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 .
Applicant’s election without traverse of Group I (Claims 1-4, 6 and 27) in the reply filed on February 24, 2026 is acknowledged.
Claims 8, 11-13, 20-26, 28 and 29 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on February 24, 2026. Accordingly, applicant need to change the status identifiers for the withdrawn claims to --- (withdrawn) ---.
Claim Objections
Claim 1 is objected to because of the following informalities: on line 3, applicant need to change “cannabinoid containing” to --- cannabinoid-containing --- (so as to make the meaning of the claim more clear). Appropriate correction is required.
Claim 4 is objected to because of the following informalities: on line 2, applicant need to insert --- the CPEVs --- between “administering” and “comprises” (so as to make the meaning of the claim more clear). Appropriate correction is required.
Claim 6 is objected to because of the following informalities: on both line 2 and line 4, applicant need to change “comprising” to --- comprises ---. Appropriate correction is required.
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 2 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.
Claim 2 recites the limitation "the composition" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 6 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.
Claim 6 recites the limitation "the mammal" in line 2. There is insufficient antecedent basis for this limitation in the claim. Instant rejection can be overcome by changing claim 6 to recite --- wherein the adjunct cancer therapy protocol comprises a radiation treatment before, during, or after the administration of the CPEVS, and/or . . .”.
Claim 27 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.
In claim 27, applicant recite percentages for each of CBD-A, CBG-A, THC-A, CBD and THC. However, it is unclear from the claim language whether those percentages are weight percentages (based on the total weight of the cannabinoids) or volume percentages (based on the total volume of a cannabinoid solution)? For the purpose of examining the claim on the merit, the Examiner assumed that applicant meant the former based on applicant’s statement (pg.20, lines 20-21) in present specification that major cannabinoid content of hemp EVs (CBD, CBD-A, THC, THC-A, CBG, CBG-A) was quantified using Liquid chromatography tandem mass spectrometry (LC-MS/MS). Appropriate correction is required.
Claim Rejections - 35 USC § 103
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.
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.
Claim(s) 1-3, 6 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Sawyer et al (US 2016/0271100 A1) in view of Rome (“Biological properties of plant-derived extracellular vesicles”, Food & Function, vol.10(2) (Feb 20, 2019), pg.529-538), Akuma et al (“Naturally Occurring Exosome Vesicles as Potential Delivery Vehicle for Bioactive Compounds”, Frontiers in Sustainable Food Systems, vol.3, Article 23 (April 16, 2019), pg.1-8, provided in the IDS), and Chukly et al (US 2021/0260201 A1).
Sawyer teaches (claims 1 and 11) a method for treating a tumor, such as a brain tumor, the method comprising identifying a subject having a tumor and administering to the subject a chemotherapy agent and/or radiation (instant co-administration of an adjunct cancer therapy protocol), and topically administering a composition containing a cannabinoid.
Sawyer does not teach instant cannabinoid-containing plant extracellular vesicles (CPEVs). As taught by Rome (see pg.534, left-hand column, last paragraph), Akuma et al (See pg.4, right-hand column, 1st paragraph) and Chukly et al (see [0065]), plant-derived extracellular vesicles are excellent candidates for the delivery of therapeutic agents, including cannabinoids, as they are able to cross mammalian barriers without inducing inflammatory response or necrosis, unlike conventional liposomal delivery vehicles. They are more biocompatible and safer than synthetic liposomes. Furthermore, Rome teaches (pg.534, right-hand column, 2nd paragraph) that plant derived extracellular vesicles (“plant-EVs” as called by Rome) are able to bind hydrophobic agents (cannabinoids are hydrophobic) increasing the bioavailability of the hydrophobic agents and their cellular uptake. Also, as taught by Rome (pg.534, left-hand column, 2nd paragraph) and Akuma (pg.4, left-hand column, 1st paragraph), plant-derived extracellular vesicles are known to be enriched in bioactive compounds from their plant source, which implies that cannabis plant-derived extracellular vesicles would naturally be enriched in cannabinoids. Since Sawyer teaches topically administering cannabinoid (in its method of treating brain tumors), it would have been obvious to one skilled in the art to use cannabis plant-derived extracellular vesicles (instant CPEVs) as Sawyer’s cannabinoid with a reasonable expectation of success because CPEVs are already enriched with cannabinoids, they can cross mammalian barriers without inducing inflammatory response or necrosis, they are more biocompatible and safter than synthetic liposomes and they increase the bioavailability and cellular uptake of the cannabinoids (hydrophobic agents). Thus, Sawyer in view of Rome, Akuma and Chukly renders obvious instant claim 1.
With respect to instant claim 6, as discussed above, Sawyer’s method for treating a tumor (such as a brain tumor) comprises administering to the subject a chemotherapy agent and/or radiation (instant co-administration of an adjunct cancer therapy protocol), and topically administering a composition containing a cannabinoid. Sawyer further teaches ([0038]) that the chemotherapy agent and/or radiation treatment can be administered (to the subject having a tumor) together with topically administering its cannabinoid composition. Sawyer also teaches (claims 20 and 6) that the cannabinoid, such as dronabinol, can be administered subsequent to or together with administering chemotherapy agents, such as taxanes, platinum compounds, vinca alkaloids, thalidomide, bortezomib, corticosteroids and bevacizumab. Thus, Sawyer in view of Rome, Akuma and Chukly renders obvious instant claim 6.
With respect to instant claims 2 and 3, Sawyer teaches ([0026]) that the cannabinoid-containing composition can be applied intranasally to the mucous membrane inside of the nose. Furthermore, Rome teaches (pg.534, right-hand column, 1st paragraph) that when plant-derived EVs (grapefruit-derived EVs) were administered intranasally, a majority of the fluorescence-labelled GF-EVs were found in the brain and lungs and GF-EVs remained in the brain for at least five days post-treatment. Thus, it would be obvious to one skilled in the art to administer the CPEVs (as Sawyer’s cannabinoid as discussed above) intranasally with a reasonable expectation that the CPEVs will remain in the brain at least for several days post-administration and thus will be more bioavailable to treat the brain tumor. Thus, Sawyer in view of Rome, Akuma and Chukly renders obvious instant claims 2 and 3.
With respect to instant claim 27, Sawyer in view of Rome, Akuma and Chukly does not explicitly teach instant composition of the CPEVs. However, Akuma teaches (pg.2, right-hand column, 2nd paragraph) that the gold standard procedure for isolating and purifying exosomes and exosome-like particles is through differential ultracentrifugation. In such process, the exosome source (for example, cannabis plant juice in this case) is subjected to a series of centrifugation processes with increasing speeds and duration to eliminate the larger and higher density components, and the pellets derived from such steps are discarded. The final round of centrifugation of the supernatant is done at higher speeds of about 100,000 x g to recover the pellet containing the exosome, which is then re-suspended and washed in a buffer. It would have been obvious to one skilled in the art to apply the process as described in Akuma to isolate the CPEVs from cannabis plant juice (hemp juice) with a reasonable expectation of success. Since Akuma’s process is almost identical to the process used by applicant to obtain their CPEVs (see pg.20, lines 10-26 of present specification), it is the Examiner’s position that the CPEVs which is isolated using Akuma’s process would inherently contain the same composition as that of instant claim 27. Thus, Sawyer in view of Rome, Akuma and Chukly renders obvious instant claim 27.
Claim(s) 4 is rejected under 35 U.S.C. 103 as being unpatentable over Sawyer et al (US 2016/0271100 A1) in view of Rome (“Biological properties of plant-derived extracellular vesicles”, Food & Function, vol.10(2) (Feb 20, 2019), pg.529-538), Akuma et al (“Naturally Occurring Exosome Vesicles as Potential Delivery Vehicle for Bioactive Compounds”, Frontiers in Sustainable Food Systems, vol.3, Article 23 (April 16, 2019), pg.1-8, provided in the IDS), and Chukly et al (US 2021/0260201 A1), as applied to claim 1 above, and further in view of Kaufman (US 2018/0296493 A1).
As discussed above, Sawyer in view of Rome, Akuma and Chukly renders it obvious to administer the CPEVs (as Sawyer’s cannabinoid) intranasally to the mucous membrane inside of the nose. Although Sawyer in view of Rome, Akuma and Chukly does not explicitly teach a specific device that can be used for the intranasal administration, as evidenced by Kaufman ([0262]), it is well known in the art that phospholipid nanoparticle formulations of cannabinoids can be delivered intranasally by using a precision liquid pump device bottle (instant pump). It would have been obvious to one skilled in the art to use a precision liquid pump device bottle to administer the CPEVs intranasally with a reasonable expectation of success. Thus, Sawyer in view of Rome, Akuma and Chukly, and further in view of Kaufman renders obvious instant claim 4.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SIN J. LEE whose telephone number is (571)272-1333. The examiner can normally be reached on M-F 9 am-5:30pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian Kwon can be reached on 571-272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SIN J LEE/
Primary Examiner, Art Unit 1613
April 3, 2026