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 .
Claim Status
Claims 1-20 are pending and examined.
Information Disclosure Statement
The information disclosure statement (IDS) received on 9/25/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claims 1, 10, and 15 are objected to because of the following informalities:
Regarding claim 1, Lns. 1-2 recite, “A method…to detect a new analyte the method comprising:”, which is grammatically incorrect. A comma should be placed between the words “analyte” and “the” to be grammatically correct.
Claim 10, Lns. 1-2 and Claim 15, Lns. 1-2 contain similar issues regarding the recitation “A method…to detect a new analyte the method comprising:”, and are similarly objected to.
Appropriate correction is required.
Claim Interpretation
The limitation “a new analyte” has been interpreted as any analyte that is being tested or detected in a new analysis procedure.
The limitation “an assay definition file (ADF)” has been interpreted as any file comprising instructions or other forms of data for performing or facilitating the performance of an assay.
Examiner’s Note: although [000169]-[000171] define an “ADF file” as a file that a file that defines both OPUS and AAM file parameters, where “OPUS" or "Opus file" or "OPUS portion" or "OPUS parameters" means control parameters of the ADF file, and "AAM file" or "AAM parameters" or "AAM portion" means analysis parameters of the ADF file, Claims 1 and 10 contradict this definition of an assay definition file, as claim 1 defines the assay definition file as, “comprising at least an AAM file…”, and claim 10 defines the assay definition file as, “comprising at least an OPUS file…”. These contradictions have necessitated the definition of the assay definition file as described above.
The limitation “an AAM file” has been interpreted as in [000170] of the instant Specification, as meaning scan data analysis parameters of the ADF.
Examiner’s Note: Claim 1, Ln. 4 initially introduces an AAM file, but does not describe what the initials “AAM” stands for. [000196] of the instant Specification discloses that AAM stands for “assay analysis module”. The Examiner suggests amending Claim 1, Ln. 4, which recites, “an AAM file” to instead recite, “an assay analysis module (AAM) file”, in order to clarify what the initials “AAM” stand for.
The limitation “an OPUS file” has been defined as in [000169] of the instant Specification, as meaning control parameters of the ADF.
Examiner’s Note: the Examiner does not suggest amending Claim 10, Ln. 4 to clarify what the initials “OPUS” stand for, as the initials of “OPUS” do not stand for anything, as best understood by the Examiner (see Applicant’s Specification at [00078], which states that a command portion with control parameters is referred to as “OPUS”).
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The subject matter eligibility test for the claims is shown below:
Subject Matter Eligibility Test, Step 1
Independent claims 1, 10, and 15 are each drawn to a method, which is a statutory category.
Subject Matter Eligibility Test, Step 2A Prong One
In Step 2A Prong One, it is determined if the claims recite an abstract idea, law of nature, or natural phenomenon. Independent claim 1 recites a method comprising “receiving and reading…an assay definition file…comprising at least an AAM file for analyzing the new analyte…”, and “sending…analysis instructions…to an assay analysis module”. The acts of receiving and reading information, and sending instructions based on the information are evaluation/determination-type mental processes, particularly as the steps are performed at a high level of generality, and do not recite a specialized computer for performing the mental processes. Evaluation/determination-type mental processes are abstract ideas. Similarly, independent claim 10 recites, “receiving and reading…an assay definition file…to process the new analyte…comprising at least an OPUS file”, and “sending…control instructions…to a sample processing bay…”, and independent claim 15 recites, “receiving and reading…an assay definition file…to process the new analyte…comprising at least an OPUS file and an AAM file…”, “sending…control instructions based on the OPUS file to a sample processing bay…”, “sending…analysis instructions comprising analysis parameters that define selection between two or more digital filters to process scan data based on the AAM file to an assay analysis module…”.These limitations are similarly evaluation/determination-type mental processes, particularly as the steps are performed at a high level of generality, and do not recite a specialized computer for performing the mental processes. Evaluation/determination-type mental processes are abstract ideas. The additional limitation in independent claim 15 of selecting between two or more digital filters based on the AAM file is a determination-type mental process, which is an abstract idea.
Subject Matter Eligibility Test, Step 2A Prong Two
In step 2A Prong Two, it is determined if the claims recite additional elements that integrate the judicial exception into a practical application. Independent claim 1 further recites: “updating”, “to process the new analyte”, and “to detect the new analyte”. These limitations correspond to linking the abstract idea to the field of endeavor and would not be considered a practical application. Similarly, independent claim 10 further recites, “updating”, “to process the new analyte”, and “to detect a new analyte”, and independent claim 15 further recites, “updating”, “to process the new analyte”, and “to detect a new analyte”, which correspond to linking the abstract idea to the field of endeavor and would not be considered a practical application. Accordingly, the additional elements recited do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. The claims are directed to an abstract idea.
Subject Matter Eligibility Test, Step 2B
In step 2B, it is determined if the claim recites additional elements that amount to significantly more than the judicial exception. In this case, the independent claims 1, 10, and 15 additionally recite “a detection instrument”, and “a sample processing bay”. These elements are well-known and conventional within the art. Similarly, the elements additionally recited in independent claims 1, 10, and 15 of “an assay analysis module” and “digital filters” are generic computer components. Additionally, the files “assay definition file (ADF)”, “AAM file”, and “OPUS file” recited in the independent claims are merely data files. Further, the application of these mental processes into a laboratory environment for sample processing is nothing more than generally linking the mental process judicial exception to a particular technological environment or field of use. See MPEP 2106.05(d) and 2106.05(e). Still further, the act of “thereby remotely updating a detection instrument to detect a new analyte” is merely insignificant extra-solution activity, and amounts to a recitation of the words “apply it”. See MPEP 2106.05(f).
Further, with regards to the generically recited detection instrument, sample processing bay, assay analysis module, digital filters, ADF, AAM file, and OPUS file being nothing more than well-understood, routine, and conventional components that are well-known in the art, the following prior art is relied upon to show that the above elements are well-understood, routine, and conventional:
Frank et al. (US Pub. No. 2014/0370609; hereinafter Frank; already of record on the IDS received 9/25/2024) teaches a detection instrument ([0098]-[0103], see Fig. 1 at analyzer 102). A sample processing bay ([0098]-[0103], see Fig. 1 at analyzer 102 including dispenser 112, analytical unit 106, analyzer controller 104, and analytical unit 106, as well as custom analysis protocol 138, see also [0068], which states that the custom analysis protocol parameters may include a sample type, a sample process input volume, a polymerase chain reaction profile, a calculation sensitivity, dilution factors, incubation time, reagent addition, volumes, temperature settings, washing steps. In this case, the sample processing bay may include the dispenser, for instance). An assay analysis module ([0098]-[0103], analysis protocol parameters 164 are moved from protocol creation system 150 to controller 104 of analyzer 102 as custom analysis protocol 138, which is used to operate analytical unit 106, see Fig. 1). ADF and OPUS files ([0098]-[0103], see Fig. 1 at analyzer 102 including dispenser 112, analytical unit 106, analyzer controller 104, and analytical unit 106, as well as custom analysis protocol 138, see also [0068], which states that the custom analysis protocol parameters may include a sample type, a sample process input volume, a polymerase chain reaction profile, a calculation sensitivity, dilution factors, incubation time, reagent addition, volumes, temperature settings, washing steps).
Bjerke et al. (US Pub. No. 2014/0252079; hereinafter Bjerke; already of record on the IDS received 9/25/2024) teaches an AAM file ([0006], [0049], [0054]-[0055]).
Matson et al. (EP Pub. No. 0222612; hereinafter Matson; already of record on the IDS received 9/25/2024) teaches digital filters (Pg. 2 Lns. 38-47).
Claims 2-9, 11-14, and 16-20 are rejected under 35 U.S.C. 101 as depending on a rejected claim.
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.
Claim 14 is 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 claim 14, Ln. 2 recites, “the analysis parameters”. There is insufficient antecedent basis for this limitation. For purposes of compact prosecution, the above limitation has been examined as, “a set of analysis parameters”.
Claim Rejections - 35 USC § 102
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 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.
Claims 10-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Frank.
Regarding claim 10, Frank discloses a method for remotely updating a detection instrument to detect a new analyte ([0002], [0109], see Figs. 2, 6). The method comprises:
receiving and reading by the detection instrument an assay definition file (ADF) from an external source to process the new analyte, the ADF comprising at least an OPUS file ([0009], [0037], [0068]-[0069], the analysis protocol parameters may include a sample type, sample process input volume, polymerase chain reaction profile, calculation sensitivity, etc., the sample process input volume, for instance, is controlled by an execution of the sample processing bay).
Sending by the detection instrument control instructions based on the OPUS file to a sample processing bay on the detection instrument thereby remotely updating a detection instrument to detect a new analyte ([0009], [0098]-[0103], analysis protocol parameters 164 are moved from protocol creation system 150 to controller 104 of analyzer 102 as custom analysis protocol 138, which is used to operate analytical unit 106, see Fig. 1).
Regarding claim 11, Frank discloses the method of claim 10, further comprising: sending a first set of control parameters to a sample processing bay whereby the sample processing bay operates a sample preparation module to prepare a sample for detection according to the first set of the control parameters ([0098]-[0103], see Fig. 1 at analyzer 102 including dispenser 112, analytical unit 106, analyzer controller 104, and analytical unit 106, as well as custom analysis protocol 138, see also [0068], which states that the custom analysis protocol parameters may include a sample type, a sample process input volume, a polymerase chain reaction profile, a calculation sensitivity, dilution factors, incubation time, reagent addition, volumes, temperature settings, washing steps. In this case, the sample preparation module may be the dispenser, for instance).
Regarding claim 12, Frank discloses the method of claim 11, further comprising: sending a second set of control parameters to the processing bay whereby the processing bay operates a sample reaction module to detect a target analyte according to the second set of the control parameters ([0098]-[0103], see Fig. 1 at analyzer 102 including dispenser 112, analytical unit 106, analyzer controller 104, and analytical unit 106, as well as custom analysis protocol 138, see also [0068], which states that the custom analysis protocol parameters may include a sample type, a sample process input volume, a polymerase chain reaction profile, a calculation sensitivity, dilution factors, incubation time, reagent addition, volumes, temperature settings, washing steps. In this case, the sample reaction module may be the analytical unit).
Regarding claim 13, Frank discloses the method of claim 12, further comprising: receiving by the detection instrument detection results from the sample processing bay ([0098]-[0103], the analytical unit acquires the analysis result).
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.
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.
Claims 1 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Frank in view of Bjerke.
Regarding claim 1, Frank discloses a method for updating a detection instrument to detect a new analyte ([0002], [0109], see Figs. 2, 6). The method comprises:
receiving and reading by the detection instrument an assay definition file (ADF) from an external source to process the new analyte ([0009], [0037], [0068]-[0069]).
Sending by the detection instrument analysis instructions based on the file to an assay analysis module on the detection instrument thereby remotely updating a detection instrument to detect the new analyte ([0009], [0098]-[0103], analysis protocol parameters 164 are moved from protocol creation system 150 to controller 104 of analyzer 102 as custom analysis protocol 138, which is used to operate analytical unit 106, see Fig. 1).
Frank fails to explicitly disclose that the ADF comprises at least an AAM file for analyzing the new analyte, and sending instructions based on the AAM file.
Bjerke is in the analogous field of biological assays (Bjerke [0001]). Bjerke teaches operating a system and sending instructions based on an ADF comprising at least an AAM file for analyzing a new analyte (Bjerke; [0006], [0049], [0054]-[0055]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the method of Frank with the teachings of Bjerke so that the ADF comprises at least an AAM file for analyzing the new analyte, and sending instructions based on the AAM file, as Bjerke teaches that analyzing sample analysis data will enable the raw data to be plotted graphically for use in a report (Bjerke; [0006], [0054]-[0055]), thereby enabling a user to be able to easily visualize the relationship between variables in a sample analysis data set.
Regarding claim 8, modified Frank discloses the method of claim 1. Frank further discloses storing by the detection instrument the ADF on a non-transitory computer readable medium coupled to a processor (Frank; [0098]-[0103], see Fig. 1 at computer storage 128, and processor 120. See also [0022]-[0025]).
Claims 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Frank in view of Bjerke as applied to claims 1 and 8 above, and further in view of Knafel et al. (US Pub. No. 2012/0109531; hereinafter Knafel).
Regarding claim 6, modified Frank discloses the method of claim 1. Modified Frank fails to explicitly disclose receiving by the detection instrument a pending test order directly from a hospital LIS.
Knafel is in the analogous field of biological sample analysis (Knafel [0002]). Knafel teaches receiving by a detection instrument a pending test order directly from a hospital LIS (Knafel; [0007], [0133]). The detection instrument processes the sample based on the pending test order (Knafel; [0007], [0133], [0143]-[0145]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the method of Frank with the teachings of Knafel so that the detection instrument receives a pending test order directly from a hospital LIS, and the detection instrument processes the sample based on the pending test order, so that the sample is able to tested in all ways as desired by a LIS (Knafel; [0007], [0133], [0143]-[0145]).
Regarding claim 7, modified Frank discloses the method of claim 6. Modified Frank further discloses processing by the detection instrument, a sample based on the pending test order and the ADF (Frank; [0009], [0098]-[0103], see Fig. 1, see also Claim 6 above at Knafel teachings processing a sample based on the pending test order by the detection instrument in [0007], [0133], [0143]-[0145]).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Frank, as applied to claims 10-13 above, in view of Bjerke.
Regarding claim 14, Frank discloses the method of claim 13.
Frank fails to explicitly disclose analyzing and reporting by the detection instrument the detection results based upon a set of analysis parameters.
Bjerke is in the analogous field of biological assays (Bjerke [0001]). Bjerke teaches analyzing and reporting by the detection instrument a set of detection results based upon a set of analysis parameters (Bjerke; [0006], [0049], [0054]-[0055]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the method of Frank with the teachings of Bjerke to include disclose analyzing and reporting by the detection instrument the detection results based upon a set of analysis parameters, as Bjerke teaches that analyzing sample analysis data will enable the raw data to be plotted graphically for use in a report (Bjerke; [0006], [0054]-[0055]), thereby enabling a user to be able to easily visualize the relationship between variables in a sample analysis data set.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 8 of U.S. Patent No. 11,300,578 (hereinafter the reference patent ‘578; already of record on the IDS received 9/25/2024). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Regarding instant claim 1, claim 1 of the reference patent ‘578 teaches a method for updating a detection instrument to detect a new analyte (Claim 1, An apparatus for processing and analyzing a sample comprising: a system that comprises a sample processing bay and an assay analysis module (AAM) configured to analyze sample scan data from the sample processing bay and generate a report, the system including a processor coupled to a non-transitory computer readable medium, the non-transitory computer readable medium storing instructions directing the processor to: receive and read an assay definition file (ADP) from an external source, the ADP comprising at least an OPUS file and an AAM file, wherein the OPUS file comprises parameters that define operations controlled by an execution of the sample processing bay and the AAM file comprises parameters that define an analysis performed by the assay analysis module…). The method comprises:
receiving and reading by the detection instrument an assay definition file (ADF) from an external source to process the new analyte, the ADF comprising at least an AAM file for analyzing the new analyte (Claim 1).
Sending by the detection instrument analysis instructions based on the AAM file to an assay analysis module on the detection instrument thereby remotely updating a detection instrument to detect the new analyte (Claim 1, …send analysis instructions based on the AAM file to the AAM…).
Dependent claims 2-9 stand rejected as being dependent on independent claim 1.
Regarding instant claim 10, claims 1 and 8 of the reference patent ‘578 teaches a method for remotely updating a detection instrument to detect a new analyte (Claim 1, An apparatus for processing and analyzing a sample comprising: a system that comprises a sample processing bay and an assay analysis module (AAM) configured to analyze sample scan data from the sample processing bay and generate a report, the system including a processor coupled to a non-transitory computer readable medium, the non-transitory computer readable medium storing instructions directing the processor to: receive and read an assay definition file (ADP) from an external source, the ADP comprising at least an OPUS file and an AAM file, wherein the OPUS file comprises parameters that define operations controlled by an execution of the sample processing bay and the AAM file comprises parameters that define an analysis performed by the assay analysis module…, see also Claim 8). The method comprises:
receiving and reading by the detection instrument an assay definition file (ADF) from an external source to process the new analyte, the ADF comprising at least an OPUS file (Claim 1, Claim 8).
Sending by the detection instrument control instructions based on the OPUS file to a sample processing bay on the detection instrument thereby remotely updating a detection instrument to detect a new analyte (Claim 1, …send control instructions based on the OPUS file to the sample processing bay…, Claim 8).
Dependent claims 11-14 stand rejected as being dependent on independent claim 10.
Regarding instant claim 15, claims 1 and 8 of the reference patent ‘578 teach a method for updating a detection instrument to detect a new analyte (Claim 1, An apparatus for processing and analyzing a sample comprising: a system that comprises a sample processing bay and an assay analysis module (AAM) configured to analyze sample scan data from the sample processing bay and generate a report, the system including a processor coupled to a non-transitory computer readable medium, the non-transitory computer readable medium storing instructions directing the processor to: receive and read an assay definition file (ADP) from an external source, the ADP comprising at least an OPUS file and an AAM file, wherein the OPUS file comprises parameters that define operations controlled by an execution of the sample processing bay and the AAM file comprises parameters that define an analysis performed by the assay analysis module…, see also Claim 8). The method comprises:
receiving and reading by the detection instrument an assay definition file (ADF) from an external source to process the new analyte, the ADF comprising at least an OPUS file and an AAM file (Claim 1, Claim 8).
Sending by the detection instrument control instructions based on the OPUS file to a sample processing bay on the detection instrument (Claim 1, …send control instructions based on the OPUS file to the sample processing bay…, Claim 8).
Sending by the detection instrument analysis instructions comprising analysis parameters that define selection between two or more digital filters to process scan data based on the AAM file to an assay analysis module on the detection instrument thereby remotely updating a detection instrument to detect a new analyte (Claim 1, …send analysis instructions based on the AAM file to the AAM; receive the sample; receive scan data for the sample from the sample processing bay; send the scan data for the sample to the AAM; receive a detection report for the sample from the AAM; and report the detection report, further comprising wherein the AAM file includes analysis parameters that define selection between two or more digital filters to process the scan data, see also Claim 8).
Dependent claims 16-20 stand rejected as being dependent on independent claim 15.
Claims 1-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,000,847 (hereinafter the reference patent ‘847). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Regarding claim 1, claim 1 of the reference patent ‘847 teaches a method for updating a detection instrument to detect a new analyte (Claim 1, An apparatus for processing and analyzing a sample comprising: a system that comprises a sample processing bay and an assay analysis module (AAM), the system including a processor coupled to a non-transitory computer readable medium, the non-transitory computer readable medium storing instructions directing the processor to: receive and read an Assay Definition File (ADF) from an external source comprising control parameters for processing a fluid sample, sensing parameters that are a function of a particular molecular detection taking place in the apparatus, and analysis parameters for analyzing the data…). The method comprises:
receiving and reading by the detection instrument an assay definition file (ADF) from an external source to process the new analyte, the ADF comprising at least an AAM file for analyzing the new analyte (Claim 1).
Sending by the detection instrument analysis instructions based on the AAM file to an assay analysis module on the detection instrument thereby remotely updating a detection instrument to detect the new analyte (Claim 1, …send analysis instructions based on the analysis parameters to the AAM…).
Dependent claims 2-9 stand rejected as being dependent on independent claim 1.
Conclusion
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/JOHN MCGUIRK/ Examiner, Art Unit 1798