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 .
Priority
The instant application was filed 23 September 2022 and is the continuation of PCT/US2021/024710 filed 29 March 2021. The Applicant claims priority to provisional application 63/002,162 filed 30 March 2020. Therefore, the effective filing date of the instant application is 30 March 2020.
Examiner’s Note
The Applicant's amendments and arguments filed 30 January 2026 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Rejections
not reiterated from previous office actions are hereby withdrawn. The following rejections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. In the Applicant’s response, filed 30 January 2026, it is noted that claims 1, 10, 13, and 16 have been amended, claims 2-9, 12, 14, 15, and 21-30 have been canceled, and no new claims have been added. Support for the amendment(s) and/or new claim(s) can be found on para. 21 of the specification. No new matter has been added.
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.
Claim(s) 1, 10, 11, and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kleidon (WO 2017/218845 A1), Malomo (Structural and Antihypertensive Properties of Enzymatic Hemp Seed Protein Hydrolysates, Nutrients, 2015), and De Angelis (Endocannabinoids Control Platelet Activation and Limit Aggregate Formation under Flow, 2013).
Kleidon teaches methods of administering an encapsulated cannabinoid capsule composition (entire teaching; abs; para 64). Kleidon also teaches that the composition is useful in treating a subject infected with influenza (para. 53, claim 5), addressing the viral infection limitation in claim 1. Kleidon teaches other antimicrobial agents may also be added (para. 94, 97, 98, 99), such as isoborneol, which is an antiviral agent for HIV (para. 106), addressing the additional antiviral compound limitation in claim 1. The composition may have a plurality of capsules (para. 153) where the individual capsule may have a diameter with a large range of at least about 0.001 micrometers (para. 128), which is interpreted as addressing the microcapsule limitation of claim 1.
Kleidon does not explicitly teach that the method of administering the composition leads to lower expression or activity of angiotensin converting enzymes in claims 1 and 13, reduced blood clot in claim 10, or reduced platelet aggregation in claim 11.
Malomo teaches that hemp seed protein hydrolysates, which contain trace amounts of cannabinoids and are derived from hemp plants and will thus contain cannabinoids in said hemp plant, have an inhibitory effect for ACE activities (pg. 7618).
De Angelis teaches that cannabinoids can affect and reduce platelet activation (abs), which is interpreted as reducing the ability for blood to clot. Anandamide, which is functionally similar to THC, inhibits glycoprotein IIB/IIIa activation (pg. 6). De Angelis teaches measuring platelet aggregation through light transmission (pg. 2). Since De Angelis teaches reduction of platelet aggregation and provides examples where aggregation is reduced (Figure 1), it is interpreted that there will be a reduction in aggregation overall.
Kleidon teaches the same composition containing a cannabinoid (in a microcapsule) to treat a viral infection. Even though Kleidon is silent about the claimed underlying mechanism of action, such underlying mechanism of action or “administering effect” by the cannabinoid compound or the composition containing the cannabinoid compound must necessarily and inevitably occur when following the steps or teaching of prior method.
Even if assuming arguendo that such administering effect is not inherent to the teaching of the prior art, Malomo makes clear that cannabinoid reduces the activity or expression of ACE in claims 1 and 13.
A person of ordinary skill in the art would have known at the relevant time that the claimed administering effect occurs when the cannabinoid is administered to a patient with a viral infection. One having ordinary skill in the would have motivated to combine the references with reasonable expectation of success to provide beneficial effects to a viral infection patient, such as influenza, by reducing the activity of ACE.
In regards to reduced blood clot in claim 10 and reduced platelet aggregation in claim 11, Kleidon teaches the same composition containing a cannabinoid (in a microcapsule) to treat a viral infection. Even though Kleidon is silent about the claimed underlying mechanism of action, such underlying mechanism of action or “administering effect” by the cannabinoid compound or the composition containing the cannabinoid compound must necessarily and inevitably occur when following the steps or teaching of prior method.
Even if assuming arguendo that such administering effect is not inherent to the teaching of the prior art, De Angelis, makes clear that cannabinoid reduces platelet activation and blood clot formation in claims 10 and 11.
A person of ordinary skill in the art would have known at the relevant time that the claimed administering effect occurs when the cannabinoid is administered to a patient with a viral infection. One having ordinary skill in the would have motivated to combine the references with reasonable expectation of success to provide beneficial effects to a viral infection patient, such as influenza, by reducing platelet activation (through inhibition of glycoprotein IIB/IIIa).
In regards to selecting the combination of encapsulated cannabinoid capsules and active agents, “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious.” KSR v. Teleflex, 127 S.Ct. 1727, 1740 (2007) (quoting Sakraida v. A.G.Pro, 425 U.S. 273, 282 (1976)). “When the question is whether a patent claiming the combination of elements of prior art is obvious,” the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR at 1741. The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742.
Consistent with this reasoning, it would have been obvious to have selected various
combination of various disclosed ingredients from within a prior art disclosure, to arrive at compositions “yielding no more than one would expect from such an arrangement.”
Claim(s) 1, 10, 11, 13, 16-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kleidon (WO 2017/218845 A1), Malomo (Structural and Antihypertensive Properties of Enzymatic Hemp Seed Protein Hydrolysates, Nutrients, 2015), De Angelis (Endocannabinoids Control Platelet Activation and Limit Aggregate Formation under Flow, 2013), and Akinola et al. (Oral Ingestion of Cannabis sativa: Risks, Benefits, and Effects on Malaria-Infected Hosts, Cannabis Cannabinoid Res., 2018).
In regards to claim(s) 1, 10, 11, and 13, Kleidon et al., as applied supra, is herein applied in its entirety for its teachings of administering an encapsulated cannabinoid capsule composition.
Kleidon teaches that their composition may include additional active agents in their microcapsule composition (para. 140), addressing claim 17. The general teaching of the formulation comprising different agents in capsules wherein the composition may have a plurality of capsules is interpreted as the limitations in claims 18 and 19. The cannabinoid may be provided in a non-encapsulated form (para. 143), addressing claim 20.
Kleidon does not specifically teach using chloroquine in claim 16.
Akinola et al. teach that there may be benefits in a combination treatment using chloroquine, a well-known drug to treat malaria, and cannabis (abs, Figure 1).
Since Kleidon does not specifically teach using chloroquine in their method and composition in claim 16, one of ordinary skill in the art would have been motivated to use Akinola’s teaching to address this deficiency. A person of ordinary skill in the art would have been led to combine the teachings because Kleidon teaches a treatment for malaria (para. 9), as well as additional antimicrobial components in their composition. Since chloroquine is well-known in the art to treat malaria and may have potential benefits in treating malaria when combined with cannabis, a skilled artisan would have been motivated to use chloroquine in Kleidon’s method and composition with a reasonable expectation of success.
Response to Arguments
Applicant's arguments filed 30 January 2026 have been fully considered but they are not persuasive.
The Applicant argues that the inherency analysis of Kleidon is based on selective reconstruction (Remarks, pg. 5).
Applicant’s argument is not found persuasive. Kleidon teaches the same composition containing a cannabinoid (in a microcapsule) to treat a viral infection. Even though Kleidon is silent about the claimed underlying mechanism of action, such underlying mechanism of action or “administering effect” (recited in instant claim 1) by the cannabinoid compound or the composition containing the cannabinoid compound must necessarily and inevitably occur when following the steps or teaching of prior method.
The Applicant argues against the prior art teachings but has amended the claims to exclude limitations, such as reduced cytokine expression or activity (Remarks, pg. 5).
The teachings from Rom, Teijaro, Dahdouh, Single, and Akinola have been removed and will not be addressed.
The Applicant argues that Single does not teach cannabinoid functionality on the angiotensin converting enzyme (Remarks, pg. 6).
The teachings from Singla have been removed and will not be addressed.
Conclusion
Applicant's amendment necessitated the new ground(s) 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 Danielle Kim whose telephone number is (571)272-2035. The examiner can normally be reached M-F: 9-5 p.m. PST.
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, Brian-Yong Kwon can be reached at (571)272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/D.A.K./Examiner, Art Unit 1613
/ANDREW S ROSENTHAL/Primary Examiner, Art Unit 1613