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 .
Response to Amendment
The amendments and remarks, filed on 11/5/2025, has been entered. The previous prior art rejection is withdrawn and a new prior art rejection is applied to address the claim amendments.
Claim Status
Claims 50, 53-57, and 61-72 are pending with claims 50, 53-57, 61-64, and 70-72 are being examined and claims 65-69 are withdrawn.
Claim Objections
Claim 50 is objected to because of the following informalities: claim 50 reads “perform an agitating operation on a small-volume blood sample” should read as “perform an agitating operation on the small-volume blood sample” in pp 2, lines 13-14. Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “a measurement setting device” in claim 61.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
Specifically, in the instant specifications, on pp 8-9, the measurement mode setting device “sets a first measurement mode and a second measurement mode; wherein the controller executes the following operations” and “the measurement mode setting device further configured to set a third measurement mode”. The applicant does not provide structure to the measurement mode setting device, thus it is unclear as to how the measurement modes are determined. Examiner interprets that any input structure capable of selecting options meets the limitation.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 50, 53-57, 61-64, and 70-72 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.
Claim 50 recites the limitation "a sample aspirator, configured to aspirate a predetermined amount of blood sample from the first sample container or the second sample container that is conveyed to a first sampling position and has been subject to the aforesaid agitating operation" on page 3, lines 1-3. There is insufficient antecedent basis for this limitation in the claim, thus the limitation is unclear. Specifically, it is unclear if the Applicant is referring to the “agitating operation” by the first agitating device or the “inverted agitating operation” by the second agitating device. For purpose of examination, the examiner interprets that the agitating operation is determined by which container the sample aspirator withdraws blood from. Claims 53-57, 61-64, and 70-72 are rejected by virtue of dependency on claim 50.
Claim 50 recites the limitation “a common-volume blood sample contained in the second sample container” in lines 18-19. The limitation is unclear as to what volume is common relative to the sample containers. Specifically, the first sample container comprises a “smaller-volume” blood sample which makes the sample in the second container not common. Claims 53-57, 61-64, and 70-72 are rejected by virtue of dependency on claim 50.
Claim limitation ““a measurement setting device” in claim 61 invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The instant specification fails to provide structure to the measurement mode setting device, thus it is unclear as to how the measurement modes are determined. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries 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 50, 53-55, 57-58, 61, 63, 70, and 72 are rejected under 35 U.S.C. 103 as being unpatentable over Kitagawa et al (US 20120028343 A1; hereinafter “Kitagawa”) in view of Hirano (US 20110104007 A1; hereinafter “Hirano”; already of record).
Regarding claim 50, Kitagawa teaches a blood sample analyzer (Kitagawa; Abstract), comprising:
a sample rack, configured to hold sample containers loaded with a blood sample (Kitagawa; para [72]; the rack 110 arranged with the sample container 101 with lid in which the blood specimen (sample) to be analyzed), wherein the sample containers comprise a first sample container and a second sample container (Kitagawa; Fig. 2, 4), and a volume of the first sample container is smaller than a volume of the second sample container (Kitagawa; para [106]; an operation of a sample of small volume smaller than the normal amount is accommodated in the sample container 101 having the recess 80 and a sample of normal amount is accommodated in the sample container 101 without the recess 80 is carried out; examiner notes that the smaller volume container is depicted in Fig. 12a-c),
a sample conveying device for conveying the sample rack loaded with the first sample container and/or the second sample container (Kitagawa; Fig. 2; para [54]; the rack transporting portion 43 is configured to transport the rack 110 to transfer the sample container 101 held in the rack 110 to the first retrieving position 43 a for providing the sample to the first measurement unit 2 and the second retrieving position 43 b for providing the sample to the second measurement unit 3),
a second agitating device capable of picking up the sample rack or the second sample container on the sample rack, and performing an inverted agitating operation on a common-volume blood sample contained in the second sample container when the second sample container is positioned at a second agitating position and is sealed with a cover (Kitagawa; para [46, 72]; a stirring motor 254 (354) for moving (turning) the hand 251 (351) in a pendulum form between an upright state and a fallen state. The stirring motor 254 (354) is configured to move (turn) the hand 251 (351) in a pendulum form between the upright state and the fallen state by the power from the stepping motor; the examiner interprets the “second agitating position” as the position where the sample container is removed from);
a sample aspirator, configured to aspirate a predetermined amount of blood sample from the second sample container that is conveyed to a first sampling position and has been subject to the aforesaid agitating operation (Kitagawa; Fig. 2; para [40]; an aspirating tube 211 (311) for aspirating blood or a sample from a sample container 101; examiner interprets the “first sampling position” to be the location/area in which the aspirating tube aspirates the sample as denoted by aspirating position 600, 700);
a sample preparing device, configured to prepare a test sample from the blood sample aspirated by the sample aspirator (Kitagawa; Fig. 2; para [40]; a specimen preparing portion 22, 32 for preparing a measurement specimen from the blood aspirated by the aspirating tube 211 (311));
a tester, configured to test the test sample prepared by the sample preparing device, so as to obtain a test result (Kitagawa; para [44]; A detection unit 23 (33) is configured by an RBC/PLT detecting portion D1 used for the RBC measurement (measurement of number of red blood cells) and the PLT measurement (measurement of number of blood platelets), an HGB detecting portion D2 used for the HGB measurement (measurement of hemoglobin amount in blood), and an optical detecting portion D3 used for the WBC measurement (measurement of number of white blood cells), the DIFF measurement (classification of white blood cells), the NRBC measurement, and the RET measurement).
Kitagawa does not teach a first agitating device having a sample stirring component for stirring a small-volume blood sample in the first sample container, the first agitating device being capable of driving the sample stirring component to perform an agitating operation on a small-volume blood sample contained in the first sample container when the first sample container is positioned at a first agitating position with a cover of the first sample container being open.
However, Hirano teaches an analogous art of an automatic analyzing device (Hirano; Fig. 1; para [21]) comprising a first agitating device (Hirano; Fig. 1, 2A; para [21, 23]; The stir unit 12) having a sample stirring component for stirring a small-volume blood sample in the first sample container (Hirano; para [21, 22]; A biochemical automatic analyzing device is known which performs biochemical analysis on a sample, such as blood, urine, or stool, by injecting the sample and a reagent into a transparent measurement container…the stir unit 12 stirs the sample 1; examiner notes the sample may be blood), the first agitating device being capable of driving the sample stirring component to perform an agitating operation on a small-volume blood sample contained in the first sample container on the sample rack at a first agitating position when the first sample container is positioned at a first agitating position with a cover of the first sample container being open (Hirano; para [24]; First, the horizontal movement motor 23 is driven to move the stir rod 19 to a position above one of the sample cells 8. Next, the vertical motor 26 is driven to insert the stir rod 19 into the reaction solution 7 in the sample cell 8. Subsequently, the rotation motor 21 is driven to rotate the stir rod 19 in the reaction solution 7, thereby performing the stir operation). It would have been obvious to one of ordinary skill in the art by the effective filing date to have modified one of the measurement units of Kitagawa to comprise the first agitating device as taught by Hirano, because Hirano teaches that the stir unit mixes the solution in a short time and suited for small volumes of reaction (Hirano; para [7, 9]). The examiner notes the modification includes the first agitating device to mix the small sample volumes of Kitagawa (Kitagawa; para [106]; an operation of a sample of small volume smaller than the normal amount is accommodated in the sample container 101 having the recess 80 and a sample of normal amount is accommodated in the sample container 101 without the recess 80 is carried out; examiner notes that the smaller volume container is depicted in Fig. 12a-c). Additionally, the examiner notes that the covers are taught by Kitagawa and it would have been obvious to one of ordinary skill in the art to remove the cover in order to mix/agitate the sample. The limitation is directed to the function and/or the manner of operating the first agitating device, all the structural limitations of the claim has been disclosed by Kitagawa in view of Hirano and the first agitating device of modified Kitagawa is capable of “perform[ing] an agitating operation on a small-volume blood sample contained in the first sample container when the first sample container is positioned at a first agitating position with a cover of the first sample container being open”. As such, it is deemed that the claimed first agitating device is not differentiated from the first agitating device of modified Kitagawa (see MPEP §2114). Examiner notes “the first agitating position” is interpreted as aspirating position that is comprised within the modified measurement unit.
Thus, modified Kitagawa teaches a controller, configured to communicate with the sample conveying device, the first agitating device and the second agitating device, and to control the sample conveying device, the first agitating device and the second agitating device (Kitagawa; Fig. 2; para [39]; a control device 5 including a PC (personal computer) electrically connected to the first measurement unit 2, the second measurement unit 3, and the sample transporting device 4). The examiner notes that the first agitating device is modified to be incorporated into either of the measurement units.
Regarding claim 53, modified Kitagawa teaches the blood sample analyzer according to claim 50 (one of the measurement units of Kitagawa is modified to comprise the first agitating device as taught by Hirano discussed above in claim 50), wherein the sample stirring component comprises a paddle-shaped head (Hirano; Fig. 2B; Further, general shapes of the stir rod 19 include a flat-plate shape).
Regarding claim 54, modified Kitagawa teaches the blood sample analyzer according to claim 50 (one of the measurement units of Kitagawa is modified to comprise the first agitating device as taught by Hirano discussed above in claim 50), wherein the controller controls the sample stirring component to perform stirring in one or any combination of rotation, circular orbit, linear swing, and up-and-down vibration modes (Hirano; para [24, 34]; First, the horizontal movement motor 23 is driven to move the stir rod 19 to a position above one of the sample cells 8. Next, the vertical motor 26 is driven to insert the stir rod 19 into the reaction solution 7 in the sample cell 8. Subsequently, the rotation motor 21 is driven to rotate the stir rod 19 in the reaction solution 7, thereby performing the stir operation… The unit control parts thereby drive the stir unit 12).
Regarding claim 55, modified Kitagawa teaches the blood sample analyzer according to claim 50 (one of the measurement units of Kitagawa is modified to comprise the first agitating device as taught by Hirano discussed above in claim 50), wherein the sample stirring component is capable of moving up and down, and is capable of moving downwards into the first sample container at the first agitating position for agitation (Hirano; para [24]; First, the horizontal movement motor 23 is driven to move the stir rod 19 to a position above one of the sample cells 8. Next, the vertical motor 26 is driven to insert the stir rod 19 into the reaction solution 7 in the sample cell 8. Subsequently, the rotation motor 21 is driven to rotate the stir rod 19 in the reaction solution 7, thereby performing the stir operation).
Regarding claim 57, modified Kitagawa teaches the blood sample analyzer according to claim 50 (one of the measurement units of Kitagawa is modified to comprise the first agitating device as taught by Hirano discussed above in claim 50), with the stirring component.
Modified Kitagawa does not teach a cleaning component, the cleaning component comprising a cleaning tank in which the sample stirring component is cleaned.
However, Hirano teaches an analogous art of an automatic analyzing device (Hirano; Fig. 1; para [21]) comprising a cleaning component (Hirano; para [24]; the cleaning unit 14), the cleaning component comprising a cleaning tank in which the sample stirring component is cleaned (Hirano; para [24]; In the process of cleaning the stir rod, the horizontal movement motor 23 is driven to move the stir rod 19 to a position above a cleaning tank in the cleaning unit 14). It would have been obvious to one of ordinary skill in the art by the effective filing date to have modified the blood sample analyzer of modified Kitagawa to comprise the cleaning component as taught by Hirano, because Hirano teaches that the stir rod is cleaned after stirring the reaction solution (Hirano; para [24]). Additionally, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to combine the sample stirring component of modified Kitagawa to be clean by the cleaning component as taught by Hirano as this is a known to yield predictable results for cleaning the stir rod in the art. The combination of familiar elements is likely to be obvious when it does no more than yield predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, A).
Regarding claim 61, modified Kitagawa teaches the blood sample analyzer according to claim 50 (one of the measurement units of Kitagawa is modified to comprise the first agitating device as taught by Hirano discussed above in claim 50), further comprising: a measurement mode setting device for setting a first measurement mode and a second measurement mode (Kitagawa; para [41]; a priority sample measurement start button 29, 39); wherein the controller executes the following operations according to a setting of the measurement mode setting device: (1) determining whether the first measurement mode or the second measurement mode is set; (2) when the first measurement mode is determined to be set, controlling the first agitating device to agitate the blood sample in the first sample container; and (3) when the second measurement mode is determined to be set, controlling the second agitating device to pick up the second sample container for agitating (Hirano; para [24]; First, the horizontal movement motor 23 is driven to move the stir rod 19 to a position above one of the sample cells 8. Next, the vertical motor 26 is driven to insert the stir rod 19 into the reaction solution 7 in the sample cell 8. Subsequently, the rotation motor 21 is driven to rotate the stir rod 19 in the reaction solution 7, thereby performing the stir operation; Kitagawa; para [46, 72]; a stirring motor 254 (354) for moving (turning) the hand 251 (351) in a pendulum form between an upright state and a fallen state. The stirring motor 254 (354) is configured to move (turn) the hand 251 (351) in a pendulum form between the upright state and the fallen state by the power from the stepping motor; the examiner interprets the “second agitating position” as the position where the sample container is removed from). The examiner interprets that the measurement mode to be selected based on the measurement button by the user. Thus, the selected measurement mode setting device would control the respective measurement unit which comprises either the first agitating device or the second agitating device.
Regarding claim 63, modified Kitagawa teaches the blood sample analyzer according to claim 61 (one of the measurement units of Kitagawa is modified to comprise the first agitating device as taught by Hirano discussed above in claim 50), wherein: the small-volume blood sample in the first sample container is pre-diluted (Hirano; para [31]; total of 130 μL of a pigment solution and a glycerine solution was pipetted into a sample cell); the measurement mode setting device is further configured to set a third measurement mode; and when the third measurement mode is determined to be set, the controller controls the first agitating device to agitate the pre-diluted small-volume blood sample in the first sample container (Hirano; para [24, 31]; the horizontal movement motor 23 is driven to move the stir rod 19 to a position above one of the sample cells 8. Next, the vertical motor 26 is driven to insert the stir rod 19 into the reaction solution 7 in the sample cell 8. Subsequently, the rotation motor 21 is driven to rotate the stir rod 19 in the reaction solution 7, thereby performing the stir operation). Examiner notes one of the measurement devices is modified to comprise the first agitating device, thus the third measurement mode is determined when the diluted sample is agitated.
Regarding claim 70, modified Kitagawa teaches the blood sample analyzer according to claim 50 (one of the measurement units of Kitagawa is modified to comprise the first agitating device as taught by Hirano discussed above in claim 50), wherein the small-volume blood sample contained in the first sample container is agitated while being clamped (Kitagawa; para [49]; The open/close part 252 (352) is configured to open/close the hand 251 (351) to grip the sample container 101; Hirano; para [24]; First, the horizontal movement motor 23 is driven to move the stir rod 19 to a position above one of the sample cells 8. Next, the vertical motor 26 is driven to insert the stir rod 19 into the reaction solution 7 in the sample cell 8. Subsequently, the rotation motor 21 is driven to rotate the stir rod 19 in the reaction solution 7, thereby performing the stir operation).
Regarding claim 72, modified Kitagawa teaches the blood sample analyzer according to claim 50, further comprising: a sample receiving assembly having a sample container fixing hole, and configured for individually conveying the first sample container or the second sample container placed in the sample container fixing hole wherein the controller is further configured to: determine whether a current feeding mode selected by a user is a first feeding mode or a second feeding mode (Kitagawa; para [41]; a priority sample measurement start button 29, 39), when the current feeding mode is determined to be the first feeding mode, control the sample conveying device to convey the sample rack loaded with the first sample container and/or the second sample container to a predetermined position, and to convey the first sample container or the second sample container containing an agitated blood sample to first sampling position; and control the sample aspirating needle to aspirate the amount of blood sample from the first sample container or second sample container at the first sampling position; and when the current feeding mode is determined to be the second feeding mode, control the sample receiving assembly to convey the first sample container or the second sample container containing the agitated blood sample individually to a second sampling position; and control the sample aspirating needle to aspirate the amount of blood sample from the first sample container or second sample container at the second sampling position (Kitagawa; Fig. 2, 6; examiner notes Figure 6 depicts the flow process of the sample container which is transported, agitated, and aspirated). The examiner interprets the first feeding mode to be determined by the user when selecting the sample measurement start button 29, 39 which corresponds to the first measurement unit or the second measurement unit. As discussed above in claim 50, Kitagawa is modified to comprise the second agitating device as taught by Hirano which would correspond to one of the measurement units. Thus, the modified measurement unit is interpreted as the second feeding mode.
Claim 56 is rejected under 35 U.S.C. 103 as being unpatentable over Kitagawa in view of Hirano, and in further view of Hammerschmidt et al (US 20170361289 A1; hereinafter “Hammerschmidt”; already of record).
Regarding claim 56, modified Kitagawa teaches the blood sample analyzer according to claim 50, with the sample stirring component.
Modified Kitagawa does not teach a cleaning component for cleaning the sample stirring component comprising a cleaning fluid inlet and a cleaning fluid outlet; the cleaning fluid outlet is configured for exhausting air to dry the sample stirring component.
However, Hammerschmidt teaches an analogous art of a mixing device implemented in analytical devices (Hammerschmidt; Abstract; para [12]) comprising a cleaning component for cleaning the sample stirring component (Hammerschmidt; Fig. 1, 3; para [41]; the mount (6) may be provided with at least a cleaning pod that removes material from the mixing rod) comprising a cleaning fluid inlet and a cleaning fluid outlet (Hammerschmidt; Fig. 3; para [42]; the mount (6) is provided with at least one orifice (11, 12) which allows the introduction of a liquid into the sleeve (10)); the cleaning fluid outlet is configured for exhausting air to dry the sample stirring component (Hammerschmidt; para [43]; the mixing rod (4) which can be flushed with cleaning liquid provided and removed through orifices (11) and (12)). The examiner notes that that the cleaning liquid is removed, thus air is removed along with the liquid because the orifices are separate structures and air is present prior to flushing. It would have been obvious to one of ordinary skill in the art by the effective filing date to have modified the blood sample analyzer of modified Kitagawa to comprise the cleaning component as taught by Hammerschmidt, because Hammerschmidt teaches that the cleaning component cleans and strips adhering mixtures from the mixing rod (Hammerschmidt; para [41]).
Claims 62 and 64 are rejected under 35 U.S.C. 103 as being unpatentable over Kitagawa in view of Hirano, and in further view of Delubac (US 20200232894 A1; hereinafter “Delubac”; priority filed 7/25/2017; already of record).
Regarding claim 62, modified Kitagawa teaches the blood sample analyzer according to claim 61, further comprising:
when the first measurement mode is determined to be set, control the sample aspirator to aspirate a first sampling amount of the blood sample from the first sample container (Hirano; para [24]; First, the horizontal movement motor 23 is driven to move the stir rod 19 to a position above one of the sample cells 8. Next, the vertical motor 26 is driven to insert the stir rod 19 into the reaction solution 7 in the sample cell 8. Subsequently, the rotation motor 21 is driven to rotate the stir rod 19 in the reaction solution 7, thereby performing the stir operation); and
when the second measurement mode is determined to be set, control the sample aspirator to aspirate a second sampling amount of the blood sample from the second sample container (Kitagawa; para [46, 72]; a stirring motor 254 (354) for moving (turning) the hand 251 (351) in a pendulum form between an upright state and a fallen state. The stirring motor 254 (354) is configured to move (turn) the hand 251 (351) in a pendulum form between the upright state and the fallen state by the power from the stepping motor).
Modified Kitagawa does not teach wherein the first sampling amount is less than the second sampling amount; the first sampling amount is 5-50 µL or 15-35 µL.
However, Delubac teaches an analogous art of device for sample extraction (Delubac; Abstract) comprising a first sampling amount and a second sampling amount (Delubac; para [50]; the first sample and the second sample are derived from blood. The first sample and the second sample may be held within a same container (e.g., a test tube or a well). The blood may be whole blood), wherein the first sampling amount is less than the second sampling amount (Delubac; para [46]; a small volume (e.g., a volume of less than about 5 μL, about 10 μL, about 25 μL, about 50 μL, about 100 μL, about 250 μL, about 500 μL, about 1000 μL, or more than about 1000 μL) of the second sample may be ejected after terminating application of the pressure drop); the first sampling amount is 5-50 µL or 15-35 µL (Delubac; para [44]; the pipette may be dimensioned to extract a sample of volume of at least about 0.5 μL, 2 μL, 5 μL). Examiner further finds that the prior art contained a product (i.e., a first sampling amount) which differed from the claimed device by the substitution of component(s) (i.e., the first sampling amount is 5-50 µL or 15-35 µL), and the substituted components and their functions were known in the art as above set forth. An ordinarily skilled artisan at the time of invention could have substituted one known element with another (i.e., a first sampling amount), and the results of the substitution (i.e., the first sampling amount is 5-50 µL or 15-35 µL) would have been predictable. The simple substitution of one known element for another is likely to be obvious when predictable results are achieved. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, B). Therefore, pursuant to MPEP §2143 (I), Examiner concludes that it would have been obvious to an ordinarily skilled artisan at the time of invention to substitute the first sampling amount of modified Kitagawa with the first sampling amount is 5-50 µL or 15-35 µL of Delubac, since the result would have been predictable.
Regarding claim 64, modified Kitagawa teaches the blood sample analyzer according to claim 50, wherein the small-volume blood sample in the first sample container is a whole blood sample ().
Modified Kitagawa does not teach the small-volume blood sample in the first sample container has a volume of 30-250 µL; or 50-200 µL; or 50-100 µL.
However, Delubac teaches an analogous art of device for sample extraction (Delubac; Abstract) comprising a small-volume blood sample, wherein the small-volume blood sample in the first sample container has a volume of 30-250 µL; or 50-200 µL; or 50-100 µL (Delubac; para [44]; The pipette may be dimensioned to extract a sample of volume of at least about 50 μL, 100 μL, 200 μL, 500 μL). The claimed range overlaps or falls within the prior art range; in cases where the claimed range overlaps or falls within the prior art range, a prima facie case of obviousness of the range exists. It would have been obvious to one having ordinary skill in the art to have selected the volume of the small-volume blood sample in the range that corresponds to the claimed range. See MPEP 2144.05(I).
Claim 71 is rejected under 35 U.S.C. 103 as being unpatentable over Kitagawa in view of Hirano, and in further view of Furrer (US 20130082099 A1; hereinafter “Furrer”).
Regarding claim 71, modified Kitagawa teaches the blood sample analyzer according to claim 50, with the controller.
Modified Kitagawa does not teach wherein the controller is further configured to determine, according to a code information of a label of the sample rack, whether the sample containers comprise the first sample container containing the small-volume blood sample or the second sample container containing the common-volume blood sample.
However, Furrer teaches an analogous art handling sample tubes (Furrer; Abstract) comprising a plurality of containers (Furrer; Fig. 2; para [72]; the system can comprise a plurality of sample tubes 214), wherein a controller is further configured to determine, according to a code information of a label of the sample rack, whether the sample containers comprise the first sample container containing the small-volume blood sample or the second sample container containing the common-volume blood sample (Furrer; para [47]; the sample's tube label indicative of the geometric properties of the tube to allow for the calculation of the inner volume of the tube). The examiner notes that the barcode would identify the type of container as modified Kitagawa teaches different containers for the small-volume blood sample and the common-volume blood sample. It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the controller of modified Kitagawa to determine the sample container based on the barcode as taught by Furrer, because Furrer teaches the barcode indicates the geometric property to determine the amount of volume to fill (Furrer; para [47]).
Response to Arguments
Applicant’s arguments filed, 11/5/2025, have been considered and the arguments are found to be persuasive. However, those arguments are directed towards the claim amendments. The examiner notes that the previous prior art rejection is withdrawn and a new prior art rejection is applied to address the claim amendments.
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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/A.Q.L./Examiner, Art Unit 1796 /DUANE SMITH/ Supervisory Patent Examiner, Art Unit 1759