Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim 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 1-4 and 7-25 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 “a second set of probes, wherein at least one of the second set of probes “. This limitation is indefinite since it is unclear how many “second set of probes” are intended to be claimed (i.e., singular (“a”) or more than one (“at least one of”). For the purpose of examination, the limitation will be interpreted as “a second set of probes, wherein at least one probe of the second set of probes” in accordance with applicant’s specification.
Claims 2-3 and 7-25 depend on claim 1.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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 1-4 and 7-24 are rejected under 35 U.S.C. 103 as being unpatentable over EP0410645 to Cohen et al. in view of U.S. Patent No. 5,104,808 to Laska et al. and U.S. Patent No. 6,143,578 to Bendele et al.
Cohen et al. discloses an immunoassay diagnostic system configured to perform a plurality of assay types and thereby detect analytes in patient samples by at least combining each of the patient samples with at least one reagent and then washing away at least unreacted components of the patient sample (See Abstract)
The immunoassay diagnostic system includes a reaction cell configured to hold a patient sample and the at least one reagent (reaction cuvette 14, Fig. 7; page 4, lines 37-51) and a washing arrangement configured to wash away at least the unreacted components of the patient sample from the reaction cell by a multiple number of wash actions (particle wash station 9, Fig. 4, with wash stand 28, Fig. 17, page 12, line 22 - page 13, line 13).
The washing arrangement is configured to wash the reaction cell within a predetermined timed sequence (page 12, lines 56-57: "protocols"), and is also configured to set the number of the wash actions to correspond with the assay type (page 12, line 51 - page 13, line 13).
Cohen et al. teaches a particle wash station that has a plurality of concentric cylindrical dual dispense-aspiration independently controlled probes adapted for insertion into successive cuvettes.
Cohen further teaches a sample probe means 36 (at least one probe) configured to aspirate and dispense solutions (Pg. 9, lines 46-58 through Pg. 10, lines 1-8; see e.g., Fig. 8).
Cohen does not explicitly teach sets of probes.
However, Laska et al. teaches an immunoassay system that uses magnetic separation of unreacted components. In Fig. 4 Laska et al. illustrates a wash station that includes probes 182, 186 and 189 that dispense wash buffer into reaction vessels (“a second set” of probes) and probes 184, 188, 190 and 192 aspirate fluid from reaction vessels (“a first set” of probes). The probes are arranged on separate blocks 208 and 212 and interpreted as two different sets or probes. (column 7, lines 14-22). It would have been obvious to one of ordinary skill in the art to combine one set probes (e.g., probes 184, 188, 190, 192) with the apparatus of Cohen et al., and combine another set of probes (e.g., 182, 186, 189) with the sample probe means 36 of Cohen, as taught by Laska, to conduct buffer dispensing and aspiration of buffer and unreacted components for purposes of cleaning reaction vessels and targets.
Cohen et al. in view of Laska et al. do not teach that the separate sets of probes are configured to perform multiple wash actions.
However, Bendele et al. teaches a method and apparatus for enabling re-suspension wash and magnetic localization of sample components bound to particles with magnetic properties in reaction vessels during separation and wash. (Abstract). As shown in Fig. 1A the apparatus includes a first set of probes 15, 17, 19 that perform aspirating; and a second set of probes 30, 32, 34 that perform dispensing. Thus, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to conduct alternating multiple steps of dispensing and aspirating buffer solution and unreacted components, in which buffer solution is dispensed prior to an aspirating step using multiple probe sets, for the purpose of removing unreacted components and buffer solution for better cleaning.
Claim 1 has been amended to recite a first probe of the second set of probes is configured to dispense a buffer solution into the reaction cell after initially aspirating the buffer solution and the unreacted components of the patient sample from the reaction cell and subsequently aspirate the buffer solution and the unreacted components of the patient sample from the reaction cell after dispensing the buffer solution into the reaction cell, wherein the first and second set of probes are thereby configured to perform a multiple number of wash actions.
The recitations in claim 1 regarding “configured to…(plus function)” do not incorporate any structural limitations to the immunoassay diagnostic system and thus are not afforded patentable weight. Specifically, the sample probe means 36 of Cohen, which is a probe of the “second set” of probes of the prior art combination of Cohen and Laska, would be capable of aspirating a first buffer solution and unreacted components, and dispensing and aspirating a second buffer solution, since the sample probe means 36 includes all of the mechanical features necessary to carry out the claimed operation. See MPEP 2114.
Thus, the combination of probes taught in Cohen et al., Laska et al., and Bendele et al. are structurally capable (i.e. configured) to function as recited in claim 1.
I.) Regarding applicant’s claim 1, as noted above Cohen et al. in view Laska et al. and Bendele et al. teaches all the elements of claim 1.
Therefore, Cohen et al. in view of Laska et al. renders claim 1 obvious.
II.) Regarding applicant’s claim 2, as noted above Cohen et al. in view of Laska et al. and Bendele et al. renders claim 1 obvious from which claim 2 depends.
Claim 2 recites that the immunoassay diagnostic system is configured to detect an antigen as one of the analytes in the patient samples.
Cohen et al. in view of Laska et al. and Bendele et al. does not teach detecting an antigen as one of the analytes in the patient samples.
Cohen et al. teaches reacting samples for analysis of analytes. (page 3, lines 5-7, et seq.)
Antigens bond to antibodies as noted by Cohen et al. (page 3, lines 53-54)
Analytes bond to antibodies as noted by Cohen et al. (page 5, lines 23-27)
It would have been obvious to one of ordinary skill in the art to detect an antigen in Cohen et al. as one of the analytes in a patient’s samples based on the known interrelationship between antigens, antibodies and analytes as taught by Cohen et al.
Therefore Cohen et al. in view of Laska et al. and Bendele et al. renders claim 2 obvious.
III.) Regarding applicant’s claim 3, as noted above Cohen et al. in view of Laska et al. and Bendele et al. renders claim 1 obvious from which claim 3 depends.
Claim 3 recites that the immunoassay diagnostic system is configured to detect an antibody as one of the analytes in the patient samples.
Cohen et al. in view of Laska et al. and Bendele et al. does not teach detecting an antibody as one of the analytes in the patient samples.
At page 3, lines 3-10 Cohen et al. discusses how the immunoassay system can detect antibodies.
Cohen et al. teaches reacting samples for analysis of analytes. (page 3, lines 5-7, et seq.)
Antigens bond to antibodies as noted by Cohen et al. (page 3, lines 53-54)
Analytes bond to antibodies as noted by Cohen et al. (page 5, lines 23-27)
It would have been obvious to one of ordinary skill in the art to detect an antibody in Cohen et al. in view of Laska et al. and Bendele et al. as one of the analytes in a patient’s samples based on the known interrelationship between antigens, antibodies and analytes as taught by Cohen et al.
Therefore, Cohen et al. in view of Laska et al. and Bendele et al. renders claim 3 obvious.
IV.) Regarding applicant’s claim 4, as noted above Cohen et al. in view of Laska et al. and Bendele et al. renders claim 1 obvious from which claim 4 depends.
Claim 4 recites that the reaction cell includes a sample vessel.
Cohen et al. teaches sample containers (“vessels”) at page 9, lines 13-22. Otherwise, the reaction cuvette 14 is interpreted as being a sample vessel.
Therefore, Cohen et al. in view of Laska et al. and Bendele et al. renders claim 4 obvious.
V.) Regarding applicant’s claim 7, as noted above Cohen et al. in view of Laska et al. and Bendele et al. renders claim 1 obvious from which claim 7 depends.
Claim 7 recites that the second probe of the second set of probes is further configured to dispense buffer solution into the reaction cell after initially aspirating the buffer solution and the unreacted components of the patient sample from the reaction cell and wherein the second probe of the second set of probes is further configured to subsequently aspirate the buffer solution and the unreacted components of the patient sample from the reaction cell after dispensing buffer solution into the reaction cell.
Cohen et al. in view of Laska et al. and Bendele et al. does not teach that the second set of probes includes a second probe that is configured to dispense and aspirate buffer fluid into the reaction cell.
It would have been obvious to one of ordinary skill in the art to modify Cohen et al. in view of Laska et al. and Bendele et al. to a second probe in the second set of probes to dispense and aspirate buffer solution, for additional cleaning. Note the mere duplication of parts is not patentable unless a new and unexpected result is produced. (MPEP 2144.04(VI)(B))
Therefore, Cohen et al. in view of Laska et al. and Bendele et al. render claim 7 obvious.
IV.) Regarding applicant’s claim 8, as noted above Cohen et al. in view of Laska et al. and Bendele et al. renders claim 1 obvious from which claim 8 depends.
Claim 8 recites wherein a first platform moves the first set of probes and a second
platform moves the second set of probes.
Cohen et al. in view of Laska et al. and Bendele et al. does not teach first and second movable platforms that support first and second sets of probes.
In Fig. 5 Laska et al. teaches movable blocks (“platforms”) 208 and 212 that support first and second sets of probes.
It would have been obvious to one of ordinary skill in the art to modify Cohen et al. in view of Laska et al. and Bendele et al. to support multiple sets of probes on separate movable platforms as taught by Laska et al. for purposes of moving and aligning the probes with reaction cuvettes during operation.
Therefore, Cohen et al. in view of Laska et al. and Bendele et al. renders claim 8 obvious.
V.) Regarding applicant’s claim 9, as noted above Cohen et al. in view of Laska et al. and Bendele et al. renders claim 1 obvious from which claim 9 depends.
Claim 9 recites that the first set of probes is configured for actuation about a first single linear degree-of-freedom and the second set of probes is configured for actuation about a second single linear degree-of-freedom.
Cohen et al. in view of Lasak et al. and Bendele et al. does not teach that the first set of probes is configured for actuation about a first single linear degree-of-freedom and the second set of probes is configured for actuation about a second single linear degree-of-freedom.
In Fig. 4 of Laska et al. the vertical double-headed arrow on the left-hand side of the drawing illustrates how the first and second sets of probes move vertically in first and second linear degrees of freedom which are the same.
It would have been obvious to move each of the first and second sets of probes in Cohen et al. in view of Laska et al. and Bendele et al. in a vertical single linear degree of freedom as taught by Laska et al for purposes accessing the reaction cuvettes with the probes.
Therefore, Cohen et al. in view of Laska et al. and Bendele et al. renders claim 9 obvious.
VI.) Regarding applicant’s claim 10, as noted above Cohen et al. in view of Laska et al. and Bendele et al. renders claim 9 obvious from which claim 10 depends.
Claim 10 recites that the first single linear degree-of-freedom and the second single linear degree-of-freedom are each vertical.
Cohen et al. in view of Laska et al and Bendele et al. does not teach that the first single linear degree-of-freedom and the second single linear degree-of-freedom are each vertical.
As noted above, in Fig. 4 of Laska et al. the vertical double-headed arrow on the left-hand side of the drawing illustrates how the first and second sets of probes move vertically in first and second linear degrees of freedom which are the same.
It would have been obvious to move each of the first and second sets of probes in Cohen et al. in view of Laska et al. and Bendele et al. in a vertical single linear degree of freedom as taught by Laska et al for purposes accessing the reaction cuvettes with the probes.
Therefore, Cohen et al. in view of Laska et al. and Bendele et al. renders claim 10 obvious.
VII.) Regarding applicant’s claim 11, as noted above Cohen et al. in view of Laska et al. and Bendele et al. renders claim 1 obvious from which claim 11 depends.
Claim 11 recites a plurality of the reaction cells, wherein the washing arrangement includes a plurality of stations, wherein the washing arrangement is configured to sequentially move each of the plurality of the reaction cells to each of the plurality of stations within the predetermined timed sequence.
Cohen et al. in view of Laska et al. and Bendele et al. does not teach a washing arrangement with plurality of stations and sequentially moving the reaction cuvettes to each of the plurality of stations.
Laska et al. teaches a wash resource 76 that is shown in Fig. 2. As shown in Fig. 4 the wash resource has a number of washing stations along a circular axis along which vessels 66 move. (column 7, lines 9-14).
It would have been obvious to one of ordinary skill in the art to modify Cohen et al. in view of Laska et al. and Bendele et al. to have a washing arrangement as taught by Laska et al., including a plurality of stations and sequentially move the reaction cuvettes to each of the plurality of stations for purposes of washing unreacted components from the reaction cuvettes.
Therefore, Cohen et al. in view of Laska et al. and Bendele et al. renders claim 11 obvious.
VIII.) Regarding applicant’s claim 12, as noted above Cohen et al. in view of Laska et al. and Bendele et al. renders claim 11 obvious from which claim 12 depends.
Claim 12 recites that the washing arrangement includes a carrier with a plurality of holders, wherein each of the holders is configured to hold a corresponding one of the plurality of the reaction cells, and wherein the carrier is configured to sequentially move each of the plurality of the holders to each of the plurality of stations within the predetermined timed sequence and thereby sequentially move each of the plurality of the reaction cells to each of the plurality of stations within the predetermined timed sequence.
Cohen et al. in view of Laska et al. and Bendele et al. do not teach that the washing arrangement includes a carrier with a plurality of holders, wherein each of the holders is configured to hold a corresponding one of the plurality of the reaction cells, and wherein the carrier is configured to sequentially move each of the plurality of the holders to each of the plurality of stations within the predetermined timed sequence and thereby sequentially move each of the plurality of the reaction cells to each of the plurality of stations within the predetermined timed sequence.
In Fig. 4 Laska et al. illustrates vessels 66 that are held in a holder and are supported on a rotatable carrier as shown in Fig. 2.
It would have been obvious to one of ordinary skill in the art to modify Cohen et al. in view of Laska et al. and Bendele et al. to have a washing arrangement as taught by Laska et al., including a carrier with a plurality of holders, wherein each of the holders is configured to hold a corresponding one of the plurality of the reaction cells, and wherein the carrier is configured to sequentially move each of the plurality of the holders to each of the plurality of stations within the predetermined timed sequence and thereby sequentially move each of the plurality of the reaction cells to each of the plurality of stations within the predetermined timed sequence for purposes of washing unreacted components from the reaction cuvettes.
Therefore, Cohen et al. in view of Laska et al. and Bendele et al. renders claim 12 obvious.
IX.) Regarding applicant’s claim 13, as noted above Cohen et al. in view of Laska et al. and Bendele et al. renders claim 12 obvious from which claim 13 depends.
Claim 13 recites that the carrier is configured to move with a single degree-of-freedom.
The carrier in Cohen et al. in view of Laska et al. and Bendele et al. as modified by Laska et al. rotates in a single degree of freedom about an axis.
Therefore, Cohen et al. in view of Laska et al. and Bendele et al. renders claim 13 obvious.
X.) Regarding applicant’s claim 14, as noted above Cohen et al. in view of Laska et al. and Bendele et al. renders claim 13 obvious from which claim 14 depends.
Claim 14 recites that the single degree-of-freedom is rotational about an axis of the washing arrangement.
The carrier in Cohen et al. as modified by Laska et al. and Bendele et al. rotates in a single degree of freedom.
Therefore, Cohen et al. in view of Laska et al. and Bendele et al. renders claim 14 obvious.
XI.) Regarding applicant’s claim 15, as noted above Cohen et al. in view of Laska et al. and Bendele et al. renders claim 14 obvious from which claim 15 depends.
Claim 15 recites that the axis of the washing arrangement is vertical.
The axis of the carrier of Laska et al. is vertical as shown in Fig. 2.
Therefore, Cohen et al. in view of Laska et al. and Bendele et al. renders claim 15 obvious.
XII.) Regarding applicant’s claim 16, as noted above Cohen et al. in view of Laska et al. and Bendele et al. renders claim 1 obvious from which claim 16 depends.
Claim 16 recites that the washing arrangement includes at least one magnetic collecting structure configured to restrain magnetic components of the at least one reagent and thereby retain within the reaction cell the at least one reagent and portions of the patient sample attached to the at least one reagent at least when the unreacted components of the patient sample are washed away by the wash actions.
Cohen et al. teaches that “the contents of the cuvettes are washed off except for the magnetic particles and the species they carry, including the enzyme label, ” (page 6, lines 22-23) and “[m]agnets located at the side of the cuvette path through the wash station draw the solid phase to the sides of the cuvettes to facilitate the washing action.” (page 7, lines 36-37)
Therefore, Cohen et al. in view of Laska et al. and Bendele et al. renders claim 16 obvious.
XIII.) Regarding applicant’s claim 17, as noted above Cohen et al. in view of Laska et al. and Bendele et al. renders claim 1 obvious from which claim 17 depends.
Claim 17 recites that the washing arrangement includes at least one magnetic collecting structure configured to restrain magnetic components of the at least one reagent and thereby retain within the reaction cell the at least one reagent and portions of the patient sample attached to the at least one reagent at least when the unreacted components of the patient sample are washed away by the wash actions and wherein the at least one magnetic collecting structure is configured to restrain the magnetic components of the at least one reagent when any of the second set of probes initially aspirates, dispenses, and subsequently aspirates.
As noted above, it would have been obvious to one of ordinary skill in the art to modify Cohen et al. in view of Laska et al. and Bendele et al. to include two multiple sets of probes to conduct buffer dispensing and aspiration of buffer and unreacted components as taught by Laska et al. for purposes of cleaning reaction targets.
Cohen et al. in view of Laska et al. and Bendele et al. does not teach that the washing arrangement includes at least one magnetic collecting structure configured to restrain magnetic components of the at least one reagent and thereby retain within the reaction cell the at least one reagent and portions of the patient sample attached to the at least one reagent at least when the unreacted components of the patient sample are washed away by the wash actions and wherein the at least one magnetic collecting structure is configured to restrain the magnetic components of the at least one reagent when any of the second set of probes initially aspirates, dispenses, and subsequently aspirates.
Laska et al. teaches providing magnets 159 in the washing station adjacent the reaction vessels 66 as shown in Fig. 4. Laska et al. teaches that “FIG. 4 illustrates the basic mechanisms, magnetic separation and fluids associated with the wash resource 76,” indicating that the magnets 159 are used for magnetic separation and removal of unreacted components.
It would have been obvious to one of ordinary skill in the art to modify Cohen et al. in view of Laska et al. and Bendele et al. to include magnets as taught by Laska et al. in the washing station and thereby retain within the reaction cell the at least one reagent and portions of the patient sample attached to the at least one reagent at least when the unreacted components of the patient sample are washed away by the wash actions and wherein the at least one magnetic collecting structure is configured to restrain the magnetic components of the at least one reagent when any of the second set of probes initially aspirates, dispenses, and subsequently aspirates for purposes of removing wash buffer and unreacted components.
Therefore, Cohen et al. in view of Laska et al. and Bendele et al. renders claim 17 obvious.
XIV.) Regarding applicant’s claim 18, as noted above Cohen et al. in view of Laska et al. and Bendele et al. renders claim 17 obvious from which claim 18 depends.
Claim 18 recites that the at least one magnetic collecting structure is configured to continuously restrain the magnetic components of the at least one reagent while the reaction cell is at a station where any of the second set of probes initially aspirates, dispenses, and subsequently aspirates.
Cohen et al. in view of Laska et al. and Bendele et al. does not teach that the at least one magnetic collecting structure is configured to continuously restrain the magnetic components of the at least one reagent while the reaction cell is at a station where any of the second set of probes initially aspirates, dispenses, and subsequently aspirates.
In Fig. 4 Laska et al. depicts magnets 159 of the magnetic collecting structure as being aligned along the washing station.
In Cohen et al. in view Laska et al. and Bendele et al. the magnetic collecting structure would be configured to continuously restrain the magnetic components of the at least one reagent while the reaction cell is at a station where any of the second set of probes initially aspirates, dispenses, and subsequently aspirates.
Therefore, Cohen et al. in view of Laska et al. and Bendele et al. renders claim 18 obvious.
XV.) Regarding applicant’s claim 19, as noted above Cohen et al. in view of Laska et al. and Bendele et al. renders claim 17 obvious from which claim 19 depends.
Claim 19 recites that the at least one magnetic collecting structure is configured to continuously restrain the magnetic components of the at least one reagent while any of the second set of probes initially aspirates, dispenses, and subsequently aspirates.
Cohen et al. in view of Laska et al. and Bendele et al. does not teach that the at least one magnetic collecting structure is configured to continuously restrain the magnetic components of the at least one reagent while any of the second set of probes initially aspirates, dispenses, and subsequently aspirates.
In Fig. 4 Laska et al. depicts magnets 159 of the magnetic collecting structure as being aligned along the washing station.
In Cohen et al. in view of Laska et al. and Bendele et al. the magnetic collecting structure would be configured to continuously restrain the magnetic components of the at least one reagent while the reaction cell is at a station where any of the second set of probes initially aspirates, dispenses, and subsequently aspirates.
Therefore, Cohen et al. in view of Laska et al. and Bendele et al. renders claim 19 obvious.
XVI.) Regarding applicant’s claim 20, as noted above Cohen et al. in view of Laska et al. and Bendele et al. renders claim 1 obvious from which claim 20 depends.
Claim 20 recites a computer and a non-transitory computer readable medium having stored thereon data operable to configure the computer to: read an assay protocol file corresponding to the at least one reagent; and transmit instructions to the washing arrangement for the washing arrangement to set the number of wash actions.
Cohen et al. teaches “a computerized control system coordinates movement and operation of the various components of the apparatus to perform the desired assay protocols.” (page 15, lines 20-21).
It would have been obvious to one of ordinary skill in the art to modify Cohen et al. in view of Laska et al. and Bendele et al. to include a computer and a non-transitory computer readable medium having stored thereon data operable to configure the computer to: read an assay protocol file corresponding to the at least one reagent; and transmit instructions to the washing arrangement for the washing arrangement to set the number of wash actions for purposes of automating the system.
Therefore, Cohen et al. in view of Laska et al. and Bendele et al. renders claim 20 obvious.
XVII.) Regarding applicant’s claim 21, as noted above Cohen et al. in view of Laska et al. and Bendele et al. renders claim 6 obvious from which claim 21 depends.
Claim 21 recites a computer; and a non-transitory computer readable medium having stored thereon data operable to configure the computer to: read an assay protocol fil
Cohen et al. in view of Laska et al. and Bendele et al. does not teach a computer; and a non-transitory computer readable medium having stored thereon data operable to configure the computer to: read an assay protocol fil
As noted above, Cohen et al. teaches “a computerized control system coordinates movement and operation of the various components of the apparatus to perform the desired assay protocols.” (page 15, lines 20-21).
Further, Cohen et al. teaches that “the drawings do not illustrate all of the mechanical and electrical elements, i.e. motors, solenoids, pumps, valves, sensors, required for driving and controlling the various components of the apparatus. (page 8, lines 36-38)
It would have been obvious to one of ordinary skill in the art to modify Cohen et al. in view of Laska et al. and Bendele et al. to include a non-transitory computer readable medium having stored thereon data operable to configure the computer to: read an assay protocol file corresponding to the at least one reagent; and transmit instructions to the washing arrangement for the washing arrangement to set the number of the wash actions, for purposes of performing different desired assay protocols, including protocols that include multiple wash actions - as taught by Cohen et al., including operating one or more valves associated with the probes of the washing system.
Therefore, Cohen et al. in view of Laska et al. and Bendele et al. renders claim 21 obvious.
XVIII.) Regarding applicant’s claim 22, as noted above Cohen et al. in view of Laska et al. and Bendele et al. renders claim 11 obvious from which claim 22 depends.
Claim 22 recites a computer; and a non-transitory computer readable medium having stored thereon data operable to configure the computer to: individually identify each of the plurality of the reaction cells, the corresponding at least one reagent contained therein, and a current corresponding station of the plurality of stations thereat; and transmit instructions to the washing arrangement for the washing arrangement to set the number of the wash actions at each of a plurality of wash stations of the plurality of stations; wherein the number of the wash actions corresponds to each of the plurality of the reaction cells at each of the plurality of wash stations.
Cohen et al. in view of Laska et al. and Bendele et al. does not teach a computer; and a non-transitory computer readable medium having stored thereon data operable to configure the computer to: individually identify each of the plurality of the reaction cells, the corresponding at least one reagent contained therein, and a current corresponding station of the plurality of stations thereat; and transmit instructions to the washing arrangement for the washing arrangement to set the number of the wash actions at each of a plurality of wash stations of the plurality of stations; wherein the number of the wash actions corresponds to each of the plurality of the reaction cells at each of the plurality of wash stations.
As noted above, Cohen et al. teaches “a computerized control system coordinates movement and operation of the various components of the apparatus to perform the desired assay protocols.” (page 15, lines 20-21)
It would have been obvious to one of ordinary skill in the art to modify Cohen et al. in view of Laska et al. and Bendele et al. include a non-transitory computer readable medium having stored thereon data operable to configure the computer to: read an assay protocol file corresponding to the at least one reagent; and transmit instructions to the washing arrangement for the washing arrangement to set the number of the wash actions, for purposes of performing different desired assay protocols, including protocols that include multiple wash actions - as taught by Cohen et al.
Therefore, Cohen et al. in view of Laska yet al. and Bendele et al. renders claim 22 obvious.
XIX.) Regarding applicant’s claim 23, as noted above Cohen et al. in view of Laska et al. and Bendele et al. render claim 22 obvious from which claim 23 depends.
Claim 23 recites that the instructions include timed signals to one or more valves in fluid communication with the second set of probes.
As noted above, Cohen et al. teaches that “the drawings do not illustrate all of the mechanical and electrical elements, i.e. motors, solenoids, pumps, valves, sensors, required for driving and controlling the various components of the apparatus. (page 8, lines 36-38)
Cohen et al. also teaches “in actual running, the current cycle is executed from the information in the current cycle event table line by combining information from it with the task timing tables into a machine control scheduler. (page 16, lines 29-30).
In Cohen et al. in view of Laska et al. and Bendele et al. it would have been obvious to use instructions for assays that include timed signals to one or more valves in fluid communication with the second set of probes for control and automation purposes.
Therefore, Cohen et al. in view of Laska et al. and Bendele et al. renders claim 23 obvious.
XX.) Regarding applicant’s claim 24, as noted above Cohen et al. in view of Laska et al. and Bendele et al. renders claim 22 obvious from which claim 24 depends.
Claim 24 recites that the data is further operable to configure the computer to read an assay protocol file corresponding to the at least one reagent of each of the plurality of the reaction cells.
As noted above, Cohen et al. teaches “a computerized control system coordinates movement and operation of the various components of the apparatus to perform the desired assay protocols.” (page 15, lines 20-21)
It would have been obvious to modify Cohen et al. in view of Laska et al. and Bendele et al. to provide data that is operable to configure the computer to read an assay protocol file corresponding to the at least one reagent of each of the plurality of the reaction cells for purposes of perform different desired assay protocols.
Therefore, Cohen et al. in view of Laska et al. renders claim 24 obvious.
3. Claims 25 is rejected under 35 U.S.C. 103 as being unpatentable over Cohen et al. in view of Laska et al. and Bendele et al. as applied to claim 1 above, and further in view of U.S. Patent No. 9,545,648 to Peter et al.
I.) Regarding applicant’s claim 25, as noted above Cohen et al. in view of Laska et al. and Bendele et al. renders claim 1 obvious from which claim 25 depends.
Claim 25 recites that the second set of probes is configured to descend into the reaction cell while aspirating, then raise within the reaction cell, then suspend aspiration, then resume aspiration, then again descend into the reaction cell while aspirating, and then raise out of the reaction cell while aspirating.
Cohen et al. in view of Laska et al. and Bendele et al. does not teach moving probes up and down in the reaction cuvettes while aspirating.
Peter et al. teaches methods and apparatus that are adapted to wash magnetic particles isolated in a vessel. At column 7, line 54 through column 9, line 7 Peter et al. teaches aspirating while moving probes in a magnetic separation process to improve “a thoroughness of a washing of the magnetic particles.” (column 1, lines 49-51).
It would have been obvious to one of ordinary skill in the art to modify Cohen et al. in view of Laska et al. and Bendele et al. to aspirate washing solutions and other components from the reaction cuvettes while moving the probes as taught by Peter et al. to improve washing of the magnetic particles.
Therefore, Cohen et al. in view of Laska et al., and Bendele and Peter et al. renders claim 25 obvious.
Response to Arguments
Applicant’s arguments with respect to claim 1 have been considered but are moot because the new ground of rejection relies on newly cited teachings and modified proposed combinations of the previously cited prior art not specifically challenged in applicant’s arguments.
Conclusion
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/M.S.G./Examiner, Art Unit 1798
/CHARLES CAPOZZI/Supervisory Patent Examiner, Art Unit 1798