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 .
Response to Amendment
This Office Action is in response to the Applicant’s amendment filed 7 April 2026 wherein Claims 1, 6, 10 – 12, 17, and 18 are amended, Claims 21 and 22 are newly added, Claims 2 – 4 are cancelled. Therefore, Claims 1 and 5 – 23 are currently pending within the application.
The Applicant’s amendment to the Specification dated 7 April 2026 has been fully considered. The amendments to the Specification have overcome each Drawing and Specification Objection set forth in the Non-Final Rejection dated 14 January 2026 (hereinafter referred to as the “Non-Final Rejection”). Therefore, each Drawing and Specification Objection set forth in the Non-Final Rejection is withdrawn.
The Applicant’s amendments to the Claims dated 7 April 2026 has been fully considered. The Applicant’s amendments to the Claims has overcome each Claim Objection set forth in the Non-Final Rejection. Similarly, the Applicant’s amendments to the Claims has overcome each Claim Rejection set forth under 35 U.S.C. § 112(b). Therefore, each Claim Objection and Claim Rejection under 35 U.S.C. § 112(b) set forth in the Non-Final Rejection is withdrawn.
Response to Arguments
Applicant’s arguments, see pages 11 – 12, filed 7 April 2026 with respect to the rejection(s) of claim(s) 1 under 35 U.S.C. § 102 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Roger (US 2008/0177222 A1) and Hetchler et al. (US 2018/0221643 A1).
Claim Objections
Claim 13 is objected to because of the following informalities:
Claim 13 recites “based on accelerometer data.” The Examiner suggests amending this to recite “based on the accelerometer data” to provide antecedent basis to the data from the at least one accelerometer recited in Claim 1.
Appropriate correction is required.
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 22 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 12 recites:
The medical pump of claim 5, wherein the processor is configured to detect that an irregular pressure spike in an infusion line is due to an electrical disturbance when no external impact is detected from the accelerometer data.
Claim 22 recites:
The medical pump of claim 12, wherein the processor is configured to determine an electrically induced pressure spike when no mechanically induced noise is detected by the accelerometer and pressure spikes are detected using an occlusion algorithm.
Claim 22 is rejected under 35 U.S.C. § 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention because it cannot be determined if the recited “pressure spikes” is referring to the irregular pressure spike recited in Claim 12, the electrically induced pressure spike recited in Claim 22, both the irregular and electrically induced pressure spikes, or neither of the irregular and electrically induced pressure spikes.
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.
Claim(s) 1, 5 – 10, and 12 is/are rejected under 35 U.S.C. 103 as being obvious over Roger (US 2008/0177222 A1) and Hetchler et al. (US 2018/0221643 A1) (hereinafter referred to as “Hetchler”).
Roger is cited in the Notice of References Cited form dated 14 January 2026.
With regards to claim 1, Roger discloses (Fig. 1) a medical pump (10) (see [0061]) comprising:
a housing (see [0067] “Accelerometer 60 on the other hand is positioned on or in the casing of the system 10, such that it does not sense a change in the weight of the control bag 30” wherein the “casing” of the system 10 is the housing);
at least one tube (16) (see [0062] and [0063]) disposed within the housing (see Fig. 1); and
at least one accelerometer (60) (see [0067]), wherein the at least one accelerometer is configured to communicate with a processor (50a) (see [0066]) operably coupled to the medical pump (see [0069]),
wherein the medical pump is configured to deliver at least one medical fluid to a patient (see [0062] “A fresh dialysate line 16 is connected fluidly to dialysate supply 12 and the inlet of filter 18.”);
wherein the processor receives data from the at least one accelerometer and makes determinations of the presence of mechanically induced noise based on the data from the at least one accelerometer (see [0032] “The three-dimensional nature of the accelerometer allows nuisance trips from the machine being bumped at virtually any angle to be detected and disregarded. It also allows compensation in weight measurement error due to machine tilt,” [0033] – [0038], [0066], [0067], and [0071] “In this control scheme controller 50a operates at least primarily as a load cell and accelerometer controller,” [0072] – [0078], and [0079] “Accelerometer 60 also measures an amount of dynamic acceleration due for example to a mechanical bumping of the machine or control bag 30 of system 10.” Here the mechanically induced noise is the bumping of the machine or control bag of the system.).
However, Roger is silent with regards to:
wherein the processor further makes determinations of a tube pull condition of the at least one tube based on the data from the at least one accelerometer.
Nonetheless Hetchler, which is within the analogous art of infusion pumps (see abstract) teaches wherein the processor (see [0055] “accelerometer (not shown) communicatively coupled to the control system” where the control system is the processor) further makes determinations of a tube pull condition of the at least one tube based on the data from the at least one accelerometer (see [0055] “The predetermined safety condition that leads to issuance of a command to remove opening force from clamp 200 can be detected at least in part based upon acceleration information measured by the accelerometer. A sensed acceleration could be indicative of an unintended physical occurrence at pump 400 such as a sudden movement or impact which could potentially cause a disconnection of the infusion line from the pump” where the disconnection of the infusion line from the pump is the tube pull condition).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the processor of the medical pump of Roger in view of at teaching of Hetchler such that the processor further makes determinations of a tube pull condition of the at least one tube based on the data from the at least one accelerometer. One of ordinary skill in the art would have been motivated to make this modification because it is beneficial for a healthcare professional using the medical pump to be made aware of a disconnection of the infusion line from the pump due to a sudden movement or impact. See [0055] of Hetchler. Additionally, the sensed acceleration is not limited to indicating a disconnection of the infusion line but also could indicate a leak from an infusion line not yet connected to patient, an unintended bolus delivery of infusate to a patient who is connected to the infusion line, and more. See [0055] of Hetchler. So a PHOSITA would also be motivated to modify the processor in this manner in order to indicate the leak from the infusion line, the unintended bolus delivery, and more.
The medical pump of Roger modified in view of Hetchler will hereinafter be referred to as the medical pump of Roger and Hetchler.
With regards to claim 5, the medical pump of Roger and Hetchler teaches the claimed invention of claim 1, and Roger further teaches (see Fig. 1) wherein the at least one accelerometer (60) (see [0067]) is configured to detect an external impact (108) (see Fig. 5, [0093], and [0094]) to the medical pump (see [0067], [0074], and [0079] “Accelerometer 60 also measures an amount of dynamic acceleration due for example to a mechanical bumping of the machine or control bag 30 of system 10.”).
With regards to claim 6, the medical pump of Roger and Hetchler teaches the claimed invention of claim 5, and Roger further teaches (see Fig. 1) wherein the processor (50a) (see [0066]) is further configured to determine whether an alarm condition (120) (see [0093], [0097], and [0104]) is due to the external impact (108) (see Fig. 5, [0093], and [0094]) based on input from the at least one accelerometer (see Fig. 5 and [0097], [0098], and [0104]).
With regards to claim 7, the medical pump of Roger and Hetchler teaches the claimed invention of claim 6, and Roger further teaches (see Fig. 1) wherein the medical pump (10) (see [0061]) is configured to generate a failure alarm signal (120) when no external impact has been determined (see Fig. 5, [0097], [0102], and [0104]).
With regards to claim 8, the medical pump of Roger and Hetchler teaches the claimed invention of claim 7, and Roger further teaches wherein the failure alarm signal is an audible alarm through at least one speaker operably coupled to the medical pump (see [0030], [0097], and [0104] “an audio, visual or audiovisual alarm” wherein the at least one speaker is the component that creates the audio/audiovisual alarm).
With regards to claim 9, the medical pump of Roger and Hetchler teaches the claimed invention of claim 7, and Roger further teaches wherein the failure alarm signal is a visual signal on a display operably coupled to the medical pump (see [0030], [0097], and [0104] “visual or audiovisual alarm” wherein the display is the component of the medical pump that creates the visual and audiovisual alarm)
With regards to claim 10, the medical pump of Roger and Hetchler teaches the claimed invention of claim 5, and Roger further teaches wherein the processor (50a) (see [0066]) is further configured to send a signal to the medical pump not to alarm (see Figure 5 and logic steps, 106, 108, 110, and 112; Additionally see [0021] “ Vibrations from a source close to the instrument could also interfere with the weight measurement. These interferences would likely cause the load cell to sense a force that is out of range or limit, causing the machine to generate an alarm even though the machine is operating properly,” [0090] – [0092], and [0093] “DSP 58 determines that a mechanical interference has occurred and sends a signal to CPU 62 to disregard any error signals from load cell 52, as seen in connection with step 110. Afterwards, the mechanical interference warning function is returned or reset to normal operation as seen at step 112.” Here the signal not to alarm is the disregard any error signal) or not to auto-restart if the alarm condition was purely caused by the external impact.
With regards to claim 12, the medical pump of Roger and Hetchler teaches the claimed invention of claim 5, and Roger further teaches wherein the processor (50a) (see [0066] “control device 50a”) is configured to detect that an irregular pressure spike (see [0069] “For example, control device 50a also receives pressure signals 42a and 42b from pressure transducers 44a and 44b, respectively.”) in an infusion line (16) (see [0062] and Fig. 1) is due to an electrical disturbance (42a) when no external impact is detected from the accelerometer data (106) (see [0091], [0092], and [0102]).
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Roger and Hetchler as applied to claims 5 above, and in further view of Bitan et al. (US 2014/0222377 A1) (hereinafter referred to as “Bitan”).
With regards to claim 11, the medical pump of Roger and Hetchler teaches the claimed invention of claim 5, however Roger is silent with regards to wherein the pump further includes at least one sensor and the processor is further configured to run a diagnostic algorithm on the at least one sensor following an indication from the at least one accelerometer that the external impact has occurred.
Nonetheless Bitan, which is within the analogous art of medical devices including accelerometers (see abstract and title), teaches the pump (200) (see [0049]) further includes at least one sensor (see [0027] “one or more accelerometers” and [0048] “the medical device 200 is substantially similar to medical device 100 described above and accordingly elements 204-222 are substantially similar to elements 104 – 122 (accordingly)” wherein one of the accelerometers is the sensor) and the processor (214) (see [0035] “Medical device control logic 114 may control and receive information from additional blocks such as therapeutic/diagnostic component 106, medical device memory 110, accelerometer 104 and more” and [0048]) is further configured to run a diagnostic algorithm (see [0049] “a self-test carried out by medical device 200…determine damage to medical device per acceleration/vibration events”) on the at least one sensor following an indication (see [0031], [0032], [0036], and [0048] where the indication is the data measured by the accelerometer) from the at least one accelerometer (see [0027] and [0048] where the at least one accelerometer is a second accelerometer of the one or more accelerometers) that the external impact has occurred (see [0026], [0027], [0041] and [0049] where the external impact is the described falling of the medical device).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the pump of Roger and Hetchler in view of a teaching of Bitan such that the pump further includes at least one sensor and the processor is further configured to run a diagnostic algorithm on the at least one sensor following an indication from the at least one accelerometer that the external impact has occurred. One of ordinary skill in the art would have been motivated to make this modification because Bitan teaches that a self-test may be carried out by the pump to determine the damage to the medical device per acceleration/vibration events. See [0049] of Bitan. A PHOSITA would recognize that performing a self-test to determine if any damage to the sensor or medical pump occurred due to the fall is beneficial so that the device may be further used after the fall.
The medical pump of Roger and Hetchler modified in view of a teaching of Bitan will hereinafter be referred to as the medical device of Roger, Hetchler, and Bitan.
Claim(s) 13 and 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Roger and Hetchler as applied to claims 1 and 5 above, and in further view of Rouleau et al. (US 2012/0123338 A1) (hereinafter referred to as “Rouleau”).
Rouleau is cited in the Notice of References Cited form dated 14 January 2026.
With regards to claim 13, the medical pump of Roger and Hetchler teaches the claimed invention of claim 5, however Roger is silent with regards to wherein the processor is configured to determine based on accelerometer data whether the external impact was due to a drop of the medical pump from a height.
Nonetheless Rouleau, which is within the analogous art of drug delivery devices (see abstract and title), teaches the processor is configured to determine based on accelerometer data whether the external impact was due to a drop of the medical pump from a height (see [0038] “the sensor comprises an accelerometer which measures the mechanical stresses (e.g. those associated with accelerations and/or vibrations) that a medication is subjected to when a device such as a portable infusion pump is rocked, jostled or dropped.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the processor and accelerometer of the medical pump of Roger and Hetchler in view of a further teaching of Rouleau such that the processor is configured to determine based on accelerometer data whether the external impact was due to a drop of the medical pump from a height. One of ordinary skill in the art would have been motivated to make this modification because Rouleau teaches that the accelerometer can determine whether the device is dropped thereby effecting the therapeutic efficacy of the drug. See [0023] of Rouleau.
With regards to claim 23, the medical pump of Roger and Hetchler teaches the claimed invention of claim 1, however Roger is silent with regards to wherein the processor is configured to generate a high priority alarm upon an indication from the accelerometer that the pump has dropped from a height.
Nonetheless Rouleau, which is within the analogous art of drug delivery devices (see abstract and title), teaches wherein the processor (12) (see [0054] “Each of the CCD 16, the sensor or monitor 14, the computer 18 and the delivery device 12 may include receiver, transmitter or transceiver electronics that allow communication with other components of the system. The delivery device 12 may include electronics and software for analyzing sensor data and for delivering the infusion medium according to sensed data and/or pre-programmed delivery routines.”) is configured to generate a high priority alarm upon an indication from the accelerometer (14) (see [0038] “ the sensor comprises an accelerometer which measures the mechanical stresses (e.g. those associated with accelerations and/or vibrations) that a medication is subjected to when a device such as a portable infusion pump is rocked, jostled or dropped” and [0054] “a sensor or monitor 14”) that the pump has dropped from a height (see [0008] “the sensing element is coupled to an alarm that is activated in the event that the fluid medication is exposed to a mechanical stress or temperature that exceeds a critical threshold (e.g. a degree of mechanical stress or temperature threshold that can compromise the activity of a polypeptide medication),” [0038] “dropped,” and [0042]) .
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the processor of the medical pump of Roger and Hetchler in view of a further teaching of Rouleau such that the processor is configured to generate a high priority alarm upon an indication from the accelerometer that the pump has dropped from a height. One of ordinary skill in the art would have been motivated to make this modification because Rouleau teaches that it is beneficial to use an accelerometer to measure the mechanical stresses (e.g., those associated with accelerations and/or vibrations) that a medication is subjected to when a device such as a portable infusion pump is rocked, jostled, or dropped. See [0038] of Rouleau. By measuring the mechanical stresses a PHOSITA would be able to determine whether a medication has become destabilized See [0002] – [0004] of Rouleau. A PHOSITA would recognize that coupling an alarm to the accelerometer is beneficial because the alarm alerts the user if the medication has been exposed to a mechanical stress that exceeds a critical threshold that can compromise the activity of the medication. See [0008] and [0042] of Rouleau.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Roger and Hetchler as applied to claim 1 above, and in further view of Tamtoro et al. (US 2020/0289740 A1; hereinafter referred to as “Tamtoro”).
Tamtoro is cited in the Notice of References Cited form dated 14 January 2026.
With regards to claim 14, the medical pump of Roger and Hetchler teaches the claimed invention of claim 1, however Roger is silent with regards to wherein the accelerometer is configured to communicate to the processor that mechanical movement or vibrations are due to movement of a door disposed on the housing.
Nonetheless Tamtoro, which is within the analogous art of drug delivery storage devices and systems (see abstract), teaches the accelerometer is configured to communicate to the processor that mechanical movement or vibrations are due to movement of a door disposed on the housing (see [0177] “The container sensor 1012 may include an accelerometer mounted on a movable lid or door 1017 of the storage container 1002, and which is adapted to sense a movement of the movable lid or door of the storage container 1002.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the accelerometer and processor of the medical pump of Roger and Hetchler in view of a teaching of Tamtoro such that the accelerometer is configured to communicate to the processor that mechanical movement or vibrations are due to movement of a door disposed on the housing. One of ordinary skill in the art would have been motivated to make this modification because Tamtoro teaches that the accelerometer is configured to communicate with the processor to determine that the mechanical movement or vibration is due to movement of a door or lid (see [0177] of Tamtoro). Roger teaches that the accelerometer is configured to communicate to the processor about mechanical movement or vibrations. However, Roger does not disclose that the mechanical movement or vibrations are due to movement of a door disposed on the housing. Tamtoro teaches that this mechanical movement or vibrations of a door disposed on the housing can be sensed by the accelerometer.
Claim(s) 15 – 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Roger and Hetchler as applied to Claim 1 above, and in further view of Halbert et al. (US 2012/0197196 A1; hereinafter referred to as “Halbert ’196”).
Halbert ’196 is cited in the Notice of References Cited form dated 14 January 2026.
With regards to claim 15, the medical pump of Roger and Hetchler teaches the claimed invention of claim 1, however Roger is silent with regards to wherein the accelerometer is configured to communicate to the processor that mechanical movement or vibrations are due to a key selection of a user pressing a key.
Nonetheless Halbert ’196, which is within the analogous art of accelerometers (see [0017]), teaches the accelerometer is configured to communicate to the processor that mechanical movement or vibrations are due to a key selection of a user pressing a key (see [0017] “gesture sensor 115 can be, but is not limited to, an accelerometer, gyroscope, etc. In one embodiment, gesture sensor 115 is an input sensor that senses a key press or a touch of a sensor.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the accelerometer of the medical pump of Roger and Hetchler in view of a teaching of Halbert ’196 such that the accelerometer is configured to communicate to the processor that mechanical movement or vibrations are due to a key selection of a user pressing a key. One of ordinary skill in the art would have been motivated to make this modification because Halbert ’196 teaches the accelerometer can sense a key press by a user (see [0017] of Halbert ’196). Roger teaches that the accelerometer is configured to communicate to the processor about mechanical movement or vibrations. However, Roger does not disclose that the mechanical movement or vibrations are due to a key selection of a user pressing a key. Halbert ’196 teaches that this mechanical movement or vibrations are due to a key selection of a user pressing a key.
The medical pump of Roger and Hetchler modified in view of a teaching of Halbert ’196 will hereinafter be referred to as the medical pump of Roger, Hetchler and Halbert ’196.
With regards to claim 16, the medical pump of Roger, Hetchler, and Halbert ’196 teaches the claimed invention of claim 15, however, Roger is silent with regards to wherein the key is a digital key on a display.
Nonetheless Halbert ’196, which is within the analogous art of accelerometers (see [0017]), wherein the key is a digital key on a display (see [0017] “gesture sensor 115 can be, but is not limited to, an accelerometer, gyroscope, etc. In one embodiment, gesture sensor 115 is an input sensor that senses a key press or a touch of a sensor” and [0032] “A gesture can be user input on one device (e.g., pressing a key) in concert with gesture on other device, or user inputs on both devices in concert (e.g., holding a push button, touching a touch screen, etc.).”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the medical pump of Roger, Hetchler, and Halbert ’196 in view of a further teaching of Halbert ’196 such that the key is a digital key on a display. One of ordinary skill in the art would have been motivated to make this modification because Halbert ’196 teaches the accelerometer can sense a key press by a user (see [0017] and [0032] of Halbert ’196). Roger teaches that the accelerometer is configured to communicate to the processor about mechanical movement or vibrations. However, Roger does not disclose that the mechanical movement or vibrations are due to a key selection of a user pressing a key. Halbert ’196 teaches that this mechanical movement or vibrations are due to a key selection of a user pressing a key.
With regards to claim 17, the medical pump of Roger, Hetchler, and Halbert ’196 teaches the claimed invention of claim 15, however, Roger is silent with regards to wherein the key is a physical key.
Nonetheless Halbert ’196, which is within the analogous art of accelerometers (see [0017]), teaches wherein the key is a physical key. (see [0017] “gesture sensor 115 can be, but is not limited to, an accelerometer, gyroscope, etc. In one embodiment, gesture sensor 115 is an input sensor that senses a key press or a touch of a sensor” and [0032] “A gesture can be user input on one device (e.g., pressing a key) in concert with gesture on other device, or user inputs on both devices in concert (e.g., holding a push button, touching a touch screen, etc.).”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the accelerometer of the medical pump of Roger, Hetchler, and Halbert ’196 in view of a further teaching of Halbert ’196 such that the key is a physical key. One of ordinary skill in the art would have been motivated to make this modification because Halbert ’196 teaches the accelerometer can sense a key press by a user (see [0017] and [0032] of Halbert ’196). Roger teaches that the accelerometer is configured to communicate to the processor about mechanical movement or vibrations. However, Roger does not disclose that the mechanical movement or vibrations are due to a key selection of a user pressing a key. Halbert ’196 teaches that this mechanical movement or vibrations are due to a key selection of a user pressing a key.
Claim(s) 18 – 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Roger and Hetchler as applied to Claim 1 above, and in further view of Kamen et al. (US 2014/0188076 A1) (hereinafter referred to as “Kamen”).
Kamen is cited in the Notice of References Cited form dated 14 January 2026.
With regards to claim 18, the medical pump of Roger and Hetchler teaches the claimed invention of claim 1, however, Roger is silent with regards to the medical pump further comprising an occlusion sensor, wherein the occlusion sensor is configured to communicate with the processor to determine if an infusion line is blocked.
Nonetheless Kamen, which is within the analogous art of syringe pumps (see abstract and title), teaches (Figs. 28 and 59) teaches an occlusion sensor (513) (see [0462]), wherein the occlusion sensor is configured to communicate with a processor (3500) (see [0589] and [0590]) that determines if an infusion line is blocked (see [0461], [0462], and [0590]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the medical pump of Roger and Hetchler in view of a teaching of Kamen such that the medical pump further comprises an occlusion sensor, wherein the occlusion sensor is configured to communicate with a processor that determines if an infusion line is blocked. One of ordinary skill in the art would have been motivated to make this modification because Kamen teaches that the inclusion of this occlusion sensor allows for the pump to determine if an occlusion has occurred and thereby stop delivering fluid (see [0462] of Kamen).
The medical pump of Roger and Hetchler modified in view of a teaching of Kamen will hereinafter be referred to as the medical pump of Roger, Hetchler, and Kamen.
With regards to claim 19, the medical pump of Roger, Hetchler, and Kamen teaches the claimed invention of Claim 18, however, Roger is silent with regards to wherein the occlusion sensor communicates with the processor to determine if the infusion line is blocked by calculating one of a slope of a force curve, a slope of a pressure curve, a comparison to a baseline force measurement, a comparison to a baseline pressure measurement, or an area under the force curve.
Nonetheless Kamen, which is within the analogous art of syringe pumps (see abstract and title), teaches (Figs. 28 and 59) the occlusion sensor (513) (see [0462]) communicates with the processor (3500) (see [0589] – [0590]) to determine if the infusion line is blocked by calculating one of a slope of a force curve, a slope of a pressure curve, a comparison to a baseline force measurement, a comparison to a baseline pressure measurement (see [0462]), or an area under the force curve.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the occlusion sensor of the medical pump of Roger, Hetchler, and Kamen in view of a further teaching of Kamen such that the occlusion sensor communicates with the processor to determine if the infusion line is blocked by calculating one of a slope of a force curve, a slope of a pressure curve, a comparison to a baseline force measurement, a comparison to a baseline pressure measurement, or an area under the force curve. One of ordinary skill in the art would have been motivated to make this modification because Kamen teaches that the inclusion of this occlusion sensor allows for the pump to determine if an occlusion has occurred and thereby stop delivering fluid (see [0462] of Kamen).
With regards to claim 20, the medical pump of Roger and Hetchler teaches the claimed invention of Claim 1, however, Roger is silent with regards to wherein the medical pump is positioned in a rack with at least one other medical pump.
Nonetheless Kamen, which is within the analogous art of syringe pumps (see abstract and title), teaches the medical pump (201) is positioned in a rack (208) with at least one other medical pump (202, 203) (see [0423]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the medical pump of Roger and Hetchler in view of a teaching of Kamen such that the medical pump is positioned in a rack with at least one other medical pump. One of ordinary skill in the art would have been motivated to make this modification because Kamen teaches that sharing the same rack facilitates multiple pumps sharing power among each other and being in electrical communication with each other (see [0425] of Kamen).
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Roger, Hetchler, and Bitan as applied to claim 11 above, and further in view of Tamari (US 5,215,450 A).
With regards to claim 21, the medical pump of Roger, Hetchler, Bitan teaches the claimed invention of Claim 11, however, Roger is silent with regards to wherein the at least one sensor includes a force sensor disposed on a drive head of the medical pump.
Nonetheless Tamari, which is within the analogous art of medical pumps (see abstract and title), teaches (see Figs. 9(a) – 9(d)) the at least one sensor (453a, 454a) (see Col. 23, line 63 – Col. 24, line 39 “Sensors 453a, 454a can be, for example, force transducers that detect the force that tube 21 exerts on roller 412 or 413 as said rollers squeeze the tubing”) includes a force sensor disposed on a drive head (410) (see Col. 20, lines 22 – 41 “pump head 410”) of the medical pump (see Col. 20, lines 22 – 41 “a peristaltic roller pump”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the drive head of the medical pump of Roger, Hetchler, and Bitan in view of a teaching of Tamari such that the at least one sensor includes a force sensor disposed on a drive head of the medical pump. One of ordinary skill in the art would have been motivated to make this modification because Tamari teaches that the sensor detects the force that the tube exerts on the roller as the rollers squeeze the tubing. See Col. 23, line 63 – Col. 24, line 39. This detection will art the user about the degree of occlusion. Id. Here the drive head of peristaltic pump 20a of Roger (see [0064]) will incorporate the force sensor(s) 453a, 454a taught by Tamari.
Claim(s) 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Roger and Hetchler as applied to claim 12 above, and further in view of Halbert et al. (US 2015/0005732 A1) (hereinafter referred to as “Halbert ’732”).
With regards to claim 22, the medical pump of Roger and Hetchler teaches the claimed invention of Claim 12, and, the medical pump of Roger and Hetchler teaches the processor is configured to determine an electrically induced pressure spike when no mechanically induced noise is detected by the accelerometer.
The language “the processor is configured to determine an electrically induced pressure spike when no mechanically induced noise is detected by the accelerometer” constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. MPEP 2173.05(g). Furthermore, the claim is an apparatus claim and is limited by structural limitations. MPEP 2114. The Office submits that the medical pump of Roger and Hetchler meets the structural limitations of the claim wherein the processor is capable of determining an electrically induced pressure spike when no mechanically induced noise is detected by the accelerometer. Here, the medical pump of Roger and Hetchler teaches the processor 50a being capable of determining an electrically induced pressure spike 42a, see [0069] of Roger, when no mechanically induced noise, see the rejection of claim 1 above wherein the mechanically induced noise is the noise created by jostling, rocking, or dropping the pump, is detected by the accelerometer 60.
However, Roger is silent with regards to the pressure spikes are detected using an occlusion algorithm.
Nonetheless Halbert ’732, which is within the analogous art of occlusion detection systems and methods (see abstract and title), teaches pressure spikes are detected using an occlusion algorithm (see [0027] and [0038]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the processor of the medical pump of Roger and Hetchler in view of a teaching of Halbert ’732 such that the pressure spikes are detected using an occlusion algorithm. One of ordinary skill in the art would have been motivated to make this modification because using an occlusion algorithm to detect an occlusion is beneficial because the algorithm can dynamically adapt based on the fluid delivered to the patient in order to detect occlusions in the fluid line while preventing activation of a false occlusion alarm. See [0003], [0006], and [0027] of Halbert ’732.
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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/ROBERT F ALLEN/Examiner, Art Unit 3783
/WILLIAM R CARPENTER/Primary Examiner, Art Unit 3783
06/04/2026
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