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 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.
Previous Rejections
Applicant’s arguments, filed August 8, 2025, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Status
Claims 1-18 are pending and are examined on the merits in this prosecution.
CLAIM REJECTIONS
Obviousness Rejections
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
1) Claims 1-9 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Huang (CN 111777201 A, English translation, cited herein, provided by Google Patent / Translate; cited on IDS dated 12/28/2022).
Huang teaches a circulating cooling water treatment method and a circulating cooling water treatment agent (pg 2: 1-4). The method recites the following composition: 15-30 parts of a corrosion and scale inhibitor, 1-2 parts of a dispersing agent, 15-20 parts of a sterilizing algicide, 5-10 parts of a stripping agent, 5-10 parts of citric acid and 50-100 parts of water (Abstract; pg 3: 16-20).
Huang teaches the corrosion and scale inhibitor contains 2-8 parts of polyepoxysuccinic acid sodium, 10-20 parts of acrylic acid-hydroxypropyl acrylate terpolymer, 5-30 parts of polyaspartic acid and 100 parts of water (pg 3: 26-28).
Huang teaches the stripping agent contains 10-30 parts of benzalkonium bromide, 20-50 parts of a biosurfactant and 20-40 parts of a penetrating agent (pg 3: 29-31). Huang teaches the preferred biosurfactant is a glycolipid (pg 3: 33).
For the claimed amount of biosurfactant, the Examiner calculates an amount based on the stripping agent, present in an amount of 5-10%, of from 0.4% to 5.0%, and an amount of citric acid of 5% to 10%; in each instance the range taught by Huang overlaps the claimed range. Finally, the ratio of biosurfactant to citric acid likewise overlaps the claimed range.
For claim 2, Huang teaches the non-oxidizing disinfectant agent benzalkonium bromide, a quaternary ammonium salt. This disinfecting agent is taught as present in between 10% and 30% of the stripping agent (pg 3: 29-31). Given that Huang teaches the stripping agent is present in 5% to 10% of the treatment agent, the amount of benzalkonium bromide present calculated by the Examiner is from 0.05% to 3%, overlapping the claimed range, and the ratio of the amount of biosurfactant to the amount of benzalkonium bromide likewise overlaps the claimed range.
For claims 3 and 13, since the composition of the treatment agent taught by Huang, with regards to both chemical composition and amounts, overlaps the claimed amounts, one of ordinary skill would have had a reasonable expectation of success in selecting amounts of each of biosurfactant and organic acid that would be effective in treating surface biofilm. As set forth in MPEP 2112(II), an inherent feature of a composition or method need not be recognized in the prior art.
For claim 4, the method of Huang teaches the cooling water be recirculated (pgs 6-7, claims 1-8). Huang also teaches the claimed amounts of biosurfactant (see above) and an organic acid (polyaspartic acid, for the purposes of this claim, in 0.75% to 9%, overlapping the claimed range; pg 3: 24-27).
For claims 5 and 6, Huang teaches the non-oxidizing disinfectant agent benzalkonium bromide, a quaternary ammonium salt. This disinfecting agent is taught as present in between 10% and 30% of the stripping agent (pg 3: 29-31). Given that Huang teaches the stripping agent is present in 5% to 10% of the treatment agent, the amount of benzalkonium bromide present calculated by the Examiner is from 0.05% to 3%, overlapping the claimed range, and the ratio of the amount of biosurfactant to the amount of benzalkonium bromide likewise overlaps the claimed range.
For claims 7 and 8, Huang teaches the sterilization rate for the method is more than 99.5% in 20 hours (pg 4: 12-14). As such, one of ordinary skill can employ the method for a short term of 20 hours, then remove the sterilization medium from the system. It is noted Huang teaches the amounts and relative rations of biosurfactant, organic acid, and non-oxidizing disinfectant recited in claims 7 and 8 (for benzalkonium bromide as the non-oxidizing disinfectant agent) as required for a discontinuous method.
For claim 9, Huang teaches a water cooler tank and water pipeline can become scaled and require a water treatment method to alleviate this problem (pg 2: 25-31).
The examiner acknowledges that some picking and choosing was used to arrive at the instantly claimed methods in view of Huang. However, the claimed combination of components, including the biosurfactant and the organic acid, is taught as known and used for a method of treating a surface. Further, Huang teaches administration with the same elements in the claimed amounts and ratios. It would have therefore been prima facie obvious to a person having ordinary skill in the art to administer the claimed method, including the biosurfactant and an organic acid such as citric acid, to a surface with a reasonable expectation of success that the treatment would be efficacious, as taught by Huang.
2) Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Huang (cited above), in view of Lakaye (US 2021/0298301 A1) and Olesen (US 2019/0075741 A1).
The teachings of Huang are discussed above.
Huang does not teach a method reciting a field irrigation system connected to a water plant.
Lakaye and Olesen teach the missing elements of Huang.
Lakaye teaches citrate perhydrates as biocides, pesticides, more particularly phytopharmaceuticals and “antimicrobial agents for medical, veterinary, domestic or industrial use, as well as disinfectants for fluids and surfaces, in particular for water, air, floors, swimming pools, work surfaces, toilets, etc.” See pg 1, [0001]-[0003]. Lakaye teaches the compositions and methods of use can include biosurfactants (pg 2, [0037]). Lakaye teaches the citrate perhydrate in water is effective in a mixture in amounts of from 0.05% to 5% (pg 3, [0038]). Lakaye further teaches the citrate perhydrates are physically and chemically stable (pg 2, [0014]).
Lakaye teaches a method for preparing these novel biobased organic molecules, which are in the form of a soluble, stable crystalline powder and which contain, at physiological pH, a novel solid form of hydrogen peroxide with a citric acid salt (pg 1, [0002] and [0011]).
Olesen teaches a method for hydroponically growing a crop, utilizing an apparatus comprising a reservoir, wherein the apparatus utilizes hydrogen peroxide for the purification of water (pg 11, claim 30).
The skilled artisan would have expected success in utilizing the method of Huang, as modified by Lakaye and Olesen, to utilize the method of Huang as a hydroponic cultivation system since Huang teaches a method of sterilizing a water system comprising the claimed amounts of an organic acid and a biosurfactant and an oxidizing agent such as sodium hypochlorite (Abstract), Lakaye teaches a method of sterilization using a solid complex comprising citrate and hydrogen peroxide, providing a source of peroxide that is stable, easily dispensed, and long-lasting and Olesen teaches a method of sterilization of a hydroponic apparatus in which the sterilizing agent is hydrogen peroxide. The person of ordinary skill in the art would have found it obvious to make the substitution of the method of Huang, using the convenient, stable peroxide source of Lakaye peroxide source for the sterilization of the hydroponic system of Olesen because ordinarily skilled artisans would have predicted that the sterilization method would be safe and effective based on the compounds' shared activity.
3) Claims 11-12 and 14-18 are rejected under 35 U.S.C. 103 as being unpatentable over Huang (cited above), in view of Lakaye (cited above).
The teachings of Huang and Lakaye (in part) are discussed above.
Huang does not teach a method reciting a water circuit of dental units (claim 11); a drinking water supply system (claim 12); or an agri-food product (claim 14). Huang further does not teach a medical-surgical instrument (claim 16-17) or disinfection with a solution comprising hydrogen peroxide or peracetic acid (claim 18).
For claims 11-12 and 14, Lakaye additionally teaches the citrate perhydrate can be used as a disinfectant for a fluid or a surface, including water (pg 4, [0071]), food-processing plants and healthcare facilities (pg 4, [0074]-[0075]), and in dental applications (pg 4, [0080]).
The skilled artisan would have expected success in substituting Lakaye’s citrate-peroxide complex in Huang’s antimicrobial water treatment method in a method reciting a water source, a food product, or water circuit of dental units treatment method because Huang teaches a sterilization method reciting the claimed amounts of biosurfactant and citric acid and Lakaye teaches that a method comprising a biosurfactant and a complex comprising citric acid and hydrogen peroxide are useful in a method for treating water facilities and healthcare facilities, and furthermore the compositions of Lakaye are taught as safe for application to the teeth. The skilled artisan could have substituted one compound for another because Lakaye teaches the pre-formed complex comprising citric acid and hydrogen peroxide is stable, unlike solutions of citric acid and hydrogen peroxide. The person of ordinary skill in the art would have found it obvious to make the substitution because ordinarily skilled artisans would have predicted that the complex comprising citric acid and hydrogen peroxide would be safe and effective based on the compounds' shared activity.
For claim 15, Huang teaches the non-oxidizing disinfectant agent benzalkonium bromide, in amounts overlapping the claimed range, as discussed in detail above.
For claim 16, Lakaye teaches the biocide is useful for medical or veterinary surfaces (pg 7, [0157]), and may be used in a method with a biosurfactant, and Huang teaches amounts of citric acid and biosurfactant claimed, as discussed in detail above.
For claim 17, Huang teaches the non-oxidizing disinfectant agent benzalkonium bromide, in amounts overlapping the claimed range, as discussed in detail above.
For claim 18, Lakaye teaches the citrate perhydrate in water is effective in a mixture in amounts of from 0.05% to 5% (pg 3, [0038]), and that the molar ratio of hydrogen peroxide to sodium citrate is 1:1 (pg 10, [0219]). Given the molecular weight of the monosodium citrate-hydrogen peroxide complex is 248.1 amu, the hydrogen peroxide (mw 34.0) comprises 14% of the molecular weight, and the percent of hydrogen peroxide taught by Lakaye is from 0.007% to 0.7%, overlapping the claimed range. It is further noted that Huang teaches the amounts of biosurfactant and organic acid recited in claims 14-17, as set forth in detail above. Because the claimed range overlaps with the range disclosed by the prior art, a prima facie case of obviousness exists.
For claims 16 and 17, the skilled artisan would have expected success in adding Lakaye's citrate perhydrate, which may comprise hydrogen peroxide and citric acid (Lakaye, pg 5, [0101]) to the water treatment method of Huang because Lakaye teaches that the citrate perhydrate is an effective antimicrobial in low concentrations, provides a stable form of hydrogen peroxide, is soluble in an aqueous solution, may be used in the presence of biosurfactants, and is an easily handled powder.
Examiner’s Reply to Declaration under 37 CFR 1.132
By Inventor Beatrice Fermi dated 8/8/2025
Inventor Beatrice Fermi submitted a Declaration (“Fermi Declaration”) showing that amounts of sophorolipids of from 0.00005% to 1% combined with 0.0005% to 0.5% citric acid (see Table 1, pg 3) provide from 32.29% to 98.27% reduction in ATP, presumably adenosine triphosphate (Table 3, pg 5). Dr. Fermi discloses that the lower range of ATP reduction is due to the lowest amounts of sophorolipids and citric acid, respectively (pg 6).
As set forth in MPEP 716.02(a), the claimed invention must be expected to result in a difference in properties or must provide unexpected results of statistical and practical significance. In the instant case, the claimed invention was not compared with the claimed amounts of sophorolipids alone, nor citric acid alone. Such comparison with standards would provide a basis for determining whether the results are indeed unexpected.
Finally, the results provided are not commensurate in scope with the claimed subject matter. See MPEP 716.02(d). The results provided in the Fermi declaration are directed to only one (sophorolipids) of the large group of biosurfactants recited in claim 1. As such, there is not an adequate basis for reasonably concluding that the number and variety of species included by the claims would behave in the same manner as those tested. See In re Lindner, 173 USPQ 356, 358 (CCPA 1972) and MPEP 2145.
Examiner’s Reply to Attorney Arguments dated 8/8/2025
1. Rejection of claims 1-9 and 13 under 35 U.S.C. 103 over Huang
The applicant argues that the amounts of biosurfactant and citric acid recited in the Office Action are those within the formulation of a stock solution and not within the aqueous solution that comes into contact with the surface to be treated. The applicant further argues that Huang addresses a different technical problem that the instantly claimed invention.
The Examiner acknowledges the arguments presented, but does not consider them persuasive. Huang teaches a method of treating water in a water treatment plant. While Huang does not specifically state that the method is used for treatment of a surface, one of ordinary skill in the art would recognize that water containment by solid surfaces is necessary in a method for reducing corrosion and scale in a water treatment system. Regarding the amounts taught by Huang, since the technical problem being solved by Huang is similar to or identical with that of the instant claims, and since Huang teaches the instantly claimed chemical elements to address the problem, it is within the ability of one of ordinary skill in the art to optimize the amounts of each element through. See MPEP 2144.05(II). As such, even if, arguendo, the amounts taught by Huang vary from the very broad claimed ranges, the claimed amount is considered obvious over the ranges cited in the prior art.
It is further noted that the applicant has not demonstrated the criticality of the claimed range of the biosurfactant and organic acid over the many biosurfactants recited in claim 1. A showing of non-obviousness of the claimed range, that is unexpected results, must be commensurate in scope with the claims the evidence is offered to support. See MPEP 716.02(d). In the instant case, the factual evidence offered in the specification and the Fermi Declaration appear to be limited to sophorolipids.
2. Rejection of claim 10 under 35 U.S.C. 103 over Huang, Lakaye and Olesen
The applicant argues Huang and Lakaye relate to different technical fields and address different technical problems.
The Examiner acknowledges the arguments presented, but does not consider them persuasive. As discussed above, Huang is directed to methods of water treatment using biocides. Lakaye is also drawn to methods of using biocides, specifically biocides with reduced toxicity (pg 1, [008]).
The applicant argues the use of hydrogen peroxide is incompatible for application within a closed circuit such as the cooling system of Huang since it is well known that hydrogen peroxide is extremely unstable and requires a constant addition in order to ensure the maintenance of its functionality. This is technically incompatible with its application in a closed circuit, wherein water is only periodically replaced, and additives may be added on a one-off basis. In sharp contrast, sodium hypochlorite has a much higher stability, thus ensuring a greater persistence within the closed circuit of Huang.
The Examiner acknowledges the argument presented, but does not consider it persuasive. Regarding the addition of agents to the method of Huang, Huang teaches that a water treatment agent such as a buffer can be added while the system is circulating (pg 4: 44-45). As such, one of ordinary skill would expect the addition of an oxidant such as hydrogen peroxide could also be added to the system. It is also noted that Olesen teaches the presence in the system of a reservoir that may contain hydrogen peroxide (claims 4 and 5), allowing straightforward addition of hydrogen peroxide when required.
The applicant argues “Even one of ordinary skill in the art would attempt to use citrate perhydrate in the formulation of Huang, he/she would not replace only one component, thus leaving all the other components unchanged.”
The Examiner acknowledges the argument presented, but does not consider it persuasive. This argument does not provide the kind of factual evidence that is required to rebut a prima facie case of obviousness. See MPEP ¶¶ 716.01(C)(I) and (II), and 2145.
The applicant further argues “the formulation of Huang is unsuitable for use in the method of Olesen, because Huang’s formulation contains components such as sulphamic acid, NaOH, hypochlorite, and isothiazolinones that are not compatible with the use in a hydroponic growing method such as that disclosed in Olesen, as they are harmful to plant species.”
The Examiner acknowledges the argument presented, but does not consider it persuasive. This argument does not provide the kind of factual evidence that is required to rebut a prima facie case of obviousness. See MPEP ¶¶ 716.01(C)(I) and (II), and 2145. It is noted that isothiazolinones are, in fact, compatible with the growing of plants. As discussed by He (Antibiotics 2021, 10, 436), plants sprayed with isothiazolinones in concentrations of up to 150 mg/liter did not show any signs of toxicity (pg 11, first partial paragraph).
3. Rejection of claims 11-12 and 14-18 under 35 U.S.C. 103 over Huang and Lakaye
The applicant argues that claim 1 is allowable and Lakaye does not remedy the alleged deficiencies of Huang.
The Examiner acknowledges the argument presented, but does not consider it persuasive since the position of the Examiner is that the rejection of Huang over claim 1 is proper. Since no further argument regarding the correctness of the rejection of claims 11-12 and 14-18 over Huang and Lakaye is presented, the rejection is maintained.
CONCLUSION
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL P COHEN whose telephone number is (571)270-7402. The examiner can normally be reached on M-Th 8:30-5:30; F 9-4.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Frederick Krass can be reached on (571)272-0580. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL P COHEN/Primary Examiner, Art Unit 1612