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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/19/2025 has been entered.
Status of Claims
Claims 25-29 and 31-47 are currently pending. Clams 25, 28, 38, 43, and 46 are currently amended. Claims 1-24 and 30 are cancelled. No new subject matter is added.
Claim Objections
Claim 43 is objected to because of the following informalities:
Claim 43 recites “the pressure signal of the within the patient” in lines 8-9 should be “the pressure signal .
Appropriate correction is required.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 25-27, 31-41, and 43-44 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 8, 10, and 21 of U.S. Patent No. 11529449 in view of Weitzel et al. (US 20080108930 A1).
Regarding Claim 25, 38, and 43, Claim 8, 10, and 21 of U.S. Patent No. 11529449 does not explicitly disclose measuring by the pressure sensor, a pressure within the patient.
Weitzel teaches a system for determining blood flow rate in a vessel which communicates blood between two locations of a patient (see Abstract) comprising a pressure sensor (40) to measure pressure within a patient (pressure sensor 40 is disposed within the vessel 24, see Paragraph [0067]; Figure 3).
The patented claims 25, 38, and 46 and Weitzel are analogous art because both teach a an elongated member with a pressure sensor.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the method of patented claims 25, 38, and 46 and further include wherein the pressure sensor is located on the tip of the elongated member to measure pressure within the patient, as taught by Weitzel. Weitzel teaches it is important to have an observation or measurement of pressure near the vessel. All the capacitance, resistance, and inductance of the pump (and conduit) will affect the measurement. For example, if the measurement is far from the vessel, there will be geometry and time dependent pressure differences from the conduit and pump that will influence the measurement. Therefore, the pressure sensor should ideally be located near to or within the vessel to minimize effects from the conduit and pump (see Paragraph [0068]).
Regarding Claim 26, Patented claim 25 and Weitzel teaches all of the limitations as discussed above respectively, and Weitzel further teaches wherein the pressure sensor (40) is disposed within the elongate member configured to be introduced into the vasculature of the patient (see Figure 3).
Regarding Claim 27, Patented claim 25 and Weitzel teaches all of the limitations as discussed above respectively, and Weitzel further teaches wherein the elongate member comprises a venous needle (38) fluidically coupled to a dialysis unit (dialysis circuit 22, see Paragraph [00560], the dialysis unit being configured to dialyze a volume of fluid extracted from the vasculature through an arterial needle and return the volume of dialyzed fluid to the vasculature through the venous needle (see Paragraph [0060]).
Regarding Claim 31, Patented claim 25 and Weitzel teaches all of the limitations as discussed above respectively, and Weitzel further teaches a system and method for measuring blood flow rate in a vessel, such as a hemodialysis access (see Paragraph [0003]), including a pressure sensor comprising a micro-electro- mechanical systems (MEMS) pressure sensor (pressure sensors 40, 42, 45, 47, 49 can include ultra-miniature types such as micro-electro-mechanical systems (MEMS), see Paragraph [0067]).
Regarding Claim 32, Patented claim 25 and Weitzel teaches all of the limitations as discussed above respectively, and Weitzel further teaches a system and method for measuring blood flow rate in a vessel, such as a hemodialysis access (see Paragraph [0003]), and detecting a venous stenosis in the vasculature based on the pressure signal (pressure measurements within the access have been used as an indicator of stenosis, decreasing access blood flow rate predicts access stenoses see, see Paragraph [0038]).
Regarding Claim 33, Patented claim 8 and Weitzel teaches all of the limitations as discussed above in claim 32 and Weitzel further teaches wherein the threshold pressure comprises a first threshold pressure (a reference value, see Col. 12 ln 65-67, Col. 14 ln 1-3; i.e. atmospheric pressure comparison, see Col. 14 ln 21-24), and wherein detecting the venous stenosis comprises: detecting the venous stenosis in response to determining the pressure adjacent the elongate member is greater than or equal to a second threshold pressure (control unit 50 can compare the pressure signal of the pressure sensor 41 to a reference value, see Col. 12 ln 65-67).
Regarding Claim 34, Patented claim 8 and Weitzel teaches all of the limitations as discussed above in claim 32 and Patented claim 8 further teaches detecting a threshold pressure change in the vasculature based on the pressure signal. However, Patented claim 8 does not explicitly disclose wherein detecting the venous stenosis comprises: determining a flow rate through the vasculature based on the pressure signal; detecting a threshold flow rate change in the vasculature based on the determined flow rate; and detecting the venous stenosis in the vasculature in response to detecting the threshold pressure change and the threshold flow rate change.
Weitzel teaches a system and method for measuring blood flow rate in a vessel, such as a hemodialysis access (see Paragraph [0003]), wherein detecting the venous stenosis (stenosis, see Paragraph [0038]) comprises: determining a flow rate through the vasculature based on the pressure signal (the access has a blood flow rate (QA) dependent on numerous factors including systemic blood pressure and central venous pressure (reflecting pressure gradient pre and post access, see Paragraph [0010]); detecting a threshold flow rate change (threshold, see Paragraph [0140]) in the vasculature based on the determined flow rate threshold for developing recirculation can be determined by integrating the velocity of reversed (retrograde) blood flow over the time period when flow is reversed within the cardiac cycle, see Paragraph [0140]; and detecting the venous stenosis in the vasculature in response to detecting the threshold pressure change and the threshold flow rate change (see Paragraph [0038]).
Patented claim 8 and Weitzel are analogous art because both teach a method for detecting pressure within a hemodialysis apparatus.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the pressure signals of patented claim 8 and further include determining a flow rate through the vasculature based on the pressure signal, detect a threshold flow rate change in the vasculature based on the determined flow rate, and include the threshold flow rate change in order to detect the venous stenosis, as taught by Weitzel. Weitzel teaches its beneficial for the purpose of predicting access stenoses and providing timely intervention that may prevent thrombosis (see Paragraph [0038]).
Regarding Claim 35, Patented claim 8 and Weitzel teaches all of the limitations as discussed above in claim 34 and Weitzel further teaches modifying an operation of a dialysis unit in response to detecting the venous stenosis (timely intervention when stenosis is predicted, see Paragraph [0038]), the dialysis unit being configured to deliver fluid to the patient via the elongate member (a venous needle 38 connected to the venous line 20 for the return of blood to access 24).
Regarding Claim 36, Patented claim 8 and Weitzel teaches all of the limitations as discussed above and Weitzel further teaches wherein receiving the pressure signal generated by the pressure sensor comprises receiving the pressure signal generated by the pressure sensor on the elongate member configured to be introduced into an arteriovenous fistula or an arteriovenous graft of the patient (the access 24 may be an artificial subcutaneous vessel, such as a polytetrafluoroethylene (PTFE) graft, or a native fistula that is surgically created between the artery 28 and the vein 32, see Figure 3; Paragraph [0059]).
Regarding Claim 37, Patented claim 8 and Weitzel teaches all of the limitations as discussed above and Weitzel further teaches a computer-readable medium comprising instructions that, when executed by processing circuitry, cause the processing circuitry to perform the method of claim 25 (signal processor 43 can be any suitable electronic device capable of receiving and analyzing the signals transmitted from the sensor 40, see Paragraph [0066]).
Regarding Claim 39, Patented claim 10 and Weitzel teaches all of the limitations as discussed above and Patented claim 10 further teaches wherein detecting the dislodgment of the elongate member is in response to determining the pressure signal does not include the pulse pressure wave component (see claim 10).
Regarding Claim 40, Patented claim 10 and Weitzel teaches all of the limitations as discussed above and Patented claim 10 further teaches generating, by the processing circuitry, an output in response to detecting the dislodgment of the elongate member from the vasculature (see claim 10).
Regarding Claim 41, Patented claim 10 and Weitzel teaches all of the limitations as discussed above and Weitzel further teaches wherein the elongate member comprises a venous needle (38) fluidically coupled to a dialysis unit (dialysis circuit 22, see Paragraph [00560], the dialysis unit being configured to dialyze a volume of fluid extracted from the vasculature through an arterial needle and return the volume of dialyzed fluid to the vasculature through the venous needle (see Paragraph [0060]).
Regarding Claim 44, Patented claim 21 and Weitzel teaches all of the limitations as discussed above and Weitzel further teaches wherein the elongate member comprises a venous needle (38) fluidically coupled to a dialysis unit (dialysis circuit 22, see Paragraph [00560], the dialysis unit being configured to dialyze a volume of fluid extracted from the vasculature through an arterial needle and return the volume of dialyzed fluid to the vasculature through the venous needle (see Paragraph [0060]).
Claim Interpretation
This application includes one or more claim limitations that use the word “means” or “step” but are nonetheless not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph because the claim limitation(s) recite(s) sufficient structure, materials, or acts to entirely perform the recited function.
Such claim limitation(s) is/are: “means for determining the analog pressure signal” in line 3 and “means for detecting the dislodgment of the needle” line 5 of claim 47.
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.
The corresponding structure described in the specification for
“means for determining the analog pressure signal” is the processing circuity (see Paragraph [0064] of SPEC),
“means for detecting the dislodgment of the needle” is pressure sensed by the pressure sensor or the reference pressure signal generated by the reference pressure sensor (see Paragraph [0088] of SPEC).
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 25-29, 31-37, and 43-46 are rejected under 35 U.S.C. 103 as being unpatentable over Wolff et al. (US 10688237 B2), hereinafter referred to as “Wolff” in view of Weitzel et al. (US 20080108930 A1), hereinafter referred to as “Weitzel”.
Regarding Claim 25, Wolff teaches a method comprising:
receiving a pressure signal generated by a pressure sensor (receiving a pressure measurement of pressure sensor 41, see Col. 5 ln 1-17), wherein the pressure sensor is disposed adjacent to an elongate member that is configured to be introduced into vasculature of a patient (the pressure sensor is arrange at or in the blood discharge line 31 and needle 31a, see Figure 1);
measuring, by the pressure sensor, a pressure (when the tube 31 is disconnected, pressure measurement is then carried out at the pressure sensor 41 continuously or at, preferably regular, time intervals until it can be determined by way of the measured pressure values whether they tend toward atmospheric pressure, see Col. 9 ln 28-32; the pressure at the pressure sensor 41, i.e. the pressure measured by the same, is adjusted to the level of the vascular pressure at the patient access, i.e. in the shunt, for example. Here a pressure of 25 mmHg corresponds to the average internal shunt pressure of an AV shunt (arteriovenous shunt) consisting of autologous material, see Paragraph [0080]); and
detecting dislodgment of the elongate member from the vasculature based on the difference between the pressure and a threshold pressure (If the pressure measuring values measured at the pressure sensor 41 show a tendency toward atmospheric pressure, i.e. a relatively fast decrease or reaching and underrunning of the threshold , the presence of venous needle dislodgement and, respectively, an undesirably faulty connection between the blood discharge tube 31 and the patient access, e.g. the shunt, is concluded, see Col. 12 ln 16-22);
However, Wolff does not explicitly disclose measuring and detecting, by the pressure sensor, a pressure within the patient.
Weitzel teaches a system for determining blood flow rate in a vessel which communicates blood between two locations of a patient (see Abstract) comprising a pressure sensor (40) to measure pressure within a patient (pressure sensor 40 is disposed within the vessel 24, see Paragraph [0067]; Figure 3).
Wolff and Weitzel are analogous art because both teach a an elongated member with a pressure sensor.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the pressure sensor of Wolff and replace it with the pressure sensor located on the tip of the elongated member to measure and detect the pressure within the patient, as taught by Weitzel. Weitzel teaches it is important to have an observation or measurement of pressure near the vessel. All the capacitance, resistance, and inductance of the pump (and conduit) will affect the measurement. For example, if the measurement is far from the vessel, there will be geometry and time dependent pressure differences from the conduit and pump that will influence the measurement. Therefore, the pressure sensor should ideally be located near to or within the vessel to minimize effects from the conduit and pump (see Paragraph [0068]).
Regarding Claim 26, Wolff and Weitzel teaches all of the limitations as discussed above in claim 25, and Weitzel further teaches wherein the pressure sensor is disposed within the elongate member configured to be introduced to the vasculature of a patient (the pressure sensor is arrange at or in the blood discharge line 31 and needle 31a, see Figure 1; see Col. 5 ln 44-45).
Regarding Claim 27, Wolff and Weitzel teaches all of the limitations as discussed above in claim 25, and Wolff further teaches wherein the elongate member comprises a venous needle (31a) fluidically coupled to a dialysis unit (dialyzer 1, see Figure 1), the dialysis unit being configured to dialyze a volume of fluid extracted from the vasculature through (first chamber 29 is connected to an intake 20 for fresh dialysis fluid , see Figure 1) an arterial needle (dual-needle operation including an arterial cannula and venous cannula, see Col. 7 ln 67, Col. 8 ln 1-2) and return the volume of dialyzed fluid to the vasculature through the venous needle (blood to be purified flows through the second chamber 30 of the dialyzer 1 and is guided at the dialyzer outlet in the arrow direction to the blood discharge line 31, see Figure 1).
Regarding Claim 28, Wolff and Weitzel teaches all of the limitations as discussed above in claim 27, and Wolff further teaches wherein generating the notification further comprises controlling the dialysis unit based on detection of the dislodgment of the venous needle (stopping or substantially reducing the speed of the blood pump and/or closing the venous hose clamp if an unpermitted difference from the reference value and/or from the reference pressure course is determined, see Paragraph [0015]).
Regarding Claim 29, Wolff and Weitzel teaches all of the limitations as discussed above in claim 28, and Wolff further teaches wherein controlling the dialysis unit comprises causing a dialysis pump of the dialysis unit to stop extracting fluid from the vasculature via the arterial needle (stopping or substantially reducing the speed of the blood pump if an unpermitted difference from the reference value and/or from the reference pressure course is determined, see Paragraph [0015]).
Regarding Claim 31, Wolff and Weitzel teaches all of the limitations as discussed above in claim 25, and Weitzel further teaches wherein the pressure sensor comprises a micro-electro- mechanical systems (MEMS) pressure sensor (pressure sensors 40, 42, 45, 47, 49 can include ultra-miniature types such as micro-electro-mechanical systems (MEMS), see Paragraph [0067]).
Regarding Claim 32, Wolff and Weitzel teaches all of the limitations as discussed above in claim 25, and Weitzel further teaches detecting a venous stenosis in the vasculature based on the pressure signal (pressure measurements within the access have been used as an indicator of stenosis, decreasing access blood flow rate predicts access stenoses see, see Paragraph [0038]).
Regarding Claim 33, Wolff teaches all of the limitations as discussed above in claim 32 and Wolff further teaches wherein the threshold pressure comprises a first threshold pressure (a reference value, see Col. 12 ln 65-67, Col. 14 ln 1-3; i.e. atmospheric pressure comparison, see Col. 14 ln 21-24), and determining the pressure adjacent the elongate member is greater than or equal to a second threshold pressure (control unit 50 can compare the pressure signal of the pressure sensor 41 to a reference value, see Col. 12 ln 65-67).
However, Wolff does not explicitly disclose detecting the venous stenosis in response to determining a pressure adjacent the elongate member based on the pressure signal and in response to determining the pressure adjacent the elongate member is greater than or equal to a threshold pressure.
Weitzel teaches a system and method for measuring blood flow rate in a vessel, such as a hemodialysis access (see Paragraph [0003]), and detecting a venous stenosis in the vasculature based on the pressure signal (pressure measurements within the access have been used as an indicator of stenosis, decreasing access blood flow rate predicts access stenoses see, see Paragraph [0038]).
Wolff and Weitzel are analogous art because both teach a method for detecting pressure within a hemodialysis apparatus.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the step of determining a pressure adjacent the elongate member based on the pressure signal and in response to determine the pressure adjacent the elongate member is greater than or equal to a threshold pressure to detect the venous stenosis, as taught by Weitzel. Weitzel teaches it is beneficial for the purpose of predicting access stenoses and providing timely intervention that may prevent thrombosis (see Paragraph [0038]).
Regarding Claim 34, Wolff teach all of the limitations of claim 33 and Wolff further teaches detecting a threshold pressure change in the vasculature based on the pressure signal (the apparatus may be configured to compare the pressure occurring in the fluid line and being measured continuously or repeatedly after closing the line shut-off to a threshold and/or to determine the rate of the pressure drop and/or to determine a final pressure value which tends to be resulting and/or to detect whether the pressure tends toward atmospheric pressure or a higher pressure occurring in the patient blood circulation, see Col. 2 ln 30-37).
However, Wolff does not explicitly disclose wherein detecting the venous stenosis comprises: determining a flow rate through the vasculature based on the pressure signal; and detecting the venous stenosis in the vasculature in response to detecting the threshold pressure change and the threshold flow rate change.
Weitzel teaches detecting the venous stenosis (stenosis, see Paragraph [0038]) comprises:
determining a flow rate through the vasculature based on the pressure signal (The access has a blood flow rate (QA) dependent on numerous factors including systemic blood pressure and central venous pressure (reflecting pressure gradient pre and post access, see Paragraph [0010]); and
detecting a threshold flow rate change (threshold, see Paragraph [0140]) in the vasculature based on the determined flow rate (threshold for developing recirculation can be determined by integrating the velocity of reversed (retrograde) blood flow over the time period when flow is reversed within the cardiac cycle, see Paragraph [0140]); and
detecting the venous stenosis in the vasculature in response to detecting the threshold pressure change and the threshold flow rate change (see Paragraph [0038]).
Wolff and Weitzel are analogous art because both teach a method for detecting pressure within a hemodialysis apparatus.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the process of Wolff and further include determining a flow rate through the vasculature based on the pressure signal, detect a threshold flow rate change in the vasculature based on the determined flow rate, and include the threshold flow rate change in order to detect the venous stenosis, as taught by Weitzel. Weitzel teaches it is beneficial for the purpose of predicting access stenoses and providing timely intervention that may prevent thrombosis (see Paragraph [0038]).
Regarding Claim 35, Wolff and Weitzel teach all of the limitations of claim 34 and Wolff further teaches the dialysis unit being configured to deliver fluid to the patient via the elongate member (blood to be purified flows through the second chamber 30 of the dialyzer 1 and is guided at the dialyzer outlet in the arrow direction to the blood discharge line 31, see Figure 1). Weitzel further teaches modifying an operation of a dialysis unit in response to detecting the venous stenosis (timely intervention when stenosis is predicted, see Paragraph [0038]).
Regarding Claim 36, Wolff and Weitzel teaches all of the limitations as discussed above in claim 25, and Wolff further teaches wherein receiving the pressure signal generated by the pressure sensor comprises receiving the pressure signal generated by the pressure sensor on the elongate member configured to be introduced into an arteriovenous fistula or an arteriovenous graft of the patient (the pressure at the pressure sensor 41, i.e. the pressure measured by the same, is adjusted to the level of the vascular pressure at the patient access, i.e. in the (arteriovenous shunt) AV shunt, see Col. 11 ln 24-34 )
Regarding Claim 37, Wolff and Weitzel teaches all of the limitations as discussed above in claim 25, and Wolff further teaches a computer-readable medium (the data processing and storage unit 50) comprising instructions that, when executed by processing circuitry, cause the processing circuitry to perform the method of claim 25 (The storage unit can be an internal memory, for instance random access memory, or else an external memory, see Col. 11 ln 12-14; the processing unit can be a data processing and evaluation unit so as to identify venous needle dislodgements, see Col. 6 ln 50-52).
Regarding Claim 43, Wolff teaches a method comprising: receiving, by processing circuitry, a pressure signal generated by a pressure sensor (receiving a pressure measurement of pressure sensor 41, see Col. 5 ln 1-17);
receiving, by the processing circuitry, a reference pressure signal indicative of a reference pressure external to the vasculature (control unit 50 can compare the pressure signal of the pressure sensor 41 to a reference value, see Col. 12 ln 65-67, Col. 14 ln 1-3; i.e. atmospheric pressure comparison, see Col. 14 ln 21-24);
calculating, by the processing circuitry, an absolute pressure relative to an ambient pressure within the vasculature based on a difference between the pressure signal and the reference pressure signal (a pressure curve which tends toward atmospheric pressure (0 mmHg difference pressure) is detected at the pressure sensor 41, see Col. 14 ln 58-60);
detecting, by the processing circuitry, dislodgment of the elongate member from the vasculature, when the absolute pressure is less than or equal to a predetermined threshold (if the pressure measuring values measured at the pressure sensor 41 show a tendency toward atmospheric pressure, i.e. a relatively fast decrease or reaching and underrunning of the threshold, the presence of venous needle dislodgement and, respectively, an undesirably faulty connection between the blood discharge tube 31 and the patient access, e.g. the shunt, is concluded., see Col. 12 ln 16-22); and
generating, by the processing circuitry, an output in response to detecting the dislodgment of the elongate member from the vasculature (if the subsequent pressure measurements at the pressure sensor 41 show a pressure drop tending toward atmospheric pressure, i.e. to a value of 0 mmHg relative to the atmospheric pressure, when the tube shut-off 40 is closed, venous needle dislodgement is present and a warning is output, for example in optical form as a visual display or in acoustic form by generating an acoustic alarm, see Col. 12 ln 32-39).
However, Wolff does not explicitly disclose a pressure signal of a pressure within a patient generated by a pressure sensor disposed on a distal end of an elongate member introduced into vasculature of the patient.
Weitzel teaches a system and method for measuring blood flow rate in a vessel, such as a hemodialysis access (see Paragraph [0003]), comprising: a pressure signal of a pressure within a patient generated by a pressure sensor (40, see Figures 3-5; Paragraph [0100]) disposed on a distal end of an elongate member (venous needle 38) introduced into vasculature of a patient (a needle may have 2 or more pressure sensors on one needle to determine the pressure in the blood conduit along the needle, see Paragraph [0100]).
Wolff and Weitzel are analogous art because both teach a method for detecting pressure within a hemodialysis apparatus.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the pressure sensor of Wolff and further include wherein the pressure sensor is disposed on a distal end of an elongated member to generate a pressure signal of a pressure within a patient, as taught by Weitzel. Weitzel teaches it is important to have an observation or measurement of pressure near the vessel. All the capacitance, resistance, and inductance of the pump (and conduit) will affect the measurement. For example, if the measurement is far from the vessel, there will be geometry and time dependent pressure differences from the conduit and pump that will influence the measurement. Therefore, the pressure sensor should ideally be located near to or within the vessel to minimize effects from the conduit and pump (see Paragraph [0068]).
Regarding Claim 44, Wolff and Weitzel teaches all of the limitations, as discussed above in claim 43 and Wolff further teaches wherein the elongate member comprises a venous needle (31a) fluidically coupled to a dialysis unit (dialyzer 1, see Figure 1), the dialysis unit being configured to dialyze a volume of fluid extracted from the vasculature through (first chamber 29 is connected to an intake 20 for fresh dialysis fluid , see Figure 1) an arterial needle (dual-needle operation including an arterial cannula and venous cannula, see Col. 7 ln 67, Col. 8 ln 1-2) and return the volume of dialyzed fluid to the vasculature through the venous needle (blood to be purified flows through the second chamber 30 of the dialyzer 1 and is guided at the dialyzer outlet in the arrow direction to the blood discharge line 31, see Figure 1).
Regarding Claim 45, Wolff and Weitzel teaches all of the limitations, as discussed above in claim 44 and Wolff further teaches wherein generating the output comprises controlling the dialysis unit based on detection of the dislodgment of the venous needle (the apparatus may be configured to stop the operation of the blood pump, when dislodgement of the connection means is determined and/or when a fluid pressure measured by the pressure sensor reaches or falls below a particular limit, see Col. 2 ln 47-49).
Regarding Claim 46, Wolff further teaches a system (apparatus that detect an interruption of the connection between a blood treatment apparatus and a patient blood circulation, see Abstract) comprising:
a needle (discharge line 31 and needle 31a, see Figure 1) configured to be introduced into vasculature of a patient (see Figure 1), the needle including a pressure sensor (the pressure sensor 41) configured to generate a pressure signal (the pressure sensor 41 arranged at or in the blood discharge line 31 and needle 31a, see Figure 1; receiving a pressure measurement of pressure sensor 41, see Col. 5 ln 1-17);
processing circuitry configured to detect dislodgment of the needle from the vasculature based on a change to the generated pressure signal (the pressure measuring values measured at the pressure sensor 41 show a tendency toward atmospheric pressure, i.e. a relatively fast decrease or reaching and underrunning of the threshold, the presence of venous needle dislodgement and, respectively, an undesirably faulty connection between the blood discharge tube 31 and the patient access, e.g. the shunt, is concluded., see Col. 12 ln 16-22); and
a user interface for generating an output in response to detecting the dislodgment of the needle from the vasculature (if the subsequent pressure measurements at the pressure sensor 41 show a pressure drop tending toward atmospheric pressure, i.e. to a value of 0 mmHg relative to the atmospheric pressure, when the tube shut-off 40 is closed, venous needle dislodgement is present and a warning is output, for example in optical form as a visual display or in acoustic form by generating an acoustic alarm, see Col. 12 ln 32-39).
However, Wolff does not explicitly disclose a pressure sensor configured to generate a pressure signal indicative of pressure within the vasculature of the patient.
Weitzel teaches a system for determining blood flow rate in a vessel which communicates blood between two locations of a patient (see Abstract) comprising a pressure sensor (40) configured to generate a pressure signal indicative of pressure within the vasculature of the patient (pressure sensor 40 is disposed within the vessel 24, see Paragraph [0067]; Figure 3).
Wolff and Weitzel are analogous art because both teach a an elongated member with a pressure sensor.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the pressure sensor of Wolff and replace it with the pressure sensor located on the tip of the elongated member to measure pressure within the patient, as taught by Weitzel. Weitzel teaches it is important to have an observation or measurement of pressure near the vessel. All the capacitance, resistance, and inductance of the pump (and conduit) will affect the measurement. For example, if the measurement is far from the vessel, there will be geometry and time dependent pressure differences from the conduit and pump that will influence the measurement. Therefore, the pressure sensor should ideally be located near to or within the vessel to minimize effects from the conduit and pump (see Paragraph [0068]).
Claims 38-42 are rejected under 35 U.S.C. 103 as being unpatentable over Wiktor et al. (US 20160158433 A1), hereinafter referred to as “Wiktor” in view of Weitzel (US 20080108930 A1) and in further view of Solem et al. (WO 2016206946 A1), hereinafter referred to as “Solem”.
Regarding Claim 38, Wiktor teaches a method comprising:
detecting, by processing circuitry (control and processing unit, see Paragraph [0047]), dislodgment of an elongate member from a vasculature of a patient (a venous needle disconnection by means of pressure pulse measurement at the extracorporeal blood circuit, see Abstract) based on a pressure signal (the pressure signals of the at least one pressure sensor may be a sum signal of the pressure impulses of the patient's heart that are transmitted to the pressure sensor via the arterial and the venous patient port if there is a correct connection, see Paragraph [0031]), wherein detecting the dislodgment of the elongate member includes,
receiving the pressure signal (wherein the control unit is programmed to evaluate the pressure signals of at least one pressure sensor, see Paragraph [0026]);
determining if the pressure signal includes a pulse pressure wave component (the pressure signals of the at least one pressure sensor may be a sum signal of the pressure impulses of the patient's heart that are transmitted to the pressure sensor via the arterial and the venous patient port if there is a correct connection, see Paragraph [0031]), the pulse pressure wave component being indicative of a pulse pressure of the patient (pressure pulses of the patient's heart, see Paragraph [0031]), by detecting a dialysis pump pressure wave component in the pressure signal (a deviation of the amplitude of the pressure pulse of less than 90% and preferably less than 75% as compared to the amplitude of the pressure pulses in case of a correct connection will be regarded as a disconnection, see Paragraph [0032]; the pressure pulses to be monitored can be generated either by means of a pressure wave generator, e.g. the blood pump itself, see Paragraph [0004]),
generating a residual wave (threshold value or reference course, see Paragraph [0026]) and
determining the residual wave does not include the pulse pressure wave component (compare the threshold value to the current reading, wherein the occurrence of inadmissible deviations from the measured amplitude of the pressure pulses from the patient's heart will be regarded as a defective vascular access, see Paragraph [0028]).
However, Wiktor does not explicitly disclose detecting a pressure signal of a pressure within the vasculature of the patient.
Weitzel teaches a system for determining blood flow rate in a vessel which communicates blood between two locations of a patient (see Abstract) comprising a pressure sensor (40) configured to detect a pressure signal indicative of pressure within the vasculature of the patient (pressure sensor 40 is disposed within the vessel 24, see Paragraph [0067]; Figure 3).
Wiktor and Weitzel are analogous art because both teach detecting pressure within a patient.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the method of Wiktor and further include receiving a pressure signal of pressure within the vasculature of the patient, as taught by Weitzel. Weitzel teaches it is important to have an observation or measurement of pressure near the vessel. All the capacitance, resistance, and inductance of the pump (and conduit) will affect the measurement. For example, if the measurement is far from the vessel, there will be geometry and time dependent pressure differences from the conduit and pump that will influence the measurement. Therefore, the pressure sensor should ideally be located near to or within the vessel to minimize effects from the conduit and pump (see Paragraph [0068]).
Wiktor and Weitzel teaches all of the limitations as discussed above. However, Wiktor and Weitzel do not explicitly disclose generating a residual wave by at least filtering the dialysis pump pressure wave component from the pressure signal.
Solem teaches a monitoring system (9) performs a method for detecting a disruption of a fluid connection (see Abstract), generating a residual wave (pressure variations (pulsations) originating from the blood pump 4, see Col.14 ln 8-9) by at least filtering the dialysis pump pressure wave component from the pressure signal (filter blocks 21, 22 may comprise analog filters (implemented by hardware components) or digital filters (implemented by software executed by a processor), or a combination thereof. In one embodiment, each of the filter blocks 21, 22 define at least one passband, see Col. 18 ln 25-35; Each of the filter blocks 21, 22 may have filter characteristics that are either fixed (pre-defined) or adjustable, e.g. with respect to the pumping rate of the blood pump 4 which is the source of the strong pulsations (pump pulses) that are to be effectively removed by the first and second filter blocks 21, 22, see Col. 18 ln 9-12).
Wiktor, Weitzel, and Solem are analogous art because both disclose a monitoring system an operable to detect a disconnection of an extracorporeal blood circuit from a vascular system of a patient.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the processing circuity of modified Wiktor and further include filters to filter the dialysis pump pressure wave, as taught by Solem. Solem teaches the filters are configured to effectively remove frequency components corresponding to an operating frequency of one or more repetitive pulse generators in the first and second fluid containing systems, implies that the frequency components are suppressed to such an extent that they do not interfere with the disruption detection (see Col. 7 ln 3-8).
Regarding Claim 39, Modified Wiktor teach all of the limitations as discussed above in claim 38 and Wiktor further teaches wherein detecting the dislodgment of the elongate member is in response to determining the pressure signal does not include the pulse pressure wave component (inadmissible deviations from the measured amplitude of the pressure pulses will be regarded as a defective vascular access, see Paragraph [0028]).
Regarding Claim 40, Modified Wiktor teach all of the limitations as discussed above in claim 38 and Wiktor further teaches generating, by the processing circuitry, an output in response to detecting the dislodgment of the elongate member from the vasculature (on a determination of an unpermitted difference, an acoustic and/or optical and/or tactile alarm can be output to allow a fast intervention, see Paragraph [0017]).
Regarding Claim 41, Modified Wiktor teach all of the limitations as discussed above in claim 38 and Wiktor further teaches wherein the elongate member comprises a venous needle (a venous blood line having a venous patient port, see Paragraph [0010]) fluidically coupled to a dialysis unit (coupled to an extracorporeal blood circuit, see Paragraph [0010]), the dialysis unit being configured to dialyze a volume of fluid extracted from the vasculature through an arterial needle (an arterial blood line having an arterial patient port, see Paragraph [0010]) and return the volume of dialyzed fluid to the vasculature through the venous needle (the extracorporeal blood treatment apparatus can, for example, be a known hemodialysis apparatus such as is described in DE 102009060668 A1, for example, see Paragraph [0043]).
Regarding Claim 42, Modified Wiktor teach all of the limitations as discussed above in claim 41 and Wiktor further teaches generating an output including controlling the dialysis unit based on detection of the dislodgment of the venous needle (stopping or substantially reducing the speed of the blood pump and/or closing the venous hose clamp if an unpermitted difference from the reference value and/or from the reference pressure course is determined, see Paragraph [0015]).
Claims 47 are rejected under 35 U.S.C. 103 as being unpatentable over Wolff (US 10688237 B2) and Weitzel (US 20080108930 A1), as applied in claim 46 above, and in further view of Wiktor (US 20160158433 A1).
Regarding Claim 47, Wolff and Weitzel teach all of the limitations, as discussed above in claim 46. However, Wolff and Weitzel do not explicitly disclose wherein the pressure signal comprises an analog pressure signal, and wherein the processing circuitry, for detecting dislodgment of the needle, comprises:
means for determining the analog pressure signal does not include a pulse pressure wave component, the pulse pressure wave component being indicative of a pulse pressure of the patient; and
means for detecting the dislodgment of the needle in response to determining the analog pressure signal does not include the pulse pressure wave component.
Wiktor teaches a method of monitoring an extracorporeal blood treatment apparatus having an extracorporeal blood circuit and in particular a venous needle disconnection by means of pressure pulse measurement at the extracorporeal blood circuit (see Abstract) wherein the pressure signal comprises an analog pressure signal (the pressure pulses to be monitored can be generated either by means of a pressure wave generator, e.g. the blood pump itself, or pressure pulses from the heart of the patient propagated in the extracorporeal blood circuit, see Paragraph [0004]), and wherein the processing circuitry (control and processing unit, see Paragraph [0047]), for detecting dislodgment of the needle (see Paragraph [0028]), comprises:
means for determining the analog pressure signal does not include a pulse pressure wave component (compare the threshold value to the current reading, wherein the occurrence of inadmissible deviations from the measured amplitude of the pressure pulses from the patient's heart will be regarded as a defective vascular access, see Paragraph [0028]), the pulse pressure wave component being indicative of a pulse pressure of the patient (the pressure signals of the at least one pressure sensor may be a sum signal of the pressure impulses of the patient's heart that are transmitted to the pressure sensor via the arterial and the venous patient port if there is a correct connection, see Paragraph [0031]); and
means for detecting the dislodgment of the needle in response to determining the analog pressure signal does not include the pulse pressure wave component (wherein the control unit is programmed to evaluate the pressure signals of at least one pressure sensor, see Paragraph [0026]; comparing the threshold value to the current reading, wherein the occurrence of inadmissible deviations from the measured amplitude of the pressure pulses from the patient's heart will be regarded as a defective vascular access, see Paragraph [0028]).
Wolff, Weitzel, and Wiktor are analogous art because both disclose a method of monitoring an extracorporeal blood treatment apparatus.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the pressure sensor and processing circuitry of Wolff and further include wherein the processing circuitry can analyze analog signals and compare them to a pulse pressure wave component to determine if there is dislodgement, as taught by Wiktor. Wiktor teaches the occurrence of inadmissible deviations from the measured amplitude of the pressure pulses from the patient's heart will be regarded as a defective vascular access (see Paragraph [0028]).
Response to Arguments
Applicant's arguments filed 12/19/2025 have been fully considered but they are not persuasive.
Specifically applicant argues that the currently amended claims would overcome the Double Patenting Rejection of Claims 25-29 and 31-46. However, Claims 25-27, 31-41, and 43-44 would still be rejected on the ground of nonstatutory double patenting as being unpatentable over claim 8, 10, and 21 of U.S. Patent No. 11529449 in view of Weitzel et al. (US 20080108930 A1), as discussed above.
Specifically, applicant argues in Claims 25, 43, and 46 that Wolff and Weitzel would fail to read on the limitation “detecting dislodgement of the elongate member from the vasculature based on the difference between the pressure within the patient and a threshold pressure”. The applicant further states that the pressure sensors of Weitzel are used to calculate access flow rate and not to detect dislodgement. The examiner disagrees that the current amendments overcome the cited prior art. As discussed above in independent claims 25, 43, and 46, Wolff teaches a pressure sensor (41) that is configured to provide a pressure of the blood line and compare it to a threshold in order to detect dislodgement. Weitzel (US 20080108930 A1) teaches a system for determining blood flow rate in a vessel which communicates blood between two locations of a patient (see Abstract) comprising a pressure sensor (40) configured to generate a pressure signal indicative of pressure within the vasculature of the patient (pressure sensor 40 is disposed within the vessel 24, see Paragraph [0067]; Figure 3). Therefore, Weitzel is only brought in to teach how the pressure sensor of the blood treatment device can be located within the vasculature of a patient to provide a pressure signal within the vasculature of patient. Wolff teaches detecting and calculating dislodgement. Claim 38 is rejected for the same reasons discussed above with regards to Weitzel. Therefore, Claims 25-47 remain rejected in view of Weitzel.
Conclusion
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/ERIC RASSAVONG/ (4/1/2026)Examiner, Art Unit 3781
/JESSICA ARBLE/Primary Examiner, Art Unit 3781