DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Preliminary Amendment
Receipt is acknowledged of the preliminary amendment filed on 09/19/2024.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because the abstract contains at least one of the phrases that can be implied, such as the phrase “the purpose of the present invention […] various reagents”. Correction is required. See MPEP § 608.01(b).
The disclosure is objected to because of the following informalities: the title is not descriptive. A new title that would include the inventive features of the claimed invention is respectfully requested.
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.
Claims 16-28 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as failing to set forth 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 16, the claim recites the phrases “a first reagent dispensing mechanism of a pipetting type that, upon aspirating a reagent, moves to a prescribed location away from the reagent and then discharges the reagent”, “the first reagent dispensing mechanism discharges the first reagent”, “a second reagent dispensing mechanism of a dispensing type that supplies a reagent via a flow path connecting an aspirating port to a discharge port for the reagent”, “a temperature adjustment mechanism that adjusts a temperature of the reagent”, “the second reagent dispensing mechanism discharges the second reagent“, which language discloses method steps required by the recited structural limitations. A single claim disclosing an apparatus and method steps for using the apparatus is considered indefinite under 35 U.S.C. 112(b) (see MPEP 2173.05(p)). In this case, inclusion of these steps in an apparatus or structural claim is not allowed, as it is unclear whether an infringement of the claimed language would occur upon the structural existence of the device or only during the use of the device (see MPEP 2173.05(p) IT).
The claim further discloses “a first reagent dispensing mechanism of a pipetting type that, upon aspirating a reagent, moves to a prescribed location away from the reagent and then discharges the reagent”, “first reagent discharged by the first reagent dispensing mechanism”, “the first reagent dispensing mechanism discharges the first reagent”, and “a second reagent dispensing mechanism of a dispensing type that supplies a reagent via a flow path connecting an aspirating port to a discharge port for the reagent”, “second reagent discharged by the second reagent dispensing mechanism”, “the second reagent dispensing mechanism discharges the second reagent“. The claim appears to disclose “a reagent” dispensed by both the first dispensing mechanism and the second dispensing mechanism and also recites “an amount of first reagent”, “an amount of second reagent”, “the first reagent” and “the second reagent” without clearly distinguishing the first and second reagent from “a reagent” or explaining whether these reagents are the same or different from one another.
The claim recites that “a first reagent dispensing mechanism […] moves to a prescribed location” without disclosing the device for moving the first reagent dispensing mechanism to a prescribed location. The claim is incomplete for omitting essential elements, such omission amounting to a gap between the elements (see MPEP § 2172.01). The omitted element is the device for moving the first reagent dispensing mechanism.
The claim states that “a first reagent dispensing mechanism […] discharges the reagent”, “discharged by the first reagent dispensing mechanism into the reaction container”, and “the first reagent dispensing mechanism discharges the first reagent” without defining whether the first reagent dispensing mechanism discharges the reagent or the first reagent into the reaction container, the common reaction container, and/or the stopped common reaction container.
The claim further discloses multiple different instances of “a common reaction container”, “the reaction container”, and “the stopped common reaction container” without defining whether these containers are the same or separate from one another, as the latter two lack proper antecedent basis.
Further clarification is respectfully requested.
Regarding claim 25, the claim recites the phrases “a first reagent dispensing mechanism of a pipetting type that, upon aspirating a reagent, moves to a prescribed location away from the reagent and then discharges the reagent”, “a second reagent dispensing mechanism of a dispensing type that supplies a reagent via a flow path connecting an aspirating port to a discharge port for the reagent”, “a temperature adjustment mechanism that adjusts a temperature of the reagent”, “the first reagent dispensing mechanism discharges a reagent aspirated from each reagent container into a common reaction container”. A single claim disclosing an apparatus and method steps for using the apparatus is considered indefinite under 35 U.S.C. 112(b) (see MPEP 2173.05(p)). In this case, inclusion of these steps in an apparatus or structural claim is not allowed, as it is unclear whether an infringement of the claimed language would occur upon the structural existence of the device or only during the use of the device (see MPEP 2173.05(p) IT).
The claim recites that “a first reagent dispensing mechanism […] moves to a prescribed location” without disclosing the device for moving the first reagent dispensing mechanism to a prescribed location. The claim is incomplete for omitting essential elements, such omission amounting to a gap between the elements (see MPEP § 2172.01). The omitted element is the device for moving the first reagent dispensing mechanism.
The claim further recites “a first reagent dispensing mechanism […] aspiring a reagent”, “a second reagent dispensing mechanism […] supplies a reagent”, and “the first reagent dispensing mechanism discharges a reagent” without explain whether the different instances of “a reagent” refer to the same or different reagents.
Further clarification is respectfully requested.
Regarding claim 27, the claim recites the phrases “a first reagent dispensing mechanism of a pipetting type that, upon aspirating a reagent, moves to a prescribed location away from the reagent and then discharges the reagent”, “a second reagent dispensing mechanism of a dispensing type that supplies a reagent via a flow path connecting an aspirating port to a discharge port for the reagent”, “a temperature adjustment mechanism that adjusts a temperature of the reagent”. A single claim disclosing an apparatus and method steps for using the apparatus is considered indefinite under 35 U.S.C. 112(b) (see MPEP 2173.05(p)). In this case, inclusion of these steps in an apparatus or structural claim is not allowed, as it is unclear whether an infringement of the claimed language would occur upon the structural existence of the device or only during the use of the device (see MPEP 2173.05(p) IT).
The claim recites the same “a reagent container” receiving both “a first reagent” and “a second reagent” without disclosing whether the same or different containers are configured to receive the first reagent and/or the second reagent.
The claim further recites “a first reagent dispensing mechanism […] aspirating a reagent […] discharges the reagent”, “a second reagent dispensing mechanism […] supplies a reagent […] discharge port for the reagent”, “adjusts a temperature of the reagent”, “a first reagent to be dispensed by the first reagent dispensing mechanism”, and “a second reagent to be dispensed by the second reagent dispensing mechanism” without explaining whether “a reagent”, “a first reagent”, and “a second reagent” refer to the same or different reagents aspirated and/or dispensed by the dispensing mechanisms.
Further clarification is respectfully requested.
Claims 17-24, 26, and 28 are rejected as being dependent on the rejected base claims.
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 following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 16, and 24-28 are rejected under 35 U.S.C. 103 as being unpatentable over Iguchi et al (Pat. No. US 7,850,921) (hereafter Iguchi) in view of Onuki et al. (Pat. No. 11,313,872) (hereafter Onuki).
Regarding claim 16, Iguchi teaches an automatic analysis device comprising:
a first reagent dispensing mechanism (i.e., one of the two reagent dispensing arm 60) (see Fig. 1-2) of a pipetting type that, upon aspirating a reagent, moves to a prescribed location away from the reagent and then discharges the reagent (i.e., the reagent dispensing arm 60 is provided to dispense the reagent within a reagent container loaded on the rotating part 20 into a cuvette 152 held in the rotating part 20) (see Column 7, lines 18-35); and
a second reagent dispensing mechanism (i.e., the other one of the two reagent dispensing arm 60) (see Fig. 1-2) of a dispensing type that supplies a reagent via a flow path (i.e., the reagent dispensing arm 60 is provided to dispense the reagent within a reagent container loaded on the rotating part 20 into a cuvette 152 held in the rotating part 20) (see Column 7, lines 18-35),
wherein the second reagent dispensing mechanism includes a temperature adjustment mechanism that adjusts a temperature of the reagent (i.e., a heating pipette 61, which configures a dispensing device with a heating function, is mounted on the tip of the reagent dispensing arm 60, and the heating pipette 61 is connected to a syringe pump 67 disposed within the reagent dispensing arm 60) (see Column 7, lines 18-35),
an amount of second reagent discharged by the second reagent dispensing mechanism into a common reaction container is larger than an amount of first reagent discharged by the first reagent dispensing mechanism into the reaction container (i.e., amount of reagent used is determined by the type of reagent used in blood coagulation analysis. The data, which includes the reagent type and the amount of reagent to be aspirated according to the analysis item, are stored on the hard disk 401d of the control device 4 beforehand by the operator. The CPU 401a specifies the type of reagent and reagent aspiration amount according to the sample analysis item included in the order information based upon these data) (see Column 12, lines 17-43),
and the first reagent dispensing mechanism discharges the first reagent, and the second reagent dispensing mechanism discharges the second reagent to the stopped common reaction container (i.e., a cuvette 152 held in the rotating part 20) (see Fig. 2); but does not explicitly teach supplying a reagent via a flow path connecting an aspirating port to a discharge port for the reagent.
Regarding the ports, Onuki teaches a second reagent dispensing mechanism of a dispensing type (i.e., dispensing device 1) (see Fig. 1) that supplies a reagent (i.e., reagent in container 2) (see Fig. 2) via a flow path (i.e., liquid transfer mechanism 3) (see Fig. 1) connecting an aspirating port (i.e., reagent suction pipe 6) (see Fig. 1) to a discharge port for the reagent (i.e., nozzle 4) (see Fig. 1 ), wherein the second reagent dispensing mechanism includes a temperature adjustment mechanism that adjusts a temperature of the reagent (i.e., temperature control mechanism 9) (see Fig. 1). In view of the teaching of Onuki, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have added the dispensing device in order to add a reagent to the analysis device having additional temperature adjustment means to further preserve the condition of the reagent.
Regarding claim 24, Iguchi teaches that the discharge port of the second reagent dispensing mechanism is located closer to a side surface of the reaction container than a discharge port of the first reagent dispensing mechanism (i.e., injection-discharge section 61c3 has an arc shaped configuration so as to discharge reagent obliquely downward from the tip of the injection-discharge section 61c3) (see Fig. 4).
Regarding claim 25, Iguchi teaches an automatic analysis device comprising:
a first reagent dispensing mechanism (i.e., one of the two reagent dispensing arm 60) (see Fig. 1-2) of a pipetting type that, upon aspirating a reagent, moves to a prescribed location away from the reagent and then discharges the reagent (i.e., the reagent dispensing arm 60 is provided to dispense the reagent within a reagent container loaded on the rotating part 20 into a cuvette 152 held in the rotating part 20) (see Column 7, lines 18-35); and
a second reagent dispensing mechanism (i.e., the other one of the two reagent dispensing arm 60) (see Fig. 1-2) of a dispensing type that supplies a reagent via a flow path (i.e., the reagent dispensing arm 60 is provided to dispense the reagent within a reagent container loaded on the rotating part 20 into a cuvette 152 held in the rotating part 20) (see Column 7, lines 18-35),
wherein the second reagent dispensing mechanism includes a temperature adjustment mechanism that adjusts a temperature of the reagent (i.e., a heating pipette 61, which configures a dispensing device with a heating function, is mounted on the tip of the reagent dispensing arm 60, and the heating pipette 61 is connected to a syringe pump 67 disposed within the reagent dispensing arm 60) (see Column 7, lines 18-35),
reagent containers are disposed at different positions on a movement trajectory of the first reagent dispensing mechanism (i.e., a cuvette 152 held in the rotating part 20) (see Fig. 2), and the first reagent dispensing mechanism discharges a reagent aspirated from each reagent container into a common reaction container (i.e., the data, which includes the reagent type and the amount of reagent to be aspirated according to the analysis item, are stored on the hard disk 401d of the control device 4 beforehand by the operator. The CPU 401a specifies the type of reagent and reagent aspiration amount according to the sample analysis item included in the order information based upon these data) (see Column 12, lines 17-43); but does not explicitly teach supplying a reagent via a flow path connecting an aspirating port to a discharge port for the reagent.
Regarding the ports, Onuki teaches a second reagent dispensing mechanism of a dispensing type (i.e., dispensing device 1) (see Fig. 1) that supplies a reagent (i.e., reagent in container 2) (see Fig. 2) via a flow path (i.e., liquid transfer mechanism 3) (see Fig. 1) connecting an aspirating port (i.e., reagent suction pipe 6) (see Fig. 1) to a discharge port for the reagent (i.e., nozzle 4) (see Fig. 1 ), wherein the second reagent dispensing mechanism includes a temperature adjustment mechanism that adjusts a temperature of the reagent (i.e., temperature control mechanism 9) (see Fig. 1). In view of the teaching of Onuki, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have added the dispensing device in order to add a reagent to the analysis device having additional temperature adjustment means to further preserve the condition of the reagent.
Regarding claim 26, Iguchi teaches that before discharging a reagent aspirated from a predetermined reagent container, the first reagent dispensing mechanism also aspirates a reagent from another reagent container (i.e., dispensing device is capable of aspirating and discharging reagent) (see Column 8, lines 3-9), and collectively discharges the reagents into the reaction container (i.e., the CPU 401a specifies the type of reagent and reagent aspiration amount according to the sample analysis item included in the order information based upon these data) (see Column 12, lines 17-43).
Regarding claim 27, Iguchi teaches an automatic analysis device comprising:
a first reagent dispensing mechanism (i.e., one of the two reagent dispensing arm 60) (see Fig. 1-2) of a pipetting type that, upon aspirating a reagent, moves to a prescribed location away from the reagent and then discharges the reagent (i.e., the reagent dispensing arm 60 is provided to dispense the reagent within a reagent container loaded on the rotating part 20 into a cuvette 152 held in the rotating part 20) (see Column 7, lines 18-35); and
a second reagent dispensing mechanism (i.e., the other one of the two reagent dispensing arm 60) (see Fig. 1-2) of a dispensing type that supplies a reagent via a flow path (i.e., the reagent dispensing arm 60 is provided to dispense the reagent within a reagent container loaded on the rotating part 20 into a cuvette 152 held in the rotating part 20) (see Column 7, lines 18-35),
wherein the second reagent dispensing mechanism includes a temperature adjustment mechanism that adjusts a temperature of the reagent (i.e., a heating pipette 61, which configures a dispensing device with a heating function, is mounted on the tip of the reagent dispensing arm 60, and the heating pipette 61 is connected to a syringe pump 67 disposed within the reagent dispensing arm 60) (see Column 7, lines 18-35), and
a reagent container that contains a first reagent to be dispensed by the first reagent dispensing mechanism and a reagent container that contains a second reagent to be dispensed by the second reagent dispensing mechanism are provided side by side in a common reagent loading position (i.e., rotating part 20 is provided to transport in a circular direction those cuvettes 152 which have been received from the cuvette supplier 10, as well as reagent containers accommodating reagent to be added to the sample in the cuvette 152) (see Column 5, line 66, to Column 6, line 18); but does not explicitly teach supplying a reagent via a flow path connecting an aspirating port to a discharge port for the reagent.
Regarding the ports, Onuki teaches a second reagent dispensing mechanism of a dispensing type (i.e., dispensing device 1) (see Fig. 1) that supplies a reagent (i.e., reagent in container 2) (see Fig. 2) via a flow path (i.e., liquid transfer mechanism 3) (see Fig. 1) connecting an aspirating port (i.e., reagent suction pipe 6) (see Fig. 1) to a discharge port for the reagent (i.e., nozzle 4) (see Fig. 1 ), wherein the second reagent dispensing mechanism includes a temperature adjustment mechanism that adjusts a temperature of the reagent (i.e., temperature control mechanism 9) (see Fig. 1). In view of the teaching of Onuki, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have added the dispensing device in order to add a reagent to the analysis device having additional temperature adjustment means to further preserve the condition of the reagent.
Regarding claim 28, Iguchi teaches that the reagent loading position is located in front of the first reagent dispensing mechanism and the second reagent dispensing mechanism (see Fig. 2).
Claims 17-23 are objected to as being dependent on the rejected base claim.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: see PTO-892.
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/Tran M. Tran/Examiner, Art Unit 2855
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