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 .
DETAILED ACTION
This Office Action is in response to Applicant’s Arguments and Amendment filed, 05/05/2026, wherein the Amendment amended claims 37 and 45, and added claim 47.
Claims 27-47 are pending.
Priority
This application claims the following priority:
PNG
media_image1.png
92
675
media_image1.png
Greyscale
Election/Restrictions
Applicant elected Group II, the method of treatment, and coronavirus as the viral respiratory infection, in the reply filed on 08/25/2025.
Claims 27-36 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim.
Claims 37-47 are examined on the merits herein.
REJECTIONS WITHDRAWN
The status for each rejection and/or objection in the previous Office Action is set out below.
35 U.S.C. § 112(b)
Applicant’s amendment to claim 45 is sufficient to overcome this rejection.
35 U.S.C. § 102(b) and 103
Applicant’s amendment to claim 37 that limits the claim to a method for the treatment of “a subject diagnosed with a viral respiratory infection,” is sufficient to overcome this rejection.
REJECTIONS—MAINTAINED, MODIFIED, & NEW
Applicant’s amendment to independent claim 1 that limits the patient population to those diagnosed with a viral respiratory infection, and the amendment that adds independent claim 47, have resulted in the below modified and new rejections.
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 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.
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.
(New) Claims 37, 39-40, and 46-47 are rejected under 35 U.S.C. 103 as being unpatentable over US 2023/0201215 to Fliri (effectively filed 04/29/2020, PTO-892) in view of Utomo (“Revealing the Potency of Citrus and Galangal Constituents to Halt SARS-CoV-2 Infection,” Preprints, published 03/2020, IDS of 01/26/2023).
Fliri teaches a method of treating a viral infection in a mammal comprising administering to the mammal a composition comprising a TMPRSS1 inhibitor, an intracellular steroid hormone, and an SKP2 inhibitor, wherein nobiletin is taught as an SKP2 inhibitor (pgs. 7-8, claims 1,2, 20).
Fliri teaches its composition as treating influenza, coronavirus, MERS-CoV, and SARS-CoV-2, and specifically exemplifies its compositions for the treatments of SARS-CoV-2 ([0022]-[0026], [0039]; Fig. 1).
Fliri teaches its compositions as oral ([0040]-[0045]).
Regarding claim 37, while Fliri teaches a method of treating SARS-CoV-2 by administering an oral composition comprising a TMPRSS1 inhibitor, an intracellular steroid hormone, and an SKP2 inhibitor, wherein nobiletin is taught as an SKP2 inhibitor, it differs from that of instant claim 37, in that it does not specifically teach coronavirus or SARS-CoV-2 as the viral infection treated by administering nobiletin as the SKP2 inhibitor.
Utomo teaches a molecular docking study for screening the binding affinity of several natural products on SARS-CoV-2 marker protein, RBD-S, PD-ACE2, and SARS-CoV-2 protease (pg.2, Methods).
Utomo teaches nobiletin as a compound with inhibitory activity on SARS-CoV-2 infection (pg. 5). Utomo teaches nobiletin as performing low binding energy to the three essential receptors, wherein these low binding energies allow nobiletin to interact tightly to the target protein, contributing to the inhibitory effect against virus infection and replication (pg. 5).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to select SARS-CoV-2 as the viral infection and nobiletin as the SKP2 inhibitor, in Fliri, to arrive at claim 37. One of ordinary skill in the art would have been motivated to make such a selection, with a reasonable expectation of success, because:
-Fliri teaches and exemplifies its compositions for the treatment SARS-CoV-2,
-Fliri teaches nobiletin as a SKP2 inhibitor for use in its compositions, and
-Utomo teaches nobiletin as a compound with inhibitory activity against SARS-CoV-2 infection, wherein nobiletin interacts tightly with the SARS-CoV-2 target protein.
As such, an ordinary skilled artisan would have been motivated to make such selections, to predictably arrive at a therapeutically effective method of treating SARS-CoV-2 that treats the virus and further inhibits infection and viral replication.
Further regarding claim 37, since the combination of Fliri and Utomo is a method of treating SARS-CoV-2 by administering nobiletin to a mammal, the mammal would necessarily be diagnosed with SARS-CoV-2.
Regarding claim 39, the combination of Fliri and Utomo teaches a method of treating SARS-CoV-2.
Regarding claim 40, Utomo teaches tangeretin as another compound from Citrus p. that exhibits inhibitory binding activity against SARS-CoV-2 infection (pgs. 3 and 5). As such, an ordinary skilled artisan would have been motivated to add tangeretin to the combined method of Fliri and Utomo, to predictably arrive at a more potent and therapeutically effective method of treating SARS-CoV-2 infection by inhibiting viral infection and replication.
Regarding claim 46, the combination of Fliri and Utomo differs from that of instant claim 46, in that it does not teach a % weight of nobiletin.
Fliri teaches nobiletin amounts between 1-15 mg for treating coronavirus infections([0028]).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to modify the amount of nobiletin in the combined method of Fliri and Utomo, to arrive at instant claim 46. One of ordinary skill in the art would have been motivated to make such a modification, with a reasonable expectation of success, because:
-Fliri teaches that its formulations can comprise a range of dosage amounts of nobelitin,
-Fliri teaches its amounts as those effective to treat coronavirus, and
- "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation," MPEP 2144.05(II).
The optimization of known amounts for known active agents is considered well within the competence level of an artisan of ordinary skill in the pharmaceutical sciences; it has been held that the selection of optimal parameters, such as amounts of active agents, to achieve a beneficial effect, is within the skill in the art of an ordinary artisan. See In re Boesch, 205 USPT 215 (CCPA 1980) and MPEP 2144.05.
Regarding claim 47, though the combined methods of Fliri and Utomo does not explicitly teach “to mitigate or prevent a cytokine storm,” it is reasonable to assume that this method would have the same effect since it administers the same active ingredient (nobiletin) in an amount effective to treat coronavirus, to the same patient population (patients with SARS-Co-V2), as that taught by the instant specification and claims. Thus while the prior art does not explicitly teaches mitigating or preventing a cytokine storm, burden in on Applicant to show that the prior art does not have this effect. See also MPEP 2111.02.
Applicants are reminded that the office does not have the facilities and resources to provide the factual evidence needed in order to establish that the product of the prior art does not possess the same material, structural and functional characteristics of the claimed product. In the absence of evidence to the contrary, the burden is on the applicant to prove that the claimed product is different from those taught by the prior art and to establish patentable differences. See In re Best 562F.2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2d 1922 (PTO Bd. Pat. App. & Int. 1989).
Claim 38 is rejected under 35 U.S.C. 103 as being unpatentable over US 2023/0201215 to Fliri (effectively filed 04/29/2020, PTO-892) and Utomo (“Revealing the Potency of Citrus and Galangal Constituents to Halt SARS-CoV-2 Infection,” Preprints, published 03/2020, IDS of 01/26/2023), as applied to claims 37, 39-40, and 46-47 above, and further in view of Chakroborty (SARS-CoV-2 causing pneumonia-associated respiratory disorder (COVID-19): diagnostic and proposed therapeutic options, Eur Rev Med Pharmacol Sci, published April 2020, PTO-892 of 11/05/2025).
Fliri and Utomo are applied as discussed above and incorporated herein.
While the combination of Fliri and Utomo teaches a method of treating SARS-CoV-2 infection by administering a composition comprising nobiletin, it differs from that of instant claim 38 in that it does not teach the patient as diagnosed with pneumonia.
Chakraborty teaches SARS-CoV-2 as causing pneumonia (title, abstract). Chakraborty teaches that clinical signs of SARS-CoV-2 infection include low-to-high fever, non-productive cough, myalgia, dyspnea, fatigue, standard or decreased leukocyte counts, and confirmed evidence of pneumonia on chest radiography (pg. 4018, Col. 2, first full sentence).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to select patients with pneumonia caused by SARS-CoV-2, as the patients treated in the methods of the combination of Fliri and Utomo, to arrive at instant claim 38. One of ordinary skill in the art would have been motivated to make such a selection, with a reasonable expectation of success, because the combined method of Fliri and Utomo teaches a method of treating SARS-CoV-2 infection, and Chakraborty teaches pneumonia as a clinical sign of SARS-CoV-2.
As such, an ordinary skilled artisan would have been motivated to make such a selection to predictably arrive at a method that treats SARS-CoV-2 patients that have pneumonia.
Claims 41-45 are rejected under 35 U.S.C. 103 as being unpatentable over US 2023/0201215 to Fliri (effectively filed 04/29/2020, PTO-892) and Utomo (“Revealing the Potency of Citrus and Galangal Constituents to Halt SARS-CoV-2 Infection,” Preprints, published 03/2020, IDS of 01/26/2023), as applied to claims 37, 39-40, and 46 above, and further in view of US2023/0218557 to Dokeniya (effectively filed 05/14/2020, PTO-892 of 11/05/2025).
Fliri and Utomo are applied as discussed above and incorporated herein.
Regarding claims 41-44, while the combination of Fliri and Utomo teaches a method of treating SARS-CoV-2 infection by administering a composition comprising nobiletin, it differs from that of instant claims 41-44 in that it does not teach omega-3 fatty acids.
Dokeniya teaches an antiviral infection comprising an effective amount of one or more fatty acids, wherein the antiviral activity is for enveloped viruses, such as SARS-CoV-2 (pg. 7, claims 1, 7-9, 11).
Dokeniya teaches EPA, DHA and alpha-linolenic acid as fatty acids (pg. 7, claims 2, 12).
Dokeniya exemplifies compositions comprising alpha-linolenic acid ([082]-[0106]).
Dokeniya specifically teaches alpha-linolenic acid as showing antiviral activity when incubated with SARS-CoV-2 cells ([0051]).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to add omega-3 fatty acids, such as DHA, EPA, alpha-linolenic acid, and combinations thereof, to the methods of the combination of Fliri and Utomo, to arrive at instant claims 41-44. One of ordinary skill in the art would have been motivated to make such an addition, with a reasonable expectation of success, because:
-both Dokeniya and the combination of Fliri and Utomo are directed toward methods of treating SARS-CoV-2,
-Dokeniya teaches compositions comprising fatty acids, such as EPA, DHA, and/or alpha-linolenic acid, as treating/preventing SARS-CoV-2, and
-Dokeniya specifically teaches alpha-linolenic acid as showing antiviral activity when incubated with SARS-CoV-2 cells.
As such, an ordinary skilled artisan would have been motivated to make such an addition to predictably arrive at a composition comprising alpha-linolenic acid or comprising alpha-linolenic acid and EPA, DHA, or a combination thereof, that more potently treats SARS-CoV-2 by inactivating/destroying SARS-CoV-2 by the detergent action of these fatty acids, wherein the fatty acids disrupts the fatty coating that envelope the virus ([0024]).
Regarding claim 45, since the combination of Fliri, Utomo, and Dokeniya teaches a combination of alpha-linolenic, DHA, and/or EPA, this combination meets the limitation of further comprising a free fatty acid, since alpha-linolenic, DHA, and/or EPA, are both free fatty acids and omega-3-fatty acids.
Response to Arguments
The above rejections rely on a new primary reference, US 2023/0201215 to Fliri. As such, the 05/05/2026 arguments directed toward Hahn are not persuasive to overcome the new rejections.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAUREN WELLS whose telephone number is (571)272-7316. The examiner can normally be reached M-F 7:00-4:30.
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, James (Jim) Alstrum-Acevedo can be reached on 571-272-5548. 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.
/LAUREN WELLS/Examiner, Art Unit 1622
Prosecution Insights