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 .
Claim Status
Claims 1-2, 7-11 and 16 are pending and under examination.
Claims 3-6 and 12-15 have been canceled.
Response to Amendment
The drawing amendments, received 02/07/2026, have overcome the previous drawing and specification objections. Accordingly, the drawing and specification objections are withdrawn.
New claim objections have been set forth.
The 112(f) claim interpretation(s) have been maintained.
Applicant’s amendments to the claims, received 02/07/2026, have overcome most of the 112(b) rejection(s) previously set forth in the Non-Final Office Action mailed on 12/29/2025. Further, based on the claim amendments, new 112(b) rejections have been set forth.
The 101 rejection(s) have been modified to address the claim amendments.
Based on applicant’s arguments and remarks made in an amendment, filed 02/27/2026, the prior art rejection over Hirano has been modified to address the amended claims (see below).
Claim Objections
Claim 11 is objected to for the following informalities:
Claim 11 recites “wherein the nozzle is configured to aspirate and discharge, as the fluid, at least one of a sample, a reagent, and a cleaning liquid for the nozzle” which the examiner believes is grammatical/clerical mistake and should recite “from the nozzle”.
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 rotation mechanism” in claim 1.
A review of applicant’s printed publication states: “FIG. 3A is a diagram illustrating alignment of the nozzle 203 in a radial direction and is a diagram illustrating a state before the alignment. The automatic analyzer 100 includes the rotation mechanism 400 that rotates the nozzle 203 in the circumferential direction in the horizontal plane, and the rotation mechanism 400 includes the rotation shaft 201, a motor (not illustrated) that rotates the rotation shaft 201 in the circumferential direction, the arm 202, a detection mechanism 305, and the like. The rotation mechanism 400 is connected to the arithmetic control device 800 (FIG. 1) by an electric signal line (not illustrated).”, see paragraph [0036]. Accordingly, the examiner is interpreting claim limitation “rotation mechanism” as a rotation shaft, a motor that rotates the shaft, an arm, and a detection mechanism that communicates with a control device.
“a height positioning mechanism” in claim 1.
A review of applicant’s printed publication states: “FIG. 5 is a view showing a state in which the nozzle 203 is brought into contact with the upper end surface 304 of the position adjustment tool 303. The automatic analyzer 100 (FIG. 1) includes a height positioning mechanism 500 that performs, by driving the nozzle 203, positioning of the position adjustment tool 303 accommodated in the accommodation portion 120 in the height direction. In the illustrated example, the height positioning mechanism 500 includes the rotation shaft 201, the arm 202, a lowering mechanism (not shown) that lowers the nozzle 203, and the detection mechanism 305. The height positioning mechanism 500 is connected to the arithmetic control device 800 (FIG. 1) by an electric signal line (not shown).” Accordingly, the examiner is interpreting claim limitation “heigh positioning mechanism” as a rotation shaft, an arm, a lowering mechanism, and a detection mechanism that communicates with a control device.
“a circumferential positioning mechanism” in claim 1.
A review of applicant’s printed publication states: “The automatic analyzer 100 (FIG. 1) includes a circumferential positioning mechanism 600 that performs positioning, in a circumferential direction, of the accommodation portion 120 accommodating the position adjustment tool 303 by bringing the nozzle 203 into contact with the position adjustment tool 303 from a side thereof after the height position of the position adjustment tool 303 is determined. The circumferential positioning mechanism 600 includes the rotation shaft 201 (FIG. 5), the arm 202 (FIG. 5), a lowering mechanism (not shown), and the detection mechanism 305 (FIG. 5). The circumferential positioning mechanism 600 is connected to the arithmetic control device 800 (FIG. 1) by an electric signal line (not shown)” Accordingly, the examiner is interpreting claim limitation “circumferential positioning mechanism” as a rotation shaft, an arm, a lowering mechanism, and a detection mechanism that communicates with a control device.
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.
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 7 and 16 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 pre-AIA the applicant regards as the invention.
Claim 7 recites “the arithmetic control device positions the accommodation portion in the circumferential direction”. However, claim 1 lines 9-12 previously recite “a circumferential positioning mechanism configured to position the accommodation portion … in a circumferential direction”. It is unclear if the accommodation portion is positioned by the circumferential positioning mechanism, as required in claim 1, or if the accommodation portion is positioned by the arithmetic control device, as required in claim 7.
Claim 16 lines 28-29 recite “the circumferential positioning mechanism”. There is insufficient antecedent basis for this term in the claims and it is unclear what applicant is referring to by this phrase.
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 1-2, 7-11, and 16 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 is directed toward an apparatus. Claim 16 is directed toward a method.
Step 2A, Prong One: Identify the law of nature/natural phenomenon/abstract ideas.
Claim 1 recites the abstract ideas “determine the position in a height direction”, “determine the position in a circumferential direction”, “calculates an adjustment values”, “calculate each of the adjustment values”, “determine a validity of a radial position of the nozzle”. Claim 16 recites the abstract ideas “determining the position in a height direction”, “determining the position in a circumferential direction”, calculating adjustment values” which are mental processes and/or mathematical concept and could be performed by a human person or by pen and paper or by a generic computer. The arithmetic control device configured to calculate/determine is merely a general-purpose computer for which to apply the abstract ideas, but does not preclude the steps from being considered an abstract idea. See MPEP 2106.04(a)(2) subsections (I) and (III).
Step 2A, Prong Two: Has the abstract idea been integrated into a particular practical application?
No. Upon calculating determining the validity of a radial position of the nozzle, no further action is performed, and therefore is not a particular practical application.
The calculation/determination(s) are performed by an arithmetic control device, which is just a general-purpose computer. However, performing the abstract idea on a general purpose computer is not enough to integrate the exception into a practical application (MPEP 2106.05(b)(I)).
Claims 1 and 16 also recites a rotation mechanism configured to rotate a nozzle that aspirates fluid in a container in an accommodation portion, a height positioning mechanism configured to position a position adjustment tool by driving the nozzle, a circumferential positioning mechanism that brings the nozzle into a contact position with a position adjustment tool, and an arithmetic control device to control the rotation mechanism, the height positioning mechanism, and the circumferential positioning mechanism. However, this is just using the device to gather data and generally linking a technological environment to be used in the abstract idea of calculating an adjustment value and determining a validity of the nozzle position. Moreover, data gather to be used in the abstract idea does not integrate the judicial exception into a practical application because data gathering is insignificant extra-solution activity, and not a particular practical application. See MPEP § 2106.05(g), Insignificant Extra-Solution Activity and § 2106.05(f), Mere Instructions To Apply an Exception.
Step 2B: Does the claim recite any elements which are significantly more than the abstract idea?
Claims 1 & 16 recite the additional elements of a rotation mechanism configured to rotate a nozzle that aspirates fluid in a container in an accommodation portion, a height positioning mechanism configured to position a position adjustment tool by driving the nozzle, a circumferential positioning mechanism that brings the nozzle into a contact position with a position adjustment tool, and an arithmetic control device to control the rotation mechanism, the height positioning mechanism, and the circumferential positioning mechanism. These additional elements do not amount to significantly more as they are well-understood, routine, and conventional (WURC) in the art as evidenced by Hirano et al. (US 2014/0093426 – hereinafter “Hirano”) and Matsui et al. (US 2013/0316336 – hereinafter “Matsui”). See MPEP § 2106.05(d), Well-Understood, Routine, Conventional Activity.
Hirano teaches a rotation mechanism configured to rotate a nozzle that aspirates fluid in a container in an accommodation portion (Hirano disclose pipetting devices 106/107 comprising a rotation shaft 121, a lowering mechanism, an arm 122/123, and a detection mechanism 128 that communicates with a control device 111; figs. 1-2, [0053-0054, 0057, 0066]), a height positioning mechanism configured to position a position adjustment tool by driving the nozzle (Hirano disclose pipetting devices 106/107 comprising a rotation shaft 121, a lowering mechanism, an arm 122/123, and a detection mechanism 128 that communicates with a control device 111; figs. 1-2, [0053-0054, 0057, 0066]), a circumferential positioning mechanism that brings the nozzle into a contact position with a position adjustment tool (Hirano disclose pipetting devices 106/107 comprising a rotation shaft 121, a lowering mechanism, an arm 122/123, and a detection mechanism 128 that communicates with a control device 111; figs. 1-2, [0053-0054, 0057, 0066]), and an arithmetic control device to control the rotation mechanism, the height positioning mechanism, and the circumferential positioning mechanism (Hirano; fig. 1, #111, [0050, 0060]).
Matsui teach a rotation mechanism configured to rotate a nozzle that aspirates fluid in a container in an accommodation portion (Matsui teach pipetting device 20 comprising a rotating shaft 23, a lowering mechanism, and a detection mechanism 53 that communicates with a control device 50 figs. 1-2, [0049, 0052, 0124]), a height positioning mechanism configured to position a position adjustment tool by driving the nozzle (Matsui teach pipetting device 20 comprising a rotating shaft 23, a lowering mechanism, and a detection mechanism 53 that communicates with a control device 50 figs. 1-2, [0049, 0052, 0124]. Nozzle 20 is brought into contact with adjustment tool 18; figs. 1 & 14, [0124-0125]), a circumferential positioning mechanism that brings the nozzle into a contact position with a position adjustment tool (Matsui teach pipetting device 20 comprising a rotating shaft 23, a lowering mechanism, and a detection mechanism 53 that communicates with a control device 50 figs. 1-2, [0049, 0052, 0124]. Nozzle 20 is brought into contact with adjustment tool 18; figs. 1 & 14, [0124-0125]), and an arithmetic control device to control the rotation mechanism, the height positioning mechanism, and the circumferential positioning mechanism (Matsui; fig. 2, #50, [0050]).
Claim 2 recites the abstract idea(s) “determines the height position of the position adjustment tool by detecting a contact position”, but does not integrate the exception under 2A prong 2 because this is just using the device to gather data and generally linking a technological environment to be used in the abstract idea of calculating an adjustment value and determining a validity of the nozzle position. Moreover, data gather to be used in the abstract idea does not integrate the judicial exception into a practical application because data gathering is insignificant extra-solution activity, and not a particular practical application. See MPEP § 2106.05(g), Insignificant Extra-Solution Activity and § 2106.05(f), Mere Instructions To Apply an Exception.
Claim 7 further limits the nozzle shape but does not integrate the exception under 2A prong 2 because these additional elements do not effectively transform or reduce the system to a different state or thing beyond such that the claims recite significantly more than well-understood, routine, and conventional activities previously known to the industry (See MPEP § 2106.05(c), Particular Transformation and MPEP § 2106.05(d), Well-Understood, Routine, Conventional Activity) as evidenced by Okuyama et al. (US 2015/0114140 – hereinafter “Okuyama”). Okuyama teach a nozzle which an outer diameter changes in the height direction; fig. 3, “C”. Further, Hirano disclose positioning the accommodation portion based on a contact position with the tool in the height direction [0059].
Claim 9 recites “an adjustment mechanism configured to adjust at least one of a radial position of the nozzle and an angle of the nozzle with respect to a rotation shaft around which the nozzle rotates”, but does not integrate the exception under 2A prong 2 because these additional elements do not effectively transform or reduce the system to a different state or thing beyond such that the claims recite significantly more than well-understood, routine, and conventional activities previously known to the industry (See MPEP § 2106.05(c), Particular Transformation and MPEP § 2106.05(d), Well-Understood, Routine, Conventional Activity) as evidenced by Hirano fig. 5, [0060-0079].
Claim 10 further limits the accommodation portion as being provided in at least one of an incubator or a holder, but does not integrate the exception under 2A prong 2 because these additional elements do not effectively transform or reduce the system to a different state or thing beyond such that the claims recite significantly more than well-understood, routine, and conventional activities previously known to the industry (See MPEP § 2106.05(c), Particular Transformation and MPEP § 2106.05(d), Well-Understood, Routine, Conventional Activity) as evidenced by Hirano; figs. 1 & 3A, 11A, #103, #104, [0050, 0052, 0106-0114].
Claim 11 further limits the rotation mechanism as including a detection mechanism, the fluid as one of a sample, reagent or cleaning fluid, the nozzle material as resin, and a arithmetic control device setting for detection sensitivity, but does not integrate the exception under 2A prong 2 because these additional elements do not effectively transform or reduce the system to a different state or thing beyond such that the claims recite significantly more than well-understood, routine, and conventional activities previously known to the industry (See MPEP § 2106.05(c), Particular Transformation and MPEP § 2106.05(d), Well-Understood, Routine, Conventional Activity) as evidenced by Hirano, Ueda et al. (US 2005/0042138 – hereinafter “Ueda”), and Haddad et al. (US 2013/0345894 – hereinafter “Haddad”). Hirano disclose a detection mechanism and the fluid as one of a sample, reagent or cleaning liquid (Hirano; figs. 1-2, #128, [0050-0054]). Ueda disclose a nozzle made of a resin material (Ueda; figs. 2 & 5, #41, [0102]), and Haddad disclose detection of a predetermined threshold indicates contact with an article/calibration target; [0033].
Claim Rejections - 35 USC § 102
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 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) 1-2, 9-10, and 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hirano et al. (US 2014/0093426; already of record – hereinafter “Hirano”).
Regarding claim 1, Hirano disclose an automatic analyzer (Hirano; fig. 1, [0050]) comprising:
a rotation mechanism configured to rotate (Hirano discloses pipetting devices 106/107 comprising a rotation shaft 121, a motor that rotates the shaft, an arm 122/123, and a detection mechanism 128 that communicates with a control device 111; figs. 1-2, [0053-0054, 0057, 0066, 0077]), in a circumferential direction in a horizontal plane (Hirano; fig. 5A, [0053, 0061-0062]), a nozzle configured to perform at least one of aspiration of a fluid in a container accommodated in an accommodation portion disposed on a rotation trajectory of the nozzle and discharge of the fluid to the container (Hirano discloses nozzle 124 for aspiration and/or discharge of a fluid in a container accommodated in an accommodation portion 104; figs. 1 & 3A, [0050]);
a height positioning mechanism (Hirano discloses pipetting devices 106/107 comprising a rotation shaft 121, a lowering mechanism, an arm 122/123, and a detection mechanism 128 that communicates with a control device 111; figs. 1-2, [0053-0054, 0057, 0066]) configured to position a position adjustment tool accommodated in the accommodation portion in a height direction by driving the nozzle (Hirano discloses a position adjustment tool 129 accommodated in the accommodation portion 104; fig. 3A, [0055], and driving the nozzle in a height direction with respect to the position adjustment tool 129 so that contact between the nozzle 124 and the position adjustment tool 129 can be determined by the control unit 111 during rotation of the rotation mechanism; figs. 3-5, [0055, 0059-0079]);
a circumferential positioning mechanism (Hirano discloses pipetting devices 106/107 comprising a rotation shaft 121, a lowering mechanism, an arm 122/123, and a detection mechanism 128 that communicates with a control device 111; figs. 1-2, [0053-0054, 0057, 0066]) configured to position the accommodation portion accommodating the position adjustment tool in a circumferential direction by bringing the nozzle into contact with the position adjustment tool from a side thereof after a height position of the position adjustment tool is determined (Hirano discloses a position adjustment tool 129 accommodated in the accommodation portion 104; fig. 3A, [0055], and driving the nozzle in a height direction with respect to the position adjustment tool 129 so that contact between the nozzle 124 and the position adjustment tool 129 can be determined by the control unit 111 during rotation of the rotation mechanism; figs. 3-5, [0055, 0059-0079]); and
an arithmetic control device configured to control the rotation mechanism, the height positioning mechanism, and the circumferential positioning mechanism (Hirano; fig. 1, #111, [0050, 0060]) to:
determine the position in a height direction of a position adjustment tool accommodated in the accommodation portion by driving the nozzle (Hirano disclose the nozzle is driven down to a height at which the nozzle 124 can contact the inner surface of the cylindrical structure 130 of the adjustment tool 129; [0063]. Accordingly, Hirano determines the position in a height direction of the position adjustment tool),
determine the position in a circumferential direction of the accommodation portion accommodating the position adjustment tool, by bringing the nozzle into contact with the position adjustment tool from a side thereof after a height position of the position adjustment tool is determined (Hirano disclose determining points A, B, C in the circumferential direction after the nozzle is driven down to a height at which the nozzle 124 can contact the inner surface of the cylindrical structure 130 of the adjustment tool; fig. 5, [0063-0067]),
calculate adjustment values that indicate a difference between a design value of a predetermined distance between a predetermined position away from the position adjustment tool and a position where the nozzle is present when the nozzle comes into contact with the position adjustment tool and an actual measurement value related to the predetermined distance when the nozzle is moved by the circumferential positioning mechanism (Hirano discloses calculating an adjustment amount between reference point P(xp, yp) and target point P(xQ, yQ) using a contact points A, B, C detected between the nozzle 124 and the position adjustment tool 129 by movement of the nozzle by the circumferential position mechanism; figs. 5B-E, θ2A, θ2B, θ2C, θ1C; [0060-0079]),
wherein the circumferential positioning mechanism is configured to bring the nozzle closer to the position adjustment tool from one direction of the circumferential direction and to bring the nozzle closer to the position adjustment tool from another direction of the circumferential direction (Hirano; figs. 5C & 5D, “Point A”, “Point B”, “Point C”, [0065-0069]),
wherein the arithmetic control device is further configured to:
calculate each of the adjustment values when the nozzle is closer to the position adjustment tool in each of the directions (Hirano discloses calculating an adjustment amount between reference point P(xp, yp) and target point P(xQ, yQ) using a contact points A, B, C detected between the nozzle 124 and the position adjustment tool 129 by movement of the nozzle by the circumferential position mechanism; figs. 5B-E, θ2A, θ2B, θ2C, θ1C; [0060-0079]), and
determine a validity of a radial position of the nozzle, based on a position of the nozzle after the nozzle is moved by a distance obtained by adding or subtracting the adjustment value to or from the design value from each of the one direction and the another direction or by determining whether the adjustment value is in a predetermined range (Hirano determines a validity of an adjustment amount between reference point P(xp, yp) and target point P(xQ, yQ) using a contact points A, B, C detected between the nozzle 124 and the position adjustment tool 129 by movement of the nozzle by the circumferential position mechanism; figs. 5B-E, θ2A, θ2B, θ2C, θ1C; [0060-0079]. Formulas 1-7 determine the validity of the radial position of the nozzle after the nozzle is moved by distances A, B, C by adding or subtracting the adjustment value to or from the design value from each of the one directions and the other direction; [0069-0079]. Hirano further disclose determining the validated based on whether the adjustment value is in a predetermined range; [0059, 0077-0078]).
Regarding claim 2, Hirano disclose the automatic analyzer according to claim 1 above,
wherein the height positioning mechanism determines the height position of the position adjustment tool by detecting a contact position between an upper end surface of the position adjustment tool and the nozzle, the contact position being detected by lowering the nozzle (Hirano; fig. 3A, [0059]), and
wherein the circumferential positioning mechanism brings the nozzle closer to the position adjustment tool from the side of the position adjustment tool in a state in which a lower end of the nozzle is disposed below the upper end surface of the position adjustment tool (Hirano; figs. 4-5, [0060-0079]).
Regarding claim 9, Hirano disclose the automatic analyzer according to claim 1 above, further comprising:
an adjustment mechanism configured to adjust at least one of a radial position of the nozzle and an angle of the nozzle with respect to a rotation shaft around which the nozzle rotates (Hirano discloses the angle of arm 122 can be adjusted so that an angle of rotation of the nozzle 124 that rotates on arm 123 is changed; fig. 5, [0060-0079]).
Regarding claim 10, Hirano disclose the automatic analyzer according to claim 1,
wherein the accommodation portion is provided in at least one of:
an incubator in which reaction containers as the container accommodating a sample and a reagent as the fluid are continuously disposed in the circumferential direction (Hirano; figs. 1 & 3A, #104, [0050, 0052]), and
a holder configured to hold the container accommodating, as the fluid, at least one of the sample, the reagent, and a cleaning liquid for the nozzle (Hirano; fig. 11A, #103, [0106-0114]).
Regarding claim 16, Hirano disclose a position adjustment method (Hirano; figs. 1 & 4, [0050, 0060]) comprising:
rotating, by a rotation mechanism, in a circumferential direction in a horizontal plane, a nozzle configured to perform at least one of aspiration of a fluid in a container accommodated in an accommodation portion disposed on a rotation trajectory of the nozzle and discharge of the fluid to the container (Hirano discloses pipetting devices 106/107 comprising a rotation shaft 121, a motor that rotates the shaft, an arm 122/123, and a detection mechanism 128 that communicates with a control device 111; figs. 1-2, [0053-0054, 0057, 0061-0062, 0066, 0077]. Nozzle 124 aspirates and/or discharges a fluid in a container accommodated in an accommodation portion 104; figs. 1 & 3A, [0050]);
positioning a position adjustment tool accommodated in the accommodation portion in a height direction by driving the nozzle (Hirano discloses a position adjustment tool 129 accommodated in the accommodation portion 104; fig. 3A, [0055], and driving the nozzle in a height direction with respect to the position adjustment tool 129 so that contact between the nozzle 124 and the position adjustment tool 129 can be determined by the control unit 111 during rotation of the rotation mechanism; figs. 3-5, [0055, 0059-0079]);
positioning the accommodation portion accommodating the position adjustment tool in a circumferential direction by bringing the nozzle into contact with the position adjustment tool from a side thereof after a height position of the position adjustment tool is determined (Hirano discloses a position adjustment tool 129 accommodated in the accommodation portion 104; fig. 3A, [0055], and driving the nozzle in a height direction with respect to the position adjustment tool 129 so that contact between the nozzle 124 and the position adjustment tool 129 can be determined by the control unit 111 during rotation of the rotation mechanism; figs. 3-5, [0055, 0059-0079]);
determining the position in a height direction of a position adjustment tool accommodated in the accommodation portion by driving the nozzle (Hirano disclose the nozzle is driven down to a height at which the nozzle 124 can contact the inner surface of the cylindrical structure 130 of the adjustment tool 129; [0063]. Accordingly, Hirano determines the position in a height direction of the position adjustment tool);
determining the position in a circumferential direction of the accommodation portion accommodating the position adjustment tool, by bringing the nozzle into contact with the position adjustment tool from a side thereof after a height position of the position adjustment tool is determined (Hirano disclose determining points A, B, C in the circumferential direction after the nozzle is driven down to a height at which the nozzle 124 can contact the inner surface of the cylindrical structure 130 of the adjustment tool; fig. 5, [0063-0067]);
calculating adjustment values that indicate a difference between a design value of a predetermined distance between a predetermined position away from the position adjustment tool and a position where the nozzle is present when the nozzle comes into contact with the position adjustment tool and an actual measurement value related to the predetermined distance when the nozzle is moved by the circumferential positioning mechanism (Hirano discloses calculating an adjustment amount between reference point P(xp, yp) and target point P(xQ, yQ) using a contact points A, B, C detected between the nozzle 124 and the position adjustment tool 129 by movement of the nozzle by the circumferential position mechanism; figs. 5B-E, θ2A, θ2B, θ2C, θ1C; [0060-0079]);
bringing the nozzle closer to the position adjustment tool from one direction of the circumferential direction and to bring the nozzle closer to the position adjustment tool from another direction of the circumferential direction (Hirano; figs. 5C & 5D, “Point A”, “Point B”, “Point C”, [0065-0069]);
calculating each of the adjustment values when the nozzle is closer to the position adjustment tool in each of the directions (Hirano discloses calculating an adjustment amount between reference point P(xp, yp) and target point P(xQ, yQ) using a contact points A, B, C detected between the nozzle 124 and the position adjustment tool 129 by movement of the nozzle by the circumferential position mechanism; figs. 5B-E, θ2A, θ2B, θ2C, θ1C; [0060-0079]); and
determining a validity of a radial position of the nozzle, based on a position of the nozzle after the nozzle is moved by a distance obtained by adding or subtracting the adjustment value to or from the design value from each of the one direction and the another direction or by determining whether the adjustment value is in a predetermined range (Hirano determines a validity of an adjustment amount between reference point P(xp, yp) and target point P(xQ, yQ) using a contact points A, B, C detected between the nozzle 124 and the position adjustment tool 129 by movement of the nozzle by the circumferential position mechanism; figs. 5B-E, θ2A, θ2B, θ2C, θ1C; [0060-0079]. Formulas 1-7 determine the validity of the radial position of the nozzle after the nozzle is moved by distances A, B, C by adding or subtracting the adjustment value to or from the design value from each of the one directions and the other direction; [0069-0079]. Hirano further disclose determining the validated based on whether the adjustment value is in a predetermined range; [0059, 0077-0078]).
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Hirano in view of Okuyama et al. (US 2015/0114140; already of record – hereinafter “Okuyama”).
Regarding claim 7, Hirano disclose the automatic analyzer according to claim 1 above,
wherein the arithmetic control device positions the accommodation portion in the circumferential direction based on a contact position of the nozzle with the position adjustment tool in the height direction (Hirano; [0059]).
Hirano does not teach the nozzle has a shape of which an outer diameter changes in the height direction.
However, Okuyama teaches the analogous art of a nozzle configured to perform at least one of aspiration of a fluid in a container (Okuyama; fig. 3, “C”, [0048]) wherein the nozzle has a shape of which an outer diameter changes in the height direction (Okuyama; fig. 3, “C”).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the nozzle of Hirano with the nozzle comprising a pipette tip that has a shape of which an outer diameter changes in the height direction, as taught by Okuyama, because Okuyama teach the pipette tip of the nozzle configured with a shape of which an outer diameter changes in the height direction allows a nozzle part 31b to attach to the pipette tip, and further reduces contamination among samples between processes (Okuyama; [0045]). One of ordinary skill in the art would have expected this modification could have been performed with a reasonable expectation of success since Hirano and Okuyama both teach a nozzle and positioning system configured to process fluid samples.
Regarding claim 8, modified Hirano teach the automatic analyzer according to claim 7 above,
wherein the nozzle includes a tip having a shape narrowing downward (The modification of the nozzle of Hirano with the nozzle comprising a pipette tip that has a shape of which an outer diameter changes in the height direction, as taught by Okuyama, has previously been discussed in claim 7 above. Okuyama teaches the nozzle includes a tip “C” having a shape narrowing downward).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Hirano, in view of Ueda et al. (US 2005/0042138; already of record – hereinafter “Ueda”) and Haddad et al. (US 2013/0345894; already of record – hereinafter “Haddad”).
Regarding claim 11, Hirano disclose the automatic analyzer according to claim 1 above,
wherein the rotation mechanism includes a detection mechanism configured to detect contact with the nozzle based on a change in capacitance (Hirano; fig. 2, #128, [0054]),
wherein the nozzle is configured to aspirate and discharge, as the fluid, at least one of a sample, a reagent, and a cleaning liquid for the nozzle (Hirano; figs. 1-2, [0050-0053]).
Hirano does not explicitly teach at least a lower end portion of the nozzle is made of a resin.
However, Ueda teaches the analogous art of an automatic analyzer (Ueda; fig. 1, #100, [0096]) comprising a nozzle (Ueda; fig. 2, #10, [0099]) with at least a lower end portion of the nozzle made of a resin (Ueda; fig. 2, #41, [0102]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the lower end portion of the nozzle of Hirano with the lower end portion made of resin, as taught by Ueda, because Ueda teach the lower end portion made of a resin contains carbon making the lower end portion a conductive resin material (Ueda; [0102]). One of ordinary skill in the art would have expected this modification could have been performed with a reasonable expectation of success since Hirano and Ueda both teach dispensing nozzle configured to aspirate/discharge fluid into a container.
Modified Hirano does not teach the arithmetic control device sets a detection sensitivity of the detection mechanism to the position adjustment tool to be higher than a detection sensitivity at the time of aspiration of the fluid.
However, Haddad teaches the analogous art of a nozzle (Haddad; fig. 1, #104, [0027]), an arithmetic control device (Haddad; fig. 1, #108, [0032]), a position adjustment tool (Haddad; fig. 1, #102A, “calibration target/calibration tool”; [0006, 0024]) and a detection mechanism (Haddad; fig. 1, #118, [0033]), wherein the arithmetic control device sets a detection sensitivity of the detection mechanism to the position adjustment to be higher than a detection sensitivity at the time of aspiration of the fluid (Haddad disclose detection of a predetermined threshold indicates contact with an article/calibration target; [0033]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the arithmetic control device and detection mechanism of modified Hirano to comprise a detection sensitivity threshold of the detection mechanism to be higher than a detection sensitivity at the time of aspiration of the fluid, as taught by Haddad, because Haddad teach the predetermined threshold signal indicating contact allows the detection mechanism to function as both a height sensing detector for liquids and calibration detector using the calibration tool. One of ordinary skill in the art would have expected this modification could have been performed with a reasonable expectation of success since modified Hirano and Haddad both teach capacitive detection for liquids and conductive calibration tools.
Response to Arguments
Applicant’s arguments, filed 02/27/2026, have been considered.
Applicant argues, see page 11 of their remarks, that the amendments to the claims overcome the 112(b) rejection(s). The examiner notes that the amendments have overcome most of the 112(b) rejections. However, the previous rejection over claim 7 has been maintained.
Applicant argues, see page 11 of their remarks, towards the 101 rejection(s) over previously presented claims 3-6, that the claims have been canceled thereby rending the rejection moot. The examiner agrees that the 101 rejection over previously presented claims 3-6 has been rendered moot. However, the abstract idea(s) from previously presented claims 3-6 have incorporated into independent claims 1. Accordingly, the 101 rejection(s) have been modified and applied to independent claim 1 to address the claim amendments. The examiner suggests applicant evaluate the instant specification for an alleged improvement, and to incorporate the alleged improvement into the claims.
Applicant argues, see pages 11-15 of their remarks, towards the 102 rejection over Hirano, that Hirano does not teach the limitations (i) “determining the position in a height direction of a position adjustment tool accommodated in the accommodation portion by driving the nozzle” or (ii) “determine a validity of a radial position of the nozzle, based on a position of the nozzle after the nozzle is moved by a distance obtained by adding or subtracting the adjustment value to or from the design value for each of the one direction and the another direction or by determining whether the adjustment value is in a predetermined range”. The examiner respectfully disagrees.
Regarding (i), Hirano disclose the nozzle is driven down to a height at which the nozzle 124 can contact the inner surface of the cylindrical structure 130 of the adjustment tool 129; [0063]. Accordingly, Hirano determines the position in a height direction of the position adjustment tool.
Regarding (ii), Hirano determines a validity of an adjustment amount between reference point P(xp, yp) and target point P(xQ, yQ) using a contact points A, B, C detected between the nozzle 124 and the position adjustment tool 129 by movement of the nozzle by the circumferential position mechanism; figs. 5B-E, θ2A, θ2B, θ2C, θ1C; [0060-0079]. Formulas 1-7 determine the validity of the radial position of the nozzle after the nozzle is moved by distances A, B, C by adding or subtracting the adjustment value to or from the design value from each of the one directions and the other direction; [0069-0079]. Hirano further disclose determining the validated based on whether the adjustment value is in a predetermined range; [0059, 0077-0078]).
Citations to art
In the above citations to documents in the art, an effort has been made to specifically cite representative passages, however rejections are in reference to the entirety of each document relied upon. Other passages, not specifically cited, may apply as well.
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 extension fee 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 date of this final action.
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/C.A.T./Examiner, Art Unit 1798
/BENJAMIN R WHATLEY/Primary Examiner, Art Unit 1798
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