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 .
Priority
This application is a national stage entry of PCT/EP2021/053389 filed 02/11/2021. Acknowledgment is made of applicant's claim for foreign priority based on an application filed in Greece on February 11, 2020 and in UNITED KINGDOM on 02/17/2020. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Response to Amendment
Applicant’s amendment filed on March 30, 2026 amending claims 1, 2, 15-16, canceling claims 3-5, 7, 9, 11, 13-14, 17-18, 27-29, and adding new claims 33-35 has been entered. Claims 16, 19 and 20 are withdrawn. Claims 6, 8, 10, 12, 21-26, 31 and 32 were previously canceled.
Claims 1, 2, 15, 30 and 33-35 are currently presented for examination.
Response to Arguments
Due to Applicant’s amendments to the claims the previous rejections under 35 USC 112(a) are hereby withdrawn.
Due to Applicant’s amendments to the claims the previous rejections under 35 USC 112(b) are hereby withdrawn.
Applicant's arguments filed March 30, 2026 with respect to the rejection under 35 USC 103 have been fully considered but they are not persuasive.
Applicant argues that Lamb does not contain any teaching regarding COVID-19, and there is no reasonable expectation that p-cymene would be suitable for treating COVID-19. Applicant further argues that the teaching of Lamb is not specific to p-cymene and nothing can be inferred about this compound in particular, as opposed to other compounds that are mixed together with p-cymene. Applicant argues that Lamb focuses on essential oil compositions rather than testing individual compounds. Applicant argues that the compositions of Lamb include 30-80% carvacrol and 10-60% thymol, and there is no disclosure in Lamb as to the effect of p-cymene in isolation. Thus, Applicant argues that Lamb provides no teaching or suggestion regarding the effect of p-cymene alone, much less against influenza or COVID-19 specifically. Applicant argues that the antiviral effects could be attributed to carvacrol or thymol rather than to p-cymene. Applicant further argues that the EO fraction can comprise up to 50% of an EO composition and thus, the maximum amount of p-cymene in the overall EO composition is 30%. Thus Applicant argues that Lamb does not contain any teaching at all of a composition comprising more than 50% p-cymene, much less any teaching that this would be effective in the treatment of both influenza and COVID-19.
These arguments are found not persuasive since the claims of the instant application use comprising language, and thus there is no requirement in the instant claims for the administration of p-cymene alone. The transitional term “comprising”, which is synonymous with “including,” “containing,” or “characterized by,” is inclusive or open-ended and does not exclude additional, unrecited elements or method steps. See, e.g., Mars Inc. v. H.J. Heinz Co., 377 F.3d 1369, 1376, 71 USPQ2d 1837, 1843 (Fed. Cir. 2004) (“like the term ‘comprising,’ the terms ‘containing’ and ‘mixture’ are open-ended.”). Invitrogen Corp. v. Biocrest Manufacturing, L.P., 327 F.3d 1364, 1368, 66 USPQ2d 1631, 1634 (Fed. Cir. 2003) (“The transition ‘comprising’ in a method claim indicates that the claim is open-ended and allows for additional steps.”); Genentech, Inc. v. Chiron Corp., 112 F.3d 495, 501, 42 USPQ2d 1608, 1613 (Fed. Cir. 1997) (“Comprising” is a term of art used in claim language which means that the named elements are essential, but other elements may be added and still form a construct within the scope of the claim.); Moleculon Research Corp. v. CBS, Inc., 793 F.2d 1261, 229 USPQ 805 (Fed. Cir. 1986); In re Baxter, 656 F.2d 679, 686, 210 USPQ 795, 803 (CCPA 1981); Ex parte Davis, 80 USPQ 448, 450 (Bd. App. 1948) ("comprising” leaves “the claim open for the inclusion of unspecified ingredients even in major amounts”).
In the instant case, claim 1 of the instant application claims the method comprising administering a composition comprising at least about 50 wt.% of one or more compounds of formula (I). Thus the method as claimed is open-ended and allows for additional steps including the administration of additional components. Furthermore the composition administered in the claim only requires at least about 50 wt.% of one or more compounds of formula (I), and thus the composition can contain at least about 50 wt.% of any other compound. Thus the claims of the instant application do not exclude the administration of a composition comprising the other components as taught in Lamb et al.
Lamb et al. specifically teaches that some EO compositions comprise an EO fraction comprising one or more of an effective amount of thymol, an effective amount of para-cymene, an effective amount of carvacrol, or an effective amount of cinnamaldehyde, wherein an effective amount of paracymene can comprise up to about 50 wt. % of the EO fraction (column 11 lines 43-61). Lamb et al. also teaches some embodiments include an EO fraction comprising about 30% to about 80% carvacrol, about 10% to about 60% thymol, and about 10% to about 60% para-cymene (column 8 lines 32-35). Lamb et al. further teaches in some embodiments, the EO fraction comprises 100% of the EO composition (column 12 lines 35-36). Thus Lamb et al. contemplates embodiments wherein the EO composition comprising 100% of the EO fraction wherein one or more of an effective amount of para-cymene is included in an amount of about 50 wt. %, which meets the limitations of claim 1. Moreover, Lamb et al. contemplates an EO fraction comprising about 60% para-cymene and 40% of carvacrol and thymol combined which may comprise 100% of the EO composition, which also meets the limitation of claim 1.
In addition, Lamb et al. specifically teaches antiviral compositions comprising at least one of thymol, para-cymene, carvacrol, or cinnamaldehyde, and thus an ordinary skilled artisan would reasonably expect all of these active compounds to have antiviral activity since the embodiments of Lamb et al. contemplates the use of one of these compounds for antiviral purposes. Thus all of the compounds specifically taught in Lamb et al. including p-cymene would have been reasonably expected to have similar antiviral properties.
Although Lamb et al. does not specifically teach the treatment of SARS-CoV-2, Lamb et al. further teaches that the compositions are effective against RNA viruses including coronaviruses (column 6 lines 31-43). Lamb et al. specifically teaches and claims the treatment of any virus included in Baltimore Classification groups I through VII, including coronaviruses included in class IV. Accordingly, since Lamb et al. teaches that the EO compositions have broad-spectrum antiviral activity, prior to the effective filing date, it would have been obvious to a person of ordinary skill in the art to treat SARS-CoV-2 infection which is a coronavirus causing COVID-19 (see background of the instant specification) with a reasonable expectation of similar success.
An "obvious to try" rationale may support a conclusion that a claim would have been obvious where one skilled in the art is choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success. " [A] person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103." KSR Int'l Co. v. Teleflex Inc., 550 U.S. 538, 421, 82 USPQ2d 1385, 1397 (2007).
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Applicant’s argument with respect to compound A is found not persuasive since the rejection over Lamb et al. pertains to the administration of p-cymene as a compound of formula I for the treatment of influenza or COVID-19 and claim 15 which specifically claims compound A was not included in the rejection.
Thus for reasons of record, and for reasons detailed above, the previous rejection under 35 USC 103 over Lamb et al. is hereby maintained, however the rejection has been modified in view of Applicant’s amendments to the claims. New claims 33-35 are being rejected on the same grounds. This action is FINAL.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 2, 30 and 33-35 are rejected under 35 U.S.C. 103 as being unpatentable over Lamb et al. U.S. Patent No. 10,512,664 B2 (Provided on IDS).
Claims 1, 2, 30 and 33-35 of the instant application claim a method of treating a disease caused by a RNA virus, wherein the disease is SARS-CoV-2 or influenza, comprising administering to a human or non-human animal a therapeutically effective amount of a composition comprising at least about 50 wt. % of a compound of Formula (1), or a pharmaceutically acceptable salt, solvate, tautomer or isomer such as p-cymene having the following structure:
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wherein R1, R3, and R4 are methyl and R2 is hydrogen.
Lamb et al. teaches antiviral essential oil compositions that include one or more essential oils, such as thyme essential oil, oregano essential oil, and/or cinnamon essential, optionally in combination with one or more emulsifiers (abstract). The use of these compositions in organisms and systems provides beneficial antiviral effects, among others (abstract). Lamb et al. teaches antiviral compositions comprising essential oils and methods for providing antiviral effects within an organism and for suppressing proliferation of a virus within an organism comprising administering an effective amount of an antiviral composition to a subject, wherein the antiviral agent comprises one or more essential oils and administration of the antiviral composition provides an antiviral effect within the organism (column 1 lines 59-67).
Lamb et al. teaches antiviral essential oil (EO) compositions which are environmentally friendly, are resistant to viral mutation, and can be administered to subjects as a general health suite which provides health benefits beyond antiviral benefits (column 2 lines 39-43). Lamb et al. further teaches that the EO compositions are effective against viruses in all seven Baltimore Scheme groups (column 2 lines 43-45). Lamb et al. teaches that the EO compositions are effective against viruses in all seven Baltimore Classification genomic groups including viruses from the genus Pestivirus (e.g., bovine viral diarrhea virus, Baltimore group IV), viruses from the genus Varicellovirus (e.g., equine herpesvirus-1, Baltimore group I), parvovirus (Baltimore group II), viruses from the enterovirus genus (e.g., enterovirus 71, also known as “hand foot and mouth disease”, Baltimore group IV), MS-2 bacteriophage virus, viruses from the Reoviridae family (e.g., bovine rotavirus and epizootic hemorrhagic disease virus, Baltimore group III)), porcine respiratory & reproductive syndrome (Baltimore group IV), porcine epidemic diarrhea virus(Baltimore group IV), transmissible gastroenteritis virus (Baltimore group IV), Newcastle disease virus (Baltimore group V), influenza viruses (e.g., H5N1, Baltimore group V), human immunodeficiency virus (Baltimore group VI), and hepatitis viruses (e.g., hepatitis B virus, (Baltimore group VII) (column 5 lines 48-67). Lamb et al. further teaches that the compositions are effective against RNA viruses including coronaviruses (column 6 lines 31-43).
Lamb et al. teaches some embodiments include an EO fraction comprising about 30% to about 80% carvacrol, about 10% to about 60% thymol, and about 10% to about 60% para-cymene (column 8 lines 32-35). Lamb et al. teaches that such embodiments are particularly efficacious against viruses belonging to Baltimore Classification groups III and IV (column 8 lines 37-39).
Lamb et al. teaches some EO compositions comprise an EO fraction comprising one or more of an effective amount of thymol, an effective amount of paracymene, an effective amount of carvacrol, or an effective amount of cinnamaldehyde, wherein an effective amount of para-cymene can comprise at least about 5 wt. %, at least about 10 wt. %, at least about 15 wt. %, at least about 18 wt. %, at least about 20 wt. %, or at least about 25 wt. % of the EO fraction; or in some embodiments, an effective amount of para-cymene can comprise up to about 10 wt. %, up to about 15 wt. %, up to about 18 wt. %, up to about 20 wt. %, up to about 35 wt. %, or up to about 50 wt. % of the EO fraction (column 11 lines 54-61).
Lamb et al. specifically exemplifies the treatment of RNA viruses including avian influenza (H5N1) virus (example 14 column 29). Claims 1, 2, 12 and 14 of Lamb et al. claim a method of inhibiting a virus within a subject or system, the method comprising: administering a treatment composition combined with a carrier to one or more of a subject and system, wherein the treatment composition is an emulsion consisting of: thyme essential oil and oregano essential oil, wherein one or more of the thyme essential oil and oregano essential oil provides effective amounts of carvacrol, thymol, and p-cymene, and wherein the virus comprises any virus included in Baltimore Classification groups I through VII, and wherein the effective amounts of carvacrol, thymol, and p-cymene are less than about 1% carvacrol, about 25%-35% thymol, and about 15%-35% p-cymene.
Lamb et al. does not specifically exemplify a composition comprising at least about 50 wt.% of p-cymene. Lamb et al. does not specifically teach the treatment of SARS-CoV-2.
Although Lamb et al. does not specifically exemplify a composition comprising at least about 50 wt.% of p-cymene, as detailed above Lamb et al. teaches an effective amount of para-cymene can comprise up to about 50 wt. % of the EO fraction, and some embodiments include an EO fraction comprising about 30% to about 80% carvacrol, about 10% to about 60% thymol, and about 10% to about 60% para-cymene. Accordingly, prior to the effective filing date, it would have been obvious to a person of ordinary skill in the art to vary and/or modify the amount of p-cymene in the formulation according to the guidance provided in the prior art. Thus a person of ordinary skill in the art would have been motivated to include at least about 50 wt.% of p-cymene in the EO formulation with a reasonable expectation of success. Furthermore, it has been held that it is within the skill in the art to select optimal parameters, such as amounts of ingredients, in a composition in order to achieve a beneficial effect. See In re Boesch, 205 USPQ 215 (CCPA 1980).
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages."); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Lab. Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In re Kulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997); Smith v. Nichols, 88 U.S. 112, 118-19 (1874) (a change in form, proportions, or degree "will not sustain a patent"); In re Williams, 36 F.2d 436, 438 (CCPA 1929) ("It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions."). See also KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007) (identifying "the need for caution in granting a patent based on the combination of elements found in the prior art.").
Although Lamb et al. does not specifically teach the treatment of SARS-CoV-2, Lamb et al. specifically teaches and claims the treatment of any virus included in Baltimore Classification groups I through VII, including coronaviruses included in class IV. Accordingly, since Lamb et al. teaches that the EO composition has broad-spectrum antiviral activity, prior to the effective filing date, it would have been obvious to a person of ordinary skill in the art to treat SARS-CoV-2 infection which is a coronavirus causing COVID-19 (see background of the instant specification) with a reasonable expectation of similar success. Thus treatment of SARS-CoV-2 is rendered obvious in view of the cited prior art teachings.
With respect to newly amended claim 2 which claims at least about 80 wt.% of the composition is a single compound of Formula (I), as detailed above, Lamb et al. teaches an effective amount of para-cymene can comprise up to about 50 wt. % of the EO fraction, and some embodiments include an EO fraction comprising about 30% to about 80% carvacrol, about 10% to about 60% thymol, and about 10% to about 60% para-cymene. Thus Lamb et al. teaches the composition can contain about 60% of p-cymene. A prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985) See also Warner-Jenkinson Co., Inc. v. Hilton Davis Chemical Co., 520 U.S. 17, 41 USPQ2d 1865 (1997); In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%); In re Waite, 168 F.2d 104, 108 (CCPA 1948); In re Scherl, 156 F.2d 72, 74-75 (CCPA 1946) (prior art showed an angle in a groove of up to 90° and an applicant claimed an angle of no less than 120°); In re Swenson, 132 F.2d 1020, 1022 (CCPA 1942); In re Bergen, 120 F.2d 329, 332 (CCPA 1941); In re Becket, 88 F.2d 684 (CCPA 1937); In re Dreyfus, 73 F.2d 931, 934 (CCPA 1934); In re Lilienfeld, 67 F.2d 920, 924 (CCPA 1933); K-Swiss Inc. v. Glide N Lock GmbH, 567 Fed. App'x 906 (Fed. Cir. 2014); In re Brandt, 886 F.3d 1171, 1177, 126 USPQ2d 1079, 1082 (Fed. Cir. 2018).
In the instant case about 60 wt.% as taught in the prior art allows for amounts greater than 60 wt.% and about 80 wt.% as claimed allows for amounts less than 80 wt.%. The concentrations are so close that prima facie one skilled in the art would have expected them to have the same properties. Moreover, generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages."); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Lab. Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In re Kulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997); Smith v. Nichols, 88 U.S. 112, 118-19 (1874) (a change in form, proportions, or degree "will not sustain a patent"); In re Williams, 36 F.2d 436, 438 (CCPA 1929) ("It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions."). See also KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007) (identifying "the need for caution in granting a patent based on the combination of elements found in the prior art.").
New claims 33 and 34 are rendered obvious for the same reasons as detailed above since Lamb et al. specifically teaches an antiviral composition comprising p-cymene. With respect to claim 34 which claims the composition consists essentially of the compound of Formula (I), the examiner respectfully points out that for the purposes of searching for and applying prior art under 35 U.S.C. 102 and 103, absent a clear indication in the specification or claims of what the basic and novel characteristics actually are, “consisting essentially of” will be construed as equivalent to “comprising.” See, e.g., PPG, 156 F.3d at 1355, 48 USPQ2d at 1355. If an applicant contends that additional steps or materials in the prior art are excluded by the recitation of “consisting essentially of,” applicant has the burden of showing that the introduction of additional steps or components would materially change the characteristics of applicant’s invention. In re De Lajarte, 337 F.2d 870, 143 USPQ 256 (CCPA 1964). See also Ex parte Hoffman, 12 USPQ2d 1061, 1063-64 (Bd. Pat. App. & Inter. 1989) (“Although consisting essentially of’ is typically used and defined in the context of compositions of matter, we find nothing intrinsically wrong with the use of such language as a modifier of method steps. . . [rendering] the claim open only for the inclusion of steps which do not materially affect the basic and novel characteristics of the claimed method. To determine the steps included versus excluded the claim must be read in light of the specification. . . . [I]t is an applicant’s burden to establish that a step practiced in a prior art method is excluded from his claims by consisting essentially of’ language.”).
With respect to new claim 35 which claims the composition consists of the compound of formula (I), Lamb et al. specifically teaches that some EO compositions comprise an EO fraction comprising one or more of an effective amount of thymol, an effective amount of para-cymene, an effective amount of carvacrol, or an effective amount of cinnamaldehyde, wherein an effective amount of paracymene can comprise up to about 50 wt. % of the EO fraction (column 11 lines 43-61). Lamb et al. further teaches in some embodiments, the EO fraction comprises 100% of the EO composition (column 12 lines 35-36). Thus Lamb et al. contemplates embodiments wherein the EO composition comprising 100% of the EO fraction wherein one of an effective amount of para-cymene is included in an amount of about 50 wt. %, which meets the limitations of claim 35. In addition, it is noted that claim 1 from which claim 35 depends utilizes comprising language and thus does not exclude additional steps which allow for the administration of additional compounds such as those taught in Lamb et al. for antiviral purposes. Lamb et al. teaches some embodiments include an EO fraction comprising about 30% to about 80% carvacrol, about 10% to about 60% thymol, and about 10% to about 60% para-cymene. Thus the administration of a composition consisting of p-cymene in addition to the administration of a composition comprising thymol and carvacrol which is allowed for by the instant claims, is rendered obvious over Lamb et al. which teaches administration of a composition which may comprise all three components.
Thus the cited claims of the instant application are rendered obvious in view of the cited prior art teachings.
Claim Objections
Claim 15 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Claims 1, 2, 30 and 33-35 are rejected. Claim 15 is objected to. Claims 16, 19 and 20 are withdrawn. Claims 3-14, 17-18, 21-29, 31 and 32 are canceled. No claims are allowed.
THIS ACTION IS MADE FINAL. 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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/KARA R. MCMILLIAN/Primary Examiner, Art Unit 1623
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