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 .
Response to Arguments
Applicant’s amendments, see pg 10, filed 08/07/2026, with respect to the abstract have been fully considered. The objection of 05/08/2026 has been withdrawn.
Applicant’s amendments, see pg 10, filed 08/07/2026, with respect to specification and figure 60C have been fully considered. The objection of 05/08/2026 has been withdrawn.
Applicant’s amendments, see pg 10-11, filed 08/07/2026, with respect to drawings have been fully considered. The objections of 05/08/2026 has been withdrawn.
Applicant’s amendments, see pg 11, filed 08/07/2026, with respect to specification and trademarks have been fully considered. The objection of 05/08/2026 has been withdrawn.
Applicant’s amendments, see pg 11, filed 08/07/2026, with respect to Claim 17 have been fully considered. The objection of 05/08/2026 has been withdrawn.
Applicant’s arguments with respect to claim(s) 1, 3, 6-7, 17-18, 20-28, and 31-33 have been considered but are moot because the amendment to the claim 1 prompts a new ground of rejection. The rejection below has been modified to reflect that amendment to the claims; however, still in part relies on the previously applied prior art such as Johansson, Tokunaga, Chow and Brueckner.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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, 9, 15, 17, 23, 24, 26, 27, 28, 31, 32, and 33 are rejected under 35 U.S.C. 103 as being unpatentable over Johansson et al. (US 20060292038 A1) in view of Tokunaga et al. (JP2013145211A) and further in view of Lee et al (US 20050014274 A1) and further in view of Takayama (JP 2010243307 A). The examiner has obtained a machine translation of the JP document above from J-Plat Pat. The rejection below is based off the machine translation.
Regarding claim 1, Johansson teaches an automated sample analyzer with cuvettes (para 0019). Johansson teaches a method of operating an automated analyzer (para 0019), the method comprising the steps of: providing the automated analyzer, the automated analyzer comprising:
a plurality of cuvettes (para 0026);
a plurality of positions (para 0026-0028), the plurality of positions comprising:
at least one reagent dispensing position (para 0028);
at least one constituent dispensing position (para 0028);
at least one cuvette washing position (para 0042);
and at least one constituent measurement position (para 0035-0037 and 0080);
at least one cuvette transporter having a plurality of cuvette holders (para 0022);
at least one photometer (para 0006);
and a controller (para 0036);
moving the plurality of cuvettes between the plurality of positions with the at least one cuvette transporter according to a schedule of the controller (para 0036);
measuring one or more cuvettes of the plurality of cuvettes during a cuvette wash sequence with at least one photometer when each of the one or more cuvettes is at the at least one constituent measurement position according to the schedule of the controller thereby
determining at least one characteristic of each of the one or more cuvettes, wherein the one or more cuvettes of the plurality of cuvettes contains a liquid during the measuring (para 0049);
and dispensing a constituent into a corresponding cuvette of the plurality of cuvettes when the corresponding cuvette is at one of the dispensing positions if a constituent test is scheduled for the corresponding cuvette at the at least one constituent measurement position according to the schedule of the controller (para 0049).
Johansson does not teach assigning each of the one or more cuvettes measured at the at least one constituent measurement position a disabled status if the at least one characteristic of the cuvette is higher than a first pre-determined threshold.
However, Tokunaga teaches an analyzer with cuvettes to analyze sample within a prescribed range. Tokunaga teaches assigning each of the one or more cuvettes measured at the at least one constituent measurement position a disabled status if the at least one characteristic of the cuvette is higher than a first pre-determined threshold (para 0019-0020, 0100).
Thus, it would be obvious to a person of ordinary skill in the art before the effective filing date to modify the teaching of Johansson with assigning each of the one or more cuvettes measured at the at least one constituent measurement position a disabled status if the at least one characteristic of the cuvette is higher than a first pre-determined threshold as taught by Tokunaga for the benefit of allowing to operator to take actions to fix the problem promptly (para 0020).
Johansson in view of Tokunaga does not teach a plurality of cuvette washing positions, a plurality of cuvette rinsing position, a plurality of cuvette drying positions, washing the plurality of cuvettes prior to assay measurement, the washing comprising:
washing the plurality of cuvettes with a detergent at two sequential cuvette washing positions;
rinsing the plurality of cuvettes with de-ionized water at four sequential cuvette rinsing positions; and,
and drying the cuvette at two sequential cuvette drying positions.
However, Lee teaches a method for cleaning used reaction cuvettes in an automatic analyzer (Abstract). Lee further teaches a plurality of reaction cuvettes with a plurality of position and reagents (para 0028). Lee further teaches a plurality of cuvette washing positions (‘ a number of washing manifolds’ para 0037), a plurality of cuvette rinsing position (‘rinsing operation’, para 0050), a plurality of cuvette drying positions (‘ a number of drying manifolds’ para 0037), washing the plurality of cuvettes prior to assay measurement (para 0035), the washing comprising: washing the plurality of cuvettes with a detergent (para 0040) at two sequential cuvette washing positions (para 0041); rinsing the plurality of cuvettes with de-ionized water at four sequential cuvette rinsing positions (para 0041); and, and drying the cuvette at two sequential cuvette drying positions (para 0037). Thus, it would be obvious to one of ordinary skill in the at before ethe effective filing date to modify the teaching of Johansson in view of Tokunaga with a plurality of washing, rinsing and drying positions as taught by Lee for the benefit of increasing assay efficiency without sacrificing assay quality (para 0008).
Johansson in view of Tokunaga and further in view of Lee does not teach checking the integrity of a cuvette. It can be interpreted that the photometer (para 0006) as taught by Tokunaga teaches checking the integrity of the cuvette.
Futhermore, Takayama teaches an automatic analyzer that determines whether a reaction tube is contaminated (pg 7, para 0001). Takayama further teaches an automatic analyzer with a photometer for detection (pg 8, para 0007). Takayama further teaches a cuvette integrity check method (pg 7, para 0002) for the benefit of improving the sensitivity in the reaction tube (pg 9, para 0009). Thus, it would be obvious to one of ordinary skill in the art before the effective filing date to modify the teachings of Johansson, Tokunaga, and in further view of Lee with checking the integrity of a cuvette for the benefit of improving the sensitivity in the reaction tube (pg 9, para 0009).
Regarding claim 9, Johansson in view of Tokunaga, Lee and Takayama recite the claimed invention in claims 1. Johansson further teaches wherein the constituent is a biological sample (para 0001).
Regarding claim 15, Johansson in view of Tokunaga, Lee and Takayama recite the claimed invention in claims 1. Johansson further teaches wherein the measuring of the one or more cuvettes of the plurality of cuvettes with the at least one photometer includes measuring absorbance for each of the cuvettes for at least one pre-determined wavelength of electromagnetic radiation, and wherein measuring absorbance for each of the cuvettes for the at least one pre-determined wavelength of electromagnetic radiation generates a plurality of absorbance data points for each of the cuvettes at each of the at least one pre-determined wavelength of electromagnetic radiation (para 0030).
Regarding claim 17, Johansson in view of Tokunaga, Lee and Takayama recite the claimed invention in claims 1. Johansson further teaches wherein the measuring of the one or more cuvettes of the plurality of cuvettes with the photometer includes measuring absorbance for each of the cuvettes with various wavelengths of electromagnetic radiation (para 0030, 0049 and 0052).
Johansson does not teach the photometer measuring absorbance for each cuvette at least 13 different pre-determined wavelengths of electromagnetic radiation.
Although the Johansson reference doesn’t teach at least 13 different wavelengths, it does teach a band pass filter which allows the passage of radiation only of a certain bandwidth into the light guide. The bandwidth includes wavelengths from 340nm to 880nm (para 0052). There are multiple filters in a filter wheel allowing the for the measurement of absorbance at multiple wavelengths. Although, the number of filters are not specified it would be obvious to a person of ordinary skill in the art before the effective filing date to add at least 13 filters for 13 wavelengths for the benefit of determining which wavelength has the maximum absorbance for various samples.
Regarding claim 23, Johansson in view of Tokunaga, Lee and Takayama recite the claimed invention in claim 1. Johansson further teaches assigning to each of the corresponding cuvettes measured at the constituent measurement position an enabled status if the at least one characteristic of the corresponding cuvette is within a pre-determined range or less than a second pre-determined threshold (para 0067).
Regarding claim 24, Johansson in view of Tokunaga, Lee and Takayama recite the claimed invention in claims 1. Johansson further teaches applying at least one additional enhanced cleaning routine to a corresponding cuvette assigned the disabled status, when the corresponding cuvette is at the at least one cuvette washing position (para 0050).
Regarding claim 26, Johansson in view of Tokunaga, Lee and Takayama recite the claimed invention in claims 24. Johansson further teaches additional cleaning routine (para 0035).
Johansson does not teach measuring the corresponding cuvette assigned the disabled status with the at least one photometer, when the corresponding cuvette is at the constituent measurement position and reassigning a disabled status if the at least one characteristic of the corresponding cuvette is higher than the first pre-determined threshold or assigning an enabled status if the at least one characteristic of the corresponding cuvette is less than the second pre-determined threshold or within a pre-determined range.
However, Tokunaga teaches measuring the corresponding cuvette assigned the disabled status with the at least one photometer, when the corresponding cuvette is at the constituent measurement position and reassigning a disabled status if the at least one characteristic of the corresponding cuvette is higher than the first pre-determined threshold or assigning an enabled status if the at least one characteristic of the corresponding cuvette is less than the second pre-determined threshold or within a pre-determined range (para 0019-0020, 0100).
Thus, it would be obvious to a person of ordinary skill in the art before the effective filing date to modify Johansson with measuring the corresponding cuvette assigned the disabled status with the at least one photometer, when the corresponding cuvette is at the constituent measurement position and reassigning a disabled status if the at least one characteristic of the corresponding cuvette is higher than the first pre-determined threshold or assigning an enabled status if the at least one characteristic of the corresponding cuvette is less than the second pre-determined threshold or within a pre-determined range as taught by Tokunaga for the benefit of ensuring the sample is not contaminated.
Regarding claim 27, Johansson in view of Tokunaga, Lee and Takayama recite the claimed invention in claims 26. Johansson teaches additional cleaning routine (para 0035).
Johansson does not teach if the corresponding cuvette is reassigned the disabled status, a subsequent additional cleaning routine is applied when the corresponding cuvette with the reassigned disabled status is at the at least one cuvette washing position.
However, Tokunaga does teach if the corresponding cuvette is reassigned the disabled status, a subsequent additional cleaning routine is applied when the corresponding cuvette with the reassigned disabled status is at the at least one cuvette washing position (para 0007 and 0046).
Thus, it would be obvious to a person of ordinary skill in the art before the effective filing date to modify Johansson with if the corresponding cuvette is reassigned the disabled status, a subsequent additional cleaning routine is applied when the corresponding cuvette with the reassigned disabled status is at the at least one cuvette washing position as taught by Tokunaga for the benefit of ensuring the sample is not contaminated.
Regarding claim 28, Johansson in view of Tokunaga, Lee and Takayama recite the claimed invention in claims 27. Johansson teaches that the cuvette will be ejected after measurements are taken (para 0050).
Johansson does not teach that the clean routine is applied for a pre-determined number of times before the cuvette is assigned a retirement status.
Although Johansson does not specify that the cuvettes are cleaned for a certain number of times before they are ejected, it is obvious to one of ordinary skill in the art before the effective filing date that after using the cuvette repeatedly it could lead to contaminated samples. Thus, it would be obvious to one of ordinary skill in the art before the effective filing date to eject the cuvette after the cuvette is used a couple of times to avoid sample contamination.
Regarding claim 31, Johansson in view of Tokunaga, Lee and Takayama teaches the instant invention in claim 1. Johansson does not teach notifying an operator of a need to replace at least one corresponding cuvette assigned the disabled status and notifying the operator of the quantity of corresponding cuvettes assigned the disabled status.
However, Tokunaga does teach notifying an operator of a need to replace at least one corresponding cuvette assigned the disabled status and notifying the operator of the quantity of corresponding cuvettes assigned the disabled status (para 0019-0020, 0108).
Thus, it would be obvious to a person of ordinary skill in the art before the effective filing date to modify the teaching of Johansson with notifying an operator of a need to replace at least one corresponding cuvette assigned the disabled status and notifying the operator of the quantity of corresponding cuvettes assigned the disabled status as taught by Tokunaga for the benefit of allowing to operator to take actions to fix the problem promptly (para 0020).
Regarding claim 32, Johansson in view of Tokunaga, Lee and Takayama teaches the instant invention in claim 1 and 31. Johansson does not teach notifying the operator of the reduced capacity of the automated analyzer due to the disabled status of at least one of the corresponding cuvettes.
However, Tokunaga does teach notifying the operator of the reduced capacity of the automated analyzer due to the disabled status of at least one of the corresponding cuvettes. (para 0019-0020, 0100, 0108).
Thus, it would be obvious to a person of ordinary skill in the art before the effective filing date to modify the teaching of Johansson with notifying the operator of the reduced capacity of the automated analyzer due to the disabled status of at least one of the corresponding cuvettes as taught by Tokunaga for the benefit of allowing to operator to take actions to fix the problem promptly (para 0020).
Regarding claim 33, Johansson in view of Tokunaga, Lee and Takayama teaches the instant invention in claim 1 and 31. Johansson does not notify the operator of a location on the cuvette transporter of each of the corresponding cuvettes to be replaced via a display screen.
However, Tokunaga does teach notify the operator of a location on the cuvette transporter of each of the corresponding cuvettes to be replaced via a display screen (para 0019-0020, 0100, 0108).
Thus, it would be obvious to a person of ordinary skill in the art before the effective filing date to modify the teaching of Johansson with notify the operator of a location on the cuvette transporter of each of the corresponding cuvettes to be replaced via a display screen as taught by Tokunaga for the benefit of allowing to operator to take actions to fix the problem promptly (para 0020).
Claims 3, 6, and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Johansson et al. (US 20060292038 A1), Tokunaga et al. (JP2013145211A), Lee et al (US 20050014274 A1) and in view of Takayama (JP 2010243307 A) as applied to claim 1 above, and further in view of Chow et al. (US 20050013737 A1).
Regarding claim 3 Johansson in view of Tokunaga, Lee and Takayama recite the claimed invention in claims 1. Johansson in view of Tokunaga, Lee, and Takayama does not teach re-scheduling the constituent test if the corresponding cuvette is assigned the disabled status wherein the rescheduling occurs in response to an earlier known disabled status or to a just-assigned disabled status.
However, Chow teaches an automated analyzer with a plurality of cuvettes for analyzing samples. Chow teaches re-scheduling the constituent test if the corresponding cuvette is assigned the disabled status wherein the rescheduling occurs in response to an earlier known disabled status or to a just-assigned disabled status (para 0007 and 0046).
Thus, it would be obvious to a person of ordinary skill in the art before the effective filing date to modify the teachings of Johansson in view of Tokunaga, Lee and Takayama with re-scheduling the constituent test if the corresponding cuvette is assigned the disabled status wherein the rescheduling occurs in response to an earlier known disabled status or to a just-assigned disabled status as taught by Chow to ensure accurate results.
Regarding claim 6, Johansson in view of Tokunaga, Lee and Takayama modified with Chow teach the instant invention in claim 1 and 3. Johansson does not teach the rescheduling results in a substitution of a non-tested constituent.
However, Chow teaches rescheduling results in a substitution of a non-tested constituent (para 0007 and 0046).
Thus, it would be obvious to a person of ordinary skill in the art before the effective filing date to modify the teachings of Johansson in view of Tokunaga, Lee and Takayama rescheduling results in a substitution of a non-tested constituent as taught by Chow to ensure the sample has not been contaminated.
Regarding claim 7, Johansson in view of Tokunaga, Lee and Takayama modified with Chow teach the instant invention in claim 1, 3, and 6. Johansson does not teach the non-tested constituent comprises a portion of a dilution or a portion of a pretreatment.
However, Chow teaches non-tested constituent comprises a portion of a pretreatment (para 0046).
Thus, it would be obvious to a person of ordinary skill in the art before the effective filing date to modify the teachings of Johansson in view of Tokunaga, Lee and Takayama with the non-tested constituent comprises a portion of a pretreatment as taught by Chow to ensure the sample is provided from the same exact specimen.
Claims 21 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Johansson et al. (US 20060292038 A1), Tokunaga et al. (JP2013145211A), Lee et al (US 20050014274 A1) and in view of Takayama (JP 2010243307 A) as applied to claim 1 and 15 above, and further in view of Brueckner et al. (WO2013160425 A1).
Regarding claim 21, Johansson in view of Tokunaga, Lee and Takayama recite the claimed invention in claims 1 and 15, however, those reference do not teach at least one characteristic of each of the one or more cuvettes includes absorbance variance.
However, Brueckner teaches a method for improvement of the sensitivity of and dynamic range of photometric assays which can be applied in automatic analyzers. Brueckner teaches that at least one characteristic of each of the one or more cuvettes includes absorbance variance (page 28, line 10-32).
Thus, it would be obvious to one of ordinary skill in the art before the effective filing date to modify Johansson in view of Tokunaga, Lee and Takayama with at least one characteristic of each of the one or more cuvettes includes absorbance variance as taught by Brueckner for the benefit of more accurate analyte quantification.
Regarding claim 22, the combination of Johansson in view of Tokunaga, Lee, and Takayama and further in view of Bruekner suggest the claimed invention. Brueckner further teaches the absorbance variance is a difference between a maximum absorbance and a minimum absorbance measured for at least one pre-determined wavelength of electromagnetic radiation (page 28, line 10-32).
Thus, it would be obvious to one of ordinary skill in the art before the effective filing date to modify Johansson in view of Tokunaga, Lee and Takayama with the absorbance variance being the difference between a maximum absorbance and a minimum absorbance measured for at least one pre-determined wavelength of electromagnetic radiation as taught by Brueckner for the benefit of more accurate analyte quantification.
Claims 18 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Johansson et al. (US 20060292038 A1), Tokunaga et al. (JP2013145211A), Lee et al (US 20050014274 A1) and in view of Takayama (JP 2010243307 A) as applied to claim 1 and 17 above, and further in view of Brueckner et al. (WO2013160425 A1).
Regarding claim 18, Johansson in view Tokunaga, Lee and Takayama recite the claimed invention in claims 1 and 17, however, those reference do not teach that the thirteen different pre-determined wavelengths of electromagnetic radiation comprise a short wavelength limit, a long wavelength limit, and eleven different wavelengths between the short wavelength limit and the long wavelength limit.
However, Bruckner teaches at least thirteen different pre-determined wavelengths of electromagnetic radiation comprise a short wavelength limit, a long wavelength limit, and eleven different wavelengths between the short wavelength limit and the long wavelength limit (page 1, line 5-11 and page 28, line 10- 32).
Thus, it would be obvious to one of ordinary skill in the art before the effective filing date to modify Johansson in view of Tokunaga, Lee and Takayama with at least thirteen different pre-determined wavelengths of electromagnetic radiation comprise a short wavelength limit, a long wavelength limit, and eleven different wavelengths between the short wavelength limit and the long wavelength limit as taught by Brueckner for the benefit of increasing the number of kinetic curves to be analyzed for the selection of the best wavelength.
Regarding claim 20, the combination of Johansson in view of Tokunaga, Lee and Takayama and further in view of Bruekner suggest the claimed invention. Johansson further teaches a photometer with a bandwidth of wavelengths from 340nm to 880nm (para 0052). A person of ordinary skill in the art before the effective filing date knows that from about 100nm to 400nm in the UV wavelength range and about 400nm to 800nm is the visible wavelength range. Thus, it would be obvious to one of ordinary skill in to art before the effective filing date that the short wavelength limit is a UV wavelength, and the long wavelength limit is a visible wavelength as shown by the range in Johansson.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/H.R.B./Examiner, Art Unit 1798
/CHARLES CAPOZZI/Supervisory Patent Examiner, Art Unit 1798
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