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 .
Status of the Claims
The Amendment filed 09/22/2025 has been entered. Claims 12, 14-15 have been amended. Claim 13 is cancelled. Claims 1-11 and 16-21 were previously withdrawn. Claims 1-12 and 14-21 are currently pending and claims 12, 14-15 are examined herein.
Status of the Rejection
The drawing and claim objections have been overcome by the applicant's amendments.
All 35 U.S.C. § 112(b) rejections, 35 U.S.C. § 101 rejections, and 112(f) claim interpretations from the previous office action are withdrawn in view of the Applicant’s amendments, except for the 112(b) rejections of claim 15. The 35 U.S.C. § 112(b) rejections of claim 15 are essentially maintained and modified in response to the amendments as outlined below.
New grounds of rejection under 35 U.S.C. § 112(a), and under 35 U.S.C. § 112(b) are necessitated by the amendments as outlined below.
New grounds of objections to the specification are necessitated by the amendments as outlined below.
All 35 U.S.C. § 103 rejections from the previous office action are withdrawn in view of the Applicant’s amendment.
New grounds of rejection under 35 U.S.C. § 103 are necessitated by the amendments as outlined below.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: The specification fails to provide proper antecedent basis for the term “rotary ball screw driver” as recited in independent claim 13.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 12 and 14-15 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 12 has been amended to recite “a rotary ball screw driver for controlling movement of the plunger”. However, there is no single instance of a “rotary ball screw driver” in the specification. The instant specification discloses, for example, a rotary encoder 63, a ball screw 65, a drive pulley 67, and a driven pulley 68 [see e.g., Para. 0028 of the instant specification], but a rotary ball screw driver as recited in claim 12, is not supported by the specification or the figures, as there is no mention in the disclosure of a rotary ball screw driver or one that controls the plunger. Therefore, claim 12 is new matter. Claims 14-15 are further rejected by virtue of its dependence upon and because it fails to cure the deficiencies of claim 12.
Claim 12 has been amended to recite “to reduce the delivery pressure to be within a predetermined pressure range” in the last 2 lines of the claim. However, the specification/figures do not support a predetermined pressure range, as a range needs two values, and not a single value. There is not a single instance of the term “pressure range” or a predetermined pressure range in the instant disclosure. The examiner notes the specification discloses “the delivery time is brought into a predetermined threshold range” (see Para. 0070 and 0072 of the instant specification), but not that the delivery pressure is brought to a predetermined pressure range. Furthermore, Fig. 19 discloses 4 pressure values: 2MPa [which is indicated as a low delivery pressure], and 5MPa or 5.5 MPa [which are indicated as a high delivery pressure] [see e.g., Para. 0065 of the instant specification and Fig. 19]. Therefore, the values of 2, 5 and 5.5 MPa would not be considered as part of the “predetermined pressure range” as these values are too low or too high to be used as the delivery pressure. Only the single value of 3.5 MPa is indicated as an appropriate delivery pressure [see e.g., Para. 0065, 0073 of the instant specification and Fig. 19], and as outlined above a single value does not support a pressure range. Therefore, claim 12 is new matter. Claims 14-15 are further rejected by virtue of its dependence upon and because it fails to cure the deficiencies of claim 12.
Claim 12 has been amended to recite “by adjusting a drive current provided to the driver to cause the plunger to move….”. However, the specification/figures do not support providing a drive current to the driver. The specification discloses, a Y-axis driver, a Z-axis driver and an X-axis driver [Para. 0021 of the instant specification]. It is unknown if “the driver” refers to all or some of the Y, Z, and/or X axis driver, or a different structure. Furthermore, the specification clearly discloses the drive current is applied to the plunger and not “the driver” as amended, stating “the plunger 61 by controlling drive current applied thereto” [Para. 0064 of the instant specification], “the drive current to the plunger 61” [Para. 0069 of the instant specification], “under the conditions that the drive current value to the plunger 61 is set to 0.5 A” [Para. 0072 of the instant specification], “the control section 1611 sets the drive current applied to the plunger 61” [Para. 0074 of the instant specification], and “changing a drive current to a plunger of the delivery mechanism [canceled claim 13]. Thus, the specification/figures support providing a drive current to the plunger, and does not support providing a drive current to “the driver” such as the Y, Z, and/or X axis driver. Therefore, claim 12 is new matter. Claims 14-15 are further rejected by virtue of its dependence upon and because it fails to cure the deficiencies of claim 12.
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 12 and 14-15 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 12, claim 12 recites “the driver”. However, it is unclear if “the driver” is a newly recited element or if it refers to the previously recited “rotary ball screw driver”. This is especially in light of the instant specification which describes a Y-axis driver and a Z-axis driver [Para. 0021 of the instant specification]. Applicant should clarify the relationship between the rotary ball screw driver and “the driver”, and whether or not the driver is a newly recited, different element. Therefore, claim 12 is indefinite. Claims 14-15 are further rejected by virtue of its dependence upon and because it fails to cure the deficiencies of claim 12.
Regarding claim 12, claim 12 recites “the plunger to move in response to detecting a change in the delivery pressure” and previously recited “the computer is configured to….change the delivery pressure”. It is unclear due to the confusing amended claim language if it is the plunger which “detects a change in the delivery pressure” to move in response, or if it is the computer. Applicant should amend to clearly state the structure which is detecting the change in the delivery pressure based on the delivery time and a predetermined relationship. Therefore, claim 12 is indefinite. Claims 14-15 are further rejected by virtue of its dependence upon and because it fails to cure the deficiencies of claim 12. For the purposes of examination, the claim is interpreted to be at least any of the previously mentioned options.
Regarding claim 12, claim 12 recites “a device controller configured to control an operation of the delivery mechanism using a rotary ball screw driver”. However, due to the wording of the amended claim, it is unclear if the rotary ball screw driver is part of the device controller, part of the delivery mechanism or a separate structure in itself. Applicant should clarify the relationship between the previously mentioned structures. Therefore, claim 12 is indefinite. Claims 14-15 are further rejected by virtue of its dependence upon and because it fails to cure the deficiencies of claim 12. For the purposes of examination, the claim is interpreted to be at least any of the previously mentioned options.
Regarding claim 14, claim 14 recites the limitation “device control section” in line 2. There is insufficient antecedent basis for this limitation in the claim. Furthermore, it is unclear if the device control section is the same as the device controller or a newly recited, different structure. Therefore, claim 14 is indefinite.
Regarding claim 14, claim 14 recites the limitation “the changed delivery pressure”. However, claim 12, on which claim 14 depends, has been amended to include “a predetermined pressure range”. It’s unclear if “the changed delivery pressure” refers to “the predetermined pressure range” or “the delivery pressure” of claim 12. Furthermore, it is unclear what the relationship is between these pressure terms. Therefore, claim 14 is indefinite.
Regarding claim 15, claim 15 recites the limitation “the changed delivery pressure”. However, claim 12, on which claim 15 depends, has been amended to include “a predetermined pressure range”. It’s unclear if “the changed delivery pressure” refers to “the predetermined pressure range” or “the delivery pressure” of claim 12. Applicant should amend to clearly state the relationship between these pressure terms. Therefore, claim 15 is indefinite.
Regarding claim 15, claim 15 has been amended to recite “based on the electrophoresis device and/or the phoresis medium container and the changed delivery pressure”. It is unclear what the determination of the delivery amount is based on: the electrophoresis device [referred to here as A], the phoresis medium container [referred to here as B], and the changed delivery pressure [referred to here as C]. Due to the wording of the amended claim, it is unclear if it is based on 1) A and B and C, 2) A or [B and C] and/or 3) [A or B] and C. Therefore, claim 15 is indefinite. For the purposes of examination, the claim is interpreted to be at least any of the previously mentioned options.
Regarding claim 15, claim 15 recites “the computer is further configured to correct a set value of delivery amount as a target delivery amount, and an estimated delivery amount determined in consideration of a standard deviation in the delivery amount”. The current claim language is very confusing and unclear of the metes and bounds of the claim. For example, it is unclear if the computer corrects “a set value of a delivery amount” and corrects “an estimated delivery amount” or if, for example, it sets a target delivery amount and determines an estimated delivery amount in consideration of the standard deviation. Applicant should rewrite the claim to clearly define what is being corrected, what is being set, and what is determined. Therefore, the scope of claim 15 is indefinite.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 12 and 14-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Aritome et al. (WO2019026133A1, English translation) in view of Kimura et al. (US20180059055A1), Shoji et al. (US20010017263A1), Yamazaki et al. (JP2006275962A, English translation), and Aritome et al. (WO-2018055714-A1, English translation), herein referred to as Aritome II. GoCardless et al. (How to Calculate a Regression Line, 2022, https://gocardless.com/guides/posts/how-to-calculate-a-regression-line/, Pages 1-10) used as evidence for claim 15.
Regarding claim 12, a measurement system comprising: an electrophoresis device; and Aritome teaches a measurement system including a capillary electrophoresis device [Fig. 6 and Para. 0024]), wherein
the electrophoresis device includes a phoresis medium container for storing a phoresis medium (Aritome teaches the electrophoresis device includes an phoresis medium container 102 that contains a phoresis medium [Abstract, Fig. 6, Para. 0015 and Para. 0023]),
a capillary having its inside filled with the phoresis medium (Aritome teaches a capillary array 101 with capillaries 401 that are filled with the phoresis medium inside it as the delivery mechanism 106 delivers the phoresis medium in the phoresis medium container 102 to each capillary 401 via the capillary head 403 [Abstract; Fig. 6; Para. 0031]),
a delivery mechanism including a plunger (Aritome teaches a liquid delivery mechanism 106 with a plunger 302 built into the liquid delivery mechanism 106 [Paras. 0031, 0023-0025 and Figs. 5-6])
The limitation “for delivering the phoresis medium in the phoresis medium container to the capillary with a delivery pressure” is a functional recitation. Apparatus claims cover what a device is, not what a device does [MPEP 2114(II)]. A functional recitation of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. See MPEP 2114. In the instant case, Aritome teaches the above liquid delivery mechanism 106 including a plunger 302 as shown in Figs. 5-6 that is specifically configured to perform the functional limitations above (Aritome teaches the liquid delivery mechanism 106 with a plunger 302 built into the liquid delivery mechanism 106, which delivers the phoresis medium in the phoresis medium container to the capillary array from the capillary head, where a load [corresponding to a delivery pressure] is applied by the plunger 302 of the liquid feeding mechanism and thus is capable to perform the functional limitations above of delivering the phoresis medium in the phoresis medium container to the capillary with a delivery pressure [Abstract, Paras. 0031, 0023-0025 and Figs. 5-6]), and
a device controller configured to control an operation of the delivery mechanism (Aritome teaches the control unit 600 [corresponding to a device controller] controls the operation of the liquid delivery mechanism 106 and drives the liquid delivery mechanism 106, thereby delivering the electrophoretic medium 506 sealed in the electrophoretic medium container 102 to each capillary 401 via the capillary head 403 [Para. 0031 and 0024; Fig. 6]); and
Aritome does not explicitly disclose using a rotary ball screw driver for controlling movement of the plunger.
Kimura discloses a capillary electrophoresis device [Abstract and see e.g., Fig 1-4]. Kimura teaches a liquid feeding mechanism 60, that feeds “delivers” the phoresis medium 26 in the phoretic medium container 20 to the capillaries 11 [Para. 0077]. Kimura further teaches a stepping motor 62 attached to a rotary encoder 63 [these structures corresponding to a rotary ball screw driver], which drives the plunger 61 [corresponding to controlling movement of the plunger] and are capable of performing 400 counts per one rotation, where the stepping motor 62 is driven with a weak driving current and the driving current is adjusted to set a thrust force of the plunger 61, and the contact of the plunger 61 is detected by detecting stepping-out of the stepping motor 62 at this time with the rotary encoder 63 [Para. 0059, 0092, 0097 and Fig. 4]. Kimura further teaches this configuration is beneficial because an amount of the phoretic medium 26 inside the phoretic medium container 20 is accurately checked so as to be capable of being used for managing an amount of liquid being fed or detecting liquid leaking, the amount of liquid feeding can be managed without receiving an influence due to the expansion of the phoretic medium container 20 with a reduction of running costs and improvement of workability of the user [Para. 0092, 0097, 0100].
Aritome and Kimura are considered analogous art to the claimed invention because they are in the same field of capillary electrophoresis apparatuses [Fig. 6 of Aritome and Fig. 1 of Kimura]. It would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to modify the electrophoretic device of Aritome, including a device controller and delivery mechanism with a plunger, to use a rotary encoder with an attached stepping motor [corresponding to a rotary ball screw driver] for controlling movement of/driving the plunger, as taught by Kimura, since Kimura teaches this configuration would be beneficial because an amount of the phoretic medium 26 inside the phoretic medium container 20 is accurately checked so as to be capable of being used for managing an amount of liquid being fed or detecting liquid leaking, the amount of liquid feeding can be managed without receiving an influence due to the expansion of the phoretic medium container 20 with a reduction of running costs and improvement of workability of the user [Para. 0092, 0097, 0100 of Kimura]. Furthermore, the claimed limitations are obvious because all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results, MPEP 2143[I][A].
Modified Aritome is silent to a computer.
Shoji teaches an electrophoretic instrument using a capillary filled with a gel of a medium for separating samples as an electrophoretic lane [Para. 0002]. Shoji further teaches the measurement system includes an electrophoresis device and a computer 11 which commands a control unit 12 [corresponding to a device controller] to inject gel [corresponding to execute a delivery to be operated, as the gel is delivered to the capillary array] and where the amount of gel [phoresis medium] remaining in a shortage is displayed on the screen of the computer 11, and where this configuration improves the processing ability of the analysis [Para. 0032, 0039 -0040, 0007, Fig. 1-2].
Aritome and Shoji are considered analogous art to the claimed invention because they are in the same field of capillary electrophoresis apparatuses [Fig. 6 of Aritome and Fig. 1 of Shoji]. It would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to modify the measurement system of modified Aritome to provide a computer which commands the device controller to execute a delivery of the electrophoretic medium, as taught by Shoji, since Shoji teaches this configuration would be beneficial for commanding the control unit/device controller for gel injection and for displaying on the screen of the computer a message of shortage of the remaining amount of the gel/phoretic medium, and improves the processing ability of the analysis [Para. 0032, 0039 -0040, 0007, Fig. 1-2 of Shoji]. Furthermore, the claimed limitations are obvious because all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results, MPEP 2143[I][A]. Additionally, to provide a mechanical or automatic means to replace manual activity, which accomplishes the same result, is within the ambit of a person of ordinary skill in the art. See In re Venner, 120 USPQ 192 (CCPA 1958) (see MPEP § 2144.04).
Modified Aritome does not explicitly disclose the computer is configured to measure a delivery time taken for filling the capillary with the phoresis medium, and
However, Aritome discloses step s15 which is the solution delivery of the phoresis medium to the capillary [corresponding to filling the capillary with the phoresis medium] which has a time associated with it, and Modified Aritome teaches the computer commands the device controller to execute a delivery of the electrophoretic medium [see rejection above and Para. 0032, 0039 -0040, 0007, Fig. 1-2 of Shoji], and the device controller controls the liquid delivery mechanism and the filling of the capillary with the phoresis medium [see rejection above; Fig. 8; Para. 0031, 0024, and 0039 of Aritome].
Yamazaki teaches an automatic apparatus for the measurement and analysis of samples such as in components contained in body fluids/biological samples [Abstract and Para. 0002]. Yamazaki discloses a processing unit 70 including detection unit 71 and calculation unit 72 which measures the reagent aspirating time information of the reagent from downward movement drive pulse information and measures the reagent suction time [Para. 0050-0054]. Thus, Yamazaki teaches a processing unit which measures a filling/dispensing time [reagent aspirating time or reagent suction time] which is beneficial for analyzing test samples efficiently and because the timing to replenish reagents can be easily determined [Para. 0012].
Modified Aritome and Yamazaki are considered analogous art to the claimed invention because they are in the same field of apparatuses for the measurement and analysis of samples such as biological samples [Para. 0002 of Yamazaki and Para. 0003 of Aritome]. It would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to modify the computer of modified Aritome, which controls the filling and delivery of the phoresis medium to the capillaries and has a specific time associated with this step, to measure this time of dispensing/delivery, as taught by Yamazaki, since Yamazaki teaches this configuration would be beneficial for analyzing test samples efficiently and because the timing to replenish reagents can be easily determined [Para. 0012 of Yamazaki]. Furthermore, the use of a known technique (i.e., measuring a time of dispensing or delivery by a processor, taught by Yamazaki) to improve similar devices in the same way is likely to be obvious. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143 [I][C]).
Modified Aritome is silent to and to change the delivery pressure by adjusting a drive current provided to the driver to cause the plunger to move in response to detecting a change in the delivery pressure based on the delivery time, and a predetermined relationship between the delivery time and the delivery pressure, to reduce the delivery pressure to be within a predetermined pressure range.
However, Modified Aritome teaches the computer commands the device controller which controls the liquid delivery mechanism including the plunger [see rejections above and Para. 0024 of Aritome; Para. 0032, 0039 -0040, 0007, Fig. 1-2 of Shoji].
Aritome II discloses a capillary electrophoresis apparatus and a liquid delivery mechanism suitable for the electrophoretic apparatus that fills capillaries or capillary arrays with gel or a fluid polymer solution that is an electrophoresis medium serving as a separation medium, and a pump mechanism suitable for such an electrophoresis apparatus. [Para. 0002]. Aritome II teaches a control unit for the liquid delivery [claims 10 and 11] where the delivery pressure is changed by adjusting a drive current that provides the pressure required for liquid transfer, the drive current provided to the stepping motor 613 [corresponding to a driver] for driving the plunger 601/causing the plunger to move in response to detecting a change in the delivery pressure based on the delivery time and the predetermined relationship between the delivery time and the delivery pressure as seen in Fig. 10. Aritome II further teaches changing the delivery pressure by setting a pressure required for liquid transfer to 3 MPA [corresponding to reducing the delivery pressure to be within a predetermined pressure range by setting the pressure to 3 MPA], where this change in delivery pressure is detected, and as outlined above, the change in delivery pressure is based on the delivery time, and the predetermined relationship between the delivery pressure and the delivery time from the start of the injection [Paras. 0034-0039, 0029 and Fig. 10].
Aritome and Aritome II are considered analogous art to the claimed invention because they are in the same field of capillary electrophoresis apparatuses [Fig. 6 of Aritome and Para. 0002 of Aritome II]. It would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to modify the computer of Modified Aritome to change the delivery pressure by adjusting a drive current provided to the driver to cause the plunger to move in response to detecting a change in the delivery pressure based on the delivery time and a predetermined relationship between the delivery time and the delivery pressure, to reduce the delivery pressure to be with a predetermined pressure range of 3 MPA, as taught by Aritome II, since Aritome II teaches this configuration would be beneficial because it reduces variations in the amount of liquid delivered [Para. 0010 of Aritome II]. Furthermore, the use of a known technique to improve similar devices in the same way is likely to be obvious. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143 [I][C]). Additionally, to provide a mechanical or automatic means to replace manual activity, which accomplishes the same result, is within the ambit of a person of ordinary skill in the art. See In re Venner, 120 USPQ 192 (CCPA 1958) (see MPEP § 2144.04).
Regarding claim 14, the measurement system according to claim 12, wherein the computer is further configured to command the device control section to execute a delivery to be operated a predetermined deliverable number of times at the changed delivery pressure (Modified Aritome teaches the computer which commands the device controller/control unit to execute a delivery to be operated of the electrophoretic medium a predetermined deliverable number of times [at least once] and Aritome teaches the control unit controls the liquid delivery mechanism to execute delivery to be operated to fill the capillaries with the phoresis medium in step s15 of Aritome [corresponding to be operated a predetermined deliverable number of times as delivery occurs at least once and is a predetermined step] [see rejection of claim 12 above; Para. 0024 and 0031 of Aritome; Para. 0032, 0039 -0040, 0007, Fig. 1-2 of Shoji] and as outlined in the rejection of claim 12 above, and the delivery occurs at the changed delivery pressure [see rejection of claim 12 above].
Regarding claim 15, the measurement system according to claim 12, Modified Aritome is silent to wherein the computer is further configured to correct a set value of a delivery amount as a target delivery amount, and an estimated delivery amount determined in consideration of a standard deviation in the delivery amount
However Modified Aritome teaches a computer which controls the target delivery amount [the amount of phoresis medium used to fill the capillaries] delivered by the liquid delivery mechanism and the delivery amount is based on the electrophoresis device [the delivery amount is based on filling the capillaries which is part of the electrophoresis device, and thus based on it] [see rejection of claim 12 above and Aritome: Para. 0031 and Fig. 6].
Yamazaki teaches the reagent information processing unit 70 which includes the reagent amount detection unit 71 which corrects the reagent amount obtained by the reagent replenishment amount [corresponding to corrects a set value of delivery amount/reagent amount for delivery/reagent control which leads to a target delivery amount for the remaining deliveries/replenishments] by using a regression equation by the least squares methods [which is in consideration of a standard deviation in the delivery amount, as evidenced by GoCardless which states that in order to calculate a regression line/equation by least squares regression then the standard deviation of the x and y values must be calculated (Pages 1-4 of GoCardless), and thus considered] determined by a relationship between the reagent aspiration time/delivery time and the reagent amount over N times and then calculates a time until the reagent shortage occurs from this regression equation [the reagent shortage corresponding to an estimated delivery amount in future deliveries/aspirations of the reagent determined in consideration of a standard deviation in the delivery amount] [Paras. 0050-0054, 0062-0073].
It would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to modify the computer of Modified Aritome, which includes controlling a target delivery amount and the delivery amount based on the electrophoresis device, to correct a set value of delivery amount leading to a target delivery amount and an estimated delivery amount determined in consideration of a standard deviation in the delivery amount, as taught by Yamazaki, since Yamazaki teaches this configuration would be beneficial for analyzing test samples efficiently and because the timing to replenish reagents can be easily determined [Para. 0012 of Yamazaki]. Furthermore, the use of a known technique to improve similar devices in the same way is likely to be obvious. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143 [I][C]). Additionally, to provide a mechanical or automatic means to replace manual activity, which accomplishes the same result, is within the ambit of a person of ordinary skill in the art. See In re Venner, 120 USPQ 192 (CCPA 1958) (see MPEP § 2144.04).
and/or the phoresis medium container and the changed delivery pressure (This limitation is optional and therefore, does not necessarily limit the claim. Thus, Modified Aritome meets all the required limitations of this claim).
Response to Arguments
Applicant's arguments, see Remarks Pgs. 41-50, filed 09/22/2025, with respect to the 35 U.S.C. § 103 rejections have been fully considered and all 103 rejections from the previous office action are withdrawn.
Applicant’s Argument #1:
Applicant argues on page 47-48 that while Kimura describes that "[a] pressure required for feeding liquid at this time is set to 3 MPa, and in order to generate the pressure, the driving current of the stepping motor 62 is adjusted so that a thrust force of the plunger 61 is set to 75 N" as noted above, there is no apparent teaching or suggesting Kimura of Applicant's particular system in which a "computer is configured to measure a delivery time taken for filling the capillary with the phoresis medium, and to change the delivery pressure by adjusting a drive current provided to the driver to cause the plunger to move in response to detecting a change in the delivery pressure based on the delivery time and a predetermined relationship between the delivery time and the delivery pressure, to reduce the delivery pressure to be within a predetermined pressure range," as now recited in Applicant's Claim 12.
Examiner’s Response #1:
Applicant’s arguments have been fully considered, but are moot in view of the new grounds of rejection. Furthermore, applicant’s arguments are unpersuasive. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Applicant’s Argument #2:
Applicant argues on page 48 that the Office Action acknowledges at page 18 that the combination of Aritome, Miyata, and Yamazaki (understood as "Modified Aritome" in the Office Action) "is silent to changes a delivery pressure by detecting a change in the delivery pressure based on the filling time, and a relationship between the filling time and the delivery pressure" (Office Action, page 18), it follows that Aritome, Miyata, and Yamazaki (understood as "Modified Aritome") also do not teach or suggest the above discussed feature.
Examiner’s Response #2:
Applicant’s arguments have been fully considered, but are moot in view of the new grounds of rejection. Furthermore, applicant’s arguments are unpersuasive. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Applicant’s Argument #3:
Applicant argues on page 48-49 that even assuming arguendo that one skilled in the art would have for some reason consulted Kimura' s disclosure, one skilled in the art would not have learned how to modify Aritome, Miyata, and Yamazaki ("Modified Ari tome") based on Kimura's description of "[a] pressure required for feeding liquid at this time is set to 3 MPa," and certainly not without any reasonable expectation of success, absent resort to impermissible hindsight inspection of the teachings provided only by Applicant. Therefore, Applicant respectfully submits that Aritome, Miyata, Yamazaki, and Kimura, whether taken alone or in combination, do not teach or suggest the above-discussed features recited in Applicant's Claim 12.
Examiner’s Response #3:
Applicant’s arguments have been fully considered, but are moot in view of the new grounds of rejection.
Furthermore, the applicant has argued there would not be a reasonable expectation of success without any citations to, evidence from, or explanations of the prior art of record. As such, these statements are conclusory and Applicant’s remarks have been considered in accordance with MPEP 716.01[C] [“The arguments of counsel cannot take the place of evidence in the record. In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965). The examiner notes obviousness does not require absolute predictability, but at least some degree of predictability is required. Evidence showing there was no reasonable expectation of success may support a conclusion of nonobviousness. Additionally, conclusive proof of efficacy is not required to show a reasonable expectation of success [see MPEP 2143.02].
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Applicant’s Argument #4:
Applicant argues on page 49 that dependent Claims 14-15 are also believed to be patentable due at least to their dependence from Claim 12, as well as for the additional features recited in the dependent claims.
Examiner’s Response #4:
Based on the above responses #1-#3, applicant’s arguments regarding the amended claim 12 are moot in view of the new grounds of rejection. In response to applicant’s arguments regarding the additional features recited in the dependent claims, Applicant's arguments fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references.
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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/S.Y.O./Examiner, Art Unit 1794
/JAMES LIN/Supervisory Patent Examiner, Art Unit 1794