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.
Election/Restrictions
Applicant’s
election without traverse of Invention I (claims 1-11)
in the reply filed on 01/30/2026 is acknowledged.
The Examiner further acknowledges for Applicant that no restriction/election was required between Ia & Ib of Invention I; the subgrouping was merely used in the formal analysis between Group I and Group II.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Acknowledgment is made that this application is a continuation of parent application 17/736,868 (USPN 12292420).
Information Disclosure Statement
While it is not necessary for the Applicant to submit an information disclosure statement that lists the prior art reference(s) previously cited by the Examiner in the parent application for the latter filed continuing application claiming the benefit under 35 U.S.C. 120 to said parent application (other than an international application that designated the U.S.), the information will not be printed on any patent issuing from the continuing application unless cited by the Applicant on an IDS or by the Examiner on a PTO-892 for the present application. See MPEP § 609.02. While the Examiner has reviewed the reference(s) of the parent application(s), the Examiner has not verified that all of the reference(s) listed in the parent application(s) appear on the present IDS and/or PTO-892.
The information disclosure statement(s) (IDS) submitted on 09/21/2023, 01/02/2024, 06/04/2024, & 12/16/2024 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.
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: “ANALYSIS OF MOBILE PHASE SUPPLY [[FROM]] TO IDENTIFY MOBILE PHASE CONTAINER”.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Instant claim(s) 1, 3 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over reference patented claim(s) 6 of U.S. Patent No. 12292420.
Instant claim(s) 2 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over reference patented claim(s) 6 of U.S. Patent No. 12292420 in view of Isoi (US 20190257731 A1; hereafter “Isoi”).
Instant claim(s) 8 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over reference patented claim(s) 6 of U.S. Patent No. 12292420 in view of Kamata et al (WO 2020170320 A1; hereafter “Kamata”).
Instant Claim(s) 9 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over reference patented claim(s) 6 of U.S. Patent No. 12292420 in view of Li (US 20100057377 A1; hereafter “Li”).
Instant Claim(s) 10, 11 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over reference patented claim(s) 6 of U.S. Patent No. 12292420 in view of Shoykhet (DE 102018100779 A1; hereafter “Shoykhet”).
Although the claims at issue are not identical, they are not patentably distinct from each other because of the reasons put forth in the table below:
One-Way Double Patenting Analysis Table
18/371,405
(instant)
USPN 12,292,420
(reference)
Obviousness Analysis of instant claim over reference claim
1
6
1. In a sample separation apparatus for separating a fluidic sample using a mobile phase provided from at least one mobile phase container, a method of identifying a mobile phase container (1. A method for controlling a sample separation apparatus for separating a fluidic sample using a mobile phase provided from at least one mobile phase container), the method comprising:
determining a weight and volume characteristic of the mobile phase container (1. determining a tare weight of the mobile phase container of the at least one mobile phase container based on a gross weight information, a volume information; 6. weight and volume characteristic of the mobile phase container); and
identifying the mobile phase container based on a comparison of the determined weight and volume characteristic of the mobile phase container with a pre-known reference weight and volume characteristic of one or more reference mobile phase containers with pre-known identity (6. identifying the mobile phase container of the at least one mobile phase container based on a comparison of a weight and volume characteristic of the mobile phase container of the at least one mobile phase container with a pre-known reference weight and volume characteristic of one or more reference mobile phase containers of the at least one mobile phase container with pre-known identity).
Indistinctly recites most limitations, differences being merely nominal nomenclatural differences or grammatical variations not amounting to patentable distinction, EXCEPT technically not explicitly stating determining the weight and volume characteristic of the mobile phase container, for which the Examiner notes as being either at once envisaged as implicitly determined as said weight & volume characteristic is utilized in the comparison step (see also citations pertaining to gross weight information and volume information as reasonably broad interpretation), 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 so trivially determine to have said knowledge for said comparison, the Examiner further emphasizing the breadth of the limitation.
2
6
+
Isoi
(USPN ‘420 is silent in claim 6) 2. The method according to claim 1, comprising one of the following features:
providing an information about the identified mobile phase container to a user of the sample separation apparatus;
providing an information about the identified mobile phase container to a user of the sample separation apparatus, and further requesting the user to confirm that the identified mobile phase container matches or not with the actual mobile phase container.
However, Isoi teaches providing an information about the identified at least one mobile phase container (fig. 1, container 6) to a user of the sample separation apparatus (liquid chromatography analysis system) ([0017] “a warning part that gives warning to a user when the liquid-for-analysis determining part determines that the liquid(s) for analysis has/have not been normally used in the decreasing operation. As a result, a user easily notices and quickly deals with disposition of a wrong liquid for analysis, a liquid for analysis connected to a wrong pipe, or an analyzer not normally operating”; [0032]; [0033] “When the liquid-for-analysis determining part 14 determines “abnormal use,” the warning part 16 gives warning to a user. For example, the warning may be displayed on a monitor connected to the system controller 10 and inform of abnormal use. Alternatively, the warning may be warning sound”; [0034] “Further, when the liquid-for-analysis determining part 14 determines “abnormal use,” the system controller 10 may transmit an instruction to the analyzer 2 so that the analyzer 2 interrupts a current operation, in addition to or instead of the warning”; [0038]; [0042]; [0043] “Consequently, if a user does not correctly dispose the liquids A to D for analysis or connects the liquids A to D for analysis to wrong tubes, for example, the liquid-for-analysis monitor 4 detects the error as abnormal use when an operation that consumes the liquids for analysis starts”), and therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine Isoi’s providing information to the user for the expected and routine purpose of enabling the user to take correction action and/or be reassured by the provided information. The Examiner further emphasizes that providing determined information to a user is a routine activity.
3
6
3. The method according to claim 1, comprising:
determining a weight and volume reduction behavior according to which weight and volume of mobile phase in a mobile phase container are reduced during conveying mobile phase from the mobile phase container in the sample separation apparatus (1. determining a weight and volume reduction behavior according to which weight and volume of mobile phase in a mobile phase container of the at least one mobile phase container are reduced during conveying mobile phase from the mobile phase container of the at least one mobile phase container in the sample separation apparatus).
Indistinctly recites most limitations, differences being merely nominal nomenclatural differences or grammatical variations not amounting to patentable distinction
8
6
+
Kamata
(USPN ‘420 is silent in claim 6) 8. The method according to claim 1, comprising at least one of the following features:
the method comprises receiving an initial mobile phase volume from a user input;
the method comprises determining an initial mobile phase volume based on a comparison of the determined weight and volume characteristic of the mobile phase container with a pre- known reference weight and volume characteristic of one or more reference mobile phase containers with pre-known initial mobile phase volume.
However, Kamata teaches wherein the method comprises receiving an initial mobile phase (mobile-phase) volume from a user input (Abstract “the operator to perform, when refilling the mobile phase containers with the mobile phases, visual measurement of the liquid volumes of the mobile phases and manual input of values of the liquid volumes to a control device”), and it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the conventional activity of the user inputting the initial volume of a mobile phase thereby providing a simple and low-tech solution to determining the volume of liquid which is easy for a user to perform and which provides an initial value for volume reduction calculations. The Examiner emphasizes that this feature is conventional in the art.
9
6
+
Li
(USPN ‘420 is silent in claim 6) 9. The method according to claim 1,
wherein the method comprises using the mobile phase from the at least one mobile phase container as carrier fluid for carrying the fluidic sample during sample separation.
However, Li teaches using the mobile phase as carrier fluid for carrying the fluidic sample during sample separation (Title; Abstract “chromatographic systems”; BACKGROUND [0001] “Chromatography is a process that provides for the physical separation, quantification and identification of various analytes in a sample in a single analysis. A chromatography system comprises a number of components, including a separation column that separates the sample into its individual components as the components are passed through the column by a mobile phase. The separation column includes an inlet portion that acts as the interface for input of the sample into a separation column. The mobile phase provides a carrier fluid and driving force to move the components of the sample from the inlet portion of the column to the outlet portion, with the separation of the components dependent on their interactions with an immobilized liquid or solid material within the column (stationary phase) and the mobile phase”), and it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to perform the routine use—as factually supported by Li—of mobile phase as a carrier fluid for carrying the fluidic sample during sample separation in chromatography thereby providing the expected conventional facilitation of moving the sample in a chromatographic apparatus. The Examiner emphasizes that this feature is conventional in the art.
10
6
+
Shoykhet
(USPN ‘420 is silent in claim 6) A sample separation apparatus for separating a fluidic sample, the sample separation apparatus comprising:
a fluid drive for driving a mobile phase, provided from at least one mobile phase container, and the fluidic sample when injected in the mobile phase;
a sample separation unit for separating the fluidic sample in the mobile phase; and
a control device configured for carrying out or controlling the method according claim 1.
However, Shoykhet teaches a sample separation apparatus (fig. 1, sample separation apparatus 10) for separating a fluidic sample (fluidic sample) (Title “Identification And Correction Of A Fluid Composition In The Sample Separator”; Abstract “A control device (70) for controlling a sample separation device (10) for separating a fluidic sample using a mobile phase to be supplied according to a target composition, wherein the control device (70) comprises a determination device (152) for determining one for a Is set of mobile phase indicative information is set up, and a correction means (154), which is adapted to at least partially correct an influence of a deviation between the target composition and the actual composition”; page 2 section EPIPHANY first paragraph “object of the invention to operate a sample separation apparatus”), the sample separation apparatus (fig. 1, sample separation apparatus 10) comprising: a control device (fig. 1, control device 70) configured to carry out or control the sample separation apparatus (fig. 1, sample separation apparatus 10), a fluid drive (fig. 1, fluid drive 20) configured to drive the mobile phase (mobile phase from supply unit 25) and the fluidic sample (fluidic sample) when injected (via fig. 1, sample application unit / injector device 40) into the mobile phase (mobile phase); and a sample separation unit (fig. 1, sample separator 30) configured to separate the fluidic sample (fluidic sample) in the mobile phase (mobile phase), wherein controlling the sample separation apparatus (fig. 1, sample separation apparatus 10) is based on a result of the determining the density of the mobile phase (mobile phase) (page 8 after middle of page “the fluid drive or fluid pump may be configured to convey the mobile phase through the system”; page 10 last paragraph “fluid pump as a fluid drive 20 containing solvents from a supply unit 25 supplied drives a mobile phase through a sample separator 30 (such as a chromatographic column)”; page 8 after middle of page “The sample separator may include a sample injector for introducing the sample into the fluidic separation path. Such a sample injector may comprise a syringe-dockable injection needle in a corresponding fluid path, which needle may be withdrawn from that seat to receive sample, wherein upon reintroduction of the needle into the seat, the sample is in a fluid path which, for Example, by switching a valve, can be switched into the separation path of the system, which leads to the introduction of the sample in the fluidic separation path”; page 6 about middle of page “the determining means for determining the information indicative of the actual composition by means of a measurement of at least one parameter from the group consisting of a density, a sound wave velocity in, and a viscosity of the mobile phase to be established. If the density, the speed of sound or the viscosity of the individual constituents are known (an empirical calibration curve can preferably be used), the respective proportion of a particular constituent can also be determined from a corresponding measurement of the respective parameter of the mobile phase composed thereof. It is also possible for two or more of the measurements mentioned to be cumulative, simultaneous, supplementary, parallel and / or complementary to determine the actual composition or indicative information. Thereby, the precision of the determination of the actual composition can be further increased”), and it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include Shoykhet’s (Examiner asserted conventional) components and thereby providing the expected results of utilizing well-known & widely used separation techniques with a mobile drive, injector, and sample separation unit for the self-definitional motivation and/or for the expected purpose of analysis, isolation, purification, and/or for distinguishing individual compounds wherein the fluid drive commonsensically is configured to drive the mobile phase and the fluidic sample when injected via injector device into the mobile phase as is well-known in the art. The With regards to the controller, it is the Examiner's position that ‘392 teaches controlling, 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), and further Shoykhet teaches using a controller for an analogous (though distinct) method and it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to automate USPN ‘420 controlling with a controller for cost/time-effective benefits and/or increased accuracy/precision. The Examiner emphasizes that these features are conventional in the art.
11
6
+
Shoykhet
(USPN ‘420 is silent in claim 6) The sample separation apparatus according to claim 10,
wherein the sample separation apparatus comprises at least one of the following features:
the sample separation apparatus is configured as an apparatus selected from the group consisting of:
a chromatography sample separation apparatus;
a liquid chromatography sample separation apparatus;
a gas chromatography sample separation apparatus; and
a supercritical fluid chromatography sample separation apparatus;
the sample separation apparatus comprises a detector configured to detect the separated fluidic sample;
the sample separation apparatus comprises a fractionating unit configured to collect separated fractions of the fluidic sample;
the sample separation apparatus comprises an injector configured to inject the fluidic sample in the mobile phase.
Shoykhet teaches: comprising at least one of the following features: the sample separation apparatus (fig. 1, sample separation apparatus 10) is configured as an apparatus selected from the group consisting of: a chromatography sample separation apparatus (fig. 1, sample separation apparatus 10); a liquid chromatography sample separation apparatus (fig. 1, sample separation apparatus 10); a gas chromatography sample separation apparatus (fig. 1, sample separation apparatus 10); and a supercritical fluid chromatography sample separation apparatus (fig. 1, sample separation apparatus 10) (bottom paragraph of page 2 through second paragraph of page 3 “In this context, a fluid is understood as meaning a liquid, a gas, a mixture of a liquid and a gas, a substance in the supercritical state” and “chromatographic sample separation”); the sample separation apparatus (fig. 1, sample separation apparatus 10) comprises each of an injector (fig. 1, sample application unit / injector device 40) configured to inject the fluidic sample (fluidic sample) into the mobile phase (mobile phase); the sample separation apparatus (fig. 1, sample separation apparatus 10) comprises a detector (fig. 1, detector 50) configured to detect the separated fluidic sample (fluidic sample); and the sample separation apparatus (fig. 1, sample separation apparatus 10) comprises a fractionating unit (fig. 1, fractionator 60) configured to collect separated fractions of the fluidic sample (fluidic sample) (page 8 after middle of page “The sample separator may include a sample injector for introducing the sample into the fluidic separation path”; top of page 11 “a detector 50 a flow cell detects separated components of the sample, and a fractionator may be provided to dispense separated components of the sample into dedicated containers; reference claim on top of page 16 “the sample separator ( 10 ) has an injector device ( 40 ) for introducing the fluidic sample into a fluidic path between the fluid drive ( 20 ) and the sample separation device ( 30 )” and “the sample separator ( 10 ) has a detector ( 50 )” and “the sample separator ( 10 ) has a sample fractionator ( 60 ) for fractionating the separated fluidic sample”. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine Shoykhet’s sample separation apparatus having injector, detector, & fractionator with ‘405’s sample separation apparatus therefore providing conventional components having the expected results of utilizing well-known & widely used components in chromatography including for usefully introducing the sample, analyzing the separated sample, and collecting separated components of the sample for further use and/or additional analysis, and thus commonsensically increasing the versatility and marketability. It further would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine in the alternative each of gas, liquid, and supercritical versions/applications of chromatography sample separation—as taught by Shoykhet—with for the increased versatility and marketability within these respective fluid applications. Examiner emphasizes that these features are conventional in the art.
Instant Claim(s) 1, 2, 3, 4 is/are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over reference claim(s) 5, 6 of copending Application No. 18/371,392.
Instant Claim(s) 8 is/are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over reference claim(s) 5, 6 of copending Application No. 18/371,392 in view of Kamata.
Instant Claim(s) 9 is/are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over reference claim(s) 5, 6 of copending Application No. 18/371,392 in view of Li.
Instant Claim(s) 10, 11 is/are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over reference claim(s) 5, 6 of copending Application No. 18/371,392 in view of Shoykhet.
Although the claims at issue are not identical, they are not patentably distinct from each other because of the reasons put forth in the table below (which provides the specific instant claims to specific reference claims and secondary reference mappings):
One-Way Provisional Double Patenting Analysis Table
18/371,405
(instant)
18/371,392
(reference)
Obviousness Analysis of instant claim over reference claim
1
5
1. In a sample separation apparatus for separating a fluidic sample using a mobile phase provided from at least one mobile phase container, a method of identifying a mobile phase container (1. In a sample separation apparatus for separating a fluidic sample using a mobile phase provided from at least one mobile phase container), the method comprising:
determining a weight and volume characteristic of the mobile phase container (5. determining a weight and volume characteristic of the at least one mobile phase container); and
identifying the mobile phase container based on a comparison of the determined weight and volume characteristic of the mobile phase container with a pre-known reference weight and volume characteristic of one or more reference mobile phase containers with pre-known identity (5. identifying the at least one mobile phase container based on a comparison of the determined weight and volume characteristic of the at least one mobile phase container with a pre-known reference weight and volume characteristic of one or more reference mobile phase containers with a pre-known identity).
Indistinctly recites most limitations, differences being merely nominal nomenclatural differences or grammatical variations not amounting to patentable distinction.
2
6
2. The method according to claim 1, comprising one of the following features (6. The method according to claim 5, comprising one of the following features):
providing an information about the identified mobile phase container to a user of the sample separation apparatus (6. providing an information about the identified at least one mobile phase container to a user of the sample separation apparatus);
providing an information about the identified mobile phase container to a user of the sample separation apparatus (6. providing an information about the identified at least one mobile phase container to a user of the sample separation apparatus), and
further requesting the user to confirm that the identified mobile phase container matches or not with the actual mobile phase container (6. requesting the user to confirm that the identified at least one mobile phase container matches or not with the actual at least one mobile phase container).
Indistinctly recites most limitations, differences being merely nominal nomenclatural differences or grammatical variations not amounting to patentable distinction.
3
5
3. The method according to claim 1, comprising:
determining a weight and volume reduction behavior according to which weight and volume of mobile phase in a mobile phase container are reduced during conveying mobile phase from the mobile phase container in the sample separation apparatus (1. determining a weight and volume reduction behavior according to which weight and volume of the mobile phase in the at least one mobile phase container are reduced during conveying the mobile phase from the at least one mobile phase container into the sample separation apparatus).
Indistinctly recites most limitations, differences being merely nominal nomenclatural differences or grammatical variations not amounting to patentable distinction.
4
5
4. The method according to claim 3, comprising determining a density of the mobile phase based on the determined weight and volume reduction behavior (1. determining the density of the mobile phase based on the determined weight and volume reduction behavior).
Indistinctly recites most limitations, differences being merely nominal nomenclatural differences or grammatical variations not amounting to patentable distinction.
8
5
+
Kamata
(‘392 is silent in claim 5) 8. The method according to claim 1, comprising at least one of the following features:
the method comprises receiving an initial mobile phase volume from a user input;
the method comprises determining an initial mobile phase volume based on a comparison of the determined weight and volume characteristic of the mobile phase container with a pre- known reference weight and volume characteristic of one or more reference mobile phase containers with pre-known initial mobile phase volume.
However, Kamata teaches wherein the method comprises receiving an initial mobile phase (mobile-phase) volume from a user input (Abstract “the operator to perform, when refilling the mobile phase containers with the mobile phases, visual measurement of the liquid volumes of the mobile phases and manual input of values of the liquid volumes to a control device”), and it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the conventional activity of the user inputting the initial volume of a mobile phase thereby providing a simple and low-tech solution to determining the volume of liquid which is easy for a user to perform and which provides an initial value for volume reduction calculations. The Examiner emphasizes that this feature is conventional in the art.
9
5
+
Li
(‘392 is silent in claim 5) 9. The method according to claim 1,
wherein the method comprises using the mobile phase from the at least one mobile phase container as carrier fluid for carrying the fluidic sample during sample separation.
However, Li teaches using the mobile phase as carrier fluid for carrying the fluidic sample during sample separation (Title; Abstract “chromatographic systems”; BACKGROUND [0001] “Chromatography is a process that provides for the physical separation, quantification and identification of various analytes in a sample in a single analysis. A chromatography system comprises a number of components, including a separation column that separates the sample into its individual components as the components are passed through the column by a mobile phase. The separation column includes an inlet portion that acts as the interface for input of the sample into a separation column. The mobile phase provides a carrier fluid and driving force to move the components of the sample from the inlet portion of the column to the outlet portion, with the separation of the components dependent on their interactions with an immobilized liquid or solid material within the column (stationary phase) and the mobile phase”), and it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to perform the routine use—as factually supported by Li—of mobile phase as a carrier fluid for carrying the fluidic sample during sample separation in chromatography thereby providing the expected conventional facilitation of moving the sample in a chromatographic apparatus. The Examiner emphasizes that this feature is conventional in the art.
10
5
+
Shoykhet
(‘392 is silent in claim 5) 10. A sample separation apparatus for separating a fluidic sample, the sample separation apparatus comprising:
a fluid drive for driving a mobile phase, provided from at least one mobile phase container, and the fluidic sample when injected in the mobile phase;
a sample separation unit for separating the fluidic sample in the mobile phase; and
a control device configured for carrying out or controlling the method according claim 1.
However, Shoykhet teaches a sample separation apparatus (fig. 1, sample separation apparatus 10) for separating a fluidic sample (fluidic sample) (Title “Identification And Correction Of A Fluid Composition In The Sample Separator”; Abstract “A control device (70) for controlling a sample separation device (10) for separating a fluidic sample using a mobile phase to be supplied according to a target composition, wherein the control device (70) comprises a determination device (152) for determining one for a Is set of mobile phase indicative information is set up, and a correction means (154), which is adapted to at least partially correct an influence of a deviation between the target composition and the actual composition”; page 2 section EPIPHANY first paragraph “object of the invention to operate a sample separation apparatus”), the sample separation apparatus (fig. 1, sample separation apparatus 10) comprising: a control device (fig. 1, control device 70) configured to carry out or control the sample separation apparatus (fig. 1, sample separation apparatus 10), a fluid drive (fig. 1, fluid drive 20) configured to drive the mobile phase (mobile phase from supply unit 25) and the fluidic sample (fluidic sample) when injected (via fig. 1, sample application unit / injector device 40) into the mobile phase (mobile phase); and a sample separation unit (fig. 1, sample separator 30) configured to separate the fluidic sample (fluidic sample) in the mobile phase (mobile phase), wherein controlling the sample separation apparatus (fig. 1, sample separation apparatus 10) is based on a result of the determining the density of the mobile phase (mobile phase) (page 8 after middle of page “the fluid drive or fluid pump may be configured to convey the mobile phase through the system”; page 10 last paragraph “fluid pump as a fluid drive 20 containing solvents from a supply unit 25 supplied drives a mobile phase through a sample separator 30 (such as a chromatographic column)”; page 8 after middle of page “The sample separator may include a sample injector for introducing the sample into the fluidic separation path. Such a sample injector may comprise a syringe-dockable injection needle in a corresponding fluid path, which needle may be withdrawn from that seat to receive sample, wherein upon reintroduction of the needle into the seat, the sample is in a fluid path which, for Example, by switching a valve, can be switched into the separation path of the system, which leads to the introduction of the sample in the fluidic separation path”; page 6 about middle of page “the determining means for determining the information indicative of the actual composition by means of a measurement of at least one parameter from the group consisting of a density, a sound wave velocity in, and a viscosity of the mobile phase to be established. If the density, the speed of sound or the viscosity of the individual constituents are known (an empirical calibration curve can preferably be used), the respective proportion of a particular constituent can also be determined from a corresponding measurement of the respective parameter of the mobile phase composed thereof. It is also possible for two or more of the measurements mentioned to be cumulative, simultaneous, supplementary, parallel and / or complementary to determine the actual composition or indicative information. Thereby, the precision of the determination of the actual composition can be further increased”), and it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include Shoykhet’s (Examiner asserted conventional) components and thereby providing the expected results of utilizing well-known & widely used separation techniques with a mobile drive, injector, and sample separation unit for the self-definitional motivation and/or for the expected purpose of analysis, isolation, purification, and/or for distinguishing individual compounds wherein the fluid drive commonsensically is configured to drive the mobile phase and the fluidic sample when injected via injector device into the mobile phase as is well-known in the art. The With regards to the controller, it is the Examiner's position that ‘392 teaches controlling, 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), and further Shoykhet teaches using a controller for an analogous (though distinct) method and it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to automate ‘392 controlling with a controller for cost/time-effective benefits and/or increased accuracy/precision. The Examiner emphasizes that these features are conventional in the art.
11
5
+
Shoykhet
(‘392 is silent in claim 5) The sample separation apparatus according to claim 10,
wherein the sample separation apparatus comprises at least one of the following features:
the sample separation apparatus is configured as an apparatus selected from the group consisting of:
a chromatography sample separation apparatus;
a liquid chromatography sample separation apparatus;
a gas chromatography sample separation apparatus; and
a supercritical fluid chromatography sample separation apparatus;
the sample separation apparatus comprises a detector configured to detect the separated fluidic sample;
the sample separation apparatus comprises a fractionating unit configured to collect separated fractions of the fluidic sample;
the sample separation apparatus comprises an injector configured to inject the fluidic sample in the mobile phase.
Shoykhet teaches: comprising at least one of the following features: the sample separation apparatus (fig. 1, sample separation apparatus 10) is configured as an apparatus selected from the group consisting of: a chromatography sample separation apparatus (fig. 1, sample separation apparatus 10); a liquid chromatography sample separation apparatus (fig. 1, sample separation apparatus 10); a gas chromatography sample separation apparatus (fig. 1, sample separation apparatus 10); and a supercritical fluid chromatography sample separation apparatus (fig. 1, sample separation apparatus 10) (bottom paragraph of page 2 through second paragraph of page 3 “In this context, a fluid is understood as meaning a liquid, a gas, a mixture of a liquid and a gas, a substance in the supercritical state” and “chromatographic sample separation”); the sample separation apparatus (fig. 1, sample separation apparatus 10) comprises each of an injector (fig. 1, sample application unit / injector device 40) configured to inject the fluidic sample (fluidic sample) into the mobile phase (mobile phase); the sample separation apparatus (fig. 1, sample separation apparatus 10) comprises a detector (fig. 1, detector 50) configured to detect the separated fluidic sample (fluidic sample); and the sample separation apparatus (fig. 1, sample separation apparatus 10) comprises a fractionating unit (fig. 1, fractionator 60) configured to collect separated fractions of the fluidic sample (fluidic sample) (page 8 after middle of page “The sample separator may include a sample injector for introducing the sample into the fluidic separation path”; top of page 11 “a detector 50 a flow cell detects separated components of the sample, and a fractionator may be provided to dispense separated components of the sample into dedicated containers; reference claim on top of page 16 “the sample separator ( 10 ) has an injector device ( 40 ) for introducing the fluidic sample into a fluidic path between the fluid drive ( 20 ) and the sample separation device ( 30 )” and “the sample separator ( 10 ) has a detector ( 50 )” and “the sample separator ( 10 ) has a sample fractionator ( 60 ) for fractionating the separated fluidic sample”. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine Shoykhet’s sample separation apparatus having injector, detector, & fractionator with ‘405’s sample separation apparatus therefore providing conventional components having the expected results of utilizing well-known & widely used components in chromatography including for usefully introducing the sample, analyzing the separated sample, and collecting separated components of the sample for further use and/or additional analysis, and thus commonsensically increasing the versatility and marketability. It further would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine in the alternative each of gas, liquid, and supercritical versions/applications of chromatography sample separation—as taught by Shoykhet—with for the increased versatility and marketability within these respective fluid applications. Examiner emphasizes that these features are conventional in the art.
Dependent reference claims of the aforementioned reference claims likewise form the basis of provisional double patenting rejections (e.g., instant claims provisionally rejectable over reference claim 5 are likewise provisionally rejectable over dependent reference claim 6). This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented as of the date of writing this Office action.
The Double Patenting Rejections will not be held in abeyance. See MPEP § 804 & 714.02.
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) 1-4 and 6-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Applicant cited Isoi (US 20190257731 A1; hereafter “Isoi”) in view of newly cited factual evidence Poole (NPL Encyclopedia of Separation Science; hereafter “Poole’s Encyclopedia”).
Regarding independent claim 1,
Isoi teaches in a sample separation apparatus (liquid chromatography analysis system) for separating (at once so envisaged that a chromatography system utilizing mobile phase inherently/implicitly includes separating; additional obviousness analysis provided) a fluidic sample (liquid sample) using a mobile phase (mobile-phase) provided from at least one mobile phase container (fig. 1, container 6), a method of identifying a mobile phase container (fig. 1, container 6) (Title “ANALYTICAL LIQUID MONITORING DEVICE”; Abstract “a liquid-for-analysis determining part configured to obtain a variation ΔM between a weight of the container weighed by the weighing scale before a decreasing operation that decreases the liquid for analysis and a weight of the container weighed by the weighing scale after the decreasing operation, and determine whether the liquid for analysis has been normally used in the decreasing operation or not, based on the obtained variation ΔM, a volume V of the decrease in the liquid in the container in the decreasing operation”; [0011] “if a liquid for analysis is not normally used, a liquid different from the liquid for analysis that needs to be used is actually used in a decreasing operation that decreases the liquid for analysis, or an analyzer does not operate normally. Because a user disposes a wrong liquid for analysis or connects a liquid for analysis to a wrong pipe, a liquid different from the liquid for analysis that needs to be used is actually used”), the method comprising:
determining a weight (via weighing scales 8) and volume characteristic of the mobile phase container (fig. 1, container 6) (Abstract “A liquid-for-analysis monitor includes: a weighing scale that weighs a container that contains a liquid as a liquid for analysis that needs to be used in analysis”; [0014] “calculates an amount of feeding of a liquid for analysis based on an amount of an operation of a feed pump, a volume V of consumption of a liquid for analysis in a decreasing operation is calculated using the function of the analyzer”; [0037] “obtained amount of consumption of the liquid corresponds to a volume V.sub.A of a decrease in a liquid in the container 6a in the decreasing operation”); and
identifying the mobile phase container (fig. 1, container 6) based on a comparison of the determined weight (ΔM of weighed container) and volume characteristic of the mobile phase container (fig. 1, container 6) with a pre-known reference weight and volume characteristic of one or more reference mobile phase containers (fig. 1, containers 6) with pre-known identity ([0043] “liquid-for-analysis monitor 4 described above determines whether liquids for analysis that need to be used are used as scheduled in an operation or not, based on variations ΔM between weights of the containers 6a to 6d before the decrease and weights of the containers 6a to 6d after the decrease, densities ρ of corresponding liquids for analysis, and amounts of consumption of liquids in the containers 6a to 6d or a consumption proportion between liquids in the containers 6a to 6d in a decreasing operation. Consequently, if a user does not correctly dispose the liquids A to D for analysis or connects the liquids A to D for analysis to wrong tubes, for example, the liquid-for-analysis monitor 4 detects the error as abnormal use when an operation that consumes the liquids for analysis start”; Examiner emphasizes that the liquid-for-analysis monitor identifies by the weight & volume characteristics whether the mobile phase containers have been swapped or are the appropriately identified mobile phase containers as intended).
Isoi does not explicitly state that the chromatography apparatus is a separation apparatus for separating.
However:
The Examiner takes Official Notice that chromatography conventionally uses separation techniques.
Furthermore, and as supporting factual evidence of the aforementioned assertion, Poole’s Encyclopedia teaches “Chromatography is the most widely used separation technique” (Chapter Chromatography, first sentence of Introduction).
In view of the above, either one of ordinary skill in the art at the time the invention was effectively filed would at once envisaged that Isoi’s chromatography is utilized for separating, 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 utilize well-known and widely used separation techniques—as factually supported by Pool’s Encyclopedia—for the self-definitional motivation and/or for the expected purpose of analysis, isolation, purification, and/or for distinguishing individual compounds.
Regarding claim 2, which depends on claim 1,
Isoi teaches comprising one of the following features:
providing an information about the identified mobile phase container (fig. 1, container 6) to a user of the sample separation apparatus (liquid chromatography analysis system) ([0017] “a warning part that gives warning to a user when the liquid-for-analysis determining part determines that the liquid(s) for analysis has/have not been normally used in the decreasing operation. As a result, a user easily notices and quickly deals with disposition of a wrong liquid for analysis, a liquid for analysis connected to a wrong pipe, or an analyzer not normally operating”; [0032]; [0033] “When the liquid-for-analysis determining part 14 determines “abnormal use,” the warning part 16 gives warning to a user. For example, the warning may be displayed on a monitor connected to the system controller 10 and inform of abnormal use. Alternatively, the warning may be warning sound”; [0034] “Further, when the liquid-for-analysis determining part 14 determines “abnormal use,” the system controller 10 may transmit an instruction to the analyzer 2 so that the analyzer 2 interrupts a current operation, in addition to or instead of the warning”; [0038]; [0042]; [0043] “Consequently, if a user does not correctly dispose the liquids A to D for analysis or connects the liquids A to D for analysis to wrong tubes, for example, the liquid-for-analysis monitor 4 detects the error as abnormal use when an operation that consumes the liquids for analysis starts”);
(silent to request) providing an information about the identified mobile phase container (fig. 1, container 6) to a user of the sample separation apparatus (liquid chromatography analysis system), and further requesting the user to confirm that the identified mobile phase container (fig. 1, container 6) matches or not with the actual mobile phase container (fig. 1, container 6).
Regarding claim 3, which depends on claim 1,
Isoi teaches comprising:
determining a weight (via weighing scales 8) and volume reduction (volume V of the decrease in the liquid in the container) behavior according to which weight and volume of mobile phase (mobile-phase) in a mobile phase container (fig. 1, container 6) are reduced during conveying (fed through an analysis path) mobile phase (mobile-phase) from the mobile phase container (fig. 1, container 6) in the sample separation apparatus (liquid chromatography analysis system) ([0025] “mobile phases fed through an analysis flow path in a liquid chromatograph”; [0014] “calculates an amount of feeding of a liquid for analysis based on an amount of an operation of a feed pump, a volume V of consumption of a liquid for analysis in a decreasing operation is calculated using the function of the analyzer”; [0026] “the liquid-for-analysis monitor 4 includes weighing scales 8a to 8d and the system controller 10. The weighing scales 8a to 8d weigh the containers 6a to 6d, respectively, and are electronic scales, for example”).
Regarding claim 4, which depends on claim 3,
Isoi teaches comprising determining a density (ρ’) of the mobile phase (mobile-phase) based on the determined weight (ΔM of weighed container) and volume reduction (volume V of the decrease in the liquid in the container) behavior ([0012] “the liquid-for-analysis determining part is configured to obtain a density ρ′ of the liquid contained in the container by dividing the variation ΔM between a weight of the container before the decreasing operation and a weight of the container after the decreasing operation by the volume V of the decrease in the liquid in the container in the decreasing operation”)
Regarding claim 6, which depends on claim 3,
Isoi teaches comprising at least one of the following features:
wherein the method comprises measuring a gross weight information and/or the weight reduction behavior (Abstract “liquid-for-analysis determining part configured to obtain a variation ΔM between a weight of the container weighed by the weighing scale before a decreasing operation that decreases the liquid for analysis and a weight of the container weighed by the weighing scale after the decreasing operation”);
(silent) wherein the method comprises receiving a gross weight information from a user input;
wherein the method comprises determining a gross weight information based on at least one of an assumption, an experience, and a previous measurement (Abstract “weighed by the weighing scale before a decreasing operation”).
Regarding claim 7, which depends on claim 3,
Isoi teaches comprising:
identifying the mobile phase (mobile-phase) (determining if correct kinds of liquids) based on a comparison of the determined weight (ΔM of weighed container) and volume reduction (volume V of the decrease in the liquid in the container) behavior with pre-known reference weight and volume reduction behavior of one or more reference mobile phase (mobile-phase) materials with pre-known identity ([0043] “the liquid-for-analysis monitor 4 described above determines whether liquids for analysis that need to be used are used as scheduled in an operation or not, based on variations ΔM between weights of the containers 6a to 6d before the decrease and weights of the containers 6a to 6d after the decrease, densities ρ of corresponding liquids for analysis, and amounts of consumption of liquids in the containers 6a to 6d or a consumption proportion between liquids in the containers 6a to 6d in a decreasing operation. Consequently, if a user does not correctly dispose the liquids A to D for analysis or connects the liquids A to D for analysis to wrong tubes, for example, the liquid-for-analysis monitor 4 detects the error as abnormal use when an operation that consumes the liquids for analysis starts”; [0008] “Using this knowledge allows determining whether correct amounts of correct kinds of liquids for analysis have been used or not. The present invention is made based on the findings and is characterized by determining whether liquids for analysis are normally used or not based on information on weights of containers that contain liquids as liquids for analysis and information on densities ρ of the liquids for analysis”; [0026] “liquid-for-analysis monitor 4 that monitors whether operations that decrease liquids for analysis, such as feeding of a mobile phase, use correct liquids for analysis as scheduled or not”; [0029] “the liquid-for-analysis determining part 14 determines whether the decreasing operation has used correct liquids for analysis”; [0031] “If the containers 6a and 6b contain correct liquids A and B for analysis, respectively, ρ′.sub.A=ρ.sub.A and ρ′.sub.B=ρ.sub.B” and “On the other hand, if ρ′.sub.A≠ρ.sub.A and/or ρ′.sub.B≠ρ.sub.B, the liquid-for-analysis determining part 14 determines that the container(s) the densities of which do not correspond with each other contain(s) a liquid that is not a liquid for analysis that needs to be contained”; [0043] “determines whether liquids for analysis that need to be used are used”).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Applicant cited Isoi in view of newly cited factual evidence Poole’s Encyclopedia and in further view of newly cited factual evidence Bell (NPL A Beginner's Guide to Uncertainty of Measurement; hereafter “Bell’s Beginner’s Guide”) with newly cited Shoykhet* (DE 102018100779 A1; hereafter “Shoykhet”).
*machine translation provided by Examiner with foreign document and utilized for English citations
Regarding claim 5, which depends on claim 3,
Isoi teaches comprising at least one of the following features:
wherein the method comprises determining the weight and volume reduction (volume V of the decrease in the liquid in the container) behavior under consideration of a flow rate (implicit to the time being sufficient and to amount of an operation of a feed pump; additional obviousness analysis provided) and a conveyance time (time is explicit) according to which the mobile phase (mobile-phase) is driven from the at least one mobile phase container (fig. 1, container 6) through the sample separation apparatus (liquid chromatography analysis system) ([0029] “When a decreasing operation has decreased some liquids for analysis (e.g. feeding of a mobile phase or cleaning with a cleaning liquid), the liquid-for-analysis determining part 14 determines whether the decreasing operation has used correct liquids for analysis as scheduled or not, based on differences ΔM between weights M1 of containers that correspond to the liquids for analysis at a time and a weights M2 of the containers after a period of time passes that is sufficiently long for measurement of the decreases in liquids in the container, densities ρ of liquids for analysis that need to be used in the decreasing operation, and volumes V of consumption of the liquids for analysis in the decreasing operation (or a proportion between volumes V)”; [0036], [0040] “After a period of time passes that is sufficiently long for measurement”; [0014] “analysis based on an amount of an operation of a feed pump”);
wherein the method comprises determining the weight and volume reduction (volume V of the decrease in the liquid in the container) behavior under consideration of a measurement of a gross weight information and/or the weight reduction behavior for threshold conclusions based thereon that are within a margin of error (silent to repeating) (Abstract; [0031] “within a range of a margin of error”).
Isoi doesn’t explicitly state item 1): wherein the determination is under consideration of a flow rate. Isoi doesn't teach item 2): repeated measurement of a gross weight information and/or the weight reduction behavior.
Regarding item 1), the Examiner takes Official Notice that flowrate (Q) multiplied by time (t) is volume (V): Q*t=V (or put another way t=V/Q).
It is the Examiner’s position that either one of ordinary skill in the art at the time the invention was effectively filed would at once envisaged that Isoi’s sufficient amount of time for liquid volume change implicitly or inherently involves knowledge about flowrate (at least to some accuracy), or nevertheless, or in the alternative, it would have been trivially obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the conventional knowledge of the relationship between flowrate, time, & volume with Isoi’s requirement for measurement sufficiency to determine based on flowrate & time if a sufficient volume change for reliable measurements has occurred and thus decreasing possibility of analysis occurring too soon to be reliable or unnecessarily too late to interrupt to prevent wastage.
Regarding item 2):
The Examiner takes Official Notice that repeating measurements (statistically) decreases error.
As supporting factual evidence of the aforementioned assertion, Bell’s Beginner’s Guide teaches to repeat measurements (Title Page “Measurement Good Practice Guide” and “A Beginner's Guide”; Abstract “Every measurement is subject to some uncertainty” and “Such uncertainties can be estimated using statistical analysis of a set of measurements”; section 3.1 ‘Measure thrice, cut once’ ... operator error “good reasons for repeating measurements many times”).
Moreover, and especially pertinent to solving a similar problem and in a same/analogous field of endeavor, Shoykhet teaches repeating measurements (Title “dentification And Correction Of A Fluid Composition In The Sample Separator”; Abstract “A control device (70) for controlling a sample separation device (10) for separating a fluidic sample using a mobile phase to be supplied according to a target composition, wherein the control device (70) comprises a determination device (152) for determining one for a Is set of mobile phase indicative information is set up, and a correction means (154), which is adapted to at least partially correct an influence of a deviation between the target composition and the actual composition”; page 6 about middle of page “the determining means for determining the information indicative of the actual composition by means of a measurement of at least one parameter from the group consisting of a density, a sound wave velocity in, and a viscosity of the mobile phase to be established” and “It is also possible for two or more of the measurements mentioned to be cumulative, simultaneous, supplementary, parallel and / or complementary to determine the actual composition or indicative information. Thereby, the precision of the determination of the actual composition can be further increased”).
In view of the above, it would have been trivially obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to commonsensically utilize repeat measurements to provide better results with less error—as factually supported by the good measurement practices in Bell’s Beginner’s Guide and as further shown by Shoykhet that cumulative measurements are known to increase precision of determinations in the art—and thus leading to better determinations of abnormalities (e.g., wrongly disposing liquids) being present or absent.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Applicant cited Isoi in view of newly cited factual evidence Poole’s Encyclopedia and in further view of newly cited Kamata* et al (WO 2020170320 A1; hereafter “Kamata”).
*machine translation provided by Examiner with foreign document and utilized for English citations
Regarding claim 8, which depends on claim 1,
Isoi is silent to comprising at least one of the following features:
the method comprises receiving an initial mobile phase volume from a user input;
the method comprises determining an initial mobile phase volume based on a comparison of the determined weight and volume characteristic of the mobile phase container with a pre-known reference weight and volume characteristic of one or more reference mobile phase containers with pre-known initial mobile phase volume.
However:
The Examiner takes Official Notice that a user inputting the initial volume of a mobile phase is a well-known & routine activity.
Furthermore, and as supporting factual evidence of the aforementioned assertion, Kamata teaches wherein the method comprises receiving an initial mobile phase (mobile-phase) volume from a user input (Title “LIQUID CHROMATOGRAPH”; Abstract “the operator to perform, when refilling the mobile phase containers with the mobile phases, visual measurement of the liquid volumes of the mobile phases and manual input of values of the liquid volumes to a control device”).
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 the conventional activity of the user inputting the initial volume of a mobile phase thereby providing a simple and low-tech solution to determining the volume of liquid which is easy for a user to perform and which provides an initial value for Isoi’s volume reduction calculations.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Applicant cited Isoi in view of newly cited factual evidence Poole’s Encyclopedia and in further view of newly cited Li (US 20100057377 A1; hereafter “Li”).
Regarding claim 9, which depends on claim 1,
Isoi teaches the mobile phase (mobile-phase) from the at least one mobile phase container (fig. 1, container 6) used for chromatography ([0001], [0024], [0025] “chromatograph”).
Isoi does not explicitly state using the mobile phase as carrier fluid for carrying the fluidic sample during sample separation.
However:
It is still (see analysis of independent claim) the Examiner’s position that Isoi’s chromatography apparatus is for separating (at once so envisaged that a chromatography system utilizing mobile phase inherently/implicitly includes separating). It is further the Examiner's position that utilizing the mobile phase as carrier fluid for carrying the fluidic sample during sample separation is likewise at once so envisaged for a chromatography system utilizing mobile phase, noting that an ordinary artisan would be knowledgeable that the jargon mobile phase implicitly, inherently, and/or definitionally is a carrier fluid.
Furthermore, Li teaches using the mobile phase as carrier fluid for carrying the fluidic sample during sample separation (Title; Abstract “chromatographic systems”; BACKGROUND [0001] “Chromatography is a process that provides for the physical separation, quantification and identification of various analytes in a sample in a single analysis. A chromatography system comprises a number of components, including a separation column that separates the sample into its individual components as the components are passed through the column by a mobile phase. The separation column includes an inlet portion that acts as the interface for input of the sample into a separation column. The mobile phase provides a carrier fluid and driving force to move the components of the sample from the inlet portion of the column to the outlet portion, with the separation of the components dependent on their interactions with an immobilized liquid or solid material within the column (stationary phase) and the mobile phase”).
In view of the above, either one of ordinary skill in the art at the time the invention was effectively filed would at once envisaged that Isoi’s chromatography system having mobile phase would use said mobile phase as a carrier fluid for carrying the fluidic sample during sample separation, 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 perform the routine use—as factually supported by Li—of mobile phase as a carrier fluid for carrying the fluidic sample during sample separation in chromatography thereby providing the expected conventional facilitation of moving the sample in a chromatographic apparatus.
Claim(s) 10-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Applicant cited Isoi in view of newly cited factual evidence Poole’s Encyclopedia and in further view of newly cited Shoykhet.
Regarding claim 10, which depends on method claim 1,
Isoi teaches a sample separation apparatus (liquid chromatography analysis system) for separating a fluidic sample (liquid sample), the sample separation apparatus (liquid chromatography analysis system) comprising:
a fluid drive (not show; means for feeding/pumping/sampling from containers 6; additional obviousness analysis provided) for driving a mobile phase (mobile-phase), provided from the at least one mobile phase container (fig. 1, container 6), and the fluidic sample (liquid sample) when introduced (silent to injector) into the mobile phase (mobile-phase) ([0024] “If the containers 6a to 6d that contain the liquids A to D for analysis are correctly disposed, the analyzer 2 sucks liquids for analysis that are necessary for an analysis operation from the containers 6a to 6d with a feed pump or a sampling needle and uses the sucked liquids. Disposing the containers 6a to 6d includes disposing the containers 6a to 6d at specific positions, or connecting the containers 6a to 6d to specific pipes”); and
a sample separation unit (not shown; sample separation unit at once envisaged as part of liquid chromatography analysis system; additional obviousness analysis provided) for separating the fluidic sample (liquid sample) in the mobile phase (mobile-phase); and
a control device (fig. 1, system controller 10) configured for carrying out or controlling the respective method according to claim 1 (see analysis of independent claim 1) ([0027] “The system controller 10 includes a density storing part 12, a liquid-for-analysis determining part 14, and a warning part 16”; [0034] “the system controller 10 may transmit an instruction to the analyzer 2 so that the analyzer 2 interrupts a current operation, in addition to or instead of the warning”).
Isoi does not explicitly state item 1) that the chromatography apparatus is a separation apparatus comprising a fluid drive and sample separation unit configured to separate the fluidic sample in the mobile phase. Isoi is silent to item 2) an injector for injecting the fluidic sample into the mobile phase.
Regarding items 1) and 2):
The Examiner (again; see independent claim) takes Official Notice that chromatography conventionally uses separation techniques, and the Examiner further takes Official Notice that sample separation units (e.g., chromatography column) are conventional and (definitionally) expected component of chromatography.
Furthermore, and as supporting factual evidence of the aforementioned assertion, Poole’s Encyclopedia teaches “Chromatography is the most widely used separation technique” (Chapter Chromatography, first sentence of Introduction), and further teaches a fluid drive (pump) configured to drive the mobile phase and a sample separation unit (column) configured to separate the fluidic sample in the mobile phase (Introduction second paragraph “Chromatography is essentially a physical method of separation in which the components of a mixture are separated by their distribution between two phases; one of these phases in the form of a porous bed, bulk liquid, layer or film is generally immobile (stationary phase), while the other is a fluid (mobile phase) that percolates through or over the stationary phase. A separation results from repeated sorption/desorption events during the movement of the sample components along the stationary phase in the general direction of mobile-phase migration”; Section Liquid Chromatography “Modern LC employs columns with small particle sizes and high packing density requiring high pressures for operation at useful mobile-phase velocities. Syringe-type or single- or multiple-head reciprocating piston pumps are commonly used to provide the operating pressures needed in configurations that depend on the design of the solvent-delivery system. A single pump is sufficient for isocratic operation. A single pump and electronically operated proportioning valves can be used for continuous variation of the mobile-phase composition (gradient elution) or, alternatively, independent pumps in parallel (commonly two) are used to pump different solvents into a mixing chamber. Between the pump and sample inlet may be a series of devices (check valves, pulse dampers, mixing chambers, flow controllers, pressure transducers, etc.) that correct or monitor pump output to ensure that a homogeneous, pulseless liquid flow is delivered to the column at a known pressure and volumetric flow rate” and “Loop-injection valves situated close to the head of the column are universally used for sample introduction”).
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Moreover, Shoykhet explicitly (substantially/exact same nomenclature) teaches a sample separation apparatus (fig. 1, sample separation apparatus 10) for separating a fluidic sample (fluidic sample) (Title “Identification And Correction Of A Fluid Composition In The Sample Separator”; Abstract “A control device (70) for controlling a sample separation device (10) for separating a fluidic sample using a mobile phase to be supplied according to a target composition, wherein the control device (70) comprises a determination device (152) for determining one for a Is set of mobile phase indicative information is set up, and a correction means (154), which is adapted to at least partially correct an influence of a deviation between the target composition and the actual composition”; page 2 section EPIPHANY first paragraph “object of the invention to operate a sample separation apparatus”), the sample separation apparatus (fig. 1, sample separation apparatus 10) comprising: a control device (fig. 1, control device 70) configured to carry out or control the sample separation apparatus (fig. 1, sample separation apparatus 10), a fluid drive (fig. 1, fluid drive 20) configured to drive the mobile phase (mobile phase) and the fluidic sample (fluidic sample) when injected (via fig. 1, sample application unit / injector device 40) into the mobile phase (mobile phase); and a sample separation unit (fig. 1, sample separator 30) configured to separate the fluidic sample (fluidic sample) in the mobile phase (mobile phase), wherein controlling the sample separation apparatus (fig. 1, sample separation apparatus 10) is based on a result of the determining the density of the mobile phase (mobile phase) (page 8 after middle of page “the fluid drive or fluid pump may be configured to convey the mobile phase through the system”; page 10 last paragraph “fluid pump as a fluid drive 20 containing solvents from a supply unit 25 supplied drives a mobile phase through a sample separator 30 (such as a chromatographic column)”; page 8 after middle of page “The sample separator may include a sample injector for introducing the sample into the fluidic separation path. Such a sample injector may comprise a syringe-dockable injection needle in a corresponding fluid path, which needle may be withdrawn from that seat to receive sample, wherein upon reintroduction of the needle into the seat, the sample is in a fluid path which, for Example, by switching a valve, can be switched into the separation path of the system, which leads to the introduction of the sample in the fluidic separation path”; page 6 about middle of page “the determining means for determining the information indicative of the actual composition by means of a measurement of at least one parameter from the group consisting of a density, a sound wave velocity in, and a viscosity of the mobile phase to be established. If the density, the speed of sound or the viscosity of the individual constituents are known (an empirical calibration curve can preferably be used), the respective proportion of a particular constituent can also be determined from a corresponding measurement of the respective parameter of the mobile phase composed thereof. It is also possible for two or more of the measurements mentioned to be cumulative, simultaneous, supplementary, parallel and / or complementary to determine the actual composition or indicative information. Thereby, the precision of the determination of the actual composition can be further increased”).
In view of the above, either one of ordinary skill in the art at the time the invention was effectively filed would at once envisaged that Isoi’s chromatography is (definitionally) utilized for separating and has the conventional and routine fluid drive, injector, & sample separating unit (see preceding citations in Isoi which suggest to an ordinary artisan that these elements are present or universally expected), 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 include such conventional components—as factually supported by Poole’s Encyclopedia and as further explicitly (nomenclaturally substantially the same as claimed) exemplified by Shoykhet—with Isoi’s chromatography apparatus, and therefore providing the expected results of utilizing well-known & widely used separation techniques with a mobile drive, injector, and sample separation unit for the self-definitional motivation and/or for the expected purpose of analysis, isolation, purification, and/or for distinguishing individual compounds wherein the fluid drive commonsensically is configured to drive the mobile phase and the fluidic sample when injected via injector device into the mobile phase as is well-known in the art. Complementarily, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine Isoi’s mobile phase analysis & associated interruption/warning for improper disposition of mobile phases with Shoykhet’s sample separation apparatus for the expected purpose of likewise assisting with preventing improper disposition of mobile phases and associated waste of material and/or improper chromatographic techniques.
Regarding claim 11, which depends on claim 10,
Isoi teaches wherein the sample separation apparatus (liquid chromatography analysis system) comprises at least one of the following features:
the sample separation apparatus (liquid chromatography analysis system) is configured as an apparatus selected from the group consisting of:
a chromatography sample separation apparatus (liquid chromatography analysis system);
a liquid chromatography sample separation apparatus (liquid chromatography analysis system);
(silent) a gas chromatography sample separation apparatus; and
(silent) a supercritical fluid chromatography sample separation apparatus;
Isoi is silent to: the sample separation apparatus comprises each of an injector configured to inject the fluidic sample into the mobile phase, a detector configured to detect the separated fluidic sample, and a fractionating unit configured to collect separated fractions of the fluidic sample.
Shoykhet teaches: comprising at least one of the following features: the sample separation apparatus (fig. 1, sample separation apparatus 10) is configured as an apparatus selected from the group consisting of: a chromatography sample separation apparatus (fig. 1, sample separation apparatus 10); a liquid chromatography sample separation apparatus (fig. 1, sample separation apparatus 10); a gas chromatography sample separation apparatus (fig. 1, sample separation apparatus 10); and a supercritical fluid chromatography sample separation apparatus (fig. 1, sample separation apparatus 10) (bottom paragraph of page 2 through second paragraph of page 3 “In this context, a fluid is understood as meaning a liquid, a gas, a mixture of a liquid and a gas, a substance in the supercritical state” and “chromatographic sample separation”); the sample separation apparatus (fig. 1, sample separation apparatus 10) comprises each of an injector (fig. 1, sample application unit / injector device 40) configured to inject the fluidic sample (fluidic sample) into the mobile phase (mobile phase); the sample separation apparatus (fig. 1, sample separation apparatus 10) comprises a detector (fig. 1, detector 50) configured to detect the separated fluidic sample (fluidic sample); and the sample separation apparatus (fig. 1, sample separation apparatus 10) comprises a fractionating unit (fig. 1, fractionator 60) configured to collect separated fractions of the fluidic sample (fluidic sample) (page 8 after middle of page “The sample separator may include a sample injector for introducing the sample into the fluidic separation path”; top of page 11 “a detector 50 a flow cell detects separated components of the sample, and a fractionator may be provided to dispense separated components of the sample into dedicated containers; reference claim on top of page 16 “the sample separator ( 10 ) has an injector device ( 40 ) for introducing the fluidic sample into a fluidic path between the fluid drive ( 20 ) and the sample separation device ( 30 )” and “the sample separator ( 10 ) has a detector ( 50 )” and “the sample separator ( 10 ) has a sample fractionator ( 60 ) for fractionating the separated fluidic sample”.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine Shoykhet’s sample separation apparatus having injector, detector, & fractionator with Isoi’s chromatography apparatus therefore providing conventional components having the expected results of utilizing well-known & widely used components in chromatography including for usefully introducing the sample, analyzing the separated sample, and collecting separated components of the sample for further use and/or additional analysis, and thus commonsensically increasing the versatility and marketability of Isoi’s chromatography apparatus. See also preceding combination and motivation analysis provided for preceding claim. It further would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine in the alternative each of gas, liquid, and supercritical versions/applications of chromatography sample separation—as taught by Shoykhet—with Isoi’s method for the increased versatility and marketability within these respective fluid applications.
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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/DAVID L SINGER/Primary Examiner, Art Unit 2855 16FEB2026