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 .
All claim rejections which were indicated in the Office action dated October 16, 2026 have been withdrawn in view of cancelation of the rejected claims.
Claim Objections
37 CFR 1.121 (c) (4) requires that no claim text shall be presented for any claim in the claim listing with the status of “canceled”. The texts of the canceled claims in the claim amendment filed on January 16, 2026 should be removed.
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 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.
Claim 27 recites a composition comprising Andrographis paniculata extract standardized to contain not less than 10% w/w andrographolides, Polygonum cuspidatum extract standardized to contain not less than 80% w/w resveratrol, Piper nigrum extract standardized to contain 95% w/w piperine, Nigella sativa extract standardized to contain 2% w/w thymoquinone. about 0.01% - 10% w/w thvmohvdroquinone, about 15% - 95% w/w fatty acids, about 0.001°%-3% w/w hederagenin or hederin, 95%, tetrahydrocurcuminoids, vitamins and minerals.
The expression “95%, tetrahydrocurcuminoids” renders the claim vague and indefinite, as it is not clear what the percentage represents.
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.
Claims 1, 3-5, 7-15 and 21-26 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sami Direct (https://www.youtube.com/watch?v=AaKB_9rnXMI, Descriptions) as evidenced by Majeed et al. (“A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of a Nutritional Supplement (ImmuActiveTM) for COVID-19”, Evid Based Complement Alternat. Med. 2021, Oct 11 ) (“Majeed I” hereunder), Resvenox® (https://resvenox.com/resvenox/introduction/) , BioPerine® (http://bioperine.com/aboutbioperine/balck-pepper-extract/), and Curcumin C3 Reduct ® (http://c3reduct.com/curcumin-c3-reduct/introduction) and in view of Majeed et al. (KR 20200100772 A, published on August 26, 2020) ("Majeed II" hereunder).
Sami Direct discloses ImmuActive™ which is a combination comprising Andrographis paniculata extract 10%, Resvenox® (resveratrol 95 %), tetrahydrocurcuminoids from “yellow turmeric”, BioPerine® (peperine), vitamin D3, selenium and zinc monomethione. See “Description”. The reference teaches that the composition fights against viral infection, maintains a healthy immune system and boosts respiratory health. See “Key Benefits”. More specifically, the reference teaches that 1) Andrographs paniculata extract 10% is a furin inhibitor and has antiviral and immunomoedulatory activity; 2) Resvenox® (resveratrol 95%) inhibits viral replication; 3) BioPerine® enhances the bioavailability of other components; 4) C3 Reduct ODN reduces oxidative stress, provides a strong immune response to viral infection, and prevents cytokine storm; 5) zinc inhibits RNA viral replication; 6) selenium helps to balance oxidative stress and reduces viral virulence; and 7) vitamin D3 helps to maintain a healthy immune response. Sami Direct teaches that composition is in the form of capsule for administration, which inherently is formulated with pharmaceutically acceptable excipients.
Majeed I teaches that andrographolides is the primary active molecule in Andrographis paniculata, and is an inhibitor of the furin protease in the lung, preventing spike protein activation and viral entry. Thus, the Andrographs paniculata extract 10% in Sami Direct must mean that the extract contains 10% andrographolides.
Resvenox® is a standardized extract prepared from the roots of the Polygonum cuspidatum containing a minimum 95 % resveratrol. See Resvenox®, Introduction, the second full paragraph.
BioPerine® is prepared from the dried fruits of Piper nigrum and contains a minimum of 95 % piperine. See BioPerine®, the first two lines.
Curcumin C3 Reduct® contains a minimum of 95% of tetrahydrocurcuminoids obtained from turmeric and reduced hydrogenated turmeric preparations. See Introduction.
Sami Direct fails to teach the Nigella sativa extract of the present claim 1.
Majeed II teaches a composition comprising 0.1 – 5 % w/w thymoquinone, 0.01-10 %/ w/w thymohydroquinone, 20-05 % w/w fatty acid, hederin and hederagenin isolated from Nigella sativa. See translation, p. 9, last paragraph. The reference teaches that the composition rich in thymohydroquinone, which is a more potent antioxidant and anti-inflammatory agent than thymoquinone, can provide improved therapeutic potential over conventional Nigella sativa extracts which is rich only in thymoquinone. See translation, p. 13, Example 3. The reference teaches that the composition can be formulated into capsules, among other oral dosage forms. See translation, p.16, n).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present application to modify the teachings of Sami Direct and incorporate to the composition the Nigella sativa extract composition of Majeed II. The skilled artisan would have been motivated to do so, as both references are directed to therapeutic compositions comprising plant extracts, and Majeed II teaches the Nigella sativa extract composition can provide potent antioxidant and anti-inflammatory agents. Since both Sami Direct and Majeed II teach capsule formulations, the one of ordinary skill in the art would have had a reasonable expectation of successfully combining the teachings of the references and producing an improved composition with enhanced antioxidant and anti-inflammatory properties.
Response to Arguments
Applicant's arguments filed on January 16, 2026 have been fully considered but they are not persuasive.
Applicant argues that combining the Nigella sativa extracts with other compositions pose common formulation challenges such as poor solubility, low bioavailability, chemical instability and interactive behavior of active ingredients with other components. Such argument is unpersuasive, as the legal standard in supporting obviousness in combining references is whether one of ordinary skill in the art would have had a reasonable expectation of success in doing so. As indicated in the rejection, both Sami Direct and Majeed II teach plant extracts in capsule form, and combining the two plant extract formulations and making a stable capsule would have been reasonably well within ordinary skill in the art. Furthermore, Majeed II teaches adding a stabilizer and a bioavailability improving agent such as piperine with the Nigella sativa extract. See Majeed II reference claims 13 and 14. The reference particularly mentions that piperine, which is present in Sami Direct, is the preferred bioavailability improving agent. It would have been obvious that that the combined formulation would have resulted in a stable capsule.
Conclusion
No claims are allowed.
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.
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/GINA C JUSTICE/Primary Examiner, Art Unit 1617