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 4/6/26. Claims 1-17 are pending and considered on the merits.
Response to Applicant’s Arguments and Amendments
In the response submitted by the Applicant the following 35 U.S.C § 103 (a) rejections are withdrawn:
Claim(s) 1, 2, 4-14, 16 and 17 were 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 (CA2629465 published 2008)The following Double Patenting rejections are withdrawn:
Claim(s) 3 were 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;
Claim(s) 15 were 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 Marsh (Vice 2016) or Smith (Atlas Obscura 2017)**. This rejection mistakenly lists Guilbauld in the lead paragraph, but the body of the rejection clearly cites Marsh and Smith to teach the food packaging limitations.
The Applicant’s amendments to claims 1 and 8 limiting collecting the released microbial cells in the absence of a microbe-specific antibody necessitated the above withdrawals. All arguments drawn to these rejections are now considered moot.
Claim Objections
Claims 15-17 are objected to since they are missing. The current claim set is 1-14 while the prior set was 1-17. 37 CFR 1.121(c) requires the complete listing of all claims every presented. While cancelled claims do not need to retain their text, they must remain with the claim set.
New Rejections Necessitated by Amendment
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-14 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claims 1 and 8 include the negative limitation the “collecting the released microbial cells in the absence of a microbe-specific antibody”. The Specification does not support excluding a microbe-specific antibody from the method.
MPEP 2173.05(i) state:
Any negative limitation or exclusionary proviso must have basis in the original disclosure. If alternative elements are positively recited in the specification, they may be explicitly excluded in the claims… The mere absence of a positive recitation is not basis for an exclusion.
The Applicant pre-empted this rejection by citing MPEP 2163. However 2173.05(i) is clear that any negative limitation must have support in the original disclosure and silence on a specific limitation is not sufficient for exclusion. The Applicant can simply list the specification supported techniques for collecting and releasing the microbial cells in step c) to overcome this rejection while avoiding re-application of the prior rejections.
Claim Rejections - 35 USC § 103
Claim(s) 1-5, and 7-14 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) in view of Wilson et al. (Res Rev J Eng. Technol 2017) and Jacobsen et al. (J. of Microbiological Methods 1997).
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). These bacteria are collected then observed by electron microscope or in a flow chamber by a fluorescence microscope (Mayton, pg. 10, Electron microscopy and Parallel-plate flow cell). While Mayton et al. teach removal, detachment, and collection of the individual bacteria from the biofilm (Mayton, Figs 3, 4, 6) for analysis, they do not teach determining the genus and species of the collected cells.
However this would be obvious in view of Wilson et al. who teach a list of quantitative and qualitative methods to analyze cells from biofilms. These include flow cytometry which can distinguish between different cell types based on the dye applied in a few hours (Wilson, pg. 40, table, 2nd entry from top). Wilson et al. does not provide specific dyes to identify the genus and species of a bacteria. However this is taught by Jacobsen et al. who identifies Listeria monocytogenes (both genus and species) with flow cytometry using one of five different fluorescent dyes (Jacobsen, Abstract).
It would be obvious to combined Mayton et al. with Wilson et al. since both desire to analyze the bacteria from biofilms. It would be obvious to use the flow cytometry techniques of Jacobsen et al. to specifically identify Listeria monocytogenes since that is one of the bacteria of interest in Mayton et al. One of ordinary skill would recognize combining the CAase detachment of bacteria from their biofilms and subsequent analysis by flow cytometry as an obvious improvement to rapidly analyze the bacteria species of a biofilm. This would be seen an obvious application of known techniques to analyze biofilms (MPEP 2141 III (C and D)).
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) 6 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) in view of Wilson et al. (Res Rev J Eng. Technol 2017) and Jacobsen et al. (J. of Microbiological Methods 1997) as applied to claims 1-5, and 7-14 above, and further in view of Van Nevel et al (Journal of Microbiological Methods, 2013).
Mayton et al., Wilson et al. and Jacobsen et al. teach the method of claim 1 by detaching bacteria from biofilm with CAase then collecting and identifying the bacteria by genus and species using flow cytometry. The step of detaching the bacteria from the biofilm with CAase takes 30 minutes. Wilson et at. teach that flow cytometry takes “a few hours” to complete. However they are not more specific if the duration of flow cytometry is less than 6 hours. This is obvious in view of Van Nevel et al. who teach a multi-well plate automated flow cytometric analysis for bacteria should be below 80 minutes (Van Nevel, Abstract). They show a typical sample processing time of 74 minutes (Van Nevel, Fig. 2). Combining the detachment time of 30 minutes and the sample processing time for 80 minutes sums to a total method time of 120 minutes, which is under 6 hours.
It would be obvious to use a preparation time of 80 minutes or less for a bacterial flow cytometric experiment since Van Nevel et al. teach this is a desirable window of time to perform this method.
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.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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
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