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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 07/09/25 has been entered.
Response to Amendment
Applicant’s amendment filed on 07/09/25 has been entered. Claims 1 and 3-15 are pending. Claims 9-15 are withdrawn from consideration. Claims 1 and 3-8 are examined herein. Applicant’s amendment and argument have overcome each and every rejection set forth in Office Action mailed on 05/09/25.
Status of Rejection
The rejection of claims 1 and 3-8 under 35 USC 112(b) has been withdrawn in view of Applicant’s amendment.
New ground of rejection of claims 1 and 3-8 are necessitated by Applicant’s amendment.
Response to Arguments
Applicant’s arguments, see Pages 9-12, filed 07/09/25, with respect to the rejection(s) of claim(s) 1 and 3-8 under 102(a)(1) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Tajima (US 20160025722 A1) over LeChance (US 20190086436 A1) as cited in Office Action mailed on 10/07/24.
Claim Interpretation
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: measurement unit in claim 1.
The claim limitation invoked 112f because:
Claim limitation invokes a term used as a substitute for “means” that is a generic placeholder (unit).
The generic placeholder is modified by functional language (“measures a state of the solution stored in any one well of the cartridges”)
The term is not modified by sufficient structure.
Applicant discloses that the measurement unit is a camera (PG Pub, Paragraph 91).
Claim Rejections - 35 USC § 112
Claim 7-8 is 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.
Regarding claim 7, the claim recites “a driving part” configured to provides a pressure for suctioning and discharging the solution of the tip. However, claim 1 already recites “a driving part” configured to the do the same function. There is insufficient antecedent basis for this limitation as it is unclear if “a driving part” of claim 7 is referring to the same “a driving part” of claim 1. Based on the specification, it appears the “a driving part” of claim 7 indeed refers to the same “a driving part” of claim 1. Examiner suggests amending “a driving part” to “the driving part” to overcome the rejection.
Claim 8 is also rejected for being dependent on claim 7.
Claim Rejections - 35 USC § 103
Claim(s) 1 and 3-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tajima in view of LeChance.
Regarding claim 1, Tajima discloses an immunoassay device comprising:
a stage (cartridge controller; The cartridge controller controls the cartridge 180 to move in the horizontal direction and determines the position of the cartridge 180 relative to the dispensing apparatus 152 and the detection apparatus 154. By controlling the position of the cartridge 180. Paragraph 194);
a plurality of cartridges (Cartridge 180, Figure 25; a plurality of cartridges 180 is shown in Figure 43) having a plurality of wells (holding portion 182, Figure 25), wherein the stage is configured to accommodate the plurality of cartridges having a plurality of wells (The cartridge controller controls the cartridge 180 to move in the horizontal direction; paragraph 194)
a solution transfer unit (nozzle unit 720, Figure 38) comprising a plurality of tips that are movable relative to the stage and are disposed to correspond to positions of the cartridges so as to suction a solution stored in the wells or discharge the suctioned solution from the wells (Figure 43, dispensing nozzles 922) (Paragraph 157);
a measurement unit (…image sensors such as CCD and MOS can be used…)(Paragraph 232) that is movable along one side of the stage and measures a state of the solution stored in any one well in the cartridges (Figure 43, detector 924) (…the detector 924 is provided above a well 927 for detection so as to be moved in the direction S traversing the first to sixth treatment lines, Paragraph 296); and
a control unit (Central processing unit 832, Figure 41) configured to control (nozzle position controller 834, Figure 41) the solution transfer unit such that the stage and the solution transfer unit are movable relative to each other (The nozzle position controller 834 has mutually orthogonal axes X and Z (2 axes), and the position of the nozzle unit 720 is controlled by 2 motors, i.e., first and second motors 861 and 862. Regarding the axes X and Z, for example, the axis X toward the direction P is approximately parallel to the arrangement direction of wells in each of the treatment lines 700A to 700F) (Paragraph 272),
wherein at least a portion of the plurality of tips simultaneously suctions the same content from the plurality of cartridges or simultaneously discharges the same content to the plurality of cartridges (In this way, treatments can be carried out along the respective treatment lines 700A to 700F without traversing the treatment lines. In this case, by simultaneously activating the nozzle units 720, it is possible to improve detection environments between the treatment lines 700A to 700F) (Paragraph 272),
wherein each of the plurality of cartridges is configured to store a plurality of reagents (paragraphs 28, 33, and 104; Figure 20a, c, d, f, and g) and comprises at least two or more empty well (Figure 20, wells 60 and 64),
wherein the control unit is configured to control a driving part (pumping controller 842, Figure 41), and
wherein the driving part is configured to apply a pressure to the tips so that at least one tip of the plurality of the tips suctions the solution stored in a well or discharges the suctioned solution from the well (paragraphs 165 and 225).
The limitation “…so as to simultaneously perform a plurality of reaction methods on the stage” is interpreted as recitation of intended use. A claim containing a “recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus” if the prior art apparatus teaches all the structural limitations of the claim (MPEP 2114, II). A recitation of 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. Moreover, Tajima discloses the device of Tajima is capable of performing a plurality of reaction methods simultaneously (4-1-2 Simultaneous Labeling Reaction Step of a Plurality of Types of Antigens using a Plurality of Antibody-Immobilized Beads, paragraphs 142-147).
Tajima does not disclose that the driving part is configured to independently apply a pressure to the tips so that while at least one tip of the plurality of the tips so that while at least one tip of the plurality of tips suctions the solution stored in the well or discharge the suctioned solution from the well, one or more other tips of the plurality of tips stands by above the empty well.
In an analogous art, LeChance discloses an automated pipetting systems for aspirating and dispensing liquids (Abstract) comprising:
a solution transfer unit comprising a plurality of tips (pipette tip 122, Figure 1b and 2) that are movable (motor 138, Figure 1b and track 230, Figure 23 and 24) relative to the stage so as to suction a solution stored in the wells or discharge the suctioned solution (Figure 1b and 2) wherein the individual pipette is of the pipette module is able tip is able be selectively controlled to suction or discharge liquid (In some embodiments, the liquid dispenser includes two or more pipette channels coupled to the manifold , wherein each valve of the two or more pipette channels is configured to be individually actuated to selectively divert gas under vacuum or gas under pressure from the manifold to each dispense head. Paragraph 13) (The independently controllable valves 12 selectively divert gas under pressure and gas under vacuum based, at least in part on, the control signals. Each independently controllable valve 12 has simultaneous access to the pressure channel 4 and the vacuum channel 5B when the respective pipette channel (pipette channel 8A, 8B, or 8C) with the independently controllable valve 12 is coupled to the manifold 2.) (Paragraph 28).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have incorporated the solution transfer unit of LeChance with the ability to independently control and actuate each individual pipette tip to the device of Tajima. Doing so allows for a highly customizable liquid handling system that can be implemented in different type of analyzers and also simplifies labor intensive sample preparation steps, specifically those that requires multiple liquid transfer (LeChance, Paragraph 4-5).
Regarding claim 3, Modified Tajima discloses the claimed invention as discussed above in claim 1. Tajima discloses the plurality of cartridges comprises at least one cartridge that stores a reagent for a first step assay (the pretreatment is carried out and then an assay such as an immunoassay and a nucleic acid assay can be carried out successively; interpreted as either the pretreatment, immunoassay or a nucleic acid assay step; paragraph 110), and
each of the plurality of cartridges store a conjugate solution containing luminant (enzyme-labeling solution), a fixture solution containing magnetic particles (a solution of magnetic particles) and a pre-trigger solution (a substrate solution) (Paragraph 110),
Neither Tajima nor LeChance explicitly discloses wherein the plurality of cartridge comprises at least one cartridge in which at least one arrangement of rows of the wells in which the conjugate and the pre-trigger solution are stored, is different.
However, Tajima suggests that arrangement of storing reagents can be dynamic and the order of storing reagents and specimen can be flexibly altered (paragraphs 200-202). It would have been obvious to one of ordinary skill in the art to alter Modified Tajima to derive a configuration wherein the plurality of cartridge comprises at least one cartridge in which at least one arrangement of rows of the wells in which the conjugate and the pre-trigger solution are stored, is different. Doing so improves efficiency (By suitably changing the arrangement order of the holding portions in this way in view of the content of the treatment, the treatment of the specimen can be carried out more efficiently. Paragraph 200) and also allows for personalization/individualization (...users can select any of the first portion, the second portion, and the combination of the first portion and the second portion according to individual cases, paragraph 202).
Regarding claim 4, Modified Tajima discloses the claimed invention as discussed above in claim 3. Neither Tajima nor LeChance explicitly provides a written disclosure of cartridges in which arrangements of rows of the wells in which the fixture solution is store, are the same. That said, any device configured to process cartridges having identical arrangement of wells is sufficient to anticipate the claim. In this instance, the device taught by Tajima is configured to process cartridges having identical arrangement of wells (see Fig. 38 and paragraph 267).
Regarding claim 5, Modified Tajima discloses the claimed invention as discussed above in claim 1. Tajima discloses the solution transfer unit comprises a magnetic force applying part (magnet M, Figure 20b) disposes behind the plurality of tips to fix magnetic particles suctioned into the tip (Figure 20).
Regarding claim 6, Modified Tajima discloses the claimed invention as discussed above in claim 5. The claim limitation of claim 6 is interpreted as a recitation of intended use. Manner of operating an apparatus does not differentiate apparatus claim from the prior art. A claim containing a “recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus” if the prior art apparatus teaches all the structural limitations of the claim (MPEP 2114, II). A recitation of 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. Moreover, Tajima discloses the magnetic force applying part applies magnetic force to the magnetic particle inside of the tip (Figure 20b-f), and after a fixture solution containing the magnetic particles are suctioned into the tip (Figure 20a), the magnetic particles are held inside the tip until the state of the solution is measured by the measurement unit (Figure 20b-f).
Regarding claim 7, Modified Tajima discloses the claimed invention as discussed above in claim 5. Tajima discloses the solution transfer unit further comprises the driving part that provide a pressure for suctioning and discharging the solution of the tip, and the driving part provides a pressure to each of the plurality of tips (pump 140, Figure 22) (The pumping controller 112 has a pump 140 and a pressure sensor 146, and controls sucking up and discharging of the liquid performed via the nozzle and the pipette chip attached to the nozzle. Paragraph 164-165).
Regarding claim 8, Modified Tajima discloses the claimed invention as discussed above in claim 7. Tajima discloses the when the tip is introduced into an empty well, the driving part is provided to prevent a pressure change within the tip (In this constitution, for example, when the tip portion of the pipette chip is immersed in the specimen in the well, the pressure detected by the pumping controller 112 exceeds a predetermined threshold, and in response to this, the drive control signal is transmitted to the servomotor. Also at the time of sucking up and discharging the specimen, the pressure sensor 146 constantly transmits the pressure signal to the pumping controller 112. Therefore, the pumping controller 112 can control driving of the servomotor with high accuracy, and monitors levels of the pressure of Sucking up the specimen and the pressure of discharging the specimen, thereby performing management so as to allow Sucking up and discharging to be carried out within a predetermined range.) (Paragraph 165)
Conclusion
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/M.H./Examiner, Art Unit 1758
/MARIS R KESSEL/Supervisory Patent Examiner, Art Unit 1758