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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 1/24/24 is being considered by the examiner.
Election and Claim Status
The restriction requirement mailed 14 July 2025 is hereby withdrawn. Claims 1-20 are pending and are examined.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the test plate in Claim 1 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 1-20 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.
Regarding Claims 1, 2, 3, 4, 11, 14, 15, 16, 17, 18, 19, and 20, the limitation “the affinity reagents” is unclear and indefinite. The claim recites “at least one conjugated (detection) affinity reagent” and not “affinity reagents. Please clarify how many affinity reagents there are.
Dependent claims are rejected by virtue of being dependent on a rejected base 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.
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.
Claims 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 14, 15, 16, 17, 18, 19, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Babu (US Pub 2013/0210025), in view of Lieke (“Sustainable aquaculture requires environmental-friendly treatment strategies for fish diseases.” Reviews in Aquaculture. 12. 943-965. 2020.”)
Regarding Claim 1, Babu teaches a device for detecting velvet disease infestation in aquaculture and fishing, the device comprising: a test plate comprising a support bearing at least one conjugated (detection) affinity reagent, the affinity reagents being bound to the support or bound to particles that can migrate along the support ([0113] Fig. 15a shows a sample analysis device (test strip) 151 and a sample collector 152. The sample collector 152 may be any type of sample collector 152 known in the art, for example the sample collector 152 could be a swab member. The sample 150 may include the analyte 153, as well as interfering particles 155 (which may include interfering proteins or interfering genes) and other interfering particles or cell debris 154. The sample analysis device 151 includes a labeled conjugate zone 158 upstream of the sample application zone 168 in this figure. Although the labeled conjugate zone 158 is shown upstream of the sample application zone 168 in this figure, the labeled conjugate zone 158 may alternatively overlap the sample application zone 168 or be downstream of the sample application zone 168. The sample application zone 168 is also a microfiltration zone, which preferably filters out cell debris and interfering particles 154 that are in the sample 150. [0117] The sample analysis device 151 also optionally includes an absorbent pad 157 upstream of the labeled conjugate zone 158 and the sample application zone 168. Buffer 156 is added and travels in the direction of the arrow to elute the test components, including the sample 150 and the labeled conjugate 165 to the detection zone 162. The sample analysis device 151 also preferably includes a waste pad 176 at the downstream end of the device 151. The sample analysis device 151 may also optionally include a backing 173.).
Babu is silent to at least one immobilized (capture) affinity reagent that are cross-reactive with one or more Amyloodinium ocellatum (AO) antigens or Piscinoodinium pillulare (PP) antigens.
Lieke teaches in the related art, an immunoabsorbent assay. Lieke teaches antibodies against Amyloodinium which can be used to monitor infestations. See page 946, paragraph 1.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added at least one antibody against Amyloodinium ocellatum, as taught by Lieke, to the device of Babu, to allow for monitoring of the pathogen.
Regarding Claim 2, Babu teaches the device of claim 1.
Babu is silent to the affinity reagents are cross-reactive with one or more AO antigens.
Lieke teaches in the related art of immunoabsorbent assay. Lieke teaches antibodies against Amyloodinium which can be used to monitor infestations. See page 946, paragraph 1.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added at least one antibody against Amyloodinium ocellatum, as taught by Lieke, to the device of Babu, to allow for monitoring of the pathogen.
Regarding Claim 3, Babu teaches the device of claim 1.
Babu is silent to the affinity reagents are cross-reactive with one or more PP antigens.
Lieke teaches Piscinoodinium pillulare (Figure 2a) and P. limneticum are important pathogens of both tropical and temperate freshwater fishes, while Amyloodinium ocellatum (Figure 2b) is the marine analogue and is one of the most important parasites infesting warm water marine or brackish water fishes. See page 944, 2nd column, last paragraph. . Lieke teaches antibodies against Amyloodinium which can be used to monitor infestations. See page 946, paragraph 1. Lieke teaches
“Levy et al. developed a sensitive and specific PCR assay to detect Amyloodinium using ribosomal DNA. They were able to detect a single cell from each of the life cycle stages. An even more sensitive and specific approach is a loop-mediated isother-mal amplification (LAMP) assay developed by Picon-Camacho et al. to detect all life stages of Amyloodinium. Using an enzyme-linked immunosorbent assay, Smith et al. showed the production of antibodies against Amyloodinium after infestation; this might also be used to monitor pathogens.”.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the Amyloodinium antibody for a Piscinoodinium pillulare antibody, to detect a second pathogen.
Regarding Claim 4, Babu is silent to the device of claim 1.
Babu is silent to the affinity reagents are cross-reactive with one or more AO antigens and one or more PP antigens.
Lieke teaches in the related art, an immunoabsorbent assay. Lieke teaches antibodies against Amyloodinium which can be used to monitor infestations. See page 946, paragraph 1. Lieke teaches Piscinoodinium pillulare (Figure 2a) and P. limneticum important pathogens of both, tropical and temperate freshwater fishes, while Amyloodinium ocellatum (Figure 2b) is the marine analogue and is one of the most important parasites infesting warm water marine or brackish water fishes. See page 944, 2nd column, last paragraph. Lieke teaches in the related art in the immunoabsorbent assay. Like teaches antibodies against Amyloodinium which can be used to monitor infestations. See page 946, paragraph 1.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the Amyloodinium antibody for a Piscinoodinium pillulare antibody, to detect a second pathogen.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added at least one antibody against Amyloodinium ocellatum, as taught by Lieke, to the device of Babu, to allow for monitoring of the pathogen.
Regarding Claim 5, modified Babu teaches the device of claim 1, wherein the affinity reagents are bound to the support ([0110] In a preferred embodiment, the specific binding partners for the analytes are monoclonal, polyclonal or recombinant antibodies or fragments of antibodies capable of binding to the analyte. In other embodiments, specific binding partners may also be antigens capable of binding to antibodies against the analyte.
Regarding Claim 6, modified Babu teaches the device of claim 1, wherein the affinity reagents are bound to particles that can migrate along the support ([0110] In a preferred embodiment, the specific binding partners for the analytes are monoclonal, polyclonal or recombinant antibodies or fragments of antibodies capable of binding to the analyte. In other embodiments, specific binding partners may also be antigens capable of binding to antibodies against the analyte.
Regarding Claim 7, modified Babu teaches the device of claim 1, further comprising the support bearing a sample ([0113] Fig. 15a The sample 150 may include the analyte 153, as well as interfering particles 155 (which may include interfering proteins or interfering genes) and other interfering particles or cell debris 154. The sample analysis device 151 includes a labeled conjugate zone 158 upstream of the sample application zone 168 in this figure.).
Regarding Claim 8, modified Babu teaches the device of claim 1, wherein the affinity reagents are aptamers ([0110] In a preferred embodiment, the specific binding partners for the analytes are monoclonal, polyclonal or recombinant antibodies or fragments of antibodies capable of binding to the analyte. In other embodiments, specific binding partners may also be antigens capable of binding to antibodies against the analyte. Other types of binding partners are bioorganic macromolecules like aptamers or receptors, nanoparticles or nucleic acids.).
Regarding Claim 9, modified Babu teaches the device of claim 1, wherein the affinity reagents are rmAbs ([0110] In a preferred embodiment, the specific binding partners for the analytes are monoclonal, polyclonal or recombinant antibodies or fragments of antibodies capable of binding to the analyte. In other embodiments, specific binding partners may also be antigens capable of binding to antibodies against the analyte. Other types of binding partners are bioorganic macromolecules like aptamers or receptors, nanoparticles or nucleic acids.).
Regarding Claim 10, modified Babu teaches the device of claim 1, wherein at least one of the affinity reagents is an aptamer and at least one of the affinity reagents is an rmAb ([0110] In a preferred embodiment, the specific binding partners for the analytes are monoclonal, polyclonal or recombinant antibodies or fragments of antibodies capable of binding to the analyte. In other embodiments, specific binding partners may also be antigens capable of binding to antibodies against the analyte. Other types of binding partners are bioorganic macromolecules like aptamers or receptors, nanoparticles or nucleic acids.).
Regarding Claim 11, Babu teaches a system for assessing the presence or absence of velvet disease infestation in aquaculture and fishing, the system comprising: a test plate comprising a support bearing i) a sample and ii) at least one conjugated (detection) affinity reagent the affinity reagents being bound to the support or bound to particles that can migrate along the support ([0113] Fig. 15a shows a sample analysis device (test strip) 151 and a sample collector 152. The sample collector 152 may be any type of sample collector 152 known in the art, for example the sample collector 152 could be a swab member. The sample 150 may include the analyte 153, as well as interfering particles 155 (which may include interfering proteins or interfering genes) and other interfering particles or cell debris 154. The sample analysis device 151 includes a labeled conjugate zone 158 upstream of the sample application zone 168 in this figure. Although the labeled conjugate zone 158 is shown upstream of the sample application zone 168 in this figure, the labeled conjugate zone 158 may alternatively overlap the sample application zone 168 or be downstream of the sample application zone 168. The sample application zone 168 is also a microfiltration zone, which preferably filters out cell debris and interfering particles 154 that are in the sample 150. [0117] The sample analysis device 151 also optionally includes an absorbent pad 157 upstream of the labeled conjugate zone 158 and the sample application zone 168. Buffer 156 is added and travels in the direction of the arrow to elute the test components, including the sample 150 and the labeled conjugate 165 to the detection zone 162. The sample analysis device 151 also preferably includes a waste pad 176 at the downstream end of the device 151. The sample analysis device 151 may also optionally include a backing 173.).
Babu is silent and at least one immobilized (capture) affinity reagent that are cross-reactive with one or more Amyloodinium ocellatum (AO) or Piscinoodinium pillulare (PP) antigens and a detector configured to measure the presence or absence of one or more AO or PP antigens in the sample based on the extent to which such AO or PP antigens become or do not become bound to such conjugated affinity reagents.
Lieke teaches in the related art in the immunoabsorbent assay. Lieke teaches antibodies against Amyloodinium which can be used to monitor infestations. See page 946, paragraph 1.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added at least one antibody against Amyloodinium ocellatum and a detector to be used for the detection of velvet disease infestation based on the extent to which AO antigens that may be in such sample become or do not become bound to such conjugated affinity reagents, as taught by Lieke, to the system of Babu, to allow for monitoring of the pathogen.
Regarding Claim 14, Babu teaches the system of claim 11, wherein the affinity reagents are aptamers ([0110] In a preferred embodiment, the specific binding partners for the analytes are monoclonal, polyclonal or recombinant antibodies or fragments of antibodies capable of binding to the analyte. In other embodiments, specific binding partners may also be antigens capable of binding to antibodies against the analyte. Other types of binding partners are bioorganic macromolecules like aptamers or receptors, nanoparticles or nucleic acids.).
Regarding Claim 15, Babu teaches the system of claim 11, wherein the affinity reagents are rmAbs ([0110] In a preferred embodiment, the specific binding partners for the analytes are monoclonal, polyclonal or recombinant antibodies or fragments of antibodies capable of binding to the analyte. In other embodiments, specific binding partners may also be antigens capable of binding to antibodies against the analyte. Other types of binding partners are bioorganic macromolecules like aptamers or receptors, nanoparticles or nucleic acids.).
Regarding Claim 16, Babu teaches the system of claim 11, wherein at least of the affinity reagents is an aptamer and at least one of the affinity reagents is an rmAb ([0110] In a preferred embodiment, the specific binding partners for the analytes are monoclonal, polyclonal or recombinant antibodies or fragments of antibodies capable of binding to the analyte. In other embodiments, specific binding partners may also be antigens capable of binding to antibodies against the analyte. Other types of binding partners are bioorganic macromolecules like aptamers or receptors, nanoparticles or nucleic acids.).
Regarding Claim 17, Babu teaches a method for assessing the presence or absence of velvet disease infestation in aquaculture and fishing, the method comprising the steps of: obtaining a sample from an aquaculture water source, aquaculture facility, aquaculture effluent or fish; contacting a test plate with the sample, the test plate comprising a support bearing at least one conjugated (detection) affinity reagent and the affinity reagents being bound to the support or bound to particles that can migrate along the support ([0113] Fig. 15a shows a sample analysis device (test strip) 151 and a sample collector 152. The sample collector 152 may be any type of sample collector 152 known in the art, for example the sample collector 152 could be a swab member. The sample 150 may include the analyte 153, as well as interfering particles 155 (which may include interfering proteins or interfering genes) and other interfering particles or cell debris 154. The sample analysis device 151 includes a labeled conjugate zone 158 upstream of the sample application zone 168 in this figure. Although the labeled conjugate zone 158 is shown upstream of the sample application zone 168 in this figure, the labeled conjugate zone 158 may alternatively overlap the sample application zone 168 or be downstream of the sample application zone 168. The sample application zone 168 is also a microfiltration zone, which preferably filters out cell debris and interfering particles 154 that are in the sample 150. [0117] The sample analysis device 151 also optionally includes an absorbent pad 157 upstream of the labeled conjugate zone 158 and the sample application zone 168. Buffer 156 is added and travels in the direction of the arrow to elute the test components, including the sample 150 and the labeled conjugate 165 to the detection zone 162. The sample analysis device 151 also preferably includes a waste pad 176 at the downstream end of the device 151. The sample analysis device 151 may also optionally include a backing 173.).
Babu is silent to at least one immobilized (capture) affinity reagent that are cross-reactive with one or more Amyloodinium ocellatum (AO) or Piscinoodinium pillulare (PP) antigens, and providing either a positive or negative detection of velvet disease infestation based on the extent to which AO or PP antigens that may be in such sample become or do not become bound to such conjugated affinity reagents.
Lieke teaches in the related art in the immunoabsorbent assay. Lieke teaches antibodies against Amyloodinium which can be used to monitor infestations. See page 946, paragraph 1.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added at least one antibody against Amyloodinium ocellatum and to be used for the detection of velvet disease infestation based on the extent to which AO antigens that may be in such sample become or do not become bound to such conjugated affinity reagents, as taught by Lieke, to the method of Babu, to allow for monitoring of the pathogen.
Regarding Claim 18, Babu teaches the method of claim 17, wherein the affinity reagents are aptamers ([0110] In a preferred embodiment, the specific binding partners for the analytes are monoclonal, polyclonal or recombinant antibodies or fragments of antibodies capable of binding to the analyte. In other embodiments, specific binding partners may also be antigens capable of binding to antibodies against the analyte. Other types of binding partners are bioorganic macromolecules like aptamers or receptors, nanoparticles or nucleic acids.).
Regarding Claim 19, Babu teaches the method of claim 17, wherein the affinity reagents are rmAbs ([0110] In a preferred embodiment, the specific binding partners for the analytes are monoclonal, polyclonal or recombinant antibodies or fragments of antibodies capable of binding to the analyte. In other embodiments, specific binding partners may also be antigens capable of binding to antibododies against the analyte. Other types of binding partners are bioorganic macromolecules like aptamers or receptors, nanoparticles or nucleic acids.).
Regarding Claim 20, Babu teaches the method of claim 17, wherein at least one of the affinity reagents is an aptamer and at least one of the affinity reagents is an rmAb ([0110] In a preferred embodiment, the specific binding partners for the analytes are monoclonal, polyclonal or recombinant antibodies or fragments of antibodies capable of binding to the analyte. In other embodiments, specific binding partners may also be antigens capable of binding to antibodies against the analyte. Other types of binding partners are bioorganic macromolecules like aptamers or receptors, nanoparticles or nucleic acids.).
Claims 12 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Babu (US Pub 2013/0210025), in view of Lieke (“Sustainable aquaculture requires environmental-friendly treatment strategies for fish diseases.” Reviews in Aquaculture. 12. 943-965. 2020.”), and further in view of Bentwich (US Pub 2006/0003322).
Regarding Claim 12, Babu teaches the system of claim 11.
Babu is silent to further comprising: a processor; and an engine for detecting AO or PP antigens in the sample.
Bentwich teaches in the related art of detection of biological components. [0112] Hardware implementation of the bioinformatic gene detection engine 100 is important, since significant computing power is preferably required in order to perform the computation of bioinformatic gene detection engine 100 in reasonable time and cost. As an example, it is estimated that using one powerful 8-processor PC Server, over 30 months of computing time (at 24 hours per day) would be required in order to detect all miRNA genes in human EST data, and their respective binding sites.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added a processor and an engine, as taught by Bentwich, to allow for processing what is exactly in the sample.
Regarding Claim 13, modified Babu teaches the system of claim 12, further comprising storage for a set of sample locations, sample dates, and detected velvet disease antigen presence in the samples ([0113] For example, in order to address this challenge at reasonable time and cost, a preferred embodiment of the present invention may comprise a cluster of a large number of personal computers (PCs), such as 100 PCs (Pentium IV, 1.7 GHz, with 40 GB storage each), connected by Ethernet to several strong servers, such as 4 servers (2-CPU, Xeon 2.2 GHz, with 200 GB storage each), combined with an 8-processor server (8-CPU, Xeon 550 Mhz w/8 GB RAM) connected via 2 HBA fiber-channels to an EMC Clariion 100-disks, 3.6 Terabyte storage device. Additionally, preferably an efficient database computer program, such as Microsoft.TM. SQL-Server database computer program is used and is optimized to the specific requirements of bioinformatic gene detection engine 100. Furthermore, the PCs are preferably optimized to operate close to 100% CPU usage continuously, as is known in the art. Using suitable hardware and software may preferably reduce the required calculation time in the abovementioned example from 30 months to 20 days. This would be computer storage).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JACQUELINE BRAZIN whose telephone number is (571)270-1457. The examiner can normally be reached M-F 8-6.
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/JB/
/JILL A WARDEN/Supervisory Patent Examiner, Art Unit 1798