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
The instant application claims benefit to PCT Application No. PCT/CN2022/072861, filed on 01/20/2022 and is acknowledged. The instant claims herein are examined using the effective filing date of 01/20/2022 for the basis of any prior art rejections.
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 07/16/2024 were properly filed in compliance with 37 CFR 1.97. Accordingly, the information disclosure statement(s) were considered.
Specification
The disclosure is objected to because of the following informalities: The use of the term AniosTM, SoluscopeTM, ExelerateTM, UltrasilTM and VortexxTM, which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Objections
Claim 1 is objected to because of the following informalities: claim 1 recites, inter alia, “cleaning the equipment with one or more CIP compositions using a CIP process”. “CIP” should be recited in fully expanded form in the first recitation in the claims before an abbreviation is used (i.e., “cleaning-in-place (CIP)”). Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-25 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites “A method for detecting or removing a microorganism or biofilm within industrial equipment, the method comprising: (1) cleaning the equipment with one or more CIP compositions using a CIP process; (2) rinsing the equipment with water; (3) adding an enzyme composition into the CIP process; and (4) adding to the CIP process a cleaning composition, an antimicrobial composition, or both” (emphasis added). Steps 1 and 4 of the claim seem to recite the same method step (cleaning with a CIP cleaning composition). As written, claim 1 is not limited to carrying out the active method steps in a specific order, such that step 1 and 4 can also be carried out simultaneously.
Put simply, it is unclear from the claims if step 4 requires the use of an additional cleaning composition or if the method only requires at least the CIP composition. For the purposes of compact patent prosecution, the examiner is interpreting the claims to require an additional cleaning composition, antimicrobial agent, or both. Note that claims 2-25 are also indefinite due to dependency on indefinite claim 1.
Claim 4 recites, inter alia, “the enzyme composition comprises one or more enzymes selected from the group consisting of peroxidase, oxidoreductase, transferase, hydrolase, lyase, isomerase, ligase, protease, peptidase, lipase, esterase, amylase, polysaccharidase, carbohydrase, cellulase, hemicellulose” (emphasis added). It is unclear how the enzyme composition can comprise hemicellulose, as hemicellulose is not an enzyme. Thus, the claim is indefinite.
Claim 17-18 and 20-25 all recite the limitation "the fluid". There is insufficient antecedent basis for this limitation in the claim. There is no previous recitation of any “fluid” recited earlier in the claims, thus rendering the claims indefinite.
Claim 25 recites the limitation "the chemistry" in line 4. There is insufficient antecedent basis for this limitation in the claim. There is no previous recitation of any “chemistry” recited earlier in claim 17 or claim 1 from which this claim depends, thus rendering the claims indefinite.
Claim interpretation
Claim 7 recites “the added enzyme composition in the CIP process forms a use solution that has a total enzyme amount in a range from about 10 ppm to about 1000 ppm.” This has been interpreted by the examiner under broadest reasonable interpretation as the final concentration of the enzyme composition in the CIP process.
Claim Rejections - 35 USC § 102/103
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
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.
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.
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.
First rejection
Claim(s) 1-6, 8-21, and 23 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Delhalle Laurent et al ((2020) Evaluation of Enzymatic Cleaning on Food Processing Installations and Food Products Bacterial Microflora. Front. Microbiol. 11:1827; cited in Applicant IDS; hereinafter “Delhalle”).
Delhalle teaches removal of microorganisms and biofilm from open and closed industrial food processing equipment using conventional cleaning using CIP cleaning using caustic soda (a CIP cleaning composition/process as in claim 1), at 85 degrees C for 90 mins, rinsing with water (as in claim 1), cleaning with alkaline chorination at 85 degrees for 30 mins followed by disinfection with peracetic acid (adding an antimicrobial agent as in claim 1) at 20 degrees for 30 mins (see “Cleaning Methods” section and Table 1). Delhalle also teaches the addition of reinforced enzymatic cleaning using enzymatic detergent containing protease, lipase, amylase, and oxidoreductase at pH 7 and 45 deg Celsius for 60 min followed by disinfection with peracetic acid and rinsing with water (adding an enzyme composition into the CIP process as in claim 1) (see Table 1 and pg. 8, col 1-2; Table 4).
In the alternative, it would have been prima facie obvious to one of ordinary skill at the time of filing to use the method of removing biofilms from industrial equipment using cleaning-in-place systems as taught by Delhalle to arrive at the claimed invention with a reasonable expectation of success. One of ordinary skill would have been motivated to use the method because Delhalle explicitly teaches that the enzymatic cleaning of closed systems using a cleaning-in-place strategy advantageously decreases total concentration of spoiling bacteria and biofilms and improves the hygiene of closed systems (see abstract, see pg. 8, col 1, see also Fig. 4).
Regarding claim 2, Delhalle teaches rinsing steps after using the antimicrobial peracetic acid disinfectant (i.e., to remove the cleaning or antimicrobial agent).
Regarding claim 3 and 14, Delhalle teaches use of peracetic acid disinfectant (i.e., antimicrobial agent), a peroxycarboxylic acid.
Regarding claim 4, Delhalle teaches lipase, amylase, oxidoreductase, and protease.
Regarding claim 5 and 15, Delhalle teaches the enzymatic cleaners contain surfactants and dispersing and chelating agents (see pg. 2, col 2).
Regarding claim 6, Delhalle teaches the enzyme composition has 0.5 to 0.1 wt% concentration (see pg. 3, col 1).
Regarding claim 8-9, Delhalle teaches using the CIP process at 85 degrees Celsius and that the enzyme composition has a pH of 7.
Regarding claim 10-13, Delhalle teaches use of acidic cleaning solutions including peracetic acid and alkaline cleaning solution (alkaline chlorinated solution) with a concentration of 3%.
Regarding claim 16, Delhalle teaches the enzymatic cleaning method reduces the microbial count from 7.7 log CFU/g to 1.0 log CFU/g, a reduction of 6.6 log (see table 3).
Regarding claim 17-21, Delhalle teaches measuring microbial count using microbial analyses by taking a sample of the cleaning liquid before and after enzymatic cleaning carried out using plate count agar, ATPmetry (a bioluminescent ATP detection method that measures level of converted ATP), and high-throughput sequencing to determine amount of bacteria (see pg. 3-4).
Regarding claim 23, Delhalle teaches microbial analyses of the CIP water sample using qPCR (i.e., a PCR-based rapid detection technique) (see pg. 5, col 2).
Accordingly, the claimed invention was anticipated, or in the alternative, rendered prima facie obvious to one of ordinary skill at the time of filing, especially in the absence of evidence to the contrary.
Claim Rejections - 35 USC § 103
Second rejection
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Delhalle as applied to claims 1-6, 8-21, and 23 above and further in view of Bolduc et al (US 20170295784 A1).
As discussed above, claims 1-6, 8-21, and 23 were anticipated by, or in the alternative, rendered prima facie obvious by the teachings of Delhalle.
Delhalle does not explicitly teach the added enzyme composition in the CIP process forms a use solution that has a total enzyme amount in a range from about 10 ppm to about 1000 ppm.
However, Bolduc teaches a method for removing microorganisms on an industrial processing hard surface comprising: contacting the hard surface with a peroxyformic acid composition comprising at least about 75 ppm peroxyformic acid, wherein the composition is dosed on site and/or generated in situ; and removing microbial growth from the surface (see claim 1, abstract). Bolduc also teaches that the solution can contain peracids and enzymes in a use solution for removing microorganisms including a catalase or peroxidase enzyme including the water source to be treated in amounts between about 1 ppm and about 1,000 ppm, preferably between about 5 ppm and 500 ppm, and more preferably between about 10 ppm and about 100 ppm to remove P. aeruginosa biofilm from dairy membranes (see para 0149-0159).
Third rejection
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Delhalle as applied to claims 1-6, 8-21, and 23 above, and further in view of Bakke et al (Development of a Novel Hygiene Monitoring System Based on the Detection of Total Adenylate (ATP+ADP+AMP). J Food Prot. 2018 May;81(5):729-737).
As discussed above, claims 1-6, 8-21, and 23 were anticipated by, or in the alternative, rendered prima facie obvious by the teachings of Delhalle.
Dehalle, while teaching the use of ATPmetry to detect microorganisms and measure ATP levels, does not explicitly teach extracting AMP or ADP from the sample and converting the AMP or ADP to ATP using one or more enzymes.
However, Bakke teaches the development of a novel hygiene monitoring system based on the detection of total adenylate (ATP+ADP+AMP) in the food industry to ensure that adequate cleanliness is being maintained (see title, abstract). Bakke teaches the novel hygiene monitoring system to measure A3 was developed based on the luciferin-luciferase assay with the combination of two enzymes, pyruvate kinase and pyruvate phosphate dikinase, that can convert ADP into ATP and recycle AMP into ATP (see abstract). Bakke further teaches the A3 detection method uses an extraction solution to extract intracellular adenylates (see pg. 735 and Fig. 6), before detection of AMP and ATP, where ATP was regenerated from AMP using pyruvate orthophosphate dikinase reactions in the presence of phosphoenol pyruvate, inorganic pyrophosphate (PPi), and Mg2+ (Fig. 3, red). This is the basis of the ATP+AMP monitoring system. Moreover, an additional enzymatic reaction was combined with ATP+AMP detection for the simultaneous detection of ADP. ADP was successively converted to ATP by a pyruvate kinase (PK) reaction in the presence of phosphoenol pyruvate, Mg2+, and K+ (see Table 1 and 3; also Fig. 3, pg. 732). Bakke teaches the use of the A3 system to successfully monitor sanitation levels of food contaminated stainless steel surfaces (see Fig. 7).
Therefore, it would have been prima facie obvious to one of ordinary skill at the time of filing to modify the method of Delhalle by using the adenylate extraction method as taught by Bakke to arrive at the claimed invention with a reasonable expectation of success. One of ordinary skill would have been motivated to make the modification because Bakke explicitly teaches that the A3 monitoring system can be used to advantageously detect AMP, ADP, and ATP levels on contaminated industrial food processing surfaces, allowing for successful monitoring of sanitation levels.
Accordingly, the claimed invention was prima facie obvious to one of ordinary skill at the time of filing, especially in the absence of evidence to the contrary.
Fourth rejection
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Delhalle as applied to claims 1-6, 8-21, and 23 above, and further in view of Bridier et al. ((2015). Biofilm-associated persistence of food-borne pathogens. Food Microbiol. 45, 167–178).
As discussed above, claims 1-6, 8-21, and 23 were anticipated by, or in the alternative, rendered prima facie obvious by the teachings of Delhalle.
Delhalle does not explicitly teach that analyzing the sample comprises measuring oxygen consumption, measuring CO2 production, measuring production of metabolites, and combinations thereof.
However, Bridier teaches that “a wide variety of bacterial species are present in food processing environments and known to form biofilms on surfaces. Because of this broad diversity, surface-associated communities are usually complex associations of different species, which interact in different ways to constitute a complex and dynamic network (Fig. 6). Such interactions play a key role in shaping biofilm architecture and are responsible for specific functions and an increasing number of studies have reported that multispecies biofilms appear to be more resistant to antimicrobial activity than their mono-species counterparts. For instance, it was shown that under most conditions, the pathogen L. monocytogenes in a mixed biofilm with Lactobacillus plantarum exhibited higher resistance to benzalkonium chloride and peracetic acid than single species biofilms and mixed-species biofilm formed by P. aeruginosa, K. pneumoniae and Pseudomonas protegens were more resistant to the antimicrobials sodium dodecyl sulphate and tobramycin than single-species biofilms. Bridier further teaches that the sharing of extracellular polymeric substances (i.e., metabolites produced by bacteria in the biofilm), and its role in resistance to sanitization, was also recently observed in a mixed biofilm formed by Shiga toxin-producing E. coli and S. Typhimurium indicate that the spatial organization of species, and the sharing of matrix components, may therefore determine the degree of persistence of pathogens in mixed communities as well as their resistance to cleaning and disinfection treatments (i.e. poorer accessibility of cleaning/disinfection agents to cells located in the internal part of a biofilm) (see pg. 171, col 2 to pg. 173, col 1; see also Table 1 and Section 5: “Emerging strategies to control biofilms in the food industry”).
Therefore, it would have been prima facie obvious to one of ordinary skill at the time of filing to modify the method of Delhalle by including the detection of metabolites produced by the biofilm as taught by Bridier to arrive at the claimed invention with a reasonable expectation of success. One of ordinary skill would have been motivated to make the modification because Bridier teaches that measurement of biofilm metabolites advantageously allows for determining the degree of persistence of pathogens in mixed communities as well as their resistance to cleaning and disinfection treatments.
Accordingly, the claimed invention was prima facie obvious to one of ordinary skill at the time of filing, especially in the absence of evidence to the contrary.
Fifth rejection
Claim(s) 25 is rejected under 35 U.S.C. 103 as being unpatentable over Delhalle.
As discussed above, claims 1-6, 8-21, and 23 were anticipated by, or in the alternative, rendered prima facie obvious by the teachings of Delhalle.
Delhalle does not explicitly teach a remediation step in response to any detected microorganism including adjusting the concentration of the CIP composition, changing the chemistry of the CIP composition, adding additional CIP compositions, adding a cleaning composition to the CIP process, adding an antimicrobial composition, and combinations thereof.
However, the remediation step as instantly claimed seems to be a routine optimization step using standard laboratory techniques available at the time of filing, i.e., adjusting the concentration of cleaning agents, adding antimicrobial compositions, changing the chemistry, etc. in response to the detection of microorganisms within the fluid sample (such as the ones taught by Delhalle). Therefore, it would have been prima facie obvious to one of ordinary skill at the time of filing to optimize the cleaning process as a result of the microbial detection step with a reasonable expectation of success. One of ordinary skill would have been motivated to do so to advantageously decreases total concentration of spoiling bacteria and biofilms and improves the hygiene of closed systems (see abstract, see pg. 8, col 1, see also Fig. 4) as taught by Delhalle (see MPEP 2144.05).
Accordingly, the claimed invention was prima facie obvious to one of ordinary skill at the time of filing, especially in the absence of evidence to the contrary.
Conclusion
NO CLAIMS ALLOWED.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
US 20180110224 A1: teaches “a method for removing or preventing a microbial growth, biofilm, biomass and/or mineral deposit on a hard surface inside an SO2 scrubber is disclosed. In particular, biocide compositions may be dosed in pulse or continuously for the reduction and prevention of biofilms on the hard surfaces inside an SO2 scrubber. A biocide composition disclosed here uses one or more non-oxidizing biocides, especially a mixture of one or more quaternary ammonium compounds and one or more other biocides.” (see abstract, throughout).
US 20140287485 A1: teaches a composition for the removal of biofilms present on a substrate, characterized in that it comprises at least one detergent component comprising a sequestrant and also a wetting agent and a dispersant and at least one enzymatic component containing at least one protease, at least one laccase and at least one polysaccharidase and using clean-in-place to remove biofilms (see abstract, throughout).
EP 1373578 B1: teaches improved methods for removing proteinaceous soils from surfaces, including an enzymatic prewash and an acidic secondary wash. More particularly, the invention is concerned with such methods for clean-in-place (CIP) treatment of dairy equipment subject to milk-borne contamination, wherein the initial prewash includes a protease enzyme (see abstract, throughout).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GEORGIANA C REGLAS whose telephone number is (571)270-0995. The examiner can normally be reached M-Th: 8:00am-2:00pm.
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/G.C.R./Examiner, Art Unit 1651
/THOMAS J. VISONE/Supervisory Patent Examiner, Art Unit 1672
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