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
This application is a 371 of PCT/US2021/55962, filed 10/21/2021, which claims the benefit of priority of U.S. Provisional Application No. 63/094,945, filed 10/22/2020.
Status of the Election/Restrictions
Applicant’s election without traverse of group I (claims 1-21 and 27) in the reply filed on 02/17/2026 is acknowledged.
Regarding the species election requirement,
For species group A: Type of enrichment media, Applicant elects selective enrichment media.
For species group B: Volume of enrichment media, Applicant elects about 1 ml to about 50 ml of enrichment media.
For species group C: Collection to Detection time, Applicant elects 12 hours or less detection time.
For species group D: Number of cells from environmental sample prior to incubation, Applicant elects about 2 to about 50 cells of Listeria.
For species group E: Detection assay, Applicant elects a thermostable helicase- dependent isothermal amplification (tHDA) assay.
For species group F: Assay detection sensitivity, Applicant elects detect presence of Listeria as little as 7 cells of Listeria.
Claim 11 is rejoined.
Claims 5, 9, 14, 16, 19-20 and 22-26 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention(s), there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 02/17/2026.
Status of the claims
Claims 1-27 are pending. Claims 1-4, 6-8, 10-11, 12-13, 15, 17-18 and 21 are currently under review.
Claim Rejections - 35 USC § 102
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.
Claims 1-4, 6-8, 11-13, 15, 17-18 and 21 are rejected under 35 U.S.C. 102(a)(1) and under 35 U.S.C. 102(a)(2) as being anticipated by Nelson et al. (pub. March 23, 2017, filed Sept 13, 2016, WO2017/048664A1) as evidenced by Neogen ANSR manual for detection of Listeria monocytogenes and Alles et al. (Nov 2018, Journal of AOAC International, 101(2), pp.444-455).
The applied reference (WO2017/048664A1) has a common assignee and common co-inventors (i.e. Preetha K. BISWAS and Lei ZHANG) with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Regarding claims 1-4 and 6-9, 11, 15, Nelson et al. teach a method of detecting Listeria in an environmental sample, the method comprising the steps of:
collecting an environmental sample comprising cells using a collection device (see para [0066],[0068]-[0069], [0012], [0048]-[0049] and/or para [00118]);
transferring the sample to an incubation container containing about 50 ml or less of enrichment media (para [0069], [0073]-[0074] and/or para [00118]: swab(s) soaked in Letheen broth are each placed in a microcentrifuge tube, each tube containing 1 ml of lysis reagent solution; or in one or more tubes each containing 450 µl of lysis reagent solution);
incubating the cells in the incubation container for about 12 hours or less (para [0082], wherein Nelson et al. teach incubation at 37± 2°C for 10 minutes; para [00118] teach a number of swabs added to tube(s) each containing 10 ml UVM for USDA method);
lysing the cells to release nucleic acids from the cells (Nelson et al. teach lysis with 80 ± 2°C heating for 20 minutes and up to 60 minutes, para [0083], [0085]); and
performing a detection assay that targets nucleic acid sequences for amplification and detection of Listeria nucleic acids released from the cells (see para [0009], [0011], [0033], Tables 1-6; or para [00119]-[00126]: Nelson et al. teach use of ANSR assay for Listeria detection).
Regarding claim 1, concerning the limitations of transferring the sample to an incubation container containing about 50 ml or less of enrichment media; incubating the cells in the incubation container for about 12 hours or less and lysing the cells to release nucleic acids from the cells, the ANSR manual teach that the ANSR assay for Listeria monocytogenes is an isothermal, amplified nucleic acid assay, based on nicking enzyme amplification reaction (NEAR) technology and provides a two-stage lysis reaction. The first is at 37 ± 2°C for 10 minutes, then at 80 ± 2°C for 20 minutes (see page 2, text of section entitled “Assay principles”).
The ANSR manual teach a portion of the lysed sample is transferred to a strip tube containing lyophilized ANSR reagents. The tubes are sealed and incubated at 56 ± 1°C on the ANSR reader. Results are generated by the reader and displayed in the ANSR software within 10 minutes. Positive results may be confirmed from the enrichment cultures following standard procedures. Each tube of ANSR reagents contains an internal positive control, ensuring that the reagents are functioning properly (see page 2, text of section entitled “Assay principles”).
Regarding claims 1, 11, 13, 15 and 17, Alles et al. teach “ANSR for Listeria is an isothermal, amplified nucleic acid assay for detection of Listeria spp. in food and environmental samples. The ANSR Listeria method uses nicking enzyme amplification reaction (NEAR) technology, preceded by the reverse transcription of 23S ribosomal RNA” (pg 445, left col. Last para and pg 445, right col., 1st para).
Regarding claim 7, Nelson et al. teach collection device is a sponge (para [0012], [0091], claim 7) and Listeria collected from low concentration environment (plastic, ceramic surfaces) (para [00116] and Tables 1-2 and para [00121]-[00122] in contrast with surfaces spiked with Listeria culture).
Regarding claim 12, Nelson et al. teach centrifuging to concentrate swab collected cells (para [0075]).
Accordingly, the instant claims 1-4, 6-8, 11-13, 15 and 17-18 and 21 are anticipated by Nelson et al. (WO2017/048664A1) as evidenced by Neogen ANSR manual for detection of Listeria monocytogenes and Alles (2018).
Claim Rejections - 35 USC § 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 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.
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.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Nelson et al. (pub. March 23, 2017, filed Sept 13, 2016, WO2017/048664A1) as evidenced by Neogen ANSR manual for detection of Listeria monocytogenes and Alles et al. (Nov 2018, Journal of AOAC International, 101(2), pp.444-455) and further in view of Pisamayarom et al. (2017, Int. J. Res. Granthaalayah., 5, pp.322-335).
The teachings of Nelson et al. (WO2017/048664A1) as evidenced by Neogen ANSR manual and Alles (2018) as it relates to claim 1 are provided above.
Regarding claim 10, Nelson et al. (WO2017/048664A1) as evidenced by Neogen ANSR manual and Alles (2018) do not teach detection assay is a thermostable helicase-dependent isothermal amplification (tHDA) assay.
Regarding claim 10, Pisamayarom et al. teach it already a matter of routine practice in the art before the effective filing date of the invention, to detect Listeria monocytogenes utilizing a tHDA assay (pg 323, 4th para and pg 325, section 2.5 and all text of pg 326-327).
It would have been prima facie obvious to an ordinary skilled artisan before the effective filing date of the instant invention to substitute the tHDA assay taught by Pisamayarom et al. for the NEAR assay of Nelson et al. (WO2017/048664A1) as evidenced by Neogen ANSR manual and Alles (2018) as both assays constitute functional alternatives of isothermal amplification suitable for Listeria monocytogenes detection.
In view of the combined teachings of all of the cited reference(s), the instant claim 10 is prima facie obvious.
Conclusion
No claims are currently allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLAYINKA A OYEYEMI whose telephone number is (571)270-5956. The examiner can normally be reached Monday -Thursday: 9:00 am - 5:00 pm, EST.
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OLAYINKA A. OYEYEMI
Examiner
Art Unit 1681
/OLAYINKA A OYEYEMI/Examiner, Art Unit 1681
/GARY BENZION/Supervisory Patent Examiner, Art Unit 1681