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 .
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 11-16-2025 is acknowledged.
Claims 8-15 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 1-5 are rejected under 35 U.S.C. 103 as being unpatentable over Idelevich,E. et al., (US20180230508A1; 2018-08-16) and in view of Saini, S. et al., (US20050082175A1; 2005-04-21).
Regarding claims 1(a), Idelevich,E. et al., teaches a method for testing microorganisms, using a receptacle, which is a barrel, element 202 (sheet 3, figure 2) that receives a liquid sample (page 6, paragraph 0049).
Regarding claim 1 (b), Idelevich,E. et al. teaches passing liquid sample through a filter element so that microorganisms are retained at a first side which is element 212 in the reference (Sheet 2, Figure 2 and page 7, paragraph 0051) ; “the filtrate (i.e. the filtered body fluid) is located in the first compartment lying above the plug, whereas the pathogenic particles filtered out of the body fluid are in the second compartment lying below the plug” (page 7, paragraph 0052).
Regarding claim 1(c), Idelevich,E. et al. teaches a liquid growth medium and microorganisms are retained on the filter, which is ‘the first filtering membrane’ (pages 2-3 paragraph 0015, 0016; page 6, paragraph 0047). The cultivation compartment then receives the filter in the liquid growth medium, which is the ‘ first growth medium capable of supporting growth of microorganisms’ (pages 3-4 paragraphs 0020, 0026; page 6,0048; page 78, paragraph 0076).
Regarding claim 1(d) Idelevich,E. et al. teaches a vessel incubated for a predetermined period of time and temperature as described in Figure 1, which is the ‘incubating first filtering membrane and growth medium at an incubation temperature’ (pages 3-4 paragraphs 0020, 0026; page 6, paragraph 0048; page 78, paragraph 0076).
Regarding claim 1(e) and (f) Idelevich,E. et al. does not teach a sensing surface of a gas sensor, to detect metabolic gas release by microorganisms on a second side, in connection to a fluid filled compartment of a first filtering membrane.
However, Saini, S. et al., teaches a method and apparatus for the detection of gas produced by microorganisms in a singular sample collection system: a detector assembly designed to detect disease odors from infecting microorganisms or metabolic disease odors imparted to bodily fluids (pages1-2, paragraphs 0006, 00017); detector assembly comprises a gas sensor, a means of delivering disease odor samples to the sensor and an electronic interface controlled via a personal computer (page 2, paragraph 0022).
Regarding claim 2, Idelevich,E.et al., teaches, a liquid growth medium (page 1, paragraph 003) where in the liquid is in contact with the filtering membrane within a barrel or by dispensing liquid filtered through membrane to a second compartment and used to retain microorganisms -- which is a first: piston, tip, which is element 116 in the reference, and a growth medium which is element 210, in the reference (Sheet 3, Figure 2; page 2, paragraph 0008; page 4, paragraphs 0025).
Regarding claim 3, Idelevich,E.et al., teaches components of first tip and piston are previously revealed. Idelevich,E.et al., further teaches first partial area and second partial area that are non-overlapping wherein the first growth medium is on the first partial area and the second is in/on the second partial area—which is a cultivation device which is element 150 of Figure 1 (Sheet 2) that is further integrated to the device of Figure 2 (Sheet 3) providing for a growth medium with multiple media and/or compartments (page 2, paragraph 0008; page 4, paragraphs 0025).
Regarding claim 4, Idelevich, E. et al., teaches a first growth medium is a liquid, and the first side, which is element 210, of the filtering membrane, which is element 212, is in contact with the growth medium with the liquid in the barrel by filtering through the membrane, which is element 212, by moving the piston, which is element 116, towards the filtering membrane. Idelevich, E et al., also teaches a multi-compartment unit which dispense liquid from the first filtering membrane, to a second compartment lying above the plug, where the pathogenic particles filtered out of the body fluid are in the second compartment lying below the plug with a flow limiter and prevents backflow, which is element 208, (page 3, paragraph 0018; page 7, paragraph 0052; page 11, paragraph 0074).
Regarding claim 5 , Idelevich, E. et al., teaches selective media, filtration and selective agents including for antibiotic-resistant pathogens (page 12, paragraphs 0079, 0080) along with stage-wise and isolated compartments for introducing selective agents into a singular device with multiple compartments that contains a barrel, piston, filtration, and performs as a device for cultivation of microorganisms (pages 4-5, paragraphs 0022, 0024, 0025, 0027,0028; page 5, paragraph 0034; page 7, paragraph 0052; page 10, paragraph 0069).
Therefore, regarding claims 1-5, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date to further modify Idelevich, E. et al., in view of Saini, S. et al., to provide a single device with a barrel, piston(s), filter membrane, divided into multiple compartments to collect, filter, and select for specific microorganisms with the simple addition of the gas sensor system to detect metabolic gases produced by microorganisms, described by Saini, S. et al.
The motivation for performing the modification is to provide a measure of gases, such as volatile organic compounds, produced by specific strains of microorganisms to further specify the identification of a strain and/or the metabolic compounds produced by specific microorganism(s) cultured in the compartment of the liquid media (with or without selective media(s) and/or agents, following the isolation of microbes through filtration. Since, microbial gas production/detection are a classically practiced diagnostic and/or analytic laboratory method for strain identification and attributes, a skilled artisan would have reasonably expected success in the combination of Idelevich, E. et al., in view of Saini, S. et al., since the combination of both are solving the same problem and concerns of isolating and/or selecting for specific microbes and measuring their growth and attributes of growth, in a single device.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Idelevich,E.et al., (US20100330603A1; 2010-12-30) in view of Saini, S. et al., (US20050082175A1; 2005-04-21), and further in view of Streiff, M. et al., (WO2018095529A1; 2018-05-31).
The teachings of Idelevich,E.et al., et al., in view of Saini, S. et al., are disclosed previously.
Regarding claim 7, Idelevich E et al., and Saini, S. et al., do not teach the use of affinity molecule carrying magnetic beads to isolate microorganisms.
As previously described, Idelevich, E et al., in view of Sanini, S. et al., teaches a singular device with multiple compartments, a barrel, piston(s), selective media(s), isolation and cultivation of microorganisms within compartments; and microbial metabolic gas detection using a gas sensor within a select compartment of a multicompartment device.
Further, Streiff et al., teaches targeted microorganisms are isolated using magnetic immunoaffinity beads and further cultured in the presence or absence of antimicrobials or selective media in a channel, which is a compartment (pages 2-3, lines 30-36 and lines 1-13 ).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the intention to modify Idelevich, E.et al., with the gas sensor described by Sanini, S. et al. et al., and combine Streiff et al., to simply add magnetic immunoaffinity beads to a given compartment, isolate the beads from the filter membrane and culture the isolated microorganisms captured by the immunoaffinity magnetic beads in a selective media. One would have been motivated to combine these technologies, to further select for a specific strain to culture, from the filtered microorganisms. As described by Streiff et al., magnetic immunoaffinity beads are well recognized in the field to support the isolation of select microorganisms from mixed samples-- using the multi-compartment system to further collect, filter, isolate, and culture microorganisms. Since Streiff et al., teaches the use of magnetic immunoaffinity beads with a multi-channel and multi-compartment growth system for selective microbes, in a singular disposable system, a skilled artisan would have reasonably expected success in the addition of immunoaffinity magnetic beads since the combination of technologies are solving the same problem and address the same concerns of isolating, filtering, and culturing select microorganisms in a multi-compartment, singular device system resulting from a ‘lab-in-a-syringe’ device.
Furthermore, since the prior art teaches the methods and apparatus, the prior art will be capable of performing the intended use.
Allowable Subject Matter
Claim 6 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Regarding claim 6 , Idelevich, E. et al., teaches selective agents (page 12, paragraphs 0079, 0080) along with stage-wise and isolated compartments for introducing selective agents into a singular device with multiple compartments that contains a barrel, piston, filtration, and performs as a device for cultivation of microorganisms (pages 4-5, paragraphs 0022, 0024, 0025, 0027,0028; page 5, paragraph 0034; page 7, paragraph 0052; page 10, paragraph 0069).
Idelevich, E. et al., does not disclose or suggest a second piston as recited in claim 6.
The most pertinent prior art references: Reinhard, M. et al., (US5788670A; published 1998-08-04), Harper, D.J. et al., (US7951108B2; published 2011-05-31 , and Waldenburg, O et al., (US6692468B1; published 2004-02-17) disclose medicinal delivery devices with dual chambers with multiple plungers. The function of the plunger is to push one material, from one compartment to a second, or third compartment, for mixing/reconstitution of a medicine. There is no motivation to provide a second piston for the sample collection device of Idelevich, E et al.
Rejoinder
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.
Correspondence Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ENUSHA KARUNASENA whose telephone number is (571)272-3972. The examiner can normally be reached Monday-Friday 7:30am-5pm.
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/ENUSHA KARUNASENA/ Examiner, Art Unit 1653
/SHARMILA G LANDAU/Supervisory Patent Examiner, Art Unit 1653