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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 02/02/2026 has been entered.
Status of Claims
Claim 1-9, 12-17, and 19-23 are pending with claims 1-9 and 12-13 under examination and claims 14-17 and 19-20 withdrawn from consideration.
Claims 10-11 and 18 have been canceled.
Response to Amendment
The amended claim, received 02/02/2026, have overcome the claim objection(s) set forth in the Final Rejection, mailed 09/24/2025. Accordingly, the claim objection(s) have been withdrawn.
Based on the amended claims, new 112(a) rejection(s) have been set forth.
Based on the amended claims and remarks, received 02/02/2026, the previous prior art rejection over Kambara has been withdrawn and a new prior art rejection is set forth (see below).
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 1 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Applicant(s) have amended claim 1 to recite “wherein the mixing bar maintains a constant shape”. However, any reference to the mixing bar’s shape is not disclosed in the remainder of the specification. Accordingly, the amended limitation “wherein the mixing bar maintains a constant shape” is new subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
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 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Kambara (Translation of JP 2009-222453A; already of record – hereinafter “Kambara”) in view of Nagai et al. (US 2012/0145552 – hereinafter “Nagai”).
Regarding claim 1, Kambara disclose a device for determining at least one parameter of a liquid sample (Kambara; fig. 1, “automatic analyzer”, [0002, 0013]), the device comprising:
(a) a body (Kambara – the frame on which the components shown in figure 1 of the automatic analyzer are mount) having a sample station (Kambara; fig. 1, #2, “sample disk”, [0013]) and an analysis station (Kambara; fig. 1, #6, “reaction disk”, [0013]) disposed within the body (Kambara; fig. 1 – the frame on which the components shown in figure 1 of the automatic analyzer are mounted), the sample station configured to receive at least a container holding the liquid sample (Kambara; fig. 1, #1, [0014]);
(b) a connection to a water supply configured to supply water to the device (Kambara; cleaning tank 8 is provided with a cleaning water discharge nozzle 31 for discharging the cleaning water, and the cleaning water discharge nozzle 31 is connected to the cleaning water tank 11 via a pipe; figs. 1 & 2, [0019]);
(c) a pump configured to move the water from the water supply within the device (Kambara; figs. 1 & 2, #10, “pump”, [0019]);
(d) a first heater configured to heat the water from the water supply to a first temperature (Kambara; figs. 1 & 2, #9, “heater … the cleaning liquid heated to a high temperature is sent to the cleaning liquid discharge nozzle 31 … the stir bar 19 is suitable for cleaning by applying a cleaning liquid heated to a high temperature by the heater 9”, [0019, 0022]); and
(e) a mixing bar configured to heat and mix a test specimen comprising at least a portion of the liquid sample (Kambara; figs. 1-3, #19, “stirring rod”, [0019, 0022-0023]),
wherein the mixing bar is configured to be heated when rinsing the mixing bar with at least a portion of the water prior to the mixing bar contacting the test specimen for mixing (Kamara; “the cleaning liquid heated to a high temperature is sent to the cleaning liquid discharge nozzle 31 … the stir bar 19 is suitable for cleaning by applying a cleaning liquid heated to a high temperature by the heater 9 … and the next reaction vessel 5 is stirred”, [0019, 0022-0023]), wherein the mixing bar is heated to a temperature exceeding a temperature of the test specimen (Kamara disclose the stirring rod 19 changes to a shape suitable for cleaning when heated by the cleaning water, and changes to a shape suitable for stirring when placed in the reaction liquid and cooled; fig. 2, [0022, 0024-0025]) such that the mixing bar is further configured to heat the test specimen within the cuvette to a predetermined temperature at which analysis of the test specimen is conducted to determine the at least one parameter of the liquid sample (Kamara disclose (1) by controlling the temperature of the liquid in the reaction vessel 5 and touching the liquid, the temperature of the stirring bar 19 is changed and the shape is changed. Accordingly, changing shape when the stirring rod touches the liquid is a heat transfer operation where heat from the stirring rod is transferred to the reaction liquid such that the test specimen within the cuvette is heated to a predetermined temperature at which analysis of the test specimen is conducted; [0022, 0025]).
Kambara does not teach the mixing bar maintains a constant shape.
However, Nagai teach the analogous art of a mixing bar (Nagai; figs. 6-8, #232, [0059]), wherein the mixing bar maintains a constant shape (Nagai disclose the mixing bar 232 as a rectangular plate-like member having a uniform thickness “t” of 3 to 5 mm, a vertical length “L1” and a lateral length “H”.
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the mixing bar of Kambara with the mixing bar that maintains a constant shape, as taught by Nagai, because Nagai teach the mixing bar that maintains a constant shape provides uniform mixing of solution (Nagai; [0059, 0061, 0077]). One of ordinary skill in the art would have expected this modification could have been performed with a reasonable expectation of success since Kambara and Nagai both teach mixing a solution with a mixing bar.
Note: How the mixing bar is heated is a matter of function and intended use, and functional language does not add any further structure to an apparatus beyond a capability. Apparatus claims must distinguish over the prior art in terms of structure rather than function (see MPEP 2114 and 2173.05(g)). Therefore, if the prior art structure is capable of performing the function, then the prior art meets the limitation in the claims.
Regarding claim 8, modified Kambara disclose the device of claim 1 above.
Modified Kambara does not teach wherein the first temperature is about 28 degrees Celsius.
However, Kambara does teach the temperature of the washing water is controlled (Kambara; [0024]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the first temperature to be controlled at about 28 degrees Celsius, because controlling the first temperature to about 28 degrees Celsius provides a safe operating temperature that reduces the risk of injury from scalding water while also dissolving contamination on the mixing bar. One of ordinary skill in the art would have expected this modification could have been performed with a reasonable expectation of success since modified Kambara teach controlling the temperature of the wash water when rising the mixing bar.
Note: What the first temperature is relates to function/intended use. However, functional language does not add any further structure to an apparatus beyond that of a capability. Apparatus claims must distinguish over the prior art in terms of structure rather than function. See MPEP 2114 and 2111.04. Therefore, if the prior art structure is capable of performing the function, then the prior art meets the limitation in the claims.
Claims 2-4 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Kambara in view of Nagai, and further in view of Oonuma et al. (US 2002/0025275; already of record – hereinafter “Oonuma”).
Regarding claim 2, modified Kambara disclose the device of claim 1, wherein the test specimen is contained (Kambara disclose the test specimen is contained in a sample container 1 and a reaction container 5; fig. 1, [0014, 0017]).
Modified Kambara does not disclose the test specimen is contained in a cuvette.
However, Oonuma teach the analogous art of a device for determining at least one parameter of a liquid sample (Oonuma; fig. 1, “automatic analyzer”, [0016]) comprising a station configured to receive at least a container holding the liquid sample (Oonuma; fig. 1, #3, “reaction disk”, [0018]), wherein the test specimen is contained in a cuvette (Oonuma; #2, “transparent plastic reaction cuvette”, [0017]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the reaction container and/or specimen container of modified Kambara with the transparent plastic cuvette, as taught by Oonuma, because the transparent plastic cuvettes are low cost, disposable, and can be used in conjunction with a photometer 5 for measuring an absorbance of the sample (Oonuma; [0019]). One of ordinary skill in the art would have expected this modification could have been performed with a reasonable expectation of success since modified Kambara and Oonuma both teach test specimen containers that store a specimen for analysis.
Regarding claim 3, modified Kambara disclose the device of claim 2 above, wherein the cuvette is made of plastic (The modification of the reaction container and/or specimen container of modified Kambara with the transparent plastic cuvette, as taught by Oonuma, has previously been discussed in claim 2 above. Oonuma teach the cuvette is made of plastic; [0017]).
Regarding claim 4, modified Kambara disclose the device of claim 3, wherein the cuvette is configured for replacement after a predetermined usage period (The modification of the reaction container and/or specimen container of modified Kambara with the transparent plastic cuvette, as taught by Oonuma, has previously been discussed in claim 2 above. Oonuma teach the cuvette is made of plastic; [0017]).
Regarding claim 12, modified Kambara disclose the device of claim 2, further comprising a probe assembly configured to transfer a portion of the liquid sample to the cuvette (The modification of the reaction container and/or specimen container of modified Kambara with the transparent plastic cuvette, as taught by Oonuma, has previously been discussed in claim 2 above. Kambara disclose a sample dispensing mechanism 3 that transfers a portion of the liquid sample to the reaction container 5; fig. 1, [0018]).
Claims 5-7 are rejected under 35 U.S.C. 103 as being unpatentable over Kambara in view of Nagai, and further in view of Mueller et al. (US 2019/0380530; already of record – hereinafter “Mueller”).
Regarding claim 5, modified Kambara disclose the device of claim 1 above.
Modified Kambara does not teach the device further comprising a second heater configured to further heat at least a portion of the water being heated to the first temperature to a second temperature.
However, Mueller teach the analogous art of a device comprising a connection to a water supply configured to supply water to the device (Mueller; fig. 1, #33, “water tank”, [0021, 0024]), wherein the device comprises a first heater configured to heat the water from the supply water to a first temperature (Mueller; fig. 1, #10, “continuous flow heater”, [0021]), and a second heater configured to further heat at least a portion of the water being heated to the first temperature to a second temperature (Mueller; fig. 1, #51, [0025]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device and first heater of modified Kambara to comprise the first heater that operates at a first temperature setpoint and a second heater that operates to further heat at least a portion of the water heated by the first heater to a second temperature, as taught by Mueller, because Mueller teaches the first heater that operates at a first temperature setpoint can distribute the water at the first temperature setpoint to a plurality of valves to perform various other functions and the second heater configured to further heat at least a portion of the water being heated to the first temperature to a second temperature allows a specific function to be performed at the second temperature (Mueller; fig. 1, [0021, 0025-0026]). One of ordinary skill in the art would have expected this modification could have been performed with a reasonable expectation of success since modified Kambara and Mueller both teach devices that use water from a water supply to perform various functions at different temperatures.
Note: The modification of modified Kambara in view of Mueller would result in the first heater of Kambara becoming in the second heater that operates at the second temperature.
Regarding claim 6, modified Kambara disclose the device of claim 5, wherein when the mixing bar is configured to be heated when rinsing the mixing bar with at least a portion of the water prior to the mixing bar contacting the test specimen for mixing, the at least a portion of the water is at the second temperature (The modification of the device and first heater of modified Kambara to comprise the first heater that operates at a first temperature setpoint and a second heater that operates to further heat at least a portion of the water heated by the first heater to a second temperature, as taught by Mueller, has previously been discussed in claim 5 above. The modification of modified Kambara in view of Mueller would result in the first heater of Kambara becoming in the second heater that operates at the second temperature. Kamara disclose “the cleaning liquid heated to a high temperature is sent to the cleaning liquid discharge nozzle 31 … the stir bar 19 is suitable for cleaning by applying a cleaning liquid heated to a high temperature by the heater 9”, [0019, 0022]).
Regarding claim 7, modified Kambara disclose the device of claim 5 comprising the second temperature.
Modified Kambara does not specifically teach wherein the second temperature is about 42 degrees Celsius.
However, Kambara does teach the temperature of the washing water is controlled (Kambara; [0024]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the second temperature to be controlled at about 42 degrees Celsius, because controlling the second temperature to about 42 degrees Celsius provides a safe operating temperature that reduces the risk of injury from scalding water while also dissolving contamination on the mixing bar. One of ordinary skill in the art would have expected this modification could have been performed with a reasonable expectation of success since modified Kambara teach controlling the temperature of the wash water when rising the mixing bar.
Note: What the second temperature is relates to function/intended use. However, functional language does not add any further structure to an apparatus beyond that of a capability. Apparatus claims must distinguish over the prior art in terms of structure rather than function. See MPEP 2114 and 2111.04. Therefore, if the prior art structure is capable of performing the function, then the prior art meets the limitation in the claims.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Kambara in view of Nagai, and further in view of Nichogi et al. (US 2011/0232769; already of record – hereinafter “Nichogi”).
Regarding claim 9, modified Kambara disclose the device of claim 1 above.
Modified Kambara does not teach the device further comprising a dry bath configured to heat the test specimen.
However, Nichogi teach the analogous art of a device (Nichogi; fig. 1, “automatic analysis apparatus”, [0088]) comprising a station configured to receive at least a container holding a liquid sample (Nichogi; figs. 1 & 2, #4, [0092]) wherein the station comprises a dry bath configured to heat the test specimen (Nichogi; fig. 2, [0092]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device of modified Kambara to comprise a dry bath configured to heat the test specimen, as taught by Nichogi, because Nichogi teach the dry bath configured to heat the test specimen has excellent maintainability but a low heat exchange rate (Nichogi; [0092]). One of ordinary skill in the art would have expected this modification could have been performed with a reasonable expectation of success since modified Kambara and Nichogi both teach heating test specimens to a controlled temperature.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Kambara in view of Nagai, and further in view of Bower et al. (US 2005/0196867; already of record – hereinafter “Bower”).
Regarding claim 13, modified Kambara disclose the device of claim 1, wherein the test specimen comprises a mixture of a portion of the liquid sample and a reagent (Kambara; fig. 1, #5, [0016]).
Modified Kambara does not teach the test specimen comprises a diluent.
However, Bower teach the analogous art of a device (Bower; fig. 1, “clinical analyzer”, [0031]) comprising a test specimen (Bower; fig. 2A, [0042]) wherein the test specimen comprises a mixture of liquid sample, a reagent, and a diluent (Bower; fig. 2A, [0042]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the test mixture of modified Kambara to further comprise a diluent, as taught by Bower, because Bower teaches the diluent is required in order to perform some assays of the sample (Bower; [0041]). One of ordinary skill in the art would have expected this modification could have been performed with a reasonable expectation of success since modified Kambara and Bower teach preparing a liquid sample for analysis.
Response to Arguments
Applicant’s arguments, filed 02/02/2026, have been considered but are moot because the arguments are towards the amended claims and do not apply to the current grounds of rejection. However, because the examiner is using the same prior art in the rejection, then the examiner will address applicant' s remarks in order to promote compact prosecution.
Applicant argues, see pages 6-8 of their remarks, that Kambara fails to disclose the amended features of claim 1 including “the mixing bar maintains a constant shape”. Applicant argues that there is no motivation to modify Kambara alone or in combination with the other cited art of record to arrive at these features since the purpose of Kambara’s mixing bar is to provide a shape-changing stirring rod for improved cleaning between test specimens, and that the stirring rod in its cleaning configuration would be unsuitable for proper mixing of the test specimen requiring redesigned to provide both cleaning capability and proper stirring functionality without relying on the shape-changing properties. The examiner agrees with applicant’s arguments. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Nagai which teaches a stirring paddle formed of PTFE. The examiner notes that Kambara shape-changing stirring rod aims to prevent washing liquid from remaining on the stirring rod (Kambara; [0022]). In this case, modifying the shape-changing stirring rod of Kambara with the PTFE stirring paddle of Nagai would achieve Kambara’s intended purpose of reducing carry over of the washing liquid when stirring a sample since PTFE is a highly hydrophobic material that causes water to bead up and roll off while also providing a constant shape of the stirring rod. Accordingly, the previous rejection over Kambara has been withdrawn and a new prior art rejection has been set forth.
Citations to art
In the above citations to documents in the art, an effort has been made to specifically cite representative passages, however rejections are in reference to the entirety of each document relied upon. Other passages, not specifically cited, may apply as well.
Other References Cited
The prior art of made of record and not relied upon is considered pertinent to Applicant’s disclosure include:
Manninen (US Patent No. 6,113,860) disclose a Teflon mixing bar.
Okabe et al. (US 2022/0206028) disclose a heat transfer member attached to a stirring rod.
Girvin et al. (US 2007/0047385) disclose a Teflon coated magnetic stir rod.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CURTIS A THOMPSON whose telephone number is (571) 272-0648. The examiner can normally be reached on M-F: 7:00 a.m. - 5:00 p.m..
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E-mail communication Authorization
Per updated USPTO Internet usage policies, Applicant and/or applicant’s representative is encouraged to authorize the USPTO examiner to discuss any subject matter concerning the above application via Internet e-mail communications. See MPEP 502.03. To approve such communications, Applicant must provide written authorization for e-mail communication by submitting the following statement via EFS Web (using PTO/SB/439) or Central Fax (571-273-8300):
Recognizing that Internet communications are not secure, I hereby authorize the USPTO to communicate with the undersigned and practitioners in accordance with 37 CFR 1.33 and 37 CFR 1.34 concerning any subject matter of this application by video conferencing, instant messaging, or electronic mail. I understand that a copy of these communications will be made of record in the application file.
Written authorizations submitted to the Examiner via e-mail are NOT proper. Written authorizations must be submitted via EFS-Web (using PTO/SB/439) or Central Fax (571-273-8300). A paper copy of e-mail correspondence will be placed in the patent application when appropriate. E-mails from the USPTO are for the sole use of the intended recipient, and may contain information subject to the confidentiality requirement set forth in 35 USC § 122. See also MPEP 502.03.
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/C.A.T./Examiner, Art Unit 1798
/BENJAMIN R WHATLEY/Primary Examiner, Art Unit 1798
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