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 .
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. DE102021117034.6, filed on 07/01/2021.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Response to Arguments
Applicant's arguments filed 08/07/2026 have been fully considered but they are not persuasive.
In response to applicant's argument that Teich et al. does not disclose “at least one processor configured to control the robotic actuator and the electrical sensor in accordance with a predefined measurement script, the predefined measurement script setting a sequence of wells of the multi-well plate into which the electrical sensor is dipped”, a recitation of the intended use 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. If the prior art structure is capable of performing the intended use, then it meets the claim. The Examiner infers that the connected desktop computer would have a processor in order to control the overall measurement system. The combination of prior art’s computer, controller, and software allow for preprogrammed script assay assignments and execution using sensors and a robotic actuator to the wells of a well plate.
Applicant's arguments fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references.
Applicant's arguments do not comply with 37 CFR 1.111(c) because they do not clearly point out the patentable novelty which he or she thinks the claims present in view of the state of the art disclosed by the references cited or the objections made. Further, they do not show how the amendments avoid such references or objections.
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.
Claim(s) 1-10 are rejected under 35 U.S.C. 102(a)(1) based upon a public use or sale or other public availability of the invention. The instant invention is anticipated by Teich et al. (US20160077083A1).
Regarding Claim 1, Teich et al. teaches a system (See the Abstract, the apparatus 100, and the Claim(s) 17-19, 21-26, 50-53, and 75-85 in [0007]-[0021], [0033]-[0094] in Fig. 1-10), comprising:
- a robotic actuator configured to engage an electrical sensor (See the elevator mechanism 145, i.e. a robotic or automated actuator, the sensor probes 170, the sensor sleeve/barrier 240, and the sensors 250 in [0033]-[0065] in Fig. 1-9 and in Claim 17),
the electrical sensor comprising a sensitive region that can be functionalized using first molecules of a first type (See how a plurality of regions 210, has a planar element that defines first, second, third, and fourth ports 230, which serve as test compound reservoirs, and a central aperture 215 to a sleeve 240 in [0036]-[0041] in Fig. 1-2b),
- a platform configured to retain a multi-well plate (See the stage or base 130 adapted to receive a multi-well plate 120 in [0034] in Fig. 1), and
- at least one processor configured to control the robotic actuator to dip the electrical sensor into one or more wells of the multi-well plate (See how the controller 175 permits the delivery of a test fluid from a port to a corresponding well when an associated sensor is disposed in the well in [0035] in Fig. 1-10), at least one of the one or more wells being filled with an analyte liquid comprising second molecules of a second type (See in [0033]-[0094] in Fig. 1-10 and in Claim 76),
wherein the at least one processor is configured to control the electrical sensor to acquire one or more time sequences of data readouts when the electrical sensor is dipped into each one of the at least one of the one or more wells (See in [0033],[0049], [0055], [0060]-[0078] in Fig. 10),
wherein the at least one processor is configured to determine at least one binding property of a binding between the first molecules and the second molecules based on at least some of the data readouts of the one or more time sequences of data readouts (See how the Desktop software 900 contains a user interface that allows a user to enter experiment design information into data file 901. Operating system software 902 also contains a user interface for viewing and modification of experiment design information and for viewing of experiment results. Experiment design information may include the type of cells, number of cells, type of drug, and concentration of drug contained in each microplate well, the required measurement time, media mixing time, the analyte to be assayed, or other data that define attributes of the experiment to be run by the instrument in [0067]-[0078] in Fig. 10 and in Claim(s) 17-19, 21-26, 50-53, and 75-85; Also, see the computer 180 and controller 175 in [0035] in Fig. 1), and
wherein the at least one processor is configured to control the robotic actuator and the electrical sensor in accordance with a predefined measurement script, the predefined measurement script setting a sequence of wells of the multi-well plate into which the electrical sensor is dipped (See how the multiplexer may be adapted to connect to a single pneumatic source to permit delivering fluid to the wells sequentially from each set of ports and how multiple scientists cam design and execute multiwell parallel assays in [0010]-[0021], [0033], [0061]-[0062], [0087]).
Regarding Claim(s) 2-3, Teich et al. teaches the system limitations of claim 1.
Teich et al. further teaches a system (See the Abstract, the apparatus 100, and the Claim(s) 17-19, 21-26, 50-53, and 75-85 in [0007]-[0021], [0033]-[0094] in Fig. 1-10), wherein the at least one processor (See the controller 127 in [0035] in Fig. 1-10) is configured to determine the at least one binding property based on a timing of said controlling of the robotic actuator to dip the electrical sensor into the one or more wells of the multi-well plate (See the elevator mechanism 145, i.e. a robotic or automated actuator, the sensor probes 170, the sensor sleeve/barrier 240, and the sensors 250 in [0033]-[0065] in Fig. 1-9);
wherein the predefined measurement script is parameterized based on at least one parameter, a value of the at least one parameter being set based on at least one of the data readouts of the one or more time sequences of data readouts (See how the Desktop software 900 contains a user interface that allows a user to enter experiment design information into data file 901. Operating system software 902 also contains a user interface for viewing and modification of experiment design information and for viewing of experiment results. Experiment design information may include the type of cells, number of cells, type of drug, and concentration of drug contained in each microplate well, the required measurement time, media mixing time, the analyte to be assayed, or other data that define attributes of the experiment to be run by the instrument in [0067]-[0078] in Fig. 10; Also, see how the multiplexer may be adapted to connect to a single pneumatic source to permit delivering fluid to the wells sequentially from each set of ports and how multiple scientists cam design and execute multiwell parallel assays in [0010]-[0021], [0033], [0061]-[0062], [0087]).
Regarding Claim 4, Teich et al. teaches the system limitations of claim 3.
Teich et al. further teaches a system (See the Abstract, the apparatus 100, and the Claim(s) 17-19, 21-26, 50-53, and 75-85 in [0007]-[0021], wherein the predefined measurement script defines a calibration phase or dissociation phase (See in [0016], [0025], [0054], [0061]-[0063] in Fig 1-10 and in Claim 17),
wherein the at least one processor is configured to control the robotic actuator to dip the electrical sensor into a first one of the one or more wells of the multi-well plate filled with a reference liquid during the calibration phase or the dissociation phase (See in Claim 17),
wherein the at least one parameter of the predefined measurement script comprises a dwell time of the electrical sensor in the first one of the one or more wells, wherein the value of the dwell time is set based on at least one of a change rate of multiple data readouts of the data readouts while the electrical sensor is dipped into the first one of the one or more wells, or an absolute signal level of the multiple data readouts while the electrical sensor is dipped into the first one of the one or more wells (See how the Desktop software 900 contains a user interface that allows a user to enter experiment design information into data file 901. Operating system software 902 also contains a user interface for viewing and modification of experiment design information and for viewing of experiment results. Experiment design information may include the type of cells, number of cells, type of drug, and concentration of drug contained in each microplate well, the required measurement time, media mixing time, the analyte to be assayed, or other data that define attributes of the experiment to be run by the instrument in [0067]-[0078] in Fig. 10 and in Claim(s) 17-19, 21-26, 50-53, and 75-85).
Regarding Claim 5, Teich et al. teaches the system limitations of claim 3.
Teich et al. further teaches a system (See the Abstract, the apparatus 100, and the Claim(s) 17-19, 21-26, 50-53, and 75-85 in [0007]-[0021], wherein the predefined measurement script defines an association phase, wherein the at least one processor is configured to control the robotic actuator to dip the electrical sensor into the at least one of the one or more wells of the multi-well plate filled with the analyte liquid during the association phase (See how the controller 175 permits the delivery of a test fluid from a port to a corresponding well when an associated sensor is disposed in the well in [0035] in Fig. 1-10 and in Claim 17),
wherein the at least one binding property comprises a binding kinetics, the binding kinetics being determined using a regression analysis of a predefined binding curve to multiple data readouts of the data readouts of a time sequence of data readouts acquired during the association phase (See in [0048], [0079]-[0094] in Fig. 1-10),
wherein the at least one parameter of the predefined measurement script comprises a time gate for the regression analysis, wherein a value of the time gate is set based on a timing of said controlling of the robotic actuator to dip the electrical sensor into the at least one of the one or more wells of the multi-well plate filled with the analyte liquid (See how the Desktop software 900 contains a user interface that allows a user to enter experiment design information into data file 901. Operating system software 902 also contains a user interface for viewing and modification of experiment design information and for viewing of experiment results. Experiment design information may include the type of cells, number of cells, type of drug, and concentration of drug contained in each microplate well, the required measurement time, media mixing time, the analyte to be assayed, or other data that define attributes of the experiment to be run by the instrument in [0067]-[0078] in Fig. 10 and in Claim(s) 17-19, 21-26, 50-53, and 75-85; Also, see how the multiplexer may be adapted to connect to a single pneumatic source to permit delivering fluid to the wells sequentially from each set of ports and how multiple scientists cam design and execute multiwell parallel assays in [0010]-[0021], [0033], [0061]-[0062], [0087]).
Regarding Claim(s) 6-9, Teich et al. teaches the system limitations of claim 1.
Teich et al. further teaches a system (See the Abstract, the apparatus 100, and the Claim(s) 17-19, 21-26, 50-53, and 75-85 in [0007]-[0021], wherein the robotic actuator (See the elevator mechanism 145, i.e. a robotic or automated actuator, the sensor probes 170, the sensor sleeve/barrier 240, and the sensors 250 in [0033]-[0065] in Fig. 1-9 and in Claim 17) is configured to engage a further electrical sensor so that the electrical sensor and the further electrical sensor are arranged at an offset which corresponds to an offset between wells of the multi-well plate (See how a plurality of regions 210, has a planar element that defines first, second, third, and fourth ports 230, which serve as test compound reservoirs, and a central aperture 215 to a sleeve 240 in [0036]-[0041] in Fig. 1-2b),
wherein the at least one processor is configured to control the further electrical sensor to acquire one or more further time sequences of further data readouts when the further electrical sensor is dipped into each one of one or more further wells of the multi-well plate, wherein the at least one processor is configured to determine the at least one property using a reference baseline obtained from at least some of the further data readouts (See how the Desktop software 900 contains a user interface that allows a user to enter experiment design information into data file 901. Operating system software 902 also contains a user interface for viewing and modification of experiment design information and for viewing of experiment results. Experiment design information may include the type of cells, number of cells, type of drug, and concentration of drug contained in each microplate well, the required measurement time, media mixing time, the analyte to be assayed, or other data that define attributes of the experiment to be run by the instrument in [0067]-[0078] in Fig. 10 and in Claim(s) 17-19, 21-26, 50-53, and 75-85; Also, see how the multiplexer may be adapted to connect to a single pneumatic source to permit delivering fluid to the wells sequentially from each set of ports and how multiple scientists cam design and execute multiwell parallel assays in [0010]-[0021], [0033], [0061]-[0062], [0087]);
wherein the predefined measurement script defines a preparation phase, wherein the at least one processor is configured to control the robotic actuator to dip the electrical sensor into a second one of the one or more wells of the multi-well plate filled with a liquid comprising the first molecules during the preparation phase, wherein the at least one processor is configured to not dip the further electrical sensor into any well of the multi-well plate filled with the liquid comprising the first molecules during the preparation phase (See in [0067]-[0078] in Fig. 10 and in Claim(s) 17-19, 21-26, 50-53, and 75-85);
wherein the at least one processor is configured to control at least one of the robotic actuator or a motor attached to the platform to relative move the electrical sensor with respect to and within the at least one of the one or more wells when the electrical sensor is dipped into each one of the at least one of the one or more wells (See in [0012], [0034]-[0036], [0040], [0056] in Fig. 1-10);
wherein the at least one binding property comprises at least one of a binding kinetics of a binding between the first molecules and the second molecules, binding affinity of the binding between the first molecules and the second molecules, concentration of the second molecules in the analyte liquid, or a conformality structure of the second molecules (See in [0048], [0079]-[0094] in Fig. 1-10).
Regarding Claim 10, Teich et al. teaches a computer-implemented method (See the Abstract, the apparatus 100, and the Claim(s) 17-19, 21-26, 50-53, and 75-85 in [0007]-[0021], [0033]-[0094] in Fig. 1-10), comprising: - controlling a robotic actuator that engages an electrical sensor that can be functionalized using first molecules of a first type to dip the electrical sensor into multiple wells of a multi-well plate (See the elevator mechanism 145, i.e. a robotic or automated actuator, the sensor probes 170, the sensor sleeve/barrier 240, and the sensors 250 in [0033]-[0065] in Fig. 1-9 and in Claim 17),
at least one of the one or more wells being filled with an analyte liquid comprising second molecules of a second type (See how a plurality of regions 210, has a planar element that defines first, second, third, and fourth ports 230, which serve as test compound reservoirs, and a central aperture 215 to a sleeve 240 in [0036]-[0041] in Fig. 1-2b),
a sequence of the multiple wells being set by a predefined measurement script (See how the multiplexer may be adapted to connect to a single pneumatic source to permit delivering fluid to the wells sequentially from each set of ports and how multiple scientists cam design and execute multiwell parallel assays in [0010]-[0021], [0033], [0061]-[0062], [0087]; Also, see the computer 180 and controller 175 in [0035] in Fig. 1),
- controlling the electrical sensor to acquire one or more time sequences of data readouts when the electrical sensor is dipped into each one of the one or more wells (See how the controller 175 permits the delivery of a test fluid from a port to a corresponding well when an associated sensor is disposed in the well in [0035] in Fig. 1-10), and
- determining at least one binding property of a binding between the first molecules and the second molecules based on at least some of the data readouts (See how the Desktop software 900 contains a user interface that allows a user to enter experiment design information into data file 901. Operating system software 902 also contains a user interface for viewing and modification of experiment design information and for viewing of experiment results. Experiment design information may include the type of cells, number of cells, type of drug, and concentration of drug contained in each microplate well, the required measurement time, media mixing time, the analyte to be assayed, or other data that define attributes of the experiment to be run by the instrument in [0067]-[0078] in Fig. 10 and in Claim(s) 17-19, 21-26, 50-53, and 75-85).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The following prior art teaches similar devices and methods: Umapathi et al. (US20180318826A1).
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRITNEY N. WASHINGTON whose telephone number is (703)756-5959. The examiner can normally be reached Monday-Friday 9:00am - 5:30pm CT.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lyle Alexander can be reached at (571) 272-1254. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRITNEY N. WASHINGTON/Examiner, Art Unit 1797
/JENNIFER WECKER/Primary Examiner, Art Unit 1797
