DETAILED ACTION
This office action is in response to applicant’s filing dated July 8, 2026.
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 Claims
Claims 1-14 and 16 are pending in the instant application. Acknowledgement is made of Applicant's amendments filed July 8, 2026. Acknowledgement is made of Applicant's amendment of claim 13; and cancelation of claim 15.
Election/Restrictions
Applicant’s election without traverse of (i) docosahexaenoic acid as the elected omega-3 polyunsaturated fatty acid species and (ii) inhibiting the infection of the SARS-CoV-2 as the elected downstream signaling pathway in the reply filed on July 8, 2026 is acknowledged.
Claims 2, 3, and 7-12 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on July 8, 2026.
Claims 1, 4-6, 13, 14, and 16 are presently under examination as they relate to the elected species: docosahexaenoic acid (DHA) and inhibiting the infection of the SARS-CoV-2.
Priority
The present application was filed on July 5, 2023 and claims benefit of foreign priority to TAIWAN 111142768 filed on November 9, 2022.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on July 5, 2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner, except where marked with a strikethrough.
Drawings
Acknowledgement is made of the drawings received on July 5, 2023. These drawings are accepted.
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 (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 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.
Claims 1, 4-6, 13, and 16 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Dokeniya et al (WO 2021/229533 A1, published November 18, 2021 and effective filing date May 14, 2020).
Regarding claims 1, 4, and 13, Dokeniya teaches a method of treating microbial infection including those caused by enveloped viruses by administering a fatty acid based composition (claim 6), wherein the method inhibits the growth of enveloped viruses by rupturing lipid-rich protein outer envelope coating of the virus (claim 7), wherein the method inhibits the growth of SARS-CoV-2 virus (claim 8). Dokeniya teaches an antiviral composition comprising an effective amount of one or more fatty acids, a suitable carrier, a preservative, one or more cosolvents, and on or more surfactants wherein, the composition comprises between 0.01% and 10% fatty acid; the composition is a disinfectant composition comprising a pH in the range of 5-7.5; and the antiviral activity is for enveloped virus including SARS-CoV-2 (claim 1) wherein the at least one fatty acid is DHA (claim 2).
Regarding claims 5 and 6, Dokeniya teaches the omega-3 polyunsaturated fatty acid, DHA, of the present invention is useful for treating SARS-CoV-2 infection and inhibiting the growth of SARS-CoV-2 virus by rupturing lipid-rich protein outer envelope coating of the virus. Moreover, Dokeniya teaches another object of the invention is to provide a composition to be delivered via oral route (page 6, 5th paragraph). Dokeniya teaches like other coronaviruses, SARS-CoV-2 are spherical in shape and have protein spikes on their surface that help the virus to attach to the human cells, which further undergoes structural change on fusion and facilitates the viral genes to enter the host cell. Interestingly, angiotensin converting enzyme 2 (ACE2) is the cellular receptor for SARS-CoV-2, which is expressed in the membranes of various cells in the body. SARS-CoV-2 spike binds ACE2 on human cells which enable SARS-CoV-2 to spread more easily from person to person (page 2, 1st paragraph).
In performing the active step (i.e. administering an effective amount of the DHA taught by Dokeniya to a subject with SARS-CoV-2 infection), the DHA would necessarily result in inhibiting expression of an angiotensin-converting enzyme 2 and an expression of a transmembrane serine protease 2 in the cell and would inhibit infection of SARS-CoV-2 infection in a human endothelial progenitor cell.
In regard to "wherein” clauses, MPEP 2111.04 states:
The determination of whether each of these clauses is a limitation in a claim depends on the specific facts of the case. See, e.g., Griffin v. Bertina, 283 F.3d 1029, 1034, 62 USPQ2d 1431 (Fed. Cir. 2002) (finding that a “wherein” clause limited a process claim where the clause gave “meaning and purpose to the manipulative steps”). In Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329, 74 USPQ2d 1481, 1483 (Fed. Cir. 2005), the court held that when a “‘whereby’ clause states a condition that is material to patentability, it cannot be ignored in order to change the substance of the invention.” Id. However, the court noted (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)) that a “‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’” Id. In the instant case, the wherein clause is directed to the intended result (i.e. inhibiting angiotensin-converting enzyme 2 and transmembrane serine protease expression in a human endothelial progenitor cell infected with SARS-CoV-2) of the process step positively recited (i.e. administering DHA to a subject having SARS-CoV-2 infection).
Regarding claim 16, Dokeniya teaches the composition is in the form of an emulsion, suspension, solution, lozenge or pastille (claim 3).
Thus, the teachings of Dokeniya anticipate the method of claims 1, 4-6, 13, and 16.
Claims 1, 4-6, 13, and 16 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Stefansson et al (WO 2021/186248 A1, published September 23, 2021 and effective filing date March 18, 2020).
Regarding claims 1, 4, and 13, Stefansson teaches a method of treating a respiratory infection from a virus in an individual subject in need thereof comprising administering to the subject an antiviral formulation comprising an effective amount of a free fatty acid (FFA) mixture wherein the amount of the FFA mixture in the antiviral formulation is at least about 0.1% (v/v) (claim 21), wherein the virus is SARS-CoV-2 (claim 24), wherein the FFA mixture comprises one or more FFA including docosahexaenoic acid (DHA) (claim 33).
Regarding claims 5 and 6, in performing the active step (i.e. administering an effective amount of the DHA taught by Stefansson to a subject with SARS-CoV-2 infection), the DHA would necessarily result in inhibiting expression of an angiotensin-converting enzyme 2 and an expression of a transmembrane serine protease 2 in the cell and would inhibit infection of SARS-CoV-2 infection in a human endothelial progenitor cell.
In regard to "wherein” clauses, MPEP 2111.04 states:
The determination of whether each of these clauses is a limitation in a claim depends on the specific facts of the case. See, e.g., Griffin v. Bertina, 283 F.3d 1029, 1034, 62 USPQ2d 1431 (Fed. Cir. 2002) (finding that a “wherein” clause limited a process claim where the clause gave “meaning and purpose to the manipulative steps”). In Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329, 74 USPQ2d 1481, 1483 (Fed. Cir. 2005), the court held that when a “‘whereby’ clause states a condition that is material to patentability, it cannot be ignored in order to change the substance of the invention.” Id. However, the court noted (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)) that a “‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’” Id. In the instant case, the wherein clause is directed to the intended result (i.e. inhibiting angiotensin-converting enzyme 2 and transmembrane serine protease expression in a human endothelial progenitor cell infected with SARS-CoV-2) of the process step positively recited (i.e. administering DHA to a subject having SARS-CoV-2 infection).
Regarding claim 16, Stefansson teaches the antiviral formulation is in a form of a mouthwash solution, a throat wash solution, a gargle solution, a liquid-filled lozenge, a liquid-filled tablet, a liquid-filled capsule, a syrup, a gargle solution (claim 15).
Thus, the teachings of Stefansson anticipate the method of claims 1, 4-6, 13, and 16.
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.
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.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Stefansson et al (WO 2021/186248 A1, published September 23, 2021 and effective filing date March 18, 2020) as applied to claims 1, 4-6, 13, and 16 above.
Stefansson teaches all the limitations of claim 14, except wherein the effective amount is the instantly claimed amounts. However, Stefansson teaches the amount of FFA mixtures is from about 1.8% to about 2.5% (v/v), wherein the FFA mixture comprises from about 100 to about 135 mg/g DHA as FFA (claims 38 and 39). It would have been prima facie obvious to one of ordinary skill in the art to utilize the amount of DHA taught by Stefansson as a starting point for optimizing the amount of DHA utilized to treat SARS-CoV-2 infection, since Stefansson teaches DHA is useful for treating SARS-CoV-2 infection and because dosage and treatment regimen are result-effective variables, i.e. a variable that achieves a recognized result. Therefore, the determination of the optimum or workable dosages would have been well within the practice of routine experimentation by the skilled artisan. Furthermore, absent any evidence demonstrating a patentable difference between the compositions and the criticality of the claimed dosage range, the determination of the optimum or workable dosing regimen given the guidance of the prior art would have been generally prima facie obvious to the skilled artisan. Please see MPEP 2144.05 [R-2](II)(A) and In re Aller, 220 F. 2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). ("[W]here the general conditions of claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.").
Taken together, all this would result in the practice of the method of claim 14 with a reasonable expectation of success.
Conclusion
Claims 1, 4-6, 13, 14, and 16 are rejected.
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RAYNA B RODRIGUEZ whose telephone number is (571)272-7088. The examiner can normally be reached 8am-5:00pm, Monday - Thursday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy L Clark can be reached at 571-272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Rayna Rodriguez/ Primary Examiner, Art Unit 1628
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