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.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 08/11/2026 has been entered.
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 08/11/2026 is acknowledged. Claim 1 is amended.
Accordingly, claims 1-19 are pending and being examined on the merits herein.
Withdrawn Rejections
The 35 USC 103 rejection over Lefkowitz for claims 1-4, 11-14, and 19, over Lefkowitz in view of Fukuoka for claims 5-10, and over Lefkowitz in view of Subramaniam for claims 15-18 are withdrawn because the claims now recite a new limitation of administering an antiviral agent comprising MEL as the only active ingredient, which was not considered in these rejections.
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, and 13-19 are rejected under 35 U.S.C. 103 as being unpatentable over Subramaniam et al. (Current Opinion in Environmental Science and Health, 2020 in IDS filed 02/06/2025) in view of Suzuki et al. (US20100168405A1 in PTO-892 dated 11/26/2025).
Subramaniam teaches recent advances in the anti-inflammatory and antiviral activities of biosurfactants (BS) and discusses the potential use of BS 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).
Although Subramaniam does not demonstrate or explicitly teach the use of MEL as an antiviral agent against COVID-19, it would have been prima facie obvious before the effective filing date of the claimed to have incorporated the MEL of Subramaniam as an anti-inflammatory and anti-viral agent into various products including cosmetic products or articles such as facemasks, medicated chewing gum, or household cleaner/detergent products to treat a COVID-19 patient and/or kill SARS-CoV-2 virus as suggested by Subramaniam.
One of ordinary skill in the art would have made the modification of incorporating MEL into these products to treat COVID-19 patient and/or kill SARS-CoV-2 with a reasonable expectation of success because Subramaniam provides guidance that BS such as MEL have anti-inflammatory action and suggest its use as an anti-inflammatory agent against COVID-19. Subramaniam also suggests potential anti-viral mechanisms of BS and recommends the incorporation of BS into household cleaner products or medicated chewing gums to target SARS-CoV-2 virus. Furthermore, Subramaniam provides guidance that BS have known applications in cosmetic products as well as in antiviral facemasks.
Subramaniam, however, does not teach an effective amount that is sufficient to reduce viral infectivity of the virus by one or two orders of magnitude or more.
Suzuki teaches an activator comprising a biosurfactant as an active ingredient, wherein the biosurfactant is MEL (claims 1-3). Suzuki teaches that the biosurfactant can be used in such a manner that the biosurfactant is mixed in cosmetics, quasi-drugs, drugs, and drinks and foods (see paragraph 0132), and that that the concentration with which the biosurfactant is mixed is preferably 0.1-20% by mass, with respect to the whole weight of the activator (see paragraph 0132). Suzuki teaches exemplary food products that the biosurfactant can be added into such as gum and among others (see paragraph 0147).
It would have been prima facie obvious before the effective filing date of the claimed to have incorporated the MEL of Subramaniam as described above at 0.1-20% by weight as disclosed in Suzuki to arrive at the claimed invention.
One of ordinary skill in the art would have made the modification of preparing the MEL at 0.1-20% by weight in these products with a reasonable expectation of success because Suzuki provides guidance of mixing MEL at 0.1-20% by weight into various similar products such as cosmetics, quasi-drugs, drugs, and drinks and foods.
Lastly, even though the combined teachings of Subramaniam and Suzuki described above do not explicitly teach that the MEL will reduce viral infectivity by one or two order of magnitude or more, this result would flow naturally from following the suggestions of these prior arts because the combined teachings of Subramaniam and Suzuki described above provide guidance of administering the same MEL at the same effective % by weight amounts per total weight of a composition to treat a patient with human coronavirus, and as evidenced by the instant specification, liquid formulations comprising MEL at 0.01% by weight / volume (which equals 0.01% weight / weight given 1 g/mL density) reduced viral infectivity titer of human coronavirus by two orders of magnitude (paragraph 0050-51 pages 17-18 and FIG. 1).
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 Subramaniam et al. (Current Opinion in Environmental Science and Health, 2020 in IDS filed 02/06/2025) in view of Suzuki et al. (US20100168405A1 in PTO-892 dated 11/26/2025), as applied to claims 1 and 8 above, and further in view of Fukuoka et al. (Carbohydrate Research, 2012 in PTO-892 dated 11/26/2025).
The combined teachings of Subramaniam and Suzuki are as described above and teach the method recited in instant claims 1 and 8 as discussed above.
The combined references, however, do not disclose the recited MEL structure in instant claims 5-7 and 8-10.
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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The R-MEL-B meets the limitation of the MEL structure recited in instant claims 7 and 10, and the S-MEL-B meets the limitations of the MEL structure recited in instant claims 6 and 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 the combined teachings of Subramaniam and Suzuki 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 made this substitution with a reasonable expectation of success because Fukuoka demonstrates all MELs including the MEL disclosed in the combined teachings of Subramaniam and Suzuki described above 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) 1-4, 11-12, and 14-18 are rejected under 35 U.S.C. 103 as being unpatentable over Li et al. (Journal of Thoracic Disease, 2018 in PTO-892 dated 11/26/2025) in view of Subramaniam et al. (Current Opinion in Environmental Science and Health, 2020 in IDS filed 02/06/2025) and Suzuki et al. (US20100168405A1 in PTO-892 dated 11/26/2025).
Li teaches anti-influenza strategies and discloses that influenza infection can lead to a hyper-inflammatory immune response that can result in serious conditions (see Abstract). Therefore, Li teaches that a treatment strategy for influenza includes a balance between anti-virus and anti-inflammation.
Li teaches that uncontrolled release of inflammatory cytokines, known as “cytokine storm”, can lead to multiple organ damage and even death. Therefore, Li teaches that methods to alleviate the damage caused by a cytokine storm in response to influenza virus infection have become an important part of anti-influenza strategies (see right column page S2248). Li teaches several anti-inflammatory therapy strategies against influenza infection including the use of glucocorticoids and passive immunotherapy (see right column page S2252 through left column page S2253).
The difference between Li and the claimed invention is that Li does not teach the use of MELs and administering an effective amount to reduce viral infectivity of the virus by one order of magnitude or more.
The independent teachings of Subramaniam and Suzuki are as described above.
It would have been prima facie obvious before the effective filing date of the claimed invention to have substituted the anti-viral and anti-inflammatory therapy strategies against influenza infection as disclosed in Li with the suggested anti-viral and anti-inflammatory effects of MEL against enveloped viruses as disclosed by Subramaniam described above and further incorporate the MEL of Subramaniam into various products including cosmetic products or articles such as facemasks, medicated chewing gum, or household cleaner/detergent products as suggested by Subramaniam at 0.1-20% by weight as disclosed in Suzuki to arrive at the claimed invention.to arrive at the claimed invention.
One of ordinary skill in the art would have made the substitution to MEL with a reasonable expectation of success because Li provides guidance of anti-viral and anti-inflammatory strategies against influenza virus infection such as alleviating the damage caused by a cytokine storm, and Subramaniam suggests the use of MEL for its anti-inflammatory action to also alleviate the effects of cytokine storm in a related SARS-CoV-2 virus infection. Furthermore, Subramaniam suggests anti-viral mechanisms of BS against enveloped viruses.
One of ordinary skill in the art would have made the modification of incorporating MEL into various products such as facemasks, medicated chewing gums, or others with a reasonable expectation of success because Subramaniam suggests potential anti-viral mechanisms of BS and recommends the incorporation of BS into household cleaner products or medicated chewing gums to target a related SARS-CoV-2 virus. Furthermore, Subramaniam provides guidance that BS have known applications in cosmetic products as well as in antiviral facemasks.
One of ordinary skill in the art would have made the modification of preparing the MEL at 0.1-20% by weight in these products with a reasonable expectation of success because Suzuki provides guidance of mixing MEL at 0.1-20% by weight into various similar products such as cosmetics, quasi-drugs, drugs, and drinks and foods.
Lastly, even though the combined teachings of Li, Subramaniam, and Suzuki described above do not explicitly teach that the MEL will reduce viral infectivity by one order of magnitude or more, this result would flow naturally from following the suggestions of these prior arts because the combined teachings of Li, Subramaniam, and Suzuki described above provide guidance of administering the same MEL at the same % by weight amounts per total weight of a composition to treat a patient with influenza virus, and as evidenced by the instant specification, liquid formulations comprising MEL at 0.1% by weight / volume (which equals 0.1% weight / weight given 1 g/mL density) reduced viral infectivity titer of influenza virus by one order of magnitude (paragraph 0050-52 pages 17-18 and FIG. 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.").”
Response to Arguments
Applicant’s arguments filed on 08/11/2026 have been fully considered in so far as Applicant’s arguments are applicable to the instant claims.
Applicant argues that Lefkowitz teaches multiple active ingredients. However, this argument is not persuasive because the newly applied rejections do not cite Lefkotwitz, rendering Applicant’s arguments moot.
Furthermore, the new prior art rejections provide guidance for incorporating MEL into various products as an anti-inflammatory and anti-viral agent against viral infections such as SARS-CoV-2 or influenza virus as discussed above.
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 Subramaniam et al. (Current Opinion in Environmental Science and Health, 2020 in IDS filed 02/06/2025) and Suzuki et al. (US20100168405A1 in PTO-892 dated 11/26/2025).
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 independent teachings of Subramaniam and Suzuki are as described above.
It would have been prima facie obvious before the effective filing date of the claimed to have incorporated the MEL recited in the claims of ‘599 as an anti-inflammatory and anti-viral agent into various products including cosmetic products or articles such as facemasks, medicated chewing gum, or household cleaner/detergent products as suggested by Subramaniam at 0.1-20% by weight as disclosed in Suzuki to treat a COVID-19 patient and/or kill SARS-CoV-2 virus as suggested by Subramaniam to arrive at the claimed invention.
One of ordinary skill in the art would have made the modification of incorporating MEL into these products to treat COVID-19 patient and/or kill SARS-CoV-2 with a reasonable expectation of success because Subramaniam provides guidance that BS such as MEL have anti-inflammatory action and suggest its use as an anti-inflammatory agent against COVID-19. Subramaniam also suggests potential anti-viral mechanisms of BS and recommends the incorporation of BS into household cleaner products or medicated chewing gums to target SARS-CoV-2 virus. Furthermore, Subramaniam provides guidance that BS have known applications in cosmetic products as well as in antiviral facemasks.
Furthermore, one of ordinary skill in the art would have made the modification of preparing the MEL at 0.1-20% by weight in these products with a reasonable expectation of success because Suzuki provides guidance of mixing MEL at 0.1-20% by weight into various similar products such as cosmetics, quasi-drugs, drugs, and drinks and foods.
Lastly, even though the combination of the claims of ‘599, Subramaniam, and Suzuki described above do not explicitly recite that the 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 combined references because the combined references described above provide guidance of administering the same MEL at the same % by weight amounts per total weight of a composition to treat a patient with human coronavirus, and as evidenced by the instant specification, liquid formulations comprising MEL at 0.01% by weight / volume (which equals 0.01% weight / weight given 1 g/mL density) reduced viral infectivity titer of human coronavirus by two orders of magnitude (paragraph 0050-51 pages 17-18 and FIG. 1).
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 Subramaniam et al. (Current Opinion in Environmental Science and Health, 2020 in IDS filed 02/06/2025) and Suzuki et al. (US20100168405A1 in PTO-892 dated 11/26/2025).
The combination of the claims of ‘599 and the teachings of Subramaniam and Suzuki 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 Subramaniam and Suzuki as described above with 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 made this substitution with a reasonable expectation of success because Fukuoka demonstrates all MELs including the MEL as recited by the combined references described above all efficiently formed vesicles and suggests their use in pharmaceutical and cosmetic materials due to their excellent liquid crystal formation and water retention.
Claims 11-4, 11-12, and 14-18 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 Subramaniam et al. (Current Opinion in Environmental Science and Health, 2020 in IDS filed 02/06/2025), Suzuki et al. (US20100168405A1 in PTO-892 dated 11/26/2025), and over Li et al. (Journal of Thoracic Disease, 2018 in PTO-892 dated 11/26/2025)
The combination of the claims of ‘599 and the teachings of Subramaniam and Suzuki are as recited above and recite the method of instant claim 1 as discussed above.
The combined references, however, do not recite an influenza virus.
The teachings of Li are as described above.
It would have been prima facie obvious before the effective filing date of the claimed invention to have modified the anti-inflammatory and anti-viral method of using MEL as recited by the combination of the claims of ‘599 and the teachings of Subramaniam and Suzuki described above as the anti-viral and anti-inflammatory therapy strategies against influenza infection as disclosed in Li and further suggested by Subramaniam to arrive at the claimed invention.
One of ordinary skill in the art would have made this modification with a reasonable expectation of success because Li provides guidance of anti-viral and anti-inflammatory strategies against influenza virus infection such as alleviating the damage caused by a cytokine storm, and Subramaniam suggests the use of MEL for its anti-inflammatory action to also alleviate the effects of cytokine storm in a related SARS-CoV-2 virus infection. Furthermore, Subramaniam suggests anti-viral mechanisms of BS against enveloped viruses.
Lastly, even though the combination of the claims of ‘599 and the teachings of Subramaniam, Suzuki, and Li described above do not explicitly recite that the MEL will reduce viral infectivity by one order of magnitude or more, this result would flow naturally from following the suggestions of these combined references because the combined references described above provide guidance of administering the same MEL at the same % by weight amounts per total weight of a composition to treat a patient with influenza virus, and as evidenced by the instant specification, liquid formulations comprising MEL at 0.01% by weight / volume (which equals 0.01% weight / weight given 1 g/mL density) reduced viral infectivity titer of influenza virus by one order of magnitude (paragraph 0050-52 pages 17-18 and FIG. 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
Response to Arguments
Applicant’s arguments filed on 08/11/2026 have been fully considered in so far as they apply to the rejections of the instant office action but were not persuasive.
Applicant provides arguments over the nonstatutory double patenting rejections on the basis that Lefkowitz teaches multiple active ingredients in their compositions as described above in the response to the obviousness rejections. However, the new nonstatutory double patenting rejections discussed above do not cite Lefkotwitz, rendering Applicant’s arguments moot.
Furthermore, the nonstatutory double patenting rejections provide guidance for incorporating MEL into various products as an anti-inflammatory and anti-viral agent against viral infections such as SARS-CoV-2 or influenza virus as discussed above.
Conclusion
No claim is found allowable.
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/D.H.C./Examiner, Art Unit 1693
/SCARLETT Y GOON/Supervisory Patent Examiner
Art Unit 1693
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