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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 05/15/2026 has been entered.
Status of the Application
Receipt is acknowledged of Applicants’ amendment and remarks, filed on 05/15/2026, in which claims 28-29 are amended.
Claims 28-29 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.
No rejections are withdrawn. The following are maintained grounds of rejection.
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.
Claim 28 is 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 disclose an embodiment containing a carrier and the disclosed active ingredients in the disclosed amounts.
It would have been prima facie obvious to formulate a composition consisting of hesperidin, quercetin, hesperetin, piperine, zinc, vitamin C, vitamin D3, and N-acetylcysteine, as well as a carrier such as nanoparticles, to arrive at the instantly claimed invention because Prokin directs 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, and 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 hesperidin as the substance for preventing viral entry into the cell, quercetin as the substance for preventing viral replication in cells, hesperetin as the substance for binding to a virus spike protein, piperine as the substance for increasing the bioavailability of other substances, zinc, vitamin C, and vitamin D3 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 consisting of a carrier and hesperidin, quercetin, hesperetin, piperine, zinc, vitamin D3, vitamin C, 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 “a zinc salt”, 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.
Claim 29 is rejected under 35 U.S.C. 103 as being unpatentable over Prokin et al. (WO 2023/219526 A1; PTO-892) in view of Chacon (US 20230218556 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).
The teachings of Prokin differ from that of the instantly claimed invention in that Prokin does not expressly disclose an embodiment containing a carrier and the disclosed active ingredients in the disclosed amounts, nor does Prokin 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].
It would have been prima facie obvious to formulate a composition consisting of hesperidin, quercetin, rutin, piperine, zinc, vitamin C, vitamin D3, and N-acetylcysteine, as well as a carrier such as nanoparticles, to arrive at the instantly claimed invention because Prokin directs 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, and 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 hesperidin as the substance for preventing viral entry into the cell, quercetin as the substance for preventing viral replication in cells, rutin as the substance for binding to the receptor of the viral spike protein, piperine as the substance for increasing the bioavailability of other substances, zinc, vitamin C, and vitamin D3 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 consisting of a carrier and hesperidin, quercetin, rutin, piperine, zinc, vitamin C, vitamin D3, 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 “a zinc salt”, 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.
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 05/15/2026 have been fully considered but they are not persuasive.
Applicant argues that it would not have been obvious to arrive at a composition as recited in the instant claims to the exclusion of the other nearly infinite number of options, combinations, and concentrations disclosed by Prokin et al. (page 3, paragraph 7). Applicant argues that it would not have been obvious because Prokin discloses many possible components (page 4, paragraph 1) and does not expressly teach any particular reason under MPEP 2144.08(A)(4)(b) to select a composition consisting of the recited elements to the exclusion of the other disclosed elements (page 17, paragraph 2 and page 33, paragraph 3). Applicant further argues that the smaller lists are still excessively large and still provide a nearly infinite number of possible combinations (page 18, paragraph 4). A practitioner in the art accordingly would not have arrived at a composition with the specifically recited elements and concentrations, to the exclusion of the other disclosed elements, from the massively broad disclosure of Prokin et al. (page 31, paragraph 1).
Prokin gives specific direction to select 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, preventing viral replication in cells, for increasing the bioavailability of other substances, and at least one substance for treatment. Prokin thus teaches that for each group any of the recited compounds would have the recited function and suggests a composition comprising active agents taught as each being suitable substances to select for 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 reasonably predict that the composition also has antiviral properties. As a result, it is prima facie obvious to choose any one of the disclosed compounds or any combination of the disclosed compounds with a reasonable expectation that it would have the indicated function. Therefore the composition of the instant claims is suggested by the teachings of Prokin because it would have been obvious to combine prior art elements according to known methods to yield the predictable result of an antiviral composition. 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.”
Applicant further argues that Prokin does not teach any preferred species or subgenera having any structural similarity to the claimed compositions because all of the exemplary compositions include compounds not included in the instantly claimed compositions and additionally do not include hesperetin, rutin, or vitamin C (page 17, paragraph 3).
The teachings of Prokin are not limited to that of the exemplary compositions, but rather include broader teachings for producing an antiviral composition and teach that, for example, hesperidin, rutin, and vitamin C as useful for the formulation of an antiviral composition. MPEP 2123(II) states that disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. Furthermore MPEP 2123(I) states that a reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments. Thus the teachings of Prokin and Prokin in view of Chacon suggest the instantly claimed compositions.
Applicant further argues that the claimed composition is not obvious because Prokin et al. does not disclose effective concentrations for each possible combination of agents (paragraph bridging pages 17-18).
Regarding the concentrations of the claimed active agents, as discussed in the grounds of rejection, Prokin suggests starting masses for each of the claimed compounds and teaches that the masses of the individual compounds may be optimized for particular viruses. 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. MPEP 2144.05(II)(A) states that, generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. Where 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. The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages. The instant disclosure does not demonstrate that the claimed concentrations are critical or provide unexpected results. Similarly, the instant disclosure does not demonstrate that the particular combination of active ingredients provide unexpected results.
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 05/15/2026.
Conclusion
No claims are allowed.
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/S.G.H./Examiner, Art Unit 1693
/SCARLETT Y GOON/Supervisory Patent Examiner, Art Unit 1693
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