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 .
Detailed Action
This Office Action is in response to the Applicant’s reply received 11/1/25 Claims 1-17 are pending and considered on the merits.
Claim Rejections - 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.
Claim(s) 1, 2, 4-14, 16 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mayton et al. (Applied and Environmental Microbiology 2021, published online on 11 June 2021, in IDS 7/25/23) and further in view of Kluge et al. (CA2629465 published 2008).
Mayton et al. teach a method of detaching bacteria from biofilms on either a polystyrene surface (an abiotic surface) or spinach leaf surfaces (a biotic surface and fresh produce) with CAase (Mayton, pg. 4). Mayton et al. teach their biofilm assays were performed by growing the biofilm in culture medium which is removed. Then 0.1-10 mg/mL of CAase is added in 10 mM KCl (e.g not growth media) to the biofilm and release the bacteria including E. coli, Salmonella typhimurium and Listeria monocytogenes (Mayton, paragraph bridging pages 9-10). Mayton et al. teach this detachment occurs over 30 minutes (Mayton, pg. 5, Fig. 5, pg. 10 1st full paragraph). While Mayton et al. teach removal and detachment of the individual bacteria from the biofilm (Mayton, Figs 3, 4, 6). They do not teach collecting the released bacteria and then determining the genus and species of the collected cells.
However this is obvious over Kluge et al. who teach detecting viable mycobacteria from a sample by (Kluge, pg. 3, lines 10-25):
Contacting the sample with magnetic beads coated with an antibody specific to mycobacteria to form a bead-bacteria complex;
Collecting the bead bacteria complex to isolate the mycobacteria in the sample;
Extracting the genomic DNA from the isolated mycobacteria; and
Identifying the isolated mycobacteria by their genomic DNA (gDNA).
The sample can be a biofilm (Kluge, pg. 15). The genus and species are identified by PCR of the gDNA (Kluge, pg. 36, lines 25). Their entire method is completed in 6 hours (Kluge, pg. 38, lines 25-30). While their method focuses on mycobacteria, they also teach Salmonella or E. coli are also suitable for isolation by magnetic beads (Kluge, pg. 31, lines 25-30).
It would be obvious to use the method of releasing the cells from the biofilm with CAase of Mayton et al. as a pretreatment of the biofilm before the collection and analysis of Kluge et al. The CAase treatment releases more bacteria from the biofilm which in turn will provide more for collection by the magnetic beads. The more bacteria collected will provide more gDNA for analysis by PCR. One of ordinary skill would recognize this combination as simply using a known technique to improve the analysis of microbial biofilms (MPEP 2141 III C).
Therefore the invention as a whole would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mayton et al. (Applied and Environmental Microbiology 2021, published online on 11 June 2021) and Kluge et al. (CA2629465 published 2008) as applied to claims 1, 2, 4-14, 16 and 17 above, and further in view of Guilbaud et al. (APPLIED AND ENVIRONMENTAL MICROBIOLOGY, Apr. 2005).
Mayton et al. and Kluge et al. render obvious a method ot identify microbial cells in a biofilm comprising the steps of:
Contacting a biofilm with CAase to release the bacteria;
Separating and collecting the bacteria from a) with magnetic beads; and
Identifying the genus and species of the bacteria of b) by PCT of their gDNA.
However Kluge et al. is focused on mycobacteria and not specifically Listeria monocytogenes. However Guilbaud et al. teach that L. monocytogenes can be detected and identified by PCR from biofilms (Guilbaud, abstract). Guilbaud et al. teach that L. monocytogenes is detached from stainless steel by sonication with surfactant and the gDNA is extracted (Guilbaud, 2192, col 1, last full paragraph). It would be obvious to incorporate the PCR techniques to identify L. monocytogenes taught by Guilbaud et al. into the PCR step taught by Kluge et al. since this improves the overall method by identifying another biofilm producing bacteria by PCR. One of ordinary skill would recognize this combination as simply using a known technique to improve the analysis of microbial biofilms by increasing the number of identifiable bacteria (MPEP 2141 III C).
Therefore the invention as a whole would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mayton et al. (Applied and Environmental Microbiology 2021, published online on 11 June 2021) and Kluge et al. (CA2629465 published 2008) as applied to claims 1, 2, 4-14, 16 and 17 above, and further in view of Guilbaud et al. (APPLIED AND ENVIRONMENTAL MICROBIOLOGY, Apr. 2005).
Mayton et al. and Kluge et al. render obvious a method to identify microbial cells in a biofilm comprising the steps of:
Contacting a biofilm on either polystyrene (an abiotic surface) or spinach (fresh produce with a biotic surface) with CAase to release the bacteria;
Separating and collecting the bacteria from a) with magnetic beads; and
Identifying the genus and species of the bacteria of b) by PCT of their gDNA.
What Mayton et al. and Kluge et al. do not teach is the polystyrene is a food preparation surface. However this would be obvious in view of either Marsh or Smith.
Both Marsh or Smith teach polystyrene is used food preparation surfaces including the ubiquitous Red Solo Cup (March 1st paragraph) coffee cups, carryout trays, and plates (Smith, pg. 2). It would be obvious to use the technique of Mayton et al. and Kluge to test the surfaces of cups, trays, and plates since these food perpetration surfaces and generally destined for immediate consumption so one of ordinary skill would recognize that ensure no biofilm contamination is critical. One of ordinary skill would recognize this combination as simply using a known technique to improve the analysis of microbial biofilms on food surfaces to reduce exposure to contaminated surfaces (MPEP 2141 III C).
Therefore the invention as a whole would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
In response to this office action the applicant should specifically point out the support for any amendments made to the disclosure, including the claims (MPEP 714.02 and 2163.06).
CONTACT INFORMATION
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THANE E UNDERDAHL whose telephone number is (303) 297-4299. The examiner can normally be reached Monday through Thursday, M-F 8-5 MST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Fereydoun Sajjadi can be reached at (571) 272-3311.The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/THANE UNDERDAHL/Primary Examiner, Art Unit 1699