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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/15/2025 has been entered.
Claim status
Claims 1-14 are pending.
Claim 1 has been amended.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Interpretation
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
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: “a plurality of processing units which execute operations related to analysis” in claim 1.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim 1 recites “a plurality of processing units which execute operations related to analysis” which interpreted as at least two of the features, which may be identical features, from Para [0033] within the specification: reagent dispensing mechanism, stirring paddle drive mechanism, reaction liquid aspiration mechanism, sample dispensing mechanism, BF separation mechanism.
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 1, 2, 5, 6, 9, and 11-13 are rejected under 35 U.S.C. 103 as being unpatentable over Dunfee (US 20050074363 A1) and further in view of Van Praet (WO 2011/011075 A2) and Holmes et. al. (US 20140296089 A1).
Regarding Claim 1, Dunfee teaches “An automatic analyzer comprising:” (Para [0001], automated apparatus, method to automatically extract a desired amount to sample fluid from a closed container); “a plurality of processing units which execute operations related to analysis” (Paras [0044] A number of reagent aspiration and dispense arms 60, 61 and 62); “and a control unit which controls the plurality of processing units,” (Para [0038] Analyzer 10 is controlled by software executed by the computer 15 based on computer programs written in a machine language).
Dunfee teaches a plurality of mounting units for probes and they can be translatable between mounting units (Paras [0044], conventional liquid reagent probes, 60P, 61P and 62P, respectively, are independently mounted).
However, Dunfee does not specifically teach mounting a measuring instrument.
Van Praet teaches medical diagnostic automatic apparatus with monitoring camera and plurality of measuring instrument mounting units arranged within the processing units within (Page 5 and 6, The camera 10 is mounted to the moving arm 40 which 20 supports the pipetting apparatus 50 and can also be mounted directly to the pipetting apparatus 50. The camera 10 could be mounted elsewhere within the housing 20 of the analyzer 2. Alternatively, multiple cameras 10 can be mounted in different locations within the housing 20.)
Dunfee and Van Praet do not distinctly point out “each of the plurality of measuring instrument mounting units has a same structure”
Holmes teaches systems and methods provided for sample processing “a plurality of measuring instrument mounting units, wherein each of the plurality of processing units has one of the plurality of measuring instrument mounting units mounted thereon and each of the plurality of measuring instrument mounting units has a same structure which is configured to allow mounting of a measuring instrument to measure each of the operations of the plurality of processing units “in addition to “wherein is removable from any one of the plurality of measuring instrument mounting units and mountable to any other one of the plurality of measuring instrument mounting units based on the plurality of measuring instrument mounting units having the same structure.” (Abstract, Paras. [1396] and [1702]; Figs. 3, 6, and 56, The device may be capable of performing multiple assays. The device may comprise one or more modules that may be capable of performing one or more of a sample preparation, sample assay, and detection step. Cameras may be provided at various locations of point of service systems, devices and modules described herein. In an embodiment, cameras (5608) are provided in modules for imaging various processing routines, including sample preparation and assaying. An internal camera may be movable within the device).
The cameras in the modules each have a mounting unit (para. [1702]). In addition, Holmes teaches the camera is movable within the device, and the mounts having the same structure as each other to allow movement of the camera (para. [1702]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Dunfee to incorporate teachings of Holmes and Van Praet to provide each processing unit with a respective measuring instrument mounting unit mounted thereon; each mounting unit having the same structure, wherein each process unit is removable from the respective mounting unit and mountable to any other one mounting unit based on the same structure. It has been held that a mere duplication of working parts of a device involves only routine skill in the art, MPEP 2144.04 (VI)(B).
Doing so would allow the apparatus to detect a fault, perform quality control assessments, perform longitudinal analysis, perform process optimization and synchronize operations as taught within para [1396] within Holmes.
Regarding claim 2 Modified Dunfee teaches all of claim 1 but Dunfee does not teach “including a display unit which displays a measurement result obtained by the measuring instrument.”.
Van Praet teaches “including a display unit which displays a measurement result obtained by the measuring instrument.” (Page 4, Camera can be a video camera or still camera. It can be coupled to a computer screen or other display to provide a real time image to an operator.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified Dunfee to incorporate the teachings of Van Praet to have a display unit which displays a measurement result of the operation obtained by the measuring instrument. Doing so would allow the user to see the measurement in real time and ensure subsequent steps of operation were appropriate based on that measurement.
Regarding Claim 5 Modified Dunfee teaches all of claim 1 as above in addition to “wherein at least one of the processing units has a rod-shaped member which comes into contact with liquid.” (Fig 9 and Para [0048], sample fluid probe 66 (observed rod-shaped) positioned within sample fluid 68).
Regarding Claim 6 Modified Dunfee teaches all of claim 5 as above and the recitation” wherein at least one of the measuring instrument mounting units is arranged so that the measuring instrument is capable of measuring a position of the rod-shaped member.” is capability of the measuring instrument mounting unit. Dunfee discloses the positively claimed structural elements of the measuring instrument mounting unit as claimed, such mounting units are said to be fully capable of the recited adaption in as much as recited and required herein.
Regarding claim 9, modified Dunfee teaches all of claim 1 as above however does not teach “wherein the measuring instrument has a lens and an image element and is capable of imaging the operation.”.
Van Praet further “wherein the measuring instrument has a lens and an image element” (Page 4 and 5, light source and lens).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified Dunfee to incorporate the further teachings of Van Praet wherein the measuring instrument has a lens and an image element. Doing so would allow for a broader range of things the measuring instrument could measure. This could assist in the measurement of moving parts within the device.
Regarding Claim 11 modified Dunfee teaches all of claim 1 as above but does not teach “including an identification label for identifying the plurality of measuring instrument mounting units.”.
Holmes teaches “including an identification label for identifying the plurality of measuring instrument mounting units.”. (Paras [0014], [1475], [1479], and [0484]- Has a supporting structure having a mounting station configured to support a module among a plurality of modules, said module being (a) detachable from said mounting station or interchangeable with at least other module of the plurality; (b) configured to perform without the aid of another module in said system (i) at least one sample preparation procedure. An identifier (e.g. bar code, RFID tag) may be provided at a module or at component level or any other level described herein (e.g., external device, groups of devices, racks, components of a device, portions of a component). Therefore, the measuring instrument mounting units having an identification label is taught by the mounting station which is part of the module which can have a identifier.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified Dunfee to incorporate additional teachings of Holmes by including an identification label for identifying the plurality of measuring instrument mounting units. Doing so would allow the automatic analyzer to automatically identify and select the correct mount within the unit needed for operation.
Regarding claim 12, Modified Dunfee teaches all of claim 1 as above however does not teach “,including a display unit which displays the another measuring instrument mounting unit in which the measuring instrument should be mounted from among the plurality of measuring instrument mounting units.”.
Van Praet further teaches “,including a display unit which displays the another measuring instrument mounting unit in which the measuring instrument should be mounted from among the plurality of measuring instrument mounting” (Page 4, This video or still image data can then be later consulted to watch the process taking place and verify that the process so recorded visually was accurately conducted.) Therefore, the video could be the display which captures and displays the mounting units.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified Dunfee to incorporate additional teachings of Van Praet including a display unit which displays the measuring instrument mounting unit in which the measuring instrument should be mounted from among the plurality of measuring instrument mounting units. Doing so would allow the user to see on the display the unit and ensure the correct one is selected. This would allow the operations of the analyzer to run smoothly and for the user to see any possible issues with that selection.
Regarding Claim 13, modified Dunfee teaches all of claim 9 as above but does not currently teach “background image plate arranged on the opposite side of the lens so as to sandwich an imaging target of the lens.”.
However, Holmes further teaches “background image plate arranged on the opposite side of the lens so as to sandwich an imaging target of the lens.” (Paras [0030], [0860], [1396], [0958], and FIG. 67C, the plurality of individual pipette units 6720 which have a pipette tip that can function as a lens on opposite side of the imaging devices 6730 and 6732 which can be a camera which includes more optical elements selected from the group consisting of a lens, a mirror, a diffraction grating, a prism, and other components for directing and/or manipulating light.) Therefore, the mirror within the imaging devices which are opposite sides of the lens within the pipette tip teaches to the background image plate.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified Dunfee to incorporate additional teachings of Holmes to include a background image plate arranged on the opposite side of the lens so as to sandwich an imaging target of the lens. Doing so would allow the user to see on the display the unit and ensure the correct one is selected. This would allow for a clearer image which will increase the efficiency of the device.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Dunfee, Van Praet and Holmes as applied to claim 2 above, and further view of Akihisa (WO 2019073649 A1), machine translation.
Regarding claim 3 Modified Dunfee teaches all of claim 2 as above but does not teach “wherein the control unit determines based on the measurement result whether or not the operations are within a predetermined criterion.”.
Akihisa teaches an automatic analyzer that automatically analyzes components contained in a biological sample such as blood and urine in addition to “wherein the control unit determines based on the measurement result whether or not the operations are within a predetermined criterion.” (Page 10, The computer 105 compares the numerical range in which each of the above three light quantities has a predetermined width with the value of the light quantity detected after the installation of the reaction container (for blood coagulation analysis) 28 and the state of the analysis port 304. In the first case, it is determined whether the second case or the third case applies, and a warning is issued if the state of the analysis port 304 is different from the scheduled state.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Dunfee to incorporate the teachings of Akihisa wherein the control unit determines based on the measurement result whether or not the operation is within a predetermined criterion. Doing so would assist in troubleshooting any errors that occur and allow for more accurate control of the device.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Dunfee, Van Praet, Holmes, and Akihisa as applied to claim 3 above, and further view of Iwamatsu et. al. (US 8409507 B2).
Regarding claim 4 Modified Dunfee teaches all of claim 3 as above but does not teach “wherein the control unit changes the operations of the processing units, based on the result of determining whether or not the operations are within the predetermined criterion.”
Iwamatsu teaches an automatic analyzer for qualitatively and quantitatively analyzing biological samples in addition to “wherein the control unit changes the operations of the processing units, based on the result of determining whether or not the operations are within the predetermined criterion.” (Claim 1, when the reagent for which said reagent amount detecting means has detected that the remaining amount has fallen to a predetermined threshold value or less has been replenished such that the amount of the reagent exceeds the predetermined threshold value, said control means is configured to perform a third step of control where, when said analysis device changes to the operation state from the standby state.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Dunfee to incorporate the teachings of Iwamatsu wherein the control unit changes the operation of the processing unit, based on the result of determining whether or not the operation is within the predetermined criterion. Doing so would assist in an automatic troubleshooting of the device or even for the automatic addition of a cleaning step to ensure that the automatic device continues to operation without disruption.
Claims 7 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Dunfee, Van Praet, Holmes as applied to claim 5 above, and further view of Takayama (US 2009/0114538).
Regarding Claim 7, Modified Dunfee teaches all of claim 5 as above in addition to “wherein the plurality of processing units include a cleaning mechanism which cleans the rod-shaped member” (Paras [0046], [0051], Remove contamination from probe 66 with liquid cleansing solutions Cleansing Module 1). However Modified Dunfee does not explicitly teach “and wherein the measuring instrument measures a cleaning liquid by the cleaning mechanism.”.
Takayama teaches an automatic sampler system which provides a temporary opening in the resealable closure of a sample container in addition to “and wherein the measuring instrument measures a cleaning liquid by the cleaning mechanism.” (Paras [0083]-[0086], a image processor (measuring instrument) to view the cleaning solutions by the cleaning mechanism).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified Dunfee to incorporate the teachings of Tayayama wherein the measuring instrument measures the cleaning liquid by the cleaning mechanism. Doing so would assist in the automation of the device by measuring the cleaning liquid the device can ensure the cleaning liquid is adequate for the next processing step. .
Regarding claim 10, Modified Dunfee teaches all of claim 7 but does not explicitly teach “wherein the measuring instrument measures the amount of the cleaning liquid of the cleaning mechanism.”.
However, it would have been obvious clearly within the ordinary skills of an artisan before the effective filing date of the claimed invention to have further modified the invention of Dunfee by having the amount of the cleaning liquid measured. Takayama teaches discriminating color of the cleaning liquid and it would have been obvious to also determined the volume of solution to ensure there was enough cleaning liquid present to perform the cleaning process.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Dunfee, Van Praet, and Holmes as applied to claim 6 as above, and further view of Yoshida et. al. (JP 2013064673A), machine translation.
Regarding claim 8, modified Dunfee teaches all of claim 6 as above however does not teach “wherein the measuring instrument measures a distance between the position of the rod-shaped member and a reference surface of the automatic analyzer.”.
Van Praet teaches, on page 4, the image capture of the pipette tip/ probe/needle as it enters a vessel. By capturing the tip as it goes into the vessel the distance can be verified.
In addition, Yoshida teaches an automatic analyzer that performs qualitative and quantitative analysis of biological in addition to “, wherein the measuring instrument measures a distance between the position of the rod-shaped member and a reference surface of the automatic analyzer.” (Page 3 and 4, an accurate distance 210 between the tip of the sample probe 3 and the reaction container bottom surface 201 is obtained in advance. This is so that during operation the sample probe can be lowered while leaving a constant gap (difference between the distance 211 and the distance 210) regardless of the reaction container. The sample probe 3 is used in order to correct the variation in the depth dimension of each reaction vessel 5 and accurately calculate the sample probe descending distance 211. This descending distance is then used to perform accurate stop position control of the sample probe tip 3 and the reaction vessel bottom surface 201.) Therefore, having the measurement between the sample probe tip to the vessel bottom measured and using that to measure the stop position of the sample probe for future use teaches to measurement of the stop position of the rod-shaped member to a reference plane.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have to modified Dunfee incorporate the teachings of Yoshida wherein the wherein the measuring instrument measures a distance between the stop position of the rod-shaped member and a reference plane of the automatic analyzer. Doing so would allow the rod-shaped member (sample probe) to not come in contact with a reference plan which could be the bottom of a vessel. Preventing that contact would ensure no damage is done to the rod-shaped member (sample probe).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Dunfee, Van Praet, and Holmes as applied to claim 13 above, and further view of Ha (US 20150029331).
Regarding Claim 14 Modified Dunfee teaches all of claim 13 as above but does not currently teach “wherein the background image plate is a positioning mark or a machine-readable text.”.
Ha teaches adjusting various mechanisms of an automatic analysis device in addition to “wherein the background image plate is a positioning mark or a machine-readable text.” (Para [0004], an optical marker is placed on the transparent base, and a relative positional relationship between the probe and the base with the holding plate secured thereon is calibrated by allowing the camera to pick up an image of the corresponding marker.).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified Dunfee to incorporate additional teachings of Ha where the background image plate is a positioning mark or a machine-readable text. Doing so would allow the capturing of information about the position of the image being taken. This could assist in further troubleshooting or analysis process steps by identifying the location of the image taken at that time.
Response to Amendments
Claim Interpretation
Examiner acknowledges that the applicant has acknowledged the claim interpretation outlined in the non-final office action dated 6/4/2025.
Response to Arguments
Applicant’s arguments with respect to claim 1 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VELVET E HERON whose telephone number is (571)272-1557. The examiner can normally be reached M-F.
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/V.E.H./Examiner, Art Unit 1798
/CHARLES CAPOZZI/Supervisory Patent Examiner, Art Unit 1798
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