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 .
Status of Application
The Amendments and Remarks filed on 11/04/25 are acknowledged.
Claims 1 and 9 were amended.
Claims 1-13 are pending and are included in the prosecution.
Information Disclosure Statement
The information disclosure statements (IDS) filed on 10/15/25 and 12/12/25 are acknowledged. The submissions are in compliance with the provisions of 37 CFR 1.97 and 1.98. Accordingly, the examiner is considering the information disclosure statements. Please see the attached copies of PTO-1449.
Response to Amendments/Arguments
Objection to the Specification
In light of the amendment of the Specification (Page 15), the objection to the Specification is withdrawn.
Rejection of claims under 35 USC § 112(b)
In light of the amendment of claim 9 to depend on claim 8, the rejection of claim 9 under 35 U.S.C. 112(b) is withdrawn.
Rejection of claims under 35 USC §§ 102(a)(1) and 103
Applicant amended claim 1 to recite the limitation of “wherein the thymoquinone is administered at a concentration of at least 1.75 wt% in a composition.”
In light of this amendment, Applicant’s arguments (Pages 6-9, filed 11/04/25) regarding the following rejections have been fully considered and are persuasive.
Rejection of claims 1-6 and 10-11 rejected under 35 U.S.C. 102(a)(2) as being anticipated by Orkhan et al. (SOJ Pharm Sci 7(1):1-5, published 27 April 2020 – “Orkhan” – cited in the IDS dated 05/02/23 as NPL # 3)
Rejection of claim 7 under 35 U.S.C. 103 as being unpatentable over Orkhan in view of Sommer et al. (Precis. Nanomed. 2020; 3 (2): 541-548 – published May 20, 2020 – “Sommer” cited in the IDS dated 05/01/23 as NPL # 2)
Rejection of claims 8 and 9 under 35 U.S.C. 103 as being unpatentable over Orkhan in view of Beck et al. (Computational and Structural Biotechnology Journal 18 (2020) 784-790, available online 30 March 2020 – “Beck”)
Rejection of claims 12 and 13 under 35 U.S.C. 103 as being unpatentable over Orkhan in view of Zeilkha (WO 2020/095307 A1)
Since the primary reference, Orkhan, does not teach that the thymoquinone is administered at a concentration of at least 1.75 wt% in a composition, the anticipation and obviousness rejections listed above are withdrawn.
New ground(s) of rejection
However, upon further consideration of the amended claims, a new ground(s) of rejection is made in view of supporting reference Albert et al. (WO 2019/180719 A1).
Since the new grounds of rejection were necessitated by Applicants’ amendment, this action is made FINAL.
Notice for all US Patent Applications filed on or after March 16, 2013
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 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.
New Rejections Necessitated by Amendment
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 at the time any inventions covered therein were effectively filed 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 at the time a later invention was effectively filed 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 1-6 and 10-13 are rejected under 35 U.S.C. 103 as being unpatentable over Orkhan et al. (SOJ Pharm Sci 7(1):1-5, published 27 April 2020 – “Orkhan”) in view of Albert et al. (WO 2019/180719 A1 – “Albert”).
Instant claim 1 is drawn to a method of preventing or treating COVID-19 infection in a subject comprising administering to the subject an effective amount of thymoquinone, wherein the thymoquinone is administered at a concentration of at least 1.75 wt% in a composition.
Orkhan discloses a method of administering 10 ml of Nigella sativa oil 3 times a day in the treatment and prevention of SARS-CoV-2 (COVID19) (Page 3, Col. 2, 1st ¶). Nigella sativa (NS) oil contains thymoquinone (TQ) (Page 1, Col. 2, 2nd to 6th ¶s). Orkhan discloses that NS has been reported as having anti-inflammatory properties and antiviral activity (Page 2, Col. 1, 1st ¶). TQ which is the major component of the volatile oil of NS has beneficial protective effects against various diseases through anti-inflammatory activities, and TQ attenuates allergic airway inflammation by inhibiting Th2 cytokines and eosinophil infiltration into the airways; thus demonstrating its potential anti-inflammatory role (¶ bridging Page 2, Col. 2 and Page 3, Col.1).
Orkhan does not expressly teach that the thymoquinone is administered at a concentration of at least 1.75 wt% in a composition.
Albert teaches a composition comprising Nigella sativa (NS) oil, wherein said oil comprises thymoquinone (TQ) at a concentration of at least 2% (w/w) (Abstract, claims 1, 2, and 9). NS is also known as black seed (Page 1, 2nd ¶). Optimal anti-inflammatory effects are achieved when the TQ concentration of the compositions is at least 2% (w/w) (Page 3, 4th and 5th ¶s). The composition may be formulated for oral administration to a mammalian subject, for the purpose of preventing or treating inflammatory conditions and other disorders (Abstract, Page 4, last ¶, Page 5, 2nd ¶, Page 7, 3rd ¶, Page 8, 2nd, 5th and 6th ¶s, claims 10 and 13).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the method of administering 10 ml of NS oil 3 times a day in the treatment and prevention of SARS-CoV-2 (COVID19) wherein the NS oil contains TQ, wherein TQ has antiinflammatory activities, as taught by Orkhan, administer NS oil that contains at least 2% (w/w) of TQ, as taught by Albert, and arrive at the instant invention.
One of ordinary skill in the art would have been motivated to do this because both the references teach that the TQ in NS oil has antiinflammatory activity. One of ordinary skill in the art would have found it obvious to use the concentration of TQ of at least 2% (w/w) as taught by Albert in the method of Orkhan and have a reasonable expectation of antiinflammatory activity and treating and preventing SARS-CoV-2 (COVID-19). According to MPEP 2141(III)(A) it is obvious to combine prior art elements according to known methods to yield predictable results.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Regarding instant claims 1 and 5-6, the limitations of a method of preventing or treating COVID-19 infection in a subject comprising administering to the subject an effective amount of TQ, wherein the TQ is administered at a concentration of at least 1.75 wt% in a composition would have been obvious over the method of administering 10 ml of NS oil 3 times a day in the treatment and prevention of SARS-CoV-2 (COVID19) (Page 3, Col. 2, 1st ¶), wherein NS oil contains thymoquinone (Page 1, Col. 2, 2nd to 6th ¶s), as taught by Orkhan, in view of the composition comprising NS oil, wherein said oil comprises TQ at a concentration of at least 2% (w/w) (Abstract, claims 1, 2, and 9), wherein optimal anti-inflammatory effects are achieved when the TQ concentration of the compositions is at least 2% (w/w) (Page 3, 4th and 5th ¶s), wherein the composition is administered to a mammalian subject (Abstract, Page 4, last ¶, Page 5, 2nd ¶, Page 7, 3rd ¶, Page 8, 2nd, 5th and 6th ¶s, claims 10 and 13), and wherein the composition may be formulated for oral administration to a mammalian subject, for the purpose of preventing or treating inflammatory conditions and other disorders (Abstract, Page 4, last ¶, Page 5, 2nd ¶, Page 7, 3rd ¶, Page 8, 2nd, 5th and 6th ¶s, claims 10 and 13), as taught by Albert.
Regarding instant claim 2, the limitation of a composition that includes black seed oil would have been obvious over the method of administering 10 ml of NS oil 3 times a day in the treatment and prevention of SARS-CoV-2 (COVID19) (Page 3, Col. 2, 1st ¶), wherein NS oil is known by different names including black cumin, black caraway seeds, and black seeds (Page 1, Col. 2, 2nd and 3rd ¶s), as taught by Orkhan, and the composition comprising NS oil (Abstract, claims 1, 2, and 9) which is also known as black seed (Page 1, 2nd ¶), as taught by Albert.
Regarding instant claims 3 and 4, the limitations of the thymoquinone administered prophylactically prior to a diagnosed infection to prevent COVID-19 infection would have been obvious over the method of administering 10 ml of NS oil 3 times a day in the prevention of SARS-CoV-2 (COVID19) (Page 3, Col. 2, 1st ¶), as taught by Orkhan, in view of the composition comprising NS oil (Abstract, claims 1, 2, and 9), wherein the composition is administered to a mammalian subject (Abstract, Page 4, last ¶, Page 5, 2nd ¶, Page 7, 3rd ¶, Page 8, 2nd, 5th and 6th ¶s, claims 10 and 13) for the purpose of preventing or treating inflammatory conditions and other disorders (Abstract, Page 4, last ¶, Page 5, 2nd ¶, Page 7, 3rd ¶, Page 8, 2nd, 5th and 6th ¶s, claims 10 and 13), as taught by Albert.
Regarding instant claims 10 and 11, the limitations of the method further comprising administering a fatty acid (instant claim 10) and the fatty acid selected from the group consisting of oleic acid, linoleic acid and palmitic acid (instant claim 11) would have been obvious over the method of administering 10 ml of NS oil 3 times a day in the prevention of SARS-CoV-2 (COVID19) (Page 3, Col. 2, 1st ¶), wherein the NS oil contains unsaturated fatty acids including linoleic acid, palmitic acid, and oleic acid (Page 1, Col. 2, 4th ¶), as taught by Orkhan, and the black seed oil CO2 extract which contains oleic acid (Pages 20-21 – Compositions 1-3).
Regarding instant claims 12 and 13, the limitations of black seed oil including at least 1.6 wt% TQ (instant claim 12) and at least 2.0 wt% TQ (instant claim 13) would have been obvious over the composition comprising NS oil, wherein said oil comprises TQ at a concentration of at least 2% (w/w) (Abstract, claims 1, 2, and 9), wherein NS is also known as black seed (Page 1, 2nd ¶), as taught by Albert.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Orkhan et al. (SOJ Pharm Sci 7(1):1-5, published 27 April 2020 – “Orkhan”) in view of Albert et al. (WO 2019/180719 A1 – “Albert”) and Sommer et al. (Precis. Nanomed. 2020; 3 (2): 541-548 – published May 20, 2020 – “Sommer”).
Instant claim 7 is drawn to the method of claim 2 wherein the subject is administered black seed oil and an additional amount of thymoquinone, in combination.
The teachings of Orkhan and Albert are discussed above.
Orkhan and Albert do not expressly teach that the subject is administered black seed oil and an additional amount of thymoquinone, in combination, as recited in instant claim 7.
Sommer teaches administering thymoquinone to treat COVID-19 (Page 541, Abstract; Page 542, Col. 2, 1st ¶; and Page 545, “Conclusion”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the method of administering 10 ml of NS oil 3 times a day in the treatment and prevention of SARS-CoV-2 (COVID19) wherein the NS oil contains TQ, wherein TQ has antiinflammatory activities, as taught by Orkhan, administer NS oil that contains at least 2% (w/w) of TQ, as taught by Albert, administer additional TQ, as taught by Sommer, and produce the instant invention.
One of ordinary skill in the art would have been motivated to do this because Sommer teaches the biologically relevant advantages of TQ, including the size of the thymoquinone molecule which allows it to reach a pathogen in a shorter time and penetrate deeper into tissue than other molecules (Page 544, Col. 2, 1st ¶). When combined with the teachings of Albert regarding TQ having antiinflammatory activity one of ordinary skill in the art would have found it obvious to administer an additional amount of TQ along with the NS oil. Furthermore, Sommer teaches the therapeutic and prophylactic potential of thymoquinone since it has double antiviral mechanisms of action along with its anti-inflammatory and immunomodulatory properties (Page 545, under “Conclusion”). One of ordinary skill in the art would have found it obvious to augment the black seed oil administration taught by Orkhan with additional thymoquinone as taught by Sommer and have a reasonable expectation of effectively treating COVID-19.
Regarding instant claim 7, the limitation of an additional amount of thymoquinone would have been obvious over the administration of thymoquinone to treat COVID-19 (Page 541, Abstract; Page 542, Col. 2, 1st ¶; and Page 545, “Conclusion”), as taught by Sommer.
Claims 8 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Orkhan et al. (SOJ Pharm Sci 7(1):1-5, published 27 April 2020 – “Orkhan”) in view of Albert et al. (WO 2019/180719 A1 – “Albert”) and Beck et al. (Computational and Structural Biotechnology Journal 18 (2020) 784-790, available online 30 March 2020 – “Beck”).
Instant claim 8 is drawn to the method of claim 1, further comprising administering an antiretroviral medication, in combination.
Instant claim 9 recites that the antiretroviral medication includes dolutegravir, or a pharmaceutically acceptable salt thereof.
The teachings of Orkhan and Albert are discussed above.
Orkhan and Albert do not expressly teach an antiretroviral medication for treating COVID-19, as recited in instant claims 8 and 9.
Beck teaches that commercially available drugs that could work on viral proteins of SARS-CoV-2 include the antiretroviral drug dolutegravir (Abstract, Tables 1-6).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the method of administering 10 ml of NS oil 3 times a day in the treatment and prevention of SARS-CoV-2 (COVID19) wherein the NS oil contains TQ, wherein TQ has antiinflammatory activities, as taught by Orkhan, administer NS oil that contains at least 2% (w/w) of TQ, as taught by Albert, administer commercially available drugs that could work on viral proteins of SARS-CoV-2 such as the antiretroviral drug dolutegravir, as taught by Beck, and produce the instant invention.
One of ordinary skill in the art would have been motivated to do this because Beck teaches that commercially available drugs that could work on viral proteins of SARS-CoV-2 include the antiretroviral drug dolutegravir, and that antiviral drugs should be considered when establishing effective treatment strategies for SARS-CoV-2 (Abstract, Tables 1-6).
Regarding instant claims 8 and 9, the limitations of an antiretroviral medication (instant claim 8) and dolutegravir (instant claim 9) would have been obvious over the commercially available drugs that could work on viral proteins of SARS-CoV-2 which include the antiretroviral drug dolutegravir, and that antiviral drugs should be considered when establishing effective treatment strategies for SARS-CoV-2 (Abstract, Tables 1-6), as taught by Beck.
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 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARADHANA SASAN whose telephone number is (571)272-9022. The examiner can normally be reached Monday to Friday from 6:30 am to 3:00 pm.
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/ARADHANA SASAN/Primary Examiner, Art Unit 1615
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