DETAILED ACTION
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 the Application
Receipt is acknowledged of Applicants’ amendment and remarks, filed on 10/21/2025, in which claims 10-13 are amended, claims 1-9 are canceled, and claims 15-29 are newly added.
Claims 10-29 are pending and are examined on the merits herein.
Priority
The instant application claims domestic benefit to 63/659,539, filed on 06/13/2024.
Information Disclosure Statement
The information disclosure statement (IDS) dated 10/21/2025 complies with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609. Accordingly, the information disclosure statement has been considered by the examiner.
Rejections Withdrawn
Applicant’s amendment and remarks, filed 10/21/2025, with respect that the drawings are objected to because labels in Figures 2-12, 18-19, 21, and 25 are not legible, figure 13A does not distinguish what data is shown in each of the two traces, and a portion of each of Figures 20, 27, 30, and 32-33 appears to be missing has been fully considered and is persuasive, as replacement drawings have been submitted for these figures. It is noted that replacement drawings have not been provided for figures 17B-17E.
Applicant’s amendment and remarks, filed 10/21/2025, with respect that claims 1-14 are rejected under 35 U.S.C. 112(b), as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention has been fully considered and is persuasive, as claims 1-9 are canceled and claims 10-14 have been amended to clarify the scope of the claim. This rejection has been withdrawn.
Applicant’s amendment and remarks, filed 10/21/2025, with respect that claim 5 is rejected under 35 U.S.C. 112(a) as failing to comply with the written description requirement has been fully considered and is persuasive, as claim 5 is canceled. This rejection has been withdrawn.
Applicant’s amendment and remarks, filed 10/21/2025, with respect that claims 1-3, 6, 8, and 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Salunke has been fully considered and is persuasive, as claims 1-3, 6, 8 are canceled, and the scope of the claims 13-14 have been amended to include the limitations of claim 10. This rejection has been withdrawn.
Applicant’s amendment and remarks, filed 10/21/2025, with respect that claims 1-4 and 6-9 are rejected under 35 U.S.C. 103 as being unpatentable over Salunke has been fully considered and is persuasive, as claims 1-4 and 6-9 are canceled. This rejection has been withdrawn.
Applicant’s amendment and remarks, filed 10/21/2025, with respect that claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Prokin in view of Naharros‐Molinero has been fully considered and is persuasive, as the scope of claim 12 has been amended to include the limitations of claim 10. This rejection has been withdrawn.
The following are maintained or new objections and grounds of rejection necessitated by Applicant’s amendment.
Objection to the Drawings
It is noted that replacement drawings have not been provided for figures 17B-17E. Figures 17B-17E of the drawings contain color and no replacement drawings have been submitted for these figures. Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 19-22 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claims 19-22 each recite a composition that does not contain the compounds catechin, gallocatechin, catechin 3-gallate, gallocatechin 3-gallate, epicatechin, epigallocatechin, epicatechin 3-gallate, leucoanthocyanidin, proanthocyanidins, kaempferol, kaempferitrin, astragalin, sophoraflavonoloside, myricetin, fisetin, isorhamnetin, pachypodol, rhamnazin, eriodictyol, homoeriodictyol, taxifolin, dihydroquercetin, dihydrokaempferol, cyanidin, delphinidin, malvidin, pelargonidin, peonidin, petunidin, phytoestrogens, genistein, daidzein, glycitein, equol, calophyllolide, dalbergichromene, coutareagenin, dalbergin, and nivetin. However, the instant disclosure does not provide support for a claim reciting these compounds.
Although the instant specification describes, for example, compositions comprising a set of flavonoids consisting of hesperidin, quercetin, and rutin, the mere absence of the newly recited compounds in newly added claims 19-22 in the disclosed sets of flavonoids does not constitute an express, implicit, or inherent disclosure for the negative limitation of a composition that does not contain the compounds listed above. MPEP 2163(I)(B) states that newly added claims or claim limitations must be supported in the specification through express, implicit, or inherent disclosure. MPEP 2173.05(i) states that any negative limitations or exclusionary proviso must have basis in the original disclosure and that the mere absence of a positive recitation is not basis for an exclusion.
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.
Claims 10-11, 13-14, 16-17, 19-25, and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Prokin et al. (WO 2023/219526 A1; PTO-892).
Prokin teaches a multitarget antiviral dietary supplement which can target viruses including SARS-CoV-2, Influenza, HIV-1, HCoV-229E, HCoV-NL63, HCoV-OC43, and HCoV-HKU1 (abstract). Prokin teaches that SARS-CoV-2 is a coronavirus (page 10, line 8). The supplement can be administered daily as a dietary supplement for the treatment of viral infection (claim 29). The supplement comprises at least one substance for binding to the viral spike protein, at least one substance for binding to the receptor of the viral spike protein, at least one substance for preventing viral entry into the cell, and at least one substance for preventing viral replication in cells (claim 1). The substance for binding to a virus spike protein is selected from, among others, hesperetin (claim 5) included in a mass of between 5-500mg (claim 16). The substance for binding to the receptor of the viral spike protein is selected from, among others, rutin (claim 6) included in a mass of between 5-500mg (claim 16). The substance for preventing viral entry into the cell is selected from, among others, hesperidin (claim 8), included in a mass of between 5-500mg (claim 16). The substance for preventing viral replication in cells is selected from, among others, quercetin (claim 15), included in a mass of between 5-500mg (claim 16). The multitarget antiviral dietary supplement may additionally comprise at least one substance for increasing the bioavailability of other substances (claim 17), selected from, among others, piperine (claim 18). The multitarget antiviral dietary supplement may additionally comprise at least one essential micronutrient (claim 19), selected from the group consisting of: vitamin D3, vitamin K2, vitamin A, vitamin C, zinc, and magnesium (claim 20). The masses of essential micronutrients used on a daily basis are selected from the group consisting of 1,000-5,000 IU of vitamin D3, 50-250 μg of vitamin K2, 25,000-125,000 IU of vitamin A, 200-1,000 mg of vitamin C, 10-50 mg of zinc, and 50-250 mg of magnesium (claim 21). The multitarget antiviral dietary supplement may additionally comprise at least one substance for treatment (claim 25) selected from, among others, N-acetylcysteine (claim 26). Prokin teaches an example of a composition for treatment in which N-acetylcysteine is administered in an amount of 150 mg (page 37, line 31). Prokin additionally teaches that the masses of the individual compounds may be optimized for particular viruses (abstract and page 45, line 27-page 46, line 1). Prokin teaches that the compositions may be administered with mesoporous silicon nanoparticles, solid lipid nanoparticles, and liposomes, thus teaching that the composition may include a carrier (page 45, lines 14-16).
Prokin does not expressly teach a single embodiment containing a carrier and a first set of flavonoids consisting of hesperidin, quercetin, and either hesperetin, rutin, or a combination of hesperetin and rutin.
It would have been prima facie obvious to formulate a composition comprising hesperidin, quercetin, and either hesperetin, rutin, or a combination of hesperetin and rutin before the effective filing date of the claimed invention by selecting these flavonoids as well as vitamin D3, vitamin C, zinc, and N-acetylcysteine, as well as a carrier such as nanoparticles, to arrive at the instantly claimed invention. It would have been prima facie obvious for one of ordinary skill in the art to formulate a composition comprising a substance for binding to a virus spike protein, a substance for binding to the receptor of the viral spike protein, a substance for preventing viral entry into the cell, a substance for preventing viral replication in cells, essential micronutrients, and a substance for treatment, together with a carrier, because it is prima facie obvious to combine the prior art elements of substances for a multitarget antiviral dietary supplement according to the known method of Prokin to yield the predictable result of an antiviral composition. Furthermore, it would have been prima facie obvious for one of ordinary skill in the art to select hesperetin as the substance for binding to a virus spike protein, rutin as the substance for binding to the receptor of the viral spike protein, hesperidin as the substance for preventing viral entry into the cell, quercetin as the substance for preventing viral replication in cells, vitamin D3, vitamin C, and zinc as essential micronutrients, and N-acetylcysteine as a substance for treatment because Prokin teaches these compounds as being suitable substances to select for each of these respective classes of substances. One of ordinary skill in the art would have a reasonable expectation of success because Prokin teaches that these substances are useful for the development of a multitarget antiviral dietary supplement. Furthermore, Prokin suggests a composition comprising active agents consisting of hesperidin, quercetin, hesperetin, rutin, vitamin D3, vitamin C, zinc, and N-acetylcysteine and teaches that the masses of the individual compounds may be optimized for particular viruses (abstract and page 45, line 27-page 46, line 1). Thus one of ordinary skill in the art would have been motivated to optimize the masses of the compounds beginning with the suggested masses in order to optimize the composition for the treatment of a particular virus, such as a SARS-CoV-2 virus.
Regarding the limitation “wherein the first set of flavonoids consists of” in line 3 of claim 10, and line 1 of each of claims 16-17 and 24-25, because the active agents are comprising a first set of flavonoids, under the broadest reasonable interpretation of the claim, the claims encompass compositions where the active agents may comprise additional active agents, including additional active flavonoids, in addition to the first set of flavonoids. Furthermore, Prokin suggests a composition in which the active agents consist of hesperidin, quercetin, vitamin D3, vitamin C, zinc, N-acetylcysteine, and either hesperetin or rutin. This composition consists of a set of flavonoids defined as hesperidin, quercetin, and either hesperetin or rutin.
Regarding instant claims 10-11, the claims recite “optionally, one or more omega-3 fatty acids” which indicates that the limitations of the claim are met regardless of whether the composition includes omega-3 fatty acids. Thus the limitations of these claims are met by the teachings of Prokin.
Regarding instant claims 10-11 and 27-29, Prokin does not expressly teach that the zinc is in the form of a zinc salt. However, Prokin teaches that zinc in the form of the salt zinc sulfate is suitable for administration in the treatment of COVID-19 patients (page 19, lines 28-32). Thus it would have been prima facie obvious to include the zinc in the composition of Prokin in the form of a zinc salt.
Regarding instant claims 19-23, Prokin suggests a composition in which the only active agents consist of hesperidin, quercetin, hesperetin, rutin, vitamin D3, vitamin C, zinc, and N-acetylcysteine. Thus Prokin suggests a composition in which there are no flavonoids other than a first set of flavonoids consisting of hesperidin, quercetin, hesperetin, and rutin.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Prokin et al. (WO 2023/219526 A1; PTO-892) as applied to claim 10, in view of Prokin et al. (WO 2023/219526 A1; PTO-892).
Prokin teaches as above. Prokin further teaches that the composition may be administered by oral administration (claim 27 and page 45, lines 6-7).
The teachings of Prokin differ from that of the instantly claimed invention in that Prokin does not teach that the composition is formulated as a capsule or gel cap.
Naharros‐Molinero teaches that soft gelatin capsules are the most widely used pharmaceutical form after tablets (abstract). Soft gelatin capsules can be administered orally and provide the benefit of good patient compliance as they are easy to swallow and can mask the taste and odor of unpleasant ingredients. Furthermore, formulation as a soft gelatin capsule improves the dosage unit homogeneity of a drug compared to other solid dosage forms. Soft gelatin capsules are considered one of the most stable dosage forms since the gelatin outer shell acts as a barrier exposed to external factors such as temperature or humidity, protecting the active components included in the inner fill (paragraph bridging pages 1-2).
One of ordinary skill in the art would have been motivated to formulate the composition of Prokin as a soft gelatin capsule because Naharros‐Molinero teaches that soft gelatin capsules improve patient compliance, dosage unit homogeneity, and formulation stability. One of ordinary skill in the art would have had a reasonable expectation of success in formulating the compositions of Prokin as a capsule because Prokin teaches that the composition may be administered orally and Naharros‐Molinero teaches that soft gelatin capsules are widely used and may be administered orally.
Claims 15, 18, 26-27, and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Prokin et al. (WO 2023/219526 A1; PTO-892) as applied to claim 10, further in view of Chacon (US 20230218556 A1; PTO-892).
Prokin teaches as above.
The teachings of Prokin differ from that of the instantly claimed invention in that Prokin does not teach one or more omega-3 fatty acids.
Chacon discloses a method for the treatment of viral infections comprising the administration of fatty acids (abstract), including the treatment of SARS-CoV-2 (claim 7). Chacon teaches that the administration of a composition comprising a fatty acid will increase serum fatty acid levels and provides a protective effect to subjects suffering from acute respiratory distress syndrome such as that caused by severe viral respiratory infections [0084], including SARS-CoV-2 [0085]. The composition may further comprise an anti-viral drug (claim 61) and may be administered orally [0129]. The fatty acid may be an omega-3 fatty acid [0017]. The effective amount of the fatty acid may be, among others, about 500 mg [0147].
One of ordinary skill in the art would have been motivated to add the omega-3 fatty acid of Chacon to the composition of Prokin because Chacon teaches that omega-3 fatty acids increase serum fatty acid levels and provide a protective effect to subjects suffering from acute respiratory distress syndrome, including SARS-CoV-2. One of ordinary skill in the art would have had a reasonable expectation of success in adding an omega-3 fatty acid to the composition of Prokin because Prokin and Chacon teach compositions for the same purpose of treating a COVID-19 infection. In addition ,Prokin teaches a multitarget antiviral dietary supplement and Chacon teaches that the composition may be administered orally and comprise additional anti-viral drugs.
Response to Arguments
Applicant’s arguments filed 10/21/2025 have been fully considered but they are not persuasive.
Applicant argues that the teachings of Prokin encompass a nearly infinite number of possible combinations and does not expressly teach any particular reason under MPEP 2144.08(A)(4)(b) to select a composition having the recited elements (Remarks, page 42, paragraph 1), and provides a list possible components recited by Prokin (Remarks, pages 23-42). This is not persuasive.
Prokin does not provide these possible components as an undifferentiated list of compounds, but rather gives further guidance for selecting compounds by providing specific direction to select at least one substance for each of: binding to the viral spike protein, binding to the receptor of the viral spike protein, preventing viral entry into the cell, and preventing viral replication in cells. Potential compounds for these roles are suggested in smaller lists beginning on page 20 line 1, page 22 line 19, page 23 line 31, and page 25 line 31, respectively.
Applicant further argues that it is therefore not predictable which combinations among the nearly infinite genus of possible combinations would be effective for treating a virus (Remarks, page 42, paragraph 3). This is not persuasive.
Although Prokin does not exemplify the composition of the instant claims, it is suggested by the teachings of Prokin because it would have been obvious to combine prior art elements according to known methods to yield predictable results. As described in the grounds of rejection, in teaching the substances contained in the multitarget antiviral composition, Prokin provides specific direction to select at least one substance for each of: binding to the viral spike protein, binding to the receptor of the viral spike protein, preventing viral entry into the cell, and preventing viral replication in cells. Prokin teaches that for each group any of the recited compounds would have the recited function. Therefore, it is prima facie obvious to choose any one of the recited compounds with a reasonable expectation that it would have the indicated function.Prokin also teaches that the multitarget antiviral dietary supplement may additionally comprise at least one substance for increasing the bioavailability of other substances and at least one substance for treatment. Prokin thus suggests a composition comprising active agents consisting of hesperidin, quercetin, hesperetin, rutin, vitamin D3, vitamin C, zinc, and N-acetylcysteine, in which these compounds are taught as being suitable substances to select for each of these respective classes of substances in the formulation of multitarget antiviral compositions. Because these components are each taught as having antiviral properties, one of ordinary skill in the art would predict that the composition also has antiviral properties. Furthermore, the combination of Prokin is described as a multitarget antiviral dietary supplement which can target viruses including SARS-CoV-2, Influenza, HIV-1, HcoV-229E, HcoV-NL63, HcoV-OC43, and HcoV-HKU1. Thus one of ordinary skill in the art would have a reasonable expectation of success in administering the combination to treat SARS-CoV-2. MPEP 2144.08(A)(4)(d) states that “If the claimed invention and the structurally similar prior art species share any useful property, that will generally be sufficient to motivate an artisan of ordinary skill to make the claimed species...Thus, evidence of similar properties or evidence of any useful properties disclosed in the prior art that would be expected to be shared by the claimed invention weighs in favor of a conclusion that the claimed invention would have been obvious.” MPEP 2144.08(A)(4)I states that “obviousness does not require absolute predictability, only a reasonable expectation of success, i.e., a reasonable expectation of obtaining similar properties.”
Because Applicant’s arguments are not persuasive, the instant claims are rejected for the reasons of record with modifications made to account for the claim amendments filed 10/21/2025.
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.
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/S.G.H./Examiner, Art Unit 1693
/SCARLETT Y GOON/Supervisory Patent Examiner, Art Unit 1693
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