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 .
Status of claims
Claims 1, 2, 11-13, 16, 46, 47 and 49 as amended on 6/09/2026 are currently pending are under examination in the instant office action.
Claim Rejections - 35 USC § 112
Indefinite
Claims 1, 2, 11-13, 15, 16 and 46-49 as amended are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 remains indefinite with regard to structural elements of the claimed invention. The claimed invention a system or an apparatus comprising several structural parts. In the instant case, a system of claim 1 comprises 2 structural parts that are: 1) a dilution container comprising a medium and a substrate as intended to form a mixture of the medium with the substrate upon the use of the system; and 2) an incubator. Claim 1 also recites that the medium has two formulations. Thus, it would be logically to assume that they have to be present in the system (apparatus) in some separate compartments of the dilution container before forming the mixture as intended upon the use of the system. But it is unclear where in the apparatus (claimed system) these 2 formulations are located, if they are indeed 2 separate formulations. In view of as-filed specification there is a single medium or one “formulation” comprising all components recited in the claim 1 together (table 1, par. 0065 of published application US 2024/0271178). Further, claim 2 positively recite “a means for dividing the mixture” into 2 or more separated compartments. But term “compartments” does not have an antecedent basis in the system (apparatus) of claim 1 since claim 1 does not recite any “compartment” but one “dilution container”.
Claim 1 is rendered indefinite by the alternative language “and/or” in the recitation about components of the “first formulation”. Language “or” excludes “first antibiotic”, thereby, creating more confusion in the claim.
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.
Claims 1, 2, 6, 11-13, 16, 19, 46, 47 and 49 as amended remain/are rejected under 35 U.S.C. 103 as being unpatentable over by Bain et al (PloS ONE, 2015, Vol. 10, issue 10, pages 1-13), US 9,127,303 (Spitz et al), Alonso et al (“Differential Susceptibility of Aeromonads and Coliforms to Cefsulodin”, Applied and Environmental Microbiology, 1996, Vol. 62, No. 6, pages 1885-1888) and Watkinson et al (“Novel Method for Rapid Assessment of Antibiotic Resistance in Escherichia coli Isolates from Environmental Waters by Use of a Modified Chromogenic Agar”. Applied and Environmental Microbiology, 2007, Vol. 73, No. 7, pages 2224-2229).
The cited reference by Bain teaches detection of E.coli in water samples upon diluting, inoculating and mixing water samples with a medium in a container and further incubation at temperature favorable for microbial metabolism (see page 3, par. 4).
Thus, the cited “system” of Bain comprises: 1) a dilution container comprising a medium and it is used for diluting samples that are collected for testing, and 2) an incubator.
The medium in the container comprises all claim-recited salts including sodium sulfate, sodium chloride, sodium phosphate, potassium phosphate, ammonium chloride, ammonium sulfate, magnesium sulfate and calcium chloride (see table 2 at page 4) as required by claim 1. The medium comprises a substrate for microbial enzyme beta-glucuronidase such as MUG or 4-methyllumbelliferyl-beta-D-glucuronide (table 2) which is metabolized by glucuronidase-producing microbes or by E.coli and releases a fluorescent detectable marker. The medium comprises sodium pyruvate, sodium dodecyl sulphate and at least one antibiotic such as cefsulodin, thus, a the very least “a first formulation” or one aspect of the claimed system as encompassed by claims 1, 12 and 13.
Thus, the cited reference by Bain teaches the similar system for determining presence of bacterial contaminants in aqueous sample except that it is silent about glucuronidase substrates with chromogenic markers such as resorufin-B-D-glucuronide, 5-bromo-6-chloro-3-indolyl-B-D- glucuronide and 5-bromo-4-chloro-3-indolyl-B-D-glucuronide.
However, beta-glucuronidase substrates with chromogenic markers such as resorufin-B-D-glucuronide, 5-bromo-6-chloro-3-indolyl-B-D-glucuronide and 5-bromo-4-chloro-3-indolyl-B-D-glucuronide have been knonw in the prior art and used for detection of glucuronidase-producing microbes including E.coli. For example: see US 9,127,303 (Spitz et al) at abstract and at col. 4, lines 15-35. The cited US 9,127,303 (Spitz et al) also teaches that chromogenic indicators are superior to fluorogenic indicator (such as MUG) because fluorescent marker released by enzymatic activity of bacterial cultures is sometimes difficult to distinguish from natural matrix fluorescence (col. 1, lines 55-67), thereby, providing a motivation for a substitution.
Therefore, it would have been obvious to one having ordinary skill in the art at the time the claimed invention was filed to substitute chromogenic substrate or chromogenic indicators of bacterial beta-glucuronidase including 5-bromo-6-chloro-3-indolyl-B-D- glucuronide and 5-bromo-4-chloro-3-indolyl-B-D-glucuronide taught by US 9,127,303 (Spitz et al) for a fluorogenic indicator or MUG in the detection system of Bain with a reasonable expectation of success in detecting microbial contaminants including E.coli in aqueous samples as based on bacterial beta-glucuronidase activity. One of skill in the art would have been motivated to do this substitution because prior art recognizes superiority of chromogenic indicators over fluorogenic indicators as adequately stated in the disclosure by US 9,127,303 (Spitz et al). Thus, the claimed invention as a whole was clearly prima facie obvious, especially in the absence of evidence to the contrary.
Further with regard to limitation drawn to a combination of “a first formulation” with a first antibiotic and “a second formulation” with “a second antibiotic different from the first antibiotic”:
The reference by Bain teaches incorporation of antibiotic cefsulodin as intended to suppress water contaminating Pseudomonas, thereby, selecting for E.coli as intended to detect E.coli contamination in water samples (see Bain at page 2, par. 3). The reference by Alonso further teaches that cefsulodin is useful selecting antibiotic which is included in coliform chromogenic media when the high levels of E.coli accompanying flora are expected in water samples. The concentration of less than 10 µg/ml inhibits about 96% of non-target accompanying isolates while MIC for E.coli is as high as 32 µg/ml (see abstract of Alonso).
Further, the reference by Watkinson recognizes that there is an increase in antibiotic resistant E.coli isolates among E.coli bacteria in environmental waters and that chromogenic selective media with tetracycline is used for rapid assessment of antibiotic resistance in E.coli isolates in waters.
Therefore, it would have been obvious to one having ordinary skill in the art at the time the claimed invention was filed to add a second antibiotic (tetracycline, for example) or a second “formulation” to the medium of Bain, which incorporates a first antibiotic (cefsulodin) for inhibiting non-target bacteria, as it would be intended to detect resistance in water samples of target isolates (E.coli isolates) to the second antibiotic (tetracycline, for example) with a reasonable expectation of success in selecting for water E.coli contaminants including antibiotic resistant E.coli because prior art demonstrates that this a well-established practice for monitoring and identifying antibiotic resistance of target bacteria such as E.coli in water samples.
Thus, the claimed invention as a whole was clearly prima facie obvious, especially in the absence of evidence to the contrary.
The claimed subject matter fails to patentably distinguish over the state art as represented be the cited references. Therefore, the claims are properly rejected under 35 USC § 103.
Further, as applied to claim 2: the primary reference by Bain discloses the use of several containers for dispensing mixture of samples with medium in the detection system (see page 3, par. 4); and, thus, means diving the mixture into separate compartments within the broadest reasonable meaning of the claims.
As applied to claim 6: although the primary reference by Bain does not explicitly describe “a lid”, it would be reasonable to conclude that container(s) has/have cover(s) or lid(s) for sterility and analysis accuracy concerns.
As applied to claim 19: the primary reference by Bain teaches that the growth medium composition comprises yeast extract and casamino acids (see table 2).
Furthermore, as applied to claims 11, 15, 16, 48 and 49: The medium used in the Bain’s system for detection of water microbial contaminants comprise identical ingredients as claimed (claims 1, 12 and 13) but in lower concentration than recited in the claims 11, 15, 16, 49.
However, it would be a reasonable interpretation of the pending claims that the recited amounts reflect a medium concentrate. Moreover, “a dilution” of samples with medium is explicitly recited in claim 1. The cited reference by Bain describe that medium can be provided as “dehydrated medium” (see page 3, par. 4), thus, as a concentrate.
Therefore, it would have been obvious to one having ordinary skill in the art at the time the claimed invention was filed to provide all culture medium ingredients as a concentrate or in concentrated amounts as claimed for further dilution to the art recognized concentrations that are optimal for microbial metabolism with a reasonable expectation of success in detecting microbial contaminants in water samples because all claimed components have been known and used in microbial culture medium and the microbial culture medium are commonly provided in concentrated form further dilution and use.
Thus, the claimed invention as a whole was clearly prima facie obvious, especially in the absence of evidence to the contrary.
The claimed subject matter fails to patentably distinguish over the state art as represented be the cited references. Therefore, the claims are properly rejected under 35 USC § 103.
Response to Arguments
Applicant's arguments filed on 6/09/2026 have been fully considered but they are not persuasive.
With regard to claim rejection under 35 U.S.C. 103 Applicant argue that the cited references do not teach a system with multiple formulations which allow for determination of the presence of E.coli and then separate determination of antibiotic resistance of E.coli (response page 7-8).
This line of arguments is not persuasive because the cited prior art references as a whole teach both aspects of the claimed invention.
The primary reference by Bain clearly teaches a system allow for determination of the presence of E.coli in a medium comprising an enzymatic substrate for glucuronidase of E.coli and all claim-recited salts including sodium sulfate, sodium chloride, sodium phosphate, potassium phosphate, ammonium chloride, ammonium sulfate, magnesium sulfate and calcium chloride and also sodium pyruvate, sodium dodecyl sulphate and antibiotic cefsulodin (see table 2 at page 4) as required by claims 1, 12 and 13. The refence by Bain clearly recognizes that incorporation of antibiotic cefsulodin is intended (and allows) to suppress water contaminating Pseudomonas, thereby, selecting for E.coli as intended to detect E.coli contamination in water samples (see Bain at page 2, par. 3).
The secondary reference by Watkinson recognizes that there is an increase in antibiotic resistant E.coli isolates among E.coli bacteria in environmental waters and that chromogenic selective media with antibiotic tetracycline is used for rapid assessment of antibiotic resistance in E.coli isolates in waters.
Therefore, it would have been obvious to one having ordinary skill in the art at the time the claimed invention was filed to add a second antibiotic (tetracycline, for example) or a second “formulation” to the “system” or to the medium of Bain (which incorporates a first antibiotic cefsulodin for inhibiting non-target bacteria) with a reasonable expectation of success in first detecting E.coli contaminants in samples and then detecting antibiotic resistant E.coli contaminants in samples because prior art demonstrates that this a well-established practice for monitoring and identifying antibiotic resistance of target bacteria such as E.coli in water samples. Thus, the claimed invention as a whole was clearly prima facie obvious, especially in the absence of evidence to the contrary.
In view of as-filed specification there is a single medium or one “formulation” comprising all components recited in the claim 1 together (table 1, par. 0065 of published application US 2024/0271178).
No claims are allowed.
Conclusion
THIS ACTION IS MADE FINAL. 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.
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Vera Afremova
August 7, 2026
/VERA AFREMOVA/ Primary Examiner, Art Unit 1653
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