1DETAILED 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.
Response to Amendment
The amendments to the claims, specification, and drawings filed 01/23/2026 have been considered and entered.
Response to Arguments
Applicant's arguments filed 01/23/2026 have been fully considered.
Regarding the objection(s) to the drawings, Applicant argued that the amendment overcame said objection(s); the Examiner is in agreement, therefore said objection(s) has/have been withdrawn.
Regarding the objection(s) to the specification, Applicant argued that the amendment overcame said objection(s); the Examiner is in agreement, therefore said objection(s) has/have been withdrawn.
Regarding the 112(b)/2nd indefinite rejection(s) of claim(s) 11, Applicant argued that the amendment overcame said rejection(s); the Examiner is in agreement, therefore said rejection(s) have been withdrawn.
Regarding the 103 prior art obviousness rejections, Applicant argued that while commercial product ÄKTApilot is capable of packing a column, ÄKTApilot does not teach a packing fluid port. The Examiner notes that been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. See MPEP § 2144(II) and Ex parte Masham, 2 USPQ2d - 164 7 (1987). In the present case commercial product ÄKTApilot teaches a port which can be used for packing (Examiner further notes that AKTApilot can also be used for packing columns, which the Examiner will exemplary and conveniently denote as non-sample inputs A1/B1) (Introduction fourth paragraph “AKTApilot can also be used for packing columns”; section 1.3.5 “columns that can be packed with media using AKTApilot”; Reference Information 5.1.1 second paragraph “It can also be used for packing columns”). The Examiner is therefore unpersuaded that commercial product ÄKTApilot does not reasonably teach a port that can be used for packing.
Furthermore, the corresponding Applicant cited ÄKTApilot User Manual explicitly explains the intended use of said denoted port for packing, see especially section 3.3.4 Automated column packing wherein said section explicitly explains that said A1/B1 are to be immersed in the packing solvent (3.3.4 “A1 and B1 in the packing solvent”). The Examiner reasonably concludes that not only would an ordinary artisan at once envisage the port at A1 and/or B1 can be utilized for the intended use of packing as previously put forth by the Examiner, but that this is actually the documented intended use of the commercial product ÄKTApilot as put forth for the user in the User Manual.
Further regarding the 103 prior art obviousness rejections, Applicant argued that one of ordinary skill in the art would recognize that a packing fluid port has a specialized meaning in the art and is structurally and functionally distinguishable from the ordinary fluid port. MPEP 2141(II)(C) states: “Office personnel may rely on their own technical expertise to describe the knowledge and skills of a person of ordinary skill in the art. The Federal Circuit has stated that examiners and administrative patent judges on the Board are “persons of scientific competence in the fields in which they work” and that their findings are “informed by their scientific knowledge, as to the meaning of prior art references to persons of ordinary skill in the art.” In re Berg, 320 F.3d 1310, 1315, 65 USPQ2d 2003, 2007 (Fed. Cir. 2003). In addition, examiners “are assumed to have some expertise in interpreting the references and to be familiar from their work with the level of skill in the art.” PowerOasis, Inc. v. T-Mobile USA, Inc., 522 F.3d 1299, 86 USPQ2d 1385 (Fed. Cir. 2008) (quoting Am. Hoist & Derrick Co. v. Sowa & Sons, 725 F.2d 1350, 1360, 220 USPQ 763, 770 (Fed. Cir. 1984). See MPEP § 2141 for a discussion of the level of ordinary skill.” In the present case, the Examiner utilized ordinary skill in the art to reasonably interpreted that a port that can be used for packing as nomenclaturally a packing port, and the corresponding Applicant cited ÄKTApilot User Manual explicitly supports this intended use.
Furthermore, MPEP § 2111 requires that during patent examination, the pending claims must be given their broadest reasonable interpretation consistent with the specification, and an Examiner must construe claim terms in the broadest reasonable manner during prosecution as is reasonably allowed in an effort to establish a clear record of what applicant intends to claim. The Examiner verified the meaning of “packing port” in the specification to see if a special definition precluded the plain meaning. No such special definition was found. The Examiner did find (bold added for emphasis):
Snippet of fig. 2 for quick reference:
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[0072] The chromatography apparatus 400 may further comprise an intelligent packing fluid port or packing fluid port 150 configured to be coupled to a packing port of the first column 441 or the second column 442. The chromatography apparatus 400 may further comprise a waste fluid port 160 configured to be coupled to a waste reservoir or drain.
Wherein the exemplified instant figure 2 according to one or more embodiments of the instant disclosure ([0017]) has 150 as the packing fluid port leading to membrane valve 250. The Examiner identifies that the plain meaning of packing fluid port includes a port utilized for packing. As commercial product ÄKTApilot likewise teaches a fluid port (e.g., A1/B1) that can be utilized for (and is further document for such use in the User Manual) for packing. Therefore, the Examiner is unpersuaded by Applicant’s arguments pertaining to the claimed packing fluid port being structurally and functionally distinguishable from the “ordinary” fluid port that ÄKTApilot has for packing.
Yet further regarding the 103 prior art obviousness rejections, Applicant argued that the Examiner’s broad reading of the claim term/phrase “packing fluid port” does not meet Applicant’s meaning that the packing port of the valve unit is coupled directly to the packing port of the column for the special function of introducing hydraulic liquid into the hydraulic chamber of the column to control the movement of the adapter of the column to compress the consolidated bed for bed compression when receiving an instruction of bed compression as Applicant’s specification describes. MPEP § 2111.01(II) IT IS IMPROPER TO IMPORT CLAIM LIMITATIONS FROM THE SPECIFICATION states in part (bold for emphasis):
Though understanding the claim language may be aided by explanations contained in the written description, it is important not to import into a claim limitations that are not part of the claim. For example, a particular embodiment appearing in the written description may not be read into a claim when the claim language is broader than the embodiment.” Superguide Corp. v. DirecTV Enterprises, Inc., 358 F.3d 870, 875, 69 USPQ2d 1865, 1868 (Fed. Cir. 2004). See also Liebel-Flarsheim Co. v. Medrad Inc., 358 F.3d 898, 906, 69 USPQ2d 1801, 1807 (Fed. Cir. 2004) (discussing recent cases wherein the court expressly rejected the contention that if a patent describes only a single embodiment, the claims of the patent must be construed as being limited to that embodiment); E-Pass Techs., Inc. v. 3Com Corp., 343 F.3d 1364, 1369, 67 USPQ2d 1947, 1950 (Fed. Cir. 2003) (“Interpretation of descriptive statements in a patent’s written description is a difficult task, as an inherent tension exists as to whether a statement is a clear lexicographic definition or a description of a preferred embodiment. The problem is to interpret claims ‘in view of the specification’ without unnecessarily importing limitations from the specification into the claims.”); Altiris Inc. v. Symantec Corp., 318 F.3d 1363, 1371, 65 USPQ2d 1865, 1869-70 (Fed. Cir. 2003).
As put forth within MPEP § 2111.01(I) THE WORDS OF A CLAIM MUST BE GIVEN THEIR “PLAIN MEANING” UNLESS SUCH MEANING IS INCONSISTENT WITH THE SPECIFICATION, the presumption that a term is given its ordinary and customary meaning may be rebutted by the applicant by clearly setting forth a different definition of the term in the specification. Therefore, the Examiner’s examination of the claim is only in view of the specification, and does not import Applicant’s disclosed embodiment—including of direct coupling to the packing port of the column—to construe the claims as being so limited by said embodiment.
Furthermore, in response to Applicant's argument that the references fail to show certain feature(s) of the invention, it is noted that the feature(s) upon which Applicant relies (e.g., packing port of column, adapter, hydraulic chamber, water, so-called intelligent packing) is/are not recited in the rejected claim(s). Although the claim(s) is/are interpreted in light of the specification, limitations from the specification are not read into the claim(s). See MPEP § 2145(VI) and In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). In the present case, Applicant’s claims are directed to a valve unit configured to be coupled to a column, and commercial product ÄKTApilot’s port which can be used for packing is likewise part of a valve unit configured to be coupled to a column including for packing (see preceding citations).
Even yet further regarding the 103 prior art obviousness rejections, Applicant argued that the instant packing is controlled automatically by the valve system until the packing factor is reached without interrupting the introduction of the hydraulic liquid unlike commercial product ÄKTApilot. The Examiner again notes that words must generally be given their plain meaning and that it is improper to import the specification (e.g., automated packing) into the claims (see preceding discussion for details). Additionally, the Examiner notes that the corresponding User Manual for the commercial product ÄKTApilot explicitly explains that the “system controls the flow and the pressure during the packing procedure, and hence provides automated and unattended column packing” (see section 3.3.4 Automated column packing). The Examiner is therefore unpersuaded by Applicant’s unclaimed generic automation difference argument.
The Examiner notes with respect to Applicant’s arguments pertaining to a special packing fluid configuration, that Applicant is welcome to propose after final claim amendments pertaining to limitations clarifyingly and more narrowly claiming the particular (so-called intelligent) special packing fluid configuration discussed in the specification in order to receive an advisory action comprising a cursory review by the Examiner as to whether such proposed claim amendments would likely be sufficient to overcome the prior art.
Also regarding the 103 prior art obviousness rejections, Applicant argued that the proposed modification to modify commercial product ÄKTApilot’s channels to be integrated internal channels as taught by secondary reference Jovanovich’s monolithic fluidic device with valves and channels was impermissible and would fundamentally change the manner in which ports and channels thereof are controlled. MPEP § 2143.01(VI) states “If the proposed modification or combination of the prior art would change the principle of operation of the prior art invention being modified, then the teachings of the references are not sufficient to render the claims prima facie obvious”, see also In re Ratti, 270 F.2d 810, 813, 123 USPQ 349, 352 (CCPA 1959). In the present case, it remains the Examiner’s position that the combination would still be able to perform the operation of automated liquid chromatography, and whereas the modification would affect the recommended facilitation of sanitization compliance, the issue would be mitigated by the absence of contaminable tubes and the need to so replace such disposable parts. Further, secondary reference Jovanovich is insensitive to contamination and dead volumes ([0105] “low dead volumes” and “the disclosure herein provides methods and the ability to create complex micro-, nano-, and pico-fluidic circuits on chips, and allows the implementation of virtually any reaction or assay onto a chip. In general, this technology can be at least substantially insensitive to variations in solution ionic strength and surface contamination, and does not require applied electric fields”), and there does not appear to be a substantial reason for concern that modification to include the monolithic channel design of Jovanovich would introduce insurmountable contamination issues affecting the operability requiring external accessibility, further including that the commercial product ÄKTApilot’s device would still be useful where such compliance was not required, and/or single-use/disposable replacement as a whole was still possible, etc., see interview summary dated 09/19/2022 in the parent application (16/648,296).
Furthermore, with respect to the combination, the Examiner notes as substantially previously put forth in the parent application with respect to Applicant’s similar arguments that the modification is based on replacement of tubes of the commercial product ÄKTApilot device with the single microfluidic device of Jovanovich, that it has been held that a mere change in size is generally recognized as being within the level of ordinary skill in the art, see MPEP 2144.04(IV)(A), In re Rose, 105 USPQ 237 (CCP A 1955), In re Rinehart, 531 F.2d 1048, 189 USPQ 143 (CCPA 1976), and Gardnerv.TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984). In the present case while the AKTA device as a whole is macroscopic, Jovanovich’s device is also as a whole macroscopic (see e.g., [0083] “4 inch diameter”, which Examiner notes is about 12.5 inches squared). The Examiner further notes that Jovanovich’s “micro” channels can have diameters of 5000 microns ([0156] “5000”) which the Examiner notes is 5 millimeters which is larger than commercial product ÄKTApilot’s “macro” device channel tubing of about 3 millimeters section 3.1.1 of Handbook “i.d. 2.9mm”). The Examiner respectfully concludes that Applicant’s previous arguments pertaining to size were not persuasive, and that only ordinary skill in the art is required to likewise form/etch channels in commercial product ÄKTApilot’s macroscopic device.
Likewise as substantially previously put forth in the parent application, Applicant had previously argued that the Examiner did not establish that the facts underlying the case law pertaining to forming in one piece an article which has been formerly been formed in two pieces and put together is sufficiently similar to the present facts of the combination, and Applicant had further previously argued that relying on monolithically forming the multiple pieces of the housing and the channels together as monolithic (one piece) is improper because it is not combining multiple tubes into a single tube In the present case, Jovanovich provides insight, understanding, and expectations for providing a monolithic structure with channels instead of several parts (hoses, clamps/fittings, etc. rigidly secured together to the valve assembly), and the use of the prior art taught one-piece construction would be of ordinary engineering skill having at least the advantages as put forth by Jovanovich. See also Conclusion in Final Office Action dated 06/30/2022 of the parent application providing additional pertinent art demonstrating the ordinary skill of making integral channels, as well as the additional pertinent prior art in the Conclusion of the later Non-Final Rejection dated 10/24/2022 of said parent application demonstrating the ordinary skill of interchanging hoses and cavities for fluidic channels. The Examiner is therefore still not persuaded that there is insufficient establishment of facts pertaining to the ordinary skill in monolithic channel design for the combination.
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Additionally pertaining to the 103 prior art obviousness rejections, Applicant alluded to the modification by Bisschops as rendering the combination fundamentally inoperable and having no teaching/suggestion/motivation to so modify. However, this argument is merely an assertion and lacks the necessary supporting evidence. MPEP § 2145(I) states:
Attorney argument is not evidence unless it is an admission, in which case, an examiner may use the admission in making a rejection. See MPEP § 2129 and § 2144.03 for a discussion of admissions as prior art.
The arguments of counsel cannot take the place of evidence in the record. In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965); In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997) (“An assertion of what seems to follow from common experience is just attorney argument and not the kind of factual evidence that is required to rebut a prima facie case of obviousness.”). See MPEP § 716.01(c) for examples of attorney statements which are not evidence and which must be supported by an appropriate affidavit or declaration.
In the present case, commercial product ÄKTApilot teaches a membrane valve (Membrane valve) of a waste fluid port (Waste F1; likewise for Waste 2) and secondary reference Bisschops teaches Bisschops teaches wherein a fluid channel (central duct; labeled as 2 in other figures for reference) defined within a body connects a fluid inlet (see one of arrows pointing into the manifold 1) to a valve (valve of a different inlet into the manifold 1) of a fluid port and a valve of a waste fluid port (see arrow pointing outward as waste) is substantially linear ([0058] “valve manifold”; [0059]), 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 Bisschops linear channel in a body connecting multiple inputs and outputs with commercial product ÄKTApilot’s valve having inlets and further including/rearranging a waste port therewith, thereby providing the expected advantages of convenient singular location for consolidating inlets and outlets for connection/replacement, avoiding drops of pressure from deviations in linearity within said linear channel of said manifold body, and/or which further facilitates cleaning of said manifold valve portion between the inlets and the waste outlet (see rejections for full details). The Examiner emphasizes that only ordinary skill in the art is required to rearrange and/or further integrate a waste outlet with commercial product ÄKTApilot’s already integrated inlets in the integrated valve comprising portion (see figures shown above for convenience of understanding). Therefore, the prior art rejection is retained. See also In re Pearson, 494 F.2d 1399, 1405 (CCPA 1974) (“Attorney’s argument in a brief cannot take the place of evidence").
For all of the above reasons and for the reasons as put forth in the rejections themselves, the Examiner retains the prior art rejections.
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) 1-12 and 14-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over General Electric’s commercial product ÄKTApilot as factually supported by Applicant previously cited non-patent literature (NPL) Instrument Handbook (hereinafter “AKTA”) and as further factually supported by Applicant previously cited to record NPL User Manual (hereinafter “AKTA User Manual”) in view of Applicant previously cited Jovanovich et al (US 20100165784 A1; hereafter “Jovanovich”) and in further view of previously cited Bisschops et al (US 20100144028 A1; hereafter “Bisschops”).
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Regarding independent claim 1,
A valve unit (components shown in fig. 5-2; see fig. 5-6 for flow path) for a chromatography apparatus (AKTApilot) (section 1.2. “chromatography system”), the valve unit (components shown in fig. 5-2; see fig. 5-6 for flow path) comprising:
a fluid inlet (inlet for fluid comprising for samples 1-4, A1-A4, and/or B1-B4; noting that Samples 1-4 are inlet through to 2, whereas A1-A4 & B1-B4 are inlet through to 1 in liquid flow path; Examiner further notes that AKTApilot can also be used for packing columns, which the Examiner will exemplary and conveniently denote as non-sample inputs A1/B1) configured to receive an input fluid,
a fluid outlet (outlet for fluid comprising Outlet valves V8 & V9) configured to provide an output fluid,
a first pair (pair of ports for Column 1) of fluid ports configured to be coupled to a first column (Column 1),
a second pair (pair of ports for Column 2) of fluid ports configured to be coupled to a second column (Column 2) (Columns 1 & 2 shown between Column valves V6 & V7 with respective ports each in fig. 5-6), and
a coupling valve assembly (assembly for coupling valves shown in figs. 5-2 & 5-6) configured to direct fluid between a selection of the fluid inlet (inlet for fluid comprising for samples 1-4, A2-A4, and/or B2-B4), the fluid outlet (outlet for fluid comprising Outlet valves V8 & V9), the first pair (pair of ports for Column 1) of fluid ports and the second pair (pair of ports for Column 2) of fluid ports in response to one or more control signals (section 1.2.1 “UNICORN'" control system controls and supervises the AKTApilot chromatography system”),
wherein the coupling valve assembly (assembly for coupling valves shown in figs. 5-2 & 5-6) is configured to direct fluid using a selection of membrane valves (Membrane valves) coupled by fluid channels (fluid channels connecting the Membrane valves) (assembly for coupling valves shown in figs. 5-2 & 5-6) (see section 1.3, subsection “Membrane valves”), and
wherein said fluid channels (fluid channels connecting the Membrane valves) connect the fluid inlet (inlet for fluid comprising for samples 1-4, A2-A4, and/or B2-B4) to a membrane valve (Membrane valve) of a packing fluid port (port chosen to be used for packing; Examiner denoting for exemplary convenience as corresponding to A1 and/or B1) (Introduction fourth paragraph “AKTApilot can also be used for packing columns”; section 1.3.5 “columns that can be packed with media using AKTApilot”; Reference Information 5.1.1 second paragraph “It can also be used for packing columns”) and a membrane valve (Membrane valve) of a waste fluid port (Waste F1; likewise for Waste 2), and wherein one of said fluid channels (indirectly; additional analysis is provided for narrower interpretation of directly) connecting the fluid inlet to a membrane valve of a packing fluid port and a membrane valve of a waste fluid port is substantially linear (fluid channels are inclusive of lines starting/ending at valves; see figs. 1-1, 5-2, & 5-6, and especially unlabeled membrane valve block diagrams in 5.2.2 which comprise linear channel between valves which are part of the connection; additional obviousness analysis provided for narrower interpretation of this limitation).
AKTA does not teach item: 1) wherein (all of) the fluid channels are defined within a body of the coupling valve assembly.
Regarding item 1) and pertinent to channel portions:
The Examiner respectfu0lly notes that it has been held that forming in one piece an article which has formerly been formed in two pieces and put together involves only routine skill in the art, Howard v. Detroit Stove Works, 150 U.S. 164 (1893); see also In re Larson, 340 F.2d 965, 968, 144 USPQ 347, 349 (CCPA 1965), and MPEP § 2144.04 (V)(B). In the present case, only ordinary skill in the art is required to define fluidic channels integrally within a fluidic assembly body.
Furthermore, Jovanovich teaches wherein channels are defined in the body of an assembly (bold for emphasis: [0085] “In the case of devices comprising diaphragm valves, a monolithic device comprises a single actuation layer (e.g., elastic layer) functioning as a diaphragm for a plurality of valves. In certain embodiments, one actuation channel can operate a plurality of valves on a monolithic device, e.g., valves in different fluidic circuits. This allows parallel activation of many fluidic circuits. Monolithic devices can have dense arrays of microfluidic circuits. These circuits function with high reliability, in part because the channels in each circuit are fabricated simultaneously on a single substrate, rather than being made independently and assembled together”; Title “INSTRUMENT WITH MICROFLUIDIC CHIP”).
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 integrate and form commercial product ÄKTApilot’s body as a monolithic fluidic circuit—as supported by Jovanovich’s monolithic fluidic device with valves and channels—thereby providing the expected advantages of being highly reliable as well as saving time by avoiding independent manufacture and assembly. The Examiner additionally notes with regards to the combination that avoiding unnecessary dead, stationary, or stagnant legs is a commonsensical advantage, and that an ordinary artisan before the effective filing date of the claimed invention would have found it obvious to not unnecessarily add forks and branches in the combination.
For compact prosecution, the Examiner further addresses narrower interpretation of the linear connecting channel:
AKTA does not teach item 2): wherein one of said fluid channels that directly connects the fluid inlet to the valve of the packing fluid port and the valve of the waste fluid port is substantially linear.
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Regarding item 2) and further pertinent to item 1):
Bisschops teaches wherein a fluid channel (central duct; labeled as 2 in other figures for reference) defined within a body connects a fluid inlet (see one of arrows pointing into the manifold 1) to a valve (valve of a different inlet into the manifold 1) of a packing fluid port (Examiner denotes port of a separate different fluid inlet can be denoted as useful for packing operation of shown column) ([0020] “packing” and “packed”) and a valve (valve in manifold 1 pertaining to arrow pointing outward therefrom) of a waste fluid port (Examiner denotes port of said valve of manifold 1 with arrow pointing outward as waste) is substantially linear ([0058] “The valve manifold is used to select the appropriate solution from the storage containers (not drawn) and to direct the cartridge effluent to either waste or product collection container (not drawn). During normal operation, the central valve 6 of the valve manifold 1 is closed. This scheme can involve as many inlets and outlets as required for the separation”; [0059] “manifold is preferably of the type illustrated with reference to FIG. 6-FIG. 10”).
The Examiner additionally notes that it has been held that forming in one piece an article which has formerly been formed in two pieces and put together involves only routine skill in the art, Howard v. Detroit Stove Works, 150 U.S. 164 (1893); see also In re Larson, 340 F.2d 965, 968, 144 USPQ 347, 349 (CCPA 1965), and MPEP § 2144.04 (V)(B). Furthermore, it has been held that rearranging parts of an invention involves only routine skill in the art, In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950), In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975), and see MPEP § 2144.04(VI)(C). In the present case, in the present case, only ordinary skill in the art is required to place a waste outlet with commercial product ÄKTApilot’s inlets.
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 Bisschops linear channel in a body connecting multiple inputs and outputs with commercial product ÄKTApilot’s valve having inlets and further including/rearranging a waste port therewith, thereby providing the expected advantages of convenient singular location for consolidating inlets and outlets for connection/replacement, avoiding drops of pressure from deviations in linearity within said linear channel of said manifold body, and/or which further facilitates cleaning of said manifold valve portion between the inlets and the waste outlet.
The Examiner notes that Applicant has argued (see Remarks dated 01/23/2026) that commercial product ÄKTApilot by General Electric does not comprise a packing fluid port. However, commercial product ÄKTApilot comprises a port (previously exemplary denoted as A1/B1 by Examiner) that can be used as a packing fluid port (ÄKTApilot Instrument Handbook: Introduction fourth paragraph “AKTApilot can also be used for packing columns”; section 1.3.5 “columns that can be packed with media using AKTApilot”; Reference Information 5.1.1 second paragraph “It can also be used for packing columns”) which is at once understood by an ordinary artisan, and the Examiner now further cites for explicit explained factual support of said commercial product ÄKTApilot the corresponding ÄKTApilot User Manual including section 3.3.4 Automated column packing, said section explaining that said A1/B1 (Examiner emphasizes these are the same membrane ports as previously cited by the Examiner as exemplary usable therefor) are to be immersed in the packing solvent (3.3.4 “A1 and B1 in the packing solvent”).
Regarding claim 2, which depends on claim 1,
AKTA teaches wherein the first pair (pair of ports for Column 1) of fluid ports comprises a first fluid port (first fluid port of Column 1) configured to be coupled to a top part (top part of Column 1) of the first column (Column 1) and a second fluid port (second fluid port of Column 1) configured to be coupled to a bottom part (bottom part of Column 1) of the first column (Column 1), wherein the second pair (pair of ports for Column 2) of fluid ports comprises a third fluid port (third fluid port of Column 2) configured to be coupled to a top part (top part of Column 2) of the second column (Column 2) and a fourth fluid port (fourth fluid port of Column 2) configured to be coupled to a bottom part (bottom part of Column 2) of the second column (Column 2) (see fig. 5-6, showing the respective top & bottom ports for the two columns).
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Regarding claim 3, which depends on claim 2,
AKTA teaches wherein the coupling valve assembly (assembly for coupling valves shown in figs. 5-2 & 5-6) is configured, in response to a first control signal (control via UNICORN control system), to couple the fluid inlet (inlet for fluid comprising for samples 1-4, A1-A4, and/or B1-B4) to the first fluid port (first fluid port of Column 1) and to couple the second fluid port (second fluid port of Column 1) to the fluid outlet (outlet for fluid comprising Outlet valves V8 & V9) (see possible flow paths by arrowed lines in fig. 5-6; see also Table 5-3 From-To Locations information; see Flowpath Instructions figure).
Regarding claim 4, which depends on claim 2,
AKTA teaches wherein the coupling valve assembly (assembly for coupling valves shown in figs. 5-2 & 5-6) is configured to, in response to a second control signal (control via UNICORN control system), couple the fluid inlet (inlet for fluid comprising for samples 1-4, A1-A4, and/or B1-B4) to the third fluid port (third fluid port of Column 2) and to couple the fourth fluid port (fourth fluid port of Column 2) to the fluid outlet (outlet for fluid comprising Outlet valves V8 & V9) (see possible flow paths by arrowed lines in fig. 5-6; see also Table 5-3 From-To Locations information; see Flowpath Instructions figure).
Regarding claim 5, which depends on claim 2,
AKTA teaches wherein the coupling valve assembly (assembly for coupling valves shown in figs. 5-2 & 5-6) is configured to, in response to a third control signal (control via UNICORN control system), couple the fluid inlet (inlet for fluid comprising for samples 1-4, A1-A4, and/or B1-B4) to the second fluid port (second fluid port of Column 1) and to couple the first fluid port (first fluid port of Column 1) to the fluid outlet (outlet for fluid comprising Outlet valves V8 & V9) (see possible flow paths by arrowed lines in fig. 5-6; see also Table 5-3 From-To Locations information; see Flowpath Instructions figure).
Regarding claim 6, which depends on claim 2,
AKTA teaches wherein the coupling valve assembly (assembly for coupling valves shown in figs. 5-2 & 5-6) is configured to, in response to a fourth control signal (control via UNICORN control system), couple the fluid inlet (inlet for fluid comprising for samples 1-4, A1-A4, and/or B1-B4) to the fourth fluid port (fourth fluid port of Column 2) and to couple the third fluid port (third fluid port of Column 2) to the fluid outlet (outlet for fluid comprising Outlet valves V8 & V9) (see possible flow paths by arrowed lines in fig. 5-6; see also Table 5-3 From-To Locations information; see Flowpath Instructions figure).
Regarding claim 7, which depends on claim 2,
AKTA teaches wherein the coupling valve assembly (assembly for coupling valves shown in figs. 5-2 & 5-6) is configured to, in response to a fifth control signal (control via UNICORN control system), couple the fluid inlet (inlet for fluid comprising for samples 1-4, A1-A4, and/or B1-B4) to the first fluid port (first fluid port of Column 1), couple the second fluid port (second fluid port of Column 1) to the third fluid port (third fluid port of Column 2), and couple the fourth fluid port (fourth fluid port of Column 2) to the fluid outlet (outlet for fluid comprising Outlet valves V8 & V9) (see possible flow paths by arrowed lines in fig. 5-6; see also Table 5-3 From-To Locations information; see Flowpath Instructions figure).
Regarding claim 8, which depends on claim 2,
AKTA teaches wherein the coupling valve assembly (assembly for coupling valves shown in figs. 5-2 & 5-6) is configured to, in response to a sixth control signal (control via UNICORN control system), couple the fluid inlet (inlet for fluid comprising for samples 1-4, A1-A4, and/or B1-B4) to the third fluid port (third fluid port of Column 2), couple the fourth fluid port (fourth fluid port of Column 2) to the first fluid port (first fluid port of Column 1), and couple the second fluid port (second fluid port of Column 1) to the fluid outlet (outlet for fluid comprising Outlet valves V8 & V9) (see possible flow paths by arrowed lines in fig. 5-6; see also Table 5-3 From-To Locations information; see Flowpath Instructions figure).
Regarding claim 9, which depends on claim 1,
AKTA teaches wherein the coupling valve assembly (assembly for coupling valves shown in figs. 5-2 & 5-6) is configured to, in response to a seventh control signal (control via UNICORN control system), an eighth control signal (control via UNICORN control system) or a ninth control signal (control via UNICORN control system), couple the fluid inlet (inlet for fluid comprising for samples 1-4, A1-A4, and/or B1-B4) to the fluid outlet (outlet for fluid comprising Outlet valves V8 & V9) (see possible flow paths by arrowed lines in fig. 5-6; see also Table 5-3 From-To Locations information; see Flowpath Instructions figure).
Regarding claim 10, which depends on claim 1,
AKTA teaches wherein the coupling valve assembly (assembly for coupling valves shown in figs. 5-2 & 5-6) further comprises a waste fluid port (Waste F1; likewise for Waste 2) and the coupling valve assembly (assembly for coupling valves shown in figs. 5-2 & 5-6) is configured to, in response to a tenth control signal (control via UNICORN control system), couple the fluid inlet (inlet for fluid comprising for samples 1-4, A1-A4, and/or B1-B4) to the waste fluid port (Waste F1; likewise for Waste 2) (see possible flow paths by arrowed lines in fig. 5-6; see also Table 5-3 From-To Locations information; see Flowpath Instructions figure).
Regarding claim 11, which depends on claim 1,
AKTA teaches wherein the fluid channels (fluid channels connecting the Membrane valves) comprise a direct shape following a line having no branches or forks between a start point of the line and an end point of the line to avoid dead/stationary/stagnant legs (fluid channels are inclusive of lines starting/ending at valves and having neither branches nor forks therebetween). The Examiner additionally notes with regards to the previous combination (see independent claim) that avoiding unnecessary dead, stationary, or stagnant legs is a commonsensical advantage, and that an ordinary artisan before the effective filing date of the claimed invention would have found it obvious to not unnecessarily add forks and branches in the combination.
Regarding claim 12, which depends on claim 1,
AKTA teaches wherein the coupling valve assembly (assembly for coupling valves shown in figs. 5-2 & 5-6) further comprises a first pressure sensor (Pressure sensor 1; likewise for Pressure sensor 3) coupled to the fluid inlet (inlet for fluid comprising for samples 1-4, A1-A4, and/or B1-B4) and configured to measure a first pressure of the received fluid and a second pressure sensor (Pressure sensor 4) coupled to the fluid outlet (outlet for fluid comprising Outlet valves V8 & V9) and configured to measure a second pressure of the provided fluid.
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Regarding claim 14, which depends on claim 1,
AKTA as modified (see analysis of independent claim) suggests a chromatography apparatus (AKTApilot system best shown in fig. 1/5-1; valve unit components shown in fig. 5-2; see fig. 5-6 for flow path) (section 1.2/5.1.1 “chromatography system”), the chromatography apparatus (AKTA) comprising:
the valve unit (components shown in fig. 5-2; see fig. 5-6 for flow path; Jovanovich teaches the channels defined in a body) according to claim 1, the Examiner explicitly noting that the aforementioned valve unit (claim 1) is comprising:
a fluid inlet (inlet for fluid comprising for samples 1-4, A1-A4, and/or B1-B4; noting that Samples 1-4 are inlet through to 2, whereas A1-A4 & B1-B4 are inlet through to 1 in liquid flow path; Examiner further notes that AKTApilot can also be used for packing columns, which the Examiner will exemplary and conveniently denote as non-sample inputs A1/B1) configured to receive an input fluid,
a fluid outlet (outlet for fluid comprising Outlet valves V8 & V9) configured to provide an output fluid,
a first pair (pair of ports for Column 1) of fluid ports configured to be coupled to a first column (Column 1),
a second pair (pair of ports for Column 2) of fluid ports configured to be coupled to a second column (Column 2) (Columns 1 & 2 shown between Column valves V6 & V7 with respective ports each in fig. 5-6), and
a coupling valve assembly (assembly for coupling valves shown in figs. 5-2 & 5-6) configured to direct fluid between a selection of the fluid inlet (inlet for fluid comprising for samples 1-4, A2-A4, and/or B2-B4), the fluid outlet (outlet for fluid comprising Outlet valves V8 & V9), the first pair (pair of ports for Column 1) of fluid ports and the second pair (pair of ports for Column 2) of fluid ports in response to one or more control signals (section 1.2.1 “UNICORN'" control system controls and supervises the AKTApilot chromatography system”),
wherein the coupling valve assembly (assembly for coupling valves shown in figs. 5-2 & 5-6) is configured to direct fluid using a selection of membrane valves (Membrane valves) coupled by fluid channels defined (as suggested by Jovanovich’s monolithic formation) within a body of the coupling valve assembly (assembly for coupling valves shown in figs. 5-2 & 5-6) (see section 1.3, subsection “Membrane valves”), and
wherein said fluid channels (fluid channels connecting the Membrane valves) connect the fluid inlet (inlet for fluid comprising for samples 1-4, A2-A4, and/or B2-B4; Examiner exemplary emphasizes at least A2-A4) to a membrane valve (Membrane valve) of a packing fluid port (port chosen to be used for packing; Examiner denoting for exemplary convenience as corresponding to A1 and/or B1) and a membrane valve (Membrane valve) of a waste fluid port (Waste F1; likewise for Waste 2), and wherein one of said fluid channels (see analysis of independent claim) connecting the fluid inlet (inlet for fluid comprising for samples 1-4, A1-A4, and/or B1-B4; noting that Samples 1-4 are inlet through to 2, whereas A1-A4 & B1-B4 are inlet through to 1 in liquid flow path) to a membrane valve (Membrane valve) of a packing fluid port (port chosen to be used for packing; Examiner denoting for exemplary convenience as corresponding to A1 and/or B1) and a membrane valve (Membrane valve) of a waste fluid port is substantially linear (fluid channels are inclusive of lines starting/ending at valves; see figs. 1-1, 5-2, & 5-6, and especially unlabeled membrane valve block diagrams in 5.2.2 which comprise linear channel between valves which are part of the connection; see obviousness analysis over Bisschops, the Examiner emphasizing the obviousness of combining at least A1-A4 with a waste outlet along a linear channel in a manifold).
(addressing further limitations of claim 14) the valve unit (components shown in fig. 5-2; see fig. 5-6 for flow path) further comprising
the fluid inlet (inlet for fluid comprising for samples 1-4, A1-A4, and/or B1-B4) coupled to the reservoir (reservoir for said fluids),
the fluid outlet (outlet for fluid comprising Outlet valves V8 & V9) configured to provide the output fluid,
the first pair (pair of ports for Column 1) of fluid ports comprising a first fluid port (first fluid port of Column 1) configured to be coupled to a top part (top part of Column 1) of the first column (Column 1),
the first pair (pair of ports for Column 1) of fluid ports comprising a second fluid port (second fluid port of Column 1) configured to be coupled to a bottom part (bottom part of Column 1) of the first column (Column 1),
the second pair (pair of ports for Column 2) of fluid ports comprising
a third fluid port (third fluid port of Column 2) configured to be coupled to a top part (top part of Column 2) of the second column (Column 2) and
a fourth fluid port (fourth fluid port of Column 2) configured to be coupled to a bottom part (bottom part of Column 2) of the second column (Column 2), and
a control unit (Computer running UNICORN) comprising circuitry (circuitry of Computer) comprising:
a processor (Computer processor), and a memory (Computer memory), said memory (Computer memory) containing instructions executable by said processor (Computer processor), whereby said chromatography apparatus (AKTApilot system is operative to control the valve unit (components shown in fig. 5-2; see fig. 5-6 for flow path) to direct fluid between a selection of the fluid inlet (inlet for fluid comprising for samples 1-4, A1-A4, and/or B1-B4), the fluid outlet (outlet for fluid comprising Outlet valves V8 & V9), the first fluid port (first fluid port of Column 1), the second fluid port (second fluid port of Column 1), the third fluid port (third fluid port of Column 2) and the fourth fluid port (fourth fluid port of Column 2) by sending one or more control signals (control via UNICORN control system) to the valve unit (components shown in fig. 5-2; see fig. 5-6 for flow path) (see possible flow paths by arrowed lines in fig. 5-6; see also Table 5-3 From-To Locations information; see Flowpath Instructions figure on page 73).
Regarding claim 15, which depends on claim 14,
AKTA teaches wherein the chromatography apparatus (AKTApilot system) is further operative to control the valve unit (components shown in fig. 5-2; see fig. 5-6 for flow path) by sending a first control signal (control via UNICORN control system) to control the valve unit (components shown in fig. 5-2; see fig. 5-6 for flow path) to couple the fluid inlet (inlet for fluid comprising for samples 1-4, A1-A4, and/or B1-B4) to the first fluid port (first fluid port of Column 1) and to couple the second fluid port (second fluid port of Column 1) to the fluid outlet (outlet for fluid comprising Outlet valves V8 & V9) (see possible flow paths by arrowed lines in fig. 5-6; see also Table 5-3 From-To Locations information; see Flowpath Instructions figure).
Regarding claim 16, which depends on claim 14,
AKTA teaches wherein the chromatography apparatus (AKTApilot system) is further operative to control the valve unit (components shown in fig. 5-2; see fig. 5-6 for flow path) by sending a second control signal (control via UNICORN control system) to control the valve unit (components shown in fig. 5-2; see fig. 5-6 for flow path) to couple the fluid inlet (inlet for fluid comprising for samples 1-4, A1-A4, and/or B1-B4) to the third fluid port (third fluid port of Column 2) and to couple the fourth fluid port (fourth fluid port of Column 2) to the fluid outlet (outlet for fluid comprising Outlet valves V8 & V9) (see possible flow paths by arrowed lines in fig. 5-6; see also Table 5-3 From-To Locations information; see Flowpath Instructions figure).
Regarding claim 17, which depends on claim 14,
AKTA teaches wherein the chromatography apparatus (AKTApilot system) is further operative to control the valve unit (components shown in fig. 5-2; see fig. 5-6 for flow path) by sending a third control signal (control via UNICORN control system) to control the valve unit (components shown in fig. 5-2; see fig. 5-6 for flow path) to couple the fluid inlet (inlet for fluid comprising for samples 1-4, A1-A4, and/or B1-B4) to the second fluid port (second fluid port of Column 1) and to couple the first fluid port (first fluid port of Column 1) to the fluid outlet (outlet for fluid comprising Outlet valves V8 & V9) in response to a third control signal (control via UNICORN control system) (see possible flow paths by arrowed lines in fig. 5-6; see also Table 5-3 From-To Locations information; see Flowpath Instructions figure).
Regarding claim 18, which depends on claim 14,
AKTA teaches wherein the chromatography apparatus (AKTApilot system) is further operative to control the valve unit (components shown in fig. 5-2; see fig. 5-6 for flow path) by sending a fourth control signal (control via UNICORN control system) to control the valve unit (components shown in fig. 5-2; see fig. 5-6 for flow path) to couple the fluid inlet (inlet for fluid comprising for samples 1-4, A1-A4, and/or B1-B4) to the fourth fluid port (fourth fluid port of Column 2) and to couple the third fluid port (third fluid port of Column 2) to the fluid outlet (outlet for fluid comprising Outlet valves V8 & V9) (see possible flow paths by arrowed lines in fig. 5-6; see also Table 5-3 From-To Locations information; see Flowpath Instructions figure).
Regarding claim 19, which depends on claim 14,
AKTA teaches wherein the chromatography apparatus (AKTApilot system) is further operative to control the valve unit (components shown in fig. 5-2; see fig. 5-6 for flow path) by sending a fifth control signal (control via UNICORN control system) to control the valve unit (components shown in fig. 5-2; see fig. 5-6 for flow path) to: couple the fluid inlet (inlet for fluid comprising for samples 1-4, A1-A4, and/or B1-B4) to the first fluid port (first fluid port of Column 1), to couple the second fluid port (second fluid port of Column 1) to the third fluid port (third fluid port of Column 2), and to couple the fourth fluid port (fourth fluid port of Column 2) to the fluid outlet (outlet for fluid comprising Outlet valves V8 & V9) (see possible flow paths by arrowed lines in fig. 5-6; see also Table 5-3 From-To Locations information; see Flowpath Instructions figure).
Regarding claim 20, which depends on claim 14,
AKTA teaches wherein the chromatography apparatus (AKTApilot system) is further operative to control the valve unit (components shown in fig. 5-2; see fig. 5-6 for flow path) by sending a sixth control signal (control via UNICORN control system) to control the valve unit (components shown in fig. 5-2; see fig. 5-6 for flow path) to: couple the fluid inlet (inlet for fluid comprising for samples 1-4, A1-A4, and/or B1-B4) to the third fluid port (third fluid port of Column 2), to couple the fourth fluid port (fourth fluid port of Column 2) to the first fluid port (first fluid port of Column 1), and to couple the second fluid port (second fluid port of Column 1) to the fluid outlet (outlet for fluid comprising Outlet valves V8 & V9) (see possible flow paths by arrowed lines in fig. 5-6; see also Table 5-3 From-To Locations information; see Flowpath Instructions figure).
Regarding claim 21, which depends on claim 14,
AKTA teaches wherein the chromatography apparatus (AKTApilot system) is further operative to control the valve unit (components shown in fig. 5-2; see fig. 5-6 for flow path) by sending a seventh control signal (control via UNICORN control system), an eighth control signal (control via UNICORN control system) or a ninth control signal (control via UNICORN control system) to control the valve unit (components shown in fig. 5-2; see fig. 5-6 for flow path) to couple the fluid inlet (inlet for fluid comprising for samples 1-4, A1-A4, and/or B1-B4) to the fluid outlet (outlet for fluid comprising Outlet valves V8 & V9) (see possible flow paths by arrowed lines in fig. 5-6; see also Table 5-3 From-To Locations information; see Flowpath Instructions figure).
Regarding claim 22, which depends on claim 14,
AKTA teaches wherein the chromatography apparatus (AKTApilot system) is further wherein the valve unit (components shown in fig. 5-2; see fig. 5-6 for flow path) further comprises a waste fluid port (Waste F1; likewise for Waste 2) and the chromatography apparatus (AKTApilot system is operative to control the valve unit (components shown in fig. 5-2; see fig. 5-6 for flow path) by sending a tenth control signal (control via UNICORN control system) to control the valve unit (components shown in fig. 5-2; see fig. 5-6 for flow path) to couple the fluid inlet (inlet for fluid comprising for samples 1-4, A1-A4, and/or B1-B4) to the waste fluid port (Waste F1; likewise for Waste 2) (see possible flow paths by arrowed lines in fig. 5-6; see also Table 5-3 From-To Locations information; see Flowpath Instructions figure).
Conclusion
The prior art made of record and not relied upon is still considered pertinent to Applicant's disclosure.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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 on Monday - Friday 8:00 am - 6:00pm CT, EXCEPT alternating Friday.
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, John Breene can be reached on 571-272-4107. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DAVID L SINGER/Primary Examiner, Art Unit 2855 13FEB2026