DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on February 11, 2026 has been entered.
Response to Amendment
The Amendment filed February 11, 2026 has been entered. Claims 1, 3, 4, 7, 9, 12 and 21 – 38 are pending in the application with claims 2, 5, 6, 8, 10, 11 and 13 – 20 being cancelled and claims 30 – 38 being newly added.
Claim Objections
Claims 1, 3, 4, 7, 9, 12 and 21 – 38 are objected to because of the following informalities:
Claim 1, last 4th line: “the sensor” should read --the bending sensor--.
Claim 7, lines 1-2: “the groove” should read --a groove--. Alternatively, the claim can be made dependent on claim 30 instead of claim 1 for proper antecedent basis with respect to phrase “the groove” since clam 1 was amended to remove the limitations that are now being recited in newly added claim 30.
Claim 12, line 4: “Sensing” should read --sensing--.
Claim 33, line 5: “mean of” should read --means of--.
Claim 33, line 7: “a end” should read --an end--.
Claims 3, 4, 7, 9, 12 and 21 – 38 are objected to for being dependent on claim 1.
Appropriate correction is required.
Claim Interpretation
As noted previously, the limitation in Claim 1 has been interpreted under 35 USC 112(f) to cover the corresponding structure described in the specification that achieves the claimed function:
(Claim 1) “remote control means and means for transmitting data collected by the sensor and the additional sensors”: Controller communicating with sensors using connection means comprising of cellular, Bluetooth, and/or Wi-Fi connection and equivalents thereof (see ¶66 of the pg.pub of the instant application).
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 38 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 38 recites the limitation “a prior learning step based on the data read by the bending sensor and the additional sensors” in lines 1-2. The claim is indefinite for following reasons. The filed specification (in ¶18 of pg. pub of the instant application) recites the phrase “a prior learning step”. However, it is unclear from the filed specification as to what “constitutes/defines” this claimed prior learning step. The filed specification does not elaborate further or provide any additional details on what this step involves and what kind of learning is being performed. For examination purposes, the “prior learning step” is being interpreted as machine learning.
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.
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, 3, 9, 12, 26, 29, 31, 36 and 38 are rejected under 35 U.S.C. 103 as being unpatentable over Karunaratne et al. (US 2019/0234399 – herein after Karunaratne) in view of Chambers et al. (US 2015/0374902 – herein after Chambers).
In reference to claim 1, Karunaratne teaches a precision pump (syringe pump, see ¶3) adapted for actuating a piston (referred as “plug portion” in ¶35) in a chamber (syringe chamber) of a cylinder (cylindrical structure, as evident from fig. 1A) of a syringe (102) for precise dosing [the underlined limitation is an intended use and thus is not considered a limitation and is of no significance to claim construction as per MPEP 2111.02(II); however note the disclosure in ¶3], the piston (“plug portion”) being provided with a head (“head” = body of the piston), mounted for sliding sealingly in the cylinder (see ¶35: “Inserted into the syringe chamber is the plunger 112 which includes a shaft and a plug portion (not shown) that is preferably formed from an inert and pliable material that is sufficiently elastic to generate a slidable seal against the inner walls of the plunger), a rod (referred as “shaft” in ¶35) that extends axially (↨ direction in view of fig. 1A) from the head to an outside of the cylinder (see fig. A below; “outside” being at the bottom end of the cylinder), and a connector (i.e. structure/element or connection means that couples bottom end of the shaft to opening in bracket 135), formed at an end of the rod opposite to the head, wherein the head comprises an annular seal (see ¶35; this seal is viewed as “slidable seal” which is formed between the plug portion and an inner circumferential wall of the cylinder; this asserted seal being further annular in shape in view of the inner circumferential wall being cylindrical as evident from fig. 1A) for making a seal between the piston and the cylinder, the pump comprising:
a rotary motor (rotary motor formed of components motor 105 and gear train 108, see ¶67 and fig. 1A) comprising a shaft forming a screw (leadscrew 103);
transmission means comprising a nut (leadnut 115) screwed onto the screw and a bracket (see fig. A below) translationally connected with said nut (at 138); said bracket being engaged by a rear end (see fig. A below) with said nut, and
a pusher (135) adapted to push upwards (“upwards” being ↑ direction in view of fig. 1A) and to pull downwards (“downwards” being ↓ direction in view of fig. 1A) the piston, comprising:
a socket (bore 136) for said connector (at bottom end of the shaft);
said pusher having a form of an L (see fig. A below: shaded region shown depicts the form of an “L”) an upright segment (see fig. A below) of which being attached to a front end of said bracket (see fig. A below);
a base (see fig. A below) of said pusher (135) comprising said socket (136), forming a beam that connects the socket to a bottom end (as evident from fig. A below) of the upright segment of the pusher, transversely (perpendicularly) to a syringe axis (shown in fig. A below);
the pump further comprising additional sensors selected from a sensor for the pressure of the ambient air, an ambient temperature sensor, a vibration sensor, an infrared sensor, an ultrasound sensor, a moisture sensor, a current sensor for the rotary motor, and/or a total electrical consumption sensor [see ¶63: “...Using this feedback data, the system controller within control logic system 110 can implement a positioning algorithm, which may be stored in the associated memory, to perform pattern recognition and execute learning algorithms as are known in the art, for example, neural networks, support vector machines, heuristic, predictive methods, or extrapolative methods, or to incorporate methods such as look-up tables and other algorithms (also stored in memory) to compensate for various physical factors, such as environmental conditions (e.g., temperature, humidity, atmospheric pressure), and variations including specific structural rigidity, fluid dynamics and other characteristics of the liquids being handled, e.g., fluid compressibility factors and dissolved gases, as well as characteristics of the materials being used to handle the liquid, and mixtures of varying physical properties…”; thus, the pump inherently has “a sensor for the pressure of the ambient air” and “an ambient temperature sensor”], and
a control means (control logic system 110) and means for transmitting data collected by the additional sensors, adapted to correct the dosing according to the pressure of the ambient air and/or the ambient temperature [see ¶57: “..control logic system 110 includes a system controller, i.e., a CPU and associated memory, which generates control signals for operating the motors and valves in accordance with preprogrammed commands, or commands received by some form of communication bus or other logic triggers, in combination with feedback signals associated with the different modules within the assembly. In additional to operational data, the control logic system may include programming for receiving environmental data to allow compensation for possible variations induced by environmental conditions…”; thus, the control means is capable of correcting the dosing according to the pressure of the ambient air and/or the ambient temperature].
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Fig. A: Edited figs. 1A and 2A of Karunaratne to show claim interpretation.
Karunaratne remains silent on the pump comprising “a bending sensor for measuring a bending of the beam about an axis perpendicular to the syringe axis”.
However, Chambers teaches a similar system comprising: a rotary motor; a pusher (56+58+59; see fig. 2) and a reciprocating element (plunger 46; see fig. 1); wherein the pusher comprises: a socket (59) for a connector (47); an attachment (56); a beam (58) that connects the socket to the attachment, transversely (perpendicularly) to a syringe axis (vertical central axis of syringe 40); a bending sensor (60: force sensor) for measuring a bending of the beam about an axis (horizontal axis) perpendicular to the syringe axis (see ¶39: force sensor 60 could be a strain gauge) [the force or strain gauge sensor 60 in fig. 1 is disposed on the bottom surface of the beam 58; a strain gauge sensor measures strain and since it is applied to beam, it measures the bending of the beam by detecting the strain caused by the bending force].
Thus, it would have been obvious to the person of ordinary skill in the art before the effective filing date of the invention to provide a sensor as taught by Chambers on an asserted beam in the pusher of Karunaratne’s precision pump for enabling measurement to be taken of the force applied on the reciprocating element of the syringe, as recognized by Chambers (in ¶39).
Thus, Karunaratne, as modified by Chambers, teaches the precision pump further comprising:
a bending sensor (of Chambers) for measuring a bending of the beam (of Karunaratne) about an axis (horizontal axis in Karunaratne; labelled “a” in fig. A above) perpendicular to the syringe axis (in Karunaratne; also shown in fig. A above);
wherein, when (in Karunaratne) the pusher moves the piston in the cylinder, (in Karunaratne) forces resulting from friction forces of the annular seal on the piston and from a pressure of a fluid located in the chamber, are generated, and wherein the bending sensor (60, of Chambers) is adapted to evaluate the friction forces of the annular seal in real time (inherent feature; see ¶39 of Chambers: sensor 60 continuously measures forces applied on the pushing structure 58; this sensor is thus capable of evaluating (i.e. measuring) friction forces of the annular seal on the piston of Karunaratne).
Karunaratne, as modified, teaches the pump comprising the control means (control logic system 110; of Karunaratne) and means for transmitting data collected by the bending sensor (60; of Chambers) and the additional sensors (of Karunaratne), adapted to correct the dosing according to the pressure of the ambient air and/or the ambient temperature.
Karunaratne, as modified, remains silent on the pump wherein the control means is “remote”.
However, Chambers teaches (see ¶43-¶44) “the controller 14 operatively coupled to the infusion apparatus may be any hardware/software architecture configured to provide the desired functionality”. The “controller functionality may be carried out by the apparatus 360..”, wherein the processing apparatus “may be, for example, any fixed or mobile computer system (e.g., a personal computer or mini-computer associated with, for example, a fluid treatment or processing system, such as a dialysis system). The exact configuration of the computing apparatus is not limiting and essentially any device capable of providing suitable computing capabilities and control capabilities (e.g., control of the infusion apparatus 12, monitoring of the force sensor signals to detect occlusions, etc.) may be used. Further, various peripheral devices, such as a computer display, mouse, keyboard, memory, printer, scanner, are contemplated to be used in combination with processing apparatus, and its associated data storage”. Chambers further teaches the remote-control means and means for transmitting data collected by the bending sensor and additional sensors (in view of disclosure in ¶32, ¶42-¶45: controller receives data from the bending sensor 60 as well as data from other sensor(s) present in the pump system).
Thus, it would have been obvious to the person of ordinary skill in the art before the effective filing date of the invention to modify the controller in the modified pump of Karunaratne so that it is remote as taught by Chambers since Chamber suggests the use of remote-controller as discussed above and use of such remote-control means provides the well-known benefits of safer, cable-free operation and centralized monitoring.
In reference to claim 3, Karunaratne, as modified above in claim 1, teaches the precision pump, wherein the rotary motor is a stepping motor (see ¶46 of Karunaratne).
In reference to claim 9, Karunaratne, as modified above in claim 1, teaches the precision pump, wherein the socket (bore 136; in Karunaratne) is adapted for removably mounting the syringe therein [see Karunaratne’s ¶15: “The syringe may also removably and replaceably disposed within the syringe bank to allow replacement”].
In reference to claim 12, Karunaratne, as modified, teaches a method for a precise dosing using the precision pump according to claim 1, comprising the following steps:
setting a dosing function (inherent step; see Karunaratne’s ¶56: a system for “precise fluid volume metering” and “continuous precision metered dispensing” is described, which inherently requires setting a dosing function within the controller),
sensing the pressure of a place where the pump is located (by Karunaratne’s ambient/environment pressure sensor; as discussed above in claim 1),
sensing the ambient temperature (by Karunaratne’s ambient/environment temperature sensor; as discussed above in claim 1 or see Karunaratne’s ¶63), and
correct or adjust the dosing function according to the pressure and/or the ambient temperature [see Karunaratne’s ¶57: “..control logic system 110 includes a system controller, i.e., a CPU and associated memory, which generates control signals for operating the motors and valves in accordance with preprogrammed commands, or commands received by some form of communication bus or other logic triggers, in combination with feedback signals associated with the different modules within the assembly. In additional to operational data, the control logic system may include programming for receiving environmental data to allow compensation for possible variations induced by environmental conditions…”; thus, the claimed step of correcting/adjusting according to the pressure and/or the ambient temperature is taught].
In reference to claim 26, Karunaratne, as modified above in claim 1, teaches the system, wherein said rod (labeled “shaft” in fig. A above) comprises a part (portion) having a reduced cross section having a constant diameter [for instance, the portion of the shaft seen has a reduced cross-section (compared to piston’s head) having a constant diameter].
In reference to claim 29, Karunaratne, as modified above in claim 1, teaches the precision pump, further comprising a linear guide (134; see ¶39 of Karunaratne and fig. 2A or fig. A above), wherein said bracket is engaged by the front end to said linear guide (as evident from fig. 2A or fig. A above).
In reference to claim 31, Karunaratne, as modified above in claim 1, teaches the precision pump, wherein said beam has a thickness correlated to a range of forces the bending sensor (60; of Chambers) is capable of measuring
[the claimed feature exists in Chambers due to rectangular cross-section of the beam because, as discussed by the applicant in the instant application {see ¶45 of the specification (cited below for convenience)}, rectangular cross-section of the beam makes it possible to have uniform stresses (force applied per unit area) in the beam;
¶45 of the specification in the instant application: “FIG. 6 illustrates a second embodiment for the pusher 12. It differs from the first embodiment, illustrated in FIG. 4, in that the cross section of the beam 38, transversely to the socket axis X41, is substantially constant and rectangular. In this configuration, if it makes it possible to have uniform stresses in the beam, for the same current thickness E8 of the beam, the bending movement of the beam is greater than the same movement in the case of the first embodiment.”
The relationship between the thickness of a beam and its bending moment is an inverse relationship. As the thickness of a beam increases, the bending moment decreases].
In reference to claim 36, Karunaratne, as modified, teaches the precision pump, wherein the remote-control means are provided with an algorithm based on artificial intelligence [“artificial intelligence” = system learning from vast amounts of data, identifying patterns to make predictions or decisions without being explicitly programmed for every scenario; see Karunaratne’s ¶63: for instance, the control logic system implements “a positioning algorithm” to perform “pattern recognition” and execute “learning algorithms”; further specifically lists neural networks and support vector machines as examples of these algorithms; neural networks are a primary branch of artificial intelligence].
In reference to claim 38, Karunaratne, as modified above in claim 12, teaches the method, further comprising a prior learning step (interpreted as machine learning) based on the data read by the bending sensor (of Chambers) and the additional sensors (of Karunaratne) [see ¶63 of Karunaratne: the system controller executes “learning algorithms” based on feedback data from the sensors].
Claims 4, 28, 32 and 33 are rejected under 35 U.S.C. 103 as being unpatentable over Karunaratne in view of Chambers and further in view of Preiswerk et al. (US 2010/0143155 – herein after Preiswerk).
Regarding claim 4,
Karunaratne, as modified above in claim 1, teaches the precision pump, wherein the sensor (of Chambers) is a strain gauge (see ¶39 of Chambers: force sensor 60 could be a strain gauge) fixed to a face of the beam (bottom face of the beam 58 in Chambers).
Karunaratne, as modified above in claim 1, remains silent on the system, wherein the strain gauge is glued to the face of the beam.
However, Preiswerk teaches a system, wherein (see fig. 13) a strain gauge sensor (49) is glued to a face of a pusher (44) [see ¶104 of Preiswerk: strain gauge 49 is fixed with adhesive].
Thus, it would have been obvious to the person of ordinary skill in the art before the effective filing date of the invention to substitute a generic fixing means for coupling Chamber’s strain gauge to a face of Karunaratne’s beam in the modified infusion pump of Karunaratne for a fixing means that involves a use of adhesive as taught by Preiswerk in order to obtain the predictable result of attaching the strain gauge to the face of the beam for a bending of the beam. KSR Int’l v. Teleflex Inc., 127 S. Ct. 1727, 1740-41, 82 USPQ2d 1385, 1396 (2007).
Regarding claim 28,
Karunaratne, as modified above in claim 1, teaches the precision pump, wherein the sensor (60 of Chambers) is adapted to measure the pressure of the fluid located in the chamber [Chambers force sensor 60 measures forces as discussed in ¶39 of Chambers; this sensor is thus capable of measuring (indirectly) pressure (pressure being “fluid pressure” in the chamber of Karunaratne)].
Karunaratne, as modified above in claim 1, remains silent on the precision pump, wherein the sensor is adapted to also measure the wear on the annular seal.
However, Preiswerk teaches a similar system (see fig. 13) with a strain gauge sensor (49). Preiswerk states (see ¶26) “Since, with said type of sensor, the measurement of mechanical forces and/or moments exerted/transmitted in/at the mechanical assemblies and components of the piston pump takes the place of a measurement providing only an indirectly measured value (e.g. a direct measurement of the delivery pressure), the accordingly monitored values, apart from controlling the pump, may also be evaluated for further functions, inter alia for checking the (ball) valves at the liquid displacement unit(s) for proper functioning and/or for checking the piston seals for the extent of wear present”.
Thus, it would have been obvious to the person of ordinary skill in the art before the effective filing date of the invention to incorporate a strain gauge sensor that monitors wear of the piston seal as taught by Preiswerk in the modified precision pump of Karunaratne since Preiswerk states that monitored values using the strain gauge may be evaluated further to check the piston seals wear, thus monitoring the life of the piston seal.
Regarding claim 32,
Karunaratne, as modified above in claim 1, remains silent on the precision pump, wherein the remote monitoring is implemented “so as to monitor the change in the wear of the annular seal”.
However, Preiswerk teaches a similar system (see fig. 13) with a strain gauge sensor (49). Preiswerk states (see ¶26) “Since, with said type of sensor, the measurement of mechanical forces and/or moments exerted/transmitted in/at the mechanical assemblies and components of the piston pump takes the place of a measurement providing only an indirectly measured value (e.g. a direct measurement of the delivery pressure), the accordingly monitored values, apart from controlling the pump, may also be evaluated for further functions, inter alia for checking the (ball) valves at the liquid displacement unit(s) for proper functioning and/or for checking the piston seals for the extent of wear present”.
Thus, it would have been obvious to the person of ordinary skill in the art before the effective filing date of the invention to incorporate a strain gauge sensor that monitors wear of the piston seal as taught by Preiswerk in the modified precision pump of Karunaratne since Preiswerk states that monitored values using the strain gauge may be evaluated further to check the piston seals wear, thus monitoring the life of the piston seal.
Regarding claim 33,
Karunaratne, as modified above in claim 1, remains silent on the precision pump, wherein said remote monitoring is implemented so as to - predict the wear of the seal and anticipate the replacement of the syringe by mean of the bending sensor, - predict mechanical breakdown by means of said vibration sensor and/or ultrasound sensor, and/or- predict an end of life by mean of the total electrical consumption sensor.
However, Preiswerk teaches a similar system (see fig. 13) with a strain gauge sensor (49). Preiswerk states (see ¶26) “Since, with said type of sensor, the measurement of mechanical forces and/or moments exerted/transmitted in/at the mechanical assemblies and components of the piston pump takes the place of a measurement providing only an indirectly measured value (e.g. a direct measurement of the delivery pressure), the accordingly monitored values, apart from controlling the pump, may also be evaluated for further functions, inter alia for checking the (ball) valves at the liquid displacement unit(s) for proper functioning and/or for checking the piston seals for the extent of wear present”. Based on the wear present, a user can anticipate the replacement of the syringe.
Thus, it would have been obvious to the person of ordinary skill in the art before the effective filing date of the invention to incorporate a strain gauge sensor that monitors wear of the piston seal as taught by Preiswerk in the modified precision pump of Karunaratne so as to predict the wear of the seal and anticipate the replacement of the syringe by mean of the bending sensor since Preiswerk states that monitored values using the strain gauge may be evaluated further to check the piston seals wear, thus monitoring the life of the piston seal.
Claims 7, 25, 27 and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Karunaratne in view of Chambers and further in view of Tecan (Cavro XE 1000 Pump – herein after Tecan).
In reference to claim 7, Karunaratne, as modified above in claim 1, does not teach the precision pump, wherein a groove comprises an axial opening for introducing the connector therein.
However, Tecan teaches a similar syringe pump system, wherein (see provided NPL copy and figs. B and C below) a groove comprises an axial opening (labelled “opening” in fig. C; axial being a direction shown by the dotted line) for introducing the connector (in the form of sphere; see fig. B) therein.
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Fig. B: Edited image on page 11 of provided Tecan’s pump NPL copy to show claim interpretation.
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Fig. C: Edited image on page 3 of provided Tecan’s pump NPL copy to show claim interpretation.
Thus, it would have been obvious to the person of ordinary skill in the art before the effective filing date of the invention to substitute a generic connection between the bottom end of the connector and the socket in the precision pump of Karunaratne for a spherical connection that involves an axial opening for introducing the connector therein as taught by Tecan in order to obtain the predictable result of operating the syringe pump by transmitting power from the motor to the piston. KSR Int’l v. Teleflex Inc., 127 S. Ct. 1727, 1740-41, 82 USPQ2d 1385, 1396 (2007)
Alternatively, it would have been obvious to the person of ordinary skill in the art before the effective filing date of the invention to modify a connection between the bottom end of the shaft and the socket in the precision pump of Karunaratne for the connection that involves an axial opening for introducing the connector therein as taught by Tecan in order to have a detachable connection that allows easy syringe replacement (see page 2 of Tecan’s NPL copy, disclosure in right col., lines 4-7) and to further allow a use of different sized syringes such as 50 μl, 100 μl, 250 μl, 500 μl, 1.0 ml, 2.5 ml and 5.0 ml (see page 4 of Tecan’s NPL copy, disclosure of syringes) so that pump offers a broad range dosing volume between 5 μl to 5ml (see page 2 of Tecan’s NPL copy, disclosure in left col., lines 2-3).
In reference to claim 25, Karunaratne, as modified above in claim 1, does not teach the precision pump, wherein the rod of the piston has a reduced cross section compared to the width of the slot of the socket so as to allow a tilting of the rod about the socket axis.
However, Tecan teaches a similar syringe pump system, (see provided NPL copy and figs. B and C above) wherein the rod of the piston has a reduced cross section compared to the width of the slot of the socket (in view of fig. B above) so as to allow a tilting of the rod about the socket axis (dotted line in view of fig. C above) [there exists a clearance/gap (shown in fig. B above) due to difference in width between the rod and the slot, this clearance/gap allows the tilting of the rod about the socket axis].
Thus, it would have been obvious to the person of ordinary skill in the art before the effective filing date of the invention to substitute a generic connection between the bottom end of the connector and the socket in the precision pump of Karunaratne for a spherical connection that involves the rod of the piston having a reduced cross section compared to the width of the slot of the socket so as to allow a tilting of the rod about the socket axis as taught by Tecan in order to obtain the predictable result of operating the syringe pump by transmitting power from the motor to the piston. KSR Int’l v. Teleflex Inc., 127 S. Ct. 1727, 1740-41, 82 USPQ2d 1385, 1396 (2007).
Alternatively, it would have been obvious to the person of ordinary skill in the art before the effective filing date of the invention to modify a connection between the bottom end of the shaft and the socket in the precision pump of Karunaratne for the connection that involves the rod of the piston having a reduced cross section compared to the width of the slot of the socket so as to allow a tilting of the rod about the socket axis as taught by Tecan in order to have a detachable connection that allows easy syringe replacement (see page 2 of Tecan’s NPL copy, disclosure in right col., lines 4-7) and to further allow a use of different sized syringes such as 50 μl, 100 μl, 250 μl, 500 μl, 1.0 ml, 2.5 ml and 5.0 ml (see page 4 of Tecan’s NPL copy, disclosure of syringes) so that pump offers a broad range dosing volume between 5 μl to 5ml (see page 2 of Tecan’s NPL copy, disclosure in left col., lines 2-3).
In reference to claim 27, Karunaratne, as modified above in claim 1, does not teach the precision pump, wherein syringes containing 100µl, 250 µl, 1000 µl, 2.5 ml, 5 ml, 12.5 ml, 25 ml or 50 ml are placed on the socket so that the precision pump doses volumes lying between 0.1 µl to 50 ml.
However, Tecan teaches a similar syringe pump system, (see provided NPL copy and figs. B and C above) with a detachable connection for syringe wherein syringes containing 100µl, 250 µl, 1000 µl, 2.5 ml, 5 ml, 12.5 ml, 25 ml or 50 ml are placed on the socket so that the precision pump doses volumes lying between 0.1 µl to 50 ml [see page 2 of Tecan’s NPL copy, disclosure in right col., lines 4-7; see page 2 of Tecan’s NPL copy, disclosure in left col., lines 2-3; see page 4 of Tecan’s NPL copy, disclosure of syringes].
Thus, it would have been obvious to the person of ordinary skill in the art before the effective filing date of the invention to modify a connection between the bottom end of the shaft and the socket in the precision pump of Karunaratne for the connection as taught by Tecan in order to have a detachable connection that allows easy syringe replacement (see page 2 of Tecan’s NPL copy, disclosure in right col., lines 4-7) and to further allow a use of different sized syringes such as 50 μl, 100 μl, 250 μl, 500 μl, 1.0 ml, 2.5 ml and 5.0 ml (see page 4 of Tecan’s NPL copy, disclosure of syringes) so that pump offers a broad range dosing volume between 5 μl to 5ml (see page 2 of Tecan’s NPL copy, disclosure in left col., lines 2-3)”.
Thus, Karunaratne, as modified above in claim 30, teaches the limitations in claim 27 since syringes with sizes of 50 μl, 100 μl, 250 μl, 500 μl, 1.0 ml, 2.5 ml and 5.0 ml are used/placed on the modified socket.
In reference to claim 30, Karunaratne, as modified above in claim 1, teaches the precision pump, wherein (see fig. A above) the socket (136) and the connector (not seen but present at the bottom end of the shaft) form a linear-annular connection between them.
Karunaratne, as modified, remains silent on the claimed details of the connector and the socket, i.e., “wherein the connector comprises a sphere and wherein the socket comprises a cylindrical groove and a slot, said cylindrical groove being designed to house said sphere therein, said cylindrical groove extending along a socket axis substantially perpendicular to the syringe axis and having a diameter substantially equal to a diameter of said sphere, and said slot being provided for a passage of said rod with a clearance when the sphere is in said cylindrical groove, so as to form a linear-annular connection between the socket and the connector”.
However, Tecan teaches a similar syringe pump system, wherein (see provided NPL copy) the connector comprises (see fig. B above) a sphere (at bottom end of axial rod) and wherein the socket comprises a cylindrical groove (in view of images in the provided NPL copy: groove extends in a direction into and out of page in view of fig. B below; thus groove being cylindrical) and a slot (see fig. B above), said cylindrical groove being designed to house said sphere therein, said cylindrical groove extending along a socket axis (axis being into and out of page in view of fig. B above) substantially perpendicular to the syringe axis (being in vertical direction in view of fig. B above) and having a diameter substantially equal to a diameter of said sphere, and said slot being provided for a passage of said rod with a clearance (see fig. B above) when the sphere is in said cylindrical groove, so as to form a linear-annular connection between the socket and the connector.
Thus, it would have been obvious to the person of ordinary skill in the art before the effective filing date of the invention to substitute a generic connection between the bottom end of the connector and the socket in the precision pump of Karunaratne for a spherical connection as taught by Tecan in order to obtain the predictable result of operating the syringe pump by transmitting power from the motor to the piston. KSR Int’l v. Teleflex Inc., 127 S. Ct. 1727, 1740-41, 82 USPQ2d 1385, 1396 (2007)
Alternatively, it would have been obvious to the person of ordinary skill in the art before the effective filing date of the invention to modify a connection between the bottom end of the shaft and the socket in the precision pump of Karunaratne for the connection as taught by Tecan in order to have a detachable connection that allows easy syringe replacement (see page 2 of Tecan’s NPL copy, disclosure in right col., lines 4-7) and to further allow a use of different sized syringes such as 50 μl, 100 μl, 250 μl, 500 μl, 1.0 ml, 2.5 ml and 5.0 ml (see page 4 of Tecan’s NPL copy, disclosure of syringes) so that pump offers a broad range dosing volume between 5 μl to 5ml (see page 2 of Tecan’s NPL copy, disclosure in left col., lines 2-3).
Claims 21 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Karunaratne in view of Chambers and further in view of Mishliborsky, Zvy (US 4,718,287 – herein after Mishliborsky).
Karunaratne, as modified above in claim 1, teaches the precision pump with the beam.
Karunaratne, as modified, remains silent on the precision pump wherein the beam has weakening zones, as claimed in claims 21 and 22.
However, Mishliborsky teaches a beam (25) wherein one surface is provided with thinner/weakening zones (27A, 27B) and surface opposite to the surface with weakening zones is provided with a circuit (28) that follow up or detect flexions in the bar.
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the invention to provide weakening zones using the teaching of Mishliborsky in a left surface/region (in view of fig. A above) of the Karunaratne’s beam (i.e. base) in the modified precision pump of Karunaratne for the purpose of achieving high accuracy of measurement and low sensitivity to eccentric loads, as recognized by Mishliborsky (see abstract).
Thus, Karunaratne, as modified above, teaches the precision pump, wherein said beam (of Karunaratne) comprises weakening zones (of Mishliborsky) adapted to increase a sensitivity of said bending sensor (since stresses are concentrated in the weakening zones), as in claim 21; and wherein said weakening zones (of Mishliborsky) consists of two semi-cylinders (as seen in fig. 4 of Mishliborsky), transverse to the beam (of Karunaratne), open towards a top (towards the left in view of fig. A above) in a top face (left face) of the beam (of Karunaratne), as in claim 22.
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Karunaratne in view of Chambers and further in view of Harris et al. (US 2021/0345952 – herein after Harris).
Karunaratne, as modified by above in claim 12, remains silent on the method further comprising one or more of following steps: - measuring one or both of heating and torque of the rotary motor by means of a current sensor, - measuring a total electrical consumption, by means of a current sensor.
However, Harris teaches (in ¶139) “The sensors 1030, 1040, 1045 can each include a device sensor (similar to device sensor 92 discussed above), an environment sensor (similar to environment sensor 94 discussed above), or a location sensor (similar to location sensor 98 discussed above). Each of the sensors 1030, 1040, 1045 is configured to gathers data for a different characteristic. The characteristics can be physiological characteristics and/or situational characteristics of the patient. Various different physiological characteristics can be monitored, such as blood sugar level (e.g., using a glucose monitor, etc.), blood pressure (e.g., using a blood pressure monitor, etc.), perspiration level (e.g., using a fluid sensor, etc.), heart rate (e.g., using a heart rate monitor, etc.), etc. Furthermore, a number of different situational characteristics can be monitored, such as core temperature, (e.g., using a temperature sensor), tremor detection (using an accelerometer, etc.), time of day (e.g., using a timer, etc.), date (e.g., using a timer, etc.), patient activity level (e.g., using a motion sensor, etc.), blood pressure (e.g., using a blood pressure monitor, etc.), metabolic rate (e.g., using heart rate as discussed herein, etc.), altitude (e.g., using an altimeter, etc.), temperature of the drug (e.g., using a temperature sensor), viscosity of the drug (e.g., using a viscometer, etc.), GPS information (e.g., using a location sensor, etc.), weather information (e.g., using a temperature sensor, humidity sensor, etc.), room or external temperature (e.g., using a temperature sensor), angular rate (e.g., using an inertial measurement unit (IMU) or MARG (magnetic, angular rate, and gravity) sensor), body orientation (e.g., using an IMU, etc.), current of a motor used in delivering the drug (e.g., using a current sensor)”. Harris further teaches (in ¶140) “While three sensors are illustrated in FIG. 11, the device 1016 can include only one sensor, can include only two sensors, or can include more than three sensors”. Thus, Harris teaches the method comprising a step of “measuring a total electrical consumption, by means of a current sensor”.
Thus, it would have been obvious to the person of ordinary skill in the art before the effective filing date of the invention provide a current sensor as taught by Harris in the modified method of Karunaratne for the purpose of controlling the modified pump based on a characteristic associated with the patient as recognized by Harris (in ¶139).
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Karunaratne in view of Chambers and further in view of Guru et al. (US 2022/0103449 – herein after Guru).
Karunaratne, as modified above in claim 12, remains silent on the method further comprising one or more of following steps: - measuring a temperature of the rotary motor by means of an infrared sensor, - measuring an ambient moisture, by means of a moisture sensor, so as to detect a potential leakage of the precision pump.
However, Guru teaches (in fig. 2) “According to the embodiment illustrated in FIG. 2, a non-contact temperature sensor 81, such as an infrared sensor, may be provided to detect heat, H, radiated from the motor 40”. Thus, Guru teaches the method comprising a step of “measuring a temperature of the rotary motor by means of an infrared sensor”.
Thus, it would have been obvious to the person of ordinary skill in the art before the effective filing date of the invention provide the infrared sensor as taught by Guru to Karunaratne’s motor in the modified method of Karunaratne for the purpose of monitoring the temperature of the motor so that an impending failure in the motor can be detected early, as recognized by Guru (in ¶7).
Claims 34 and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Karunaratne in view of Chambers and Langer Pump (MSP1-D1 Industries Syringe Pump – herein after Langer).
In reference to claim 34, Karunaratne, as modified above in claim 1, teaches the precision pump, (see Kaunaratne) said syringe (102, see fig. 1A) comprising a male fluid socket (threaded central port that is screwed into the valve 109; see ¶35 and fig. 1A), the precision pump further comprising a valve (109), adapted to rotate about a valve axis and actuated by a valve motor (106; see ¶64 and figs. 1A-1C), and comprising one female fluid socket (claimed as “first female fluid socket”, in the claim ahead), wherein a first female fluid socket (socket/opening that mates with threaded central port of the syringe 102) is adapted to engage with said male fluid socket.
Karunaratne remains silent on the precision pump, wherein the valve further comprises of a second and a third female sockets, each connected to a tube so that the valve has “three” female fluid sockets.
However, Langer teaches a similar syringe pump system having a similar valve that further comprises (see image shown on page 4 of provided Langer’s NPL copy) a second and a third female sockets, each connected to a tube.
Thus, it would have been obvious to the person of ordinary skill in the art before the effective filing date of the invention to modify the valve in the precision pump of Karunaratne for providing it with a second and third female sockets as taught by Langer for the purpose of coupling the tube for pumping/dosing the fluid through it.
In reference to claim 35, Karunaratne, as modified above in claim 34, teaches the precision pump, wherein said valve motor (106of Karunaratne) is a stepping motor (see Karunaratne’s ¶64).
Claim 37 is rejected under 35 U.S.C. 103 as being unpatentable over Karunaratne in view of Chambers and further in view of Li, Yue-hua (CN 201607322U – herein after Li).
Karunaratne, as modified above in claim 12, remains silent on the method further comprising the steps of:
measuring the friction forces of the annular seal in real or deferred time so as monitor a change in the wear on the annular seal over time, by means of the sensor,
plan a replacement of the annular seal or the syringe based on the measured friction forces and proceed to the replacement of the syringe based on a wear measurement, so as to avoid the leak.
However, Li teaches a method that involves the steps of measuring the friction forces of the annular seal in real or deferred time so as monitor a change in the wear on the annular seal over time, by means of the sensor (see ¶9-¶10 of translation: “The utility model is a reciprocating hydraulic polyurethane sealing ring test bench, which can perform the following tests on the piston rod hydraulic sealing ring: (1) Friction of the hydraulic piston rod seal including starting friction, running friction, and wear rate of the sealing ring lip”; see ¶20 of translation “The force sensor 14 tests the starting friction force (including the friction force generated by the two Y-shaped hydraulic sealing rings 12, the two Y-shaped dust seals 2, and the two support rings), and records the starting friction force data at this time”), and plan a replacement of the annular seal or the syringe based on the measured friction forces and proceed to the replacement of the syringe based on a wear measurement, so as to avoid the leak (see ¶25-¶29 of translation).
Thus, it would have been obvious to the person of ordinary skill in the art before the effective filing date of the invention to modify the method in the modified system of Karunaratne for adding steps of measuring friction forces of the annular seal and plan its replacement as taught by Li for the purpose of monitoring life of the seal and plan its replacement, when needed, so that the pump is operated in an efficient manner.
Response to Arguments
Applicant's arguments filed 02/11/2026 have been fully considered but they are not persuasive. Applicant merely states that none of the references disclose features to correct the dosing function according to ambient parameters. Examiner disagrees. As stated above in the rejection, the primary reference of Karunaratne teaches this newly added limitation in claim 1.
Conclusion
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/CHIRAG JARIWALA/Examiner, Art Unit 3746
/ESSAMA OMGBA/Supervisory Patent Examiner, Art Unit 3746