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 .
Status of the Claims
The amendment filed on 08/06/2026 has been entered. Claims 1-4, 11, and 23-25 have been amended. No claims have been canceled and claims 26-28 have been added. Therefore, claims 1-28 remain pending in the application.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 07/28/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Objections
Applicant has amended claim 23 to overcome the objection of claim 23. Therefore, the objection of said claim is hereby withdrawn.
Claim Rejections - 35 USC § 112
Applicant has amended claims 24 and 25 to overcome the 112(b) rejection of said claims cited in the Office Action mailed on 04/22/2026. Therefore, the 112(b) rejection of said claims is hereby withdrawn.
Claim Rejections - 35 USC § 101
Applicant has submitted a subject matter eligibility declaration discussing that the claimed invention provides an improvement. Therefore, the 101 rejection of claims 2-6 are withdrawn.
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.
Claims 1-18, 20-21, and 24-25 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Guarracina et al (US 2021/0208171 A1; hereafter “Guarracina”).
Regarding claim 1, Guarracina discloses a system for controlling an integrated software system by functionally integrating a plurality of commands from one or more of software applications (software provided in accordance with aspects of the disclosed embodiment can instruct, prompt, and/or time and capture all relevant experiment data for experiments, para. [0022], lines 9-11) for automating a robotic nucleic acid preparation and sequencing workflow (different applications may also include sample replication, sample retrieval, DNA (deoxyribonucleic acid) extraction and sequencing, cell culture operator, operator for work in BSL (biological safety level) 3 and 4 laboratories, clinical laboratory operator—including, e.g., sample accessioning and/or chemistry synthesis operator—,and/or any other suit able laboratory applications, para. [0043], lines 8-14) comprising: receiving, by the system, a request for analyzing a (i) selected at least one genome and a selected breadth of sequencing coverage for the at least one genome or (ii) a number of target amplicons within a sample; (robots are configured to run the steps of the process that make sense for automation, and humans are instructed or prompted as applicable, para. [0021], lines 16-19; different applications may also include sample replication, sample retrieval, DNA (deoxyribonucleic acid) extraction and sequencing, cell culture operator, operator for work in BSL (biological safety level) 3 and 4 laboratories, clinical laboratory operator—including, e.g., sample accessioning and/or chemistry synthesis operator—,and/or any other suitable laboratory applications, para. [0043], lines 8-14). It should be noted that that the term “or” in the claim is being interpreted to indicate that one of the clauses needs to be met by the prior art in order to anticipate or render the instant claim obvious.
“inputting, by the system, (i) a size of the selected at least one genome and the selected sequencing coverage or (ii) a number of target amplicons within the sample into a flow cell capacity bar whereby the flow cell capacity bar is configured to process a percent usage of a flow cell for the selected at least one genome and the selected sequencing coverage or for (ii) the number of target amplicons within the sample;”: Guarracina discloses robots are configured to run the steps of the process that make sense for automation, and humans are instructed or prompted as applicable, para. [0021], lines 16-19; software provided in accordance with aspects of the disclosed embodiment can instruct, prompt, and/or time and capture all relevant experiment data for experiments being run by combinations of mobile robotic operators and human operators, para. [0022], lines 9-13). It should be noted that that the term “or” in the claim is being interpreted to indicate that one of the clauses needs to be met by the prior art in order to anticipate or render the instant claim obvious.
“outputting, by the system, a percent capacity of the flow cell capacity bar, thereby providing a software application for determining a capacity of each sequencing run”: Guarracina discloses robots are configured to run the steps of the process that make sense for automation, and humans are instructed or prompted as applicable, para. [0021], lines 16-19; software provided in accordance with aspects of the disclosed embodiment can instruct, prompt, and/or time and capture all relevant experiment data for experiments being run by combinations of mobile robotic operators and human operators, para. [0022], lines 9-13).
“a web application thereby providing a system for user defined sample analysis output metrics”: Guarracina discloses the robots described herein are configured to run the steps of the process that make sense for automation, and humans are instructed or prompted as applicable; i.e., serially, or simultaneously, or in parallel with automation, to run elements of the process with data sent to mobile devices that are accessible to the humans, para. [0021], lines 16-22). Moreover, Guarracina discloses an application program interface 999A may be accessible from non-transitory computer code resident on the user interfaces 940 or in any other suitable manner such as through a web-browser; submit requests for a new job for a defined process, monitor a status of a running job, review data from completed jobs, perform error recovery, review data generated by laboratory software and systems, and/or control any devices (para. [0056]).
Regarding claim 2, Guarracina discloses whereby the system calculates a sample pooling volume based on (i) a reference genome size of a genus of the at least one genome or (ii) a number of target amplicons based on the disease model being analyzed (software provided in accordance with aspects of the disclosed embodiment can instruct, prompt, and/or time and capture all relevant experiment data for experiments being run by combinations of mobile robotic opera tors and human operators, to provide a richer history of data that can be evaluated to gauge experimental performance, para. [0022], lines 9-14; that is, the software provided is capable of calculating via the automation and the mobile devices disclosed above). It should be noted that that the term “or” in the claim is being interpreted to indicate that one of the clauses needs to be met by the prior art in order to anticipate or render the instant claim obvious.
Regarding claim 3, Guarracina discloses whereby nucleic acid sequencing reads are input into the percent usage of the flow cell (the robots described herein are configured to run the steps of the process that make sense for automation, and humans are instructed or prompted as applicable; i.e., serially, or simultaneously, or in parallel with automation, to run elements of the process with data sent to mobile devices that are accessible to the humans, para. [0021], lines 16-22; that is, the device disclosed is capable of inputting nucleic sequence reads into percent usage of a flow cell via the instructions from the user of the device).
Regarding claim 4, Guarracina discloses the system calculates a sample pooling amount for each sample based on (i) the selected sequencing coverage depth needed for a particular application or (ii) a number of samples based on the application selected (a history of data that can be analyzed to determine if the steps of the process were correctly followed and if the timings of the experiment match the original experimental definition, para. [0022], lines 15-17). It should be noted that that the term “or” in the claim is being interpreted to indicate that one of the clauses needs to be met by the prior art in order to anticipate or render the instant claim obvious.
Regarding claim 5, Guarracina discloses sample pooling amount is a volume amount of nucleic acids (a history of data that can be analyzed to determine if the steps of the process were correctly followed and if the timings of the experiment match the original experimental definition, para. [0022], lines 15-17).
Regarding claim 6, Guarracina discloses computer instructions for actuating a liquid handling system for loading the sample pooling amount into a rack on a workstation of an apparatus for automating a nucleic acid sequencing process (software provided in accordance with aspects of the disclosed embodiment can instruct, prompt, and/or time and capture all relevant experiment data for experiments being run by combinations of mobile robotic operators and human operators, to provide a richer history of data that can be evaluated to gauge experimental performance, para. [0022], lines 9-14; further, the aspects of the disclosed embodiment include a series of robotic manipulators to open instrument doors, press buttons and perform operation steps in a similar way to humans, para. [0022], lines 33-35).
Regarding claim 7, Guarracina discloses computer instructions for automatically actuating a robotic system or a liquid handling system for automating a nucleic acid sequencing process from sample preparation to loading into a sequencer upon receiving the sample parameters of each sequencing run (software provided in accordance with aspects of the disclosed embodiment can instruct, prompt, and/or time and capture all relevant experiment data for experiments being run by combinations of mobile robotic operators and human operators, to provide a richer history of data that can be evaluated to gauge experimental performance, para. [0022], lines 9-14; further, the aspects of the disclosed embodiment include a series of robotic manipulators to open instrument doors, press buttons and perform operation steps in a similar way to humans, para. [0022], lines 33-35).
Regarding claim 8, Guarracina discloses computer instructions dynamically actuate the liquid handling system in real time (software provided in accordance with aspects of the disclosed embodiment can instruct, prompt, and/or time and capture all relevant experiment data for experiments being run by combinations of mobile robotic operators and human operators, to provide a richer history of data that can be evaluated to gauge experimental performance, para. [0022], lines 9-14; further, the aspects of the disclosed embodiment include a series of robotic manipulators to open instrument doors, press buttons and perform operation steps in a similar way to humans, para. [0022], lines 33-35).
Regarding claim 9, Guarracina discloses computer instructions actuate the liquid handling system for piercing a cover of a loading port of a sequencing cartridge (whereby the computer instructions actuate the liquid handling system for piercing a cover of a loading port of a sequencing cartridge).
Regarding claim 10, Guarracina discloses computer instructions actuate the liquid handling system for opening of a door of a sequencer machine for loading a sequencing module into the sequencer (software provided in accordance with aspects of the disclosed embodiment can instruct, prompt, and/or time and capture all relevant experiment data for experiments being run by combinations of mobile robotic operators and human operators, to provide a richer history of data that can be evaluated to gauge experimental performance, para. [0022], lines 9-14; further, the aspects of the disclosed embodiment include a series of robotic manipulators to open instrument doors, press buttons and perform operation steps in a similar way to humans, para. [0022], lines 33-35).
Regarding claim 11, Guarracina discloses computer instructions actuate the liquid handling system for pooling a volume of a nucleic acid sample for a sequencing library calculated to meet (i) the selected sequencing coverage or (ii) the number of samples (software provided in accordance with aspects of the disclosed embodiment can instruct, prompt, and/or time and capture all relevant experiment data for experiments being run by combinations of mobile robotic operators and human operators, to provide a richer history of data that can be evaluated to gauge experimental performance, para. [0022], lines 9-14; further, the aspects of the disclosed embodiment include a series of robotic manipulators to open instrument doors, press buttons and perform operation steps in a similar way to humans, para. [0022], lines 33-35). It should be noted that that the term “or” in the claim is being interpreted to indicate that one of the clauses needs to be met by the prior art in order to anticipate or render the instant claim obvious.
Regarding claim 12, Guarracina discloses computer instructions actuate the liquid handling system for moving a nucleic acid sample into a chamber with reagents for extracting a nucleic acid from a cell (software provided in accordance with aspects of the disclosed embodiment can instruct, prompt, and/or time and capture all relevant experiment data for experiments being run by combinations of mobile robotic operators and human operators, to provide a richer history of data that can be evaluated to gauge experimental performance, para. [0022], lines 9-14; further, the aspects of the disclosed embodiment include a series of robotic manipulators to open instrument doors, press buttons and perform operation steps in a similar way to humans, para. [0022], lines 33-35).
Regarding claim 13, Guarracina discloses reagents for extracting the nucleic acids from the cell are reagents for cell lysis (dispensing liquids, para. [0038], lines 9-10; and DNA extraction, para. [0043], lines 9-10; that is, the system provides means for extracting DNA from a sample).
Regarding claim 14, Guarracina discloses computer instructions actuate the liquid handling system for moving a nucleic acid sample into a chamber with reagents for fragmentation of a nucleic acid (software provided in accordance with aspects of the disclosed embodiment can instruct, prompt, and/or time and capture all relevant experiment data for experiments being run by combinations of mobile robotic operators and human operators, to provide a richer history of data that can be evaluated to gauge experimental performance, para. [0022], lines 9-14; further, the aspects of the disclosed embodiment include a series of robotic manipulators to open instrument doors, press buttons and perform operation steps in a similar way to humans, para. [0022], lines 33-35).
Regarding claim 15, Guarracina discloses computer instructions actuate the liquid handling system for moving a nucleic acid sample into a chamber with reagents for end repair of a nucleic acid (software provided in accordance with aspects of the disclosed embodiment can instruct, prompt, and/or time and capture all relevant experiment data for experiments being run by combinations of mobile robotic operators and human operators, to provide a richer history of data that can be evaluated to gauge experimental performance, para. [0022], lines 9-14; further, the aspects of the disclosed embodiment include a series of robotic manipulators to open instrument doors, press buttons and perform operation steps in a similar way to humans, para. [0022], lines 33-35).
Regarding claim 16, Guarracina discloses computer instructions actuate the liquid handling system for moving a nucleic acid sample into a chamber with reagents for reverse transcription of one or more nucleic acids (software provided in accordance with aspects of the disclosed embodiment can instruct, prompt, and/or time and capture all relevant experiment data for experiments being run by combinations of mobile robotic operators and human operators, to provide a richer history of data that can be evaluated to gauge experimental performance, para. [0022], lines 9-14; further, the aspects of the disclosed embodiment include a series of robotic manipulators to open instrument doors, press buttons and perform operation steps in a similar way to humans, para. [0022], lines 33-35). It should be noted that that the term “or” in the claim is being interpreted to indicate that one of the clauses needs to be met by the prior art in order to anticipate or render the instant claim obvious.
Regarding claim 17, Guarracina discloses computer instructions actuate the liquid handling system for moving a nucleic acid sample into a chamber with reagents for amplification of one or more nucleic acids (software provided in accordance with aspects of the disclosed embodiment can instruct, prompt, and/or time and capture all relevant experiment data for experiments being run by combinations of mobile robotic operators and human operators, to provide a richer history of data that can be evaluated to gauge experimental performance, para. [0022], lines 9-14; further, the aspects of the disclosed embodiment include a series of robotic manipulators to open instrument doors, press buttons and perform operation steps in a similar way to humans, para. [0022], lines 33-35). It should be noted that that the term “or” in the claim is being interpreted to indicate that one of the clauses needs to be met by the prior art in order to anticipate or render the instant claim obvious.
Regarding claim 18, Guarracina discloses computer instructions actuate the liquid handling system for moving a nucleic acid sample into a chamber with reagents for adding a sequencing adaptor to one or more nucleic acids (software provided in accordance with aspects of the disclosed embodiment can instruct, prompt, and/or time and capture all relevant experiment data for experiments being run by combinations of mobile robotic operators and human operators, to provide a richer history of data that can be evaluated to gauge experimental performance, para. [0022], lines 9-14; further, the aspects of the disclosed embodiment include a series of robotic manipulators to open instrument doors, press buttons and perform operation steps in a similar way to humans, para. [0022], lines 33-35). It should be noted that that the term “or” in the claim is being interpreted to indicate that one of the clauses needs to be met by the prior art in order to anticipate or render the instant claim obvious.
Regarding claim 20, Guarracina discloses computer instructions actuate the liquid handling system or the robotic arm for moving a chamber having a nucleic acid sample therein to a vacuum manifold in the workstation (software provided in accordance with aspects of the disclosed embodiment can instruct, prompt, and/or time and capture all relevant experiment data for experiments being run by combinations of mobile robotic operators and human operators, to provide a richer history of data that can be evaluated to gauge experimental performance, para. [0022], lines 9-14; further, the aspects of the disclosed embodiment include a series of robotic manipulators to open instrument doors, press buttons and perform operation steps in a similar way to humans, para. [0022], lines 33-35). It should be noted that that the term “or” in the claim is being interpreted to indicate that one of the clauses needs to be met by the prior art in order to anticipate or render the instant claim obvious.
Regarding claim 21, Guarracina discloses computer instructions actuate the liquid handling system or the robotic arm for moving a chamber having a nucleic acid sample therein to a thermal cycler in the workstation (software provided in accordance with aspects of the disclosed embodiment can instruct, prompt, and/or time and capture all relevant experiment data for experiments being run by combinations of mobile robotic operators and human operators, to provide a richer history of data that can be evaluated to gauge experimental performance, para. [0022], lines 9-14; further, the aspects of the disclosed embodiment include a series of robotic manipulators to open instrument doors, press buttons and perform operation steps in a similar way to humans, para. [0022], lines 33-35; also discloses the collaborative apparatus described herein in accordance with the disclosed embodiment are configured to use these automation ready devices, but also devices that are normally driven by humans, para. [0022], lines 29-32; processing stations with one or more process tools may include (e.g., refrigeration, freezers, incubators, clean environments, hoods, etc., para. [0027], lines 6-8). It should be noted that that the term “or” in the claim is being interpreted to indicate that one of the clauses needs to be met by the prior art in order to anticipate or render the instant claim obvious.
Regarding claim 24, Guarracina discloses a single or a series of software application(s) are responsible for tracking sample-related information and metadata from the inputs to a bioinformatics pipeline output (software provided in accordance with aspects of the disclosed embodiment can instruct, prompt, and/or time and capture all relevant experiment data for experiments being run by combinations of mobile robotic operators and human operators, to provide a richer history of data that can be evaluated to gauge experimental performance, para. [0022], lines 9-14). Moreover, Guarracina discloses a controller to track or otherwise communicate with processing stations (para. [0059]).
Regarding claim 25, Guarracina discloses single or the series of software application(s) making up the software system allow for the communication of the automation workflow and for controlling one or more bioinformatics pipelines (software provided in accordance with aspects of the disclosed embodiment can instruct, prompt, and/or time and capture all relevant experiment data for experiments being run by combinations of mobile robotic operators and human operators, to provide a richer history of data that can be evaluated to gauge experimental performance, para. [0022], lines 9-14). Guarracina discloses a controller to track or otherwise communicate with processing stations (para. [0059]). It should be noted that that the term “or” in the claim is being interpreted to indicate that one of the clauses needs to be met by the prior art in order to anticipate or render the instant claim obvious.
Regarding claim 26, Guarracina discloses computer instructions actuate the liquid handling system for moving a nucleic acid sample into a chamber with reagents for hybridization of one or more nucleic acids (software provided in accordance with aspects of the disclosed embodiment can instruct, prompt, and/or time and capture all relevant experiment data for experiments being run by combinations of mobile robotic operators and human operators, to provide a richer history of data that can be evaluated to gauge experimental performance, para. [0022], lines 9-14; further, the aspects of the disclosed embodiment include a series of robotic manipulators to open instrument doors, press buttons and perform operation steps in a similar way to humans, para. [0022], lines 33-35). It should be noted that that the term “or” in the claim is being interpreted to indicate that one of the clauses needs to be met by the prior art in order to anticipate or render the instant claim obvious.
Regarding claim 27, Guarracina discloses computer instructions actuate the liquid handling system for moving a nucleic acid sample into a chamber with reagents for capture of one or more nucleic acids via beads containing magnetic, protein-binding, antigen-binding, ligand-binding, and/or chemical bonding properties (software provided in accordance with aspects of the disclosed embodiment can instruct, prompt, and/or time and capture all relevant experiment data for experiments being run by combinations of mobile robotic operators and human operators, to provide a richer history of data that can be evaluated to gauge experimental performance, para. [0022], lines 9-14; further, the aspects of the disclosed embodiment include a series of robotic manipulators to open instrument doors, press buttons and perform operation steps in a similar way to humans, para. [0022], lines 33-35). It should be noted that that the term “and/or” in the claim is being interpreted to indicate that one of the clauses needs to be met by the prior art in order to anticipate or render the instant claim obvious.
Regarding claim 28, Guarracina discloses the sample contains one or more amplicons (applications may also include sample replication, sample retrieval, DNA extraction and sequencing, para. [0043]). It is noted that neither the manner of operating a disclosed device nor material or article worked upon further limit an apparatus claim. Said limitations do not differentiate apparatus claims from prior art. It has been well established that it is fundamental that an apparatus claim defines the structure of the invention and not how the structure is used in a process, or what materials the structure houses in carry out the process. It is further noted that a recitation directed to the manner in which a claimed apparatus is intended to be used does not distinguish the claimed apparatus from the prior art, if the prior art has the capability to so perform. See MPEP §2144 and 2115. The system/device disclosed in Guarracina is discloses all of the structural limitations, and is considered capable of performing the functioning as claimed.
Therefore, the reference of Guarracina meets the limitations of claims 1-21 and 24-28.
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.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Guarracina (US 2021/0208171 A1; hereafter “Guarracina”) as applied to claim 7 above, and further in view of US 10,900,032 B2- Handique et al (hereinafter “Handique”).
Regarding claim 19, Guarracina teaches the invention discussed above in claim 7. Further, Guarracina teaches a robotic arm of the system (robot arm 206, para. [0027], lines 29-30). However, Guarracina does not explicitly teach a magnet plate.
For claim 19, Handique teaches a system related to enabling at least partial automation of protocols involved in single cell capture and subsequent processing (col. 2, lines 40-41) and Handique teaches magnetic separation components (col. 3, lines 14-15), which reads on the instant claim limitation of a magnet plate.
Therefore, it would have been obvious to one of ordinary skill, in the art at the time, to further include a magnet plate—magnetic components as taught by Handique, because Handique teaches the magnetic components of the system allow for fluid handling and separation, and the system and/or method can confer the benefit of providing automated sample and library cleanup steps (col. 3, lines 15-17).
Claims 22-23 are rejected under 35 U.S.C. 103 as being unpatentable over Guarracina (US 2021/0208171 A1; hereafter “Guarracina”) as applied to claim 1 above, and further in view of AU2015249160A1-Williams.
Regarding claim 22, Guarracina teaches the invention discussed above in claim 1. Further, Guarracina teaches sample extraction and sequencing, and various applications of the system. However, Guarracina does not teach a genome of the Escherichia genus, the Listeria genus, the Salmonella genus, or the Campylobacter genus.
For claim 22, Williams teaches an invention relating to systems for extracting polynucleotides from multiple samples, particularly from biological samples, and additionally to systems that subsequently amplify and detect the extracted polynucleotides (para. [0002], lines 1-3; and Williams teaches the apparatuses as described herein therefore find application to analyzing any nucleic acid containing sample for any purpose, including but not limited to genetic testing, para. [0102], lines 1-3) and Williams teaches a probe selective for a polynucleotide sequence that is characteristic of an organism selected from the group consisting of Escherichia (para. [0234], lines 1-2 and 13), which reads on the instant claim limitation of a genome of the Escherichia genus. It should be noted that that the term “or” in the claim is being interpreted to indicate that one of the clauses needs to be met by the prior art in order to anticipate or render the instant claim obvious.
Therefore, it would have been obvious to one of ordinary skill, in the art at the time, to further include at least the selected one microorganism genome is a genome of the Escherichia genus as taught by Williams, because Williams teaches the probe can be selective for a polynucleotide sequence that is characteristic of an organism, for example any organism that employs deoxyribonucleic acid or ribonucleic acid polynucleotides. Thus, the probe can be selective for any organism the probe; and Williams teaches the probe is selective for microorganisms, for example, organisms used in food production (for example, yeasts employed in fermented products, molds or bacteria employed in cheeses, and the like) or pathogens (e.g., of humans, domesticated or wild mammals, domesticated or wild birds, and the like, para. [0233], lines 3-10).
Regarding claim 23, Guarracina teaches the invention discussed above in claim 1. However, Guarracina does not teach whereby at least the selected one microorganism genome is a SARS- CoV-2, an influenza A, an influenza B, or Human Respiratory Syncytial Virus (RSV) genome.
For claim 23, Williams teaches an invention relating to systems for extracting polynucleotides from multiple samples, particularly from biological samples, and additionally to systems that subsequently amplify and detect the extracted polynucleotides (para. [0002], lines 1-3; and Williams teaches the apparatuses as described herein therefore find application to analyzing any nucleic acid containing sample for any purpose, including but not limited to genetic testing, para. [0102], lines 1-3) and Williams teaches the targets for which clinical assays currently exist, and that may be tested for using the apparatus and methods may be bacterial or viral, and include Influenza A (para. [0102], lines 1-6), which reads on the instant claim limitation of one microorganism genome is Influenza A. It should be noted that that the term “or” in the claim is being interpreted to indicate that one of the clauses needs to be met by the prior art in order to anticipate or render the instant claim obvious.
Therefore, it would have been obvious to one of ordinary skill, in the art at the time, to further include one microorganism genome is Influenza A as taught by Williams, because Williams the system allows for analyzing any nucleic acid containing sample for any purpose, including but not limited to genetic testing, and clinical testing for various infectious diseases in humans (para. [0102], lines 1-6).
Response to Arguments
On pages 1 through the top of page 3, applicant discusses the amendment to the claims and newly added claims 26-28. On the middle of page 3, applicant discusses the 112(b) rejection of claims 24 and 25. Regarding the latter, applicant has amended said claims to overcome the rejection cited in the previously mailed Office Action. On the bottom of page 3 through the top of page 8, applicant discusses the 101 rejection cited in the last Office Action. It is noted that applicant has submitted a subject matter edibility declaration (SMED), which also argues many of the arguments regarding the 101 rejection. As discussed above in the beginning of the Office Action, the 101 rejection is hereby withdrawn. Applicant’s arguments regarding the prior art rejection of the claims begin on middle of page 8. Applicant's arguments filed 08/06/2026 have been fully considered but they are not persuasive. On the middle of page 8 of applicant’s remarks, applicant discusses disclosure of Guarracina and to the relied upon citations of Guarracina cited in the previously mailed Office Action on the bottom of page 8 and the top and middle of page 9. Further, applicant asserts the relied upon art “merely describe Guarracina’s general desire to automate laboratory processes and capture experiment data; they say nothing about the size of a selected genome… and ‘percent capacity’…”.
In response, claim 1 of the instant applicate recite “a system for…”, where the latter is essentially a computer and comprises enough physical structure to perform the functions of the claimed limitations. Guarracina discloses a computer to receive a command as well as a mobile device and/or tablet computer, also capable of receiving a command and therefore outputting information. Also, as discussed above in the rejection, Guarracina discloses software provided in accordance with aspects of the disclosed embodiment can instruct, prompt, and/or time and capture all relevant experiment data for experiments, para. [0022]. That is, this is merely a system for and therefore a general computer, hence is why the cited reference meets the limitations recited. On the middle and bottom of page 9 and the top of page 10, applicant again argues the alleged “citation to the generic data-capture passage of paragraph [0022]”, as it pertains to dependent claims 2, 3 and 5, 12-18.
In response, as noted above in this section, claim 2 merely recites the system of claim 1 performing a calculation of a sample pool. As discussed previously, the claimed invention is merely a computer. Guarracina discloses a computer to receive a command as well as a mobile device and/or tablet computer, also capable of receiving a command and therefore outputting information. Also, as discussed above in the rejection, Guarracina discloses software provided in accordance with aspects of the disclosed embodiment can instruct, prompt, and/or time and capture all relevant experiment data for experiments, para. [0022]. That is, this is merely a system for and therefore a general computer, hence is why the cited reference meets the limitations recited in claim 2, since a user can merely input a command to the computer and perform the function of the claimed limitations.
Referring to applicant’s argument pertaining to claims 3 and 5, limitations pertains to inputting a command into a system, this the instant case, the system is a generic computer. Moreover, Guarracina discloses a computer to receive a command as well as a mobile device and/or tablet computer, also capable of receiving a command and therefore outputting information. Also, as discussed above in the rejection, Guarracina discloses software provided in accordance with aspects of the disclosed embodiment can instruct, prompt, and/or time and capture all relevant experiment data for experiments, para. [0022]. That is, this is merely a system for and therefore a general computer, hence is why the cited reference meets the limitations recited in claims 3 and 5, since a user can merely input a command to the computer and perform the function of the claimed limitations.
Pertaining to applicant’s arguments regarding claim 12-18, the limitation recite a system performing instructions of the limitations recited in said claims. In the latter, the claimed system is a computer, capable of receiving commands and therefore, outputting information. Moreover, Guarracina discloses a computer to receive a command as well as a mobile device and/or tablet computer, also capable of receiving a command and therefore outputting information. Also, as discussed above in the rejection, Guarracina discloses software provided in accordance with aspects of the disclosed embodiment can instruct, prompt, and/or time and capture all relevant experiment data for experiments, para. [0022]. That is, this is merely a system for and therefore a general computer, hence is why the cited reference meets the limitations recited in claims 12-18, since a user can merely input a command to the computer and perform the function of the claimed limitations.
On the middle of page 10, applicant asserts the prior art does not disclose the claim and cannot support a finding of anticipation, for claim 9, which “requires that the computer instructions ‘actuate the liquid handling system for piercing a cover of a loading port…”. In response, as noted, applicant has clearly indicated that a computer provides instructions to perform said limitation of claim 9. The claimed system is a computer, capable of receiving commands and therefore, outputting information. Moreover, Guarracina discloses a computer to receive a command as well as a mobile device and/or tablet computer, also capable of receiving a command and therefore outputting information. Also, as discussed above in the rejection, Guarracina discloses software provided in accordance with aspects of the disclosed embodiment can instruct, prompt, and/or time and capture all relevant experiment data for experiments, para. [0022]. That is, this is merely a system for and therefore a general computer, hence is why the cited reference meets the limitations recited in claim 9, since a user can merely input a command to the computer and perform the function of the claimed limitations. That is, the invention of Guarracina is capable of actuating receiving commands. Also, Guarracina discloses a series of robotic manipulators to open instrument doors, press buttons and perform operation steps in a similar way to humans (para. [0022]).
Toward the bottom of page 10, applicant asserts “claims 24 and 25 are likewise not disclosed” and disagrees with “Guarracina’s generic statement that Guarracina’s software captures experiment data does not disclose a software for tracking sample-related information…”. In response, as previously discussed above in this section, claims 24 and 24 also pertain to a “system for”, whereby the claimed system, is merely a generic computer. Also, the device of Guarracina is capable of performing the limitations of claims 24 and 25 Guarracina discloses a computer to receive a command as well as a mobile device and/or tablet computer, also capable of receiving a command and therefore outputting information. Moreover, Guarracina’s disclosure discusses a controller may track or other communicate with processing stations (para. [0059]).
Regarding the bottom of page 10 and the top and middle of page 11, applicant asserts the secondary reference, “Handique fails to remedy the deficiency of Guarracina, because applicant asserts the primary reference fails to disclose, teach, or suggest ‘inputting, by the system, a size of the selected at least one genome and the selected sequencing coverage …”. The latter argument is also not found persuasive for the reasons previously discussed above pertaining to the recitations of “a system for” which indicates a general computer. The device of Guarracina discloses a system which includes a computer and controller for receiving commands and outputting information. Moreover, Guarracina discloses software for performing various applications and functions and instructing users to run specific parts of experiments (para. [0021-0022]). Guarracina also discloses the application program interface may be configured so that laboratory technicians may define experiments/processes, submit requests for a new job for a defined process, monitor a status of a running job, review data from completed jobs perform error recovery, review data generated by laboratory software and systems and/or control any devices connected to the controller (para. [0056]).
Regarding claims 22 and 23, the primary reference addresses the limitations of claim 1 of the instant application. As acknowledged by applicant, the additional reference, Williams, was relied upon for the specified genome claimed. The limitations of claim 1 were met by the primary reference and discussed above in this section. Therefore, the claims of the instant application stand rejected.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/LENORA A ABEL/Examiner, Art Unit 1799
/MICHAEL L HOBBS/Primary Examiner, Art Unit 1799
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