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
The instant application is a U.S. national phase of PCT/EP2019/086742, filed on 12/20/2019, and has foreign application NO20181688, filed December 21, 2018. Applicant’s amendment filed November 14, 2025 is acknowledged.
Claims 2, 21-23, and 26-27 are canceled, and claims 1 and 4 are amended. Claims 1, 3-20, and 24-25 are pending. Claims 13-15 and 18-20 are withdrawn.
Claims 1, 3-12, 16-17, and 24-25 are under examination.
Claim Objections
Claim 1 is objected to because of convoluted and ungrammatical phrases in lines 19-23. Claim 1 may be amended to “…said method further comprising the enumeration of the rhamnose fermenting Listeria sppportion of the suspension prepared in step i) to a multi-well tray and
determined by the color change in step iii).”
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 16 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 16 depends on a canceled claim, thus is of improper dependent form. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
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.
Claims 1, 3-12, 16-17, and 24-25 are rejected under 35 U.S.C. 103 as being unpatentable over Schabert (EP 1506309 B1, cited in PTO-892 filed February 8, 2024) in view of Sigma-Aldrich (53707 HiCrome™ Listeria Agar Base product information, 2013, pgs. 1-2, cited in PTO-892 filed February 8, 2024, hereinafter “Sigma”) and Cloke, et al. (Journal of AOAC International Vol. 99, No. 3, 2016, cited in PTO-892 filed February 8, 2024, hereinafter “Cloke”)., as evidenced by Birrell (MS Thesis, University of Tasmania, 2005, pgs. 1-234, cited in PTO-892 mailed 10/22/2024) and Koutsoumanis et al. (Food Microbiology 21 (2004) pgs. 415–422, cited in PTO-892 mailed 5/14/2025, hereinafter “Koutsoumanis”).
Regarding claims 1, 3, 5-9, 12, 16-17, and 24-25, Schabert teaches a method of plating media to detect Listeria monocytogenes (para 3). Schabert teaches the plating media comprises suitable carbon sources such as L-rhamnose (para 69). Schabert teaches the plating agar contains, lithium chloride (5.0g/l which meets the limitation of claim 7), cycloheximide, polymyxin B, nalidixic acid, and ceftazidime (which meets the limitations of claims 1 and 5) (para 95, 98). Schabert teaches plating media according to the invention include such liquid or semi-liquid forms as well as dry plating media, and the media need not be contained in a dry, semi-liquid (synonymous with semi-solid) or liquid plating medium according to the invention since the actual user may wish to adapt it in view of specific requirements (para 57 & 62). Schabert teaches the plating media of the present invention may also be used for direct counting of the target microorganisms without any enrichment step (para 24).
The plating medium was inoculated from a pre-enrichment broth and incubated at 36⁰C for 24 hours (para 103). Schabert teaches the presence of a fluorogenic constituent of formula (I) and of a chromogenic substrate of formula (IV) in a single medium allows for a fast presumptive positive reaction (due to the fluorogenic constituent) within a period of typically 24 hours followed by incubation for a further period of time, e.g. 24 hours, and identifying the colony on the solid medium using the chromogenic effect as a confirmatory reaction which meets the limitations of claims 1 and 3 (para 50). Schabert teaches the primary sample used in the methods can be obtained directly from a suspected source that may be of physiological or other origin, such as blood, excrements, or infected foods, feeds, water sources, drinks or the like materials capable of harboring the bacteria of interest, also samples from food processing, which meets the limitation of claim 9 (para 30). As evidenced by Birrell, L. monocytogenes is commonly found in human and animal waste, which inherently meets the limitations of claims 24 and 25 (pg. 17, sec. 1.4.1.2).
Schabert does not explicitly teach a pH color indicator (such as phenol red), nor the specific amount of rhamnose present in the medium.
However, Sigma teaches a HiCrome Listeria agar that comprises phenol red (pH indicator) and rhamnose in the concentration of 10g/l which meets the limitations of claims 1, 6, and 8 (pg. 1). Sigma also teaches the differentiation in Listeria species is based on the property of rhamnose fermentation, which show up as blue with a yellow background for positive rhamnose fermentation (pg. 1).
Although neither Schabert nor Sigma explicitly teach the media is in the form of a liquid wherein the bacteria is suspended, Koutsoumanis discloses the difference between planktonic and solid surface growth limits of L. monocytogenes indicates that cells immobilized on solid media may have to overcome an additional stress in order to initiate growth compared to cells in suspensions; this stress could be related to a number of factors including rate of nutrient diffusion, oxygen availability and cell-to-cell communication (pg. 418, col. 2, para 2). Koutsoumanis also discloses during growth in liquids, the planktonic cells can exhibit a faster growth rate than immobilized colonies on solid media, which the slower growth rate can mainly be attributed to modifications of the local environment, such as a decrease of pH, within the colonies resulting in reduced metabolic activity in the colony (pg. 418, col. 1, para 2). Thus the results of Koutsoumanis’ studies indicated that models developed in broth for predicting microbial growth limits in solid foods would lead to fail-safe predictions (pg. 420, col. 2, para 2).
Schabert does not teach transferring the suspension into a multi-well tray and finally calculating the Listeria such as by a most probable number (MPN) method.
Schabert does not teach further including a step of confirming L. monocytogenes such as by polymerase chain reaction (PCR), nor that the method is performed in a closed system.
However, Cloke teaches a validation method of the Applied Biosystems 7500 Fast Instrument for detection of L. monocytogenes with the SureTect L. monocytogenes PCR assay (title). Cloke teaches the use of the SureTect assay on a 96 well format PCR cycler allows enumeration of L. monocytogenes in presumptive and confirmation samples comparable to MPN which meets the limitations in claims 2, 16, 21, 23, and 27 (pg. 683, Table 3). Cloke teaches a closed system by way of the PCR instrument being self-contained (pg. 679, col. 2, para (f)). Cloke also teaches following incubation, 10 μL of the Fraser Broth enrichment, regardless of any color change, was streaked on to a plate of OCLA (ISO) and PALCAM Agar, which meets the limitation of claims 2 and 3 (pg. 682, col. 1, para 6).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the methods of screening, detection, and isolation of L. monocytogenes with the selective medium as a liquid comprising the recited elements in the claims as taught by Schabert and combine the ingredients of the HiCrome Listeria agar comprising the phenol red indicator and specific rhamnose concentrations as taught by Sigma to facilitate detection and enumeration, utilizing the MPN method taught by Cloke. One of ordinary skill in the art would have been motivated to combine the ingredients to advantageously create a more selective and differential media to isolate L. monocytogenes from samples, as such modifications represent predictable variations using known techniques in the art to improve usability and detection efficiency. The phenol red indicator shows the rhamnose fermentation of the bacteria as taught by Sigma (pg. 1). Further, it would have been prima facie obvious to one of ordinary skill to utilize the media as a liquid suspension for the detection and isolation of L. monocytogenes, as liquid media enables a faster growth rate of the bacteria due to the cells being less stressed as grown in colonies on solid agar, as evidenced by Koutsoumanis.
Regarding claims 4 and 10-11, Schabert and Sigma do not explicitly teach the sample preparation is obtained by dividing sample into small pieces, nor that the sample can be a food sample such as meat, or an environmental sample such as a swab.
However, Cloke teaches a validation method performed on a range of food matrixes, including raw turkey, as well as surface swab samples (abstract). Cloke teaches the food matrix or surface sponges are added to a homogenizer bag and homogenized in LEB broth (pg. 678, col. 2, SureTect Method).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the methods taught by Schabert and Sigma with the sample preparation of homogenizing different food matrixes and surface swabs taught by Cloke with a reasonable expectation of success. One of ordinary skill in the art would have been motivated to homogenize food samples and surface swabs in the culture media to thoroughly mix the sample for further analysis. Further, one of ordinary skill in the art would have recognized analyzing food samples such as raw meat and environmental samples such as surface swabs as a common practice in the food safety industry as taught by Cloke (pg. 676, col. 2, “Reviewers”).
Response to Arguments
Applicant's arguments filed November 14, 2025 have been fully considered but they are not persuasive.
Regarding the U.S.C. 103 rejections, Applicant disagrees with the Examiner’s reasoning that transforming solid medium to liquid medium would have the same diagnostic traits and inhibitors as the solid form, and points to Netten that discloses the liquid form is not reliable for detection by visual inspection - in particular see the final paragraph of "Liquid media" on page 313 of Netten, and turbidity was not found to be a reliable indicator of growth. Applicant also submits Koutsoumanis is non-analagous art because the reference does not relate to diagnostic or selective media (the field of the present invention) but instead concerns a study comparing the growth limits of Listeria monocytogenes in suspension versus on a solid surface. Applicant agues Schabert’s method is to detect a microbe within an undefined sample, i.e. a sample where the presence of the desired bacteria is not known and which may contain other bacteria which could cause false positives. The culture media must therefore be selective in order to suppress the growth of non-target bacterial species. Therefore, Applicant submits there is no suggestion in any of the cited prior art to use a liquid suspension for the detection and enumeration of Listeria as presently claimed. It is therefore submitted that the skilled person would not have had any motivation to switch from solid to liquid media based on the disclosure of Schabert as evidenced by Koutsoumanis. Applicant also argues The SureTect assay is not a method of enumeration, nor does it provide results comparable to MPN. Rather, the SureTect assay is a means of detection, i.e. the output of the SureTect assay is merely positive (bacterium present) or negative (bacterium not present). Therefore, Cloke does not make up for the deficiencies of Schabert (and Sigma), and Applicant respectfully requests withdrawal of the same.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). The examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). As discussed in the 103 rejection, Schabert does teach the media can be transformed into a liquid medium and also teaches the medium can be used without any pre-enrichment step. It is well-known in the art to transform solid medium to liquid medium or vice-versa, to suit the practitioner’s needs. Both Schabert and Sigma teaches selective differential medium, albeit solid forms, however one of ordinary skill in the art could readily transform the solid medium taught by the references to arrive at the claimed method. Furthermore, the Suretect assay used by Cloke repeatedly compared with the conventional MPN method, and is incorporated as a test limit for the detection of L. monocytogenes, thus teaches this limitation in the claimed method.
In response to applicant's argument that Koutsoumanis is nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, Koutsoumanis was evaluating growth rates of L. monocytogenes, the target bacteria the claimed method aims to detect, therefore, relevant in the detection of the rhamnose L monocytogenes in mixed samples.
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, Schabert teaches selective/differential media for L. monocytogenes comprising the elements of the claimed invention, wherein the selective portion are the antibiotics (inhibiting other bacteria) and the differential portion is the bacteria producing the PI-PLC enzyme indicating presence of the target bacteria. Sigma teaches a similarly selective/differential media not comprising the exact selective elements of Schabert’s and utilizing a differential indicator as the phenol red pH indicator, as well as the rhamnose sugar. It would be obvious to one of ordinary skill in the art to incorporate the differential elements in Sigma into Schabert to arrive at the claimed invention. Regarding the neutrality of the media, the preparation of the instant media states the pH is 7.4 ± 0.2 (Specification, pg. 23), which is a neutral pH and within the range of the media taught by Schabert at pH 7.1-7.2 (para 96). Thus, the motivation to combine Schabert and Sigma could be considered two-fold indicating the presence of L. monocytogenes by two separate differential indicators, which render the present invention obvious over the cited prior art. Furthermore, enumerating bacterial growth following selective culture is a conventional and expected step that does not impart patentable distinction to the method over the prior art.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JESSICA EDWARDS whose telephone number is (571)270-0938. The examiner can normally be reached M-F 8am-5pm EST.
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/LOUISE W HUMPHREY/Supervisory Patent Examiner, Art Unit 1657
/JESSICA EDWARDS/
Examiner, Art Unit 1657