Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Status
Claims 1, and 4-20 are pending with claims 1, and 4-20 being examined. Claims 2-3 are canceled.
Response to Amendment
As to the claim amendments and remarks filed on 12/05/2025, the previous 12(b) rejection is withdrawn. Applicant addressed the issues
The previous claim objection is withdrawn. Applicant has amended claims 1, 19-20 to address the issue.
The previous drawing objection is withdrawn. Applicant identified the fluid processing unit, fluid flow channel, fluid flow path, and device for chromatographic separation.
The previous claim objection is withdrawn. Applicant addressed the deficiencies.
As to the remarks, the examiner has found the Applicant’s arguments not persuasive and will be addressed below.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1 and 4-20 are rejected under 35 U.S.C. 103 as being unpatentable over Schick et al. (US 20150323486 A1; hereinafter “Schick” previous of record), in view of Andersson et al. (US 20120256641 A1; hereinafter “Andersson” previous of record), further in view of Gagne (US 20160327416 A1).
Regarding claim 1, Schick teaches a fluid processing system comprising a fluid processing unit (Schick; fig. 2 and 3) and a tubing arrangement providing fluid flow to and from said fluid processing unit (Schick; fig. 2 and 3 and [0073], [0075]), wherein said tubing arrangement comprises one or more flow cells (Schick; fig. 2. 155, 157), each one of said one or more flow cells comprising:
a functional element (Schick; fig. 7. 207);
a body (Schick; fig. 4. 201) having an inlet and an outlet and a fluid flow channel extending from the inlet to the outlet of the body (Schick; fig. 7. 205 illustrates an inlet, the opposite side of 205 illustrates an outlet, and [0083] “pathway of fluids progressing through fluid conduit”), said body further comprising a receptacle (Schick; fig. 7. 212) comprising a chamber forming a part of the fluid flow channel of the body (Schick; inner part of 205), said chamber comprising a first opening (Schick; fig, 7. 211) for connecting a functional element to said one or more flow cells such that the functional element is in contact with or exposed to a fluid flow passing through the fluid flow channel (Schick; fig. 7. 207 [0083] “electrodes 207 are positioned in opening 211”); a first tubular connector arranged adjacent to the inlet of the body (Schick; fig. 7. 205);
a second tubular connector arranged adjacent to the outlet of the body (Schick; fig. 7 opposite end of 205);
and wherein said fluid processing unit is selected from a unit comprising a single use tangential flow filtration mobile skid and a unit comprising a device for chromatographic separation (Schick; [0067] “typical TFF application, manifold shown in figure 3”).
Schick fails to teach a fluid flow path extending from the first tubular connector through the inlet of the body, the body and its receptacle to the outlet of the body to the second tubular connector; wherein said fluid flow path of the flow cell has a predetermined, consistent cross- sectional area at least within and along the first and second tubular connectors, and wherein the volume of the chamber of the body of the flow cell is configured to provide a cross-sectional area of the fluid flow path equal to or larger than the cross-sectional area of the fluid flow path within and along the first and second tubular connectors, including when the functional element is connected to the openings and extends into the chamber.
However, Andersson teaches the analogous art of a flow-through type conductivity sensor (Andersson; [0033]) that includes a flow path 9Andersson; fig. 8. 51) a chamber (Andersson; fig. 8. 51a) and a cross-sectional area (Andersson; fig. 7. 70) wherein the fluid flow path extending from the first tubular connector through the inlet of the body, the body and its receptacle to the outlet of the body to the second tubular connector (Andersson; fig. 8. 51, 66, 67), wherein the fluid flow path of the flow cell has a predetermined, essentially consistent cross-sectional area (Andersson; fig. 7. 70) at least within and along the first and second tubular connectors (Andersson; fig. 8. 51, 66, 67), and the volume of the chamber of the body of the flow cell is configured to provide a cross-sectional area of the fluid flow path equal to or larger than the cross-sectional area of the fluid flow path within and along the first and second tubular connectors, including when the functional element is connected to the opening and extends into the chamber (Andersson; fig. 8. 51a, 66, 67, 70) (in the same manner Applicant illustrates in fig. 3. 18, 20, 24).
If Andersson is noy taken to illustrate the volume of the chamber of the body of the flow cell is configured to provide a cross-sectional area of the fluid flow path equal to or larger than the cross-sectional area of the fluid flow path within and along the first and second tubular connectors, including when the functional element is connected to the opening and extends into the chamber. Gagne teaches a fluid processing system (Gagne; Title) that includes a flow path with a cross-sectional area of the fluid flow path equal to or larger than the cross-sectional area of the fluid flow path within and along the first and second tubular connectors, including when the functional element is connected to the opening and extends into the chamber (Gagne; fig. 3F. 12, 18).
To one of ordinary skill in the art before the effective filing date of the invention it would have been obvious to modify Schick’s fluid processing system to include a fluid flow path extending from the first tubular connector through the inlet of the body, the body and its receptacle to the outlet of the body to the second tubular connector, to have a predetermined, essentially consistent cross-sectional area at least within and along the first and second tubular connectors, and to have a volume of the body of the flow cell to provide a cross-sectional area of the fluid flow path equal to or larger than the cross-sectional area of the fluid flow path within and along the first and second tubular connectors, including when the functional element is connected to the opening and extends into the chamber as taught by Andersson because Andersson teaches a fluid flow path extending from the first tubular connector through the inlet of the body, the body and its receptacle to the outlet of the body to the second tubular connector (Andersson; fig. 8. 51, 66, 67), a fluid flow path (Andersson; fig 8. 51a), wherein the fluid flow path of the flow cell has a predetermined, essentially consistent cross-sectional area at least within and along the first and second tubular connectors (Andersson; fig. 8. 51, 66, 67, 70), and the volume of the chamber of the body of the flow cell is configured to provide a cross-sectional area of the fluid flow path equal to or larger than the cross-sectional area of the fluid flow path within and along the first and second tubular connectors including when the functional element is connected to the opening and extends into the chamber (Andersson; fig. 8. 51a, 66, 67, 70).
The modification allows fluid to flow from the inlet to the outlet and making contact with the functional element with unrestricted flow of fluid.
Examiner notes that Applicant does not provide embodiments wherein the cross-sectional area of the fluid flow path equal to or larger than the cross-sectional area of the fluid flow path within and along the first and second tubular connectors, including when the functional element is connected to the opening and extends into the chamber.
Regarding claim 4, modified Schick teaches the system according to claim 1 (see above), wherein said tubular connectors of the flow cell are directly attached to the body (Schick; fig. 4. 201, 205 and opposite end of 205).
Regarding claim 5, modified Schick teaches the system according to claim 1 (see above) to include a body (see above).
Modified Schick fails to teach the body and/or said tubular connectors of the flow cell are made of metal.
However, Gagne teaches the analogous art of a fluid monitoring assembly (Gagne; Title) that includes a housing (body) (Gagne; fig. 2. 16) and a flow cell (Gagne; fig. 1. 14) wherein the body of the flow cell is made of metal, or a plastic material (Gagne; [0040] “the housing 16 may be formed of from fluoropolymers and may also be made of metals”).
To one of ordinary skill in the art before the effective filing date of the invention it would have been obvious to modify Schick’s body to be made of metal as taught by Gagne because Gagne teaches a fluid monitoring assembly (Gagne; Title) that includes a housing (body) (Gagne; fig. 2. 16) and a flow cell (Gagne; fig. 1. 14) wherein the body of the flow cell is made of metal, or a plastic material (Gagne; [0040] “the housing 16 may be formed of from fluoropolymers and may also be made of metals”).
Manufacturing the body of the flow cell from metal would provide a heat resistant body, while manufacturing the body of the flow cell from a plastic material would allow for a disposable flow cell.
Regarding claim 6, modified Schick teaches the system according to claim 1 (see above), wherein the fluid flow channel of the body of the flow cell has a straight configuration (Schick; fig. 7. area between 205 and the opposite end of 205 illustrates a fluid pathway, and [0083] “pathway of fluids progressing through fluid conduit”).
Regarding claim 7, modified Schick teaches the system according to claim 1 (see above) to include a flow channel (see above).
Modified Schick fails to teach the fluid flow channel of the body of the flow cell is of an arcuate or curved configuration, an angled configuration, or a T- shaped configuration.
However, Andersson teaches the analogous art of a flow-through type conductivity sensor (Andersson; [0033]) that includes a flow channel (Andersson; fig. 8. 51) wherein the flow channel has a T- shaped configuration (Andersson; fig. 8. 51, 70).
To one of ordinary skill in the art before the effective filing date of the invention it would have been obvious to modify Schick’s flow channel to have a T-shaped configuration as taught by Andersson because Andersson teaches the flow channel has a T- shaped configuration (Andersson; fig. 8. 51, 70).
A T-shape configuration allows to accommodate the functional element such as a probe within the chamber to contact the flow in the flow channel.
Regarding claim 8, modified Schick teaches the system according to claim 1 (see above) to include a chamber with a first opening (see above).
Modified Schick fails to teach the chamber of the receptacle of the body of the flow cell has a second opening opposite to the first opening, said second opening providing one of the inlet and outlet of the body.
However, Gagne teaches the analogous art of a fluid monitoring assembly (Gagne; Title) that includes a flow cell (Gagne; fig. 1. 10) and chamber with a first opening (Gagne; fig. 2C 18, 54) wherein the chamber of the receptacle of the body of the flow cell has a second opening opposite to the first opening (Gagne; fig. 3I 18, 54), said second opening providing one of the inlet and outlet of the body (Gagne; fig. 2C. 30).
To one of ordinary skill in the art before the effective filing date of the invention it would have been obvious to modify Schick’s chamber with a first opening to include a second opening opposite to the first opening, said second opening providing one of the inlet and outlet of the body as taught by Gagne because Gagne teaches the chamber of the receptacle of the body of the flow cell has a second opening opposite to the first opening (Gagne; fig. 3I 18, 54), said second opening providing one of the inlet and outlet of the body (Gagne; fig. 2C. 30).
This allows to connect a UV sensor with an emitter portion and a receiver portion (Gagne; [0044]).
Regarding claim 9, modified Schick teaches the system according to claim 1 (see above), wherein the chamber of the receptacle of the body of the flow cell has an essentially hollow cylindrical shape (Schick; inner part of 205).
Regarding claim 10, modified Schick teaches the system according to claim 1 (see above), wherein the first opening of the chamber of the body of the flow cell comprises a circular projection extending away from said body to receive said functional element (Schick; fig. fig. 7. 211 illustrates the first opening, fig. 8A. 218 illustrates what appears to be circular projections extending away from said body to receive said functional element, Schick; [0086] connectors 218 for making electrode connections”).
Regarding claim 11, modified Schick teaches the system according to claim 1 (see above), wherein said first opening of the chamber of the body of the flow cell accommodates an adapter for positioning one end of the functional element in a predefined position (Schick; fig. 8A. 218 illustrates what appears to be circular projections extending away from said body to receive said functional element, Schick; [0086] connectors 218 for making electrode connections”).
Regarding claim 12, modified Schick teaches the system according to claim 1 (see above), wherein said functional element is selected from a static mixer, a conductivity sensor, a pH sensor, a pressure sensor, an electrical grounding element, a redox sensing element, a temperature sensor, a capacitive sensor, a flow sensor, an optical sensor, and an element for taking liquid samples (Schick; fig. 6. 207 “electrodes” and [0084]).
Regarding claim 13, modified Schick teaches the system of claim 12 (see above) to include a functional element (see above).
Modified Schick fails to teach the functional element is mounted in the opening extending with a probe end into the chamber, wherein the probe end extending into the chamber is positioned such that it keeps a distance to wall parts of the chamber of about 12 mm or more.
It would have been obvious to position the probe end extending into the chamber positioned such that it keeps a distance to wall parts of the chamber of about 12 mm or more to provide a clearance for the fluid to flow through the probe.
However, Andersson teaches the analogous art of a flow-through type conductivity sensor (Andersson; [0033]) that includes a functional element which is also a probe (Andersson; [0070] “A pH sensor meter, or probe”, [0071] “pH probe”) the functional element is mounted in the opening extending with a probe end into the chamber, wherein the probe end extending into the chamber is positioned such that it keeps a distance to wall parts of the chamber (Andersson; fig, 9, 51,80).
This allows to place the probe end of the functional element to contact the fluid flow.
Regarding claim 14, modified Schick teaches the system according to claim 1 (see above) to include a cross-sectional area of the fluid flow path along the flow channel (see above).
Modified Schick fails to teach the cross-sectional area of the fluid flow path along the flow channel corresponds essentially to the cross-sectional area in the first and second tubular connectors.
However, Andersson teaches the analogous art of a flow-through type conductivity sensor (Andersson; [0033]) that includes a flow channel (Andersson; fig. 8. 51), a cross-sectional area (Andersson; fig. 8. 51a, 70) and first and second tubular connectors (Andersson; fig. 8. 51, 66, 67), wherein the cross-sectional area of the fluid flow path along the flow channel corresponds essentially to the cross-sectional area in the first and second tubular connectors (Andersson; fig. 8. 51, 66, 67, 70).
To one of ordinary skill in the art before the effective filing date of the invention it would have been obvious to modify Schick’s cross-sectional area of the fluid flow path along the flow channel to correspond to the cross-sectional area in the first and second tubular connectors as taught by Andersson because Andersson teaches the cross-sectional area of the fluid flow path along the flow channel corresponds essentially to the cross-sectional area in the first and second tubular connectors (Andersson; fig. 8. 51, 66, 67, 70).
The cross-sectional area of the fluid flow path along the flow channel allows to accommodate the functional element such as a probe within the chamber to contact the flow in the flow channel.
Regarding claim 15, modified Schick teaches the system according to claim 4 (see above), wherein said tubular connectors are formed integrally with the body (Schick; fig. 4. 201, 205 and opposite side of 205).
Regarding claim 16, modified Schick teaches the system according to claim 5 (see above) to include a body (see above).
Modified Schick fails to teach the body and/or said tubular connectors of the flow cell are made of stainless steel.
However, Gagne teaches the analogous art of a fluid monitoring assembly (Gagne; Title) that includes a housing (body) (Gagne; fig. 2. 16) and a flow cell (Gagne; fig. 1. 14) wherein the body of the flow cell are made of metal (Gagne; [0040]). Gagne does not explicitly teach the body and/or said tubular connectors of the flow cell are made of stainless steel.
It would have been obvious to make the body and/or the tubular connectors of stainless steel to provide corrosion resistance to the body and/or said tubular connectors of the flow cell.
Regarding claim 17, modified Schick teaches the system according to claim 5 (see above) to include a body (see above).
Modified Schick fails to teach the body and/or said tubular connectors of the flow cell are polycarbonate, polypropylene, polysulfone, polyethersulfone, polybutylene terephthalate, polyethylene terephthalate, polyetherether ketone, polyetherimide, low density polyethylene, high density polyethylene, and/or silicone.
However, Andersson teaches the analogous art of a flow-through type conductivity sensor (Andersson; [0033]) that includes a body (Andersson; fig. 7. 50) wherein the body is manufactured by injection moulding (Andersson; [0064]).
It is known in the art that polypropylene is used as a raw material in injection moulding manufacturing.
To one of ordinary skill in the art before the effective filing date of the invention it would have been obvious to modify Schick’s body to be manufactured by injection moulding as taught by Andersson because Andersson teaches fluid processing system wherein the body is manufactured by injection moulding (Andersson; [0064]).
This would serve as an electrical insulator (Andersson; [0044]).
Regarding claim 18, modified Schick; teaches the system of claim 13 (see above), wherein said functional element is selected from a conductivity sensor and a pH sensor (Schick; [0007]).
Regarding claim 19, modified Schick teaches the system of claim 18 (see above) to include a chamber (see above).
Modified Schick fails to teach all dimensions of the chamber perpendicular to the direction of the sensor with its probe end extends into the chamber is about 25 mm or more.
However, without some statement of criticality or showing of unexpected results, to one of ordinary skill in the art before the effective filing data of the invention it would have been obvious to include a chamber wherein the dimensions of the chamber perpendicular to the direction of the sensor with its probe end extends into the chamber is about 25 mm or more.
This modification would provide even flow distribution throughout the chamber when the probe extends into the chamber.
Regarding claim 20, modified Schick teaches the system of claim 18 (see above) to include a chamber (see above).
Modified Schick fails to teach all dimensions of the chamber perpendicular to the direction of the sensor with its probe end extended into the chamber is between about 28 mm and about 50 mm.
However, without some statement of criticality or showing of unexpected results, to one of ordinary skill in the art before the effective filing data of the invention it would have been obvious to include a chamber wherein the dimensions of the chamber perpendicular to the direction of the sensor with its probe end extends into the chamber is between about 28 mm to about 50 mm.
This modification would provide even flow distribution throughout the chamber when the probe extends into the chamber.
Response to Arguments
Applicant’s arguments, filed on 12/30/2025, with respect to the prior art rejections over Schick in view of Andersson and Gagne have been fully considered and are persuasive The rejections have been modified in accord with the amendment.
With respect to claim 1, Applicant argues Schick does not teach maintaining the flow path cross-sectional area equal to or larger through the chamber when the functional element is inserted.
Examiner disagrees. Andersson teaches the volume of the chamber of the body of the flow cell is configured to provide a cross-sectional area of the fluid flow path equal to or larger than the cross-sectional area of the fluid flow path within and along the first and second tubular connectors, including when the functional element is connected to the opening and extends into the chamber in the same manner Applicant illustrates in fig. 3. 18, 20, 24.
If Andersson is noy taken to illustrate the volume of the chamber of the body of the flow cell is configured to provide a cross-sectional area of the fluid flow path equal to or larger than the cross-sectional area of the fluid flow path within and along the first and second tubular connectors, including when the functional element is connected to the opening and extends into the chamber. Gagne teaches a flow path with a cross-sectional area of the fluid flow path equal to or larger than the cross-sectional area of the fluid flow path within and along the first and second tubular connectors, including when the functional element is connected to the opening and extends into the chamber.
Examiner notes that Applicant does not provide embodiments wherein the cross-sectional area of the fluid flow path equal to or larger than the cross-sectional area of the fluid flow path within and along the first and second tubular connectors, including when the functional element is connected to the opening and extends into the chamber.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/A.R./Examiner, Art Unit 1798
/CHARLES CAPOZZI/Supervisory Patent Examiner, Art Unit 1798