DETAILED CORRESPONDENCE
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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 7/31/24 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Status and Remarks
Claims 63-84 are pending and examined.
The preliminary amendment filed on 7/31/24 has been entered.
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 for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 63-80, 82 are rejected under 35 U.S.C. 102a1/a2 as being anticipated by Wilson et al (US 20130130369; hereinafter “Wilson”; already of record).
As to claim 63, Wilson teaches a method of continuously analyzing biological samples by an automated sample analysis system (Wilson; Fig. 1, 19, abstract), comprising:
loading the biological samples into a sample loading area comprising two or more sample loading positions (Wilson teaches loading samples into 110; [185, 192, 212-216], Figs. 1, 2a, 19. The examiner notes that the multiple areas/positions that are recited in the instant claims are interpreted as arbitrary regions of space and are not further constrained by structure.);
loading sample preparation (SP) cartridges into an SP cartridge loading area comprising two or more SP cartridge loading positions (Wilson teaches loading cartridges into 112; [185, 202, 746] Figs. 1, 19);
transporting, with a robotic SP cartridge handler, the SP cartridges from the SP cartridge loading area to one of two or more positions of an SP cartridge bulk reagent filling station (Wilson teaches using a robotic shuttle or a pusher; [202, 539, 747]. Wilson teaches loading cartridges into 112, where the cartridges are transported from 112 to the reagent filling positions in station 116h; Fig. 1 [541, 749].);
filling SP cartridges with bulk reagents from the SP cartridge bulk reagent filling station (Wilson teaches reagent filling positions in station 116h; Fig. 1 [541, 749]);
transporting the SP cartridges from the bulk reagent filling station to one of two or more positions of an SP cartridge sample filling station (Wilson teaches moving the cartridges between the reagent filling station 116h and a sample filling position in station 116f where there are multiple regions of space in 116f; [192, 537, 539, 541, 747, 749].);
pipetting, with a robotic pipettor, the biological samples from the sample loading area into the SP cartridges at the SP cartridge sample filling station (Wilson teaches pipettor 700; [232, 260, 270, 420, 537, 565, 567, 573] Fig. 1, 13. Wilson also teaches pipettor 70; Fig. 1, [539]. Wilson teaches sample filling via the pipettor at station 116f; [192, 537, 539, 747].);
transporting the SP cartridges from the SP cartridge sample filling station to one of two or more positions of a sample preparation station (Wilson teaches moving the cartridges to sample preparation stations 116a/b; [188, 510, 542, 795]. Wilson also teaches an assay mixture formed in a reaction vessel in 116e/g; [537, 543, 544, 784, 787]);
preparing the biological samples in the SP cartridges for analysis of an analyte present in the biological samples by isolating the analyte present in the biological samples at the sample preparation station (Wilson; [171, 641], and [181, 198, 320, 442]. Wilson teaches isolation and purification; [302, 501], and [181, 198, 320, 442]. Wilson teaches sample preparation; [188, 510, 542, 795]. Wilson also teaches an assay mixture formed in a reaction vessel in 116e/g; [537, 543, 544, 784, 787].);
combining the isolated analyte with assay reagents to form assay mixtures (Wilson teaches an assay mixture formed in a reaction vessel; [537, 543, 544, 784, 787]); and
performing, in a sample analysis station comprising two or more sample analysis units, analyte detection assays on the assay mixtures to analyze the samples (Wilson teaches analysis stations as thermal cyclers 30/1200 with analysis wells for accepting reaction vessels in figures 1, 16, 18; [658, 668, 675, 730]. Wilson teaches detection on reaction vessel in cartridge; [32, 171, 180, 181, 185, 198, 320, 442, 641, 746, 750, 791]. Wilson teaches moving capped vessel to PCR analysis station; [255, 283, 337, 338, 368, 499, 543, 808, 809, 658, 668, 675, 730].),
wherein, the method comprises, without ceasing operation of the system, accessing the system for replenishment or removal of biological samples, bulk reagents, commodities, and/or waste (The system of Wilson enables performance of the assays without ceasing operation, whereby the operator has access to the system; Fig. 19, [180, 247, 393, 588, 738]. The without ceasing of operation during use could be the process of the analyzer being started and turned on, but waiting for the loading/unloading of various consumables, whereby no process is being interrupted by a user. When looking at figure 1a of Wilson, it can be seen that regions of 110 and 112 are directly accessible and exposed to an operator, and access to areas 110/112 by an operator is possible at any point in time, including during analysis. The examiner notes that only one of the potential consumables needs to be capable of being replenished/removed as they are recited in the alternative under BRI in the last three lines of the claim. Wilson teaches that the operator has access to sample loading area 110 for loading/unloading samples/tube racks and SP cartridge loading area 112 for loading/unloading SP cartridges; Figs. 1a, 1b. Wilson also teaches the reagent station for the loading/unloading of reagents; Fig. 8a-8b. Additionally, Wilson teaches that indicators indicate when reagents need to be replaced, where the replacement of the reagents is not interrupting the system but rather helping the system run; [419]. Wilson teaches that the operator has access to the liquid waste 94 and solid waste 92/882, where the liquid and solid waste are accessed on the lower level of the analyzer; Fig. 1d, 14 [199]).
As to claim 64, Wilson teaches the method of claim 63, further comprising: transferring, using the robotic pipettor, the assay mixture to a reaction vessel from reaction vessels of the SP cartridges; and transporting the reaction vessel from an SP cartridge of the SP cartridges to respective reaction vessel well of two or more sample analysis units of the sample analysis station (Wilson teaches an assay mixture formed in a reaction vessel; [537, 543, 544, 784, 787]. Wilson teaches the vessel 221/246 in the cartridge; Fig. 4-5. Wilson teaches picking up the cap 222 and capping vessel 221 using pipettor; [255, 283, 337, 338, 368, 499, 543, 808, 809]. Wilson teaches moving capped vessel to PCR analysis station; [255, 283, 337, 338, 368, 499, 543, 808, 809, 658, 668, 675, 730]. Wilson teaches detection on reaction vessel in cartridge; [32, 171, 180, 181, 198, 320, 442, 641, 746, 750, 791]).
As to claim 65, Wilson teaches the method of claim 63, wherein said isolating the analyte present in the biological samples comprises isolating and purifying the analyte present in the biological samples (Wilson; [171, 641], and [181, 198, 320, 442]. Wilson teaches isolation and purification; [302, 501], and [181, 198, 320, 442]. Wilson teaches sample preparation; [188, 510, 542, 795]. Wilson also teaches an assay mixture formed in a reaction vessel in 116e/g; [537, 543, 544, 784, 787]).
As to claim 66, Wilson teaches the method according to claim 64, comprising picking up, using the robotic pipettor, a reaction vessel cap and capping the reaction vessel (Wilson teaches picking up the cap 222 and capping vessel 221 using pipettor; [255, 283, 337, 338, 368, 499, 543, 808, 809]. Wilson teaches moving capped vessel to PCR analysis station; [255, 283, 337, 338, 368, 499, 543, 808, 809, 658, 668, 675, 730]. Wilson teaches detection on reaction vessel in cartridge; [32, 171, 180, 181, 198, 320, 442, 641, 746, 750, 791]).
As to claim 67, Wilson teaches the method according to claim 63, comprising performing two or more different analyte detection assays, wherein the system provides random access to any of the two or more different analyte detection assays (Wilson teaches multiple assays; [180, 746, 750, 791]).
As to claim 68, Wilson teaches the method according to claim 63, wherein biological samples loaded into the system are present in sample tubes (Wilson teaches loading sample tubes; [185, 192, 212-216], Figs. 1, 2a, 19.);
As to claim 69, Wilson teaches the method according to claim 68, wherein the sample tubes are present in sample tube racks, and wherein loading biological samples into the system comprises loading sample tube racks into one of two or more lanes of a sample loading station of the system (Wilson teaches sample tubes in racks in multiple lanes in the sample loading positions; [213-216] Fig. 1, 2a).
As to claim 70, Wilson teaches the method according to claim 69, wherein the system comprises from 2 to 20 lanes of the sample loading station for sample tube racks (Wilson teaches sample tubes in racks in multiple lanes; [213-216] Fig. 1, 2a).
As to claim 71, Wilson teaches the method according to claim 69, comprising reading sample identification information present on the sample tubes as the sample tube racks are loaded into the system (Wilson teaches sample tubes are read by barcode reader; [213, 243-244], Fig. 2a).
As to claim 72, Wilson teaches the method according to claim 69, comprising reading sample tube rack identification information present on the sample tube racks upon loading of the sample tube racks into the system (Wilson teaches sample racks/holders are read by barcode reader; [244, 741], Fig. 2a).
As to claim 73, Wilson teaches the method according to claim 63, wherein the system comprises a pipette tip storage area where pipette tips are stored (Wilson teaches pipettor 700 and pipettes in storage area; [232, 260, 270, 420, 537, 565, 567, 573] Fig. 1, 13).
As to claim 74, Wilson teaches the method according to claim 73, comprising picking up, using the robotic pipettor, a disposable pipette tip from the pipette tip storage area, aspirating a biological sample from a sample tube present at the sample introduction area, and dispensing the biological sample into a first well of the SP cartridge (Wilson teaches pipettor 700 for transferring samples to the cartridge and pipettes in storage area; [232, 260, 270, 420, 537, 565, 567, 573] Fig. 1, 13. Wilson teaches pipettor 700; [232, 260, 270, 420, 537, 565, 567, 573] Fig. 1, 13. Wilson also teaches pipettor 70; Fig. 1, [539]. Wilson teaches sample filling via the pipettor at station 116f; [192, 537, 539, 747]).
As to claim 75, Wilson teaches the method according to claim 63, wherein performing the analyte detection assays comprises performing nucleic acid detection assays (Wilson; [32, 171, 641-644, 648, 653, 669] Fig. 16a-16b. Wilson; [171, 641], and [181, 198, 320, 442]).
As to claim 76, Wilson teaches the method according to claim 75, wherein performing nucleic acid detection assays comprises performing real-time nucleic acid amplification and detection (Wilson; [171, 641], and [181, 198, 320, 442]).
As to claim 77, Wilson teaches the method according to claim 75, wherein preparing the biological samples in the SP cartridges for analysis comprises isolating nucleic acids present in the samples (Wilson; [171, 641], and [181, 198, 320, 442]. Wilson teaches isolation and purification; [302, 501], and [181, 198, 320, 442]. Wilson teaches sample preparation; [188, 510, 542, 795]).
As to claim 78, Wilson teaches the method according to claim 77, wherein isolating nucleic acids present in the biological samples comprises capturing the nucleic acids using magnetic particles (Wilson; [302, 501], and [181, 198, 320, 442]).
As to claim 79, Wilson teaches the method according to claim 63, comprising disposing liquid waste generated during operation of the system into a liquid waste storage area (Wilson teaches disposing of liquid waste in 94 or 116c; [199, 476, 537] Fig. 1. Wilson also teaches that wells can hold waste; [290]. Wilson also teaches 908; [584] Fig. 14. Wilson teaches a waste chute; [260]. Wilson also teaches a waste bin 882; [581, 588, 813] Fig. 14. Wilson teaches that cartridges can be disposed in waste with the fluid in them; [581]).
As to claim 80, Wilson teaches the method according to claim 79, wherein the liquid waste storage area comprises a liquid waste chute and a liquid waste container (Wilson teaches disposing of liquid waste in 94 or 116c; [199, 476, 537] Fig. 1. Wilson also teaches that wells can hold waste; [290]. Wilson also teaches 908; [584] Fig. 14. Wilson teaches a waste chute; [260, 329, 544, 588-590, 592], Fig. 14. Wilson also teaches a waste bin 882; [581, 588, 813] Fig. 14. Wilson teaches that cartridges can be disposed in waste with the fluid in them; [581]).
As to claim 82, Wilson teaches the method according to claim 63, comprising disposing solid waste generated during operation of the system into a solid waste storage area (Wilson also teaches that wells can hold waste; [290]. Wilson also teaches 908; [584] Fig. 14. Wilson teaches a waste chute; [260, 329, 544, 588-590, 592], Fig. 14. Wilson also teaches a waste bin 882; [581, 588, 813] Fig. 14).
Claim Rejections - 35 USC § 103
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.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 81, 83 are rejected under 35 U.S.C. 103 as being unpatentable over Wilson et al (US 20130130369; hereinafter “Wilson”; already of record) in view of Godsey et al (US 20110159578; hereinafter “Godsey”; already of record).
As to claim 81, Wilson teaches the method according to claim 80, with the liquid waste area and liquid waste chute (see above. Wilson teaches a waste chute; [260, 329, 544, 588-590, 592], Fig. 14. Wilson also teaches a waste bin 882; [581, 588, 813] Fig. 14).
Wilson does not specifically teach that the waste storage area is present in a drawer, and the waste chute is not in communication with the waste container when the drawer is open. However, Godsey teaches the analogous art of an automated analyzer (Godsey; Title, abstract) with a waste storage area is present in a drawer, and the waste chute is not in communication with the solid waste container when the drawer is open (Godsey teaches drawer 816 which includes waste container 838 and waste passage 232, and where when the drawer is open the container is pulled out and not in communication with the waste chute; Figs 8A-8B [55-56, 58, 59, 65]). It would have been obvious to one of ordinary skill in the art to have modified the waste container receiving waste from a chute of Wilson to have included the waste container on a drawer as in Godsey because Godsey teaches that using a drawer enables the waste containers to be easily accessed, removed, and replaced by a user (Godsey; [59], Fig. 8a-b).
As to claim 83, Wilson teaches the method according to claim 82, ere the solid waste storage area comprises a solid waste storage container (see above).
Wilson does not specifically teach two or more solid waste storage containers. It would have been obvious to one having ordinary skill in the art at the time the invention was made to included multiple waste storage containers in Wilson to provide the advantage of ensuring that enough waste was collected, since it has been held that the mere duplication of essential working parts of a device involves only routine skill in the art. (See MPEP 2144.04 Section VI (B) and St. Regis Paper Co. v Bemis Co., 193 USPQ 8). However, Godsey teaches the analogous art of an automated analyzer (Godsey; Title, abstract) with two or more solid waste containers (Godsey teaches drawer 816 which includes waste containers 838; Figs 8A-8B [55-56, 58, 59, 65]. Godsey specifically teaches more than one waste container 838; [59]). It would have been obvious to one of ordinary skill in the art to have modified the waste container of Wilson to have included multiple waste containers on a drawer as in Godsey because Godsey teaches that using a drawer enables the waste containers to be easily accessed, removed, and replaced by a user (Godsey; [59], Fig. 8a-b).
Claim 84 is rejected under 35 U.S.C. 103 as being unpatentable over Wilson et al (US 20130130369; hereinafter “Wilson”; already of record) in view of Miller, KI (US 20090003981; hereinafter “Miller”; already of record).
As to claim 84, Wilson teaches the method according to claim 63, wherein the SP cartridges are loaded into a cartridge loading area comprising a cartridge storage unit (See above).
Wilson does not specifically teach the cartridge storage unit comprises one or more SP cartridge elevators. However, Miller teaches the analogous art of an automated analyzer (Miller; Title, abstract) with a cartridge storage unit comprises one or more SP cartridge elevators (Miller teaches an elevator which enables sample racks to be moved into and out of storage; [37, 38, 39, 42, 43, 44], Fig. 2, 3). It would have been obvious to one of ordinary skill in the art to have modified the cartridge loading area of Wilson to have a cartridge storage with an elevator as in Miller because Miller teaches that using an elevator enables racks to be easily passed into and out of storage (Miller; [37, 38, 39, 42, 43, 44]), and this would also automate the manual process of placing the cartridges thereby providing an automated device which would decrease user error and increase throughput.
Claims 63-80, 82 are rejected under 35 U.S.C. 103 as being unpatentable over Wilson et al (US 20130130369; hereinafter “Wilson”; already of record) in view of Clark et al (US 5358691; hereinafter “Clark”; already of record).
As to claim 63, Wilson teaches a method of continuously analyzing biological samples by an automated sample analysis system (Wilson; Fig. 1, 19, abstract), comprising:
loading the biological samples into a sample loading area comprising two or more sample loading positions (Wilson teaches loading samples into 110; [185, 192, 212-216], Figs. 1, 2a, 19. The examiner notes that the multiple areas/positions that are recited in the instant claims are interpreted as arbitrary regions of space and are not further constrained by structure.);
loading sample preparation (SP) cartridges into an SP cartridge loading area comprising two or more SP cartridge loading positions (Wilson teaches loading cartridges into 112; [185, 202, 746] Figs. 1, 19);
transporting, with a robotic SP cartridge handler, the SP cartridges from the SP cartridge loading area to one of two or more positions of an SP cartridge bulk reagent filling station (Wilson teaches using a robotic shuttle or a pusher; [202, 539, 747]. Wilson teaches loading cartridges into 112, where the cartridges are transported from 112 to the reagent filling positions in station 116h; Fig. 1 [541, 749].);
filling SP cartridges with bulk reagents from the SP cartridge bulk reagent filling station (Wilson teaches reagent filling positions in station 116h; Fig. 1 [541, 749]);
transporting the SP cartridges from the bulk reagent filling station to one of two or more positions of an SP cartridge sample filling station (Wilson teaches moving the cartridges between the reagent filling station 116h and a sample filling position in station 116f where there are multiple regions of space in 116f; [192, 537, 539, 541, 747, 749].);
pipetting, with a robotic pipettor, the biological samples from the sample loading area into the SP cartridges at the SP cartridge sample filling station (Wilson teaches pipettor 700; [232, 260, 270, 420, 537, 565, 567, 573] Fig. 1, 13. Wilson also teaches pipettor 70; Fig. 1, [539]. Wilson teaches sample filling via the pipettor at station 116f; [192, 537, 539, 747].);
transporting the SP cartridges from the SP cartridge sample filling station to one of two or more positions of a sample preparation station (Wilson teaches moving the cartridges to sample preparation stations 116a/b; [188, 510, 542, 795]. Wilson also teaches an assay mixture formed in a reaction vessel in 116e/g; [537, 543, 544, 784, 787]);
preparing the biological samples in the SP cartridges for analysis of an analyte present in the biological samples by isolating the analyte present in the biological samples at the sample preparation station (Wilson; [171, 641], and [181, 198, 320, 442]. Wilson teaches isolation and purification; [302, 501], and [181, 198, 320, 442]. Wilson teaches sample preparation; [188, 510, 542, 795]. Wilson also teaches an assay mixture formed in a reaction vessel in 116e/g; [537, 543, 544, 784, 787].);
combining the isolated analyte with assay reagents to form assay mixtures (Wilson teaches an assay mixture formed in a reaction vessel; [537, 543, 544, 784, 787]); and
performing, in a sample analysis station comprising two or more sample analysis units, analyte detection assays on the assay mixtures to analyze the samples (Wilson teaches analysis stations as thermal cyclers 30/1200 with analysis wells for accepting reaction vessels in figures 1, 16, 18; [658, 668, 675, 730]. Wilson teaches detection on reaction vessel in cartridge; [32, 171, 180, 181, 185, 198, 320, 442, 641, 746, 750, 791]. Wilson teaches moving capped vessel to PCR analysis station; [255, 283, 337, 338, 368, 499, 543, 808, 809, 658, 668, 675, 730].),
wherein, the method comprises, without ceasing operation of the system, accessing the system for replenishment or removal of biological samples, bulk reagents, commodities, and/or waste (The system of Wilson enables performance of the assays without ceasing operation, whereby the operator has access to the system; Fig. 19, [180, 247, 393, 588, 738]. The without ceasing of operation during use could be the process of the analyzer being started and turned on, but waiting for the loading/unloading of various consumables, whereby no process is being interrupted by a user. When looking at figure 1a of Wilson, it can be seen that regions of 110 and 112 are directly accessible and exposed to an operator, and access to areas 110/112 by an operator is possible at any point in time, including during analysis. The examiner notes that only one of the potential consumables needs to be capable of being replenished/removed as they are recited in the alternative under BRI in the last three lines of the claim. Wilson teaches that the operator has access to sample loading area 110 for loading/unloading samples/tube racks and SP cartridge loading area 112 for loading/unloading SP cartridges; Figs. 1a, 1b. Wilson also teaches the reagent station for the loading/unloading of reagents; Fig. 8a-8b. Additionally, Wilson teaches that indicators indicate when reagents need to be replaced, where the replacement of the reagents is not interrupting the system but rather helping the system run; [419]. Wilson teaches that the operator has access to the liquid waste 94 and solid waste 92/882, where the liquid and solid waste are accessed on the lower level of the analyzer; Fig. 1d, 14 [199]).
If it is deemed that Wilson does not teach wherein continuous access by an operator without ceasing operation of the system during use for replenishment or removal of one or any combination of: samples, sample tube racks, SP cartridges, bulk reagents, and waste generated during sample preparation and analysis of the samples, then Clark teaches the analogous art of an automated sample analysis system (Clark; Title) with continuous access by an operator without ceasing operation of the system during use for replenishment or removal of one or any combination of: samples, sample tube racks, SP cartridges, bulk reagents, and waste generated during sample preparation and analysis of the samples (Clark teaches the advantage of continuous access, which provides the operator to replace samples racks, cartridges, and reagents without interruption of the system; col. 6 line 6-12, col. 44 line 56-61). It would have been obvious to one of ordinary skill in the art to have modified the system with duplicate positions of Wilson to have allowed continuous access to samples and reagents as in Clark because Clark teaches that continuous access enables the ability to add consumables without interrupting the system (Clark; col. 6 line 6-12).
As to claim 64, Wilson teaches the method of claim 63, further comprising: transferring, using the robotic pipettor, the assay mixture to a reaction vessel from reaction vessels of the SP cartridges; and transporting the reaction vessel from an SP cartridge of the SP cartridges to respective reaction vessel well of two or more sample analysis units of the sample analysis station (Wilson teaches an assay mixture formed in a reaction vessel; [537, 543, 544, 784, 787]. Wilson teaches the vessel 221/246 in the cartridge; Fig. 4-5. Wilson teaches picking up the cap 222 and capping vessel 221 using pipettor; [255, 283, 337, 338, 368, 499, 543, 808, 809]. Wilson teaches moving capped vessel to PCR analysis station; [255, 283, 337, 338, 368, 499, 543, 808, 809, 658, 668, 675, 730]. Wilson teaches detection on reaction vessel in cartridge; [32, 171, 180, 181, 198, 320, 442, 641, 746, 750, 791]).
As to claim 65, Wilson teaches the method of claim 63, wherein said isolating the analyte present in the biological samples comprises isolating and purifying the analyte present in the biological samples (Wilson; [171, 641], and [181, 198, 320, 442]. Wilson teaches isolation and purification; [302, 501], and [181, 198, 320, 442]. Wilson teaches sample preparation; [188, 510, 542, 795]. Wilson also teaches an assay mixture formed in a reaction vessel in 116e/g; [537, 543, 544, 784, 787]).
As to claim 66, Wilson teaches the method according to claim 64, comprising picking up, using the robotic pipettor, a reaction vessel cap and capping the reaction vessel (Wilson teaches picking up the cap 222 and capping vessel 221 using pipettor; [255, 283, 337, 338, 368, 499, 543, 808, 809]. Wilson teaches moving capped vessel to PCR analysis station; [255, 283, 337, 338, 368, 499, 543, 808, 809, 658, 668, 675, 730]. Wilson teaches detection on reaction vessel in cartridge; [32, 171, 180, 181, 198, 320, 442, 641, 746, 750, 791]).
As to claim 67, Wilson teaches the method according to claim 63, comprising performing two or more different analyte detection assays, wherein the system provides random access to any of the two or more different analyte detection assays (Wilson teaches multiple assays; [180, 746, 750, 791]).
As to claim 68, Wilson teaches the method according to claim 63, wherein biological samples loaded into the system are present in sample tubes (Wilson teaches loading sample tubes; [185, 192, 212-216], Figs. 1, 2a, 19.);
As to claim 69, Wilson teaches the method according to claim 68, wherein the sample tubes are present in sample tube racks, and wherein loading biological samples into the system comprises loading sample tube racks into one of two or more lanes of a sample loading station of the system (Wilson teaches sample tubes in racks in multiple lanes in the sample loading positions; [213-216] Fig. 1, 2a).
As to claim 70, Wilson teaches the method according to claim 69, wherein the system comprises from 2 to 20 lanes of the sample loading station for sample tube racks (Wilson teaches sample tubes in racks in multiple lanes; [213-216] Fig. 1, 2a).
As to claim 71, Wilson teaches the method according to claim 69, comprising reading sample identification information present on the sample tubes as the sample tube racks are loaded into the system (Wilson teaches sample tubes are read by barcode reader; [213, 243-244], Fig. 2a).
As to claim 72, Wilson teaches the method according to claim 69, comprising reading sample tube rack identification information present on the sample tube racks upon loading of the sample tube racks into the system (Wilson teaches sample racks/holders are read by barcode reader; [244, 741], Fig. 2a).
As to claim 73, Wilson teaches the method according to claim 63, wherein the system comprises a pipette tip storage area where pipette tips are stored (Wilson teaches pipettor 700 and pipettes in storage area; [232, 260, 270, 420, 537, 565, 567, 573] Fig. 1, 13).
As to claim 74, Wilson teaches the method according to claim 73, comprising picking up, using the robotic pipettor, a disposable pipette tip from the pipette tip storage area, aspirating a biological sample from a sample tube present at the sample introduction area, and dispensing the biological sample into a first well of the SP cartridge (Wilson teaches pipettor 700 for transferring samples to the cartridge and pipettes in storage area; [232, 260, 270, 420, 537, 565, 567, 573] Fig. 1, 13. Wilson teaches pipettor 700; [232, 260, 270, 420, 537, 565, 567, 573] Fig. 1, 13. Wilson also teaches pipettor 70; Fig. 1, [539]. Wilson teaches sample filling via the pipettor at station 116f; [192, 537, 539, 747]).
As to claim 75, Wilson teaches the method according to claim 63, wherein performing the analyte detection assays comprises performing nucleic acid detection assays (Wilson; [32, 171, 641-644, 648, 653, 669] Fig. 16a-16b. Wilson; [171, 641], and [181, 198, 320, 442]).
As to claim 76, Wilson teaches the method according to claim 75, wherein performing nucleic acid detection assays comprises performing real-time nucleic acid amplification and detection (Wilson; [171, 641], and [181, 198, 320, 442]).
As to claim 77, Wilson teaches the method according to claim 75, wherein preparing the biological samples in the SP cartridges for analysis comprises isolating nucleic acids present in the samples (Wilson; [171, 641], and [181, 198, 320, 442]. Wilson teaches isolation and purification; [302, 501], and [181, 198, 320, 442]. Wilson teaches sample preparation; [188, 510, 542, 795]).
As to claim 78, Wilson teaches the method according to claim 77, wherein isolating nucleic acids present in the biological samples comprises capturing the nucleic acids using magnetic particles (Wilson; [302, 501], and [181, 198, 320, 442]).
As to claim 79, Wilson teaches the method according to claim 63, comprising disposing liquid waste generated during operation of the system into a liquid waste storage area (Wilson teaches disposing of liquid waste in 94 or 116c; [199, 476, 537] Fig. 1. Wilson also teaches that wells can hold waste; [290]. Wilson also teaches 908; [584] Fig. 14. Wilson teaches a waste chute; [260]. Wilson also teaches a waste bin 882; [581, 588, 813] Fig. 14. Wilson teaches that cartridges can be disposed in waste with the fluid in them; [581]).
As to claim 80, Wilson teaches the method according to claim 79, wherein the liquid waste storage area comprises a liquid waste chute and a liquid waste container (Wilson teaches disposing of liquid waste in 94 or 116c; [199, 476, 537] Fig. 1. Wilson also teaches that wells can hold waste; [290]. Wilson also teaches 908; [584] Fig. 14. Wilson teaches a waste chute; [260, 329, 544, 588-590, 592], Fig. 14. Wilson also teaches a waste bin 882; [581, 588, 813] Fig. 14. Wilson teaches that cartridges can be disposed in waste with the fluid in them; [581]).
As to claim 82, Wilson teaches the method according to claim 63, comprising disposing solid waste generated during operation of the system into a solid waste storage area (Wilson also teaches that wells can hold waste; [290]. Wilson also teaches 908; [584] Fig. 14. Wilson teaches a waste chute; [260, 329, 544, 588-590, 592], Fig. 14. Wilson also teaches a waste bin 882; [581, 588, 813] Fig. 14).
Claims 81, 83 are rejected under 35 U.S.C. 103 as being unpatentable over Wilson et al (US 20130130369; hereinafter “Wilson”; already of record) in view of Clark et al (US 5358691; hereinafter “Clark”; already of record) in view of Godsey et al (US 20110159578; hereinafter “Godsey”; already of record).
As to claim 81, Wilson teaches the method according to claim 80, with the liquid waste area and liquid waste chute (see above. Wilson teaches a waste chute; [260, 329, 544, 588-590, 592], Fig. 14. Wilson also teaches a waste bin 882; [581, 588, 813] Fig. 14).
Wilson does not specifically teach that the waste storage area is present in a drawer, and the waste chute is not in communication with the waste container when the drawer is open. However, Godsey teaches the analogous art of an automated analyzer (Godsey; Title, abstract) with a waste storage area is present in a drawer, and the waste chute is not in communication with the solid waste container when the drawer is open (Godsey teaches drawer 816 which includes waste container 838 and waste passage 232, and where when the drawer is open the container is pulled out and not in communication with the waste chute; Figs 8A-8B [55-56, 58, 59, 65]). It would have been obvious to one of ordinary skill in the art to have modified the waste container receiving waste from a chute of Wilson to have included the waste container on a drawer as in Godsey because Godsey teaches that using a drawer enables the waste containers to be easily accessed, removed, and replaced by a user (Godsey; [59], Fig. 8a-b).
As to claim 83, Wilson teaches the method according to claim 82, ere the solid waste storage area comprises a solid waste storage container (see above).
Wilson does not specifically teach two or more solid waste storage containers. It would have been obvious to one having ordinary skill in the art at the time the invention was made to included multiple waste storage containers in Wilson to provide the advantage of ensuring that enough waste was collected, since it has been held that the mere duplication of essential working parts of a device involves only routine skill in the art. (See MPEP 2144.04 Section VI (B) and St. Regis Paper Co. v Bemis Co., 193 USPQ 8). However, Godsey teaches the analogous art of an automated analyzer (Godsey; Title, abstract) with two or more solid waste containers (Godsey teaches drawer 816 which includes waste containers 838; Figs 8A-8B [55-56, 58, 59, 65]. Godsey specifically teaches more than one waste container 838; [59]). It would have been obvious to one of ordinary skill in the art to have modified the waste container of Wilson to have included multiple waste containers on a drawer as in Godsey because Godsey teaches that using a drawer enables the waste containers to be easily accessed, removed, and replaced by a user (Godsey; [59], Fig. 8a-b).
Claim 84 is rejected under 35 U.S.C. 103 as being unpatentable over Wilson et al (US 20130130369; hereinafter “Wilson”; already of record) in view of Clark et al (US 5358691; hereinafter “Clark”; already of record) in view of Miller, KI (US 20090003981; hereinafter “Miller”; already of record).
As to claim 84, Wilson teaches the method according to claim 63, wherein the SP cartridges are loaded into a cartridge loading area comprising a cartridge storage unit (See above).
Wilson does not specifically teach the cartridge storage unit comprises one or more SP cartridge elevators. However, Miller teaches the analogous art of an automated analyzer (Miller; Title, abstract) with a cartridge storage unit comprises one or more SP cartridge elevators (Miller teaches an elevator which enables sample racks to be moved into and out of storage; [37, 38, 39, 42, 43, 44], Fig. 2, 3). It would have been obvious to one of ordinary skill in the art to have modified the cartridge loading area of Wilson to have a cartridge storage with an elevator as in Miller because Miller teaches that using an elevator enables racks to be easily passed into and out of storage (Miller; [37, 38, 39, 42, 43, 44]), and this would also automate the manual process of placing the cartridges thereby providing an automated device which would decrease user error and increase throughput.
Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claim 1 is rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 1 of prior U.S. Patent No. 10775401. This is a statutory double patenting rejection.
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the claims at issue are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 1202563. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of US 12025630 is directed towards a system and it would be be obvious to perform the analysis method disclosed in the instant claims using the system of claim 1 of U.S. Patent No. 1202563. Thus, all of the elements of the invention recited in the instant claims are encompassed by the claims of US 12025630.
Conclusion
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/Benjamin R Whatley/Primary Examiner, Art Unit 1798
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