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 .
The examiner acknowledges receipt of IDS filed 01/15/2026 and remarks filed 01/30/2026.
No claim is amended.
Original claims 1-22 are pending.
Priority
This application is application claims benefit of 63/495,055 filed 04/07/2023, and is a Continuation-in-part (CIP) of 17/827,504 filed 05/27/2022, now US 11857570 B2, which is a Continuation of 16/500,926 filed 10/04/2019, now US 11369632 B2, which is a 371 of 371 of PCT/IB2018/052324 filed 04/04/2018.
Information Disclosure Statement
The IDS filed 01/15/2026 has been considered by the examiner.
Response to Arguments
On pages 5-7, applicant argues that there are significant differences between the compositions disclosed in Swenholt, Brusk, Yosef, and Tyagi such that a person of ordinary skill in the art would not have a reasonable expectation of success, the differences are:
Swenholt and Brusk do not teach the claimed liquid plant extract from lemongrass.
Response: The examiner agrees that Swenholk and Brusk do not teach lemongrass oil in their compositions and that is the reason for making the rejection under 35 USC 103 describing how the deficiency is made up by the secondary references Tyagi and Yosef.
Yosef and Tyagi merely teach lemongrass essential oil without being combined with olive oil or ozonized olive oil. Yosef uses volatile phase of lemongrass for treating respiratory pathogens (page 269, left column, 1st full paragraph) and that the concentrations of lemon grass described in Yosef are for volatiles of the oils (page 264, right column, 2nd paragraph). Tyagi does not teach using lemongrass with another oil but experiments using lemongrass oil in “yeast potato dextrose broth (PDB) medium (page 3, left column, 1st full paragraph).
Response: Yosef and Tyagi were relied upon for teaching lemongrass essential oil has antifungal activity against Candida albicans fungal pathogen as stated in the office action mailed 10/01/2025. Yosef and Tyagi were not relied upon to teach that lemongrass oil is combined with other oils to have antifungal activity against Candida albicans fungal pathogen.
Obviousness requires more than a mere showing that the prior art includes separate references covering each limitation in a claim under examination, but that obviousness requires the additional showing that a person of ordinary skill at the time of the invention would have selected and combined those prior art elements in the normal course of research and development to yield the claimed invention, citing KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418, (2007). Further, obviousness determination also requires reasonable expectation of success, citing In re Merck & Co., Inc., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986)." MPEP § 2143.02.
Response: The rejection using Swenholt and Brusk in view of Yosef and Tyagi is not a mere showing that prior art includes separate references covering each limitation in a claim under examination. Rather, the rejection clearly articulated that the composition of Swenholt and Brusk comprising ozonized olive oil having peroxide value of 263.8 mEq/kg treats Candida albicans fungal pathogen. Yosef and Tyagi were relied upon for teaching lemongrass essential oil has antifungal activity against Candida albicans fungal pathogen. Thus two composition having the same effect/utility/function can be combined to form a third composition that would be expected to predictably having the same effect/utility/function. Therefore, the premise of KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418, (2007) and In re Merck & Co., Inc., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986)." MPEP § 2143.02 are not violated.
The office action appears to be combining various ingredients from functionally different compositions without regard to compatibility or functionality; that Swenholt combines ozonizable oils, plant extracts oils and antimicrobials with sodium chlorite; Brusk teaches sanitary articles containing live bacteria and impregnated with olive oil; Yosef and Tyagi teach lemongrass oil or its vapor without combining the lemongrass oil with other active element. That nothing in these references provides any motivation or rationale for the ordinary skilled artisan to combine the separate teachings and the office action did not provide explanation as to why a person of skill in the art would choose lemongrass oil to combine with ozonized olive oil. Such a combination derives from the instant claims. The pharmaceutical art is unpredictable and as such it does not stand to reason that the skilled artisan would choose to combine ingredients from such widely difference products.
Response: The examiner disagrees that the compositions of Swenholt and Brusk cannot be combined with the Yosef and Tyagi because compositions that have been taught to be useful for the same purpose can be combined to form another composition to be used for the very same purpose, see In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). In the instant case, the composition of Swenholt and Brusk comprising ozonized olive oil having peroxide value of 263.8 mEq/kg treats Candida albicans fungal pathogen infection. The composition of Yosef and Tyagi comprising lemongrass essential oil treats Candida albicans fungal pathogen. Thus according In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980), the compositions of Swenholt and Brusk can be combined with the composition of Yosef and Tyagi and the combined composition would be reasonably expected to predictably treat Candida albicans fungal pathogen infections. The comprising language is open and does exclude sodium chlorite.
On pages 8-9, applicant argues:
The office action is silent on the inclusion of liquid plant extract from lemon balm for claim 9.
Response: Claim 9 was rejected because the composition of Swenholt for treating candida albicans or having antifungal effects comprises lemon oil or other citrus oil (see at least paragraphs [0014] and [0060]).
For claim 17, Swenholt does not teach the claimed peroxide value of 50-900 mEq O2/Kg were the ozonized olive oil includes thymol.
Response: The examiner agrees Swenholt teaches ozonized olive oil and does not teach peroxide value of 50-900 mEq O2/Kg. However, BRUSK teaches ozonated olive oil having peroxide value of 263.8 mEq/Kg and this peroxide value of 263.8 mEq/kg is a species of the claimed range of 50-350 mEq/Kg in the claims.
There is no rationale to combine separate teachings of Swenholt and Brusk to arrive at the combination of the features of claim 17.
Response: The examiner disagrees. Before the effective date of the invention, the ordinary skilled artisan looking to Swenholt and FORSGREN BRUSK that teach treating Candida albicans fungal pathogen with ozonized olive oil and also looking to Sulaiman Ali AI Yosef and Tyagi which teaches that lemongrass essential oil has antifungal activity, would be motivated to include essential oil from lemongrass in the composition of Swenholt and FORSGREN BRUSK that would predictably enhance the antifungal activity of the composition comprising ozonized olive oil. Combining the essential oil from lemongrass with the composition containing ozonized olive oil flows from separate teachings that each has antifungal activity against Candida albicans fungal pathogen.
Applicant argues that there are significant differences between the compositions disclosed in Swenholt and Brusk such that a person of ordinary skill in the art would not have a reasonable expectation of success.
Response: Swenholt and Brusk teach composition comprising ozonized olive oil having peroxide value of 263.8 mEq/kg that treats Candida albicans fungal pathogen infection. Swenholt and Brusk are thus not different with respect to teaching treating Candida albicans fungal pathogen infection.
Applicant argues that at least some of the dependent claims are separately patentable such as claim 18 where the liquid plant extract is present at 0.0001-10%; Naik is silent with respect to thymol and that there is nothing that correlates the claimed concentration of thymol with the concentration of lemongrass oil by Naik.
Response: The examiner disagrees. Mohd Irfan Naik teaches that minimum concentration of the lemongrass essential oil to inhibit growth of microorganism was found to range from 0.5% to 0.015 % (first full paragraph, right column of page 536). Therefore, before the effective date of the invention the artisan guided by the teaches of Mohd Irfan Naik would reasonably expect that concentrations of lemon grass essential oil between 0.5% and 0.015% would predictably inhibit the growth of Candida albicans fungal pathogen.
No claim is amended. The rejections are reiterated herein below without substantial . The rejection is the same because the claims have not been amended.
Maintained Rejections
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 4-9 and 12-22 remain rejected under 35 U.S.C. 103 as being unpatentable over Swenholt (US 20140287064 Al) in combination with FORSGREN BRUSK et al. (WO 2010128906 A1) in view of Sulaiman Ali AI Yosef, “Antifungal Activity of Volatiles from Lemongrass (Cymbopogon citratus) and Peppermint (Mentha piperita) oils Against Some Respiratory Pathogenic Species of Aspergilus” in Int. J.Curr.Microbiol.App.Sci (2013) 2(6): 261-272 and Tyagi et al., “Liquid and vapour-phase antifungal activities of selected essential oils against candida albicans: microscopic observations and chemical characterization of cymbopogon citratus” in Complementary and Alternative Medicine 2010, at http://www.biomedcentral.com/1472-6882/10/65 and further in view of Mohd Irfan Naik et al., “Antibacterial activity of lemongrass (Cymbopogon citratus) oil against some selected pathogenic bacterias” in Asian Pacific Journal of Tropical Medicine, 2010 for claims 4, 12 and 18 for reasons of record and reiterated herein below.
Swenholt teaches that ozonized olive oil is an antifungal (see paragraph [0010] and teaches treating fungal infection with thymol, plant based antifungal agent (paragraph [0013]) and ozonized plant and vegetable extract oil such as olive oil (abstract, paragraphs [0010]-[001 l], [0068]-[0069], [0076]); the composition is cream (paragraph [0082], [0087]). In the background Swenholt teaches Thymol, which is Thymus Vulgaris as an essential oil (paragraph [0007]). Swenholt also teaches that ozonated olive oil has been used in pharmaceuticals and cosmetic industry (paragraph [0011]). Swenholt does not teach the peroxide value of the ozonized olive oil.
FORSGREN BRUSK teaches sanitary article such as a sanitary napkin, panty liner, diaper, pant diaper, adult incontinence guard, hygiene tissue and the article comprises oxidized lipids ( see the whole document with emphasis on the title; abstract; page 4, lines 13--31 ); olive oil and sunflower oils are two of the lipids oxidized with ozone and ozonated olive oil has a peroxide value of 263.8 mEq/kg (page 18, lines 13-16: Table 4). The sanitary article provides enhanced effect against Candida albicans and other unwanted microorganisms (page 1, lines 3-6; page 4, lines 18-26). One or more components are added to the hygiene tissue together with the oxidized lipid and cleaning agents, skin care agents and fragrances are examples of components added to the hygiene tissue with the oxidized lipid (page 16, lines 23-27). A peroxide value of 263.8 mEq/kg is a species of the claimed range of 50-350 mEq/Kg in the claims. Candida albicans is a fungal pathogen.
Swenholt and FORSGREN BRUSK teach treating fungal infection with ozonized olive oil. FORSGREN BRUSK is specifically mentions Candida albicans fungal pathogen. 263.8 mEq/kg is a species of the claimed range of 50-350 mEq/Kg as required by claims 1, 6, 9, 14, 17 and 20.
The composition of Swenholt as modified by FORSGREN BRUSK does not contain extract of lemongrass.
However, it is known in the art that lemongrass essential oil has antifungal activity against Candida albicans fungal pathogen (see at least the abstract and introduction, last two lines of left column of page 268 of Sulaiman Ali AI Yosef and abstract and background of Tyagi.
Therefore, before the effective date of the invention, the ordinary skilled artisan looking to Swenholt and FORSGREN BRUSK that teach treating Candida albicans fungal pathogen with ozonized olive oil and also looking to Sulaiman Ali AI Yosef and Tyagi which teaches that lemongrass essential oil has antifungal activity, would be motivated to include essential oil from lemongrass in the composition of Swenholt and FORSGREN BRUSK that would predictably enhance the antifungal activity of the composition comprising ozonized olive oil. Combining the essential oil from lemongrass with the composition containing ozonized olive oil flows from separate teachings that each has antifungal activity against Candida albicans fungal pathogen.
For claims 5 and 13 and 19, the essential oil of lemongrass meets the claim.
For claims 4, 12 and 18, Mohd Irfan Naik teaches that minimum concentration of the lemongrass essential oil to inhibit growth of microorganism was found to range from 0.5% to 0.015 % (first full paragraph, right column of page 536). Therefore, before the effective date of the invention the artisan guided by the teaches of Mohd Irfan Naik would reasonably expect that concentrations of lemon grass essential oil between 0.5% and 0.015% would predictably inhibit the growth of Candida albicans fungal pathogen.
For claims 7, 15 and 21, the lemongrass essential oil, which is an extract of from lemongrass meets the claims --- gleaning form applicant’s as filed specification at paragraphs [0040] and [0042] shows that pharmacologically acceptable extract is plant or vegetable extract.
For claims 8, 16 and 22, “for medical treatment of genital herpes” (clam 8), “for medical treatment of cold sores” (claim 16), and “for medical treatment of bacterial vaginosis” (claim 22) are the intended uses of ozonized olive oil and the ozonized olive oil of the prior art is capable of the intended use. No specific form is claims in claims 8, 16 and 22 and the cream in Swenholt, which is a form of the composition that meets the form in these claims.
Thus, Swenholt and FORSGREN BRUSK, in view of Sulaiman Ali AI Yosef and Tyagi and further in view of Mohd Irfan Naik renders claims 1, 4-9 and 12-22 prima facie obvious.
Claim(s) 1, 2-3, 9 and 10-11 remain rejected under 35 U.S.C. 103 as being unpatentable over Swenholt (US 20140287064 Al) in combination with FORSGREN BRUSK et al. (WO 2010128906 A1) in view of Sulaiman Ali AI Yosef, “Antifungal Activity of Volatiles from Lemongrass (Cymbopogon citratus) and Peppermint (Mentha piperita) oils Against Some Respiratory Pathogenic Species of Aspergilus” in Int. J.Curr.Microbiol.App.Sci (2013) 2(6): 261-272 and Tyagi et al., “Liquid and vapour-phase antifungal activities of selected essential oils against candida albicans: microscopic observations and chemical characterization of cymbopogon citratus” in Complementary and Alternative Medicine 2010, at http://www.biomedcentral.com/1472-6882/10/65 as applied to claims 1 and 9, in view of LURYA et al. (US 20160175228 A1) reiterated herein below.
Claims 2 and 3 depend from claim 1. Claims 10 and 11 depend from claim 9.
Swenholt and FORSGREN BRUSK, in view of Sulaiman Ali AI Yosef and Tyagi have been described above to render claims 1 and 9 prima facie obvious.
Swenholt teaches that ozonated olive oil has been used in pharmaceuticals and cosmetic industry (paragraph [0011]). Swenholt does not teach the olive oil containing composition to contain jojoba, willow bark and colloidal oatmeal and arnica. However, it is known in the art that arnica, jojoba oil, colloidal oatmeal and willow bark are components in cosmetic composition (see paragraph [0042] and claim 17 of LURYA). Therefore, before the effective date of the invention, the artisan would use components known to be used in cosmetic composition in the composition of Swenholt.
Therefore, Swenholt and FORSGREN BRUSK, in view of Sulaiman Ali AI Yosef and Tyagi and further in view of LURYA renders claims 2-3 and 10-11 prima facie obvious.
No claim is allowed.
The specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BLESSING M FUBARA whose telephone number is (571)272-0594. The examiner can normally be reached 7:30 am-6 pm (M-T).
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/BLESSING M FUBARA/Primary Examiner, Art Unit 1613