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 responsive to the Response to Election/Restriction filed 08/25/2025. The preliminary amendment filed 01/26/2023, cancelled claims 1-26 and added claims
27-46.
Claims 27-46 are pending.
Priority
This application claims the following priority:
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Election/Restrictions
Applicant’s election without traverse of Group II, the method of treatment, and coronavirus as the viral respiratory infection, in the reply filed on 08/25/2025, is acknowledged.
Claims 27-36 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim.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 37-46 are examined on the merits herein.
Claim Rejections - 35 USC § 112(b)
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 45 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.
-In claim 45, the phrase “restructured triglycerides” in line 3, renders the claim indefinite since neither the specification nor the prior art teach or define “restructured triglyceride.” As such, it is not clear if a restructured triglyceride is merely a synthetic triglyceride or if a restructured triglyceride is a triglyceride that is structurally altered, but retains the structure of an ester formed from a glycerol and three fatty acid groups, or if a restructured triglyceride is a triglyceride that is structurally altered and does not retain the structure of an ester formed from a glycerol and three fatty acid groups.
Thus, the metes and bounds of this phrase are unclear.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim 37 is rejected under 35 U.S.C. 102(a)(2) as being anticipated by US 2022/0054535 to Hahn (effectively filed 2018, PTO-892).
Hahn teaches compositions for treating inflammation and tissue damage due to irritation and inflammation by administering strontium and nobiletin (abstract, title).
Hahn teaches a compositions for the treatment of a viral infection, wherein the composition comprises strontium and the synergistic agent, nobiletin (pgs. 30-32, claims 1, 3, 8, 24-25, 36-37).
Though Hahn does not teach “for prevention of a viral respiratory infection,” Hahn teaches a method of administering strontium and nobiletin to a subject. Since any mammal is a subject in need of the prevention of a viral respiratory infection, as recited in the claims, administering the composition comprising nobiletin and strontium to the patient populations taught by Hahn, meets the limitation of “prevention of a viral respiratory infection in a subject in need thereof.” Applicant is respectfully reminded that if the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. MPEP 2111.02.
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.
Claims 37, 39, 40, and 46 are rejected under 35 U.S.C. 103 as being unpatentable over US 2022/0054535 to Hahn (effectively filed 2018, 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).
Hahn is applied to claim 37, as discussed in the above rejection, and incorporated herein.
Regarding claim 39, while Hahn teaches a method of treating a viral infection comprising administering strontium and nobiletin, it differs from that of instant claim 39, in that it does not teach coronavirus or SARS-CoV-2.
Hahn additionally teaches that its methods for treating viruses, such as influenza, is based on the belief that many viruses require the activation of NF-Kappa B to infect host cells and that post infection, viruses use the NF-Kappa B pathway for its antiapoptotic properties to evade the host defense mechanisms or to trigger apoptosis as a mechanism of virus spread ([0104]-[0105]). NF-Kappa B is taught as the most important of redox-sensitive regulatory pathways, wherein NF-Kappa B is responsible for directly or indirectly inducing the synthesis of the most important and powerful inflammation activators, including TNF-alpha and many of the inflammatory interleukins and chemokines ([0098]). Since NF-Kappa B acts as a “final common pathway” for activation of multiple inflammatory pathways, substances that reduce or block NF-Kappa B activation have substantial and broad anti-inflammatory activity and block many forms of immune system-mediated activation of inflammatory pathways. NF-Kappa B is also one of the many regulatory molecules that is directly activated by an oxidative intracellular environment-one in which the ratio of reduced glutathione to oxidized glutathione is minimized. Hahn teaches nobiletin as a potent inhibitor of NF-Kappa B and multiple pro-inflammatory cytokines ([0236]).
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 treated in Hahn, to arrive at claim 39. One of ordinary skill in the art would have been motivated to make such a selection, with a reasonable expectation of success, because:
-Hahn teaches compositions comprising nobiletin for the treatment of viral infection,
-Hahn teaches nobiletin as a potent inhibitor of NF-Kappa B and multiple pro-inflammatory cytokines, 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 a selection, to predictably arrive at a therapeutically effective method of treating SARS-CoV-2 that both decreases inflammatory compounds and inhibits viral infection and replication.
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 methods of the combination of Hahn 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, Hahn exemplifies a composition comprising 3% nobiletin ([0392]). In the case where the claimed ranges “overlap or lie inside ranges disclosed in the prior art,” a prima facie case of obviousness exists. See MPEP 2144.05.
Claim 38 is rejected under 35 U.S.C. 103 as being unpatentable over US 2022/0054535 to Hahn (effectively filed 2018, 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 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).
Hahn and Utomo are applied as discussed above and incorporated herein.
While the combination of Hahn 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 Hahn 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 Hahn 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 2022/0054535 to Hahn (effectively filed 2018, 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).
Hahn and Utomo are applied as discussed above and incorporated herein.
Regarding claims 41-44, while the combination of Hahn 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 Hahn 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 Hahn 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 Hahn, 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.
Conclusion
No claims are allowed.
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.
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/LAUREN WELLS/Examiner, Art Unit 1622