol (CBL), cannabivarin (CBV), tetrahydrocannabivarin (THCV), cannabidivarin (CBDV), cannabichromevarin (CBCV), cannabigerovarin (CBGV), cannabigerol monomethyl ether (CBGM), cannabinerolic acid, cannabidiolic acid (CBDA), cannabinol propyl variant (CBNV), cannabitriol (CBO), tetrahydrocannabmolic acid (THCA), and tetrahydrocannabivarinic acid (THCV A)”. Claim 10 recites “A composition as claimed in claim 1, wherein the constituent, derivative, or extract of cannabis is present in an amount of from 0.1 to 30% by weight, based on the total weight of the composition”. Claim 11 recites “A composition as claimed in claim 1, having enhanced bioavailability properties in the gastrointestinal system”. Claim 12 recites “A composition as claimed in claim 1, comprising one or more components enhancing enterocyte intestinal absorption of the one or more constituent, derivative, or extract of cannabis”. Claim 13 recites “A composition as claimed in claim 1, comprising a terpene, a grapefruit extract, piperine or a black pepper extract”. Claim 15 recites “A composition as claimed in claim 1, comprising a pH modifier, a flavour or sensate, and/or a further active agent”. Claim 18 recites “A composition as claimed in claim 1, wherein the composition is water soluble”. Claim 21 recites “A composition as claimed in claim 1, wherein the composition is an aqueous solution or colloidal dispersion”. Claim 25 recites “A beverage for providing gastric delivery of one or more constituent, derivative, or extract of cannabis, comprising a composition as claimed in claim 1”.
Heller recites a colloidal cannabinoid formulation: “The present disclosure involves a cannabinoid formulation that comprises encapsulated cannabinoids entrapped in a polymer matrix. The
cannabinoid embedded polymer matrix can be in a gel or colloidal solution (e.g., “sol”) state or can be
dehydrated to make a millable free flowing powder. The polymer matrix can be readily dissolvable in
aqueous environments upon which the encapsulated cannabinoids can be released into the aqueous
medium creating a substantially homogenous and substantially-perpetual stable emulsion” (paragraph
[0010]; instant claims 1, 3, 5, 18, and 21).
Heller further recites emulsifiers and surfactants useful to make encapsulated
emulsions: “Polymer based emulsifiers can be utilized to create encapsulated cannabinoid emulsions. However, it is possible to create cannabinoid emulsions using a wide variety and combination of different emulsifiers and surfactants. These include but are not limited to: Q-naturale (quillaja saponins), polysorbates (Tween 20, 60, 80), Span (20, 60, 80, 83, 85, 120), vegetable lecithins (phospholipids), polyethylene glycols (PEG 300, 400, 600) polyethylene glycol esters, polyethylene glycol ethers, polypropylene glycol ethers, polyol esters, poloxamers” (paragraph [0142]; instant claims 3, 5, and 8). It is within the knowledge of one of skill in the art that emulsifying cannabinoids limits the scale of the aggregation of cannabinoid molecules, and therefore, inhibits their crystallization (instant claim 1).
Heller further recites cannabinoid active ingredients: “The component, interchangeably referred
to herein as the active ingredient, can include oils, resins and molecules derived from the cannabis plant
or modeled after the components found in the cannabis plant. … These active ingredients include
cannabinoids such as: delta-9-tetrahydrocannabinolic acid (THCa), delta-9-tetrahydrocannabinol (THC),
cannabidiol acid (CBDa), cannabidiol (CBD), cannabinol (CBN), cannabigerol (CBG), cannabichromene (CBC), tetrahydrocannabivarin (THCV), cannabidivarin (CBDV), or combinations thereof” (paragraph [0012]; instant claims 1 and 9).
Heller further recites the inclusion of terpenes: “The addition of terpenes can be used to enhance or alter the effect of cannabinoids, or elicit their own physiological reaction. Terpenes found in the cannabis plant include: alpha-pinene, linalool, myrcene, limonene, ocimene, terpinolene, terpineol, valencene, beta-caryophyllene, geraniol, humulene, phellandrene, carene, terpinene, fenchol, borneol, bisabolol, phytol, camphene, sabinene, camphor, isoborneol, menthol, cedrene, nerolidol, guaiol, isopulegol, geranyl acetate, cymene, eucalyptol, pulegone” (paragraph [0012]; instant claim 13).
Heller recites including flavoring additives in the emulsion system: “Additives can be included in
the emulsion system or the polymer matrix to improve the flavor of the system. These flavoring
additives include but are not limited to: sugar, sucrose, sorbitol, sucralose, saccharin sodium, sodium
cyclamate, aspartame, neotame, acesulfame potassium, stevioside, sodium chloride, D-limonene, citric
acid, essential oils, natural and artificial flavors” (paragraph [0361]; instant claim 15).
Heller further recites the use of micelles to make emulsions: “Emulsifiers and surfactants are responsible for encapsulating the oily fraction and partitioning it from the aqueous phase. Depending on the type of emulsifier/surfactant used emulsions can be made from micelles or liposomes” (paragraph [0090]; instant claims 3 and 5).
Heller recites emulsion particles penetrating throughout the sub-mucosal layers in the intestine
(paragraph [0357]; instant claims 11 and 25), and beverages made with the cannabinoid emulsions of
Heller’s invention (paragraph [0379]; instant claim 25).
Although Heller does not explicitly recite enhancing intestinal enterocyte absorption, Ahn
recites “Compared with other lipid-based nanoparticles, liposomes have the ability to encapsulate and
protect drugs and to increase their absorption into enterocytes” (under heading: Liposomal
formulations for lymphatic drug transport; instant claims 1, 11, and 12). Ahn further recites liposomes engineered to increase efficiency of their uptake into enterocytes, through the incorporation of bile salts, and through making the liposomes elastic (Ahn, subheading: Improvement of liposome absorption into enterocytes; instant claims 1, 11, and 12).
Although Heller does not explicitly recite increasing intestinal lymphatic transport, Ahn recites
“Lipids of liposomes can also be utilized to stimulate the production of chylomicrons in enterocytes, thus
enhancing drug transport into the lymphatic system” (under heading: Liposomal formulations for lymphatic drug transport; instant claims 1, 11, and 12), where enterocytes are broadly understood in the art as cells comprising the intestines (instant claims 1, 11, and 12).
Therefore, it would have been obvious to the person having ordinary skill in the art to
manufacture a composition with liposomal components as disclosed by Ahn to enhance and increase
enterocyte intestinal absorption and intestinal lymphatic transport, because Heller discloses liposomal
compositions for intestinal transport.
Instant claim 7 is distinguished from Heller in that Heller does not recite a surfactant weight percentage of 0.5-20% in a composition comprising a one or more components increasing intestinal lymphatic transport of the one or more constituent, derivative, or extract of cannabis. (reasonably, a liposomal emulsion, per the teachings of the prior art). Instant claim 10 is distinguished from Heller in that Heller does not recite a constituent, derivative, or extract of cannabis weight percentage of 0.1-30% in a composition comprising one or more components increasing intestinal lymphatic transport of the one or more constituent, derivative, or extract of cannabis. (reasonably, a liposomal emulsion, per the teachings of the prior art). However, both of these parameters are obvious to one of skill in the art over routine optimization. One of skill in the art could control these weight percents though the use of a laboratory scale. One of skill in the art could observe, at fixed time intervals, compositions prepared according to different weight percents of surfactant and/or the one or more constituent, derivative, or extract of cannabis. During this observation, one of skill in the art could check for phase separation and thereby compare different compositions in terms of the duration of the one or more constituent, derivative, or extract of cannabis remaining solubilized (instant claims 7 and 10).
Heller and Ahn are relied upon for the reasons discussed above. If not expressly taught thereby, based upon the overall beneficial teachings provided by the references with respect to providing the components of the instantly claimed composition, the adjustments of particular conventional working conditions (e.g., the selection from among known components and determining one or more suitable ranges (amounts, proportions, ratios thereof) in which to provide the composition), is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan.
From the teachings of Heller in view of Ahn, the invention as a whole, drawn to a composition comprising a constituent , derivative, or extract of cannabis as described in Claims 1, 3, 5, 7-13, 15, 18, 21, and 25, would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, and one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Please note, since the Office does not have the facilities for examining and comparing
Applicants’ composition with the composition of the prior art, the burden is on applicant to show
a novel or unobvious difference between the claimed product and the product of the prior art. See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald, 619 F.2d 67, 205 USPQ 594 (CCPA 1980), and “as a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith.” In re Brown, 459 F.2d 531, 535, 173 USPQ 685, 688 (CCPA 1972).
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new grounds 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 Robert F Spaine whose telephone number is (571)272-9099. The examiner can normally be reached 8:00 AM - 4:00 PM United States Eastern Time, Monday-Friday.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anand Desai can be reached at (571) 272-0947. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/R.F.S./Examiner, Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655
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