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 .
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.
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.
Claim(s) 1-17, 20 & 27-28 is/are rejected under 35 U.S.C. 102((a)(1)) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Wariar (US 2007/0175827) in view of Humes (US 2006/0286078).
Wariar discloses;
1.
A system for cardiorenal syndrome (CRS) therapy, comprising:
E.G. via the disclosed cardiac and renal disease management system that comprises a renal therapy device and at least one cardiac rhythm management (CRM) device, {[0013] & (Fig. 1)}.
a therapy-delivery device configured to be disposed within a patient, where the therapy-
delivery device is a blood pump, a blood flow or pressure restrictor or enhancer;
E.G. via the disclosed renal therapy device 104a and at least one CRM device, wherein the renal therapy device is modified by controlling the flow of fluid into and out of the renal therapy device {[0013], [0025]-[0027])
*Note: Under the broadest reasonable interpretation a ‘therapy device’ comprising a blood pump, flow restrictor or pressure enhancer encompasses devices that drive, regulate or modulate blood flow within a treatment device. Wariar discloses a renal therapy device 104a that controls the flow of fluid into and out of the device and further explicitly states “blood pump flow,” indicating the presence and use of a blood pump within the system. Additionally, the modification of therapy based on the disclosed parameters in respect to blood flow and blood pressure demonstrates regulation of flow and pressure conditions, which reasonably corresponds to flow restriction and/or pressure enhancement mechanisms. Accordingly, the renal therapy device of the reference includes functionality that meets the claimed therapy device under the broadest reasonable interpretation.
a controller operably coupled to the therapy-delivery device, where the controller is
configured to adjust a therapy delivered by the therapy-delivery device based on a parameter
related to renal function.
E.G. via the disclosed renal therapy device being modified by parameters such as blood pump flow, arterial pressure, changes in heart rate, etc. and/or other patient specific thresholds for hypotension and ultrafiltration profiles that are related to receiving renal therapy via host system 112a, that also processes said measured parameters to enhance care [0027].
Note that the examiner is interpreting the disclosed host system as being the claimed controller.
In the alternative, Wariar discloses a renal therapy device 104a and at least one CRM device, wherein the renal therapy device is modified by controlling the flow of fluid into and out of the renal therapy device, except wherein said renal therapy device is explicitly defined as a blood pump, blood flow or pressure restrictor or enhancer.
Humes teaches that it is well known in the art to utilize a method of treating a patient with cardiorenal syndrome, wherein said method further includes managing the flow of blood via a pump system {[0007], [0030] & (Fig 1).
Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the renal therapy device with the blood pumping system as taught by Humes since such a modification would provide the predictable results pertaining to effectively treating a patient with cardiorenal syndrome {Humes, [0007], [0030] & (Fig 1).
2.
The system of claim 1, wherein the therapy-delivery device is a blood pump disposed in a blood vessel forming part of a patient's arterial circulation.
E.G. via the disclosed pumping system that is integrated with arterial blood flow [Humes, 0026].
3.
The system of claim 1, wherein the therapy-delivery device is a blood pump disposed in a blood vessel forming part of a patient's venous circulation.
E.G. via the disclosed pumping system that is integrated with venous blood flow {Humes, [0030] & (Fig 1)}.
4.
The system of claim 1, wherein the therapy-delivery device is a blood flow
or pressure restrictor disposed in a blood vessel forming part of a patient's arterial
circulation.
E.G. via the disclosed pumping system that is integrated with venous blood flow {Humes, [0026], [0030] & (Fig 1)}.
5.
The system of claim 1, wherein the therapy-delivery device is a blood flow or pressure restrictor disposed in a blood vessel forming part of a patient's venous circulation.
E.G. via the disclosed pumping system that is integrated with venous blood flow {Humes, [0026], [0030] & (Fig 1)}.
6.
The system of claim 1, wherein the therapy-delivery device is a blood flow or pressure enhancer disposed in a blood vessel forming part of a patient's arterial circulation.
E.G. via the disclosed renal therapy device 104a and at least one CRM device, wherein the renal therapy device is modified by controlling the flow of fluid into and out of the renal therapy device {Wariar, [0013], [0025]-[0027])
7.
The system of claim 1, wherein the therapy-delivery device is a blood flow or pressure enhancer disposed in a blood vessel forming part of a patient's venous circulation.
E.G. via the disclosed renal therapy device 104a and at least one CRM device, wherein the renal therapy device is modified by controlling the flow of fluid into and out of the renal therapy device {Warier, [0013], [0025]-[0027]).
8.
The system of claim 1, wherein the therapy-delivery device is a blood pump disposed in a blood vessel forming part of a patient's arterial circulation and a valve like structure is used to separate the inlet and outlet and improve pump hydrodynamic performance.
E.G. {Humes, [0026], [0030] & (Fig 1)}.
9.
The system of claim 1, wherein the therapy-delivery device is a blood pump disposed in a blood vessel forming part of a patient's venous circulation and a valve like structure is used to separate the inlet and outlet and improve pump hydrodynamic performance.
E.G. {Humes, [0026], [0030] & (Fig 1)}.
10.
The system of claim 1, wherein the parameter related to renal function is a hemodynamic parameter, a renal function parameter, or a combination thereof.
E.G. [Warier, 0027].
11.
The system of claim 10, wherein the hemodynamic parameter is renal blood flow, cardiac index, or a combination thereof.
E.G. (Warier, [0026]-[0027] & [0033]).
12.
The system of claim 10, wherein the renal function parameter is serum creatinine concentration, urine creatinine concentration, blood urea nitrogen (BUN), urinary output, net fluid output (fluid input - urine output), serum sodium concentration, urinary sodium concentration, total urinary sodium content, blood concentration or hematocrit, change in body weight, estimated glomerular filtration rate (eGFR), direct glomerular filtration rate (GFR), a renal injury marker, or a combination thereof.
E.G. (Warier, [0028]-[0029])
13.
The system of claim 12, wherein the renal injury marker is Neutrophil gelatinase- associated lipocalin (NGAL), Cystatin C, TIMP-2, IGFBP-7, KIM 1, or a marker of renal oxygenation.
E.G. via the disclosed sensors for measuring oxygenation [Warier, 0026].
14.
The system of claim 1, wherein the controller is configured to receive data from a user, the data including the parameter related to renal function.
E.G. via the disclosed renal therapy device being modified by parameters measured during the renal therapy such as blood pump flow, arterial pressure, changes in heart rate, etc. and/or other patient specific thresholds for hypotension and ultrafiltration profiles that are related to receiving renal therapy [Wariar, 0027].
15.
The system of claim 1, wherein the controller is configured to receive the parameter related to renal function from a real-time diagnostic sensor.
E.G. via the disclosed sensors for measuring the patient physiological parameters (Wariar, [0026]-[0027]).
16.
The system of claim 15, wherein the real-time diagnostic sensor is integrated into the therapy-delivery device.
E.G. via the disclosed sensors being part of the CRM device 102a E.G. via the disclosed sensors for measuring the patient physiological parameters (Wariar, [0026]-[0027]).
17.
The system of claim 15, wherein the real-time diagnostic sensor is a separate device from the therapy-delivery device.
E.G. via the disclosed devices 102, 104, 106, etc. that may be external devices that provide sensing and data analysis (Wariar, [0031]-[0032]).
20.
The system of claim 15, wherein the real-time diagnostic sensor is configured to detect an optical, electrical, and/or mechanical change in response to a measured biomarker.
E.G. (Wariar, [0033]-[0036]).
27.
The system of claim 1, wherein when the controller is further configured to determine adequacy of therapy withdrawal timing and duration.
E.G. via the disclosed host system 112a being able to monitor the autonomic withdrawl associated with the parameters measured during renal therapy [Warier, 0027].
28.
A method for cardiorenal syndrome (CRS) therapy,
E.G. via the disclosed patient monitoring method which further utilizes cardiac and renal disease management system that comprises a renal therapy device and at least one cardiac rhythm management (CRM) device, {Warier, [0001], [0013] & (Fig. 1)}.
comprising: disposing a therapy-delivery device within a patient, where the therapy-delivery device is a blood pump, a blood flow or pressure restrictor or enhancer;
E.G. via the disclosed renal therapy device 104a and at least one CRM device, wherein the renal therapy device is modified by controlling the flow of fluid into and out of the renal therapy device {Warier, [0013], [0025]-[0027])
AND
{Humes, [0007], [0030] & (Fig 1).
receiving information related to renal function; adjusting a therapy delivered by the therapy-delivery device based on information related to renal function.
E.G. via the disclosed renal therapy device being modified by parameters such as blood pump flow, arterial pressure, changes in heart rate, etc. and/or other patient specific thresholds for hypotension and ultrafiltration profiles that are related to receiving renal therapy via host system 112a, that also processes said measured parameters to enhance care, wherein the patient parameters are measured via the CRM device 102a during renal therapy [0027].
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NICOLE F JOHNSON whose telephone number is (571)270-5040. The examiner can normally be reached Monday-Friday 8:00am-5:00pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at 571-270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NICOLE F JOHNSON/Primary Examiner, Art Unit 3796
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