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 .
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.
Priority
US National Stage of PCT
Acknowledgment is made that this application is the US national phase of international application PCT/JP2022/004255 filed 02/03/2022 which designated the U.S. and claims the benefit of JP2021-073538, filed 04/23/2021.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 10/11/2023 & 05/21/2025 is/are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement(s) is/are being considered by the Examiner.
Drawings
The drawings (fig(s). 1-3, 5-6, 12-15, 18-20) are objected to because unlabeled non-descriptive representations are impermissible under 37 CFR 1.83(a) which states (bold for emphasis):
(a) The drawing in a nonprovisional application must show every feature of the invention specified in the claims. However, conventional features disclosed in the description and claims, where their detailed illustration is not essential for a proper understanding of the invention, should be illustrated in the drawing in the form of a graphical drawing symbol or a labeled representation (e.g., a labeled rectangular box). In addition, tables that are included in the specification and sequences that are included in sequence listings should not be duplicated in the drawings.
The drawings are correspondingly objected to for failing to comply with PCT Rule 11 as catchwords are indispensable to the understanding of the unlabeled non-descriptive representations, wherein PCT Rule 11.11 Words in Drawings states (bold for emphasis):
(a) The drawings shall not contain text matter, except a single word or words, when absolutely indispensable, such as "water," "steam," "open," "closed," "section on AB," and, in the case of electric circuits and block schematic or flow sheet diagrams, a few short catchwords indispensable for understanding.
(b) Any words used shall be so placed that, if translated, they may be pasted over without interfering with any lines of the drawings.
Non-descriptive representation(s) 109-111,118 (e.g., Examiner will accept a “V” for valve in the circle, a legend, or another symbol identifiable by an ordinary artisan as a valve), 201-203 (Examiner suggests a symbol identifiable by an ordinary artisan as light), 119 (MS), 101 (controller), 1021 (input), & 102 (display) of figs. 1 & 12, 700, 701, 702, 703, 200, 314, 308 of fig. 3, 309, 310, 312, 313, 314, 701, & 101 of figs. 2, 5-6, 13-15, 18-20 need (an) appropriate legend(s) in the form of descriptive text label(s) (and/or conventionally identifiable symbols) in addition to any reference character(s) already present. Empty or not labeled rectangular boxes and non-descriptive representations of features are not descriptive, and therefore incomplete. The Examiner emphasizes that the requested text matter is indispensable for proper understanding. The descriptive text labels should contain as few words as possible. See also 37 CFR 1.84(n) (conventional symbols), 1.84(o) (required descriptive legends), & 1.84(p) (standards for the text labels), MPEP 608.02(b)(II)(¶ 6.22) (“descriptive text label”), and MPEP Appendix T Rule 11.11. The Appropriate Correction is required.
Fig. 7 is objected to for S8 verb tense inconsistency, the Examiner suggesting “send”.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed. This may result in slightly longer titles, but the loss in brevity of title will be more than offset by the gain in its informative value in indexing, classifying, searching, etc. If a satisfactory title is not supplied by the applicant, the Examiner may, at the time of allowance, change the title by an Examiner’s amendment. See MPEP § 1302.04(a).
The following title is suggested: “ANALYZER AND CONTROL METHOD FOR LOCKING ANALYZER COLUMNS”.
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.
Claim(s) 28 is/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 independent claim 28,
there is insufficient antecedent basis for the limitation "the control device" in the claim. Additionally, the limitation “wherein the control device releases the restriction by the lock mechanism by using detection of an end of an analysis in the separation column as a trigger” is generally narrative and appears to be a literal translation into English from a foreign document; the limitation as written fails to conform to current U.S. practice. In particular, the Examiner respectfully notes that independent claim 28 is a method claim, whereas the narrative wherein statement references structure and at best pertains to an unclaimed releasing step. The Examiner suggests providing proper antecedent basis for the control device and rephrasing the narrative wherein statement instead—or at least in part—as a proper method step.
Claim Rejections - 35 USC § 103
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.
Claim(s) 16-18 and 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Applicant cited Hasegawa et al (US 20200025727 A1; hereafter “Hasegawa”) in view of newly cited Brann (US 20130206653 A1; hereafter “Brann”) and in further view of newly cited Staats III et al (US 5193703 A; hereafter “Staats”) with newly cited Ando et al (US 20230349868 A1; hereafter “Ando”).
Regarding independent claim 16,
Hasegawa teaches an analyzer (not fully shown in a single figure; see fig. 25, analysis system 24; see fig. 23 showing an exemplary configuration of a separation column connecting device 1; additional obviousness analysis provided) (Title “SEPARATION COLUMN CONNECTION DEVICE, CONNECTION METHOD, AND ANALYSIS SYSTEM”; Abstract; [0013] “analysis”; [0166] “the separation column connecting device is basically configured almost the same way as that shown in FIGS. 2A to 2D”; [0172] “the separation column connecting device and the analysis system are basically configured almost the same way as those shown in FIGS. 2A to 2D and FIG. 3”), comprising:
a plurality of separation columns (fig. 25, separation columns 2a & 2b) ([0173] “While the figure illustrates the analysis system including two separation columns, the number of separation columns is not limited to two but may be three or more”) that are connected in parallel and are removable ([0156] “enables the attachment and removal of the separation column”);
a plurality of analysis flow passages (flow passages comprising pipes 5 and 6) that are respectively connected to the plurality of separation columns (fig. 25, separation columns 2a & 2b) and configured to allow a sample to flow through each of the plurality of separation columns (fig. 25, separation columns 2a & 2b) ([0065] “After establishment of the state of FIG. 2C, sample analysis is performed by passing a solution from the upstream pipe 5 through the separation column 2 in a direction of an arrow 32”; [0010] “a sample to the separation column via the upstream pipe”);
a drive mechanism (fig. 23, driver 16) that is configured to control removal of the separation columns (fig. 25, separation columns 2a & 2b) other than the separation column (fig. 25, separation column 2) to be removed ([0173] “In the case of the embodiment shown in FIG. 25, the connecting device includes: a pair of separation columns 2a, 2b; associated two pairs of first fittings 3a, 3b and second fittings 4a, 4b; and a pair of drivers 15a, 15b. The driver 15a and the driver 15b can operate independently”); and
a control device (control device comprising unshown control unit and controller 46) ([0110] “and the like of the motor 42 are controlled by a controller 46”; [0138] “external control unit (not shown)”) that is configured to control a drive mechanism (fig. 23, driver 16), wherein the control device (control device comprising unshown control unit and controller 46) controls the drive mechanism (figs. 2A-2C, locking portions 18 & 19) by using detection of an end of an analysis in the separation column (fig. 25, separation column 2) as a trigger (automated trigger) ([0071] “The driver 15 may be manually operated or automated”; [0111] “automatic connection and disconnection of the separation column”; [0153] “automating a transporting operation for disposal of a used separation column or for setting a new separation column”; [0007] “To prevent the invasion of air into the separation column, the replacement of the separation column must be performed as follows. When the separation column is disconnected, a secondary side (downstream) pipe is first disconnected from the separation column. When the separation column is connected, a primary side (upstream) pipe is first connected to the separation column”; [0013] “prevent the air invasion and provide highly reproducible analysis”; [0064] “In a case where the replacement of the separation column 2 or the like is necessary, the separation column 2 is released according to the order of the citation FIG. 2C.fwdarw.FIG. 2B FIG. 2A (releasing process)”; [0167] “liquid sensor 80”; [0166] “first position sensor 81 for detecting the connection between the seal portion 7 and the seal portion 9, and a second position sensor 84 for detecting the connection between the seal portion 8 with the seal portion 10”; [0168] “second liquid sensor 83”; [0169] “For the detection of the solution or the position, not only the contact type sensors shown in FIG. 23 but also an optical sensor and the like are usable”).
While the primary reference does not expressly show all of the above claimed features clearly in a single
depicted embodiment as a single figure, either one of ordinary skill in the art would at once envisaged the
combination from primary reference’s generic teachings and specific possible choices of the structural components
thereof, or, in the alternative, it at least would have been obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to nevertheless so combine the above features for the purpose and combinations as proposed by the primary reference and as analyzed by the Examiner including the citations and Examiner comments provided above in the reference to the claimed features. The Examiner notes in particular that it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine Hasegawa’s analysis system (see fig. 25) with Hasegawa’s separation column connecting device (see fig. 23) thereby providing the advantages of each, including controlled connection with sensor feedback as well as individual operation & desired separation between different columns.
Additionally, the Examiner notes that: choosing from a finite number of identified,
predictable solutions, with a reasonable expectation of success is obvious to try, see MPEP § 2143(I)(E). In the present case, Hasegawa teaches a finite number of alternative solutions from which to choose and optimizing the device for the desired modularity, driving means, and sensing abilities are within ordinary skill in the
art. With respect to the automation (inclusive of sensing abilities for feedback/control), the Examiner further notes it has been held that broadly providing a mechanical or automatic means to replace manual activity which has accomplished the same result involves only routine skill in the art, see MPEP § 2144.04(III) and In re Venner, 262 F.2d 91, 95, 120 USPQ 193, 194 (CCPA 1958). In the present case, Hasegawa explicitly teaches optional automation of the disconnection and it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine Hasegawa’s automation of disconnection with Hasegawa’s aforementioned embodiments with the expected benefits of saving on manual costs/labor and/or reducing human error such as improperly timed disconnection (e.g., during analysis process).
Hasegawa does not teach the combination of items: 1a) the claimed locking mechanism (Examiner notes that there is a different mechanism nomenclaturally similar, however, within context the Examiner notes the affect as distinguished); and 1b) wherein the control device releases the restriction by the lock mechanism by using detection of an end of an analysis in the separation column as a trigger.
Regarding item 1a), Brann teaches an analyzer (see fig. 2; see fig. 3A for columns in cartridge; see fig. 4A showing lock mechanism for slidable coupling) (Title “Modular Multiple-Column Chromatography Cartridge”; Abstract; [0052] “FIG. 4A is an illustration of a first exemplary connector apparatus 100 for coupling a tubing to an end of a chromatographic column in accordance with the present teachings. In some embodiments, the apparatus 100 may be employed as one or more of the connectors 48 (FIGS. 2, 3). Such apparatus may be employed to facilitate quick connection and disconnection of the cartridge 40 from the system 30 shown in FIG. 2.”), comprising: a plurality of separation columns (figs. 2-3A, columns 42 & 44 of cartridge 40; see fig. 4A, column 103) that are connected in parallel and are removable; a plurality of analysis flow passages (fig. 3A, fluid tubing lines 6) that are respectively connected to the plurality of separation columns (fig. 3A, columns 42 & 44) and configured to allow a sample to flow through each of the plurality of separation columns (fig. 3A, columns 42 & 44); and a lock mechanism (fig. 4A, locking mechanism of latching mechanism 124) that is configured to restrict removal of the separation columns (fig. 3A, columns 42 & 44) other than the separation column (fig. 3A, column 42 or 44) to be removed ([0055] “Optionally, the slidable coupling may be provided with a locking mechanism to prevent movement when a desired position is achieved”; [0059] “user may place the apparatus 100 in operation (with the tubing 6 and the ferrule 122a already in place within the apparatus and the deformable sealing member or ferrule 122b already in place on the tubing) by operating a clamping and latching mechanism 124 (comprising both a pushing mechanism and a locking mechanism) which pushes the three body members (and, consequently, also the support member 116, the tubing 6 and the hardware within the body members) in the direction of the fixed column 103 and its end fitting 104”; [0044] “passive identification feature (an indicator or identifier), e.g., a barcode 54 or an RFID module, etc. that may be employed to identify the cartridge and its associated chromatography methods to external apparatus/software”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine Brann’s locking mechanism for a slidable chromatography column coupling with Hasegawa’s slideable chromatography coupling, thereby providing the advantage of preventing movement of the slideable coupling when a desired position is achieved, the Examiner further emphasizing that a locking mechanism for the coupled column provides the expected benefits of preventing human error of movement (including improperly timed removal) of said coupled column.
Hasegawa as modified by Brann still does not explicitly teach item 1b).
Regarding item 1b):
In an analogous art and solving a similar problem, Staats teaches a system (fig. 8 instrument 25) for subsequent analysis (Title “Methods And Apparatus For Forming An Integral High Pressure Seal Using Mechanical Actuation”; Abstract “for subsequent chemical analysis”), comprising: a cylinder (fig. 2, vessel 50) that is connected and removable; a plurality of flow passages (fig. 8, tubes 210) that are respectively connected to the cylinder (fig. 2, vessel 50) and configured to allow a sample to flow through the cylinder (fig. 2, vessel 50); a lock mechanism (fig. 8, mechanical means 254) that is configured to restrict removal of the cylinder (fig. 2, vessel 50) other than the cylinder (fig. 2, vessel 50) to be removed; and a control device (not shown; at once so envisaged from control over access through sensing; see additional reference brought in for explicit obviousness analysis) that is configured to control the lock mechanism (fig. 8, means 254), wherein the control device (not shown; at once so envisaged) releases the restriction by the lock mechanism (fig. 8, means 254) by using detection of an end of an analysis operation in the cylinder (fig. 2, vessel 50) as a trigger (col. 8, ll. 10-25 “The actuator 220 is contained within a housing 250 which interacts with the actuator and its movement to isolate the mechanism from interference through the access door 252 by sensing that the door has been closed and providing mechanical means 254 for preventing the door from opening at any time other than when a safe position has been achieved”; col. 7 line 55 through col. 8 line 9 “Sensors provided at the closed and open positions of the actuator to verify position/movement and which can be used in concert with the motor encoder for diagnostics and control are also included”; col. 9, ll. 31-42 “appropriate conditions of temperature and pressure”; col. 10 line 57 through col. 11 line 31 “pressure transducer”; col. 11 line 65 through col. 12 line 21” diagnostic information is provided by monitoring downstream flow or pressure”). The Examiner emphasizes that this reference teaches controlled safety locking mechanisms pertaining to temperature, pressure, & actuator positioning for connection of flow passages, but acknowledges that the control device is neither shown nor explicitly referenced.
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Ando teaches an analyzer (fig. 6, liquid chromatograph 100; see details of column accommodation in fig. 1; see details of control in fig. 3) (Title “COLUMN ACCOMMODATION DEVICE AND LIQUID CHROMATOGRAPH”; Abstract), comprising: a separation column (figs. 1 & 6 column 6) that is connectable and removable; a plurality of analysis flow passages (fig. 1, pipes 44) that are respectively connected to the separation column (figs. 1 & 6 column 6) and configured to allow a sample to flow through the separation column (figs. 1 & 6 column 6) ([0031] “connecting and releasing an inlet pipe and an outlet pipe (only one pipe 44 is shown in the figure) to and from each of the two openings 42 of the chip column 6”); a lock mechanism (fig. 3, lock mechanism 48) that is configured to restrict removal of the separation column (figs. 1 & 6 column 6); and a control device (fig. 3, controller 46; fig. 6, control device 56) that is configured to control the lock mechanism (fig. 3, lock mechanism 48), wherein the control device (fig. 3, controller 46; fig. 6, control device 56) releases the restriction by the lock mechanism (fig. 3, lock mechanism 48) by using detection of an end of an operation in the separation column (figs. 1 & 6 column 6) as a trigger ([0009] “prevent the liquid feeding pump from being operated in a state where the outlet of the pipe from the liquid feeding pump is opened in the column accommodation device”; [0010] “replacement work of the separation column becomes simple. As a result, the influence of the skill level of the worker is reduced, and the reproducibility of the analysis result of liquid chromatography is improved”; [0045] “the controller 46 may be configured to lock the door 12 by the lock mechanism 48”; [0068] “a lock mechanism for fixing the door in a closed state to prevent manual opening” and “controller can be configured to control operation of the lock mechanism so as to prevent the door from being manually opened by the lock mechanism during operation”; [0018] “column 6 using a heater 8 and a temperature sensor 10”; [0050] “a pressure sensor for detecting a liquid feeding pressure, and a pressure signal from the pressure sensor is input to the column oven 1 via the control device 56. In the column oven 1, the pressure in the inlet pipe 44 connected to the inlet side of the chip column 6 is monitored based on the pressure signal input via the control device 56, and the pressure value and a threshold value are compared to determine whether or not the pipe 44 can be released from the chip column 6 during the discharge operation of the chip column 6”; [0021] “The opening and closing cover 16 is configured to maintain the insertion port 14 in a closed state except when the chip column 6 is introduced into the column accommodation space 4 and when the chip column 6 is discharged from the column accommodation space 4.”). The Examiner emphasizes that Ando explicitly teaches a controller controlling the lock mechanism which maintains closure except for during column removal, and is complementary for teaching corresponding pressure/temperature sensors as directly applicable to column chromatography.
In view of the above, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further combine Staats safety control features for a locking mechanism with Hasegawa’s slideable chromatography column couplings having Bran’s locking mechanism for a slidable chromatography column coupling (see previous modification analysis) for the expected benefit of explicitly providing safety by controlling when to release restriction by a lock mechanism by detecting safe pressures, temperatures, etc. Either one of ordinary skill in the art at the time the invention was effectively filed would at once envisaged that the combination suggests a controller for the aforementioned safety control of a locking mechanism, or nevertheless, or in the alternative, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further combine Ando’s controller for controlling a lock mechanism with the aforementioned control modification thereby providing the expected advantages of a controller including commercial availability, flexibility, and/or ease of implementation/modification of the control (especially as compared to non-controller hardware/mechanical configurations).
Regarding independent claim 28, as best understood,
Hasegawa teaches a control method for an analyzer, the analyzer (not fully shown in a single figure; see fig. 25, analysis system 24; see fig. 23 showing an exemplary configuration of a separation column connecting device 1; additional obviousness analysis provided) (Title “SEPARATION COLUMN CONNECTION DEVICE, CONNECTION METHOD, AND ANALYSIS SYSTEM”; Abstract; [0013] “analysis”; [0166] “the separation column connecting device is basically configured almost the same way as that shown in FIGS. 2A to 2D”; [0172] “the separation column connecting device and the analysis system are basically configured almost the same way as those shown in FIGS. 2A to 2D and FIG. 3”), comprising: a plurality of separation columns (fig. 25, separation columns 2a & 2b) ([0173] “While the figure illustrates the analysis system including two separation columns, the number of separation columns is not limited to two but may be three or more”) that are connected in parallel and are removable ([0156] “enables the attachment and removal of the separation column”); a plurality of analysis flow passages (flow passages comprising pipes 5 and 6) that are respectively connected to the plurality of separation columns (fig. 25, separation columns 2a & 2b) and configured to allow a sample to flow through each of the plurality of separation columns (fig. 25, separation columns 2a & 2b) ([0065] “After establishment of the state of FIG. 2C, sample analysis is performed by passing a solution from the upstream pipe 5 through the separation column 2 in a direction of an arrow 32”; [0010] “a sample to the separation column via the upstream pipe”); a drive mechanism (fig. 23, driver 16) that is configured to control removal of the separation columns (fig. 25, separation columns 2a & 2b) other than the separation column (fig. 25, separation column 2) to be removed ([0173] “In the case of the embodiment shown in FIG. 25, the connecting device includes: a pair of separation columns 2a, 2b; associated two pairs of first fittings 3a, 3b and second fittings 4a, 4b; and a pair of drivers 15a, 15b. The driver 15a and the driver 15b can operate independently”); and a control device (control device comprising unshown control unit and controller 46) ([0110] “and the like of the motor 42 are controlled by a controller 46”; [0138] “external control unit (not shown)”) that is configured to control a drive mechanism (fig. 23, driver 16),
wherein the control device (control device comprising unshown control unit and controller 46) controls the drive mechanism (figs. 2A-2C, locking portions 18 & 19) by using detection of an end of an analysis in the separation column (fig. 25, separation column 2) as a trigger (automated trigger) ([0071] “The driver 15 may be manually operated or automated”; [0111] “automatic connection and disconnection of the separation column”; [0153] “automating a transporting operation for disposal of a used separation column or for setting a new separation column”; [0007] “To prevent the invasion of air into the separation column, the replacement of the separation column must be performed as follows. When the separation column is disconnected, a secondary side (downstream) pipe is first disconnected from the separation column. When the separation column is connected, a primary side (upstream) pipe is first connected to the separation column”; [0013] “prevent the air invasion and provide highly reproducible analysis”; [0064] “In a case where the replacement of the separation column 2 or the like is necessary, the separation column 2 is released according to the order of the citation FIG. 2C.fwdarw.FIG. 2B FIG. 2A (releasing process)”; [0167] “liquid sensor 80”; [0166] “first position sensor 81 for detecting the connection between the seal portion 7 and the seal portion 9, and a second position sensor 84 for detecting the connection between the seal portion 8 with the seal portion 10”; [0168] “second liquid sensor 83”; [0169] “For the detection of the solution or the position, not only the contact type sensors shown in FIG. 23 but also an optical sensor and the like are usable”), and a corresponding control method comprising a step of removing a separation column (denoting a separation column 2 that is being removed) while other than the separation column (fig. 25, separation column 2) to be removed among the plurality of the separation columns (fig. 25, separation columns 2a & 2b) that are connected in parallel and are removable remain (Examiner emphasizes fig. 25 and [0173] “The driver 15a and the driver 15b can operate independently”; see also preceding citations).
While the primary reference does not expressly show all of the above claimed features clearly in a single
depicted embodiment as a single figure, either one of ordinary skill in the art would at once envisaged the
combination from primary reference’s generic teachings and specific possible choices of the structural components
thereof, or, in the alternative, it at least would have been obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to nevertheless so combine the above features for the purpose and combinations as proposed by the primary reference and as analyzed by the Examiner including the citations and Examiner comments provided above in the reference to the claimed features. The Examiner notes in particular that it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine Hasegawa’s analysis system (see fig. 25) with Hasegawa’s separation column connecting device (see fig. 23) thereby providing the advantages of each, including controlled connection with sensor feedback as well as individual operation & desired separation between different columns.
Additionally, the Examiner notes that: choosing from a finite number of identified,
predictable solutions, with a reasonable expectation of success is obvious to try, see MPEP § 2143(I)(E). In the present case, Hasegawa teaches a finite number of alternative solutions from which to choose and optimizing the device for the desired modularity, driving means, and sensing abilities are within ordinary skill in the
art. With respect to the automation (inclusive of sensing abilities for feedback/control), the Examiner further notes it has been held that broadly providing a mechanical or automatic means to replace manual activity which has accomplished the same result involves only routine skill in the art, see MPEP § 2144.04(III) and In re Venner, 262 F.2d 91, 95, 120 USPQ 193, 194 (CCPA 1958). In the present case, Hasegawa explicitly teaches optional automation of the disconnection and it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine Hasegawa’s automation of disconnection with Hasegawa’s aforementioned embodiments with the expected benefits of saving on manual costs/labor and/or reducing human error such as improperly timed disconnection (e.g., during analysis process).
Hasegawa does not teach the combination of items: 1a) the claimed locking mechanism (Examiner notes that there is a different mechanism nomenclaturally similar, however, within context the Examiner notes the affect as distinguished); 1b) wherein the control device releases the restriction by the lock mechanism by using detection of an end of an analysis in the separation column as a trigger. Hasegawa does not teach item 2), the associated method of a lock step of restricting, by the lock mechanism, removal of separation columns other than the separation column to be removed among the plurality of separation columns that are connected in parallel and are removable.
Regarding item 1a) and item 2), Brann teaches an analyzer (see fig. 2; see fig. 3A for columns in cartridge; see fig. 4A showing lock mechanism for slidable coupling) (Title “Modular Multiple-Column Chromatography Cartridge”; Abstract; [0052] “FIG. 4A is an illustration of a first exemplary connector apparatus 100 for coupling a tubing to an end of a chromatographic column in accordance with the present teachings. In some embodiments, the apparatus 100 may be employed as one or more of the connectors 48 (FIGS. 2, 3). Such apparatus may be employed to facilitate quick connection and disconnection of the cartridge 40 from the system 30 shown in FIG. 2.”) and an associated control method for the analyzer, the analyzer comprising: a plurality of separation columns (figs. 2-3A, columns 42 & 44 of cartridge 40; see fig. 4A, column 103) that are connected in parallel and are removable; a plurality of analysis flow passages (fig. 3A, fluid tubing lines 6) that are respectively connected to the plurality of separation columns (fig. 3A, columns 42 & 44) and configured to allow a sample to flow through each of the plurality of separation columns (fig. 3A, columns 42 & 44); and a lock mechanism (fig. 4A, locking mechanism of latching mechanism 124) that is configured to restrict removal of the separation columns (fig. 3A, columns 42 & 44) other than the separation column (fig. 3A, column 42 or 44) to be removed, wherein the control method comprises a lock step of restricting, by the lock mechanism (fig. 4A, locking mechanism of latching mechanism 124) (Examiner emphasizes that locking mechanism is a separate component for each of columns 42 and 44) (see also [0043], Examiner notes that columns are not necessarily affixed to the housing, and further notes that the columns therein may be matched for specific purposes), removal of separation columns (fig. 3A, columns 42 and/or 44) other than a separation column (denoting to be removed column 42 or 44) to be removed among a plurality of separation columns (fig. 3A, columns 42 & 44) that are connected in parallel and are removable ([0055] “Optionally, the slidable coupling may be provided with a locking mechanism to prevent movement when a desired position is achieved”; [0059] “user may place the apparatus 100 in operation (with the tubing 6 and the ferrule 122a already in place within the apparatus and the deformable sealing member or ferrule 122b already in place on the tubing) by operating a clamping and latching mechanism 124 (comprising both a pushing mechanism and a locking mechanism) which pushes the three body members (and, consequently, also the support member 116, the tubing 6 and the hardware within the body members) in the direction of the fixed column 103 and its end fitting 104”; [0044] “passive identification feature (an indicator or identifier), e.g., a barcode 54 or an RFID module, etc. that may be employed to identify the cartridge and its associated chromatography methods to external apparatus/software”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine Brann’s locking mechanism for a slidable chromatography column coupling with Hasegawa’s slideable chromatography coupling, thereby providing the advantage of preventing movement of the slideable coupling when a desired position is achieved, the Examiner further emphasizing that a locking mechanism for the coupled column provides the expected benefits of preventing human error of movement (including improperly timed removal) of said coupled column.
Hasegawa as modified by Brann still does not explicitly teach item 1b).
Regarding item 1b):
In an analogous art and solving a similar problem, Staats teaches a system (fig. 8 instrument 25) for subsequent analysis (Title “Methods And Apparatus For Forming An Integral High Pressure Seal Using Mechanical Actuation”; Abstract “for subsequent chemical analysis”), comprising: a cylinder (fig. 2, vessel 50) that is connected and removable; a plurality of flow passages (fig. 8, tubes 210) that are respectively connected to the cylinder (fig. 2, vessel 50) and configured to allow a sample to flow through the cylinder (fig. 2, vessel 50); a lock mechanism (fig. 8, mechanical means 254) that is configured to restrict removal of the cylinder (fig. 2, vessel 50) other than the cylinder (fig. 2, vessel 50) to be removed; and a control device (not shown; at once so envisaged from control over access through sensing; see additional reference brought in for explicit obviousness analysis) that is configured to control the lock mechanism (fig. 8, means 254), wherein the control device (not shown; at once so envisaged) releases the restriction by the lock mechanism (fig. 8, means 254) by using detection of an end of an analysis operation in the cylinder (fig. 2, vessel 50) as a trigger (col. 8, ll. 10-25 “The actuator 220 is contained within a housing 250 which interacts with the actuator and its movement to isolate the mechanism from interference through the access door 252 by sensing that the door has been closed and providing mechanical means 254 for preventing the door from opening at any time other than when a safe position has been achieved”; col. 7 line 55 through col. 8 line 9 “Sensors provided at the closed and open positions of the actuator to verify position/movement and which can be used in concert with the motor encoder for diagnostics and control are also included”; col. 9, ll. 31-42 “appropriate conditions of temperature and pressure”; col. 10 line 57 through col. 11 line 31 “pressure transducer”; col. 11 line 65 through col. 12 line 21” diagnostic information is provided by monitoring downstream flow or pressure”), and an associated control method of a lock step of restricting, by the lock mechanism (fig. 8, mechanical means 254), removal of the removable cylinder (fig. 2, vessel 50) not to be removed. The Examiner emphasizes that this reference teaches controlled safety locking mechanisms pertaining to temperature, pressure, & actuator positioning for connection of flow passages, but acknowledges that the control device is neither shown nor explicitly referenced.
Ando teaches an analyzer (fig. 6, liquid chromatograph 100; see details of column accommodation in fig. 1; see details of control in fig. 3) (Title “COLUMN ACCOMMODATION DEVICE AND LIQUID CHROMATOGRAPH”; Abstract), comprising: a separation column (figs. 1 & 6 column 6) that is connectable and removable; a plurality of analysis flow passages (fig. 1, pipes 44) that are respectively connected to the separation column (figs. 1 & 6 column 6) and configured to allow a sample to flow through the separation column (figs. 1 & 6 column 6) ([0031] “connecting and releasing an inlet pipe and an outlet pipe (only one pipe 44 is shown in the figure) to and from each of the two openings 42 of the chip column 6”); a lock mechanism (fig. 3, lock mechanism 48) that is configured to restrict removal of the separation column (figs. 1 & 6 column 6); and a control device (fig. 3, controller 46; fig. 6, control device 56) that is configured to control the lock mechanism (fig. 3, lock mechanism 48), wherein the control device (fig. 3, controller 46; fig. 6, control device 56) releases the restriction by the lock mechanism (fig. 3, lock mechanism 48) by using detection of an end of an operation in the separation column (figs. 1 & 6 column 6) as a trigger ([0009] “prevent the liquid feeding pump from being operated in a state where the outlet of the pipe from the liquid feeding pump is opened in the column accommodation device”; [0010] “replacement work of the separation column becomes simple. As a result, the influence of the skill level of the worker is reduced, and the reproducibility of the analysis result of liquid chromatography is improved”; [0045] “the controller 46 may be configured to lock the door 12 by the lock mechanism 48”; [0068] “a lock mechanism for fixing the door in a closed state to prevent manual opening” and “controller can be configured to control operation of the lock mechanism so as to prevent the door from being manually opened by the lock mechanism during operation”; [0018] “column 6 using a heater 8 and a temperature sensor 10”; [0050] “a pressure sensor for detecting a liquid feeding pressure, and a pressure signal from the pressure sensor is input to the column oven 1 via the control device 56. In the column oven 1, the pressure in the inlet pipe 44 connected to the inlet side of the chip column 6 is monitored based on the pressure signal input via the control device 56, and the pressure value and a threshold value are compared to determine whether or not the pipe 44 can be released from the chip column 6 during the discharge operation of the chip column 6”; [0021] “The opening and closing cover 16 is configured to maintain the insertion port 14 in a closed state except when the chip column 6 is introduced into the column accommodation space 4 and when the chip column 6 is discharged from the column accommodation space 4”), and an associated control method for the analyzer (fig. 6, liquid chromatograph 100) of a lock step of restricting, by the lock mechanism (fig. 3, lock mechanism 48), removal of the removable separation column (figs. 1 & 6 column 6) not to be removed. The Examiner emphasizes that Ando explicitly teaches a controller controlling the lock mechanism which maintains closure except for during column removal, and is complementary for teaching corresponding pressure/temperature sensors as directly applicable to column chromatography.
In view of the above, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further combine Staats safety control features for a locking mechanism with Hasegawa’s slideable chromatography column couplings having Bran’s locking mechanism for a slidable chromatography column coupling (see previous modification analysis) for the expected benefit of explicitly providing safety by controlling when to release restriction by a lock mechanism by detecting safe pressures, temperatures, etc. Either one of ordinary skill in the art at the time the invention was effectively filed would at once envisaged that the combination suggests a controller for the aforementioned safety control of a locking mechanism, or nevertheless, or in the alternative, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further combine Ando’s controller for controlling a lock mechanism with the aforementioned control modification thereby providing the expected advantages of a controller including commercial availability, flexibility, and/or ease of implementation/modification of the control (especially as compared to non-controller hardware/mechanical configurations).
Regarding claim 17, which depends on claim 16,
Hasegawa does not teach items: 1) a heating device configured to heat the separation column in the aforementioned and relied upon figures (Examiner again notes that Hasegawa teaches different component features in different figures rather than shown in a single figured embodiment); and 2) wherein the control device is configured to release the restriction by the lock mechanism when a temperature of the separation column is equal to or lower than a predetermined value.
Regarding item 1), Hasegawa teaches in fig. 16 a heating device (fig. 16, temperature control parts 60, 61, 63) configured to heat the separation column (separation column 2) ([0138] “temperature control parts 60, 61 and 63 for controlling the temperature of the separation column 2, the first fitting 3 and the pipe 5. The temperature control parts 60, 61 and 63 each include a heater, a sensor for temperature monitoring and the like, and provide temperature control by way of an external control unit (not shown). The temperature control parts 60, 61 and 63 use the column holder 11, the first fitting holder 12, and a pipe holder 62 as heat blocks” and “device may also be provided with means for controlling the temperature of the second fitting 4 and the pipe 6”; [0134] “viscosity of a solution in the separation column is lowered by raising the temperature” and “raising the temperature of the separation column 2 to several dozen degrees Celsius whereby the throughput of analysis can be increased”; Examiner notes that an expected operating range of several dozen degrees Celsius is commonsensically dangerously hot for humans).
While the primary reference does not expressly show all of the above claimed features clearly in a single
depicted embodiment as a single figure, either one of ordinary skill in the art would at once envisaged the
combination from primary reference’s generic teachings and specific possible choices of the structural components
thereof, or, in the alternative, it at least would have been obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to nevertheless so combine the above features for the purpose and combinations as proposed by the primary reference and as analyzed by the Examiner including the citations and Examiner comments provided above in the reference to the claimed features. The Examiner notes in particular that it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine Hasegawa’s heating device (fig. 16) with Hasegawa’s analysis system (see analysis of independent claim) for the expected advantage(s) of increasing throughput in the analysis (inclusive of by lowering viscosity), lowering backpressure, improving separation performance, and/or improving reproducibility by ensuring consistency of temperature related affects on the chromatography. Examiner notes that the combination includes Hasegawa’s column temperature monitoring sensors.
Regarding item 2), Staats teaches releasing the restriction by the lock mechanism (fig. 8, means 254) when a temperature of the cylinder (fig. 2, vessel 50) is equal to or lower than a predetermined value (satisfactorily safe temperature condition) (col. 8, ll. 10-25 “mechanical means 254 for preventing the door from opening at any time other than when a safe position has been achieved”; col. 9, ll. 31-42 “If appropriate conditions of temperature”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine Staats (temperature) safety control features for a locking mechanism with Hasegawa’s slideable chromatography column couplings having Bran’s locking mechanism for a slidable chromatography column coupling (see previous modification analysis) for the same combination and motivation provide for the independent claim, the Examiner further emphasizing that the combination commonsensically suggests the advantage of safely keeping humans from being exposed to dangerously hot temperatures column components and/or fluids thereof.
Regarding claim 18, which depends on claim 16,
Hasegawa teaches a separation column that is intended to be under high pressure when in operation ([0002] “high-performance LC requiring high pressure”; [0056] “high-performance LC separation”; the Examiner notes that this pressure would be at once understood by an ordinary artisan to pose at least an indirect risk to humans from exposure to any expelled contents), and wherein the control device (control device comprising unshown control unit and controller 46) is configured to automatically disconnect the separation column (fig. 25, separation column 2) when (after) an internal pressure of at least one of the analysis flow passage (flow passage comprising pipes 5 and 6) and the separation column (separation column 2) is equal to or less than a predetermined value (at once so envisaged; additional obviousness analysis provided) ([0111] “automatic connection and disconnection of the separation column”; [0153] “automating a transporting operation for disposal of a used separation column or for setting a new separation column”; Examiner emphasizes that commonsensically the device isn’t automatically disconnecting while still under high pressure).
Furthermore, Staats teaches releasing the restriction by the lock mechanism (fig. 8, means 254) when a pressure is equal to or lower than a predetermined value (satisfactorily safe pressure condition) (col. 8, ll. 10-25 “mechanical means 254 for preventing the door from opening at any time other than when a safe position has been achieved”; col. 9, ll. 31-42 “appropriate conditions of temperature and pressure”; col. 10 line 57 through col. 11 line 31 “pressure transducer”; col. 11 line 65 through col. 12 line 21” diagnostic information is provided by monitoring downstream flow or pressure”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine Staats (pressure) safety control features for a locking mechanism with Hasegawa’s slideable chromatography column couplings having Bran’s locking mechanism for a slidable chromatography column coupling (see previous modification analysis) for the same combination and motivation provide for the independent claim, the Examiner further emphasizing that the combination commonsensically suggests the advantage of safely keeping humans (and the environment they occupy) from being exposed to pressurized column chromatography fluids—especially any components that might be hazardous.
Claim 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Applicant cited Hasegawa in view of newly cited Brann, newly cited Staats with newly cited Ando, and in further view of Applicant cited Fukuda et al (US 20080102443 A1; hereafter “Fukuda”).
Regarding claim 26, which depends on claim 16,
Hasegawa does not teach further comprising: a notification device configured to make a notification of a removable separation column among the plurality of separation columns.
Fukuda teaches a notification device (fig. 1, display 7) configured to make a notification of a removable separation column (column of multiple column 100) among the plurality of separation columns (fig. 1, multiple column 100) (Title “COLUMN CARTRIDGE, COLUMN CARTRIDGES ASSEMBLY, ANALYZER, AND ANALYZING METHOD”; Abstract; [0046] “The display 7 is capable of displaying the content of an operation to be performed next by the user, and alerts the user to the completion of predetermined operation. As shown in FIG. 12, the display 7 is configured by a display unit 7a and an input unit 7b (touch panel), and is configured so that the controller 8 of the sample preparing device 1 can be informed of the completion of operation content”; [0086] “a screen instructing the user to collect the second enzyme pre-reaction buffer and remove the multiple column 100 is displayed on the display 7”; [0087] “The user removes the multiple column 100 after sucking and disposing of the discharged second enzyme pre-reaction buffer using a pipette or the like pursuant with the instructions on the display”; [0108] “user is informed of the sample preparation completion and instructed to remove the multiple column 100 on the display 8. The user reads the display 8 and removes the multiple column 100”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine Fukuda’s instructional notification display with Hasegawa’s analyzer for the expected purpose of providing a display instructions enabling safe, correct, & repeatable manual labor—including proper column removal—without requiring automation and therefore saving on automation hardware (especially where scaling to make use of the initial expenses for automation isn’t practical/feasible) and/or for providing manual redundancy assistance when automation is flawed and requires human intervention.
Claim 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Applicant cited Hasegawa in view of newly cited Brann, newly cited Staats with newly cited Ando, and in further view of newly cited Bystron et al (US 20120175289 A1; hereafter “Bystron”).
Regarding claim 27, which depends on claim 16,
Hasegawa does not teach further comprising a reading device configured to read information recorded on a medium including information for identifying the installed separation column.
However:
It has been held that broadly providing a mechanical or automatic means to replace manual activity which has accomplished the same result involves only routine skill in the art, see MPEP § 2144.04(III) and In re Venner, 262 F.2d 91, 95, 120 USPQ 193, 194 (CCPA 1958). In the present case it is the Examiner’s position that only ordinary skill in the art is required to automate the otherwise conventional manual activity of reading a column and identifying said column
Furthermore, and as supporting factual evidence of the aforementioned assertion, Bystron teaches system (Title “Chromatography Systems And System Components”; Abstract; [0003] “chromatography systems and system components that enable accurate and efficient reading of machine readable tags (e.g., RFID tags) within a chromatography system”; [0054]-[0064] section on Machine Readable Tag Readers/Writers) a reading device (fig. 3, reader 30) configured to read information recorded on a medium (fig. 3, readable tag 32) including information for identifying (via said identification tag) the installed separation column (fig. 3, column 321) ([0063] “position an outer surface 38 of tag reader component 37 adjacent to column or cartridge 31 and near or over an outer surface 39 of machine readable tag 32”; Examples [0108] “A 12 g Reveleris silica cartridge, equipped with an RFID tag, is installed on a Reveleris flash chromatography system. The RFID reader on the Reveleris system reads the tag on the silica cartridge that contains the column size, packing type and number of times the cartridge has been used. Based on the column size, the Reveleris sets the default flow to 25 ml/minute and the system upper pressure limit to 200 psig”).
In view of the above, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine Bystron’s column ID reading device and associated method for a chromatography system with Hasegawa’s chromatography analyzer for the expected purpose of properly identifying columns for configuration of said analyzer thereby reducing manual costs/labor and/or reducing human error through automation thereof.
Allowable Subject Matter
Claim(s) 19-25 is/are allowed.
The following is the Examiner’s statement of reasons for allowance:
Regarding independent claim 19,
the prior art fails to disclose or motivate one skilled in the art to manufacture an analyzer comprising “a first sensor configured to detect connection of the analysis flow passage to the one end side; and a second sensor configured to detect disconnection of the analysis flow passage to the other end side, and the control device performs the restriction by the lock mechanism at a time of detection by either the first sensor or the second sensor" in further combination with the remaining limitations of the claim.
Dependent claims thereof are likewise allowed.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
The prior art made of record and not relied upon is considered pertinent to Applicant's disclosure. Applicant is invited to review PTO form 892 accompanying this Office Action listing Prior Art relevant to the instant invention cited by the Examiner.
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Any inquiry concerning this communication or earlier communications from the Examiner should be directed to DAVID L SINGER whose telephone number is 303-297-4317. The Examiner can normally be reached Monday - Friday 8:00 am - 6:00pm CT, EXCEPT alternating Friday.
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/DAVID L SINGER/Primary Examiner, Art Unit 2855 22NOV2025