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
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicants’ submission filed on 05/11/2026 has been entered.
The Examiner further acknowledges the following:
Claims 30 and 100-103 are withdrawn. Examiner respectfully submits that the withdrawn composition claims are ineligible for rejoinder due to the election of the process claims and not product claims. Where restriction was required between a product and a process of making and/or using the product, and the product invention was elected and subsequently found allowable, all claims to a nonelected process invention must depend from or otherwise require all the limitations of an allowable claim for the claims directed to that process invention to be eligible for rejoinder. See MPEP § 821.04(b).
Claims 1-2, 23-25 and 98-99 are under current examination.
The species election to silver sulfate in the response filed on 5/19/2025 has been extended to include silver nanoparticles, silver nitrate and silver sulfadiazine (a sulfonamide).
Applicants' remarks and amendments filed on 05/19/2025, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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. Applicants’ remarks with regard to a combination with Holladay are considered moot in view of the new rejections presented below. Applicants argue that each of the previously cited references has too broad a teaching for cannabinoids consisting of CBC and CBG with silver compounds. This is found unpersuasive because the composition exemplified in Murphy below is an express combination of CBC with CBG.
With regards to Brenner Applicants argue that Brenner does not demonstrate synergism with the claimed compounds. Examiner notes that Brenner expressly teaches a synergistic pharmaceutical composition comprising at least one anti-bacterial agent, at least one cannabinoid, and a pharmaceutically acceptable carrier. The antibacterial is expressly taught to be inclusive of sulfonamides. Furthermore, Tel-Ari et al. (WO2019244160) does expressly teach that a combination of cannabinoids with silver results in synergism. Both Brenner and Tel-Ari recognize that combination of at least one cannabinoid with antibacterial agent imparts synergism. Applicants point to the examples in the spec (e.g. example 11) to show synergism, however cannabinoids and silver salts are provided in specific concentration, see paragraph [0059]. Objective evidence of nonobviousness including commercial success must be commensurate in scope with the claims. In re Tiffin, 448 F.2d 791, 171 USPQ 294 (CCPA 1971)
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 2 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 2 recites that the positive-positive drug-drug interaction is a positive antibiotic drug-drug interaction that enhances the antimicrobial effect of the cannabinoid and/or the one or more silver containing substances.
Claim 1 recites the positive drug-drug interaction comprises a synergistically effective combined antimicrobial activity which is implicitly enhancement of the cannabinoids and/or the silver containing substances. Accordingly, claim 2 does not further limit.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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, 2, 23, and 24-25 are rejected under 35 U.S.C. 103 as being unpatentable over Murphy et al. (WO2020051284) in view of Tel-Ari et al. (WO2019244160-of record).
Murphy et al. teach cannabinoid compositions for the treatment of gram-positive infections wherein such compositions can reduce microorganisms and/or biofilm on medical device surfaces, see abstract and page 4, lines 1-2, page 5, lines 22-30 and claims 1 and 6. The cannabinoid composition can comprise a CBD derivative in combination with cannabigerol (CBG), see page 14, lines 24-30. Exemplary CBD derivatives are cannabichromene, see page 15 at lines 8-9. Table 5 exemplifies a combination of cannabigerol (CBG) plus cannabichromene (CBC) together, thus the cannabinoids can consist of CBC and CBG, see Tale 5. Table 5 does not contain additional therapeutics however, additional therapeutic antimicrobial agents can be incorporated with the composition, see page 27 at line 24 and page 28 at line 2 as in one embodiment, the method comprises administering to the subject an effective amount of CBD or a CBD derivative, Cannabigerol (CBG) or a CBG derivative, and an additional therapeutic agent. Human subjects can be treated, see page 9, lines 29-30 and entire document.
Murphy does not teach that the medical device composition can contain one or more silver substances that are silver salt and/or silver nanoparticles.
Tel-Ari teaches an antimicrobial composition comprising one or more cannabinoids as compound A with silver as compound B see claims 1 and 5. Murphy teaches synergistic therapeutic effect in treating infections by administering cannabinoid and silver nano powders, see Example IA through Example 1C. The silver includes salt forms, see claim 5.
It would have been prima facie obvious to incorporate silver nanoparticles as the therapeutic agent with Murphy’s cannabinoid composition at Table 1.
One of ordinary skill in the art would have been motivated to do so because Tel-Ari expressly teaches that silver nanoparticles (i.e. nano powders) when combined with cannabinoids results in synergistic therapeutic effect against infections.
The combination of the silver nanoparticles with Murphys CBC and CBG example would contain silver nanoparticles and CBC plus CBG the only therapeutic antimicrobials and would necessarily result in a positive synergistic drug interaction.
Claims 98-99 are rejected under 35 U.S.C. 103 as being unpatentable over Murphy et al. (WO2020051284) in view of Tel-Ari et al. (WO2019244160-of record) as applied to all claims 1, 2, 23, and 24-25 above, and further in view of Callahan et al. (WO2020000024) and Song et al. (United States Patent Publication 2011/0244256).
Neither Murphy nor Tel-Ari teach silver nitrate or silver sulfate salts.
Callahan et al. teach that cannabinoid in combination with additional silver compounds such as silver particles or silver salts including silver nitrate are useful in treatment of bacteria, see abstract, paragraphs [0011], [0033], [0082], [0087], [0132] and claims 1 and 6. The composition can treat medical device surfaces, see paragraphs [0115]-[0118].
Callahan does not teach the silver compounds include silver sulfate.
Song et al. teach that for coatings of metal devices silver sulfate is useful in the alternative to silver nitrate as an antimicrobial metal compound, se claims 1-2 and 9-12.
It would have been prima facie obvious to provide silver nitrate or silver sulfate in the alternative to silver nanoparticles of the modified Murphy et al.
One of ordinary skill in the art would have been motivated to do so because silver nanoparticles are taught to be synergistic with cannabinoids per the teachings of Tel-Ari and per the teaching of Callahan cannabinoid compounds are combinable with silver particles or silver salts for treatment of bacteria. Song teaches that both silver nitrate and silver sulfate provide antimicrobial properties as silver salts.
There would have been a reasonable expectation of success because Murphy et al. teach their composition may include a further therapeutic agent.
Claim(s) 1-2,24-25 and 98-99 rejected under 35 U.S.C. 103 as being unpatentable over Brener et al. (WO2018011813-of record) in view of Tel-Ari et al. (WO2019244160-of record), Murphy et al. (WO2020051284) and Nunes et al. (Silver complexes with sulfathiazole and sulfamethoxazole: Synthesis, spectroscopic characterization, crystal structure and antibacterial assays).
Brener et al. teach a synergistic pharmaceutical formulation comprising an anti-bacterial agent, at least one cannabinoid and a carrier, see claim 1. The composition treats microbial infections or biofilms, see abstract. 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 sulfonamide see claim 4 and abstract and pages 9, and 13. The at least one cannabinoid 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. The composition can be delivered from medical devices.
Brenner does not exemplify synergism with silver compounds.
Tel-Ari teaches an antimicrobial composition comprising one or more cannabinoids as compound A with silver, see claims 1 and 5. Murphy teaches synergistic therapeutic effect in treating infections by administering cannabinoid and silver nano powders, see Example IA through Example 1C. Therefore, like Brener, Tel-Ari recognizes that cannabinoids impart synergism with antimicrobial compounds.
Neither Brener nor Tel-Ari expressly teach a combination of CBC and CBG or that the sulfonamide compound includes silver sulfadiazine.
However, regarding the CBC and CBG combination, Murphy et al. teach cannabinoid compositions for the treatment of gram-positive infections wherein such compositions can reduce microorganisms and/or biofilm on medical device surfaces, see abstract and page 4, lines 1-2, page 5, lines 22-30 and claims 1 and 6. The composition can comprise a CBD derivative in combination with cannabigerol (CBG), see page 14, lines 24-30. Exemplary CBD derivatives are cannabichromene, see page 15 at lines 8-9. Table 5 exemplifies a combination of cannabigerol (CBG) plus cannabichromene (CBC) together, thus the cannabinoids can consist of CBC and CBG, see Tale 5. Table 5 does not contain additional therapeutic however, additional therapeutic antimicrobial agents can be incorporated with the composition, see page 27 at line 24 and page 28 at line 2 as in one embodiment, the method comprises administering to the subject an effective amount of CBD or a CBD derivative, Cannabigerol (CBG) or a CBG derivative, and an additional therapeutic agent. Human subjects can be treated, see page 9, lines 29-30 and entire document.
Nunes et al. teach that silver sulfadiazine was the first silver sulfonamide compound developed and is 50 times more effective than sulfadiazine alone.
It would have been prima facie obvious to provide the cannabinoids of Brener as a CBC and CBG combination. One would have been motivated to do so because Murphy et al. teach that cannabinoids including CBC and CBG have antibacterial activity against gram positive bacteria. There would have been a reasonable expectation of success as Brener already teaches the use of cannabinoids.
It would have additionally been prima facie obvious to substitute the sulfonamide antimicrobial of Brener for the sulfonamide of silver sulfadiazine because silver sulfadiazine is more effective than utilizing sulfadiazine as the sulfonamide alone.
With regards to the positive-positive drug interaction that enhances the antimicrobial effect of cannabinoid and/or silver substance, and synergism, since Brener teaches that cannabinoid with a sulfonamide is synergistic, and Tel-Ari teaches that silver is synergistic with cannabinoids, a combination of silver sulfadiazine with CBC and CBG would necessarily result in synergistic enhancement of antimicrobial effect.
Conclusion
Currently, no claims are allowed, and all claims are rejected.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH ALAWADI whose telephone number is (571)270-7678. The examiner can normally be reached Monday-Friday 10:00am-6:30pm EST.
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, David Blanchard can be reached at 571-272-0827. 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.
/SARAH ALAWADI/Primary Examiner, Art Unit 1619
Prosecution Insights