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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 1 December 2025 has been entered.
Response to Amendment
This is an office action in response to Applicant’s arguments and remarks filed on 1 December 2025. Claims 1-9 and 11 are pending in this application. Claims 1-9 and 11 are being examined herein.
Status of Objections and Rejections
The interpretation of claim 1, 2, 6, 8, and 11 under 35 U.S.C. § 112(f) in regards to “a reading unit” are maintained.
The interpretation of claim 1, 2, 8, and 11 under 35 U.S.C. § 112(f) in regards to “a control” are maintained.
The rejection of claim 1 under 35 U.S.C. § 103 in view of Kondou, et. al. (US 20090221090 A1; as cited in previous OA) in view of Opalsky (US 20170235984 A1; as cited in previous OA) is withdrawn in view of amendments; however, a new ground of rejection is made.
The rejections of claims 2-4 and 6-9 under 35 U.S.C. § 103 in view of Kondou, et. al. (US 20090221090 A1; as cited in previous OA) and Opalsky (US 20170235984 A1; as cited in previous OA), in further view of Natsukari, et. al. (JP 2004054645 A; as cited in previous OA) is withdrawn in view of amendments; however, a new ground of rejection is made.
The rejection of claim 5 under 35 U.S.C. § 103 in view of Kondou, et. al. (US 20090221090 A1; as cited in previous OA), Opalsky (US 20170235984 A1; as cited in previous OA), and Natsukari, et. al. (JP 2004054645 A; as cited in previous OA), in further view of Watari, et. al. (US 20020134623 A1; as cited in previous OA) is withdrawn in view of amendments; however, a new ground of rejection is made.
The rejection of claim 11 under 35 U.S.C. § 103 in view of Kondou, et. al. (US 20090221090 A1; as cited in previous OA) in view of Opalsky (US 20170235984 A1; as cited in previous OA) and Natsukari, et. al. (JP 2004054645 A; as cited in previous OA) is withdrawn in view of amendments; however, a new ground of rejection is made.
Response to Arguments
Applicant’s arguments, see pages 6-11, filed 1 December 2025, with respect to the rejections of claim 1 under 35 U.S.C. § 103 in view of Kondou in view of Opalsky and claim 11 under 35 U.S.C. § 103 in view of Kondou in view of Opalsky and Natsukari 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 Kondou in view of Opalsky and Oonuma, et. al. (US 20170205436 A1) (for claim 1) and Kondou in view of Opalsky, Natsukari, and Oonuma, et. al. (US 20170205436 A1) (for claim 1).
Applicant argues newly amended claims 1 and 11 now include additional structural limitations to the upper cover of the device, specifically, the “downwardly extending suspended portion” has been amended to be radially inward from the edge of the top cover and the top cover extends radially inward (attributing to a circular shape) (remarks pg. 10-11).
Applicant further argues that amendments include sufficient structure to no invoke interpretation under 35 U.S.C. § 112(f) (remarks, pg. 6, par. 02). Examiner notes amendments provided 1 December 2025 only contribute to structural elements of the upper cover and not the reading unit and control unit. Because both the reading unit and the control unit are described by the functional limitations, the interpretation of the components under 35 U.S.C. § 112(f) is maintained.
Claim Interpretation
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 reading unit" in claims 1, 5, 6, 8, and 11.
"a control unit" in claims 1, 5, 8, and 11.
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 Rejections - 35 USC § 103
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 1 is rejected under 35 U.S.C. 103 as being unpatentable over Kondou, et. al. (US 20090221090 A1; as cited in previous OA) in view of Oonuma, et. al. (US 20170205436 A1) and Opalsky (US 20170235984 A1; as cited in previous OA).
Regarding claim 1, Kondou teaches a sample analysis apparatus (Abstract). Kondou teaches the analysis apparatus comprises container racks 13 and 14 that each house holding parts 131, 1382, 141-146 (a mounting unit) that hold sample containers (Fig. 3-5; par. 0043, 0047, 0049) (a mounting unit for mounting a specimen vessel that stores a specimen to be analyzed). Kondou teaches at the back of the holding parts 131, 132, 141-146 has barcodes 131c, 132c, 141c-146c that are located behind a sample/reagent vessel when a sample/reagent vessel is installed in the holding parts (Fig. 4, 5; par. 0048, 0050) (behind the specimen vessel configured to be mounted in the mounting unit with respect to an irradiation direction of the reading unit).
There is additionally a barcode reader 3 to read barcodes on the holding parts and in communication with a control section (Fig. 3; par. 0045) (a reading unit arranged at a front position of the mounting unit and reading the first identifier). Kondou teaches the barcode reader 3 is in communication with control section 4 (Fig. 1; par. 0045); the barcode reader 3 scans the barcode by irradiating light and receiving reflected light back from the barcode and outputting a signal corresponding with the light intensity reflected back (Fig. 8; par. 0057). A threshold value is set to determine if the voltage signal is high enough to overcome the threshold or not, ultimately letting the control section 4 determine the status of a container in the holding part (Fig. 8, par. 0057) (a control unit configured to determine whether the specimen vessel is mounted on the mounting unit based on whether a contrast value indicated by a signal of the reading unit of the light reflected from the first identifier is equal to or greater than a threshold). Ultimately, Kondou teaches the barcodes on the back of holding parts serve the purpose of allowing the CPU 41 of the control section 4 to determine the presence or absence of a sample/reagent vessel because if the vessel is present the vessel blocks barcodes 131c, 132c, 141c-146c making them unreadable to barcode reader 3, and readable to barcode reader 3 when a vessel is absent (par. 0052-0054).
Kondou is silent to an upper cover covering the mounting unit having a downwardly extending suspended portion, the downwardly extending suspended portion being behind the specimen vessel, wherein the downwardly extending suspended portion extends downwardly from a top portion of the cover and is recessed radially inward from an outermost radial edge of the top cover, and wherein the top portion of the cover extends radially inward from the downwardly extending suspended portion.
Oonuma teaches an automatic analysis device capable of transporting containers through the system (Abstract). Oonuma teaches the automatic analysis device comprises a loading portion 201, acting as a cover for the refrigerated storage area 105, has a cutout 213 with slots 211 for loading containers 101 (Fig. 5-7). Above cutout 213 and slots 211 is shielding member 212 that is L-shaped with a portion protruding behind containers (par. 0034). The protruding member can be seen circled in re-created Figure 6 below (an upper cover covering the mounting unit having a downwardly extending suspended portion) (the downwardly extending suspended portion being behind the specimen vessel) (wherein the downwardly extending suspended portion extends downwardly from a top portion of the cover and is recessed radially inward from an outermost radial edge of the top cover).
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As seen in recreated Figure 6 above, the loading portion 201, acting as a cover, extends beyond the protrusions from shielding member 212. Oonuma teaches the device has a generally circular shape resulting in all points extending radially from a center (Fig. 8-9) (and wherein the top portion of the cover extends radially inward from the downwardly extending suspended portion). Oonuma additionally teaches use of RDIF 142 to track and read tags on reagent containers (Fig. 5-7; par. 039). Oonuma teaches the L-shape of the shielding member in combination with the other loading portion 201 components keep containers thermally isolated when during the loading process (par. 0035, 0037).
It would have been obvious for one of ordinary skill in the art before the effectively filing date of the invention to modify the analysis device of Kondou to further include a cover with a downward protrusion as taught by Oonuma in order to isolate containers in the loading process from previously loaded containers, in particular if parts of the device are thermally different. Because both automatic analysis devices need containers loaded to operate, modifying the device to include a cover with a downward protrusion behind the containers as provided by Oonuma, provides likewise sought functionality with reasonable expectation of success. MPEP 2143(I)(G).
Modified Kondou is silent to the downwardly extending suspended portion on which a first identifier is disposed.
Opalsky teaches a sample processing instrument that uses machine-readable marks and an image capturing device (Abstract). Opalsky teaches a sample rack 112 with pockets 140A-E that hold sample vessels 136. Sample rack 112 additionally comprises a cover 151 with fiducial marks 150A-E and label 156 (Fig. 7, 9; par. 0038, 0045-0046); the fiducial marks being two dimensional codes (par. 0037). As seen in Figure 7, the cover has a top surface and with two portions that suspend downward from the upper surface of the lid on with the fiducial marks 150A-E are disposed (on which a first identifier is disposed). The use of machine readable marks on the lid of the device (in addition to identifying marks on the sample container themselves) is to store information regarding location within the sample rack (par. 0037).
It would have been obvious to one skilled in the art before the effective filing date of the invention to modify the cover of modified Kondou with barcodes a taught by Opalsky in order to store extra location-based readable information. Because both devices use a movable disk to move sample vessel and rely on readable codes for identification modifying the machine-readable mark on a cover with a downward extended portion as provided by Opalsky, provides likewise sought functionality with reasonable expectation of success. MPEP § 2143(I)(G).
Claims 2-4 and 6-9 are rejected under 35 U.S.C. 103 as being unpatentable over Kondou, et. al. (US 20090221090 A1) in view of Oonuma, et. al. (US 20170205436 A1) and Opalsky (US 20170235984 A1) as applied to claim 1 above, and further in view of Natsukari, et. al. (JP 2004054645 A; as cited in previous OA).
Regarding claim 2, modified Kondou teaches the first identifier is a barcode 131c, 132c, 141c-146c (Fig. 4, 5; par. 0048, 0050).
Kondou is silent to the barcode first identifier being a two-dimensional code.
Natsukari teaches a two-dimensional code, code reader, and code reading program (lines 10-11). Natsukari teaches a two-dimensional code on an object, a two- dimensional code reader configured to determine the color contrast of areas (lines 50- 57) (the first identifier is a two-dimensional code). Once the two-dimensional code is illuminated and imaged, the code reader receives image data and converted to an analog signal to determine threshold value by the program (Fig. 1; lines 444-463). Natsukari teaches two-dimensional codes are an improvement over one-dimensional codes because the repetitive nature of the vertical and horizontal lines it has the ability to correct errors (lines 19-26).
It would have been obvious to one skilled in the art before the effective filing date of the invention to substitute the one-dimensional barcode identifiers of Kondou to the two-dimensional codes of Natsukari because two-dimensional codes are less prone to errors. Because both devices use codes as a means to identify, substituting the one dimensional code for a two-dimensional as provided by Natsukari, provides likewise sought functionality wherein the substitution would yield predictable results. MPEP § 2143(1)(B).
Regarding claim 3, modified Kondou in view of Natsukari teaches one type of two-dimensional code that can be used in the system is a data matrix code (Natsukari, Fig. 2; lines 384-387) (the two-dimensional code is a data matrix).
Regarding claim 4, modified Kondou in view of Natsukari teaches two dimensional codes are patterned dark and light portions, the code reader calculates contrast between the patterned portions (Natsukari, lines 414-417) (the contrast value is calculated from the signals of a black part and a white part of the two-dimensional code).
Regarding claim 6, modified Kondou teaches a second barcode 200a on the side of a container 200; the second barcode 200a is read by barcode reader 3 (Kondou, Fig. 6, 7; par. 0051-0054) (a second identifier is arranged on a side surface of the specimen vessel, and the reading unit reads the second identifier).
Regarding claim 7, modified Kondou teaches the second identifier on the container is a barcode 220a (Kondou, Fig. 6, 7; par. 0051-0054) (the second identifier is a barcode).
Regarding claim 8, modified Kondou teaches barcode 200a contains information about the container that is processed by the CPU of the control section 4 (Kondou, par. 0008, 0052, 0054) (the control unit identifies a specimen in the specimen vessel based on the second identifier read by the reading unit).
Regarding claim 9, modified Kondou teaches the holding parts 131, 132, and 141-146 are installed within container racks 13 and 14 sample table 12 (Kondou, Fig. 3). As seen in Figure 3, the circular areas surrounding the outer perimeter of the containers racks 13 and 14 are where the holding parts are located (a reagent specimen disk, wherein the mounting unit is located at an outer peripheral portion of the reagent specimen disk).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Kondou, et. al. (US 20090221090 A1) in view of Oonuma, et. al. (US 20170205436 A1), Opalsky (US 20170235984 A1), and Natsukari, et. al. (JP 2004054645 A) as applied to claim 2 above, and further in view of Watari, et. al. (US 20020134623 A1; as cited in previous OA).
Regarding claim 5, modified Kondou teaches the limitations as applied to claim 2 above, specifically regards to the two-dimensional codes provided by Natsukari.
Modified Kondou is silent to a plurality of the two-dimensional codes are arranged, and the control unit determines the type of the specimen vessel based on the number of the two-dimensional code read by the reading unit.
Watari teaches an automatic analyzer that can evaluate the height of test tubes based on optical information (Abstract). Watari teaches the analyzer comprises a sample cup 37 loaded on rack 13 that holds test tube 11 with a code pattern 12 (Fig. 1; par. 0030-0032). Behind test tube 11 is background panel 14 and opposite to optical information reader 7 (Fig. 1; par. 0034). The optical reader detects a reference line 15 on background panel 14 to calculate the height associated with the test tube based on scattered and reflected light from the background panel 14 and reference line 15 (Fig. 1; par. 0036-0037). Watari teaches that the optical information reader having the ability to calculate container height in such a way results in fewer sensors being needed on the instrument, increasing reliability and decreasing maintenance (par. 0041) (the control unit determines the type of the specimen vessel based on the number of the two dimensional code read by the reading unit). Watari further teaches background panel 14 can have an auxiliary symbol and checkpoint lines in addition to reference line 15 to increase precision when calculating height (Fig. 6, 7; par. 0042-0044) (a plurality of the two-dimensional codes).
It would have been obvious to one skilled in the art before the effective filing date of the invention to modify the single identifier on the mounting unit of modified Kondou to include a plurality of markings (identifier codes) that allow the control unit to calculate the height (and type) of the vessel based on reflected and scattered light of exposed marks as taught by Watari in order to reduce number of sensors on the instrument and increase height calculation precision. Because both devices use light reflected off of marking and codes as a means to identify information about a specimen vessel, using plurality of mark behind the vessel to determine height as provided by Watari, provides likewise sought functionality that would have reasonable expectation of success. MPEP § 2143(I)(G).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Kondou, et. al. (US 20090221090 A1) in view of Oonuma, et. al. (US 20170205436 A1), Opalsky (US 20170235984 A1) and Natsukari, et. al. (JP 2004054645 A).
Regarding claim 11, Kondou teaches the holding parts 131, 132, and 141-146 are installed within container racks 13 and 14 sample table 12 (Fig. 3). As seen in Figure 3, the circular areas surrounding the outer perimeter of the containers racks 13 and 14 are where the holding parts are located (a reagent specimen disk including a mounting unit for mounting a specimen vessel that stores a specimen to be analyzed on an outer peripheral portion thereof). Kondou teaches at the back of the holding parts 131, 132, 141-146 has barcodes 131c, 132c, 141c-146c that are located behind a sample/reagent vessel when a sample/reagent vessel is installed in the holding parts (Fig. 4, 5; par. 0048, 0050) and a second barcode 200a on the side of a container 200; the second barcode 200a is read by barcode reader 3 (Fig. 6, 7; par. 0051-0054) (behind the specimen vessel mounted in the mounting unit with respect to an irradiation direction of the reading unit) (a barcode arranged on a side surface of the specimen vessel).
There is additionally a barcode reader 3 to read barcodes on the holding parts and in communication with a control section (Fig. 3; par. 0045) (a reading unit arranged at a front position of the mounting unit and capable of reading the... code and the barcode). Kondou teaches the barcode reader 3 is in communication with control section 4 (Fig. 1; par. 0045); the barcode reader 3 scans the barcode by irradiating light and receiving reflected light back from the barcode and outputting a signal corresponding with the light intensity reflected back (Fig. 8; par. 0057). A threshold value is set to determine if the voltage signal is high enough to overcome the threshold or not, ultimately letting the control section 4 determine the status of a container in the holding part (Fig. 8, par. 0057) (a control unit configured to determine for determining whether the specimen vessel is mounted on the mounting unit based on whether a contrast value indicated by a signal output from the reading unit of the light reflected from the… code is equal to or greater than a threshold). Ultimately, Kondou teaches the barcodes on the back of holding parts serve the purpose of allowing the CPU 41 of the control section 4 to determine the presence or absence of a sample/reagent vessel because if the vessel is present the vessel blocks barcodes 131c, 132c, 141c-146c making them unreadable to barcode reader 3, and readable to barcode reader 3 when a vessel is absent (par. 0052-0054).
Kondou is silent to the code being a two-dimensional code, the reading unit capable of reading a two-dimensional code, and the control unit calculating from the two-dimensional code.
Natsukari teaches a two-dimensional code, code reader, and code reading program (lines 10-11). Natsukari teaches a two-dimensional code on an object (a two dimensional code), a two-dimensional code reader configured to determine the color contrast of areas (lines 50-57) (a reading unit... capable of reading the two-dimensional code). Once the two-dimensional code is illuminated and imaged, the code reader receives image data and converted to an analog signal to determine threshold value by the program (Fig. 1; lines 444-463) (a control unit... of the light reflected from the two dimensional code). Natsukari teaches two-dimensional codes are an improvement over one-dimensional codes because the repetitive nature of the vertical and horizontal lines it has the ability to correct errors (lines 19-26).
It would have been obvious to one skilled in the art before the effective filing date of the invention to substitute the one-dimensional barcode identifiers of Kondou to the two-dimensional codes of Natsukari because two-dimensional codes are less prone to errors. Because both devices use codes as a means to identify, substituting the one-dimensional code for a two-dimensional as provided by Natsukari, provides likewise sought functionality wherein the substitution would yield predictable results. MPEP § 2143(1)(B).
Kondou is silent to an upper cover covering the mounting unit having a downwardly extending suspended portion, the downwardly extending suspended portion being behind the specimen vessel, wherein the downwardly extending suspended portion extends downwardly from a top portion of the cover and is recessed radially inward from an outermost radial edge of the top cover, and wherein the top portion of the cover extends radially inward from the downwardly extending suspended portion.
Oonuma teaches an automatic analysis device capable of transporting containers through the system (Abstract). Oonuma teaches the automatic analysis device comprises a loading portion 201, acting as a cover for the refrigerated storage area 105, has a cutout 213 with slots 211 for loading containers 101 (Fig. 5-7). Above cutout 213 and slots 211 is shielding member 212 that is L-shaped with a portion protruding behind containers (par. 0034). The protruding member can be seen circled in re-created Figure 6 below (an upper cover covering the mounting unit having a downwardly extending suspended portion) (the downwardly extending suspended portion being behind the specimen vessel) (wherein the downwardly extending suspended portion extends downwardly from a top portion of the cover and is recessed radially inward from an outermost radial edge of the top cover).
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As seen in recreated Figure 6 above, the loading portion 201, acting as a cover, extends beyond the protrusions from shielding member 212. Oonuma teaches the device has a generally circular shape resulting in all points extending radially from a center (Fig. 8-9) (and wherein the top portion of the cover extends radially inward from the downwardly extending suspended portion). Oonuma additionally teaches use of RDIF 142 to track and read tags on reagent containers (Fig. 5-7; par. 039). Oonuma teaches the L-shape of the shielding member in combination with the other loading portion 201 components keep containers thermally isolated when during the loading process (par. 0035, 0037).
It would have been obvious for one of ordinary skill in the art before the effectively filing date of the invention to modify the analysis device of Kondou to further include a cover with a downward protrusion as taught by Oonuma in order to isolate containers in the loading process from previously loaded containers, in particular if parts of the device are thermally different. Because both automatic analysis devices need containers loaded to operate, modifying the device to include a cover with a downward protrusion behind the containers as provided by Oonuma, provides likewise sought functionality with reasonable expectation of success. MPEP 2143(I)(G).
Modified Kondou is silent to the downwardly extending suspended portion on which a first identifier is disposed.
Opalsky teaches a sample processing instrument that uses machine-readable marks and an image capturing device (Abstract). Opalsky teaches a sample rack 112 with pockets 140A-E that hold sample vessels 136. Sample rack 112 additionally comprises a cover 151 with fiducial marks 150A-E and label 156 (Fig. 7, 9; par. 0038, 0045-0046); the fiducial marks being two dimensional codes (par. 0037). As seen in Figure 7, the cover has a top surface and with two portions that suspend downward from the upper surface of the lid on with the fiducial marks 150A-E are disposed (on which a first identifier is disposed). The use of machine readable marks on the lid of the device (in addition to identifying marks on the sample container themselves) is to store information regarding location within the sample rack (par. 0037).
It would have been obvious to one skilled in the art before the effective filing date of the invention to modify the cover of modified Kondou with barcodes a taught by Opalsky in order to store extra location-based readable information. Because both devices use a movable disk to move sample vessel and rely on readable codes for identification modifying the machine-readable mark on a cover with a downward extended portion as provided by Opalsky, provides likewise sought functionality with reasonable expectation of success. MPEP § 2143(I)(G).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MADISON T HERBERT whose telephone number is (571)270-1448. The examiner can normally be reached Monday-Friday 8:30a-5:00p.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maris Kessel can be reached at (571) 270-7698. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/M.T.H./Examiner, Art Unit 1758
/SAMUEL P SIEFKE/Primary Examiner, Art Unit 1758