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 (claims 1-2) in the reply filed on 7/27/26 is acknowledged.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1 and 2 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 recites in line 4 “preferentially”. Claim 1 is not clear as to whether or not the limitations following “preferentially” is required by the claim.
Similarly, claim 2 recites in line 4 “preferentially. Claim 2 is not clear as to whether or not the limitations following “preferentially” is required by the claim.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1-2 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by US 20200132687 (hereinafter “El-Dweik”).
Applicant’s claim 1 recites:
A system for monitoring of a pathogenic analyte, comprising:
a reservoir configured to receive a sample suspected of including the pathogenic analyte, wherein the reservoir is configured to be essentially closed with respect to the pathogenic analyte;
a sterile growth medium formulated to preferentially grow the pathogenic analyte disposed within the reservoir;
the growth medium comprising: a plurality of isolation particles comprising a first moiety capable of binding to the pathogenic analyte, if present;
and a plurality of signaling entities comprising a second moiety capable of binding to the pathogenic analyte, if present.
El-Dweik discloses the following, which meets Applicant’s claims (discussed further below).
The disclosure provides an apparatus comprising a capture antibody linked to an immobilization moiety, wherein the immobilization moiety is a magnetic particle with a diameter from 20 nm to 165 μm and wherein the magnetic particle is coated with protein; and a detector antibody linked to a detection moiety, and wherein the capture antibody and detector antibody specifically bind to the same antigen at distinct sites. Para. 0023 (emphasis added).
The method and device use optical platform separation (OPS), which is also known as immunomagnetic separation (IMS) to isolate and purify specific molecules from a fluid known to or suspected of containing a pathogen. OPS uses paramagnetic particles coated with antibodies (Abs) to specifically isolate target antigens. By applying a magnetic field, the particles with the captured antigen are attracted to the magnet, which allows the rest of the liquid solution to be decanted. Para. 0040 (emphasis added).
The capture antibody described herein specifically binds to a desired antigen to be detected. The capture antibody is typically bound to the substrate according to the embodiments described herein. In other embodiments, the detector antibody is an antigen binding portion of an antibody as described herein. Para. 0046 (emphasis added).
The detector antibody described herein specifically binds to the same antigen as the corresponding capture antibody. In certain embodiments, the detector antibody specifically binds to this antigen at a site distinct from which the corresponding capture antibody binds. Para. 0047.
In some embodiments, the detector antibody further comprises a detection moiety. Para. 0048 (emphasis added).
The detection moiety is any moiety that allows detection and quantitation of the presence of the detector antibody. Detection moieties include horseradish peroxidase (HRP) and fluorescein isothiocyanate (FITC). Other examples of detection moieties include, radioisotopes or radionuclides, chromogens, fluorescent labels (e.g., FITC, rhodamine, lanthanide phosphors), enzymatic labels… Para. 0049 (emphasis added).
The antigen that the capture and detector antibodies specifically bind to are expressed by microbes.. Para. 0050 (emphasis added).
In certain embodiments, to prepare the sample, a sample of food or drink is incubated for a period of time under conditions that are conducive to growing the pathogen in question. For bacteria, a number of bacterial media can be used to enrich a sample for a pathogen to increase the chances of detection. In one embodiment, the medium is Tryptic Soy Broth (TSB). In certain embodiments, the TSB includes novobiocin. Other media includes LB broth, Terrific broth and M9 minimal medium. The sample is grown in media at a desired temperature for a period of time that allows sufficient growth of the microbe to allow its detection. Para. 0053 (emphasis added).
Also provided are kits that provide in one or more containers some or all of the reagents disclosed herein, e.g., capture and/or detector antibodies disclosed herein, magnetic particles, blocking agents (such as bovine serum albumin or BLOTTO™ mix), as well as reagents for detecting detection moieties of same. The kit may additionally include a sealed container. Para. 0056 (emphasis added).
Thus, as to Applicant’s claim 1, El-Dweik discloses:
a system for monitoring of a pathogenic analyte, comprising:
a reservoir configured to receive a sample suspected of including the pathogenic analyte, wherein the reservoir is configured to be essentially closed with respect to the pathogenic analyte
[see para. 0056 disclosing a container in which all the disclosed reagents are provided (see below regarding the reagents: capture antibodies, detector antibodies, magnetic particle, and broth/growth media), and in which the container is a sealed container];
a sterile growth medium formulated to grow the pathogenic analyte disposed within the reservoir
[see paras. 0053 and 0056 disclosing bacterial media such as broth to enrich a sample for a pathogen to allow its detection; Examiner notes that the medium, such as the broth, is equivalent to Applicant’s growth medium, and that it is understood that the medium is sterile to prevent contamination, since the purpose is to detect bacteria in the sample as opposed to bacteria inadvertently introduced through the broth, which would make the assay result inaccurate for detecting bacteria in just the sample; alternatively, this would have been obvious in order to accurately detect the bacteria in the sample];
the growth medium comprising: a plurality of isolation particles comprising a first moiety capable of binding to the pathogenic analyte, if present
[see para. 0023 disclosing capture antibody linked to a magnetic particle, wherein the capture antibody and detector antibody specifically bind to the same antigen at distinct sites; see also paras. 0040, 0046 and 0047 regarding the capture antibodies; see para. 0050 disclosing that the antigen is a microbe; Examiner notes that it is understood that the sample, and thus the growth medium, is contacted with the detector antibody, wherein such solution is equivalent to Applicant’s growth medium, in the sealed container, used for performing the assay; alternatively, it have been obvious to one skilled in the art as to provide the capture antibodies in the growth medium in the sealed container disclosed by El-Dweik, as this would have resulted in a predictable outcome of providing the disclosed reagents for performing the assay disclosed by El-Dweik];
and a plurality of signaling entities comprising a second moiety capable of binding to the pathogenic analyte, if present
[see para. 0023 disclosing detector antibody linked to a detection moiety, wherein the capture antibody and detector antibody specifically bind to the same antigen at distinct sites; see also in paras. 0048 and 0049 regarding the detection antibodies and detection moieties].
As to Applicant’s claim 2, El-Dweik discloses the limitations as follows:
a kit, comprising:
a reservoir configured to receive a pathogenic analyte and a growth medium,
wherein the reservoir is configured to be essentially closed with respect to the pathogenic analyte once closed
[see para. 0056 disclosing a container in which all the disclosed reagents are provided (see below regarding the reagents: capture antibodies, detector antibodies, magnetic particle, and broth/growth media), and in which the container is a sealed container];
a sterile growth medium formulated to preferentially grow the pathogenic analyte disposed within the reservoir
[see paras. 0053 and 0056 disclosing bacterial media such as broth to enrich a sample for a pathogen to allow its detection; Examiner notes that the medium, such as the broth, is equivalent to Applicant’s growth medium, and that it is understood that the medium is sterile to prevent contamination, since the purpose is to detect bacteria in the sample as opposed to bacteria inadvertently introduced through the broth, which would make the assay result inaccurate for detecting bacteria in just the sample; alternatively, this would have been obvious in order to accurately detect the bacteria in the sample];
the growth medium comprising a plurality of isolation particles comprising a first moiety capable of binding to the pathogenic analyte
[see para. 0023 disclosing capture antibody linked to a magnetic particle, wherein the capture antibody and detector antibody specifically bind to the same antigen at distinct sites; see also paras. 0040, 0046 and 0047 regarding the capture antibodies; see para. 0050 disclosing that the antigen is a microbe; Examiner notes that it is understood that the sample, and thus the growth medium, is contacted with the detector antibody, wherein such solution is equivalent to Applicant’s growth medium, in the sealed container, used for performing the assay; alternatively, it have been obvious to one skilled in the art as to provide the capture antibodies in the growth medium in the sealed container disclosed by El-Dweik, as this would have resulted in a predictable outcome of providing the disclosed reagents for performing the assay disclosed by El-Dweik].
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 20180030398 (“Castillo”).
Castillo discloses a system that comprises at least one cell culture unit comprising at least one bioreactor for culturing cells, at least one technical control unit for controlling a cell growth parameters, said technical control unit is at least fluidly connected to the cell culture unit, and at least one air treatment unit for treating ambient air, said air treatment unit is fluidly connected to the cell culture unit. The system is characterized in that the system is autonomous and the bioreactor total volume is at most 1000 L. Abstract.
The cell culture unit provides for production of cells and cell derived products in a closed, self-sufficient environment. Said unit may comprise at least one bioreactor for cells and/or their products expansion with minimal need for technician interaction. Said bioreactor may be attached to the system in a fixed manner, or may be removably attached to said system. Para. 0033.
The system, according to any embodiment of the invention, provides for production of cells and cell derived products in a closed, self-sufficient environment. Para. 0070.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Ann Montgomery whose telephone number is (571)272-0894. The examiner can normally be reached Mon-Fri, 9-5:30 PM PST.
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/Ann Montgomery/Primary Examiner, Art Unit 1678
