DETAILED ACTION
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 . 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.
Priority
The instant application is a 371 of PCT/JP2022/006587 filed on 02/18/2022 and claims foreign priority to Japanese application no. JP2021-153308 filed on 09/21/2021 and JP2021-036197 filed on 03/08/2021. The certified copies of the foreign priority applications filed on 09/05/2023 are acknowledged.
Status of the Claims
The claim amendments and remarks filed on 02/25/2026 is acknowledged. Claims 1-4 and 16-18 are amended. Claim 19 is newly added.
Accordingly, claims 1-19 are pending and being examined on the merits herein.
Withdrawn Objections/Rejections
The objection to claim 4 is withdrawn in view of amended claim 4 having consistency with the amendments for the recited “antiviral agent”.
The 35 USC 112(b) rejection for claims 2-4 are withdrawn because claim 1 now recites an antiviral agent comprising an effective amount of MEL, which makes it clear that the recited wt% ranges of MEL are in relation to the antiviral agent.
The 35 USC 103 rejection over Subramaniam for claims 1, 11, and 13-18, over Subramaniam in view of Fukuoka for claims 5-10, over Subramaniam in view of Suzuki for claims 2-4, and over Li in view of Subramaniam for claims 1 and 11-12 are withdrawn because the claims now recite the new limitations “reducing viral infectivity of a virus” as well as “wherein the effective amount is an amount sufficient to reduce viral infectivity of the virus by one order of magnitude or more”, which has changed the scope of the claims and requires new search and consideration.
The nonstatutory double patenting rejection over US Patent No. 7,989,599 is withdrawn because the claims now recite the new limitations “reducing viral infectivity of a virus” as well as “wherein the effective amount is an amount sufficient to reduce viral infectivity of the virus by one order of magnitude or more”, which has changed the scope of the claims and requires new search and consideration.
The following grounds of rejection are new as necessitated by Applicant’s amendments.
Claim Rejections - 35 USC § 103
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(s) 1-4, 11-14, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Lefkowitz et al. (WO2020154712A1 in PTO-892).
Lefkowitz discloses compositions and methods for treating a subject diagnosed with autism spectrum disorder (ASD). Lefkowitz discloses in preferred embodiments, the subject compositions comprise tellimagrandin II, glycyrrhizin, monolaurin, selenium, honokiol, a probiotic, and one or more biological amphiphilic molecules, which when administered to a subject, can support immune and/or digestive health, and suppress and/or disable viral pathogenic agents in the body (Abstract). Lefkowitz discloses that their subject may be infected with coronavirus, influenza, and other viral infections (claim 16).
Lefkowitz discloses the one or more biological amphiphilic molecules is preferably biosurfactants (page 11 lines 29-30). Lefkowitz discloses that the biosurfactants are selected from glycolipids, such as rhamnolipids (RLP), sophorolipids (SLP), trehalose lipids (TL), cellobiose lipids and/or mannosylerythritol lipids (MEL) (page 12 lines 29-31). Lefkowitz discloses that the concentration of the biosurfactants in their compositions can be about 5% or less, or preferably 0.5% to about 2.5% (page 11 lines 24-28). Lefkowitz discloses that biosurfactants provide additional immune support against viral, bacterial, and fungal infections, and enhance the bioavailability of the other components of their compositions (page 11 lines 29-35).
Lefkowitz discloses that due to their amphiphilic structure, biosurfactants accumulate at interfaces, thus reducing interfacial tension and leading to the formation of aggregated micellar structures in solution, increase the surface area of hydrophobic water-insoluble substances and increase the water bioavailability of such substances (page 12 lines 17-20). Lefkowitz discloses that the amphiphilic structure of biosurfactants also allows for self-association and interaction with biological membranes. Additionally, the ability of biosurfactants to form pores and destabilize biological membranes permits their use as, e.g., antiviral, antibacterial, antifungal, and hemolytic agents. Combined with the characteristics of low toxicity and biodegradability, biosurfactants are advantageous for use in a variety of application, including human health (page 12 lines 21-25).
Even though Lefkowitz does not demonstrate the use of MEL to treat a viral infection, it would have been prima facie obvious before the effective filing date of the claimed invention to have selected biosurfactants such as MEL as the biological amphiphilic molecule in their compositions and further prepare the MEL at a concentration of 5% or less to treat a viral infection such as influenza or coronavirus as disclosed in Lefkowitz to arrive at the claimed invention.
One of ordinary skill in the art would have been motivated to select biosurfactants such as MEL because Lefkowitz discloses that biosurfactants provide additional immune support against viral, bacterial, and fungal infections, and enhance the bioavailability of the other components of their compositions. Lefkowitz further discloses that biosurfactants have to ability to form pores and destabilize biological membranes which permits their use as, e.g., antiviral, antibacterial, antifungal, and hemolytic agents.
One of ordinary skill in the art would have a reasonable expectation of success because Lefkotwitz lists MEL as a suitable biosurfactant to use in their compositions to treat a viral infection including influenza and coronavirus.
One of ordinary skill in the art would have combined known prior art elements according to known methods of preparing MEL at a concentration of 5% or less to yield predictable results and would have a reasonable expectation of success in doing so because Lefkowitz provides guidance to prepare that their compositions include biosurfactants at less than 5% concentration, which overlaps with the recited wt% in instant claims 2-4. See MPEP 2144.05 I.
Lastly, even though Lefkowitz described above does not explicitly teach that the administered MEL will reduce viral infectivity by one or two order of magnitude or more, this result would flow naturally from following the suggestions of the prior art because Lefkowitz described above discloses administering the same MEL within the same effective amounts (less than 5% concentration) to treat a patient with coronavirus or influenza, and as evidenced by the instant specification, formulations comprising MEL at 0.01% or 0.1% by weight reduced viral infectivity titer of human coronavirus by two orders of magnitude as well as influenza virus by one orders of magnitude (paragraph 0050-51 pages 17-18 and FIG. 1-2).
MPEP 2145 II recites “The fact that appellant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious." Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter.m 1985) (The prior art taught combustion fluid analyzers which used labyrinth heaters to maintain the samples at a uniform temperature. Although appellant showed that an unexpectedly shorter response time was obtained when a labyrinth heater was employed, the Board held this advantage would flow naturally from following the suggestion of the prior art.). See also Lantech Inc. v. Kaufman Co. of Ohio Inc., 878 F.2d 1446, 12 USPQ2d 1076, 1077 (Fed. Cir. 1989), cert. denied, 493 U.S. 1058 (1990) (unpublished — not citable as precedent) ("The recitation of an additional advantage associated with doing what the prior art suggests does not lend patentability to an otherwise unpatentable invention.").”
Claim(s) 5-10 are rejected under 35 U.S.C. 103 as being unpatentable over Lefkowitz et al. (WO2020154712A1 in PTO-892), as applied to claim 1 above, and further in view of Fukuoka et al. (Carbohydrate Research, 2012 in PTO-892 dated 11/26/2025).
The teachings of Lefkowitz are as described above and teach the method recited in instant claim 1 as discussed above.
The difference between Lefkowitz and the claimed invention is that Lefkowitz does not
disclose the recited MEL structure in instant claims 5-10.
Fukuoka teaches diastereomers of MEL (see Abstract). Fukuoka prepared four different diastereomers of MEL as seen in Figure 2 on page 82 and shown below:
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Here, the R-MEL-B meets the limitation of the MEL structure recited in instant claims 5, 7-8 and 10, and the S-MEL-B meets the limitations of the MEL structure recited in instant claims 5-6 and 8-9. Furthermore, Fukuoka teaches that the n integer can be 2-14 as shown in Figure 1 on page 82.
Fukuoka demonstrates in Figure 5 on page 85 that all four MEL diastereomers efficiently formed vesicles (see page column page 84). Fukuoka concludes that MELs can be used in pharmaceutical and cosmetic materials due to their excellent liquid crystal formation and water retention (see right column page 85).
It would have been prima facie obvious before the effective filing date of the claimed invention
to have substituted the MEL as disclosed by Lefkowitz described above with either the R-MEL-B or S- MEL-B of Fukuoka to arrive at the claimed invention.
One of ordinary skill in the art would have substituted one known element (MEL) for another (R-MEL-B or S-MEL-B) to obtain predictable results and would have a reasonable expectation of success in doing so because Fukuoka demonstrates all MELs including the MEL disclosed in Lefkowitz all efficiently formed vesicles and suggests their use in pharmaceutical and cosmetic materials due to their excellent liquid crystal formation and water retention.
Claim(s) 15-18 are rejected under 35 U.S.C. 103 as being unpatentable over Lefkowitz et al. (WO2020154712A1 in PTO-892), as applied to claim 1 above, and further in view of Subramaniam et al. (Current Opinion in Environmental Science and Health, 2020 in IDS filed 02/06/2025)
The teachings of Lefkowitz are as described above and teach the method recited in instant claim 1 as discussed above.
The difference between Lefkowitz and the claimed invention is that Lefkowitz does not
disclose that their compositions are in the form a cosmetic product, disinfectant, or cleaner as recited in instant claims 15-18.
Subramaniam teaches recent advances in the anti-inflammatory and antiviral activities of biosurfactants (BS) and discusses the potential use of these compounds against COVID-19 (see Abstract).
Subramaniam teaches that BS are amphiphilic molecules that are used in a wide range of applications due to its eco-friendly nature and biodegradability as well as its unique properties like specificity, low toxicity, and smooth preparation (see right column page 72). Subramaniam further teaches that BS have gained attention in broad areas of cleaning and other applications for commercialization including cosmetics, pharmaceuticals, and more (see right column page 72 through left column page 73). Subramaniam teaches that BS are generally used in hand washes and personal hygiene purposes to prevent viral transmission, getting rid of viral disease systems, acting as drug transport, and also as anti-viral facemasks (see left column page 73). Subramaniam teaches that the essential property of BS is the surface and interfacial tension (see left column page 73) and has listed several classes of BS from various organisms as listed in Table 1 on page 73 which includes mannosylerythritol lipids (MEL) shown below:
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Subramaniam teaches that MEL have anti-inflammatory action and are suggested to be used as a potential therapeutic agent against inflammatory diseases (see left column page 75).
Subramaniam further suggests the anti-inflammatory role BS can have against COVID-19 treatment (see right column page 75). Subramaniam teaches that once SARS-CoV-2 enters the human host cell, a large number of immune cells respond against the virus and further reports high levels of cytokine storm in COVID-19 patients (see right column page 75). Subramaniam teaches that this cytokine storm exaggerates the immune system and kills off healthy cells, which may lead to irrevocable damage to various organs (see right column page 75 through left column page 76). Therefore, Subramaniam suggests the use of BS to minimize the impact of cytokine storm caused by SARS-CoV-2 infection because BS have a known role in inducing anti-inflammation in the human body (see left column page 76). Subramaniam illustrates in Figure 1 on page 75 how a BS molecule may be used as an anti-inflammation agent for treating COVID-19. Subramaniam further suggests that BS could be used as a combinational drug against COVID-19, since BS also has a known emulsification role in drugs and vaccines (see right column page 78).
Subramaniam also teaches that BS may have anti-viral activity against COVID-19 by disruption of the viral membrane structure and the outer covering as seen in other enveloped viruses (see right column page 78). Subramaniam illustrates this potential mechanism against SARS-CoV-2 in Figure 2 on page 76.
Subramaniam recommends the use of BS in drug/vaccine formulations for treating COVID-19 due to its known emulsification property for drug delivery as well as its potential anti-inflammatory and anti-viral mechanisms against SARS-CoV-2 virus (see left column page 79). Furthermore, Subramaniam recommends incorporating BS into household cleaning products or detergents to target and kill SARS-CoV-2 virus as well as into a medicated chewing gum (see left column page 79).
it would have also been prima facie obvious before the effective filing date of the claimed inventio to have further modified the composition of Lefkowitz described above by incorporating their compositions into formulations/products such as household cleaner/detergent products, facemasks, and/or cosmetics as disclosed in Subramaniam to arrive at the claimed invention.
One of ordinary skill in the art would have combined known prior art elements according to known methods to yield predictable results and would have a reasonable expectation of success in doing so because both Lefkowitz and Subramaniam discloses the use of biosurfactants due to its antiviral properties as well as the ability to enhance other active drugs in the formulations, and Subramaniam further suggests the incorporation of BS into drug/vaccine formulations due to its additional emulsification properties as well as into household cleaner products to target coronavirus, as well as further provides guidance that BS have known applications in cosmetic products as well as in antiviral facemasks.
Response to Arguments
Applicant’s arguments filed on 02/25/2026 have been fully considered in so far as they apply to the rejections of the instant office action, but were not persuasive.
Applicant states that Subramaniam does not demonstrate an effective amount of MELs to reduce the viral infectivity of the virus by one order of magnitude or more. Applicant states that Subramaniam merely provides a list of biosurfactants and their role in various potential medical application. Applicant notes that biosurfactants have very diverse biological activities depending on their molecular structure as evidenced by the submitted Khandara reference. Applicant states that MELs are not disclosed in Subramaniam as having potential anti-viral activity and therefore one would not have a motivation to select MELs as anti-viral agents and further states that Subramaniam teaches away from the claimed method. Applicant further states that neither Suzuki nor Fukuoka cure the deficiencies of Subramaniam for reducing viral infectivity by one order of magnitude or more of a virus by applying MEL in an effective amount.
Applicant’s argument described above were not found persuasive because the new rejection uses Lefkowitz to establish obviousness in using MEL for reducing viral infectivity of a virus, and Subramaniam is only brought into the new rejection as a secondary reference to establish obviousness to incorporate the compositions of Lefkowitz into the products recited in instants claim 15-18. Therefore, Applicant’s arguments over Subramaniam are rendered moot.
Furthermore in regards to Applicant’s statement that biosurfactants have very diverse biological activities depending on their molecular structure, Lefkowitz provides guidance that biosurfactants provide additional immune support against viral, bacterial, and fungal infections, and enhance the bioavailability of the other components of their compositions as well as have an amphiphilic structure that allows for self-association and interaction with biological membranes and further discloses the ability of biosurfactants to form pores and destabilize biological membranes permits their use as, e.g., antiviral, antibacterial, antifungal, and hemolytic agents. Furthermore, Lefkowitz lists MEL as a biosurfactant to use in their compositions for the treatment of viral infections such as influenza and coronavirus. Therefore, an ordinary skilled would have been motivated to include biosurfactants such as MEL with a reasonable expectation of success.
Lastly, it is noted that even though Lefkowitz does not explicitly teach the use of MEL to reduce viral infectivity by one or two order of magnitude or more, this result would flow naturally from following the suggestions of the prior art because Lefkowitz described above discloses administering the same MEL within the same effective amounts to a patient with coronavirus or influenza, and as evidenced by the instant specification, formulations comprising MEL at 0.01% or 0.1% by weight reduced viral infectivity titer of human coronavirus by two orders of magnitude as well as influenza virus by one orders of magnitude (paragraph 0050-51 pages 17-18 and FIG. 1-2).). See MPEP 2145 II.
Applicant further states in response to the prior art rejection over Li as the primary reference that Li does not suggest the use of MELs to treat influenza and thus does not suggest or disclose the recited reduced viral infectivity by one order of magnitude or more. Applicant further states that even if an ordinary skilled artisan were motivated to modify the anti-inflammatory therapy strategy of Li to include MEL as suggested, Applicant states that an ordinary skilled artisan would still not arrive at the claimed invention, which requires the described reduced viral infectivity.
Applicant’s argument described above were not found persuasive because the new rejections above do not cite Li. Therefore, Applicant’s arguments regarding Li are rendered moot.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-4 and 13-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 7,989,599 (‘599) in view of Lefkowitz et al. (WO2020154712A1 in PTO-892).
Claim 1 of ‘599 recites a mannosylerythritol lipid having a structure represented by formula (1) shown below:
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, wherein substituents R1 are the same as each other or different from each other and represent fatty series acyl groups having 4-24 carbon atoms, substituents R2 are the same as each other or different from each other and represent hydrogen or acetyl groups, and a substituent R3 represents hydrogen or a fatty series acyl group having 2-24 carbon atoms, excluding a structure wherein the substituents R1 are fatty series acyl groups having 12 carbon atoms, the substituents R2 are acetyl groups, and the substituent R3 is hydrogen.
The difference between the claims of ‘599 and the claimed invention is that the claims of ‘599 do not recite a method of reducing viral infectivity of a virus and an effective amount that is sufficient to reduce viral infectivity of the virus by one order of magnitude or more.
The teachings of Lefkowitz are as described above.
It would have been prima facie obvious before the effective filing date of the claimed to have prepared the MEL recited in the claims of ‘599 at a concentration of 5% or less into a composition for treating viral infections such as coronavirus or influenza as disclosed in Lefkowitz to arrive at the claimed invention.
One of ordinary skill in the art would have combined known prior art elements according to known methods to yield predictable results and would have a reasonable expectation of success in doing so because Lefkowitz discloses that biosurfactants have to ability to form pores and destabilize biological membranes permits their use as, e.g., antiviral, antibacterial, antifungal, and hemolytic agents and further lists MEL as an biosurfactant to use in their compositions to treat a viral infection including influenza and coronavirus. Furthermore, Lefkowitz provides guidance to prepare the MEL at less than 5% concentration, which overlaps with the recited wt% in instant claims 2-4. See MPEP 2144.05 I.
Lastly, even though the combined references described above do not explicitly teach that the administered MEL will reduce viral infectivity by one or two order of magnitude or more, this result would flow naturally from following the suggestions of the prior art because the combined references described above disclose administering the same MEL within the same effective amounts (less than 5% concentration) to treat a patient with coronavirus or influenza, and as evidenced by the instant specification, formulations comprising MEL at 0.01% or 0.1% by weight reduced viral infectivity titer of human coronavirus by two orders of magnitude as well as influenza virus by one orders of magnitude (paragraph 0050-51 pages 17-18 and FIG. 1-2).
MPEP 2145 II recites “The fact that appellant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious." Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter.m 1985) (The prior art taught combustion fluid analyzers which used labyrinth heaters to maintain the samples at a uniform temperature. Although appellant showed that an unexpectedly shorter response time was obtained when a labyrinth heater was employed, the Board held this advantage would flow naturally from following the suggestion of the prior art.). See also Lantech Inc. v. Kaufman Co. of Ohio Inc., 878 F.2d 1446, 12 USPQ2d 1076, 1077 (Fed. Cir. 1989), cert. denied, 493 U.S. 1058 (1990) (unpublished — not citable as precedent) ("The recitation of an additional advantage associated with doing what the prior art suggests does not lend patentability to an otherwise unpatentable invention.").”
Claims 1 and 5-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 7,989,599 (‘599) in view of Lefkowitz et al. (WO2020154712A1 in PTO-892) and Fukuoka et al. (Carbohydrate Research, 2012 in PTO-892 dated 11/26/2025).
The combination of the claims of ‘599 and the teachings of Lefkowitz are as recited above and recite the method of instant claim 1 as discussed above.
The combined references, however, do not recite the recited MEL structure in instant claims 5-10.
The teachings of Fukuoka are as described above.
It would have been prima facie obvious before the effective filing date of the claimed invention to have substituted the MEL as recited by the combination of the claims of ‘599 and the teachings of Lefkowitz as described above with the S-MEL-B of Fukuoka to arrive at the claimed invention
One of ordinary skill in the art would have substituted one known element (MEL) for another (R-MEL-B or S-MEL-B) to obtain predictable results and would have a reasonable expectation of success in doing so because Fukuoka demonstrates all MELs including the MEL disclosed in Lefkowitz all efficiently formed vesicles and suggests their use in pharmaceutical and cosmetic materials due to their excellent liquid crystal formation and water retention.
Claims 1 and 15-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 7,989,599 (‘599) in view of Lefkowitz et al. (WO2020154712A1 in PTO-892) and Subramaniam et al. (Current Opinion in Environmental Science and Health, 2020 in IDS filed 02/06/2025),
The combination of the claims of ‘599 and the teachings of Lefkowitz are as recited above and recite the method of instant claim 1 as discussed above.
The combined references, however, do not recite compositions tjat are in the form a cosmetic product, disinfectant, or cleaner as recited in instant claims 15-18.
The teachings of Subramaniam are as described above.
It would have been prima facie obvious before the effective filing date of the claimed invention to have further modified the composition as recited by the combination of the claims of ‘599 and the teachings of Lefkowitz as described above by incorporating their compositions into formulations/products such as household cleaner/detergent products, facemasks, and/or cosmetics as disclosed in Subramaniam to arrive at the claimed invention.
One of ordinary skill in the art would have combined known prior art elements according to known methods to yield predictable results and would have a reasonable expectation of success in doing so because both the combined references and Subramaniam disclose the use of biosurfactants due to its antiviral properties as well as the ability to enhance other active drugs in the formulations, and Subramaniam further suggests the incorporation of BS into drug/vaccine formulations due to its additional emulsification properties as well as into household cleaner products to target coronavirus, as well as further provides guidance that BS have known applications in cosmetic products as well as in antiviral facemasks.
Response to Arguments
Applicant’s arguments filed on 02/25/2026 have been fully considered in so far as they apply to the rejections of the instant office action, but were not persuasive.
Applicant states that as discussed above with respect to the obviousness rejections, none of the references provide any teaching or motivation to use MELs to reduce viral infectivity a virus by one order of magnitude or more. Applicant further states that Subramaniam teaches away from the claimed method.
Applicant’s argument described above were not found persuasive because the new rejection uses Lefkowitz to establish obviousness in using MEL for reducing viral infectivity of a virus, and Subramaniam is only brought into the new rejection as a secondary reference to establish obviousness to incorporate the compositions of Lefkowitz into the products recited in instants claim 15-18. Therefore, Applicant’s arguments over Subramaniam are rendered moot.
Furthermore, it is noted that even though the combined references described above does not explicitly teach the use of MEL to reduce viral infectivity by one or two order of magnitude or more, this result would flow naturally from following the suggestions of the prior art because the combined references described above recites administering the same MEL within the same effective amounts to a patient with coronavirus or influenza, and as evidenced by the instant specification, formulations comprising MEL at 0.01% or 0.1% by weight reduced viral infectivity titer of human coronavirus by two orders of magnitude as well as influenza virus by one orders of magnitude (paragraph 0050-51 pages 17-18 and FIG. 1-2).). See MPEP 2145 II.
Conclusion
No claim is found allowable.
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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/D.H.C./Examiner, Art Unit 1693
/SCARLETT Y GOON/Supervisory Patent Examiner, Art Unit 1693
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