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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 1-2 and 4-15 are pending in the application. Claim 3 has previously been cancelled. Claims 1-2 and 4-15 are being examined herein.
Status of Objections and Rejections
The rejection of claims 1-2 and 4-8 under 35 U.S.C. § 103 in view of Kadota (JP S6385459 A; as cited in OA dated 10 June 2025) and Gebrian (US 20050013735 A1; as cited in OA dated 10 June 2025) and Zhang (US 20190346469 A1) are withdrawn in view of amendments.
The rejection of claims 9-11 under 35 U.S.C. § 103 in view of Kadota and Gebrian and Zhang as applied to claim 1 above, and further in view of Rousseau (US 7998432 B2; as cited in OA dated 10 June 2025) are withdrawn in view of amendments.
The rejection of claims 12-15 under 35 U.S.C. § 103 in view of Kadota and Gebrian and Zhang as applied to claim 1 above, and further in view of Huang, et. al. (Aspartate Aminotransferase (AST/GOT) and Alanine Aminotransferase (ALT/GPT) Detection Techniques), Edberg (US 20160138071 A1), and Rousseau (US 7998432 B2) (all cited in OA dated 10 June 2025) are withdrawn in view of amendments.
Response to Arguments
Applicant’s arguments, see remarks pages 7-10, filed 1 December 2025, with respect to the rejection(s) of claim(s) 1-2 and 4-8 under 35 U.S.C. § 103 in view of Kadota (JP S6385459 A; as cited in OA dated 10 June 2025) and Gebrian (US 20050013735 A1; as cited in OA dated 10 June 2025) and Zhang (US 20190346469 A1) 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 Therefore, the rejection has been withdrawn.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 Kadota (JP S6385459 A; as cited in OA dated 10 June 2025) in view of Burow, et. al. (US 20020090320 A1) and Zhang (US 20190346469 A1).
Applicant’s arguments center around the amendments made to independent claim 1, with a focus on the structure of the robotic arm having “a swiveling element having a first end and a second end, wherein through the first end an axis of rotation passes, and wherein at the second end the end effector is arranged, and wherein about said axis of rotation the end effector can move along a circular path” (remarks, pg. 8, par. 02). The new rejection of record takes into account the newly amended structural and functional elements of the robotic arm in amended claim 1.
Kadota teaches an automatic analyzer for analysis of body fluid (pg. 1, lines 1-3) using a vessel transfer system (Abstract). Kadota teaches analysis areas 21 and 22 with sample tray 23 between the four reagent trays 9, 10, 13, and 14, two reaction trays 2, and 3, and two measuring devices 17 and 18 (Fig. 1; pg. 7, lines 17-22).
Burow teaches a system using a rotational robot for high throughput automated processing systems (Abstract). Burow teaches the automated system comprises at least one rotational robot between adjacent work perimeters, for example, the rotational robot can transfer sample holders from a transfer station to a work perimeter (par. 0045, 0054).
Zhang teaches an in-vitro diagnostic automatic analyzer (par. 0001). Zhang teaches sample transport device 30 in the shape of a sample carousel that holds sample tube 31 and is controlled by a driving unit to move sample tubes into aspirating positions (Fig. 4; par. 0044).
Applicant offers no further argument for claims 9-15 aside from their dependence on claim 1 (Remarks, pg. 9, par. 05 – pg. 10, par. 01).
Claim Rejections - 35 USC § 103
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-2 and 4-7 are rejected under 35 U.S.C. 103 as being unpatentable over Kadota (JP S6385459 A; as cited in OA dated 10 June 2025) in view of Burow, et. al. (US 20020090320 A1) and Zhang (US 20190346469 A1).
Regarding claim 1, Kadota teaches an automatic analyzer for analysis of body fluid (pg. 1, lines 1-3) (apparatus for the automated analysis of liquid samples) using a vessel transfer system (Abstract). Kadota teaches analysis areas 21 and 22 with sample tray 23 between the four reagent trays 9, 10, 13, and 14, two reaction trays 2, and 3, and two measuring devices 17 and 18 (Fig. 1; pg. 7, lines 17-22) (apparatus comprises an analysis area, wherein the analysis area comprises a sample tray for receiving sample containers, at least two reagent trays for receiving reagent containers, at least two reaction trays for receiving reaction vessels, and at least two measuring devices). While a specific type of measuring device is not stated, Kadota teaches the system is used for "blood, plasma, serum, urine and other body fluids and secretions," specifically for GOT/GPT and T-BIL/D-BIL ratios (pg. 1, lines 19-23) that are measured by measuring devices 17 and 18 (pg. 5, lines 17-19). The measuring devices 17 and 18 transfers the measurements to the memory device to calculate GOT/GPT ratios, this means measuring devices 17 and 18 must measure a property in order to calculate GOT and GPT amounts to determine the ratio (pg. 5, lines 37-39) (measuring devices for measuring a physical or chemical property).
Kadota teaches as per Figure 1:
the sample tray 23 is in the middle of the analysis areas 21 and 23 (wherein the sample tray is… arranged in the center of the analysis area)
the reaction trays 2 and 3 are adjacent to sample tray 23 (the at least two reaction trays are arranged adjacent to the sample tray)
reagent trays 9,10, 13, and 14 are adjacent to reaction trays 2 and 3 (the at least two reagent trays are arranged adjacent to the reaction trays)
measuring devices 17 and 18 are adjacent to reaction trays (the at least two measuring devices are arranged adjacent to the reaction trays)
Kadota teaches pipetting devices 7 and 8 that transfer liquid between sample container and reaction vessels (Fig. 1; pg. 5, lines 4-8) (wherein between the sample disc and each of the at least two reaction trays there is a first pipetting device for transferring liquid sample from sample containers in the sample tray to the reaction vessels in the reaction trays). Kadota also teaches pipetting devices 11, 12, 15, and 16 for pipetting liquid between reagent trays and reaction vessels (Fig. 1; pg. 3, lines 10-16) (and wherein between each of the at least two reagent trays and their corresponding reaction trays there is a second pipetting device for transferring reagent from reagent containers in the reagent trays to the reaction vessels in the reaction trays).
Kadota teaches analysis area 21 and 22 are arranged within the bounds of automatic analyzer 1 (Fig. 1). As seen depicted in Figure 1, the device is surrounded within boxes representing a housing. While no specifics of the housing for the analyzer 1 are given, it is understood that all the parts making up the analyzer 1 are contained in some sort of container or housing and not placed flat out on a table, for example (wherein the analysis area is arranged in a housing). At the front end of automatic analyzer 1 is supply section 30 where a plurality of pre-packed sample racks can be placed/loaded before being moved to the sampling position (pg. 4, lines 18-25) (having a loading opening for receiving sample containers… either individually or prepacked in racks). Kadota teaches from supply section 30 (loading opening), rack tray 27 moves down conveyor path 28 until the sample tray 23 containing the sample to be analyzed reaches connection 29 where the sample tray 23 is moved to conveyor path 24 for analysis (Fig. 1; pg. 4, lines 28-32).
Kadota is silent to a loading opening for receiving the reagent containers, and the loading opening comprises a robotic arm wherein the robotic arm is a movable transport device having an end effector for transporting the sample containers and the reagent containers either individually or in the form of prepacked racks from the loading opening to the sample tray or the reagent trays, and wherein the robotic arm has a swiveling element having a first end and a second end, wherein through the first end an axis of rotation passes, and wherein at the second end the end effector is arranged, and wherein about said axis of rotation the end effector can move along a circular path.
Burow teaches a system using a rotational robot for high throughput automated processing systems (Abstract). Burow teaches the automated system comprises at least one rotational robot between adjacent work perimeters, for example, the rotational robot can transfer sample holders from a transfer station (loading opening) to a work perimeter (analysis area) (par. 0045, 0054) (the loading opening comprises a robotic arm). Burow teaches the robotic arm comprises a rotational axis 135, 140, 145 on which one end of an arm 150, 155, 160 is attached and capable of almost 360° motion and a second end comprises a griper 165, 170, 175 (end effector) to transfer sample holders (Fig. 1; par. 0056-0058, 0064) (wherein the robotic arm is a movable transport device having an end effector) (and wherein the robotic arm has a swiveling element having a first end and a second end, wherein through the first end an axis of rotation passes, and wherein at the second end the end effector is arranged, and wherein about said axis of rotation the end effector can move along a circular path). Burow teaches the robotic arm is capable of transferring sample containers in a wide variety of forms ranging from test tube arrays to multiwell plates from a transfer station 195 to a work perimeter 105, 115, 125 that house processing and analysis instruments 225, 270, 285, 290, 280, 295, etc. (Fig. 1; par. 0114) (for transporting the sample containers… either individually or in the form of prepacked racks from the loading opening to the sample tray).
Burow teaches the robotic arms are not limited to transferring samples but can also transfer reagent holders or assay holders through the same process as described above (par. 0014). This means reagent containers can be located in a transfer station 195 and transferred by a robotic arm to a work perimeter 105, 115, 125 with this concept being further supported by the fact the robotic arms have sensors for detecting what containers needs to be transferred where (par. 0059) (a loading opening for receiving the reagent containers) (for transporting… the reagent containers either individually or in the form of prepacked racks from the loading opening to… the reagent trays). Burow teaches the use of a rotational robot in automated processing systems allows for an accurate and reliable system with the added benefit of being flexible due to the multi-directional movement ability (par. 0008).
It would have been obvious to one skilled in the art before the effective filing date of the invention to modify the transport system of Kadota to include a rotational robotic arm to transfer sample and reagent containers as taught by Burow in order to add more flexibility to the automated system through multi-directional movement to increase throughput. Because both systems are automated sample processing systems that involve the transfer of samples from one location to another, modifying the transfer element of the system to be a rotational robotic arm as provided by Burow, provides likewise sought functionality with reasonable expectation of success. MPEP 2143(I)(G).
Modified Kadota in view of Burow is still silent to the sample tray being (in the shape of) a sample disc.
Zhang teaches an in-vitro diagnostic automatic analyzer (par. 0001). Zhang teaches sample transport device 30 in the shape of a sample carousel that holds sample tube 31 and is controlled by a driving unit to move sample tubes into aspirating positions (Fig. 4; par. 0044) (the sample tray is a sample disc). The carousel/disc shape allows for multiple samples to be readied for analysis and the shape allows the plurality of samples to be easily and automatically be rotated to ready to use position (increasing throughput) while still decrease instrument size (par. 0015).
It would have been obvious to one skilled in the art before the effective filing date of the invention to substitute rectangular sample tray of Kadota to instead comprise a sample disc as taught by Zhang in order to increase the throughput of the system. Because both devices require a structure for holding sample vessels in an automatic analysis device, substituting the tray structure to a rotatable circular disc as provided by Zhang, provides likewise sought functionality that would yield a predictable result. MPEP § 2143(I)(B).
Regarding claim 2, Modified Kadota does not explicitly teach that the reagent trays 9, 10, 13, 14 are rotatable, but one can conclude the reagent trays are rotatable based on multiple reagent vessel positions as seen in Figure 1, but only select positions, 37, 38, 41, 42, on the reagents trays 9, 10, 13, 14 are accessible by reagent dispensers 11, 12, 15, and 16 (the at least two reagent trays are in the form of rotatable reagent discs). The reaction trays 2, 3 are rotatable discs (Kadota, pg. 5, lines 5-9) and adjacent to the sample tray (Kadota, Fig. 1) (the at least two reaction trays are either in the form of a rotatable reaction disc being arranged adjacent to the sample tray or in the form of a static reaction ring). Pipetting devices 7, 8, 11, 12, 15, 16 are swiveling arms with one end, the circular end, serving as the axis of rotation, and the other end, pointed end, serving as the dispensing end that moves along a circular path (seen as a line in Kadota, Fig. 1) (the pipetting devices are in the form of swiveling pipetting arms having an axis of rotation on one end of the pipetting arm) (movable along a circular path). Pipetting devices 7, 8, 11, 12, 15, 16 have a center of rotation (circular end) are between the trays/discs from which they sample (Kadota, Fig. 1) (the axis of rotation of the pipetting devices is located between the sample disc and each reaction disc/ring or between each reagent disc and its corresponding reaction disc/ring).
Kadota is silent to the sample tray [being] in the form of a rotatable sample disc and a pipetting needle on the other end of the pipetting arm.
Zhang teaches an in-vitro diagnostic automatic analyzer (par. 0001). Zhang teaches sample transport device 30 in the shape of a sample carousel that holds sample tube 31 and is controlled by a driving unit to move sample tubes into aspirating positions (Fig. 4; par. 0044) (the sample tray is in the form of a rotatable sample disc). Once in the aspirating position, samples within sample tube 31 are aspirated by dispensing unit 20 (Fig. 4; par. 0046). The dispensing unit includes one end composed of a steel needle (par. 0033) that can be used for aspirating capped samples (a pipetting needle on the other end of the pipetting arm). The carousel/disc shape allows for multiple samples to be readied for analysis and the shape allows the plurality of samples to be easily and automatically be rotated to ready to use position (increasing throughput) while still decrease instrument size (par. 0015).
It would have been obvious to one skilled in the art before the effective filing date of the invention to substitute rectangular sample tray of Kadota to instead comprise a rotatable sample disc as taught by Zhang in order to increase the throughput of the system. Because both devices require a structure for holding sample vessels in an automatic analysis device, substituting the tray structure to a rotatable circular disc as provided by Zhang, provides likewise sought functionality that would yield a predictable result. MPEP § 2143(I)(B). Additionally, it would have been obvious to one skilled in the art before the effective filing date of the invention to modify the pipette tip of Kadota to comprise a needle as taught by Zhang as it is common modification generally known in the art. Because both devices use a pipette to aspirate liquids, modifying the end of the pipette tip to be a needle as provided by Zhang, provides likewise sought functionality that would have reasonable expectation of success. MPEP § 2143(I)(G).
Regarding claim 4, modified Kadota teaches supply section 30 is located at the front of automatic analyzer 1 (Kadota, Fig. 1) (the loading opening is arranged in a front wall of the housing).
Regarding claim 5, modified Kadota teaches code reader 43, that reads symbols like bar codes on sample containers (Kadota, pg. 2, lines 32-41) (the loading opening comprises a 1D code, 2D code and/or RFID reader).
Regarding claim 6, modified Kadota teaches conveyer path 28 moves rack tray 27 holding sample containers 25 and moves them for analysis (Kadota, pg. 4, lines 23-24) (a conveyor for transporting sample containers... in the form of prepacked racks to or from the loading opening).
Regarding claim 7, modified Kadota teaches this system is used for "blood, plasma, serum, urine and other body fluids and secretions," specifically for GOT/GPT and T- BIL/D-BIL ratios (Kadota, pg. 1, lines 19-23) (the physical... property measured by at least one of the at least two measuring devices is a result of... a clinical chemistry assay).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Kadota (JP S6385459 A; as cited in OA dated 10 June 2025) in view of Burow, et. al. (US 20020090320 A1) and Zhang (US 20190346469 A1) as applied to claim 1 above, and further in view of Gebrian (US 20050013735 A1; as cited in OA dated 10 June 2025).
Regarding claim 8, Modified Kadota teaches all the requirements for claim 1 as explained above. Modified Kadota in view of Burow teaches the robotic arm is capable of accommodating a wide variety of sample holders (Burow, par. 0011, 0058, 114).
Modified Kadota is silent to the sample disc has receiving pockets for receiving longish sample container racks having 2 to 20 slots for receiving sample containers along the central longitudinal axis of the racks, wherein the receiving pockets are oriented radially on the sample disc.
Gebrian teaches the devices has loading tray 29 which moves containers 30 or 30A (reagent and vial carrier respectively) that have multiple wells or sections for holding multiple vials (Fig. 5, 5A; par. 0025); Figure 5A shows container 30A has 5 sections or holding up to 5 vials. A container shuttle moves the containers 30 or 30A on carousels 26A and 26B where the containers are arranged radially on a carousel/disc (Fig. 6; par. 0025, 0031) (wherein the… has receiving pockets for receiving… container racks having 2 to 20 slots for receiving sample containers along the central longitudinal axis of the racks, wherein the receiving pockets are oriented radially on the sample disc). Gebrian teaches this configuration moves solutions within the system more efficiently and quickly to increase throughput of sample analysis because of the increased storage abilities of the container and carousel (par. 0003-004, 0012).
The sample transfer system of Kadota can be combined with the reagent transferring shuttle of Gebrian. Therefore, the orientation of the reagents and reagent vessels of Gebrian can be applied to the transfer of samples as well.
It would have been obvious to one skilled in the art before the effective filing date of the invention to modify the transportation and storage of containers in Kadota to instead comprise container rack that holds multiple vessels and a carousel to accommodate the racks radially as taught by Gebrian in order to increase throughput of sample analysis. Because both devices require the storage of reaction vessels/sample containers, modifying the structure to include a container to hold multiple vessels and radially organize the containers holding the vessels as provided by Gebrian, provides likewise sought functionality that would have reasonable expectation of success. MPEP § 2143(I)(G).
Claims 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over Kadota (JP S6385459 A; as cited in OA dated 10 June 2025) in view of Burow, et. al. (US 20020090320 A1) and Zhang (US 20190346469 A1) as applied to claim 1 above, and further in view of Rousseau (US 7998432 B2; as cited in OA dated 10 June 2025).
Regarding claim 9, Modified Kadota teaches a reaction tray having slots to accommodate reaction vessels 5 being arranged in a round shape (Kadota, Fig. 1) (slots for receiving the reaction vessels, said slots being circumferentially arranged side by side).
Kadota is silent to wherein at least one of the reaction trays is in the form of a static reaction ring, wherein outside the static reaction ring there is concentrically arranged a transport ring having at least one slot for receiving the reaction vessel, said slot being arranged on the same level as the slots in the static reaction ring such that the reaction vessel can be transferred from the at least one slot in the transport ring to one of the slots in the static reaction ring and back by horizontal movement on a radial axis of the static reaction ring.
Rousseau teaches a rotatable holder for cuvettes (Abstract) to be used in an automatic analyzer for in vitro diagnosis (col. 1, lines 1-3). Rousseau teaches a rotor 7 that drive crown wheel 8 with radially outward open cavities 9 (Fig. 3, 6; col. 8, lines 39- 43) (concentrically arranged a transport ring having at least one slot for receiving the reaction vessel). Crown wheel 8 is surrounded by stationary piece 10, and within piece 10 are openings 12 configured to allow for the introduction and/or withdrawal of cuvettes from cavity 9 (Fig. 3; col. 8, lines 43-55) (at least one of the reaction trays is in the form of a static reaction ring). Figure 3 illustrates that the opening 12 in piece 10 is aligned on the same level as cavity 9 in rotor 7 (slot being arranged on the same level as the slots in the static reaction ring). Rousseau teaches a push rod at the end of a shaft that is the means for moving cuvettes into and out of position (col. 4, lines 20-26) (such that the reaction vessel can be transferred from the at least one slot in the transport ring to one of the slots in the static reaction ring and back by horizontal movement on a radial axis of the static reaction ring). The radial openings in the outer branch and cuvette cavities allow for multiple steps of the analysis process to be completed simultaneously which increases throughput (col. 4, lines 3-19).
Rousseau is silent to said slots being circumferentially arranged side by side on the static reaction ring and outside the static reaction ring there is concentrically arranged a transport ring.
Rousseau teaches the slots are circumferentially arranged side by side on the transport ring and the static ring is concentrically arranged outside the transport ring (Fig. 3). Rousseau teaches this arrangement this embodiment allows for cuvettes to only be released when need and can remain out of the way of other cuvettes during the analysis process, therefore maintaining throughput of the device (col. 4, lines 3-13).
It would have been obvious to one skilled in the art before the effective filing date of the invention to modify the reaction ring of Kadota to be comprise a static portion and a transport portion as taught be Rousseau in order to increase throughput of the device. Because all devices use a reaction disk to move sample vessels into and out of a measurement area, modifying the structure include a static and transport ring with slots to easily move sample vessels as provided by Rousseau, provides likewise sought functionality that would have reasonable expectation of success. MPEP § 2143(I)(G). Additionally, Rousseau teaches while arranged differently, the function is not changed, and the use is not destroyed. Specifically, Rousseau teaches this arrangement that contains all the same structural parts and functions the same way would have been obvious for one skilled in the art to try. MPEP § 2144(VI)(C).
Regarding claim 10, modified Kadota in view of Rousseau teaches the number of cavities 9 is based on sample processing rates of the samples, specifically based on optimization of incubation time, measurement times, and cuvette transfers (Rousseau, col. 5, lines 47-51). Rousseau additionally teaches the number of openings 12 on stationary piece 10 is based on the number of stations/modules that require transport of the cuvette (Rousseau, col. 8, lines 51-57). These conditions are considered to make the instrument simple to use (Rousseau, col. 3, lines 32-33). Rousseau teaches at the modules a push rod controls the movement of the cuvette. For example, at the loading module, push rod 36 pushes cuvette 22 into cavity 9 through opening 12 in piece 10 (Rousseau, Fig. 10; col. 10, lines 25-27) (a sliding arm arranged at each slot for transferring the reaction vessel from the corresponding slot in the transport ring to one of the slots in the static reaction ring and back by horizontal movement on a radial axis of the reaction ring).
Rousseau is silent to the at least one slot of the transport ring has one, two, three or four slots for receiving reaction vessels.
Rousseau teaches the number of cavities/slots and openings is a result effective variable. Specifically, Rousseau teaches that the number of cavities/slots and openings are based on the optimization factors of the reactions being measured. Since this particular parameter is recognized as result-effective variable, i.e., a variable which achieves a recognized result, the determination of the optimum or workable ranges of said variable can be characterized as routine experimentation. MPEP § 2144.05(II)(A)- (B). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filling date of the invention to modify the at least one slot of the transport ring to have one, two, three or four slots for receiving reaction vessels.
Regarding claim 11, modified Kadota in view of Rousseau teaches a rotor 7 that drive crown wheel 8 with radially outward open cavities 9 (Rousseau, Fig. 3, 6; col. 8, lines 39- 43). Crown wheel 8 is surrounded by stationary piece 10, and within piece 10 are openings 12 configured to allow for the introduction and/or withdrawal of cuvettes from cavity 9 (Rousseau, Fig. 3; col. 8, lines 43-55) (outside the transport ring there is at least one external slot for receiving the reaction vessel). Figure 3 illustrates that the opening 12 in piece 10 is aligned on the same level as cavity 9 in rotor 7, and when lined up a cuvette can move into and out of cavity 9 and through opening 12 across the bottom (said at least one external slot being on the same level as the at least one slot for receiving the reaction vessels in the transport ring such that the reaction vessels can be transferred from the at least one slot in the transport ring to said at least one external slot for receiving a reaction vessel and back by horizontal movement on a radial axis of the transport ring).
Claims 12-15 are rejected under 35 U.S.C. 103 as being unpatentable over Kadota (JP S6385459 A; as cited in OA dated 10 June 2025) in view of Burow, et. al. (US 20020090320 A1) and Zhang (US 20190346469 A1) as applied to claim 1 above, and further in view of Huang, et. al. (Aspartate Aminotransferase (AST/GOT) and Alanine Aminotransferase (ALT/GPT) Detection Techniques), Edberg (US 20160138071 A1), and Rousseau (US 7998432 B2; as cited in OA dated 10 June 2025).
Regarding claim 12, modified Kadota teaches a measuring device that measures an optical property of a liquid sample that undergoes a reaction with a reagent. Kadota teaches the system is used for "blood, plasma, serum, urine and other body fluids and secretions," specifically for GOT/GPT and T-BIL/D-BIL ratios (pg. 1, lines 19-23). As outlined in claim 1 above, GOT and GPT are measured by measuring devices 17 and 18 and the GOT/GPT ratio is calculated.
Kadota is silent to at least one of the measuring devices (is) for measuring an optical property of a liquid sample treated with a reagent in a reaction vessel.
Huang reviews multiple techniques for body fluid samples for ratios comprising GOT and GPT (Abstract). Huang teaches different optical-based analysis methods for GOT and GPT measurements (at least one of the measuring devices is for measuring an optical property of a liquid sample treated with a reagent in a reaction vessel). First, Huang teaches colorimetric assays can be used by forming a light-absorbing complex (pg. 757, section 2 “Colorimetric Analysis”). Huang teaches spectrophotometric methods are commonly used to measure GOT and GPT in blood sample because spectrophotometric methods allow for wider measurement ranges and continuous testing (pg. 759, section 3 “Spectrophotometric Measurement”). Finally, Huang teaches chemiluminescence detection for GOT and GPT is also used because of its high sensitivity and wide range of measurable concentrations (pg. 761, section 4 “Chemiluminescence”). Huang teaches these optical measurement methods are favored over other methods because of their simplicity in operation (pg. 765, section 7 “Radiochemical Analysis”) and better signal resolution (pg. 765, section 8 “Electrochemical Techniques’).
It would have been obvious to one skilled in the art before the effective filing date of the invention to modify the measuring devices of Kadota to be a type of optical measurement as taught by Huang in order to improve ease of operation of the system and improve resolution and sensitivity of the system. Because the main goal of the measurement devices is to measure components of a biological sample, modifying the vague measurement devices of Kadota with the optical measurement devices of Huang, provides likewise sought functionality that would have reasonable expectation of success. MPEP § 2143(I)(G).
Kadota is silent to said measuring vessel [comprising] a rotatable transport cylinder having a cylinder wall and a cylinder top, wherein there is at least one slot in the cylinder wall for receiving a reaction vessel, a cylindrical housing having a cylindrical housing wall and a cylindrical housing top, said cylindrical housing being concentrically arranged around the transport cylinder, wherein there is at least one opening for inserting and/or ejecting a reaction vessel to or from the at least one slot in the transport cylinder, and a light detector for detecting light being emitted from a liquid in a reaction vessel being inserted in the at least one slot of the transport cylinder.
Edberg teaches an optical detection carousel system for the analysis of multiple samples (Abstract). Edberg teaches the optical detection instrument 20 is in a housing 26 that includes a base 38 and cover 40 that come tother to form walls (Fig. 1; par. 0051) (a cylindrical housing having a cylindrical housing wall and a cylindrical housing top). Enclosed in the housing 26 is carousel 28 and carousel drive mechanism 30 for rotating carousel (Fig. 5; par. 0050, 0053) (said cylindrical housing being concentrically arranged around the transport cylinder). Along with drive mechanism 30, carousel 28 additionally comprises a top surface 46 and base flange 48 and a wall (unlabeled) connecting the two (Fig. 5; par. 0052) (a rotatable transport cylinder having a cylinder wall and a cylinder top). Edberg teaches withing the housing is a stationary light source 32 and light detector 34 that remain in a fixed position and measure sample containers within the cavities 50 of the top surface 46 of the carousel 28 (Fig. 5, 6; par. 0053) (a light detector for detecting light being emitted from a liquid in a reaction vessel being inserted in the at least one slot of the transport cylinder). Edberg teaches this design allows for more accurate optical results with only small concentration of target sample needed because the enclosed house minimized effects from stray light (par. 0009).
Modified Kadota in view of Edberg is silent to there [being] at least one slot in the cylinder wall for receiving a reaction vessel and there [being] at least one opening for inserting and/or ejecting a reaction vessel to or from the at least one slot in the transport cylinder.
Rousseau teaches a rotatable holder for cuvettes (Abstract) to be used in an automatic analyzer for in vitro diagnosis (col. 1, lines 1-3). Rousseau teaches a rotor 7 that drive crown wheel 8 with radially outward open cavities 9 (Fig. 3, 6; col. 8, lines 39-43). Crown wheel 8 is surrounded by piece 10, and within piece 10 are openings 12 configured to allow for the introduction and/or withdrawal of cuvettes from cavity 9 (Fig. 3; col. 8, lines 43-55) (wherein there is at least one slot in the cylinder wall for receiving a reaction vessel). The open cavities 9 are configured securely hold a cuvette and have an opening on its radially outermost side to insert the cuvette (Fig. 6; col. 9, lines 44-50) (there is at least one opening for inserting and/or ejecting a reaction vessel to or from the at least one slot in the transport cylinder). The radial openings in the outer branch and cuvette cavities allow for multiple steps of the analysis process to be completed simultaneously, like loading and unloading of cuvette while another cuvette is being measured which increases throughput (col. 4, lines 3-19).
It would have been obvious to one skilled in the art before the effective filing date of the invention to modify the measuring devices of Kadota to be enclosed in a housing with its own rotational system as taught by Edberg in order to increase accuracy of measurement, and to further modify the walls to include slots/openings for inserting/ejecting vessels as taught by Rousseau in order to increase throughput by having multiple areas accessible simultaneously. Because all devices use a rotatable disk to move sample vessels into and out of a measurement area, modifying the structure to enclose the measurement area as provided by Edberg and include slots to easily move sample vessels as provided by Rousseau, provides likewise sought functionality that would have reasonable expectation of success. MPEP § 2143(I)(G).
Regarding claim 13, modified Kadota teaches the limitation of claim 12, as outlined above.
Modified Kadota is silent to vertical fins protrude upwards or downwards from horizontal surfaces of the transport cylinder and/or the cylindrical housing.
Rousseau teaches the automatic analyzer includes module 13 that is a spectrophotometry device (Fig. 2; col. 10, lines 40-55). Rousseau teaches the cuvette is placed in cavity 9 for measurement; cavity 9 comprises two side walls that support the cuvette and separate the cuvette from adjacent cavities/cuvettes (Fig. 9; col. 9, lines 43- 50) (vertical fins protrude upwards or downwards from horizontal surfaces of the transport cylinder). The walls of cavity 9 that support and separate the cuvette allows the photometer to work in tandem with the rotor (col. 10, lines 48-55).
It would have been obvious to one skilled in the art before the effective filing date of the invention to modify the sample holder of modified Kadota to be enclosed in a cavity with walls separating the cuvette from other samples as taught by Rousseau in order to allow the measurement device to work in tandem with the rotor. Because all devices use a rotatable disk to move sample vessels into and out of a measurement area, modifying the structure to enclose the cavity with walls/fins as provided by Rousseau, provides likewise sought functionality that would have reasonable expectation of success. MPEP § 2143(I)(G).
Regarding claim 14, modified Kadota teaches the limitations of claim 12, as outlined above.
Modified Kadota is silent to the rotatable transport cylinder [having] 3 slots for receiving the reaction vessel, said slots being arranged in the cylinder wall at an angle of 120°.
Rousseau teaches the number of cavities 9 is based on sample processing rates of the samples, specifically based on optimization of incubation time, measurement times, and cuvette transfers (col. 5, lines 47-51). These conditions are considered to make the instrument simple to use (col. 3, lines 32-33). Additionally, it can be seen in Figures 6 and 10 that the cavities 9/slots are spaced evenly apart.
Rousseau teaches the number of cavities/slots is a result effective variable. Specifically, Rousseau teaches that the number of cavities/slots are based on the optimization factors of the reactions being measured. Since this particular parameter is recognized as result-effective variable, i.e., a variable which achieves a recognized result, the determination of the optimum or workable ranges of said variable can be characterized as routine experimentation. MPEP § 2144.05(II)(A)-(B). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filling date of the invention to modify the rotatable transport cylinder [having] 3 slots for receiving the reaction vessel. Further, if there are 3 slots, one skilled in the art can conclude said slots being arranged in the cylinder wall at an angle of 120° because Rousseau teaches even spacing between the cavities/slots.
Regarding claim 15, modified Kadota in view of Edberg teaches cylindrical housing surrounding the transport cylinder, and in view of Rousseau teaches slots in a transport ring and surrounding wall where vessels are inserted and removed, see claim 12 above. Rousseau teaches cuvettes are inserted into cavity 9 through slot 12 from module 20 (Rousseau, Fig. 2, 10; col. 10, lines 18-27) (cylindrical housing has one loading opening for inserting the reaction vessel to the at least one slot in the transport cylinder), and cuvettes can be pushed out of cavity 9 to dispose of waste at module 14 (Rousseau, Fig. 2; col. 11, lines 50-66) (one unloading opening for ejecting the reaction vessel from the at least one slot in the transport cylinder).
Examiner notes that the limitation “loading opening’ and “unloading opening’ are directed to the function of the apparatus and/or the manner of operating the apparatus, all the structural limitations of the claim has been disclosed by Rousseau and the apparatus of Rousseau is capable of the loading opening is in the cylindrical housing top, and wherein the unloading opening is in the cylindrical housing wall because the cavity is open both on the sides and the top (Fig. 6). As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of modified Kadota in view of Edberg and Rousseau. MPEP §2114.
Conclusion
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/M.T.H./Examiner, Art Unit 1758
/MARIS R KESSEL/Supervisory Patent Examiner, Art Unit 1758
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