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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 14 August 2026 has been entered.
Response to Amendment
This office action is responsive to the amendment filed on 14 August 2026. As directed by the amendment: claims 1 and 9 have been amended, claims 10 and 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 Thus claims 1-9 and 12-25 are presently pending in this application and claims 16-25 remain withdrawn.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 the 35 U.S.C. 112(b) rejection previously set forth in the Final Office Action mailed 15 May 2026.
Response to Arguments
Applicant’s arguments, see REMARKS, filed 14 August 2026, with respect to the newly amended limitations in claim(s) 1 and 9 under El-Ghouch 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 Therefore, the rejection has been withdrawn.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 with an alternate interpretation of the claim. The examiner notes claims 7, 8, 14, and 15 are not rejected with this interpretation, as outlined in the Allowable Subject Matter section below.
Applicant argues regarding claim 9 that El-Ghouch neither identifies nor evaluates an acceptable operating-pressure range for a fluid-container pressure-providing element because El-Ghouch has no such element. Applicant argues El-Ghouch’s alarm responds to a patient’s derived blood pressure measurement or an inter-limb difference in such measurements- not to an operating-pressure condition of a fluid-container pressurization element.
The examiner respectfully disagrees. The amended claims allow a new interpretation such that the part of the cuff of El-Ghouch that inflates with air is the fluid-container. With the current interpretation of the cuff forming the fluid container, the oscillometric process of El-Ghouch in view of Hersh et al. does measure the air pressure of the pressure-providing element to derive the blood pressure measurements ([0023] “the cuff pressure at step 124 represents the patient's MAP, and the patient's systolic and diastolic pressures can be determined therefrom”).
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-2 and 5-6 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), the pressure providing element further comprising a fluid container (the interior of the air filled cuff 150 inflates to contain a gas which is a fluid); 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”) and the air pump ([0018] “commands by the control system 160 to operate the pump 120”) 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 ([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), 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.”).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 3-4, 9, and 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over El-Ghouch (WO 2013/147738 A1) in view of 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) the pressure providing element further comprising a fluid container (the interior of the air filled cuff 150 inflates to contain a gas which is a fluid); 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 within a single 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.”), 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.”).
Allowable Subject Matter
Claims 7-8 and 14-15 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 7 and 14, because the fluid container of El-Ghouch is a part of the pressure-providing element in the rejection of claims 1 and 9, El-Ghouch fails to teach “the pressure-providing element pressurizing the fluid container, the pressure-providing element applies pressure to the fluid container” as required by claims 7 and 14.
Claims 8 and 15 are indicated allowable subject matter as being dependent on claims 7 and 14.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Weiner (US 2005/0027237 A1) discloses a system that controls a blood pressure cuff in addition to intravenous infusion.
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/A.E.V./Examiner, Art Unit 3783
/COURTNEY FREDRICKSON/Primary Examiner, Art Unit 3783