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 Status
Applicants' arguments and Declaration filed 09/30/2025, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claims 1-3,23-25 and 98 are under current examination.
Information Disclosure Statements
Information Disclosure Statements (IDS) filed on 09/30/2025 and 10/24/2025 have been considered by the Examiner. A signed copy of the IDS is included with the present Office Action.
Rejections maintained and modified to include addition of new claim 98
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, 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, 23-25 and new claim 98 are rejected under 35 U.S.C. 103 as being unpatentable over Holladay et al. (United States Patent Publication 20200171083), Tel-Ari et al. (WO2019244160) and Edwards et al. (EP0241175 A1).
Holladay et al. teach compositions which comprise silver and one or more cannabinoids, see paragraph [0008]. The silver includes salts thereof, see paragraph [00031]. The composition is used in a method to combat and treat bacterial infection and reduce inflammation, see paragraph [0080] and [0084] and [0174]-[0175]. The composition is applied to the body including skin surfaces, see paragraph [0019]. The cannabinoids include one or more of cannabichromene CBC and CBG cannabigerol, see paragraph [0013], [0025], [0037]-[0038],[0040], [0113], and [0157]-[0158]. The product can be applied to human (thus a mammal) or animals, see paragraph [0118]. Concentrations of the silver can comprise 0.1-1000ppm (0.00001-0.1% or 0.0001mg/ml-1mg/ml), see paragraph [0046]. The one or more cannabinoids are taught to be present from 10-1000mcg (.01mg/mL-1mg/ml). The positive-positive drug interaction would be the natural result of the combination of the cannabinoids with silver salt. Holladay et al. teach the composition can be in a dry powder form (paragraphs [0019] and [0114] [0117]) and can comprise oils, see paragraphs [0043], [0064], [0070], [0117], and [0129]. The formulations can further comprise antibiotics, see paragraph [0079].
Holliday et al. does not teach that the silver enhances the antimicrobial effect of the cannabinoid and/or silver containing substance or that there is a synergistically effective antimicrobial activity.
However, Tel-Ari et al. providing for an antimicrobial composition having cannabinoid and inorganic salts including silver examples 1A-1C and claims 1-5 and 17. The cannabinoids of Group A and the inorganic salts including silver salts can provide synergism in treating infections, see page 3. The composition of inorganic salts and cannabinoids provides for reduction in bacteria, see page 13.
Edwards et al. teach synergistic mixtures of silver compound with antibiotics such as metronidazole, see abstract and claims 1-2, 9 and 20-21. The silver can comprise silver sulphate or silver nitrate, see pages 3 and 6. The composition provides for synergistic antimicrobial activity, see abstract and pages 2 and 5.
It would have been prima facie obvious to provide the silver salt of Holladay as a silver sulphate in combination with Holladay’s cannabinoids CBC and CBC and to provide a mixture with the antibiotic metronidazole with the motivation of providing synergistic effective antimicrobial activity.
There would have been a reasonable expectation of success because Tel-Ari teaches the advantages of providing a combination of cannabinoids with silver compounds and Holladay teaches the combination of cannabinoids with silver compounds to combat bacterial infections on a body surface with Holladay expressly teach that their mixture can further include antibiotics. The combination of silver with antibiotics has known synergism per the teachings of Edwards.
With regards to the positive-positive drug interaction that enhances the antimicrobial effect of cannabinoid and/or silver substance, and synergism, and wherein the silver is administered in a regimen that reduces the MIC of the cannabinoids, wherein the cannabinoids reduce the MIC of the silver substance when the cannabinoids are present in an amount less than the MIC of cannabinoids, wherein the silver substance reduces the MIC of the cannabinoids when the silver substance is present in an amount that is less than the MIC of the silver containing substance, wherein the cannabinoids are present in a relative amount that provides at least a 2-128 decrease in MIC of the silver substance, wherein the silver containing substance is administered in a relative amount that provides at least a 2-128 decrease in the MIC of the cannabinoids is the natural result of combining silver sulfate with the cannabinoids of Holliday. The combination of silver sulfate with the cannabinoids and metronidazole of the modified Holladay would necessarily have these synergistic antimicrobial properties. Per Edwards, silver has synergism with antimicrobial compounds including metronidazole and cannabinoids have synergism also with antimicrobial compounds such as silver (see Tel-Ari), therefore the combination of silver sulfate with the cannabinoid and metronidazole of Holliday in view of Tel-Ari and Edwards would necessarily have synergistic antimicrobial properties. The fact that the silver substance is administered to reduce the MIC of cannabinoids and that cannabinoids provide decrease in the MIC of silver compounds would be the natural result of the combination of silver sulphate and CBC with CBG. With regards to the concentration of silver sulfate and cannabinoids, the instant specification at paragraph [0059] teaches that cannabinoids are present in as little as 0.125-16mg/l (equivalent to 0.000125-0.016mg/ml) with silver sulfate present in as little as from 0.01-10mg/l (equivalent to 0.00001mg/ml to 0.01mg/ml; equivalent to 0.000001-0.001%). The combination of Holliday and Edwards and Tel-Ari arrives at a silver nitrate concentration and cannabinoids MIC concentration that overlaps the concentrations of the instant application. Therefore, as the combination of Holliday with Edwards and Tel-Ari render obvious the combination of silver compound with cannabinoids, the 2 to 128 decrease in the MIC of silver substance or cannabinoids and the reduction of the MIC of the cannabinoids when silver is present in an amount that is less than the MIC of the silver substance would necessarily follow. It is noted that per the teachings of Tel-Ari, the combination of cannabinoids with antimicrobial compounds imparts synergy.
Claims 1-3, 23-25 and new claim 98 are rejected under 35 U.S.C. 103 as being unpatentable over Brener et al. (WO2018011813) , Edwards et al. (EP0241175 A1) and Holladay et al. (United States Patent Publication 20200171083).
Brener et al. teach a synergistic pharmaceutical formulation comprising an anti-bacterial agent, at least one cannabinoid and a carrier, see claim 1. The antibacterial efficacy is better than the efficacy of the same formulation having 2 to 150 times the amount of antibacterial agent, see claim 2. The MIC of the antibiotics is reduced 4-16 fold in combination with cannabinoids, see pages 21-22. The antibacterial can comprise azoles such as metronidazole (azole), see claim 4 and abstract and pages 9, and 13. The at least one cannabinoids comprise cannabigerol or cannabichromene, see pages 7, 9,14, and claim 1-4 and 18. The invention provides for a method of treating bacterial infections, see abstract, page 3-8, claims 35-41 and entire document. The cannabinoids is exemplified in at least 0.0002mg/ml however can be present from 0.5-50mg (.05-5%), see pages 17 and 21-23. Brener teaches administering the at least one cannabinoid and antibacterial agent together to treat a human patient, see page 10, 17, and claim 42.The treatment involves treating bacterial infections or biofilms, see pages 3-4,9,10,15, 26 and claims 34-35 and entire document. The composition can be in powder form and can comprise oily excipients, see pages 12 and 19.
Brener does not teach the inclusion of silver compounds such as silver sulfate with the cannabinoids.
Edwards et al. teach synergistic mixtures of silver compound with antibiotics such as metronidazole, see abstract and claims 1-2, 9 and 20-21. The silver can comprise silver sulphate or silver nitrate, see pages 3 and 6. The composition provides for synergistic antimicrobial activity, see abstract and pages 2 and 5.
Holladay et al. teach compositions which comprise siler and one or more cannabinoids, see paragraph [0008]. The composition is used to combat and treat bacterial infection and reduce inflammation, see paragraph [0080] and [0084] and [0174]-[0175]. The composition is applied to the body including skin surfaces, see paragraph [0019]. The cannabinoids include one or more of BCB and CBG see paragraph [0013], [0025], [0037]-[0038],[0040], [0113], and [0157]-[0158]. The product can be applied to human (thus a mammal) or animals, see paragraph [0118]. Concentrations of the silver can comprise 0.1-1000ppm (0.00001-0.1% weight), see paragraph [0046].The positive drug interaction would be the natural result of the combination of the cannabinoids with silver nitrate.
It would have been prima facie obvious to provide the composition of Brener with silver sulphate to form a synergistic antimicrobial composition having silver sulphate, antibiotic (e.g. metronidazole) and cannabinoids such as cannabichromene and cannabigerol.
One of ordinary skill in the art would have been motivated to do so because it is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose. The idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted). Here, from the teachings of Brener, cannabinoids such as CBC and CBG have synergy with vancomycin or gentamicin, and per the teachings of Edwards et al., silver also has synergism with antibiotics such as metronidazole. Thus, the combination of silver with metronidazole and cannabinoids such as cannabigerol and cannabichromene would provide a synergistic antimicrobial composition. There would have been a reasonable expectation of success because per the teachings of Holladay, silver compounds which include salts can be combined with cannabinoids for treating infections and both silver and cannabinoids have synergetic properties with vancomycin or gentamicin.
With regards to the positive-positive drug interaction that enhances the antimicrobial effect of cannabinoid and/or silver substance, and synergism, and wherein the silver is administered in a regimen that reduces the MIC of the cannabinoids, wherein the cannabinoids reduce the MIC of the silver substance when the cannabinoids are present in an amount less than the MIC of cannabinoids, wherein the silver substance reduces the MIC of the cannabinoids when the silver substance is present in an amount that is less than the MIC of the silver containing substance, wherein the cannabinoids are present in a relative amount that provides at least a 2-128 decrease in MIC of the silver substance, wherein the silver containing substance is administered in a relative amount that provides at least a 2-128 decrease in the MIC of the cannabinoids is the natural result of combining silver sulfate with the cannabinoids of Brener. The combination of silver sulfate with the cannabinoids and metronidazole of the modified Brener would necessarily have these synergistic antimicrobial properties. silver has synergism with antimicrobial compounds including metronidazole and cannabinoids have synergism also with antimicrobial compounds such as metronidazole, therefore the combination of silver nitrate with the cannabinoid and metronidazole of Brener would necessarily have synergistic antimicrobial properties. The fact that the silver substance is administered to reduce the MIC of cannabinoids and that cannabinoids provide decrease in the MIC of silver compounds would be the natural result of the combination of silver sulphate and CBC with CBG. With regards to the concentration of silver nitrate and cannabinoids, the instant specification at paragraph [0059] teaches that cannabinoids are present in as little as 0.125-16mg/l (equivalent to 0.000125-0.016mg/ml) with silver sulfate present in as little as from 0.01-10mg/l (equivalent to 0.00001mg/ml to 0.01mg/ml; equivalent to 0.000001-0.001%). The combination of Brener and Edwards and Holladay arrives at a silver nitrate concentration and cannabinoids MIC concentration that overlaps the concentrations of the instant application. Therefore, as the combination of Brener with Edwards and Holladay render obvious the combination of silver compound with cannabinoids, the 2 to 128 decrease in the MIC of silver substance or cannabinoids and the reduction of the MIC of the cannabinoids when silver is present in an amount that is less than the MIC of the silver substance would necessarily follow. It is noted that per the teachings of Brener, the combination of cannabinoids with antimicrobial compounds imparts synergy and enables the MIC value to be reduced.
Response to Remarks
Applicants argue that the references do not teach any claimed combination of CBC with CBG and silver containing substance with any specificity. Holladay and Tel-Ari list only a broad range of cannabinoids and nothing teaches the combination with specific specificity of CBG and CBC. Applicants argue that Tel-Ari and Holladay suggest that all the cannabinoids are essentially equivalent and any cannabinoid could be used in the composition.
In response, examiner respectfully submits that claim 1 does not limit a combination of just CBG and CBC such that there is specificity to the combination. Rather, claim 1 recites cannabinoids comprising CBG and CBC. The cannabinoids of Holladay can comprise one or more specific cannabinoids or multiple cannabinoids and include CBC, CBCN, CBE, CBG, CBL, CBN, CBND, CBT, isocannabinoids and THC. It would have been obvious to combine said cannabinoids which include CBC and CBG with silver per the teachings of Holliday which combine mixtures of cannabinoids with silver compounds. Furthermore, Tel-Ari’s group A is at least one member which includes mixtures thereof.. in this teaching of group A there is CBG and CBC and the reference teaches and mixtures thereof of Group A components. Tel-Ari teaches Group A includes one or more cannabinoids selected from a group consisting of active cannabinoids, including inter alia, THC (Tetrahydrocannabinol), THCA (Tetrahydrocannabinolic acid), BDA (Cannabidiolic Acid), CBN (Cannabinol), CBG (Cannabigerol), CBC (Cannabichromene), CBD (Cannabidiol and/or CBDA) CBL (Cannabicyclol), CBV (Cannabivarin), THCV (Tetrahydrocannabivarin), CBDV (Cannabidivarin), CBCV (Cannabichromevarin), CBGV (Cannabigerovarin), CBGM (Cannabigerol Monomethyl Ether), CBE (Cannabielsoin), CBT (Cannabicitran), hemp oil, cannabis oil, cannabis-seed oil derivatives, and any derivatives, extracts and mixtures thereof.
Applicants argue that while Tel-Ari refers to synergy, no results are exemplified and without data Tel-Ari merely asserts synergism. Furthermore, the only cannabinoids specifically identified in Tel-Ari is CBD. Applicants argue that based on such generic disclosure in Tel-Ari, the reference would not convey that any positive drug-drug interaction could be achieved using any of the compositions disclosed therein.
Examiner respectfully submits that while only CBD is exemplified, from the teaching of Tel-Ari one of ordinary skill in the art is notified that the cannabinoids include mixtures thereof and that cannabinoids can be mixed with silver compounds to have a synergistic therapeutic effect. Examiner notes that suggestion of synergism would indicate a positive drug interaction, however the instant claim1 does not necessarily require synergism. Nevertheless, even if Tel-Ari does not focus on synergism examples, Edwards et al. teach synergistic mixtures of silver compound with antibiotics such as metronidazole, see abstract and claims 1-2, 9 and 20-21. The silver can comprise silver sulphate or silver nitrate, see pages 3 and 6. The composition provides for synergistic antimicrobial activity, see abstract and pages 2 and 5. would have been prima facie obvious to provide the silver salt of Holladay as a silver sulphate in combination with Holladay’s cannabinoids CBC and CBC and to provide a mixture with the antibiotic metronidazole with the motivation of providing synergistic effective antimicrobial activity. The combination of cannabinoids with silver and metronidazole would result in synergism because per the teachings of Edwards, silver is synergistic with antibiotics and per the teachings of Holladay, the silver plus cannabinoid compositions can further comprise an antibiotic compound. Examiner notes that the instant claims recite comprising language, thus synergy can be achieved with addition of silver compound and antibiotic.
Applicants argue that Edwards is silent about cannabinoids.
Examiner respectfully submits that even though Edwards does not teach cannabinoids, Halladay teaches a combination cannabinoids with silver and an further including antibiotic.
Edwards et al. teach synergistic mixtures of silver compound with antibiotics such as metronidazole, see abstract and claims 1-2, 9 and 20-21. The silver can comprise silver sulphate or silver nitrate, see pages 3 and 6. The composition provides for synergistic antimicrobial activity, see abstract and pages 2 and 5. The mixture of antibiotics as taught by Edwards with silver is already known to impart synergistic results. Since the cannabinoids and silver are taught to further contain an antibiotic, per the teachings of Edwards the mixture of antibiotics with silver results in synergism, therefore the combination having cannabinoids, silver and antibiotic would necessarily result in synergistic results. Furthermore, the examiner brings to applicant's attention that the reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. See, e.g., In re Kahn, 441 F.3d 977, 987, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006) (motivation question arises in the context of the general problem confronting the inventor rather than the specific problem solved by the invention); Cross Med. Prods., Inc. v. Medtronic Sofamor Danek, Inc., 424 F.3d 1293, 1323, 76 USPQ2d 1662, 1685 (Fed. Cir. 2005) (“One of ordinary skill in the art need not see the identical problem addressed in a prior art reference to be motivated to apply its teachings.”); In re Linter, 458 F.2d 1013, 173 USPQ 560 (CCPA 1972); In re Dillon, 919 F.2d 688, 16 USPQ2d 1897 (Fed. Cir. 1990), cert. denied, 500 U.S. 904 (1991). Here, the motivation to combined cannabinoids with silver sulfate or silver nitrate and metronidazole antibiotic would be to impart synergy. Although Edwards does not recognize that the synergism is from the combination of CBC and CGG with silver compounds like Applicants recognizes, the resultant product of the prior art imparts synergism as suggested by Edwards.
Applicants argue that Brenner states that a wide range of cannabinoids are synergistic with a wide range of antibiotics. Applicants argue that Brenner fails to show synergy as shown in the Thompson Declaration. Applicants argue that the alleged equivalence between different cannabinoids is disproved in the present application and that the present application and post filing evidence show the surprising and unexpected positive drug interactions between CBC and CBG and silver containing substances.
Examiner respectfully submits that while Brenner does not show synergism between CBC plus CBC and silver compounds, Brenner teaches synergism between cannabinoids and antibiotic compounds. Edwards et al. teach synergistic mixtures of silver compound with antibiotics such as metronidazole, see abstract and claims 1-2, 9 and 20-21. The silver can comprise silver sulphate or silver nitrate, see pages 3 and 6. The composition provides for synergistic antimicrobial activity, see abstract and pages 2 and 5. It would have been prima facie obvious to provide the composition of Brener with silver sulphate and metronidazole to form a synergistic antimicrobial composition having silver sulphate, antibiotic (e.g. metronidazole) and cannabinoids such as cannabichromene and cannabigerol because silver compounds are taught in Edwards to impart synergism with antibiotic and Brenner teaches the presence of antibiotic compounds. The combination with silver and cannabinoids would necessarily be synergistic because synergy is demonstrated between silver and antibiotics. Brener teaches at least one cannabinoid selected from BCC, CBD and any combination thereof with antibiotics. Applicants argue that Brenner fails to show synergism like in the Thompson declaration however the instant claims do not exclude the combination with antibiotic to achieve synergism. In addition, the instant claims do not require CBC and CBG alone and furthermore the claim just requires a positive drug interaction which does not necessarily require synergism.
Applicants argue that the instant specification as well as the Cameron Declaration discloses antimicrobial effects of cannabinoids combined with different silver preparations. As an example, Table C shows FICI for cannabinoids combined with silver sulfate or silver nanoparticles and only one out of 20 silver combinations met the threshold of synergy against E.coli (CBCA plus silver sulfate) with 11 tested combinations not demonstrating synergism. Applicants argue that the Cameron Declaration demonstrates that several silver cannabinoid combinations are not effective for antimicrobial purposes and thus determining synergistic combinations is unpredictable. Applicants argue that from paragraph 16 to 39 of the Cameron Declaration demonstrates that a combination of CBG and CBC with one or more silver substances exhibited synergism.
Applicants remarks are considered unpersuasive for the reasons discussed below in the Declaration section. In summary, the instant claims do not commensurate in scope with the data presented in that the claims to not limit the cannabinoids, do not require any concentration of each and are generically recites a silver containing compound. Silver sulfadiazine and silver lactate and chloride are claimed but do not appear have results to synergism demonstrated. Furthermore, the prior art teaches synergism between silver and the antibiotic metronidazole, thus the reason or motivation to combine Brenner with Edwards is because the combination is synergistic and Brener teaches the inclusion of antibiotics. This reason to combine is not the same as Applicant’s reason for combining the claimed cannabinoids with silver containing compounds to achieve synergy, however per the teachings of Edwards, silver demonstrates synergism with metronidazole. The instant claims do not preclude this combination with antibiotic to achieve the same result in that there is synergism of the composition.
37 CFR 1.132 Declaration
The examiner acknowledges receipt of the Declaration under 37 CFR 1.132 by Dr. Dale Cameron filed on 09/30/2025.
The Declaration under 37 CFR 1.132 filed 09/30/2025 is insufficient to overcome the rejection rejections of record for the reason set forth below.
Dr. Cameron notes that the Application discloses that antimicrobial effects differ greatly when different cannabinoids are combined with different silver containing compounds. For example, Table C showed only that CBCA and silver sulfate met the threshold for synergy against E. coli. The remaining 11 combinations were not synergistic for E. coli demonstrating that not all cannabinoids act synergistically with all silver containing substances.
Examiner respectfully submits that the instant claims do not even require CBCA or silver sulfate, the claims recite a genus of CBC with CBG which in view of the comprising language does not exclude combinations with other cannabinoids. From MPEP 716.02(d) Whether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the "objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support." In other words, the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range. In re Clemens, 622 F.2d 1029, 1036, 206 USPQ 289, 296 (CCPA 1980). In the instant case, the silver compounds tested were silver nitrate, silver sulfate and silver nanoparticles for different microorganisms together with six types of cannabinoids, notably wherein the concentration of the silver is 0.31-32mg/L with silver nanoparticles being from 0.01-10 mgL with silver sulfate being from 0.01-10mg/L with the concentration of cannabinoids from 0.125 to 16mg/L, whereas claim 1 does not require any concentration thus it is unclear if the synergy would be recognized across any range for CBC and CBG and silver compound. Furthermore, for E. coli CBCA is most effective, however per paragraph [0061], on MRSA CBC, CBG and CBGA are effective for silver nitrate whereas silver nanoparticles were most effective. Thus, the synergism depends on the silver compound, microorganisms being treated and cannabinoid compound. It is further noted that the instant claims do not exclude mixtures of cannabinoids or the presence of antibiotic compound which per the teachings of Edwards, silver salts with antibiotics result in synergism.
Declarant points out that for example 12, certain combinations of cannabinoid and silver sulfate demonstrate an antimicrobial effect against E. Coli whereas other silver sulfate combinations with cannabinoid do not. Declarant notes that CBD fails to give any synergism with E. Coli.
Examiner respectfully submits that while there is no synergism of CBD with silver sulfate on E. coli, the combination of CBD with silver sulfate at Example 11 shows an additive effect and not an indifference. All of the cannabinoids at Example 11 when combined with silver sulfate demonstrated an improvement in efficacy against E. coli. Examiner agrees that none of the cannabinoids with silver compounds give a consistent antimicrobial effect against Staphylococcus, MRSA or E. Coli, however claim 1 does not specify the silver compound giving the synergism across all three microorganisms or the amounts of the cannabinoid and silver compound. Even the CBG instantly claimed does not demonstrate synergism at Example 11 against E coli. A showing of unexpected results for a single member of a claimed subgenus, or a narrow portion of a claimed range would be sufficient to rebut a prima facie case of obviousness if a skilled artisan "could ascertain a trend in the exemplified data that would allow him to reasonably extend the probative value thereof." In re Clemens, 622 F.2d 1029, 1036, 206 USPQ 289, 296 (CCPA 1980). Here, as the specification demonstrates, silver sulfate reacts differently with certain cannabinoids than silver nanoparticles. For example, at Example 11, silver sulfate shows synergism with CBCA, however CBCA does not with silver nanoparticles on E. coli. There does not appear to be enough data to ascertain a trend that one of ordinary skill in the art could expected the unexpected synergism for any silver compound with CBC and CBG in any amounts.
At Table 5 of the Declaration, Declarant notes that no silver cannabinoid combination was synergistic to P. aeruginosa. However, FICI for CBC and silver nanoparticle is 0.75 which per paragraph [0060] of the instant specification can be considered a partial synergism since partial synergism is from 0.5<0.75.
Declarant notes that the data presented reveals that certain combinations of cannabinoids work better with silver compounds and are capable of providing synergism which is not a generic feature to all cannabinoid.
Examiner respectfully submits that the instant claims do not preclude a mixture of all cannabinoids they are not just limited to CBC and CBG. Furthermore, the data shows it depends on the silver compound and microorganism being treated to achieve synergies. For example, CBG which is instantly claimed is not synergistic against MRSA with silver nitrate or silver sulfate. From example 11, CBC nor CBG show full synergism (FICI less than or equal to 0.5) with silver sulfate nor silver nanoparticles against E. coli. Thus, it depends on the microorganism and silver salt being combined with the cannabinoids such that one of ordinary skill in the art would not be able to ascertain a trend. CBC shows synergism against MRSA with silver nitrate but not E. coli with silver sulfate. The instant claims are not specific to the microorganism and utilize any silver compound which from the data it depends on the compound being used along with the cannabinoid combination. One of ordinary skill would not expect synergism for any silver compound combination with CBC and CBG against any microorganism since the data shows that it depends on the selection of the cannabinoid with silver compound and microorganism being treated.
The Data presented by Declarant at Tables 11-17 demonstrates CBC plus CBG and silver nanoparticles synergism against MRSA, P. Aeruginosa, and E.coli. The CBC plus CBG and silver sulfate demonstrated synergism against MRSA and E. Coli. Silver sulfate is not shown with CBG plus CBC on P. Aeruginosa. The CBC and CBG combination with silver sulfate is demonstrated synergism against MRSA at concentrations having various ratios of CBC:CBG. However, the ratios tested for E. coli are only inclusive of more CBC. Claim 1 does not provide ratios wherein CBC is greater than CBG (i.e. Table 17 of Declaration) nor does it provide silver sulfate or silver nanoparticles. In addition, claim 1 does not limit the cannabinoids to just CBC and CBG in view of the comprising language. Claim 1 encompasses any silver containing substance with any concentrations for the cannabinoids and silver containing compound and thus the breadth of claim 1 does not presently commensurate in scope with the Data presented by Declarants. Claim 98 includes silver lactate and silver sulfadiazine however none of these have date demonstrating synergism. Examiner agrees that the data shows that determining combinations of cannabinoids and silver that have synergism is unpredictable, however the clams must commensurate in scope with the alleged unexpected synergistic results.
Upon consideration of the facts taught by the prior art and the information submitted by the Affiant, the Affidavit is unpersuasive for the reasons discussed above and in summary as the claims do not commensurate in scope with the data presented demonstrating synergism.
Conclusion
Currently, no claims are allowed and all claims are rejected.
Applicant’s arguments/remarks are considered unpersuasive. 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 extension fee 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.
Correspondence
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/SARAH ALAWADI/Primary Examiner, Art Unit 1619