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 .
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Interpretation
Content of Specification
(k) CLAIM OR CLAIMS: See 37 CFR 1.75 and MPEP § 608.01(m). The claim or claims must commence on a separate sheet or electronic page (37 CFR 1.52(b)(3)). Where a claim sets forth a plurality of elements or steps, each element or step of the claim should be separated by a line indentation. There may be plural indentations to further segregate subcombinations or related steps. See 37 CFR 1.75 and MPEP 608.01(i)-(p).
The claimed invention is defined by the positively claimed elements, the structural elements listed on separate indented lines listed in the body of the claim after the transitional phrase, “comprising”.
A claim is only limited by positively claimed elements. Thus, "[i]nclusion of the material or article worked upon by a structure being claimed does not impart patentability to the claims”. MPEP 2115 Material or Article Worked Upon by Apparatus.
It is noted that the device claims mention a reaction vessel, sample, blood, urine, reagent, information, analysis item, and test liquid. However, none of such are positively claimed as structural elements of the analysis device. All of such are considered as materials and/or articles intended to be, can be worked upon, used with the device. The device of the claims is defined by the positively claimed structural elements listed in the body of the claim after the transitional phrase, “comprising”. There is no requirement for the device to be used in any process including being used with any unclaimed materials and structures.
It is noted that the various “units” recited throughout the claims are defined by any specific structures. The respective names of the units and the “configured to…” do not provide for any structure of the “units”. What the various units are intended to/can be used relative to the unclaimed materials and articles do not provide for any structure of the units.
It is noted that the method of claim 8 is defined by the steps listed after the phrase “the method comprising”. The text prior to such does not provide for any steps of the method.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-15 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The claims are generally narrative and indefinite, failing to conform with current U.S. practice. They appear to be a literal translation into English from a foreign document and are replete with grammatical and idiomatic errors.
As to claim 1, it is unclear where the preamble of the claim ends and the body of the claim begins because it is unclear if the term “including” is intended to be a transitional phrase. Therefore, it is unclear if “a reaction unit” and “reagent supply unit” are intended to be elements of the device. If so, the term “including” should be “comprising” and each positively claimed structural element should be listed afterwards on separate indented lines and the further phrase “the automatic analysis device comprising” would be redundant and unnecessary.
Regarding claims 1 and 8, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). As noted above, a sample collected from a person and a person are not structural elements of the device. However, it is unclear what is the sample because the phrase “such as” does not clearly state what is the sample.
As to claim 1, it is unclear what is the phrase, “and obtaining measurement information with regard to a predetermined analysis item by measuring a test liquid obtained by mixing and reacting the reagent supplied from the reagent supply unit to the reaction vessel with the sample” is directed to because phrase reads as process steps. There is no requirement for any obtaining, measuring, determining, mixing, reacting, supplying, etc. to be done nor are there any structural elements claimed that can be used to perform any of such.
Although not positively claimed as a structural element, it is unclear what is “a predetermined analysis item” because such is not defined in the claim. Furthermore, there is no requirement for anyone nor anything to make and determination of such “pre” before any specific event.
As to claim 1, it is unclear how the analysis device as claimed is “automatic” because there is no structure, control unit 10, positively claimed as an element of the device to provide for automation. Furthermore, it is noted that no measurement unit and further other elements disclosed in the specification and drawings are not claimed as elements of the automatic analysis device.
As to claims 1-8, it is unclear what is the structural nexus, connectivity of the respective “units” to each other because the claims do not provide for such. None of such are required to be structurally connected to each other. The claims provide for a list of elements that are not required to be structurally connected. Therefore, it is unclear how the unconnected elements (units) are considered as defining a single device.
It is unclear what is structurally required to define each of the “units” the claims do not provide for such. The selected names of the units and respective configured to clauses do not provide for any structure of the respective units. It is unclear if each of the units are actual structures or programs/coding within the CPU 12, RAM 14, Storage 18, or other components of the unclaimed control unit 10.
Although “history information” is not structure nor claimed as an element of the device, required to be stored in/on the storage unit, it is unclear what is such history information and such information is related to the device now being claimed because there is no requirement for any analysis to have been previously conducted by anyone nor anything. Therefore, it is if such history information is directed to prior usage of the device being claimed/defined in the claim (used to perform some analysis method of something not specified in claim) or by some other means. The claims are directed to a device not a prior method nor instant method of use.
As to claim 1, no calculations are required to be performed by any units. Therefore, in addition to the reasons stated above, it is unclear what is considered as a number of “analyses per unit (what, which unit?...it is unclear what is relationship of such to any of the units recited in the claim) and “analyses per day” because no analyses using any unit is required to be performed for any number of days.
Claim 1 recites the limitations "each analysis day” and “each analysis item” in the paragraph beginning with “a number-of-analyses calculation unit”. There is insufficient antecedent basis for this limitation in the claim. Although not structure, there is no prior mention of analysis days nor analysis items.
Claim 1 recites the limitation "the history information stored in the history information storage unit” in the paragraph beginning with “a number-of-analyses calculation unit”. There is insufficient antecedent basis for this limitation in the claim. No such information is claimed as being stored in the history information storage information.
Claim 1 recites the limitation "each day of a week” in the paragraph beginning with “a classification/storage unit”. There is insufficient antecedent basis for this limitation in the claim. There is no requirement for any number to have been calculated for each day of any week.
Furthermore, although no classifying is required to be performed. It is unclear what constitutes (is considered as) “classifying” and what are the classifications because the claim does not clearly provide for such.
Claim 1 recites the limitation "each reagent in the reagent supply unit" in the paragraph beginning with “a reagent….” There is insufficient antecedent basis for this limitation in the claim. The reagent supply unit has not been positively claimed as an element of the device, and no reagents have been positively claimed as being in the reagent supply.
Claim 1 recites the limitation "each number of analyses per unit" in the paragraph beginning with “a conversion unit…”. There is insufficient antecedent basis for this limitation in the claim. Although no reading and converting are required to be performed. There is only a prior mention of “a number of analyses per unit”. Furthermore, it is unclear what is required by “a predetermined period corresponding to a day of a week” because no determination of any period (presumptively meaning…period of time) is required to be made by anyone nor anything “pre” prior to anything. Further there is no indication as to what is required of such period to be considered as “corresponding to” a day of a week. Any amount of time is within a day of a week.
Claim 1 recites the limitation "each reagent used for the analysis for each analysis item" in the paragraph beginning with “a conversion unit…”. There is insufficient antecedent basis for this limitation in the claim. Although no analysis is required to be performed, there is no prior mention of any reagents being used in any analysis. See also rejection above directed to “each analysis item”.
As to the last paragraph of claim 1, although no arranging and displaying information is required to be performed. It is unclear what is required to be done to be considered as “arranging” information because the claim does not clearly provide for such. Also applicable to claims 7-8 and 14.
Furthermore, it is unclear what is required of information to be considered as being “associated with” each reagent usage amount. Any information can be subjectively considered as being “associated with” anything one so desires as such. Also applicable to claims 7, 8, and 14.
Claim 1 recites the limitation "each reagent usage amount converted by the conversion unit” and “each reagent detected by the reagent remaining amount detection unit" in the last paragraph. There is insufficient antecedent basis for this limitation in the claim. Furthermore, it is unclear what/which reagents are being referenced in the clause “for each reagent” because the claim does not clearly recite such.
Dependent claims 2-7 and 9-15 are rejected via dependency upon a rejected claim.
As to claim 2, it is unclear what is structurally required to be considered as “a period selection unit” and what is the structural connectivity of such to the prior positively claimed elements of claim 1 because the claim does not provide for such. This is also applicable to the notification unit of claim 6 and analysis input unit of claim 7. See also prior rejections of claim 1 above.
As to claims 3-5, it is unclear what is further structurally required by the claims because the claims do not provide for any additional structural elements nor further structure of a prior positively claimed structural element. Instead, the claims provide for further process steps, possible uses of respective “units”.
As to claim 3, although no classifying is required to occur, it is unclear what is considered as constitutes, defines “a number of calibrator measurements, a number of accuracy management sample measurements, a number of initial tests, a number of retests, and a total number thereof”. None of such are defined in the claim nor indicated as to how such is structurally related to the claimed device. No measurements, testing, etc. of any kind is required to be performed. It is unclear what total number of what is being referenced by the phrase “a total number thereof” because the claim does not clearly state such.
Claim 3 recites the limitation "each of the number of calibrator measurements, the number of accuracy management sample measurements, the number of initial tests, the number of retests, and the total number thereof read from the classification/storage unit" in the last paragraph. There is insufficient antecedent basis for this limitation in the claim. Although no reading is required to be performed, there is no prior mention of any of such being read by anything from the classification/storage unit.
Claim 4 recites the limitation "the number of calibrator measurements” and “the number of accuracy management sample measurements". There is insufficient antecedent basis for this limitation in the claim. See also prior rejection of claim 3. Furthermore, it is unclear what/which analysis item is being referenced by “the analysis item” and what is the nexus of such to “each analysis item” recited in claim 1.
As to claim 5, although no analysis and reanalysis of anything is required to be performed, it is unclear what is considered as “reanalysis frequency” and what is required of information to be considered as information “on” the reanalysis frequency because such are not defined in the claim.
As to claim 6, although no notifying and detecting are required to occur. It is unclear who or what can be notified and what is required to be done to be as notifying.
Furthermore, it is unclear what is the nexus of “each reagent detected” to “each reagent in the supply unit” recited in claim 1, if such are the same or different because the claim does not clearly indicate such.
Furthermore, it is noted that the claim is directed to a conditional clause as indicated by the “when” clause. The clause is directed to a condition that is never required to occur, be performed. Also applicable to claim 13.
As to claim 7, see prior applicable rejections/remarks above. Although not a structural element and not required to be executed by anyone nor anything, it is unclear what is the nexus of “an analysis item” to be executed to the previously recited “each analysis item” in claim 1.
It is noted that claims 8-15 employ the same or similar language as that of claims 1-7, therefore see applicable rejections of claims 1-7 above.
As to claims 8-15, it is unclear who or what is required to perform each of the steps because the claims do not provide for such. It is noted that although the preamble of claim 8 mentions an automatic analysis device, such device is only defined as including a sample reaction unit and reagent supply unit. However, it is unclear how each of the method steps are related to such device because such device nor any element of such is required to be employed to perform the claimed steps.
It is unclear if is intended for the method to comprising collecting a sample, obtaining…measuring, mixing, reacting, supplying reagent from the supply vessel, etc. As presently drafted, no such steps define the method because such are not listed in the body of the claim.
It is unclear what is an analysis item because such is defined in the claim and how such is related to, involved in the method steps because the claims do not clearly provide for such.
It is noted that the method does not provide for any steps of performing/conducting any analysis of anything prior to anything. No analysis of anything is required to be performed on any period (of time), days/days, nor for any weeks. It is unclear what is meant required by the phrase “per unit” because it is unclear what unit/units is being referenced in the claim. No units are mentioned nor required to be employed in any method steps.
It is noted that a number steps recited in the claims can be performed mentally. For example, storing information, calculating…, classifying…, detecting, reading, converting…, selecting, notifying, inputting, etc. can be done mentally and visually via one’s brain and eyes.
The claim is confusing because it is unclear what steps are required to be done by who and/or what to define the method. See also prior remarks/rejections directed to claims 1-7.
It is unclear what is required by claims 10-12 and each of the last paragraphs of claims 14-15 because the claims recite that the steps do. However, while someone or something can perform the steps, the steps themselves are not capable of doing anything. The steps do not perform any classifying, converting, calculating, reading, arranging, displaying, etc. See also applicable rejections of claims 3-6 above.
As to claim 14, it is unclear what/who is required to perform the inputting and what such is inputted into because the claim does not provide for such.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-15 is/are rejected under 35 U.S.C. 102(a)(1),(a)(2) as being anticipated by Wakamiya; Yuji et al., US 2012/0275956.
Wakamiya discloses
An automatic analysis device including a reaction unit configured to hold a reaction vessel into which a sample collected from a person such as blood or urine is dispensed, and
see Fig. 1, "sample analyzer 1 "; see [0047], "A sample analyzer according to the present embodiment is an immune analyzer that performs tests for various items [ ... ], using a sample such as blood"; also see Figs. 1, 2 with [0056], "a sample from a test tube that has been transported to a sample aspirating position 1 a by the sample transporting unit 3, and dispenses (discharges) the sample into the cuvette at the sample discharging position 1 b into which the R1 reagent has been dispensed by the R1 reagent dispensing arm 6. Then, the cuvette is transported to the reaction part 9 by a catcher (not shown) of the R1 reagent dispensing arm 6."emphasis added;
a reagent supply unit configured to supply a reagent,
see Fig. 2 with [0052], "The measurement mechanism unit 2 includes a sample dispensing arm 5, an R1 reagent dispensing arm 6, an R2 reagent dispensing arm 7, an R3 reagent dispensing arm 8, a reaction part 9, a cuvette feeder 10, a primary BF separator 11, the secondary BF separator 12, a pipette tip feeder 13, a detector 14, an R4/R5 reagent feeder 15, and a reagent setting part 16. "; emphasis added;
and obtaining measurement information with regard to a predetermined analysis item by measuring a test liquid obtained by mixing and reacting the reagent supplied from the reagent supply unit to the reaction vessel with the sample,
see Fig. 2, "detector 14", with [0063], "The detector 14 obtains, by means of a photo multiplier tube, light that is generated in a reaction between the luminescent substrate and the labeled antibody bound to an antigen in the sample on which the above-described predetermined processes have been performed, thereby measuring the amount of the antigen contained in the sample.";
the automatic analysis device comprising:
a history information storage unit configured to store history information related to a previously conducted analysis;
see Fig. 4, "information processing apparatus 4", with [0084], "The hard disk 404 is provided with a reagent usage history database OB200. A usage history of a reagent used for each measurement item is recorded in the reagent usage history database DB200"; also see Fig. 1 0;
a number-of-analyses calculation unit configured to calculate a number of analyses per unit, the number of analyses per unit being a number of analyses per day on each analysis day, for each analysis item from the history information stored in the history information storage unit;
see Fig. 10, with [0084], "[ ... ] Each cell of the reagent usage history database OB200 corresponds to one day, and the amount of a reagent used on the day is stored in the cell. As the 'amount of a reagent', the number of tests (the number of times of measurements) performed by using the reagent is stored."
a classification/ storage unit configured to classify the number of analyses per unit calculated by the number-ofanalyses calculation unit for each day of a week and store the number of analyses per unit;
see Fig. 10, with [0084], "The reagent usage history database OB200 is structured, divided into seven days of the week, that is, from Monday to Sunday.";
a reagent remaining amount detection unit configured to detect a current remaining amount of each reagent in the reagent supply unit;
see [0070], "An RFID tag is affixed to each reagent container set on the reagent setting part 16. Reagent management information for managing the reagent is stored in the RFID tag. The reagent management information contains information such as a measurement item, a lot number, a serial number, a reagent type, a preservation period, a filling amount, and a remaining amount.", emphasis added; [0097], "in the reagent DB, the remaining amount (the remaining number of tests) of the R1 reagent container 100 and the remaining amount (the remaining number of tests) of the R3 reagent container 120 are stored separately."
a conversion unit configured to read each number of analyses per unit over a predetermined period corresponding to a day of a week of an analysis implementation date from the classification/storage unit and convert the read each number of analyses per unit into a reagent usage amount with regard to each reagent used for the analysis for each analysis item; and
see Fig. Fig. 7B, step 122, with [0101], "In the reagent usage amount estimation process of step S122, a usage amount of a reagent for the current day is estimated";
Fig. 8, step S202 with [0108], "when the target estimation day is Monday, an average usage amount of the reagent per past Monday is calculated, based on only usage amounts of the reagent of operation days among data of Mondays stored in the reagent usage history database DB200";
a display unit configured to arrange and display information associated with each reagent usage amount converted by the conversion unit and a remaining amount of each reagent detected by the reagent remaining amount detection unit for each reagent.
see display unit 420 (paragraph 0050, 80-81, 93, 98; Figures 1 and 5); Fig. 22, with [0190], "in step S912, the CPU 401 generates a graph regarding a remaining amount of a reagent for each measurement item (step S914). [ ... ] Each graph regarding a remaining amount of a reagent includes a graph (bar) indicating a remaining amount of the reagent, a bar graph (bar) indicating an estimated usage amount of the reagent, and a bar graph indicating a shortage amount of the reagent.";
also see Fig. 23 with [0192], "in step S912, the CPU 401 generates a graph regarding a remaining amount of a reagent for each measurement item (step S914). As described below, a graph regarding a remaining amount of a reagent for each measurement item is displayed on the maintenance status confirmation screen. Each graph regarding a remaining amount of a reagent includes a graph (bar) indicating a remaining amount of the reagent, a bar graph (bar) indicating an estimated usage amount of the reagent, and a bar graph indicating a shortage amount of the reagent."
As to claim 2, a date/time can be selected (time selection unit). See paragraphs 0005, 37, 85 (operational day table), 180-183, 202, 204, 206, 208, 236).
As to claims 3-5, the claims are directed to the same structural features addressed above. See also claim interpretations.
As to claim 6, see Fig. 23, C102, with [0192], "numerical information C102 indicating an excess or shortage amount of the reagent"; and Fig. 23, C106, with [0195], "The shortage amount is displayed by a bar G106, which is red."
As to claim 7 see input unit 410 (Figures 5 paragraphs 0050, 83, 86, 92, 98, 185, 206, 210) and prior discussion of display unit 420 above.
As to method claims 8-14, see prior teachings above directed to claims 1-7.
As to claim 15, see Fig. 23, with [0211], "in the sample analyzer 1 according to the present embodiment, a remaining amount of a reagent and an estimated usage amount of the reagent is graphically displayed in a bar graph. Therefore, the user can intuitively discern the remaining amount of the reagent and the estimated usage amount. Moreover, since a numerical value of the remaining amount of the reagent and a numerical value of the estimated usage amount are also displayed, the user can easily discern the necessary refill amount of the reagent."
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. HIRABAYASHI; Yuichi et al.; Kurono; Hiroshi; Nakasawa; Takashi et al.; ARIYOSHI; Shunsuke; Wakamiya; Yuji et al.; NISHIKAWA; Ken et al.; Nakata; Shinpei et al.; KONDOU; Keitarou; SAKAGAMI; Toshio; Yagi; Kenichi et al.; Magnant; Gary P. et al.; Kureshy, Fareed et al. and Toi, Hiroatsu et al. disclose automatic analyzers.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN R GORDON whose telephone number is (571)272-1258. The examiner can normally be reached M-F, 8-5:30pm; off every other Friday..
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Capozzi can be reached at 571-270-3638. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRIAN R GORDON/Primary Examiner, Art Unit 1798
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