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 .
Response to Amendment
The amendments and remarks, filed on 4/1/2026, has been entered. The claim amendments overcome the previous claim objections of claims 1, 3, 8, 10, 11, 12, 13, 14, 15, 18-20, 24, 25-27, and 37 and 112(b) rejection of claims 1, 3, 8, 10, 11, 37, and 38.
The amendments and remarks, filed on 4/1/2026, has been entered. The claim amendments do not overcome the previous prior art rejection.
Claim Status
Claims 1-38 are pending and being examined.
Claim Objections
Claims 1 and 18-23 are objected to because of the following informalities:
claim 1 read “the fully automated system” should read “the fully automated software system” in line 27; and
claims 18-23 read “where the plurality of racks include” should read “where the plurality of racks includes” in line 1; and
claim 38 read “the fully automated system” should read “the fully automated software system” in line 24. Appropriate corrections are required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1 and 3-39 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation "wherein the fully automated system is adapted to receive a first input comprising at least one flow cell sequencing capacity and a second input comprising a plurality of sizes of genomes" in lines 27-29. The limitation is unclear as to what “the input” is describing. Specifically, is the input received by an external user? Or is the input previously installed within the automated software system? For purpose of examination the Examiner interprets “the input” as something the software system comprises in order to identify if the flow cell is present and the types of genomes. Claims 3-38 are rejected by virtue of dependency on claim 1.
Claim 39 recites the limitation "wherein the fully automated system is adapted to receive a first input comprising at least one flow cell sequencing capacity and a second input comprising a plurality of sizes of genomes" in lines 24-26. The limitation is unclear as to what “the input” is describing. Specifically, is the input received by an external user? Or is the input previously installed within the automated software system? For purpose of examination the Examiner interprets “the input” as something the software system comprises in order to identify if the flow cell is present and the types of genomes.
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 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 1-23 and 26-39 are rejected under 35 U.S.C. 103 as being unpatentable over Rasab et al (US 20240077506 A1; hereinafter “Rasab”; priority filed on 10/7/2021; already of record) in view of Downs et al (US 20020117380 A1; hereinafter “Downs”; already of record).
Regarding claim 1, Rasab teaches a system for automating a nucleic acid sequencing process (Rasab; Abstract; para [9]; Systems for processing a sample may include one or more of input modules, processing modules, thermal modules, detection modules, or computer processors…the method further comprises using a sequencing unit to amplify or sequence at least a portion of the sample), the system comprising:
a sequencer adapted to sequence a sample or a plurality of samples in a sequencing flow cell of a sequencing module1 (Rasab; para [361]; the robotic handling sub-system may collect a flow cell from the flow cell holder in the lab and insert the flow cell into the sequencer. Once the sample cartridge, flow cell, and reagent bottles are placed inside the sequencer, the control unit may activate the sequencer to commence sequencing. The sequencer may begin sequencing and may provide the raw reads to the in-lab analytics unit); and
a robotic arm (Rasab; para [104]; The laboratory robotics may be automated robotics that carries out the picking and placing of the chips, loading of the sequencer consumables into the sequencer as well as sequencer chips with the constructed sample libraries), an apparatus for actuating one or more programmed movements of the robotic arm (Rasab; para [104]; the sequencer may be an integrated next generation sequencer (NGS), integrated with and adapted to work with the control unit, robotics, and NGS analytics), wherein the apparatus is configured for receiving an input from a fully automated software system (Rasab; para [170]; The computer server may include (i) a database (e.g., knowledge base) for storing test information and clinical information (ii) a memory for storing a set of software instructions, and (iii) one or more computer processors configured to execute a set of software instructions);
whereby the system is controlled by the fully automated software system (Rasab; para [170]; The computer server may include (i) a database (e.g., knowledge base) for storing test information and clinical information (ii) a memory for storing a set of software instructions, and (iii) one or more computer processors configured to execute a set of software instructions) and wherein the fully automated system is adapted to receive a first input comprising at least one flow cell sequencing capacity and a second input comprising a plurality of sizes of genomes (Fig. 4, 6; para [105, 106]; Examiner notes the system comprises a data of genomic sets and can identify when the chips are positioned within the sequencer)
1 The limitation is directed to the function and/or the manner of operating the sequencer, all the structural limitations of the claim has been disclosed by Rasab and the sequencer of Rasab is capable of “sequencing a sample or a plurality of samples in the sequencing flow cell of the sequencing module”. As such, it is deemed that the claimed sequencer is not differentiated from the sequencer of Rasab (see MPEP §2114). Further, the examiner notes that the sequencing flow cell of the sequencing module are not positively recited elements and are intended use of the apparatus described below.
Rasab does not teach the robotic arm having a left effector and a right effector, wherein each of the left and right effector is adapted to move via linear translation and rotation within a common plane, said robotic arm connected to a rotary axis and adapted to enable coordinated rotation of the left effector and right effector through 360 degrees of rotation within the common plane, said rotary axis connected to the apparatus.
However, Downs teaches an analogous art a gripper apparatus (Downs; Abstract), wherein the robotic arm has a left effector and a right effector (Downs; Fig. 2; para [36]; grasping arms A and B extend from the body 22 and include pivot members 35), wherein each of the left and right effector is adapted to move via linear translation and rotation within a common plane2 (Downs; Fig. 3; para [41, 43]), said robotic arm connected to a rotary axis and adapted to enable coordinated rotation of the left effector and right effector through 360 degrees of rotation within the common plane2 (Downs; Fig. 1, 2; para [31, 32]; the robotic gripper 10 comprises a grasping mechanism 20 movably connected to a boom 12 that is movable relative to a base 14…the boom 12 is capable of about 360 degrees of rotation), said rotary axis connected to an apparatus (Downs; para [29]; In accordance with the present invention, a robotic gripper apparatus (also referred to herein as a robotic gripper mechanism) is provided. Although this disclosed example is designed to be employed with a specific high throughput system, other uses for the present invention are contemplated). It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the robotic arm of Rasab to comprise the left effector and the right effector as taught by Downs, because Downs teaches that the robotic gripper mechanism grips, transports and positions sample plates from a station to another station (Downs; para [39]). Further, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the robotic arm of Rasab to comprise the rotary axis as taught by Downs, because Downs teaches the boom rotates the robotic arm to define the work perimeter (Downs; para [32, 33]).
2 The limitations are directed to the function and/or the manner of operating the robotic arm, all the structural limitations of the claim has been disclosed by Rasab and the robotic arm of Rasab is capable of being “adapted to move via linear translation and rotation within a common plane” and “adapted to enable coordinated rotation of the left effector and right effector through 360 degrees of rotation within the common plane”. As such, it is deemed that the claimed robotic arm is not differentiated from the robotic arm of Rasab (see MPEP §2114)
Thus, modified Rasab teaches moving said robotic arm towards a sequencing module, comprising a sequencing cartridge and sequencing flow cell, on a location (Downs; para [40]; When employed in a high throughput process, the controller 15 instructs the robotic gripper mechanism 10 to move the boom 12 toward a station 30; Rasab; para [361]; A robotic handling sub-system may insert the cartridge into the sequencer and place the relevant reagent bottles needed by the sequencer); extending the left effector and the right effector of the robotic arm around the sequencing module on the location and subsequently contracting said effectors around the sequencing module, thereby holding the sequencing module with the robotic arm (Downs; Fig. 5; para [39]; the robotic gripper mechanism 10 grips, transports and positions sample plates 25 from a station 30 to another station 30 or to a hand-off area or to another location within the work perimeter of the robotic gripper mechanism 10); moving the sequencing module that is held by the robotic arm into a sequencer thereby loading the sequencing module (Rasab; para [361]; the robotic handling sub-system may collect a flow cell from the flow cell holder in the lab and insert the flow cell into the sequencer)3.
3 The limitations are directed to the function and/or the manner of operating the apparatus, all the structural limitations of the claim has been disclosed by Rasab in view of Downs and the apparatus of modified Rasab is capable of “moving said robotic arm towards a sequencing module, comprising a sequencing cartridge and sequencing flow cell, on a location; extending the left effector and the right effector of the robotic arm around the sequencing module on the location and subsequently contracting said effectors around the sequencing module, thereby holding the sequencing module with the robotic arm; moving the sequencing module that is held by the robotic arm into a sequencer thereby loading the sequencing module”. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of modified Rasab (see MPEP §2114)
Regarding claim 3, modified Rasab teaches the system of claim 1 (the robotic arm of Rasab is modified to comprise the rotary axis as taught by Downs discussed above in claim 1), wherein the rotary axis rotates the robotic arm above the location housing the sequencing module, comprising a sequencing cartridge and sequencing flow cell (Downs; Fig. 5; para [39]; the robotic gripper mechanism 10 grips, transports and positions sample plates 25 from a station 30 to another station 30 or to a hand-off area or to another location within the work perimeter of the robotic gripper mechanism 10; Rasab; para [361]; the robotic handling sub-system may collect a flow cell from the flow cell holder in the lab and insert the flow cell into the sequencer).
Regarding claim 4, modified Rasab teaches the system of claim 1 (the robotic arm of Rasab is modified to comprise the rotary axis as taught by Downs discussed above in claim 1), wherein the left effector and the right effector are symmetrical (Downs; Fig. 2, 5).
Regarding claim 5, modified Rasab teaches the system of claim 1, wherein the left effector and the right effector are configured for lifting at least 1 pound, at least 2 pounds, at least 5 pounds, or at least 10 pounds (Downs; Fig. 5). The limitation is interpreted as intended use and/or functional language. The Courts have held that the manner in which a claimed apparatus is intended to be employed does not differentiate an apparatus claim from the prior art, if the prior art apparatus teaches all of the structural limitations of the claim. See Ex parte Masham, 2 USPQ2d 1647 (BPAI 1987). A functional recitation of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. See MPEP § 2114. Thus, modified Rasab teaches that the left effector and right effector are capable of lifting at least 1 pound.
Regarding claim 6, modified Rasab teaches the system of claim 1, wherein the sequencer is configured for performing sequencing-by-synthesis. The limitation is interpreted as intended use and/or functional language. The Courts have held that the manner in which a claimed apparatus is intended to be employed does not differentiate an apparatus claim from the prior art, if the prior art apparatus teaches all of the structural limitations of the claim. See Ex parte Masham, 2 USPQ2d 1647 (BPAI 1987). A functional recitation of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. See MPEP § 2114. Thus, modified Rasab teaches that the sequencer is capable of performing sequencing-by-synthesis.
Regarding claim 7, modified Rasab teaches the system of claim 1, wherein the sequencer is configured for receiving one or more inputs directly from the system (Rasab; para [361]; the robotic handling sub-system may collect a flow cell from the flow cell holder in the lab and insert the flow cell into the sequencer).
Regarding claim 8, modified Rasab teaches the system of claim 1, wherein the sequencer automatically starts a sequencing run upon loading of the sequencing module, comprising a sequencing cartridge and sequencing flow cell (Rasab; para [361]; Once the sample cartridge, flow cell, and reagent bottles are placed inside the sequencer, the control unit may activate the sequencer to commence sequencing).
Regarding claim 9, modified Rasab teaches the system of claim 1, where the system further comprises a liquid handling system functionally connected to a multi-module workstation (Rasab; para [360]; the constructed sample may be transferred to a sequencer cartridge using robotic liquid handlers and pipettes for sequencing). The multi-module workstation is interpreted as the different locations in which different steps of the sequencing process occurs as described in paragraphs [360-361].
Regarding claim 10, modified Rasab teaches the system of claim 9, where the liquid handling system is configured for piercing a cover of the loading port of a sequencing cartridge (Rasab; para [135]; Fluid may be introduced or extracted from a port via a needle puncturing the seal of the port).
Regarding claim 11, modified Rasab teaches the system of claim 10, where the liquid handling system is configured for loading the pierced sequencing module, comprising a sequencing cartridge and sequencing flow cell, with a sample or a plurality of sample prepared for sequencing (Rasab; para [360]; If the results are in line with the standards of the specific test, the constructed sample may be transferred to a sequencer cartridge using robotic liquid handlers and pipettes for sequencing).
Regarding claim 12, modified Rasab teaches the system of claim 11, where the sample or a plurality of sample was prepared for sequencing in the multi-module workstation (Rasab; para [360-361]).
Regarding claim 13, modified Rasab teaches the system of claim 12, where the sample or a plurality of sample was robotically prepared for sequencing in the multi-module workstation without human intervention (Rasab; para [360-361]).
Regarding claim 14, modified Rasab teaches the system of claim 9, where the workstation comprises a plurality of multi-well plates for receiving samples (Rasab; para [114]; the system is capable of processing tubes, microwells plates, sample cups with injection ports, or any combination thereof).
Regarding claim 15, modified Rasab teaches the system of claim 9, where the workstation comprises a plurality of racks (Rasab; para [104]; The sample holder and loader may include an electro-mechanical sub system for holding sample tubes, containers, or chips for wet lab processing). The examiner interprets the sample holder as the rack.
Regarding claim 16, modified Rasab teaches the system of claim 15, where the plurality of racks include racks for holding reagents for extracting a nucleic acids from a cell (Rasab; para [23, 28]; the at least one function is selected from the group consisting of extracting nucleic acid from the sample, library preparation, sequencing the sample, separating components from the sample, and performing an assay on the sample…a chip of the one or more chips is configured to (i) hold the sample or (ii) provide buffers, reagents, or other additives to the sample). Examiner notes that the “the reagents” are not positively recited elements of the claim, and therefore, are not elements of the claimed racks. Thus, the limitation “for extracting a nucleic acids from a cell” is not required.
Regarding claim 17, modified Rasab teaches the system of claim 16, where the reagents for extracting the nucleic acids from the cell include reagents for cell lysis (Rasab; para [23, 28]). Examiner notes that the “the reagents” are not positively recited elements of the claim, and therefore, are not elements of the claimed racks. Thus, the limitation “for extracting the nucleic acids from the cell include reagents for cell lysis” is not required.
Regarding claim 18, modified Rasab teaches the system of claim 15, where the plurality of racks includes chambers for holding reagents for fragmentation of a nucleic acids (Rasab; para [23, 28]). Examiner notes that the “the reagents” are not positively recited elements of the claim, and therefore, are not elements of the claimed racks. Thus, Rasab teaches the claimed limitation as Rasab teaches the reagents are provided to the sample which is held within the chip and “for fragmentation of a nucleic acids” is not required.
Regarding claim 19, modified Rasab teaches the system of claim 15, where the plurality of racks includes chambers for holding reagents for end repair of a nucleic acids (Rasab; para [23, 28]). Examiner notes that the “the reagents” are not positively recited elements of the claim, and therefore, are not elements of the claimed racks. Thus, Rasab teaches the claimed limitation as Rasab teaches the reagents are provided to the sample which is held within the chip and “for end repair of a nucleic acids” is not required.
Regarding claim 20, modified Rasab teaches the system of claim 15, where the plurality of racks includes chambers for holding reagents for reverse transcription of a nucleic acids (Rasab; para [23, 28]). Examiner notes that the “the reagents” are not positively recited elements of the claim, and therefore, are not elements of the claimed racks. Thus, Rasab teaches the claimed limitation as Rasab teaches the reagents are provided to the sample which is held within the chip and “for reverse transcription of a nucleic acids” is not required.
Regarding claim 21, modified Rasab teaches the system of claim 15, where the plurality of racks includes chambers for holding reagents for amplification of one or more nucleic acids (Rasab; para [23, 28]). Examiner notes that the “the reagents” are not positively recited elements of the claim, and therefore, are not elements of the claimed racks. Thus, Rasab teaches the claimed limitation as Rasab teaches the reagents are provided to the sample which is held within the chip and “for amplification of one or more nucleic acids” is not required.
Regarding claim 22, modified Rasab teaches the system of claim 21, where the plurality of racks includes chambers for holding reagents for indexing of one or more nucleic acids (Rasab; para [23, 28]). Examiner notes that “the reagents” are not positively recited elements of the claim, and therefore, are not elements of the claimed racks. Thus, Rasab teaches the claimed limitation as Rasab teaches the reagents are provided to the sample which is held within the chip and “for indexing of one or more nucleic acids” is not required.
Regarding claim 23, modified Rasab teaches the system of claim 15, where the plurality of racks includes chambers for holding reagents for adding a sequencing adaptor or a plurality of sequencing adaptors to one or more nucleic acids (Rasab; para [23, 28]). Examiner notes that “the reagents” are not positively recited elements of the claim, and therefore, are not elements of the claimed racks. Thus, Rasab teaches the claimed limitation as Rasab teaches the reagents are provided to the sample which is held within the chip and “for adding a sequencing adaptor or a plurality of sequencing adaptors to one or more nucleic acids” is not required.
Regarding claim 26, modified Rasab teaches the system of claim 9, where the workstation comprises a thermal cycler (Rasab; para [138]; The system may include a thermal module. The thermal module may be configured to contact at least a portion of a cartridge, a chip, or both a cartridge and a chip. The thermal module may be configured to control a temperature of a portion or all of the cartridge, chip, or both).
Regarding claim 27, modified Rasab teaches the system of claim 9, where the workstation is an open workstation (Rasab; para [360- 361]). Examiner notes that the workstation would be open when the sequencer is receiving the flow cell.
Regarding claim 28, modified Rasab teaches the system of claim 1, wherein the fully automated software system comprises a plurality of software subsystems, software applications, software components, and software modules networked together (Rasab; para [29, 200]).
Regarding claim 29, modified Rasab teaches the system of claim 28, where in the fully automated software system comprises a plurality of External APIs (Rasab; para [200]; All or portions of the software may at times be communicated through the Internet or various other telecommunication networks. Such communications, for example, may enable loading of the software from one computer or processor into another, for example, from a management server or host computer into the computer platform of an application server. Thus, another type of media that may bear the software elements includes optical, electrical and electromagnetic waves, such as used across physical interfaces between local devices, through wired and optical landline networks and over various air-links).
Regarding claim 30, modified Rasab teaches the system of claim 28, where in the fully automated software system comprises a plurality of internal APIs (Rasab; para [200]; All or portions of the software may at times be communicated through the Internet or various other telecommunication networks. Such communications, for example, may enable loading of the software from one computer or processor into another, for example, from a management server or host computer into the computer platform of an application server. Thus, another type of media that may bear the software elements includes optical, electrical and electromagnetic waves, such as used across physical interfaces between local devices, through wired and optical landline networks).
Regarding claim 31, modified Rasab teaches the system of claim 28, where in the fully automated software system comprises a plurality of AI software applications and systems (Rasab; para [102, 105]; sample analysis may be easy to interpret due to a curated database (e.g., knowledge base) and artificial intelligence assisted report interpretation… The database (e.g., knowledge base) and bioinformatics may be an artificial intelligence or machine learning based system that matches the sequenced data with the most relevant genomics data sets, published clinical studies, and published scientific research papers).
Regarding claim 32, modified Rasab teaches the system of claim 28, where in the fully automated software system comprises a plurality of bioinformatics pipelines (Rasab; para [105]; The database (e.g., knowledge base) and bioinformatics may be an artificial intelligence or machine learning based system that matches the sequenced data with the most relevant genomics data sets, published clinical studies, and published scientific research papers).
Regarding claim 33, modified Rasab teaches the system of claim 28, where in the fully automated software system comprises a plurality of analytical and reporting software or modules (Rasab; para [29]).
Regarding claim 34, modified Rasab teaches the system of claim 1, wherein the fully automated software system comprises a plurality of software applications networked together (Rasab; para [200]).
Regarding claim 35, modified Rasab teaches the system of claim 9, wherein the fully automated software application network is integrated with a bioinformatics pipeline and a software application provides input to the liquid handling system, based on parameters determined by software application to meet desired output parameters from the bioinformatics pipeline functionally connected to the multi-module workstation (Rasab; para [105, 118, 360, 361]; The database (e.g., knowledge base) and bioinformatics may be an artificial intelligence or machine learning based system that matches the sequenced data with the most relevant genomics data sets, published clinical studies, and published scientific research papers)…processing module may include a liquid handling unit). The process of determining if the sample meets quality standards is discussed in para 360.
Regarding claim 36, modified Rasab teaches the system of claim 35, wherein the input is a sample pooling volume for a sequencing library (Rasab; para [104, 196]; laboratory robotics may be automated robotics that carries out the picking and placing of the chips, loading of the sequencer consumables into the sequencer as well as sequencer chips with the constructed sample libraries…The storage unit 4015 can store files, such as drivers, libraries and saved programs).
Regarding claim 37, modified Rasab teaches a software application comprising instructions which, when the program is executed by a computer, cause the computer to instruct the system of claim 1 to robotically insert a sequencing module, comprising a sequencing cartridge and sequencing flow cell, into a sequencer (Rasab; para [360, 361]).
Regarding claim 38, modified Rasab teaches a process for robotically inserting a cartridge into a sequencer comprising using a robotic system of claim 1 (Rasab; para [360, 361]).
Regarding claim 39, modified Rasab teaches a system for automating a nucleic acid sequencing process (Rasab; Abstract; para [9]; Systems for processing a sample may include one or more of input modules, processing modules, thermal modules, detection modules, or computer processors…the method further comprises using a sequencing unit to amplify or sequence at least a portion of the sample), the system comprising:
a robotic arm (Rasab; para [104]; The laboratory robotics may be automated robotics that carries out the picking and placing of the chips, loading of the sequencer consumables into the sequencer as well as sequencer chips with the constructed sample libraries),
whereby the system is controlled by the fully automated software system (Rasab; para [170]; The computer server may include (i) a database (e.g., knowledge base) for storing test information and clinical information (ii) a memory for storing a set of software instructions, and (iii) one or more computer processors configured to execute a set of software instructions) and wherein the fully automated system is adapted to receive a first input comprising at least one flow cell sequencing capacity and a second input comprising a plurality of sizes of genomes (Fig. 4, 6; para [105, 106]).
Rasab does not teach the robotic arm having a left effector and a right effector, wherein each of the left and right effector is adapted to move via linear translation and rotation within a common plane, said robotic arm connected to a rotary axis and adapted to enable coordinated rotation of the left effector and right effector through 360 degrees of rotation within the common plane, said rotary axis connected to the apparatus.
However, Downs teaches an analogous art a gripper apparatus (Downs; Abstract), wherein the robotic arm has a left effector and a right effector (Downs; Fig. 2; para [36]; grasping arms A and B extend from the body 22 and include pivot members 35), wherein each of the left and right effector is adapted to move via linear translation and rotation within a common plane4 (Downs; Fig. 3; para [41, 43]), said robotic arm connected to a rotary axis and adapted to enable coordinated rotation of the left effector and right effector through 360 degrees of rotation within the common plane4 (Downs; Fig. 1, 2; para [31, 32]; the robotic gripper 10 comprises a grasping mechanism 20 movably connected to a boom 12 that is movable relative to a base 14…the boom 12 is capable of about 360 degrees of rotation), said rotary axis connected to an apparatus (Downs; para [29]; In accordance with the present invention, a robotic gripper apparatus (also referred to herein as a robotic gripper mechanism) is provided. Although this disclosed example is designed to be employed with a specific high throughput system, other uses for the present invention are contemplated). It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the robotic arm of Rasab to comprise the left effector and the right effector as taught by Downs, because Downs teaches that the robotic gripper mechanism grips, transports and positions sample plates from a station to another station (Downs; para [39]). Further, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the robotic arm of Rasab to comprise the rotary axis as taught by Downs, because Downs teaches the boom rotates the robotic arm to define the work perimeter (Downs; para [32, 33]).
4 The limitations are directed to the function and/or the manner of operating the robotic arm, all the structural limitations of the claim has been disclosed by Rasab and the robotic arm of Rasab is capable of being “adapted to move via linear translation and rotation within a common plane” and “adapted to enable coordinated rotation of the left effector and right effector through 360 degrees of rotation within the common plane”. As such, it is deemed that the claimed robotic arm is not differentiated from the robotic arm of Rasab (see MPEP §2114)
Thus, modified Rasab teaches moving said robotic arm towards a sequencing module, comprising a sequencing cartridge and sequencing flow cell, on a location (Downs; para [40]; When employed in a high throughput process, the controller 15 instructs the robotic gripper mechanism 10 to move the boom 12 toward a station 30; Rasab; para [361]; A robotic handling sub-system may insert the cartridge into the sequencer and place the relevant reagent bottles needed by the sequencer); extending the left effector and the right effector of the robotic arm around the sequencing module on the location and subsequently contracting said effectors around the sequencing module, thereby holding the sequencing module with the robotic arm (Downs; Fig. 5; para [39]; the robotic gripper mechanism 10 grips, transports and positions sample plates 25 from a station 30 to another station 30 or to a hand-off area or to another location within the work perimeter of the robotic gripper mechanism 10); moving the sequencing module that is held by the robotic arm into a sequencer thereby loading the sequencing module (Rasab; para [361]; the robotic handling sub-system may collect a flow cell from the flow cell holder in the lab and insert the flow cell into the sequencer)5.
5 The limitations are directed to the function and/or the manner of operating the apparatus, all the structural limitations of the claim has been disclosed by Rasab in view of Downs and the apparatus of modified Rasab is capable of “moving said robotic arm towards a sequencing module, comprising a sequencing cartridge and sequencing flow cell, on a location; extending the left effector and the right effector of the robotic arm around the sequencing module on the location and subsequently contracting said effectors around the sequencing module, thereby holding the sequencing module with the robotic arm; moving the sequencing module that is held by the robotic arm into a sequencer thereby loading the sequencing module”. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of modified Rasab (see MPEP §2114)
Claims 24-25 are rejected under 35 U.S.C. 103 as being unpatentable over Rasab in view of Downs, and in further view of Zarling et al (US 20030082551 A1; hereinafter “Zarling”; already of record).
Regarding claim 24, modified Rasab teaches the system of claim 9, with the workstation.
Modified Rasab does not teach where the workstation comprises a magnet plate.
However, Zarling teaches an analogous art using high-throughput methods for gene targeting, recombination, phenotype screening (Zarling; Abstract) comprising a workstation where the workstation comprises a magnet plate (Zarling; para [27]; The deck is equipped with a magnetic bead-processing unit). It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the workstation of modified Rasab to comprise the magnet plate as taught by Zarling, because Zarling teaches that the magnetic beads isolate the targeting polynucleotide:target sequence complex (Zarling; para [98]).
Regarding claim 25, modified Rasab teaches the system of claim 9, with the workstation.
Modified Rasab does not teach where the workstation comprises a vacuum manifold.
However, Zarling teaches an analogous art using high-throughput methods for gene targeting, recombination, phenotype screening (Zarling; Abstract) comprising a workstation where the workstation comprises a vacuum manifold (Zarling; para [22]; the invention utilize many robotic systems comprising of computer workstations programmed to manipulate devices selected from…a vacuum filtration unit). It would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to substitute the workstation of modified Rasab to comprise the vacuum manifold as taught by Zarling this is a known and suitable workstation for system in the art. The simple substitution of one known element for another is likely to be obvious when predictable results are achieved. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, B).
Response to Arguments
Applicant’s arguments have been fully considered, and the arguments are not found to be persuasive. The non-persuasive arguments are addressed below.
In the Applicant’s, on page 2-3, the Applicant argues “introducing 360-degree rotational capability to Downs’ grasping arms fundamentally undermines the invention”. The Examiner respectfully disagrees. The claim amendments read that “the robotic arm…adapted to enable coordinated rotation of the left effector and the right effector through 360 degrees of rotation within the common plane”. First, the limitation is directed to the function and/or the manner of operating the robotic arm, and all the structural limitations of the claim has been disclosed by Rasab in view of Downs discussed above. Second, the claim is interpreted that the “left effector and right effector” rotate along a common plane. As seen in Figure 2 of Downs, both effectors are capable of rotating along a common plane when boon rotates (Downs; para [32]).
In response to applicant’s argument, on page 3-4, that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, paragraph 9 of the Final Rejection clearly provides the motivation established to modify the primary reference.
In the Applicant’s, on page 5-7, the Applicant argues Downs fails to teach the claim limitations because the grasping arms A and B are not adapted to move via linear translation and rotation within a common plane and adapted to enable coordinated rotation of the left effector and the right effector through 360 degrees of rotation within the common plane”. Again, the limitation is directed to the function and/or the manner of operating the robotic arm, and all the structural limitations of the claim has been disclosed by Rasab in view of Downs discussed above. In Figure 2 of Downs and paragraph 32, the boon is capable of rotating. The Examiner notes that the rotation of the boon in turn rotates the grasping arms. For examiner, if the boon rotates 360 degrees clockwise then the grasping arms A and B rotate as well with respect to the boon/common plane.
In response to applicant's argument, on page 7-8, that a POSITA would not look to combine the robotic arm of Downs with the system of Rasab, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). Specifically, Rasab teaches that a robotic arm may be used to place chips within the sequencer, thus the modification of Downs to comprise the arms improves accuracy as described by the Applicant. Further, the applicant's arguments against the references individually, cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
In the Applicant’s, on page 9, the Applicant argues Rasab in view of Downs fails to teach the “first input” and “second input”. The limitation is unclear as discussed above in the 112(b) rejection.
In the Applicant’s, on page 9, the arguments regarding the dependent claims merely refer back to the teachings of the references not meeting independent claim 1. However, the arguments regarding claim 1 are addressed above.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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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/A.Q.L./Examiner, Art Unit 1796
/MATTHEW D KRCHA/Primary Examiner, Art Unit 1796
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