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 responsive to the amendment filed on 25 March 2026. As directed by the amendment: claims 1 and 9 have been amended, claims 10-11 have been or remain canceled. Thus claims 1-9 and 12-25 are presently pending in this application, and claims 16-25 remain withdrawn. Applicant’s amendments to the Claims have overcome each objection previously set forth in the Non-Final Office Action mailed 6 January 2026.
Response to Arguments
Applicant’s arguments, see REMARKS, filed 25 March 2026, with respect to the rejection(s) of claim 1 under Vankatachalapathy 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 Therefore, the rejection has been withdrawn.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 El-Ghouch.
Applicant's arguments with respect to the rejection of claim 9 has been fully considered and is not persuasive. Applicant argues El-Ghouch does not disclose a pressure-providing element configured to pressure a fluid container because El-Ghouch has not fluid container, no IV bag, no pressure-providing element for fluid pressurization, and no fluid delivery function of any kind. Applicant argues the NIBP cuff of El-Ghouch is not a pressure-providing element configured to pressurize a fluid container, these are structurally different, functionally different, and clinically different elements. The examiner respectfully disagrees. The cuff of El-Ghouch is clearly an element that provides pressure. The examiner agrees that the intended function of the cuff of El-Ghouch is different than that of the pressure-providing element of the instant application, however, the structural differences are not claimed. The cuff of El-Ghouch has an opening that can receive a fluid container in the same way it can receive an arm, the cuff can apply pressure to a fluid container in the same way as is applies pressure to an arm. While not used for this rejection, Hillborg et al. (WO 2006/001744) shows how a NIBP cuff can also be used to pressurize a fluid container. The fluid container is claimed functionally (“a pressure-providing element configured to pressurize a fluid container”) so the prior art does not necessarily have to include a fluid container, it has to be structured to pressurize a fluid container. The NIBP cuff of El-Ghouch is structured to pressurize a fluid container.
Applicant argues El-Ghouch does not teach generating an alarm based on the air pressure value of a pressure-providing element being outside of a predetermined acceptable range. Applicant argues El-Ghouch teaches a clinical alarm based on a patient’s physiological blood pressure readings, and amended Claim 9 requires monitoring the air pressure value of the pressure-providing element which is a device equipment parameter and generating an alarm when that air pressure value is outside a predetermine acceptable range. Applicant argues these are categorically different alarm conditions serving categorically different clinical purposes.
The examiner agrees that there are categorical differences between the alarms of the instant application and that of modified El-Ghouch, and the examiner agrees with the characterization of the alarms, however, the position of the examiner is that the differences are not adequately specified in the claims. El-Ghouch in combination with Hersh et al. includes the pressure monitoring and alarm generation as claimed. The purpose of the monitoring and the use of the monitored values are different; however, the purpose and the different use is not required by the claims, the claims only require the air pressure value to be monitored and to generate an alarm when the pressure is determined to be outside a predetermined acceptable range. The device of El-Ghouch in view of Hersh et al. teaches this.
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.
Claims 1-8 are 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 1 recites “one or more processors are programmed to control the single controllable multi- port valve to alternately route airflow through the first port, the second port, and the third port within a single defined measurement cycle, thereby regulating a first air pressure in the NIBP cuff by allowing an airflow from the air pump through the first port to the NIBP cuff through the second port while blocking the airflow through the third port in a same airflow cycle which is the single defined measurement cycle”. Because the “single defined measurement cycle” is defined in the claim as the cycle when air is flowing from the first port through the second port and being blocked from flow through the third port, it is unclear how the one or more processors can control the valve to alternately route air flow through the third port within the single defined measurement cycle as well. Further, the phrase “alternately route airflow through the first port, the second port, and the third port” implies the airflow is routed through each of the ports separately, but according to the specification, the first port would necessarily route airflow at the same time as either the second or third ports route airflow.
Claims 2-8 are rejected as being dependent on, and failing to cure the deficiencies of, rejected independent claim 1.
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.
Claim(s) 1-2, 5-8 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by El-Ghouch (WO 2013/147738 A1).
Regarding claim 1, El-Ghouch discloses a pressure control device, comprising: a single controllable multi-port valve (130 Fig 1, [0006] “The multi-port switching valve includes a first port connected to the first hose, a second port connected to the second hose, and a third port connected to the inflation line.” the examiner notes this rejection uses a different labels for the first, second, and third ports as outlined in annotated Fig 1) with a first port (See the first port in annotated Fig 1), a second port (See the second port in annotated Fig 1), and a third port (See the third port in annotated Fig 1), wherein: the first port is connected with an air pump (120 Fig 1); the second port is connected with a non-invasive blood pressure ("NIBP") cuff (140 Fig 1); and the third port is connected with a pressure-providing element (150 Fig 1) configured to pressurize a fluid container (the fluid container is claimed functionally “configured to pressurize a fluid container” meaning the fluid container itself is not required to satisfy the claim, only that the pressure-providing element is structured to be able to pressurize a fluid container, the cuff of El-Ghouch is fully capable of pressurizing a fluid container, the cuff of El-Ghouch has an opening that can receive a fluid container in the same way as an arm and can apply pressure to it in the same way as is applies pressure to an arm); and one or more processors ([0037] “at least one programmable processor”) are programmed to control the single controllable multi- port valve ([0018] “commands by the control system 160 to operate […] the multi-port switching valve 130”) to alternately route airflow through the first port, the second port, and the third port ([0019] “The multi-port switching valve 130 operates to allow compressed gas to flow from the inflation line 125 to the first hose 135 or from the inflation line to the second hose 145.”) within a single defined measurement cycle, thereby regulating a first air pressure in the NIBP cuff by allowing an airflow from the air pump through the first port to the NIBP cuff through the second port while blocking the airflow through the third port in a same airflow cycle ([0019] “The multi-port switching valve 130 operates to allow compressed gas to flow from the inflation line 125 to the first hose 135 or from the inflation line to the second hose 145. The multi-port switching valve 130 does not allow for fluid communication, that is the flow of gas such as air, simultaneously between the inflation line 125 and both the first and second hoses 135 and 145.” Flow from the inflation line 125 to the first hose 135, while flow through the second hose 145 is blocked), which is the single defined measurement cycle, and regulating a second air pressure in the pressure-providing element by allowing the airflow from the air pump through the first port to the pressure-providing element through the third port while blocking the airflow through the second port in the same airflow cycle ([0019] “The multi-port switching valve 130 operates to allow compressed gas to flow from the inflation line 125 to the first hose 135 or from the inflation line to the second hose 145. The multi-port switching valve 130 does not allow for fluid communication, that is the flow of gas such as air, simultaneously between the inflation line 125 and both the first and second hoses 135 and 145.” Flow from the inflation line 125 to the second hose 145, while flow through the first hose 135 is blocked).
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Regarding claim 2, El-Ghouch discloses the pressure control device according to claim 1. El-Ghouch further discloses wherein: the one or more processors comprise at least one of a host device processor or a valve control processor ([0022] “The monitor system 105 can further process the measurements”, “The monitor system 105 can store multiple blood pressure measurement values, associate each with a particular time, date, and/or patient, and can display these values on the display 110 or transmit the information to an external location.”, [0037] “programmable processor, which can be special or general purpose”).
Regarding claim 5, El-Ghouch discloses the pressure control device according to claim 1. El-Ghouch further teaches further comprising: a communications interface ([0027] “A transmission module can be a part of the monitor system 105.”), wherein the pressure control device is communicatively coupled to at least one of a host device or a network via the communications interface ([0027] “The monitor system 105 can be in communication with a central patient monitor via the transmission module”).
Regarding claim 6, El-Ghouch discloses the pressure control device according to claim 5. El-Ghouch further discloses wherein: the one or more processors are programmed to transmit data, via the communications interface, to the at least one of the host device or the network ([0037] “programmable processor, which can be special or general purpose, coupled to receive data and instructions from, and to transmit data and instructions to, a storage system, at least one input device, and at least one output device.”).
Regarding claim 7, El-Ghouch discloses the pressure control device according to claim 1. El-Ghouch further discloses wherein: when the multi-port valve is controlled to adjust the airflow between the air pump and the pressure-providing element pressurizing the fluid container, the pressure-providing element applies pressure to the fluid container (the fluid container is introduced functionally in claim 1 and remains functionally claimed in subsequent dependent claims, it has not been positively recited, as such, the claim requires the pressure-providing element to be structured in a way that is capable of applying pressure to a fluid container, the cuff of El-Ghouch has an opening that can receive a fluid container in the same way as an arm and can apply pressure to it in the same way as is applies pressure to an arm, [0019] “The multi-port switching valve 130 operates to allow compressed gas to flow from the inflation line 125 to the first hose 135 or from the inflation line to the second hose 145.”).
Regarding claim 8, El-Ghouch discloses the pressure control device according to claim 7. El-Ghouch further discloses wherein: the fluid container includes liquid used in an intravenous infusion process (The fluid container is introduced functionally in claim 1 and remains functionally claimed in subsequent dependent claims, it has not been positively recited, as such, the claim requires the pressure-providing element to be structured in a way that it is capable of applying pressure to a fluid container that includes a liquid used in an intravenous infusion process. As outlined in the rejection of claim 7, the opening of the pressure providing element of El-Ghouch can receive the fluid container and the fluid container can include an iv infusion fluid), and the pressure-providing element is configured to control the liquid to flow out of the fluid container by applying the pressure to the fluid container (If a fluid container were positioned within the cuff of El-Ghouch, the inflation of the cuff would control the liquid to flow out of the fluid container).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 3-4, 9, and 12-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over El-Ghouch (WO 2013/147738 A1) in view or Hersh et al. (US 2004/0171943 A1).
Regarding claim 3, El-Ghouch discloses the pressure control device according to claim 1. However, El-Ghouch is silent to further discloses wherein: the one or more processors are programmed to monitor an air pressure value of the pressure-providing element while controlling the multi-port valve.
Hersh et al. teaches a pressure-providing element wherein one or more processors (107 Fig 1) are configured to monitor an air pressure value of the pressure-providing element ([0004] “a pressure sensor continues to measure the cuff pressure. The sensitivity of the sensor is such that pressure fluctuations within the cuff resulting from the beats of the patient's heart may be detected.” The air pressure value is the detected pressure fluctuation from a blood pressure measurement, [0022] “These cuff pressure oscillations are sensed by pressure transducer 104 and converted into an electrical signal and coupled over path 106 to microprocessor 107 for processing.”) while controlling the valve ([0007] “when taking an oscillometric blood pressure determination, a device will pump up to a supra-systolic cuff pressure level and take small deflation steps in order to completely measure the properties of the oscillometric envelope”, [0022] “The inflate valve 111 is electrically controlled through a connection 113 from the microprocessor 107.”).It would have been obvious to one of ordinary skill in the art at the time of effective filing for the one or more processors of El-Ghouch to be configured with the limitations as taught by Hersh et al. to provide the configuration to determine blood pressure using oscillometric blood pressure measurements to provide “an automatic device which can accurately, quickly and non-invasively estimate these blood pressure values.” [0002].
Regarding claim 4, modified El-Ghouch teaches the pressure control device according to claim 3. El-Ghouch further teaches wherein the one or more processors are further programmed to: determine whether the air pressure value of the pressure-providing element is outside a predetermined acceptable range, and generate an alarm signal when the air pressure value of the pressure-providing element is determined to be outside the predetermined acceptable range ([0025] “The monitor system 105 can enter an alarm state when one or more blood pressure measurements acquired by the blood pressure monitoring cuffs 140 and 150 are not within an acceptable range. An alarm state can be triggered when one or more blood pressure measurements are not within an acceptable range that is based upon a preset value.”, [0037] “These various implementations can include implementation in one or more computer programs that are executable and/or interpretable on a programmable system including at least one programmable processor”).
Regarding claim 9, El-Ghouch discloses a pressure control system, comprising: a single controllable multi-port valve (130 Fig 1, [0006] “The multi-port switching valve includes a first port connected to the first hose, a second port connected to the second hose, and a third port connected to the inflation line.” the examiner notes this rejection uses a different labels for the first, second, and third ports as outlined in annotated Fig 1) with a first port (See the first port in annotated Fig 1), a second port (See the second port in annotated Fig 1), and a third port (See the third port in annotated Fig 1), wherein: the first port is connected to an air pump (120 Fig 1), the second port is connected to a non-invasive blood pressure ("NIBP") cuff (140 Fig 1) worn by a patient (the cuff is fully capable of being worn by a patient), and the third port is connected to a pressure-providing element (150 Fig 1) configured to pressurize a fluid container (The cuff is fully capable of pressurizing a fluid container); and one or more processors ([0037] “at least one programmable processor”) configured to: non-invasively measure a blood pressure of the patient [0029] while controlling the single multi-port valve to alternately route an airflow between the air pump and the NIBP cuff by allowing the airflow from the air pump through the first port to the NIBP cuff through the second port while blocking the airflow through the third port ([0019] “The multi-port switching valve 130 operates to allow compressed gas to flow from the inflation line 125 to the first hose 135 or from the inflation line to the second hose 145. The multi-port switching valve 130 does not allow for fluid communication, that is the flow of gas such as air, simultaneously between the inflation line 125 and both the first and second hoses 135 and 145.”), and control pressure provided to the fluid container by controlling the single multi-port valve to alternately route an airflow between the air pump and the pressure-providing element by allowing the airflow from the air pump through the first port to the pressure-providing element through the third port while blocking the airflow through the second port ([0019] “The multi-port switching valve 130 operates to allow compressed gas to flow from the inflation line 125 to the first hose 135 or from the inflation line to the second hose 145. The multi-port switching valve 130 does not allow for fluid communication, that is the flow of gas such as air, simultaneously between the inflation line 125 and both the first and second hoses 135 and 145.”), wherein: the one or more processors are configured to: determine whether the air pressure value of the pressure-providing element is outside a predetermined acceptable range; and generate an alarm signal when the air pressure value of the pressure-providing element is determined to be outside the predetermined acceptable range ([0025] “The monitor system 105 can enter an alarm state when one or more blood pressure measurements acquired by the blood pressure monitoring cuffs 140 and 150 are not within an acceptable range. An alarm state can be triggered when one or more blood pressure measurements are not within an acceptable range that is based upon a preset value.”, [0037] “These various implementations can include implementation in one or more computer programs that are executable and/or interpretable on a programmable system including at least one programmable processor”).
However, El-Ghouch is silent to further discloses wherein: the one or more processors are configured to monitor an air pressure value of the pressure-providing element while controlling the multi-port valve to allow the airflow between the air pump and the pressure-providing element.
Hersh et al. teaches a pressure-providing element wherein one or more processors (107 Fig 1) are configured to monitor an air pressure value of the pressure-providing element ([0004] “a pressure sensor continues to measure the cuff pressure. The sensitivity of the sensor is such that pressure fluctuations within the cuff resulting from the beats of the patient's heart may be detected.” The air pressure value is the detected pressure fluctuation from a blood pressure measurement, [0022] “These cuff pressure oscillations are sensed by pressure transducer 104 and converted into an electrical signal and coupled over path 106 to microprocessor 107 for processing.”) while controlling the valve to allow the airflow between the air pump and the pressure-providing element ([0007] “when taking an oscillometric blood pressure determination, a device will pump up to a supra-systolic cuff pressure level and take small deflation steps in order to completely measure the properties of the oscillometric envelope”, [0022] “The inflate valve 111 is electrically controlled through a connection 113 from the microprocessor 107.”).
It would have been obvious to one of ordinary skill in the art at the time of effective filing for the one or more processors of El-Ghouch to be configured with the limitations as taught by Hersh et al. to provide the configuration to determine blood pressure using oscillometric blood pressure measurements to provide “an automatic device which can accurately, quickly and non-invasively estimate these blood pressure values.” [0002].
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Regarding claim 12, modified El-Ghouch discloses the pressure control system according to claim 9. El-Ghouch further discloses comprising: a communications interface ([0027] “A transmission module can be a part of the monitor system 105.”), wherein the pressure control device is communicatively coupled with at least one of a host device or a network ([0027] “The monitor system 105 can be in communication with a central patient monitor via the transmission module”).
Regarding claim 13, modified El-Ghouch discloses the pressure control system according to claim 12. El-Ghouch further discloses wherein: the one or more processors are communicatively coupled to the communications interface to transmit data to the at least one of the host device or the network ([0037] “programmable processor, which can be special or general purpose, coupled to receive data and instructions from, and to transmit data and instructions to, a storage system, at least one input device, and at least one output device.”).
Regarding claim 14, modified El-Ghouch discloses the pressure control system according to claim 9. El-Ghouch further discloses wherein: when the multi-port valve (130 Fig 1) is controlled to allow the airflow between the air pump (120 Fig 1) and the pressure-providing element (150 Fig 1) pressurizing the fluid container, the pressure- providing element applies pressure to the fluid container (the fluid container is claimed functionally in claim 9, the pressure-providing element is fully capable of applying pressure to a fluid container when there is airflow being introduced to the pressure-providing element).
Regarding claim 15, modified El-Ghouch discloses the pressure control system according to claim 14. El- Ghouch further discloses wherein: the fluid container includes liquid used in an intravenous infusion process (the fluid container is claimed functionally in claims 9 and 14, the pressure-providing element of El-Ghouch is fully capable of pressurizing a fluid container that includes a liquid used in an intravenous infusion process such as saline); and the pressure-providing element is configured to control a flow rate of the liquid out of the fluid container by applying the pressure to the fluid container (the pressure-providing element of El-Ghouch is fully capable of applying pressure to a fluid container which would necessarily control a flow rate out of the fluid container if it has an outlet).
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Anna Vargas whose telephone number is (571)270-3873. The examiner can normally be reached Mon-Fri 4:00 PM-9:00 PM EST.
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/A.E.V./Examiner, Art Unit 3783
/BHISMA MEHTA/Supervisory Patent Examiner, Art Unit 3783
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