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 claims are directed to an apparatus. Although the claims mention a container, a blood sample containing plasma, a subject, coagulation time measurement reagent, coagulation activation reagent, signals, and a profile, none of such are positively claimed as structural elements of the apparatus. None of such are required to be present. All of such are considered as materials and/or articles intended to be, can be worked upon or used with the apparatus.
It is noted that the various “configured to…”; “to…”; and “for…” clauses recited throughout the claims do not provide for any further structural elements of the apparatus, but are directed to intended, possible use. There is no requirement for any process steps to be performed, conducted relative to any container nor any other unclaimed articles and/or materials.
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 19-31 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.
It is noted that new claims 19-31 were added in an amendment filed on 5/2/25 after the original filing date of 12/21/23. However, applicant fails to indicate where support for each of the claims are provided for in the originally filed specification. The new claims are not consistent with the originally filed claims 1-18 and specification.
It is unclear what structures disclosed in the specification and drawings correspond to each of the claimed structures recited in the claims. For example, it is unclear what structures disclosed in the specification correspond to the blood coagulation analyzer, the holder, and sample preparator. It is noted that the specification describes an analyzer 100, but such analyzer is not disclosed as comprising the elements as recited in the claims. It is unclear if the holder is intended to be “holding part 22a” of the detector 22 or some other structure (such as a cuvette table). If such holder is the holding part 22a, it is noted that the holder is not recited in claim 19 as being an element of the detector as disclosed in the specification. It is further unclear if the “sample preparator” is the same as, an element of, or different from the sample preparation unit 23. No “sample preparator” is described in the specification. It is presumed that such is intended to be the same as the sample preparation unit 23. However, such unit is described in the specification my more structures than just a pipette. A single pipette alone is not capable performing the recited intended use recited in the claim. Furthermore, it is unclear how a pipette can be present without providing for an arm (417, 418, as described in the specification). Furthermore, it is unclear if the light source corresponds to the light application unit 20 or one of the light sources 321-325. Furthermore, it is unclear if a controller is intended to be single controller or is actually defined by a combination of all of the different controllers described in the specification. It is noted that the analyzer 100 is disclosed as only comprising a controller 10. It is further unclear what it is intended to correspond to the processor and storage (storage units 12 and/or 13?). Furthermore, it is unclear what is “a profile of light detected” because there is no description of such in the specification nor mention of any controller being capable of, storing such a profile, digitally converting any signals, etc. as recited in the claim. Therefore, the claims are directed to new matter.
The term “poor” in claims 19 and 29-31 is a relative term which renders the claims indefinite. The term “poor blood collection” is not defined by the claims, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The claims do provide for any definition of the phrase, provide for any definitive standard, relative basis as to what is considered as “poor blood collection”. What may be considered as poor blood collection may not be considered as such to another and vice versa. The same is applicable to the term “likely poor”. It is noted that what the light measurements are considered to indicate, represent, mean, etc. is subjective. There are number of factors that could affect the timing/rate of coagulation of a blood sample (including, but no limited to a condition, disease, etc. of the subject; environmental conditions, storage conditions, materials employed to conduct the collection, amount time between the collection and actual analysis, and further different things that may occur between the time the sample was collected and actually analyzed, etc.). There is no direct correlation between the timing/rate of coagulation and the quality of a blood sample collection process, how the blood sample was previously collected from a subject (not defined as being any specific person nor animal).
As to claims 19, 26, and 30, it is unclear if the phrase “the light” is the same or different from “the detected light”. If the same, consistent terminology should be employed to clearly indicate such.
Dependent claims 20-31 are rejected via dependency upon a rejected claim.
It is unclear what is further structurally required by claims 20-21 because the claims do not provide for any further structural element nor further limit any prior positively claimed structural element. The claims are directed to unclaimed, reagents (not elements of the invention). It is presumed that “the blood coagulation time measurement reagent” is intended to refer to the prior recited “coagulation time measurement reagent”. If so, consistent terminology should be employed throughout the claims to reference such. It is noted that the “for measuring…” clause is also directed to intended use.
As to claim 22, it is unclear what is the structural nexus of the A/D convertor to the prior claimed controller because it appears as if the controller has been attributed with being capable of performing digital conversion of signals. If the controller is not capable of such, then it is unclear how the analyzer in claim 1 can function as claimed without the A/D converter because such signals cannot be converted without the A/D converter.
It is unclear what is further structurally required by claims 23-25 and 27-28 because the claims do not provide for any further structural elements nor further limit any prior positively claimed structural element. The claims are directed to the first value, second values, and analysis result that are not structures. What such values are considered as/intended to represent does not structurally define the invention. Furthermore, it is noted that the various “when” clauses are directed to conditionally process steps that are not required to be performed. The claims are directed to an apparatus not a process of use (no dispensing of any reagents, blood sample, etc. into the unclaimed container, coagulating the blood sample at any rate, nor any other process steps are required to be performed.
It is further unclear what is required by the term “predetermined” because there is no requirement for any determination of any coagulation state nor coagulation rate to be performed nor prior to any specific time nor event. However, any anything can be considered as “predetermined” relative to a future time or event. However, it is unclear what is required of a rate to be considered as a “maximum” rate because such is not defined in the claim by any definitive relative basis so as to determine what is considered as such.
It is unclear what is further structurally required by claims 26 and 29-30 because the claims appear to redundant in view of claim 19 which already states the controller can make a determination/obtain results of poor blood collection based on the profile of the light.
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.
Claims 19-31 are 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. There is no description of an analyzer as claimed disclosed in the original filed specification. See prior 112 rejections above. It is hereby requested that applicant provide for the specific text of the specification that supports each of the new claims and any all amendments.
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) 19- is/are rejected under 35 U.S.C. 102(a)(1),(a)(2) as being anticipate by MATSUOKA; Yuya et al. US 2019/0212262.
Matsuoka discloses an automatic blood coagulation analysis apparatus is provided with: an analysis port comprising a reaction container holding part (holder) that holds a reaction container storing the liquid mixture of a sample and a reagent, a light source (light source) that emits light to the liquid mixture stored in the reaction container held by the reaction container holding part, and a detector (detector) that detects light generated when the light from the light source is emitted to the liquid mixture; and a control unit (controller) that controls the analysis port, and analyzes the sample on the basis of information about the detected light. (Abstract).
The analyzer comprises dispensing probe 12 is arranged between the sample disk 11 and the reaction disk 13. Due to a rotation operation of the sample dispensing probe 12, an operation of aspirating and dispensing the sample can be performed on the sample container 27 on the sample disk 11, the reaction container (for biochemical analysis) 26 on the reaction disk 13, and a reaction container (for blood coagulation analysis) 28 at a sample dispensing position 18 of the blood coagulation time analyzing unit 2. (paragraph 0029).
A dispensing operation such as aspiration or discharge can be performed on the reaction container (for biochemical analysis) 26 on the reaction disk 13 and the reagent containers on the first reagent disk 15 and the second reagent disk 16. (paragraph 0030).
The blood coagulation time analyzing unit 2 mainly includes a blood coagulation time detecting unit 21. (paragraph 0031).
The analyzer also includes a control system and a signal processing system relating to the automatic analysis apparatus 1 will be simply described. A computer 105 (including a processor of a controller) is connected to a sample dispensing control unit 201, a reagent dispensing control unit (1) 206, a reagent dispensing control unit (2) 207, a blood coagulation reagent dispensing control unit 204, an A/D converter (1) 205, an A/D converter (2) 203 (claim 22), and a transport mechanism control unit 202 through an interface 101 and transmits a signal as an instruction to each of the control units. (paragraphs 0032, 37, 41, and 48).
The blood coagulation reagent dispensing control unit 204 causes the blood coagulation reagent dispensing probe 20 to dispense a reagent for blood coagulation into the reaction container (for blood coagulation analysis) 28 storing the sample that is dispensed by the sample dispensing probe 12 and held by a reaction container holding part of the analysis port 304 based on an instruction received from the computer 105. Alternatively, the blood coagulation reagent dispensing control unit 204 causes the blood coagulation reagent dispensing probe 20 to dispense a pre-treatment solution into the empty reaction container (for blood coagulation analysis) 28, the pre-treatment solution being a liquid mixture that is obtained by mixing the sample and a first reagent for blood coagulation analysis with each other in the reaction container (for biochemical analysis) 26. In this case, subsequently, the blood coagulation reagent dispensing control unit 204 causes the blood coagulation reagent dispensing probe 20 to dispense a second reagent for blood coagulation analysis into the reaction container 28 storing the pre-treatment solution. Here, the reagents for blood coagulation analysis are arranged in the first reagent disk 15 and the second reagent disk 16 and are used for blood coagulation analysis after being temporarily dispensed into the reaction container (for biochemical analysis) 26 on the reaction disk 13 by the first reagent dispensing probe 17 and the second reagent dispensing probe 18 as necessary. (paragraph 0036;sample preparator including a pipette). A pipette nozzle of each of the first reagent dispensing probe 17 and the second reagent dispensing probe 14 dispenses a predetermined amount of reagent solution into the reaction container (for biochemical analysis) 26 according to analysis parameters of the corresponding examination item. (paragraph 0040).
A printer 106 for printing a measurement result as a report or the like, a memory 104 as a storage device (storage of controller), an external output medium 102, an input device 107 such as a keyboard for inputting an operation instruction or the like, and a display device 103 for displaying a screen are connected to the interface 101. Examples of the display device 103 include a liquid crystal display and a CRT display. (paragraphs 0038). After the measurement, the operator checks the analysis result through the operation screen on the display device 103. (paragraphs 0042-43;display; claim 31).
The time required for blood coagulation reaction (hereinafter, also simply referred to as “blood coagulation time”) is obtained using the converted numerical value. For example, regarding an examination item such as ATPP (activated partial thromboplastin time), the blood coagulation time obtained as described above is output as the analysis result. Here, regarding an examination item such as Fbg (fibrinogen), component concentration data is further obtained with respect to the obtained blood coagulation time based on a calibration curve estimated in advance with an analysis method designated per examination item and is output as the analysis result. The blood coagulation time or the component concentration data as the analysis result of each examination item is output to the printer 106 or the screen of the display device 103. (paragraph 0049).
FIG. 2, the blood coagulation time detecting unit 21 includes a light source 302 and a scattered light detector 303 in one or plural analysis ports 304 where the disposable reaction container (for blood coagulation analysis) 28 can be loaded, and the blood coagulation time detecting unit 21 can detect an intensity of scattered light of light emitted to the reaction solution in the reaction container (for blood coagulation analysis) 28. (paragraph 0053, 55-56).
As to claims 21, 23-25, 27-28, see claim interpretations above.
As to claims 22, 26, and 29-31, Matsuoka discloses as stated above a blood analyzer comprising the same structural elements or structural equivalents of the positively claimed in the instant claims that are structurally capable of performing the recited intended/possible uses.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Matsuoka; Yuya et al.; YABUTANI; Chie et al.; Yabutani; Chie et al.; and MATSUOKA; Yuya et al. disclose blood analyzers and methods of use.
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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