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 .
Amendment
Receipt is acknowledged of the amendment filed on 01/22/2026.
Response to Arguments
Applicant's arguments filed 01/22/2026 have been fully considered but they are not persuasive.
In response to the applicant’s argument that “it is clear that these connections are not used to couple to the medium as would be required for the common understanding of a process fluid (i.e., medium) connection”, the examiner respectfully disagrees. The examiner respectfully submits that, assuming that with the “common understanding of a process fluid”, the claim only requires that “each process fluid connection being configured to couple a cooperative process fluid coupling”. In this case, Pfauch teaches that each process fluid connection being configured to couple (i.e., first connection 30 and second connection 34 are coupled to media connection 7 and complementary connecting means 8 via the lower region 13 of the housing 2) (see Fig. 1a) a cooperative process fluid coupling (i.e., media connection 7 and complementary connecting means 8) (see Fig. 1a). The examiner respectfully submits that the media connection 7 and complementary connecting means 8 of housing 2 are used to couple the first connection 30 and the second connection 34 to the medium 5 in the containment 1.
Claim Objections
Claim 15 is objected to because of the following informalities: “the retractable fluid chamber” should be corrected to –the fluid chamber—for proper antecedent basis. Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3, 7-9, and 13-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pfauch et al. (Pat. No. US 9,091,570) (hereafter Pfauch)
Regarding claim 1, Pfauch teaches a process fluid connector (i.e., housing 2) (see Fig. 1a) for a single-use process fluid sensing system, the process fluid connector comprising:
a pair of process fluid connections (i.e., a first connection 30 to the treatment chamber 3 and a second connection 34 to the treatment chamber 3) (see Fig. 1a), each process fluid connection being configured to couple to a cooperative process fluid coupling (i.e., first connection 30 and second connection 34 are coupled to media connection 7 and complementary connecting means 8 via the lower region 13 of the housing 2) (see Fig. 1a);
a process fluid conduit section operably coupled to each of the process fluid connections (i.e., immersion tube 10 and lower region 13 of the housing 2 are coupled to each first connection 30 and second connection 34) (see Fig. 1a);
a sensor attachment port coupled to the process fluid conduit section (i.e., the probe 4 is held in such a manner in the immersion tube 10, that the probe head 6 is arranged within the protective cylinder 37) (see Fig. 1a) and configured to receive and mount a process fluid sensor (i.e., probe 4 and probe head 6) (see Fig. 1a); and
a fluid chamber (i.e., treatment chamber 3) (see Fig. 1a) coupled to the process fluid conduit section (i.e., treatment chamber 3 is coupled to the immersion tube 10 and the lower region 13 of the housing 2) (see Fig. 1a).
Regarding claim 2, Pfauch teaches that the fluid storage chamber is retractable without breaching a sterile process barrier of the downstream process fluid connector (i.e., seal 36 seals the probe 4 in the treatment chamber 3 relative to the medium 5) (see Fig. 1a).
Regarding claim 3, Pfauch teaches that the retractable fluid chamber is operably coupled to at least one user actuatable elements (i.e., the shifting the immersion tube 10 is effected manually or automatically, for example, by a pneumatic or electrical drive 9) (see Column 5, lines 54-57).
Regarding claim 7, Pfauch teaches that the retractable fluid chamber contains a buffer solution having a known pH (i.e., an option provides that the probe 4 is calibrated through the use of calibration medium inflowing to the treatment chamber 3 through connection 30) (see Column 7, lines 53-58).
Regarding claim 8, Pfauch teaches that each of the pair of process connections includes a sanitary flange (i.e., a housing 2, which is connected with a containment 1 by means of a media connection 7 with complementary connecting means 8. This can be accomplished, for example, by way of a flange connection) (see Column 5, lines 36-44).
Regarding claim 9, Pfauch teaches that each sanitary flange includes an o-ring groove configured to receive an o-ring (i.e., sealing system 20 comprises seals that are O-rings and grooves for receiving o-ring) (see Fig. 1a).
Regarding claim 13, Pfauch teaches that a moveable member of the retractable fluid chamber is configured to slide completely out of a process flow stream of the process fluid conduit section (i.e., If the immersion tube 10 is moved by the drive 9 further downwards, i.e. in the direction of containment 1, the medium, for example, rinsing liquid or air, located in the treatment chamber 3 escapes through the connection 34. Through the movement of the immersion tube 10 downwards, the treatment chamber 3 becomes smaller in volume) (see Column 8, lines 21-30).
Regarding claim 14, Pfauch teaches that at least one of the pair of process connections is selected from the group consisting of: a threaded connection, a flanged connection, a barbed connection, an ascetic connection, an open pipe section (i.e., through the connection 30 can flow washing, or rinsing, medium into the treatment chamber 3 for rinsing, cleaning, calibration, sterilization and/or for purging, pressure emptying, sucking out, etc.; and via a second connection 34, the washing, or rinsing, medium can drain from the treatment chamber 3) (see Column 6, line 62, to Column 7, line 28), attached tubing, and a secondary adapter.
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.
Claims 4-6 and 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over Pfauch et al. (Pat. No. US 9,091,570) (hereafter Pfauch) in view of Hu et al. (Pub. No. US 2019/0264161) (hereafter Hu).
Regarding claims 4-6, Pfauch as disclosed above does not directly or implicitly teach that the at least one user actuatable elements includes a pair of wings extending from opposite sides of the retractable fluid chamber, the pair of wings being configured to transition the retractable fluid chamber from a storage configuration to an operating configuration (claim 4);
at least one locking member operably coupled to at least one actuatable elements, the at least one locking member being configured to inhibit displacement of the at least one user actuatable element (claim 5);
the at least one locking member includes a pair of locks, each lock being offset with the other lock, and requiring removal of the pair of locks before enabling displacement of the user actuatable elements to the operating configuration (claim 6).
Regarding the pair of wings, Hu teaches that the at least one user actuatable elements includes a pair of wings extending from opposite sides of the retractable fluid chamber, the pair of wings being configured to transition the retractable fluid chamber from a storage configuration to an operating configuration (i.e., plunger flange 118) (see paragraph section [0024]) (claim 4);
at least one locking member operably coupled to at least one actuatable elements, the at least one locking member being configured to inhibit displacement of the at least one user actuatable element (i.e., a slide lock 120 movable in the direction of arrows 122 to provide a locked or unlocked position) (see paragraph section [0024]) (claim 5);
the at least one locking member includes a pair of locks, each lock being offset with the other lock, and requiring removal of the pair of locks before enabling displacement of the user actuatable elements to the operating configuration (i.e., slide lock 120 also provides two holes 136, 138 for lockout/tagout to prevent undesired sliding) (see Fig. 2) (claim 6).
In view of the teaching of Hu, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have added the locks in order to secure the sensor and to prevent undesirable displacement of the immersion tube during measurement.
Regarding claim 15, Pfauch teaches a process fluid sensing system comprising:
process fluid connector including, a pair of process fluid connections (i.e., a first connection 30 to the treatment chamber 3 and a second connection 34 to the treatment chamber 3) (see Fig. 1a), each process fluid connection being configured to couple to a cooperative process fluid coupling (i.e., media connection 7 via complementary connecting means 8) (see Fig. 1a);
a process fluid conduit section operably coupled to each of the process fluid connections (i.e., immersion tube 10 and lower region 13 of the housing 2 are coupled to each first connection 30 and second connection 34) (see Fig. 1a);
a sensor attachment port coupled to the process fluid conduit section (i.e., the probe 4 is held in such a manner in the immersion tube 10, that the probe head 6 is arranged within the protective cylinder 37) (see Fig. 1a) and configured to receive and mount a process fluid sensor (i.e., probe 4 and probe head 6) (see Fig. 1a);
a fluid chamber (i.e., treatment chamber 3) (see Fig. 1a) coupled to the process fluid conduit section (i.e., treatment chamber 3 is coupled to the immersion tube 10 and the lower region 13 of the housing 2) (see Fig. 1a);
a fixed-position amperometric process fluid sensor (i.e., probe 4) (see Fig. 1a) mounted to the sensor attachment port of the process fluid connector (i.e., process variables, which can be registered with the probe 4, include, for example, pH-value, also via ISFET, redox-potential, absorption of electromagnetic waves in the medium 5, for example, with wavelengths in the UV-, IR-, and/or visible region, oxygen content, conductivity, turbidity, concentration of metal and/or non-metal substances and temperature) (see Column 6, lines 27-44), wherein the fluid chamber provides wet storage for a sensing component of the fixed- position amperometric process fluid sensor (i.e., an option provides that the probe 4 is calibrated through the use of calibration medium inflowing to the treatment chamber 3 through connection 30) (see Column 7, lines 53-58); but does not explicitly teach that
the fixed-position amperometric process fluid sensor having a plurality of sensing elements disposed within a buffer solution within the retractable fluid chamber.
Regarding the plurality of sensing elements, Hu teaches the fixed-position amperometric process fluid sensor having a plurality of sensing elements (i.e., temperature sensitive element 164, electrode 152 having a silver/silver chloride wire that is protected by a glass tubing and two ceramic reference junctions 162, 150, and pH glass electrode 142) (see paragraph sections [0031]-[0034]) disposed within a buffer solution within the retractable fluid chamber (i.e., pH glass electrode 142 is sealed within storage fill solution cavity 168 and one reference junction 162 is located at the end of the glass tubing and the second junction 150 is located between the reference fill cavity 154 and storage fill solution cavity 168. Storage fill solution is selected to have a known pH value. Thus, prior to placing pH sensor 100 in its operating position, a calibration operation can be done by causing pH glass electrode to sense the pH of the storage fill solution) (see paragraph section [0031]-[0034]). In view of the teaching of Hu, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have used additional sensing elements in order to further compensate and adjust the readings of the fluid sensor.
Regarding claim 16, Pfauch teaches that the fixed-position amperometric process fluid sensor is configured to be pressurized at a point of use (i.e., retractable assemblies serve to introduce probes into a process, and, therewith, into a medium, and then to withdraw such from the process, without interrupting the process as it is running, at pressures up to 10 bar and more. Through the connection 30 can flow washing, or rinsing, medium into the treatment chamber 3 for rinsing, cleaning, calibration, sterilization and/or for purging, pressure emptying, sucking out, etc. Options include standard pressure, positive pressure as well as also subpressure operating modes of the rinse or washing medium. The inflowing washing, or rinsing, medium can be, for example, superheated steam with a temperature greater than 80oC, especially greater than 100oC., for example, 120oC. It can be introduced under pressure) (see Column 1, lines 9-17; and Column 6, line 62, to Column 7, line 28).
Regarding claim 17, Pfauch teaches that the fixed-position amperometric process fluid sensor includes a pressurization mechanism that is configured to be manually operated to pressurize a reference electrolyte of the fixed-position process fluid sensor (i.e., an option provides that the probe 4 is calibrated through the use of calibration medium inflowing through connection 30. During the calibration procedure, the connection 34 is closed by a system associated with the connection 34, e.g. a valve (not shown), which is opened after terminating the procedure, in order to drain the calibration medium away) (see Column 7, lines 53-58).
Claims 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over Pfauch et al. (Pat. No. US 9,091,570) (hereafter Pfauch) in view of Neukum (Pat. No. US 5,139,641) (hereafter Neukum).
Regarding claims 10-12, Pfauch as disclosed above does not directly or implicitly teach
an endcap; a shaft mounted to the endcap at a distal end and proximal end spaced from the distal end; and a fixed position piston mounted to the proximal end of the shaft, the fixed position piston having a diameter sized to cooperate with an internal surface of a wet storage cylinder of the retractable fluid chamber (claim 10);
at least one o-ring disposed about an exterior diameter of the fixed position piston (claim 11);
an o-ring disposed about an exterior diameter of the wet storage cylinder (claim 12).
Regarding the fixed position piston assembly, Neukum teaches an endcap (i.e., contact plate 37) (see Fig. 2); a shaft mounted to the endcap at a distal end and proximal end spaced from the distal end (i.e., piston supporting element 20 is mounted to the contact plate 37 via the spring 35 and stationary contact bushing 31) (see Fig. 2); and a fixed position piston mounted to the proximal end of the shaft, the fixed position piston having a diameter sized to cooperate with an internal surface of a wet storage cylinder of the retractable fluid chamber (i.e., piston 22’) (see Fig. 2) (claim 10);
at least one o-ring disposed about an exterior diameter of the fixed position piston (i.e., an improved sealing effect may be achieved by two annular grooves 40a, 40b provided in the forward area of the piston 22', with an axially resilient sealing element 41 engaging such grooves, similar to the arrangement of a medical syringe, whereby perfect sealing of the electrolyte chamber from the outside can be achieved) (see Column 7, lines 16-27) (claim 11);
an o-ring disposed about an exterior diameter of the wet storage cylinder (i.e., an improved sealing effect may be achieved by two annular grooves 40a, 40b provided in the forward area of the piston 22', with an axially resilient sealing element 41 engaging such grooves, similar to the arrangement of a medical syringe, whereby perfect sealing of the electrolyte chamber from the outside can be achieved) (see Column 7, lines 16-27) (claim 12).
In view of the teaching of Neukum, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have added a pressuring means in order to adjust the pressure of the reference fluid chamber without using a pump to pressurize the chamber, so as to save on costs and to use the sensor without power
Claims 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Pfauch et al. (Pat. No. US 9,091,570) (hereafter Pfauch) in view of Hu et al. (Pub. No. US 2019/0264161) (hereafter Hu) and in further view of Neukum (Pat. No. US 5,139,641) (hereafter Neukum)
Regarding claims 18-20, Pfauch as modified by Hu as disclosed above does not directly or implicitly teach that
the pressurization mechanism includes a spring-biased piston (claim 18);
wherein the pressurization mechanism includes a manually operable knob that is configured to engage the pressurization mechanism (claim 19);
wherein the knob is configured to generate a user-selectable amount or pressure in the reference electrolyte (claim 20).
Regarding the spring-based piston, Neukum teaches that
the pressurization mechanism includes a spring-biased piston (claim 18) (i.e., biassing spring 35 seated in recess 36 of the sliding pipe 33 and against piston 22’ via the contact bussing 31) (see Fig. 2);
wherein the pressurization mechanism includes a manually operable knob that is configured to engage the pressurization mechanism (claim 19) (i.e., the manual force which is exerted via the handle upon the reference electrode 12 or the latter's diaphragm 30, during introduction of the pH measuring chain, when the diaphragm 30 gets into contact with the medium under examination, produces a force acting upon the cylinder of the movable electrolyte vessel which tends to urge the cylinder back, whereby at the same time safe physical and electric contact is established in the diaphragm area of the reference electrode) (see Column 7, line 3, to Column 8, line 12);
wherein the knob is configured to generate a user-selectable amount or pressure in the reference electrolyte (claim 20) (i.e., to enable the reference electrode system to be locked in position, different means may be provided, for example an inwardly projecting and manually operable spring element engaging successive notches in the sliding pipe, like a catch, so that the sliding pipe is locked against the action of the biassing spring 35) (see Column 7, line 3, to Column 8, line 12).
In view of the teaching Neukum, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have added the spring and piston mechanism in order to adjust the pressure of the reference fluid chamber without using a pump to pressurize the chamber, so as to save on costs and to use the sensor without power.
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TRAN M. TRAN whose telephone number is (571)270-0307. The examiner can normally be reached Mon-Fri 11:30am - 7:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Laura Martin can be reached on (571)-272-2160. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Tran M. Tran/Examiner, Art Unit 2855
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