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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 28 April 2025 has been entered.
Response to Amendment
This office action is responsive to the amendment filed on 28 April 2025. As directed by the amendment: claims 1, 3, 6, 9, and 14 have been amended, claims 10-11 have been 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 Thus claims 1-9 and 12-25 are presently pending in this application, and claims 16-25 remain withdrawn.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 Final Office Action mailed 28 January 2025.
Response to Arguments
Applicant argues on pages 10 and 11 of REMARKS that El-Ghouch discloses that an alarm state can be triggered when patient’s blood pressure measurements are not within an acceptable range that is based upon a preset value, which is completely different from the claimed “the one or more processors are configured to … generate an alarm signal when the air pressure value of the pressure-providing element is determined to be outside the predetermined acceptable range”.
The examiner respectfully disagrees. The position of the examiner is that because the blood pressure is measured by determining the air pressure in the cuff, determining if the blood pressure is not within an acceptable range involves determining if the air pressure value of the pressure-providing element is also outside of an acceptable range as claimed. Paragraph [0003] of El-Ghouch describes how the blood pressure measurement is made from the air pressure value: “The oscillometric method is another NIBP measurement method that involves the electronic observation of oscillations in the sphygmomanometer cuff pressure caused by the changes in arterial flow resulting from inflating and deflating the cuff. The cuff pressure oscillations are observed using a pressure sensor or transducer and electronics to automatically interpret the oscillations.”. This is the method used in the system of El-Ghouch as described in paragraph [0017]: “FIG. 1 is a schematic representation of an oscillometric blood pressure monitor system”.
Applicant argues on pages 13 and 14 of REMARKS that Venkatachalapathy the opening 132a and 132b are open and closed in different cycles while in the presently claimed invention the second and third ports are open and closed in the same air flow cycle.
The examiner respectfully disagrees. What can be interpreted as an air flow cycle is broad. A cycle can be defined as a repeatable sequence of events, so an air flow cycle could be a sequence of air flow events. The processes of Venkatachalapathy includes a repeatable sequence of air flow events.
While drain, fill and dwell are individually cycles, the position of the examiner is that the entire process can also be defined as a single cycle. The prior art reference can be interpreted beyond the limited words used. Paragraph [0094] describes the control unit programmed with sequences of performing drain, fill and dwell patient cycles for dialysis treatment. Although the programmed sequence is not always explicitly called a cycle, the programmed sequence still fits the definition and can be interpreted as a single cycle. In fact the combination of fill and drain processes does appear to be defined as a single repeatable cycle in paragraph [0009].
There may not be adequate support for a more limited interpretation. The specification of the instant application refers to a cycle only with respect to an NIBP measurement cycle. The regulating of a second air pressure by allowing the airflow through the third port while blocking the airflow through the second port is not described as being in the same airflow cycle. Therefore, an interpretation of a cycle as including more than one process in a repeatable sequence would have written description, but there does not appear to be an isolated cycle described in the specification that includes the claimed valve control.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “a pressure-providing element” introduced in claims 1 and 9.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Objections
Claim 9 is objected to because of the following informalities:
Claim 9 is objected to because the period before the newly amended limitations should be removed.
Appropriate correction is required.
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 1-2 and 5-8 are rejected under 35 U.S.C. 103 as being unpatentable over Venkatachalapathy (US 2023/0293795 A1) in view of Hillborg et al. (WO 2006/001744 A1).
Regarding claim 1, Venkatachalapathy discloses a pressure control device (Fig 1), comprising: a controllable multi-port valve (122 Fig 1 and the valves 132a-d make up the multi-port valve) with a first port (the opening in 122 that connects to 128d, [0070] “pneumatic pump line 128d may be connected to pneumatic line connector 122 via a line connector”), a second port (the opening in 132b Fig 1), and a third port (the opening in 132a Fig 1), wherein: the first port is connected with an air pump (124 Fig 1); the second port is connected with a pressure-providing container (114b Fig 1); and the third port is connected with a pressure-providing element (114a Fig 1) configured to pressurize a fluid container (116a Fig 1); and one or more processors ([0075] “Control unit 104 includes at least one processor”) are programmed to control the controllable multi-port valve to adjust airflows through the first port, the second port, and the third port ([0075] “control valves or clamps 132a, 132b, 132c, 132d, 134a, 134b, 134c, 134d and 134e, air pump 124 and drain pump 126 to drive and direct fluid flow in PD system 100.” Such control would adjust airflows though all ports), thereby regulating a first air pressure in the pressure-providing container (the air pressure in 114b would be regulated by control of the valve 132b, [0073] “When in an open position, valves 132a, 132b, 132c and 132d enable air to flow through a pneumatic line or connecting tube”, [0080] “As air is introduced (e.g., by an air pump) into nesting container interior 208, air pressure within closed volume nesting container interior 208 increases.”) by allowing an airflow from the air pump through the first port to the pressure-providing container through the second port while blocking the airflow through the third port ([0092] “Valve 132d is closed and valve 132b is opened so that the only open air pathway from pump 124 is to nesting container 114b.”) in a same airflow cycle (The airflow cycle is the sequence described in paragraphs [0088]-[0093], [0088] “In one example, control unit 104 is programmed to execute the following sequence[…]”), and regulating a second air pressure in the pressure-providing element (the air pressure in 114a would be regulated by control of the valve 132a, [0073] “When in an open position, valves 132a, 132b, 132c and 132d enable air to flow through a pneumatic line or connecting tube”, [0080] “As air is introduced (e.g., by an air pump) into nesting container interior 208, air pressure within closed volume nesting container interior 208 increases.”) 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 ([0090] “Valve 132d is closed and valve 132a is opened so that the only open air pathway from pump 124 is to nesting container 114a”) in the same airflow cycle (The airflow cycle is the sequence described in paragraphs [0088]-[0093]).
However, Venkatachalapathy fails to disclose the pressure-providing container is a NIBP cuff.
Hillborg et al. teaches a controllable multi-port valve (5 Fig 1) with a first port (6/7 Fig 1), wherein: the first port is connected with an air supply (20 Fig 1); the second port (51 Fig 1) is connected with a pressure providing container that is a NIBP cuff (2 Fig 1).
Hillborg et al. further teaches the pressure providing container (2 Fig 1 and 2) can function as either a NIBP cuff (as shown in Fig 1) or to provide pressure to an infusion element (as shown in Fig 2). It would have been obvious to one of ordinary skill in the art at the time of effective filing for the pressure providing container of Venkatachalapathy to function as a NIBP cuff as taught by Hillborg et al. to provide the system with the ability to measure the blood pressure of a patient (page 2 line 8).
Regarding claim 2, modified Venkatachalapathy teaches the pressure control device according to claim 1. Modified Venkatachalapathy further teaches wherein: the one or more processors comprise at least one of a host device processor or a valve control processor ([0075] “programming logic stored in the memory of control unit 104 and executed by the processor of control unit 104”, “the control unit 104 is programmed to control valves or clamps”).
Regarding claim 5, modified Venkatachalapathy teaches the pressure control device according to claim 1. Modified Venkatachalapathy further teaches further comprising: a communications interface ([0075] “Control unit 104, in some instances, also includes a wired or wireless transceiver for sending information to and receiving information from an external device.”), wherein the pressure control device is communicatively coupled to at least one of a host device ([0075] “external device”) or a network via the communications interface.
Regarding claim 6, modified Venkatachalapathy teaches the pressure control device according to claim 5. Modified Venkatachalapathy further teaches wherein: the one or more processors are programmed to transmit data, via the communications interface, to the at least one of the host device ([0075] “Control unit 104, in some instances, also includes a wired or wireless transceiver for sending information to and receiving information from an external device.” “programming logic stored in the memory of control unit 104 and executed by the processor of control unit 104”) or the network.
Regarding claim 7, modified Venkatachalapathy teaches the pressure control device according to claim 1. Modified Venkatachalapathy further teaches 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 ([0073] “When in an open position, valves 132a, 132b, 132c and 132d enable air to flow through a pneumatic line or connecting tube”, [0080] “As air is introduced (e.g., by an air pump) into nesting container interior 208, air pressure within closed volume nesting container interior 208 increases.” “The inward force applied to fluid supply bag 202 from the air pressure drives fluid out of fluid supply bag 202 and through fluid outlet 214 and fluid supply line 216. The rate at which fluid exits fluid supply bag 202 is dependent upon the rate at which air is introduced into nesting container 204.”).
Regarding claim 8, modified Venkatachalapathy teaches the pressure control device according to claim 7. Modified Venkatachalapathy further teaches wherein: the fluid container (116a Fig 1) includes liquid used in an intravenous infusion process (while peritoneal dialysis is generally performed by infusing fluid into a peritoneal cavity, not intravenously, the fluid is fully capable of being used in an intravenous infusion process as it is a fluid that would flow through a catheter, further, the fluid container includes, in part, water which is a liquid used in intravenous infusion processes), and the pressure-providing element (116a Fig 1) is configured to control the liquid to flow out of the fluid container by applying the pressure to the fluid container ([0080] “As air is introduced (e.g., by an air pump) into nesting container interior 208, air pressure within closed volume nesting container interior 208 increases.” “The inward force applied to fluid supply bag 202 from the air pressure drives fluid out of fluid supply bag 202 and through fluid outlet 214 and fluid supply line 216. The rate at which fluid exits fluid supply bag 202 is dependent upon the rate at which air is introduced into nesting container 204.”).
Claims 3 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Venkatachalapathy (US 2023/0293795 A1) in view of Hillborg et al. (WO 2006/001744 A1) and Boyle et al. (US 2017/0000946 A1).
Regarding claim 3, modified Venkatachalapathy teaches the pressure control device according to claim 1. Modified Venkatachalapathy teaches the one or more processors are programmed to control the multi-port valve ([0075] “control valves or clamps 132a, 132b, 132c, 132d, 134a, 134b, 134c, 134d and 134e, air pump 124 and drain pump 126 to drive and direct fluid flow in PD system 100.”).
However, modified Venkatachalapathy fails to teach wherein: the one or more processors are programmed to monitor an air pressure value of the pressure-providing element.
Boyle et al. teaches one or more processors ([0080] “The controller 210 can include a processor and associated memory to enable it to execute one or more programs that control the operation of the pump assembly 200 and the system 100.”) are programmed to monitor an air pressure value of the pressure-providing element ([0075] “Pressure sensor 262 can be connected to the controller 210 to provide the air pressure measurement that is displayed on the touch screen.”). 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 modified Venkatachalapathy to be programmed as taught by Boyle et al. to allow the user to determine and control the pressure of the dispensed fluid to allow the user control over flow rate and infusion pressure preventing harm and pain.
Regarding claim 4, modified Venkatachalapathy teaches the pressure control device according to claim 3. Modified Venkatachalapathy further teaches wherein the one or more processors are further programmed to (Boyle et al.- [0080] “a processor and associated memory to enable it to execute one or more programs that control the operation of the pump assembly 200 and the system 100.”): determine whether the air pressure value of the pressure-providing element is outside a predetermined acceptable range (Boyle et al.- [0075] “a pressure sensor 262 can be connected to the regulated side of the air supply between the pressure regulator 250 and air bladder 310.”, [0079] “the controller 210 can maintain set values for pressure”), and generate an alarm signal when the air pressure value of the pressure-providing element is determined to be outside the predetermined acceptable range (Boyle et al.- [0079] “If the measured temperature, volume, and/or pressure are not the same as the set values within a preset tolerance, an alarm can be configured to sound (beep).”).
Claims 9 and 12-15 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 9, El-Ghouch discloses a pressure control system, comprising: a 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 multi-port valve to adjust 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 multi-port valve to adjust 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
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
/COURTNEY B FREDRICKSON/Primary Examiner, Art Unit 3783