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
Applicant’s amendment of 16 March 2026, in which claims 1-5, 11-16 have been amended, is acknowledged.
Claims 1-17 are pending in the application.
Claims 6-10, 17 are withdrawn, as being drawn to a non-elected invention.
Claims 1-5, 11-16 are being examined herewith.
Response to arguments of 16 March 2026
In view of Applicant’s amendment of 16 March 2026, the objections to claims 1, 2, 4, 11, 12 are herein withdrawn. The objections to claims 4, 14 are herein maintained. New objections are made below, based on Applicant’s amendment of 16 March 2026.
Applicant has not deleted the recitation "enveloped virus including SARS-CoV-2" from claim 1. As a result, the rejection of claims 1-5 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite, is herein maintained.
Applicant has not clarified the language of claim 11. As a result, the rejection of claim 11 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite, is herein maintained.
In view of Applicant’s amendment of 16 March 2026, the rejection of claim 12 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite, is herein withdrawn. Applicant has deleted the term “monoglycerides” from claim 12.
Applicant has not clarified the language of claim 16. As a result, the rejection of claim 16 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite, is herein maintained.
Applicant’s arguments (Remarks of 16 March 2026, pages 4-6) against the rejection of claims 1, 3, 5, 11, 13, 15 under 35 U.S.C. 102(a)(1) over Singh et al. (RSC Adv. 2016, 6, 101602-101612), as evidenced by Singh et al. (RSC Adv. 2016, 6, 77590-77602), have been considered.
Applicant’s argument is focused on the fact (page 4, last paragraph) that neither Singh I nor Singh II discloses antiviral compositions for site specific antiviral activity against enveloped viruses including SARS-CoV-2. Applicant argues (page 5) that Singh discloses a microemulsion system for improving drug retention in buccal tissue and not to antiviral disinfection or treatment of enveloped virus infections.
In response, 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. Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See also Rowe v. Dror, 112 F.3d 473, 478, 42 USPQ2d 1550, 1553 (Fed. Cir. 1997) (“where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention, the preamble is not a claim limitation”). See MPEP 2111.02. In this case, the body of claims 1-5, 11-16 fully and intrinsically set forth all the limitations of the claimed invention, namely a composition comprising one or more fatty acids, a carrier, a preservative, one or more cosolvents, and one or more surfactants; the preamble “antiviral, […] the antiviral activity is for enveloped virus including SARS-CoV-2” only states the intended use of the composition. Thus, the preamble is not given any patentable weight.
"[T]he patentability of apparatus or composition claims depends on the claimed structure, not on the use or purpose of that structure." Catalina Mktg. Int'l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801,809 (Fed. Cir. 2002).
It is well settled that “intended use” of a composition or product, e.g., “antiviral activity for enveloped virus/SARS-CoV-2”, will not further limit claims drawn to a composition or product, so long as the prior art discloses the same composition comprising the same ingredients in an effective amount, as the instantly claimed. See, e.g., Ex parte Masham, 2 USPQ2d 1647 (1987) and In re Hack 114, USPQ 161
Applicant is invited to amend the claims to recite a method of treatment of a specific disease with said composition, in order for the recitation “antiviral activity for enveloped virus/SARS-CoV-2” to be given patentable weight.
In this case, Singh I and Singh II together teach all the elements of a composition of instant claims 1, 3, 5, 11, 13, 15.
The rejection of claims 1, 3, 5, 11, 13, 15 under 35 U.S.C. 102(a)(1) over Singh et al. (RSC Adv. 2016, 6, 101602-101612), as evidenced by Singh et al. (RSC Adv. 2016, 6, 77590-77602), is herein maintained and is reproduced below.
Applicant’s arguments (page 5) against the rejection of claims 1, 3-4, 11, 13-14 under 35 U.S.C. 102(a)(1) and 102(a)(2) over Shinohara, have been considered.
Applicant argues that Shinohara discloses cosmetic skin compositions for preventing pigmentation, and does not disclose antiviral activity or treatment of enveloped viral infections. The argument related to intended use in composition claims has been addressed above. For the reason above, the rejection of claims 1, 3-4, 11, 13-14 under 35 U.S.C. 102(a)(1) and 102(a)(2) over Shinohara, is herein maintained and is reproduced below.
Applicant’s arguments (page 6) against the rejection of claims 1, 3, 4, 11, 13, 14 under 35 U.S.C. 102(a)(1) as being anticipated by Fletcher, have been considered.
Applicant argues (page 6, first paragraph) that Fletcher relies on caprylic acid, while the present claims require PUFAs such as LA, GLA, DGLA; thus, the primary component in Fletcher is structurally and functionally different. This argument is not persuasive. Only claims 2 and 12, which are not included in the rejection, require LA, GLA, or DGLA. Claims 1 and 11 recite one or more fatty acids, and caprylic acid in Fletcher is encompassed by the genus of fatty acids in the instant claims.
Applicant’s argument related to >4 log viral reduction is not persuasive (see intended use argument above).
For the reasons above, the rejection of claims 1, 3, 4, 11, 13, 14 under 35 U.S.C. 102(a)(1) over Fletcher is herein maintained and is reproduced below.
Applicant’s arguments (pages 6-8) against the rejection of claims 1-5, 11-15 under AIA 35 U.S.C. 103 over Isaacs, in view of Fletcher; and against the rejection of claims 11, 16 under AIA 35 U.S.C. 103 over Isaacs, in view of Fletcher, as applied to claim 11, in further view of Szente, have been considered.
Applicant argues (page 7, last paragraph) lack of motivation to combine Isaac, which discusses naturally occurring milk lipids, with Fletcher which focusses on short chain saturated fatty acids, whereas the instant invention utilizes PUFAs; and Szente which focusses on host-guest chemistry.
In response, it is maintained that the person of ordinary skill in the art would have been motivated to replace a fatty acid which is caprylic acid in an antiviral ViroSAL formulation taught by Fletcher, with another fatty acid which is linoleic acid (LA), or gamma linolenic acid (GLA), or arachidonic acid (ARA), or with a mixture of two or more fatty acids, because Isaac teaches that caprylic acid, linoleic acid (LA), gamma linolenic acid (GLA), arachidonic acid (ARA), and mixtures thereof, have antiviral properties against enveloped viruses, and Fletcher teaches the advantages of formulating fatty acids as ViroSAL formulation, where said formulation significantly inhibited viral entry compared with the fatty acid alone. Thus, the person of ordinary skill in the art would have replaced caprylic acid with LA, GLA or ARA in a ViroSAL formulation, with the expectation that the resulting composition retains antiviral properties.
Further, the person of ordinary skill in the art would have prepared a composition comprising a mixture of two or more fatty acids selected from LA, GLA, ARA, as a ViroSAL formulation, because Isaacs teaches that linoleic, linolenic acid, arachidonic acid, have antiviral properties against enveloped viruses. One of ordinary skill in the art would have reasonably expected that combining LA and GLA, or LA and ARA, or GLA and ARA, or LA, GLA and ARA, known to be useful for the same purpose, will result in aa antiviral composition useful against enveloped viruses. Since each of LA, GLA and ARA are known to be active ingredients in antiviral compositions, it is considered prima facie obvious to combine them into a single composition useful for the same purpose. At least additive effects would have been reasonably expected. See In re Kerkhoven, 205 USPQ 1069 (CCPA 1980).
Further, the person of ordinary skill in the art would have varied the ratio between the fatty acids in the composition, as in instant claim 11, in order to optime the antiviral effect seen with the composition.
Szente is used in the rejection of claim 16 for the teaching that cyclodextrins are effective to improve water solubility and bioavailability of fatty acids in compositions.
Applicant argues (page 8) unexpected results in terms of >4-log reduction of SARS-CoV-2, low cytotoxicity and stable formulations at pH 5-7.5. In response, the examiner acknowledges the data, yet notes that the instant claims are drawn to a composition. The antiviral activity against SARS-CoV-2 is an intended use (see explanation above).
Regarding the establishment of unexpected results, a few notable principles are well settled. It is applicant’s burden to explain any proffered data and establish how any results therein should be taken to be unexpected and significant. See MPEP 716.02 (b). The claims must be commensurate in the scope with any evidence of unexpected results. See MPEP 716.02 (d). Further, A DECLARATION UNDER 37 CFR 1.132 must compare the claimed subject matter with the closest prior art in order to be effective to rebut a prima facie case of obviousness. See, MPEP 716.02 (e).
For all these reasons, the rejection of claims 1-5, 11-15 under AIA 35 U.S.C. 103 over Isaacs, in view of Fletcher; and against the rejection of claims 11, 16 under AIA 35 U.S.C. 103 over Isaacs, in view of Fletcher, as applied to claim 11, in further view of Szente, are herein maintained and are reproduced below.
Applicant’s amendment of 16 March 2026 necessitated the following new/modified objections and rejections.
Objection to the Claims
Claims 6-10, 17, while currently withdrawn, are objected to because of the following informality: they are presented in a non-compliant form. Specifically, the claim text for claims 6-10, 17 is not presented, even though the claims are withdrawn, not cancelled. The text of all pending claims is to be presented, except for any claim with the status Cancelled. See MPEP 714 reciting 37 CFR 1.121, (c) (4).
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Claim 12 is objected to because it was amended, yet the text of the deleted matter “and/or their monoglycerides” is not shown at all. All claims being currently amended in an amendment paper shall be presented in the claim listing, indicate a status of “currently amended,” and be submitted with markings to indicate the changes that have been made relative to the immediate prior version of the claims. The text of any deleted matter must be shown by strike-through except that double brackets placed before and after the deleted characters may be used to show deletion of five or fewer consecutive characters.
See MPEP 714 reciting 37 CFR 1.121, (c) (2).
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Claims 1, 11 contain newly added text
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underlined and in double brackets. Claims 2, 12 contain newly added text
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underlined and in double brackets. This is confusing, because (see MPEP 714 reciting 37 CFR 1.121, (c) (2) above) the text of any added subject matter must be shown by underlining the added text. Double brackets are used to show deletion of five or fewer consecutive characters. There is no use for a combination of underlining text and double brackets.
Appropriate correction is required.
Claims 1, 11 are objected to because they recite “an antiviral composition comprising of one or more fatty acids”. They should read --An antiviral composition comprising one or more fatty acids--.
Claims 1, 11 are objected to because the newly added text “each in effective amounts” is confusing, at least because the claims do no indicate what are the effective amounts for each listed ingredient; further, a carrier (or a preservative) in a composition does not have therapeutic effect, and, as such, it is unclear how it could be present in “effective amount”.
Claim 1 is drawn to an antiviral composition […] wherein the antiviral activity is for enveloped virus. It is unclear what is the relationship between the composition claimed and the enveloped virus. If the antiviral composition is effective against an enveloped virus, the claim could state that (see however the section on claim interpretation regarding intended use, below).
Claim 4 is objected to because the recitation “is the form of […] mouth spray and topical ointment” should read --in the form of […] mouth spray or topical ointment--, as one understands it cannot be both at the same time.
Claim 11 is drawn to an antiviral composition […] wherein the antiviral activity is for enveloped virus. It is unclear what is the relationship between the composition claimed and the enveloped virus. If the antiviral composition is effective against an enveloped virus, the claim could state that (see however the section on claim interpretation regarding intended use, below).
Claim 14 is objected to because the recitation “is the form of […] mouth spray and topical ointment” should read --in the form of […] mouth spray or topical ointment--, as one understands it cannot be both at the same time.
Claims 2, 12 are objected to for reciting “the at least one fatty acids”, while the claim(s) they depend on (claim 2 depends on claim 1; claim 12 depends on claim 11) recite “one or more fatty acids”. For consistency, Applicant is invited to amend claim 2 to recite “the composition of claim 1, wherein the one or more fatty acids”.
Claim Rejections- 35 USC 112
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.
Claims 1-5 are 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 1 recites the broad recitation “enveloped virus”, and the claim also recites “SARS-CoV-2”, which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Regarding claim 1, the phrase "enveloped virus including SARS-CoV-2" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 2 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 2, the phrase “the at least one fatty acid is selected from the group consisting of LA, GLA, DGLA” would mean that the claim is open ended in the closed Markush expression “the group consisting of”.
Applicant is required to amend claim 2 to recite “the one or more fatty acid is selected from the group consisting of LA, GLA, and DGLA.”
Appropriate clarification of the claim language is required.
Claims 11-16 are 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.
Claim 11 is indefinite because it is unclear what is meant by “one or more of the fatty acids is selected in the ratio of 5:1 to about 1:5”. The language of claim 11 recites a ratio between two components without clearly explaining what the ratio refers to, and without defining the two components.
Since claim 11 recites “one or more fatty acids”, claim 11 includes a possibility that the composition comprises only one fatty acid. It is unclear, if that is the case, what the claimed ratio refers to.
Appropriate clarification/correction of the claim language is required.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 11 recites the broad recitation “enveloped virus”, and the claim also recites “SARS-CoV-2”, which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Regarding claim 11, the phrase "enveloped virus including SARS-CoV-2" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Appropriate clarification of the claim language is required.
Claim 16 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.
Claim 16 is indefinite because it depends on claim 11 and recites “wherein the fatty acids mixed with cyclodextrin as a preferred surfactant”. Claim 11 recites a composition comprising one or more fatty acids, […] and one or more surfactants. However, claim 11 does not recite a cyclodextrin. As such, there is insufficient antecedent basis for the recitation “mixed with cyclodextrin” of claim 16, in claim 11.
Further, cyclodextrins are not known as surfactants, and it is unclear what a “preferred” surfactant is in claim 16, or how a mixture with cyclodextrin is a surfactant/ preferred surfactant.
Moreover, claim 16 depends on claim 11 and recites “the fatty acids”, yet claim 11 recites “one or more fatty acids”. As such, claim 16 should clarify whether it refers to more than one fatty acids.
Further the recitation [are] “mixed with” seems to point to a step of mixing in a composition claim, which renders the claim indefinite.
Appropriate clarification of the claim language is required.
In the interest of compact prosecution, the examiner considers that claim 16 is drawn to the composition of claim 11, further comprising a cyclodextrin.
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.
Claim interpretation: 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. Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See also Rowe v. Dror, 112 F.3d 473, 478, 42 USPQ2d 1550, 1553 (Fed. Cir. 1997) (“where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention, the preamble is not a claim limitation”). See MPEP 2111.02. In this case, the body of claims 1-5, 11-16 fully and intrinsically set forth all the limitations of the claimed invention, namely a composition comprising one or more fatty acids, a carrier, a preservative, one or more cosolvents, and one or more surfactants; the preamble “antiviral, […] the antiviral activity is for enveloped virus including SARS-CoV-2” only states the intended use of the composition. Thus, the preamble is not given any patentable weight.
"[T]he patentability of apparatus or composition claims depends on the claimed structure, not on the use or purpose of that structure." Catalina Mktg. Int'l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801,809 (Fed. Cir. 2002).
Claims 1, 3, 5, 11, 13, 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Singh et al. (RSC Adv. 2016, 6, 101602-101612, cited in PTO-892 of 10 December 2025), as evidenced by Singh et al. (RSC Adv. 2016, 6, 77590-77602, cited in PTO-892 of 10 December 2025).
Singh et al. (RSC Adv. 2016, 6, 101602-101612) teaches (page 101604, left column, first two paragraphs) a composition (MEBG4) comprising MES4 (14 g MES4 in 100 g of MEBG) and a gel base comprising water as carrier; propyl paraben and methyl paraben as preservatives; glycerin and polyethylene glycol cosolvents (page 101603, right column, last paragraph), wherein the pH of the composition is 7.18 (Table 1, page 101606), which is within the range in instant claims 1, 11.
The composition is a microemulsion (page 101604, left column, first line), as in instant claims 3, 13, and is mucoadhesive/ bucco adhesive (page 101606, right column, point 3.3), as in instant claims 5, 15.
While Singh (RSC Adv. 2016, 6, 101602-101612) does not teach the components of MES4 in the composition, Singh (RSC Adv. 2016, 6, 77590-77602) teaches that MES4 comprises (Table 1, page 77593, and page 77591, right column, fourth paragraph)
a lipid phase which is alpha-linolenic acid;
Smix (1:1) which is a 1:1 mixture of Kolliphor EL40 and transcutol HP as surfactants (page 77591, right column, fourth paragraph, also Figure 2); and
water.
Singh (RSC Adv. 2016, 6, 77590-77602) teaches (Table 1) that the concentration of alpha-linolenic acid in MES4 is 15% w/w.
Thus, Singh et al. (RSC Adv. 2016, 6, 101602-101612), as evidenced by Singh et al. (RSC Adv. 2016, 6, 77590-77602) teach a composition comprising
a fatty acid which is alpha-linolenic acid;
a carrier which is water;
a preservative which is propyl paraben and methyl paraben;
glycerin and polyethylene glycol cosolvents;
a mixture of Kolliphor EL40 and transcutol HP as surfactants,
wherein the pH of the composition is 7.18, and
wherein the composition comprises 15% x 14% = 2.1% fatty acid, which is within the range in instant claims 1, 11,
and wherein the composition is a microemulsion, as in instant claims 3, 13, and is mucoadhesive/ bucco adhesive, as in instant claims 5, 15.
As such, a composition of instant claims 1, 3, 5, 11, 13 15 is anticipated by Singh et al. (RSC Adv. 2016, 6, 101602-101612), as evidenced by Singh et al. (RSC Adv. 2016, 6, 77590-77602).
Claims 1, 3-4, 11, 13-14 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Shinohara et al. (AU 2005285903, cited in PTO-892 of 10 December 2025).
Shinohara et al. (AU 2005285903) teaches (Example 7, page 16), a composition comprising fatty acids linolic acid LA 2%, and stearic acid 3%, as in instant claims 1, 11, wherein the composition comprises 5% fatty acids, which is within the range in instant claims 1, 11, the composition further comprising water carrier, glycerin cosolvent, PEG monostearate surfactant, and a preservative, wherein the pH of the composition is 6.5, which is within the range in instant claims 1, 11.
The composition is a cream, as in instant claims 3, 13, for topical application/topical ointment, as in instant claims 4, 14.
As such, a composition of instant claims 1, 3-4, 11, 13-14 is anticipated by Shinohara.
Claims 1, 3, 4, 11, 13, 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fletcher et al. (bioRxiv preprint doi: https://doi.org/10.1101/2020.03.29.009464; pages 1-30; version posted March 30, 2020; accessed 22 August 2025, cited in PTO-892 of 25 August 2025).
Fletcher discloses (under 1.2.4, page 9, last paragraph, page 10, first two paragraphs) a composition (ViroSAL) comprising a fatty acid which is caprylic acid, a carrier (water), a cosolvent (15% glycerol, page 10, second paragraph), sodium citrate buffer (preservative), and one or more surfactants (de-lipidized lecithin, Pluronic and DPPG mix), wherein the composition comprises 10% caprylic acid (or diluted 0.2% caprylic acid, page 10, first paragraph), and has a pH of 5.0, as in instant claims 1, 11, and wherein the composition is antiviral against a range of enveloped viruses in vitro and in vivo, including Epstein-Barr, measles, herpes simplex, Zika and orf parapoxvirus, together with Ebola, Lassa, vesicular stomatitis and SARS-CoV-1 pseudoviruses (Abstract). Evaluation of the components of ViroSAL revealed that caprylic acid was the main antiviral component; however, the ViroSAL formulation significantly inhibited viral entry compared with caprylic acid alone.
The composition is an emulsion (page 9, line 4 under point 1.2.4), as in instant claims 3, 13.
Fletcher also teaches the composition as gel for topical application to the skin/topical ointment (page 10, second paragraph), as in instant claims 4, 14.
As such, a composition of instant claims 1, 3, 4, 11, 13, 14 is anticipated by Fletcher.
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 1-5, 11-15 are rejected under AIA 35 U.S.C. 103 as being unpatentable over Isaacs et al. (US 5,466,714 of 14 November 1995, cited in PTO-892 of 10 December 2025), in view of Fletcher et al. (bioRxiv preprint doi: https://doi.org/10.1101/2020.03.29.009464; pages 1-30; version posted March 30, 2020; accessed 22 August 2025, cited in PTO-892 of 25 August 2025).
Isaac (US 5,466,714) teaches (column 4, 1-25) a composition comprising a fatty acid, where the concentration of the fatty acid (Table 2) in water/buffer carrier is 1 mg/ml (for linoleic acid, or for linolenic acid) or is 0.5 mg/mL (for arachidonic acid), which is within the range in instant claims 1, 11.
The composition (Column 4, lines 1-25) is an emulsion in water/buffer as carrier, as in instant claims 3, 13, where the emulsions of fatty acids were neutralized to pH 7, as in instant claims 1, 11.
Isaac also teaches a composition comprising a mixture of fatty acids, where the concentration of the fatty acid (Table 4) in water/buffer carrier is 0.5 mg/ml for linoleic acid, or 0.3 mg/ml for linolenic acid, which is within the range in instant claims 1, 11.
Isaacs teaches (Table 2, column 5) that fatty acids
caprylic acid;
linoleic acid (18:2), which is LA of instant claims 2, 12;
linolenic acid (18:3), which contains gamma linolenic acid GLA of instant claims 2, 12;
arachidonic acid (20:4), which is ARA of instant claims 2, 12,
have antiviral activity (column 3, lines 1-3, column 3, lines 40-41) against enveloped viruses VSV (Vesicular stomatitis virus), HSV-1 (herpes simplex virus type 1), or VV (Visna virus).
Isaacs also teaches (column 6, Table 3) that monoglycerides of fatty acids such as monocaprylin, or monolinolein (18:2), which is a monoglyceride of instant claim 12, have antiviral activity against enveloped viruses VSV (Vesicular stomatitis virus), or HSV-1 (herpes simplex virus type 1).
Isaac teaches (Table 4) a composition comprising mixtures of fatty acids linoleic acid and linolenic acid, having antiviral activity against enveloped viruses VSV (Vesicular stomatitis virus).
Isaacs teaches (column 19, lines 30-39) compositions comprising compounds of the invention as an active ingredient and an inert pharmaceutical carrier, in the form of solutions, suspensions, emulsions, as in instant claims 3, 13, or as creams/ topical ointment, as in instant claims 4, 14.
Isaacs does not teach that the composition comprises a preservative, one or more cosolvents, and one or more surfactants, as in instant claims 1-5, 11-15.
Isaacs does not teach that the composition is mucoadhesive, as in instant claims 5, 15.
Fletcher discloses (under 1.2.4, page 9, last paragraph, page 10, first two paragraphs) a composition (ViroSAL) comprising a fatty acid which is caprylic acid, a carrier (water), a cosolvent (15% glycerol, page 10, second paragraph), sodium citrate buffer (preservative), and one or more surfactants (de-lipidized lecithin, Pluronic and DPPG mix), wherein the composition comprises 10% caprylic acid (or diluted 0.2% caprylic acid, page 10, first paragraph), and has a pH of 5.0, as in instant claims 1, 11, and wherein the composition is antiviral against a range of enveloped viruses in vitro and in vivo, including Epstein-Barr, measles, herpes simplex, Zika and orf parapoxvirus, together with Ebola, Lassa, vesicular stomatitis and SARS-CoV-1 pseudoviruses (Abstract). Evaluation of the components of ViroSAL revealed that caprylic acid was the main antiviral component; however, the ViroSAL formulation significantly inhibited viral entry compared with caprylic acid alone.
The composition is an emulsion (page 9, line 4 under point 1.2.4), as in instant claims 3, 13.
Fletcher also teaches the composition as gel for topical application to the skin/topical ointment (page 10, second paragraph), as in instant claims 4, 14.
Fletcher teaches (page 10, second paragraph) that the composition further comprises Carbopol 974P, which is known to instill mucoadhesive properties to a formulation, as in instant claims 5, 15.
Fletcher teaches (page 22, first paragraph) that ViroSAL has optimal activity at pH 5.5 and is consequently suitable for use in environments close to this pH, such as skin, oral cavity, and mucous membranes, which are also portals of infection.
Fletcher does not teach a composition comprising fatty acid LA, GLA, or ARA, as in instant claims 2, 12.
It would have been obvious to a person of ordinary skill in the art to combine the teachings of Isaacs and Fletcher to arrive at the instantly claimed invention. The person of ordinary skill in the art would have been motivated to replace a fatty acid which is caprylic acid in an antiviral ViroSAL formulation taught by Fletcher, with another fatty acid which is linoleic acid (LA), or gamma linolenic acid (GLA), or arachidonic acid (ARA), or with a mixture of two or more fatty acids, because Isaac teaches that caprylic acid, linoleic acid (LA), gamma linolenic acid (GLA), arachidonic acid (ARA), and mixtures thereof, have antiviral properties against enveloped viruses, and Fletcher teaches the advantages of formulating fatty acids as ViroSAL formulation, where said formulation significantly inhibited viral entry compared with the fatty acid alone. Thus, the person of ordinary skill in the art would have replaced caprylic acid with LA, GLA or ARA in a ViroSAL formulation, with the expectation that the resulting composition retains antiviral properties.
Further, the person of ordinary skill in the art would have prepared a composition comprising a mixture of two or more fatty acids selected from LA, GLA, ARA, as a ViroSAL formulation, because Isaacs teaches that linoleic, linolenic acid, arachidonic acid, have antiviral properties against enveloped viruses. One of ordinary skill in the art would have reasonably expected that combining LA and GLA, or LA and ARA, or GLA and ARA, or LA, GLA and ARA, known to be useful for the same purpose, will result in aa antiviral composition useful against enveloped viruses. Since each of LA, GLA and ARA are known to be active ingredients in antiviral compositions, it is considered prima facie obvious to combine them into a single composition useful for the same purpose. At least additive effects would have been reasonably expected. See In re Kerkhoven, 205 USPQ 1069 (CCPA 1980).
Further, the person of ordinary skill in the art would have varied the ratio between the fatty acids in the composition, as in instant claim 11, in order to optime the antiviral effect seen with the composition.
Further, regarding claims 5, 15, the person of ordinary skill in the art would have explored different amounts of Carbopol 974P in the composition, and would have measured the mucoadhesive properties of the resulting composition, with the expectation that addition of Carbopol 974P imparts mucoadhesive properties to the formulation, which makes the composition suitable for use in mucous membranes, as taught by Fletcher.
As such, claims 1-5, 11-15 are rejected as being prima facie obvious.
Claims 11, 16 are rejected under AIA 35 U.S.C. 103 as being unpatentable over Isaacs et al. (US 5,466,714 of 14 November 1995, cited in PTO-892 of 10 December 2025), in view of Fletcher et al. (bioRxiv preprint doi: https://doi.org/10.1101/2020.03.29.009464; pages 1-30; version posted March 30, 2020; accessed 22 August 2025, cited in PTO-892 of 25 August 2025), as applied to claim 11 above, in further view of Szente et al. (Journal of Inclusion Phenomena and Molecular Recognition in Chemistry 1993, 16, 339-354, cited in PTO-892 of 10 December 2025).
Isaac and Fletcher are as above.
Neither Isaac, nor Fletcher teach that the composition comprises a cyclodextrin, as in instant claim 16.
Szente teaches (Abstract) that the complexation of fatty acids with various cyclodextrins greatly modifies their properties, resulting in improved water solubility and bioavailability.
Szente teaches (page 341, second and third paragraphs, also Figure 2) that molecular encapsulation of linoleic acid or arachidonic acid resulted in improved stability against oxidation.
Szente teaches (Figure 5, page 346, also Table 1, page 347) improved solubility of linoleic acid in aqueous cyclodextrins at room temperature.
It would have been obvious to a person of ordinary skill in the art to combine the teachings of Isaacs, Fletcher and Szente to arrive at the instantly claimed invention. The person of ordinary skill in the art would have been motivated to replace a fatty acid which is caprylic acid in an antiviral ViroSAL formulation taught by Fletcher, with another fatty acid which is linoleic acid (LA), or gamma linolenic acid (GLA), or arachidonic acid (ARA), or with a mixture of two or more fatty acids, because Isaac teaches that caprylic acid, linoleic acid (LA), gamma linolenic acid (GLA), arachidonic acid (ARA), and mixtures thereof, have antiviral properties against enveloped viruses, and Fletcher teaches the advantages of formulating fatty acids as ViroSAL formulation, where said formulation significantly inhibited viral entry compared with the fatty acid alone. Thus, the person of ordinary skill in the art would have replaced caprylic acid with LA, GLA or ARA in a ViroSAL formulation, with the expectation that the resulting composition retains antiviral properties.
Further, the person of ordinary skill in the art would have added a cyclodextrin to such a formulation comprising one or more fatty acids selected from LA, GLA, ARA, because Szente teaches the advantages of the complexation of fatty acids with cyclodextrins, resulting in improved water solubility, improved stability towards oxidation and improved bioavailability. Thus, a person of ordinary skill in the art would have added a cyclodextrin to form a fatty acid complex with cyclodextrin in a fatty acid formulation, with the expectation that such fatty acid complex with cyclodextrin will result in improved water solubility, stability and bioavailability compared to the uncomplexed fatty acid containing formulation.
As such, claims 11, 16 are rejected as being prima facie obvious.
Conclusion
Claims 1-5, 11-16 are rejected.
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.
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/IRINA NEAGU/Primary Examiner, Art Unit 1629
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