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
Applicant is reminded of the proper content of an abstract of the disclosure.
A patent abstract is a concise statement of the technical disclosure of the patent and should include that which is new in the art to which the invention pertains. The abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art.
If the patent is of a basic nature, the entire technical disclosure may be new in the art, and the abstract should be directed to the entire disclosure. If the patent is in the nature of an improvement in an old apparatus, process, product, or composition, the abstract should include the technical disclosure of the improvement. The abstract should also mention by way of example any preferred modifications or alternatives.
Where applicable, the abstract should include the following: (1) if a machine or apparatus, its organization and operation; (2) if an article, its method of making; (3) if a chemical compound, its identity and use; (4) if a mixture, its ingredients; (5) if a process, the steps.
Extensive mechanical and design details of an apparatus should not be included in the abstract. The abstract should be in narrative form and generally limited to a single paragraph within the range of 50 to 150 words in length.
See MPEP § 608.01(b) for guidelines for the preparation of patent abstracts.
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 2 and 5 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.
Regarding claim 2, the term “like" in the limitation “disk-like shape” renders the claim indefinite because the claim includes elements not actually disclosed (those encompassed by "like"), thereby rendering the scope of the claim unascertainable. See MPEP § 2173.05(d). The limitation will be interpreted as “disk-shape” for clarity.
Claim 5 is rejected as being dependent on claim 2 (i.e., any one of claims 1 to 4).
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-11 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Claim 1 recites the steps for analyzing a blood coagulation reaction. Thus, the claim is a method, which is one of the statutory categories of invention. Claim 2-11 are dependent on Claim 1.
Step 2A Prong One: Claim 1 recite a judicial exception and identify the abstract idea/law of nature/natural phenomenon. Claim 1 recites “determining whether or not the coagulation reaction of a sample solution is complete”. The "mental processes" abstract idea grouping is defined as concepts performed in the human mind, and examples of mental processes include observations, evaluations, judgments, and opinions (See MPEP 2106(a)(2)(III)).Determining if a reaction complete is a mental evaluation. Thus, the determining step would fall under the abstract idea groups of mental processes. (Step 2A -Prong 1: Yes)
Step 2A Prong Two: The judicial exception is not integrated into a practical application because the claims do not impose any meaningful limits on practicing the abstract idea. Claim 1 describes “determining” if the reaction is complete. Claim 1 adds the additional element of measuring by the analysis device and obtaining time series data which is data gathering steps. Data gathering steps used in the abstract idea is insignificant extra-solution activity and not a particular practical application. Additionally, claim 1 recites terminating the measurement when the reaction is completed which is adding insignificant post solution activity and would noy be considered particular practical application. See MPEP 2106.05(g). Accordingly, this additional element does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea. (Step 2A -Prong 2: No)
Step 2B: Claim 1 includes additional elements such as the blood coagulation device that has a reaction table and measurement port which is well understood routine and conventional and would not amount to significantly more. Claim 1 also include terminating the reaction when completed. Any analyzer would terminate operation once the reaction was complete to save time and resources. Claims 1 does not have any steps or feature which are significantly more and the steps are well known in the art as taught in the prior art below. Claim 1 is ineligible. Claims 2-11 do not appear to have ‘significantly’ more. Claims 2-4 merely add parameters for the reaction table which are well understood routine and conventional as referenced in the prior art below. Claim 5 adds a step to the method for analyzing the blood coagulation reaction which is well understood routine and conventional as referenced in the prior art below. Claims 6-11 add more parameters for the reaction table and the measurement port. Since it is claimed at a high level of generality, there are no meaningful limitation claimed, such as a particular or unconventional machine or transformation of a particular article. (Step 2B: No)
Thus, claim 1 is ineligible. Claims 2-11 are dependent on Claim 1, and are also rejected.
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, 2, 3, 4 ,5, 6, 7, 8, 9, 10 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Tanimizu (JP 8-101199 A) as cited in in the IDS provided on 04/12/2024, and further in view of Makino et al (US 20170269113 A1).
Regarding claim 1, Tanimizu teaches a method for analyzing a blood coagulation reaction (para 0008), comprising,
by a blood coagulation analysis device (para 0026), measuring a coagulation reaction of a sample solution including a subject blood specimen (para 0023);
determining whether or not the coagulation reaction of the sample solution is completed (para 0023);
and when it is determined that the coagulation reaction is completed, terminating measurement of the coagulation reaction of the sample solution (para 0023),
wherein the blood coagulation analysis device includes a reaction table which is rotated in one direction (para 0010, Fig. 1),
the reaction table includes a measurement port to which a cell can be attached (‘measurement unit module detachably holds one cuvette’ para 0011, Fig. 1),
the coagulation reaction of the sample solution in the cell supplied to the measurement port is measured (para 0011, Fig. 2),
whether or not the coagulation reaction is completed is determined from the measurement data of the coagulation reaction (para 0023), and
when it is determined that the coagulation reaction is completed, the measurement of the coagulation reaction of the sample solution is terminated, and the cell containing the sample solution is removed from the measurement port (para 0023).
Tanimizu does not teach time series data of the measured coagulation reaction is accumulated.
However, Makino teaches an automatic analyzer including a blood coagulation time measuring device that eliminates the need for a new cold insulation container for the reagent (para 0078). Makino further teaches using an analyzer to measure the light scattering signal value over time to calculate the blood coagulation time (para 0003) for the benefit of improving the reliability of measurement results. Thus it would be obvious to one of ordinary skill in the art before the effective filing date to modify the teaching of Tanimizu with obtaining time series data of the measured coagulation reaction as taught by Makino for the benefit of improving the reliability of measurement results.
Regarding claim 2, Tanimizu in view of Makino teaches the invention of claim 1. Tanimizu further teaches the reaction table has a disk-shape (Fig. 1).
Regarding claim 3, Tanimizu in view of Makino teaches the invention of claim 1.
Tanimizu does not teaches the reaction table performs an intermittent rotation operation, and a time for which the reaction table completes one full round of rotation is from 320 to 380 seconds.
Makino teaches the reagent disk is capable of intermittent rotation (para 0060) and about 3-7 minutes (180 – 420 seconds) for analysis time depending on the type of detector (para 0011). Examiner interprets analysis time language to read on the analyzer rotating the reagent disk in a specific amount of time for the analysis to be complete. Thus it would be obvious to one of ordinary skill in the art before ethe effective filling date to modify the teaching of Tanimizu with the reaction table performs an intermittent rotation operation, and a time for which the reaction table completes one full round of rotation is from 320 to 380 seconds for the benefit of complete analysis of the blood coagulation reaction.
Regarding claim 4, Tanimizu in view of Makino teaches the invention of claim 3.
Tanimizu does not teach an interval of the intermittent rotation operation is α seconds, and a number of the measurement port on the reaction table is β, where α = 8 to 20, β= 16 to 47, and [α x β] = 320 to 380 seconds, and a rotation angle of the reaction table in one intermittent rotation operation is [360ᴼ/ β].
However, Makino teaches the reagent disk is capable of intermittent rotation (para 0060) and about 3-7 minutes (180 – 420 seconds) for analysis time depending on the type of detector (para 0011). Examiner interprets analysis time language to read on the analyzer rotating the reagent disk in a specific amount of time for the analysis to be complete. Fig. 9d-f also shows arrows that show rotation of the reagent disk going 360° (Fig. 9d-f). Makino further teaches how the reagent disk can make one rotation with various amounts of stops that will determine the total time of rotation (para 0084). Thus it would be obvious to one of ordinary skill in the art before the effective filing date to modify the teachings of Tanimizu with an interval of the intermittent rotation operation is α seconds, and a number of the measurement port on the reaction table is β, where α = 8 to 20, β= 16 to 47, and [α x β] = 320 to 380 seconds, and a rotation angle of the reaction table in one intermittent rotation operation is [360ᴼ/ β] as taught by Makino for the benefit of controlling the time of analysis.
Regarding claim 5, the claim set filed on 04/29/2024 include an improper multiple dependent claim issue that was corrected in a claim set with status identifiers filed on 04/12/2024. Thus, the corrected claim set with status identifiers submitted on 04/12/2024 is used for examination for claim 5. Further regarding claim 5, Tanimizu in view of Makino teaches the invention of claim 1. Tanimizu further teaches the measurement of the coagulation reaction of the sample solution including the subject blood specimen comprises:
supplying a cell to the measurement port of the reaction table (‘cuvette’, para 0011);
dispensing the subject blood specimen to the cell (para 0011);
dispensing a reagent to the cell containing the subject blood specimen to prepare the sample solution (para 0011); and
measuring the coagulation reaction of the sample solution (para 0012), and
supplying of the cell to the measurement port, the dispensing of the subject blood specimen to the cell, and the dispensing of the reagent to the cell containing the subject blood specimen are performed when the measurement port reaches a predetermined position for each (para 0011-0013), and
the terminating the measurement of the coagulation reaction of the sample solution is performed when the measurement port reaches a predetermined position for the terminating (para 0015).
Tanimizu does not teach heating the subject blood specimen.
However, Makino further teaches heating the sample after dispensing in it to a reaction cell (para 0090) for the benefit of starting the blood coagulation reaction (para 0091). Thus it would be obvious to one of ordinary skill in the art before the effective filing date to modify the teachings of Tanimizu with heating the subject blood specimen as taught by Makino for the benefit of starting the blood coagulation reaction (para 0091).
Regarding claim 6, Tanimizu in view of Makino teaches the invention of claim 5. Tanimizu further teaches the measurement port of the reaction table reaches a predetermined position A, the cell is supplied to the measurement port, when the measurement port reaches a predetermined position B, the subject blood specimen is dispensed to the cell, when the measurement port reaches a predetermined position C or a predetermined position D, the reagent is dispensed to the cell, and thereafter, when the measurement port reaches the predetermined position A or a predetermined position E, the cell is removed from the measurement port (para 0011-0015).
Regarding claim 7, Tanimizu in view of Makino teaches the invention of claim 6. Tanimizu further teaches the position A is disposed on a location shifted from another cuvette position in a rotation direction by one intermittent rotation operation of the reaction table (para 0012, Fig. 1). Although, the position next to position A is not labeled position E in the prior art it would be obvious for one of ordinary skill in the art to make the position next to position A be labeled position E as there are cuvette positions located next to position A according to Fig. 1 of the prior art. Figure 1 of the prior art is shown below.
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Regarding claim 8, Tanimizu in view of Makino teaches the invention of claim 6. Tanimizu further teaches the cell supplied to the measurement port reaches the position E on the reaction table, if it has been determined that the coagulation reaction of the sample solution in the cell is completed, measurement of the coagulation reaction of the sample solution is terminated, and then, at the position E, or when the cell reaches the position A, the cell is removed from the measurement port (‘cuvette discarding unit [5]’ para 0012).
Regarding claim 9, Tanimizu in view of Makino teaches the invention of claim 6. Tanimizu further teaches when the cell supplied to the measurement port reaches the position E on the reaction table, if it has not been determined that the coagulation reaction of the sample solution in the cell is completed, the cell is rotated on the reaction table without being removed from the measurement port, and measurement of the coagulation reaction of the sample solution in the cell is continued (para 0023).
Regarding claim 10, Tanimizu in view of Makino teaches the invention of claim 6. Tanimizu further teaches after dispensing the subject blood specimen to the cell supplied to the measurement port at the position B (para 0013), when the measurement port reaches position D for the first time, the reagent is dispensed to the cell (para 0013).
Regarding claim 11, Tanimizu in view of Makino teaches the invention of claim 6. Tanimizu further teaches after dispensing the subject blood specimen to the cell at the position B (para 0013), before dispensing the reagent to the cell at position D (para 0013), the reaction table is rotated one or more times (para 0010).
Tanimizu does not teach heating of the subject blood specimen being continued between the sample being dispensed at position B and reagent being added at position D.
Makino teaches the sample discharged to the disposable reaction vessel being heated by the reaction vessel temperature-regulating block in the analysis section (para 0076). Thus it would be obvious to one of ordinary skill in the art before the effective filing date to modify the teaching of Tanimizu with heating of the subject blood specimen being continued between the sample being dispensed at position B and reagent being added at position D as taught by Makino for the benefit of efficient use of the reaction cells (para 0023).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HENA BERA whose telephone number is (571)272-9964. The examiner can normally be reached Mon-Fri 8:00-5:00pm EST.
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/H.R.B./Examiner, Art Unit 1798
/CHARLES CAPOZZI/Supervisory Patent Examiner, Art Unit 1798
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