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
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 16/546805, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The claims where were filed on 6/28/2023 do not have support in the parent application and are therefore not entitled to the benefit of the filing date of the prior application. A detailed discussed of the claims are listed below under not have proper antecedent basis in the specification and is claim 11.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: Claim 1 states “incubating the portions of the fluid sampled … inserting the portions of the fluid sample that were incubated into an optical measuring instrument” which the specification does not discuss. The specification discusses the incubation of portions of the fluid sample before measuring the fluid samples with the optical measuring instrument. However, the specification does not mention inserting the incubated into the optical measuring instrument thereby implying that the initial incubation occurs in a different device. The specification discusses the incubation of the fluid sample before and during/after the measurement, but only states that the incubation occurs within the device inside the optical measuring instrument and not outside of the instrument as seeming to be stated with the claims.
Claim Objections
Claim 21 is objected to because of the following informalities: Claim 21 is missing a coordinating conjunction, the examiner suggests to add “or” before the last of the listing of items. Appropriate correction is required.
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.
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.
Claim(s) 11-16, 18, 20 and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over United States Application Publication No. 2016/0160260, hereinafter Marshall in view of United States Application Publication No. 2010/0285447, hereinafter Walsh and United States Application Publication No. 2015/0118688, hereinafter Weidemaier.
Regarding claim 11, Marshall teaches a method of detecting and identifying a microorganism in a fluid sample (abstract) comprising: placing a portion of the fluid sample in each of a plurality of fluid containers (item 520, figure 15), inserting the portions of fluid samples into an optical measuring instrument (item 522, figure 15); within the optical measuring instrument, sequentially passing an input beam through each portion of the fluid sample and measuring a first forward-scatter signal for each portion of the fluid sample (item 524, figure 15 and paragraph [0062]; continuing to incubate the portions of the fluid sample within the optical measuring instrument for a period of time (item 526, figure 15); and after the period of time, sequentially passing the input beam through each portion of the fluid sample and measuring a second forward-scatter signal for each portion of the fluid sample (item 528, figure 15 and claim 13), a difference between the first forward-scatter signal and the second forward-scatter signal for each portion of the fluid sample being indicative of a presence and an identity of at least one of the plurality of types of microorganisms within the portion of the fluid sample (claim 13), and a change in a concentration of the at least one of the plurality of types of microorganisms within the portion of the fluid sample (claim 13).
Marshall further teaches having different antibodies and different concentrations of antibiotics in each of the plurality of fluid containers (paragraph [0081]); however, Marshall fails to teach wherein each of the plurality of fluid containers comprises a distinct microorganism-attracting substance disposed therein, and wherein the distinct microorganism-attracting substance is configured to attract a respective one of a plurality of types of microorganisms such that each of the plurality of fluid containers is associated with the respective one of the plurality of types of microorganisms.
Walsh teaches a method for antimicrobial resistance determination in which either different antibiotics are utilized in determining the antibiotic resistance of microorganisms and the use of agents that bind to specific microorganisms such as affinity ligands to identify a class or species of microorganisms which are made from an affinity body coupled to one or more molecules of respective binding partners (Walsh, paragraph [0076]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have replaced at least some of the substances in the plurality of fluid containers with agents that bind to specific microorganisms such as affinity ligands made from an affinity body coupled to one or more molecules of respective binding partners because it would help to identify a class or species of microorganisms (Walsh, paragraph [0076]).
Marshall and Walsh fail to teach incubating the portions of the fluid sample with the distinct microorganism-attracting substance within the plurality of fluid containers and that the fluid samples inserted into the optical measuring instrument were incubated.
Weidemaier teaches the use of an enrichment vessel which is incubated for a predetermined period of time and the sample is transferred to a detection vial which is placed into a detection system for further incubation and automated analysis (Weidemaier, paragraph [0142]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have initially incubated the fluid sample and then inserted the incubated sample into the optical measuring instrument because it would allow for the sample to be further enriched before the initial detection of the sample in the optical measuring instrument (Weidemaier, paragraph [0142]).
Regarding claim 12, Marshall teaches each of the plurality of fluid containers has a first window (item 116) for receiving the input beam and a second window (item 118) for transmitting a forward-scatter signal caused by the input beam (paragraphs [0063]-[0064]) and wherein said inserting the portions of fluid samples that were incubated into an optical measuring instrument comprises inserting the portions of fluid samples within the plurality of containers (item 520, figure 15).
Regarding claim 13, Marshall teaches further comprising within the optical measuring instrument, incubating the portion of the fluid sample within a corresponding one of a plurality of cuvette chambers (item 526, figure 15).
Regarding claim 14, Marshall teaches further comprising agitating the portions of the fluid sample to further facilitate interactions between the microorganism-attracting substance in each of the plurality of fluid containers and the microorganisms within the fluid sample (paragraph [0077]).
Regarding claim 15, Marshall teaches wherein agitating the portions of the fluid sample is achieved by physical movement of the fluid containers selected from a group of physical movements including translational movement, rotational movement, revolutionary movement (paragraph [0077]).
Regarding claim 16, Marshall teaches wherein agitating the portions of the fluid sample is achieved by movement of affinity bodies (paragraph [0077], vibrating the platform would move the affinity bodies).
Regarding claim 18, Marshall teaches further comprising adding a growth medium to the plurality of fluid containers (paragraph [0054]).
Regarding claim 20, Marshall teaches wherein a first forward-scatter signal is at least one forward signal (claim 13) and a second forward-scatter signal is at least one second forward-scatter signal (claim 13) so as to detect potential microorganism growth (claim 13).
Regarding claim 21, Marshall teaches wherein the optical instrument is selected from a group of optical instruments including forward-scatter laser measurements (paragraph [0059]).
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Marshall, Walsh and Weidemaier as applied to claim 11 above, and further in view of United States Application Publication No. 2008/0125330, hereinafter Cady.
Regarding claim 17, Marshall, Walsh and Weidemaier teach all limitations of claim 11; however, they fail to teach removing from the plurality of fluid containers substances other than the microorganism-attracting substance and the sample.
Cady teaches a detection device in which removal of unwanted components is performed for subsequent processes such as PCR since inhibitory compounds are often found in growth media and/or the cell lysate.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have removed substances other than the microorganism-attracting substance and the sample from the containers because it would remove unwanted components which are inhibitory compounds are often found in growth media and/or the cell lysate.
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Marshall, Walsh and Weidemaier as applied to claim 18 above, and further in view of United States Application Publication No. 2012/0040472, hereinafter Churski.
Regarding claim 19, Marshall, Walsh and Weidemaier teach all limitaitons of claim 18; however, they fail to teach a volume of the growth medium that is added into the fluid containers is less than a volume of other substances within the fluid.
Churski teaches a method for the automated generation and handling of liquid in which the composition of media is optimized for the most rapid growth of selected strains of microorganisms (Churski, paragraph [0165]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to determine, through routine experimentation, the optimum volume of growth media added to the fluid container so that it is less than a volume of other substances with the fluid which would allow for the most rapid growth of selected strains of microorganisms (Churski, paragraph [0165]). (MPEP § 2144.05 (II)).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW D KRCHA whose telephone number is (571)270-0386. The examiner can normally be reached M-Th 7am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maris Kessel can be reached at (571)270-7698. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MATTHEW D KRCHA/Primary Examiner, Art Unit 1796
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