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 response filed on May 18, 2026 is received.
Claims 1-31 are pending in this application, claims 27-31 are withdrawn from further consideration, and claims 1-26 are being examined to the extent they read on the elected species.
Restriction/Election:
Applicant’s election without traverse of, Group I claims 1-26, in the reply filed on 05/18/2026 is acknowledged. The election without traverse of the species of digestive enzyme “pectinase” in the same reply is also acknowledged.
Claims 27-31 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 05/18/2026.
Claim Rejection - 35 USC §102
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.
Claims 1-5, 7-16, 20-22 and 25-26 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wang et al. (J Food Prot. 2016 Aug;79(8):1378-86).
Regarding claim 1, Wang et al. disclose a method of preparing a food or environmental sample for detection of microbial contamination, the method comprising providing a food or environmental sample contaminated with a microbial contaminant; adding one or more digestion enzymes to the food or environmental sample; digesting the food or environmental sample using the one or more digested enzymes to form a liquid digested sample; separating all or a portion of the liquid digested sample from remaining solid non-digested food or environmental sample material; and one or both of the following steps: (a) isolating the microbial contaminant in the liquid digested sample by passing the liquid digested sample through a membrane and capturing the microbial contaminant on the membrane, or (b) isolating the microbial contaminant in the liquid digested sample by centrifugation (lettuce and spinach leaves inoculated with Salmonella culture placed in a buffer containing enzyme and placed in a filter bag and shaken, and following enzyme digestion the liquified sample is taken out to determine and calculating Salmonella concentration, plate counts, etc.) (See for example, p. 1380 left-hand column, Title: “Inoculation of the produce and sample preparation” and right-hand column, and p. 1380 figure 1 and description, p. 1379 right-hand column Title: “Optimization of enzyme conditions”, and p. 1382 right-hand column last paragraph).
Regarding claim 2, Wang et al. disclose the one or more digestion enzymes comprises one or more digestion enzymes selected from the group consisting of pectinase (elected species), lactase, glucoamylase, acid amylase, saccharase, sucrase, cellulase, hemicellulase, beta-glucanase, xylanase, hydrolase, lyase, pectin methyl esterase, laccase, peptidase, protease, pepsin, trypsin, diastase, phospholipase, pullulanase, and lipase (pectinase and cellulase) (See for example, p. 1379 right-hand column Title: “Optimization of enzyme conditions”).
Regarding claim 3, Wang et al. disclose the food or environmental sample is a food sample (lettuce and spinach leaves) (See for example, p. 1379 right-hand column 2nd paragraph).
Regarding claim 4, Wang et al. disclose the food or environmental sample is an environmental collection device (bagged spinach and lettuce) (See for example, p. p. 1379 right-hand column).
Regarding claim 5, Wang et al. disclose the food or environmental sample is a solid-in-liquid suspension (enzyme digested sample) (See for example, p. 1380 figure 1 part c)).
Regarding claim 7, Wang et al. disclose the one or more digestion enzymes comprises pectinase (elected species) and xylanase (pectinase and cellulase) (See for example, p. 1379 right-hand column Title: “Optimization of enzyme conditions”)..
Regarding claim 8, Wang et al. disclose the ratio of the one or more digestion enzymes to the solid-in-liquid suspension is from about 50:1 to about 200:1 by volume (7. 5 U/ml pectinase and 2.5 U/ml cellulase) (See for example, p. 1380 left-hand column last paragraph).
Regarding claim 9, Wang et al. disclose the food or environmental sample is a solid; the method further comprising suspending the solid food or environmental sample in a liquid (samples placed in PBS buffer) (See for example, p. 1380 left-hand column last paragraph).
Regarding claim 10, Wang et al. disclose the liquid is an enrichment media; the method further comprising enriching the microbial contaminant in the enrichment media at least partially concurrent with digesting the food or environmental sample (concentrated samples are plated on Hektoen enteric agar, and plate counting) (See for example, p. 1380 right-hand column 2nd paragraph below figure 1).
Regarding claim 11, Wang et al. disclose the enrichment media is buffered peptone water (Hektoen enteric agar, which contains peptone) (See for example, p. 1380 right-hand column 2nd paragraph below figure 1).
Regarding claim 12, Wang et al. disclose the solid food or environmental sample is fruit, leafy greens, or meat (lettuce and spinach leaves) (See for example, p. 1380 left-hand column 2nd paragraph below figure 1).
Regarding claim 13, Wang et al. disclose the concentration of the solid food or environmental sample suspended in the liquid is from about 0.1 g/ml to about 2 g/ml (10 g of each sample into 90 ml of buffer, which is equivalent of 0.1 g/ml) (See for example, p. 1380 right-hand column 2nd paragraph below figure 1).).
Regarding claim 14, Wang et al. disclose digesting the food or environmental sample is performed for about 2 to about 8 hours (digestion time 2 hours) (See for example, p. 1381 left-hand column figure 2 and description).
Regarding claim 15, Wang et al. disclose digesting the food or environmental sample is performed for about 2 to about 4 hours (digestion time 2 hours) (See for example, p. 1381 left-hand column figure 2 and description).
Regarding claim 16, Wang et al. disclose digesting the food or environmental sample is performed at from about 30 to about 45 °C (enzyme digestion at 37°C) (See for example, p. 1380 right-hand column 1st paragraph below figure 1, and figure 1b).
Regarding claim 20, Wang et al. disclose the microbial contaminant is bacteria, yeast, mold, fungus, virus, or parasite, or any combination thereof (bacteria, i.e., Salmonella culture) (See for example, p. 1380 left-hand column last paragraph).
Regarding claim 21, Wang et al. disclose the microbial contaminant comprises one or more of Salmonella, Listeria, E. coli, Campylobacter, and Clostridium perfringens (Salmonella culture) (See for example, p. 1380 left-hand column last paragraph).
Regarding claim 22, Wang et al. disclose the one or more digestion enzymes comprises pectinase (elected species), hemicellulase, beta-glucanase, and xylanase (pectinase and cellulase) (See for example, p. 1379 right-hand column Title: “Optimization of enzyme conditions”)..
Regarding claim 25, Wang et al. disclose the method further comprising enriching the microbial contaminant for about 8 to about 24 hours at least partially concurrent with digesting the food or environmental sample (plated onto Hektoen enteric agar and incubated for 24 h at 37°C) (See for example, p. 1380 right-hand column 2nd paragraph below figure 1).
Regarding claim 26, Wang et al. disclose wherein the food or environmental sample is leafy greens and the one or more digestion enzymes comprises pectinase (elected species), hemicellulase, beta-glucanase, and xylanase (lettuce and spinach leaves digesting with pectinase and cellulase and) (See for example, p. 1379 right-hand column Title: “Optimization of enzyme conditions”).
Wang et al. therefore anticipate the claimed method of preparing a food or environmental sample for detection of microbial contamination.
Claim Rejection - 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.
Claims 1-26 are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (J Food Prot. 2016 Aug;79(8):1378-86) as applied to claims 1-5, 7-16, 20-22 and 25-26 above, and further in view of Fachmann et al. (Appl Environ Microbiol. 2017 Feb 15;83(5):e03151-16) and Iqbal et al. (Open Microbiol J. 2015 Jul 31;9:26-32) and Speegle et al. (J Food Prot. 2009 Dec;72(12):2592-6).
The teachings of Wang et al. with respect to the limitations of claims 1-5, 7-16, 20-22 and 25-26 were discussed above.
Wang et al. do not teach , the solid-in-liquid suspension is a fruit juice (claim 6), wherein the membrane for capturing the microbial contaminant has a pore size of from about 0.2 to about 0.5 pm (claim 17), wherein the membrane for capturing the microbial contaminant is a cellulose nitrate membrane (claim 18), the method of comprising centrifuging the liquid digested sample by applying a centrifugal force from about 1000 to 8000 RCF for about 1 to 10 minutes (claim 19), the food or environmental sample is a fruit juice (claim 23), and the food or environmental sample is a fruit puree (claim 24).
However, regarding claims 6, 23 and 24, Iqbal et al. teach the presence of microbial contamination in environmental samples including fruit juice and fruit puree (See for example, p. 26 Introduction).
Therefore, a person of ordinary skill in the art before the effective filing date of the invention recognizing the presence of microbial contamination in fruit juice and fruit puree (as taught by Iqbal et al.) would have been motivated to apply the method taught by Wang et al. to prepare environmental samples fruit juice and fruit puree with a reasonable expectation of success in preparing environmental samples fruit juice and fruit puree for detection of microbial contamination. Because Wang et al. teach a method of preparing a food or environmental sample for detection of microbial contamination, the method comprising providing a food or environmental sample contaminated with a microbial contaminant; adding one or more digestion enzymes to the food or environmental sample; digesting the food or environmental sample using the one or more digested enzymes to form a liquid digested sample; separating all or a portion of the liquid digested sample from remaining solid non-digested food or environmental sample material; and one or both of the following steps: (a) isolating the microbial contaminant in the liquid digested sample by passing the liquid digested sample through a membrane and capturing the microbial contaminant on the membrane, or (b) isolating the microbial contaminant in the liquid digested sample by centrifugation, and because Iqbal et al. teach the presence of microbial contamination in fruit juice and fruit puree.
Regarding claim 19, Wang et al. teach bound bacteria release from a sample matrix by using enzymes and separation by filtration and centrifugation among well-known techniques (See for example, p. 1379 left-hand 2nd paragraphs).
Moreover, before the effective filing date of the invention, Fachmann et al. teach applying centrifuging during a method of preparing a food or environmental sample for detection of microbial contamination, by applying centrifugal force from about 1000 to 8000 RCF for about 1 to 10 minutes (centrifuging enriched filtrate, and centrifuging at 3,000 X g for 5 minutes) (See for example, p. 9 2nd and 6th paragraphs).
In addition, regarding claims 17 and 18, before the effective filing date of the invention, Speegle et al. teach using a cellulose nitrate membrane for capturing the microbial contaminant which has a pore size of from about 0.2 to about 0.5 µm (cellulose nitrate filters pore size 0.45 µm) (See for example, p. 2592 left-hand column).
Therefore a person of ordinary skill in the art before the effective filing date of the invention would have been capable of applying the prior arts teachings (as taught by Fachmann et al. and Speegle et al.) and modify the method taught by prior art by applying centrifugal force from about 1000 to 8000 RCF for about 1 to 10 minutes and use a cellulose nitrate membrane for capturing the microbial contaminant which has a pore size of from about 0.2 to about 0.5 µm during the preparation a food or environmental sample for detection of microbial contamination method according to the teachings of Wang et al. with a reasonable expectation of success in providing the claimed method of preparing a food or environmental sample for detection of microbial contamination, because Wang et al. method of preparing a food or environmental sample for detection of microbial contamination, the method comprising providing a food or environmental sample contaminated with a microbial contaminant; adding one or more digestion enzymes to the food or environmental sample; digesting the food or environmental sample using the one or more digested enzymes to form a liquid digested sample; separating all or a portion of the liquid digested sample from remaining solid non-digested food or environmental sample material; and one or both of the following steps: (a) isolating the microbial contaminant in the liquid digested sample by passing the liquid digested sample through a membrane and capturing the microbial contaminant on the membrane, or (b) isolating the microbial contaminant in the liquid digested sample by centrifugation, because Fachmann et al. teach applying centrifuging during a method of preparing a food or environmental sample for detection of microbial contamination, by applying centrifugal force from about 1000 to 8000 RCF for about 1 to 10 minutes, and because Speegle et al. teach using a cellulose nitrate membrane for capturing the microbial contaminant which has a pore size of from about 0.2 to about 0.5 µm.
Conclusion(s):
No claim(s) is allowed at this time.
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/KADE ARIANI/Primary Examiner, Art Unit 1651
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