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 § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-2, 4-5, 7-12, 15 and 18-27 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claims 1, the claim limitations “detecting, by means of said at least one processor, vessel deformation and/or pulse wave characteristics from the at least one image and/or the at least one speckle image” in lines 14-16 was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The specification discloses detecting vessel deformation and pulse wave characteristics from at least one image (see par. [0021], [0222] of the Pg Pub. version of the specification), and the specification only recites speckle image in one paragraph (see par. [0166] of the Pg Pub. version of the specification), but the specification does not explicitly state detecting vessel deformation and pulse wave characteristics from the speckle image.
Claims 2, 4-5, 7-12, 15 and 21-27 are rejected as they depend from rejected claim 1.
Regarding claim 18, the claim limitations “detecting, by means of said at least one processor, vessel deformation and/or pulse wave characteristics from the at least one image and/or the at least one speckle image” in lines 9-10 was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The specification discloses detecting vessel deformation and pulse wave characteristics from at least one image (see par. [0021], [0222] of the Pg Pub. version of the specification), and the specification only recites speckle image in one paragraph (see par. [0166] of the Pg Pub. version of the specification), but the specification does not explicitly state detecting vessel deformation and pulse wave characteristics from the speckle image.
Claims 19 is rejected as they depend from rejected claim 18.
Regarding claim 20, the claim limitations “detect, by means of said at least one processor, vessel deformation and/or pulse wave characteristics from the at least one image and/or the at least one speckle image” in lines 12-14 was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The specification discloses detecting vessel deformation and pulse wave characteristics from at least one image (see par. [0021], [0222] of the Pg Pub. version of the specification), and the specification only recites speckle image in one paragraph (see par. [0166] of the Pg Pub. version of the specification), but the specification does not explicitly state detecting vessel deformation and pulse wave characteristics from the speckle image.
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.
Claims 1, 2, 7, 21 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Soto (US 8,888,714), in view of Min et al. (US 10,912,865), in view of Ferguson, JR. et al. (US 2013/0245456; hereinafter Ferguson).
Regarding claim 1, Soto discloses an automatic blood draw system and method. Soto shows a method for monitoring vascular access construct functionality (see col. 5, lines 39-53), the method performed complete by a device, the method comprising: illuminating one or more blood vessels through a patient’s skin using at least on illuminator in said device (see col. 5, lines 39-53); capturing at least one image of the blood vessels using at least one camera in said device (see col. 5, lines 39-53); analyzing geometric properties of the blood vessel in the at least one image of at least one processor in said device (col. 2, lines 44-60; col. 5, lines 39-53; col. 6, lines 13-25, col. 6, lines 57-67). Furthermore, Soto shows based on the analyzing geometric properties, determining, by means of said at least one processor, a parameter associated with vascular access construct (col. 2, lines 44-60; col. 5, lines 39-53; col. 6, lines 13-25, col. 6, lines 57-67; and claim 15).
But, Soto fails to explicitly state acquiring speckle image using camera and analyzing speckle image using at least one processor, detecting vessel deformation and/or pulse wave characteristic from the at least one image and/or the at least one speckle image.
Min discloses a rapid prototype and in vitro modeling of patient specific coronary artery bypass grafts. Min teaches detecting vessel deformation for at least one image (see claim 1) and determining a parameter of VA construct (see claim 1).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claim invention, to have utilized the teaching of detecting vessel deformation for at least one image (see claim 1) and determining a parameter of VA construct in the invention of Soto, as taught by Min, to provide an accurate and patient specific VA construct, and be able to monitor the VA construct with additional data such as vessel deformation.
But, Soto and Min fail to explicitly state acquiring and analyzing speckle image.
Ferguson discloses an optical imaging. Ferguson teaches acquiring and analyzing speckle image (see abstract; par. [0114]), and assessing speckle image to determine parameter such as blood pressure, velocity and flow (see abstract; par. [0014], the examiner notes vascular blood parameter such as blood, velocity and flow are related to vascular access).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to have utilized additional imaging such as acquiring and analyzing speckle image in the invention of Soto and Min, as taught by Ferguson, to provide additional information and higher resolution image for visualizing blood vessel which will help with presentation of non-maturing or failing AVF. The examiner notes that upon modification of prior art Soto and Min to incorporate the teaching of Ferguson would also provide the based on speckle analyzing, determining a parameter associated with VA construct.
Regarding claim 2, Soto, Min and Ferguson disclose the invention substantially as described in the 103 rejection above, furthermore, Soto shows automatically detecting a location of the VA construct in at least one image (col. 2, lines 44-60; col. 5, lines 39-53; col. 6, lines 13-25, col. 6, lines 57-67).
Regarding claim 7, Soto, Min and Ferguson disclose the invention substantially as described in the 103 rejection above, furthermore, Soto shows calculating a dimeter of blood vessel (col. 2, lines 44-60; col. 5, lines 39-53; col. 6, lines 13-25, col. 6, lines 57-67), and Sharm also teaches calculating a diameter of blood vessel (see “AVF surveillance” on page 48), and Sharm teaches information indicative of collateral vessels and a count of collateral vessels (see page 47).
Regarding claim 21, Soto, Min and Ferguson disclose the invention substantially as described in the 103 rejection above, furthermore, Soto shows wherein the at least one image comprises just one image (see col. 5, lines 39-53).
Regarding claim 27, Soto, Min and Ferguson disclose the invention substantially as described in the 103 rejection above, furthermore, Soto shows that the VA construct is an intravenous catheter (col. 2, lines 44-60; col. 5, lines 39-53; col. 6, lines 13-25, col. 6, lines 57-67; and claim 15).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Soto (US 8,888,714), in view of Min et al. (US 10,912,865), in view of Ferguson, JR. et al. (US 2013/0245456; hereinafter Ferguson) as applied to claim 1 above, and further in view of in view of Meissner et al. (US 2009/0287066; hereinafter Meissner).
Regarding claim 4, Soto, Min and Ferguson disclose the invention substantially as described in the 103 rejection above, but fails to explicitly state a physician marking a location of vascular access (VA) in the at least one image
Meissner discloses a method for minimally invasive medical intervention. Meissner teaches a physician marking a location of treatment location in the one image (see par. [0019]).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention, to have utilized the teaching of a physician marking a location of treatment location in the at one image in the invention of Soto, Min and Ferguson for vascular access, as taught by Meissner, to assist in accurate placement of treatment device.
Claims 5, 12 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Soto (US 8,888,714), in view of Min et al. (US 10,912,865), in view of Ferguson, JR. et al. (US 2013/0245456; hereinafter Ferguson) as applied to claim 1 above, and further in view of Ertel et al. (US 2017/0287132; hereinafter Ertel).
Regarding claim 5, Soto, Min and Ferguson disclose the invention substantially as described in the 103 rejection above, fails to explicitly state detecting a meeting of a vein and an artery.
Ertel discloses a method for detecting collateral information describing blood flow in collaterals blood vessel. Ertel teaches detecting a meeting of a vein and artery is performed using the device (see abstract; par. [0027], [0039], [0042] [0050]; fig. 2).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention, to have utilized the teaching of detecting a meeting of a vein and artery is performed using the device in the invention of Soto, Min and Ferguson, as taught by Ertel, to be able to calculate and evaluate collateral information which may be used to evaluate whether a patient has sufficient and hemodynamically intact collaterals to exert a positive influence on stroke treatment.
Regarding claim 12, Soto, Min and Ferguson disclose the invention substantially as described in the 103 rejection above, but fails to explicitly state automatically detecting collateral veins by comparing a number of veins in a specific image area in a current image relative to a baseline measurement.
Ertel discloses a method for detecting collateral information describing blood flow in collaterals blood vessel. Ertel teaches automatically detecting collateral veins by comparing a number of veins in a specific image area in a current image relative to a baseline measurement (see abstract; par. [0027], [0050]).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention, to have utilized the teaching of automatically detecting collateral veins by comparing a number of veins in a specific image area in a current image relative to a baseline measurement in the invention of Soto, Min and Ferguson, as taught by Ertel, to be able to calculate and evaluate automatically. For example, collateral information may be used to evaluate whether a patient has sufficient and hemodynamically intact collaterals to exert a positive influence on stroke treatment.
Regarding claim 22, Soto, Min and Ferguson disclose the invention substantially as described in the 103 rejection above, but fails to explicitly state automatically detected collateral veins and calculating a shape of the detected collateral veins.
Ertel discloses a method for detecting collateral information describing blood flow in collaterals blood vessel. Ertel teaches automatically detecting collateral veins (see abstract; par. [0027], [0050]), and calculating a shape of the detected collateral veins (see abstract; and see fig. 2).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention, to have utilized the teaching of automatically detecting collateral veins and calculating a shape of the detected collateral veins in the invention of Soto, Min and Ferguson, as taught by Ertel, to be able to calculate and evaluate automatically. For example, collateral information may be used to evaluate whether a patient has sufficient and hemodynamically intact collaterals to exert a positive influence on stroke treatment.
Claims 8 is rejected under 35 U.S.C. 103 as being unpatentable over Soto (US 8,888,714), in view of Min et al. (US 10,912,865), in view of Ferguson, JR. et al. (US 2013/0245456; hereinafter Ferguson) as applied to claim 1 above, and further in view of Kotanko et al. (US 2017/0119258; hereinafter Kotanko).
Regarding claim 8, Soto, Min and Ferguson disclose the invention substantially as described in the 103 rejection above, but fails to explicitly state estimating a probability of failure of the VA construct functionally based on the parameter.
Kotanko discloses a method and apparatus of assessment of access flow in hemodialysis patients by video image processing. Kotanko teaches estimating a probability of failure of a VA construct functionally based on parameter (see par. [0026], [0043], [0046], [0047], [0085]).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention, to have utilized the teaching of estimating a probability of failure of VA construct functionally based on parameter in the invention of Soto, Min and Ferguson, as taught by Kotanko, to be able to diagnosis of onset of thrombosis in hemodialysis patients which may be employed by physicians to intervene before the vascular access fails thereby extending the useful life of the vascular access.
Claims 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over Soto (US 8,888,714), in view of Min et al. (US 10,912,865), in view of Ferguson, JR. et al. (US 2013/0245456; hereinafter Ferguson) as applied to claim 7 above, and further in view of Kotanko et al. (US 2017/0119258; hereinafter Kotanko).
Regarding claim 9, Soto, Min and Ferguson disclose the invention substantially as described in the 103 rejection above, but fails to explicitly state calculating a rate of change of one or more of the parameters based on performing several measurements, at different times, of the one or more of the parameters, some of the measurements based on historical data associated with the patient retrieved from a database.
Kotanko teaches calculating a rate of change of one or more of the parameters based on performing several measurements, at different times, of the one or more of the parameters, some of the measurements based on historical data associated with the patient retrieved from a database (see par. [0014], [0015], [0053], [0057], [0067], [0070], [0082]).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention, to have utilized the teaching of calculating a rate of change of one or more of the parameters based on performing several measurements, at different times, of the one or more of the parameters, some of the measurements based on historical data associated with the patient retrieved from a database in the invention of Soto, Min and Ferguson, as taught by Kotanko, to be able to diagnosis of onset of thrombosis in hemodialysis patients which may be employed by physicians to intervene before the vascular access fails thereby extending the useful life of the vascular access.
Regarding claim 10, Soto, Min, Ferguson, and Kotanko disclose the invention substantially as described in the 103 rejection above, furthermore, Kotanko teaches estimating a probability of failure of VA construct functionally based on the rate of change of the one or more of the parameters (see par. [0026], [0043], [0046], [0047], [0085)).
Regarding claim 11, Soto, Min, Ferguson and Kotanko disclose the invention substantially as described in the 103 rejection above, furthermore, Kotanko teaches estimating a maturity of a VA based on the rate of change of the one or more of the parameters (see par. [0008], [0014], [0026], [(0046)]).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Soto (US 8,888,714), in view of Min et al. (US 10,912,865), in view of Ferguson, JR. et al. (US 2013/0245456; hereinafter Ferguson) as applied to claim 1 above, and further in view of Bhat et al. (US 2017/0337412; hereinafter Bhat).
Regarding claim 15, Soto, Min and Ferguson discloses the invention substantially as described in the 102 rejection above, but fails to explicitly state performing spectroscopy analysis of the at least one image.
Bhat discloses light emitter and sensor for detecting biologic characteristics. Bhat teaches performing spectroscopy analysis of at least one image (see par. [0049]).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention, to have utilized the teaching of spectroscopic analysis from image in the invention of Soto, Min and Ferguson, as taught by Bhat, to provide additional characteristics of blood in the patient to help physician further diagnosis the patient.
Claims 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Donnelly et al. (US 2010/0130864; hereinafter Donnelly), in view of Min et al. (US 10,912,865), in view of Kazmi et al. (“Flux or speed? Examining speckle contrast imaging of vascular flows”, Biomedical Optics Express, 2015; hereinafter Kazmi).
Regarding claim 18, Donnelly discloses ultrasonic evaluation of venous structures. Donnelly shows a method for replacing a physical examination performed by medical staff for monitoring blood vessel functionality in dialysis patients (see fig. 1-3), the method comprising: producing at least one image of a patient organ which includes the patient’s fistula instead of manually manipulating the patient’s organ (see fig. 1-3; par. [0040], [0042]); analyzing geometric properties of the patient’s fistula in at last one image (see abstract; figs. 1-3,par. [0021]). Donnelly shows classifying the patient’s fistula status to be one of suitable for dialysis based on the analyzing geometric properties (see par. [0020], [0066]).
But, Donnelly fails to explicitly state acquiring and analyzing speckle image, assessing palpated pulsation of the VA from said at least one speckle image analysis, detecting vessel deformation and/or pulse wave characteristic from the at least one image and/or the at least one speckle image.
Min discloses a rapid prototype and in vitro modeling of patient specific coronary artery bypass grafts. Min teaches detecting vessel deformation for at least one image (see claim 1) and determining a parameter of VA construct (see claim 1).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claim invention, to have utilized the teaching of detecting vessel deformation for at least one image (see claim 1) and determining a parameter of VA construct in the invention of Soto, as taught by Min, to provide an accurate and patient specific VA construct, and be able to monitor the VA construct with additional data such as vessel deformation.
But, Donnelly and Min fail to explicitly state acquiring and analyzing speckle image.
Kazmi discloses analyzing speckle contrast imaging. Kazmi teaches acquiring and analyzing speckle image (see abstract; introduction and fig. 2), a parameter associated with VA construct based on image analysis of the speckle image (see abstract; introduction and fig. 2, the examiner notes vascular blood parameter such as blood, velocity and flow are related to vascular access).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to have utilized the teaching of acquiring and analyzing speckle image in the invention of Soto, as taught by Kazmi, to provide additional information and higher resolution image for visualizing blood vessel which will help with presentation of non-maturing or failing AVF. The examiner notes that upon modification of prior art Donnelly to incorporate the teaching of Kazmi would also provide the classifying the patient’s fistula status in view of the analyzing of the speckle image.
Regarding claim 19, Donnelly, Man and Kazmi disclose the invention substantially as described in the 103 rejection above, furthermore, Donnelly shows calculating a parameter associated with blood vessel functionality based upon image analysis (see par. [0021], [0040], [0042]), but fails to explicitly state illuminating one or more blood vessel through a patient’s skin.
Kazmi teaches illuminating one or more blood vessel through a patient’s skin (abstract and fig. 1 and 4).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention, to have utilized the teaching of illuminating one or more blood vessel through a patient’s skin in the invention of Donnelly and Kazmi, as taught by Kazmi, to be able to calculate multiple different measurements of blood vessel parameter to provide a better and accurate blood vessel parameter.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Soto (US 8,888,714), in view of Min et al. (US 10,912,865), in view of Kazmi et al. (“Flux or speed? Examining speckle contrast imaging of vascular flows”, Biomedical Optics Express, 2015; hereinafter Kazmi), and in view of Sharma et al. (“Arteriovenous fistula (AVF) monitoring and surveillance; Clinical Queries: Nephorology (2014); hereinafter Sharma).
Regarding claim 20, Soto discloses an automatic blood draw system and method. Soto shows a system for non-invasive monitoring blood vessel functionality (see abstract and fig. 1), the system comprising at least one illuminator configured to illuminate a patient’s blood vessels through the patient’s skin (see col. 5, lines 39-53); at least one camera configured to capture at least one image of the blood vessels through the patient’s skin (see col. 5, lines 39-53); at least one processor configured to: perform analysis on the at least one image and analyzing geometric properties of the blood vessel in the at least one image (col. 2, lines 44-60; col. 5, lines 39-53; col. 6, lines 13-25, col. 6, lines 57-67); calculate a parameter associated with vascular access construct functionality based on the image analysis of the at least one image (col. 2, lines 44-60; col. 5, lines 39-53; col. 6, lines 13-25, col. 6, lines 57-67; and claim 15).
But, Soto fails to explicitly state acquiring and analyzing speckle image, a parameter associated with VA construct based on image analysis of the speckle image, detecting vessel deformation and/or pulse wave characteristic from the at least one image and/or the at least one speckle image; and at least one display configured to provide a report of at least one of patient’s status and a parameter associated with blood vessel functionality to a caregiver.
Min discloses a rapid prototype and in vitro modeling of patient specific coronary artery bypass grafts. Min teaches detecting vessel deformation for at least one image (see claim 1) and determining a parameter of VA construct (see claim 1).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claim invention, to have utilized the teaching of detecting vessel deformation for at least one image (see claim 1) and determining a parameter of VA construct in the invention of Soto, as taught by Min, to provide an accurate and patient specific VA construct, and be able to monitor the VA construct with additional data such as vessel deformation.
But, Soto and Min fail to explicitly state acquiring and analyzing speckle image, a parameter associated with VA construct based on image analysis of the speckle image; and at least one display configured to provide a report of at least one of patient’s status and a parameter associated with blood vessel functionality to a caregiver.
Kazmi discloses analyzing speckle contrast imaging. acquiring and analyzing speckle image (see abstract; introduction and fig. 2), a parameter associated with VA construct based on image analysis of the speckle image and assessing palpated pulsation of the VA from the at least one speckle image analysis (see abstract; introduction and fig. 2, the examiner notes vascular blood parameter such as blood, velocity and flow are related to vascular access).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to have utilized acquiring and analyzing speckle image, a parameter associated with VA construct based on image analysis of the speckle image and assessing palpated pulsation of the VA from the at least one speckle image analysis in the invention of Soto and Min, as taught by Kazmi, to provide additional information and higher resolution image for visualizing blood vessel which will help with presentation of non-maturing or failing AVF. The examiner notes that upon modification of prior art Soto to incorporate the teaching of Kazmi would also provide the based on speckle analyzing, determining a parameter associated with VA construct.
But, Soto, Min and Kazmi fail to explicitly state classify the patient’s status to be one of suitable for dialysis or at risk for dialysis; and at least one display configured to provide a report of at least one of patient’s status and a parameter associated with blood vessel functionality to a caregiver.
Sharma discloses AVF monitoring and surveillance. Sharma teaches classify the patient’s status to be one of suitable for dialysis or at risk for dialysis (see page 47-48; table 2).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claim invention, to have utilized the teaching of classify the patient’s status to be one of suitable for dialysis or at risk for dialysis in the invention of Soto, Min and Kazmi, as taught by Sharma, to provide both a physical examination and imaging investigations to detect of a non-maturing or failing AVF which with help in timely actions and decreases in incidence of complications like stenosis/thrombosis in the AVF.
Regarding the limitations of “...configured to provide a report of at least one of the patient’s status and a parameter associated with blood vessel functionality to a caregiver" directed to the intended use of the invention. It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. Therefore, as taught, the combined invention disclosed by Soto, Min, Kazmi and Sharma is capable of performing the functions as set forth by applicant. Also, see MPEP 2114.
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Soto (US 8,888,714), in view of Min et al. (US 10,912,865), in view of Ferguson, JR. et al. (US 2013/0245456; hereinafter Ferguson) as applied to claim 1 above, and further in view of Gladshtein et al. (US 2016/0367154; hereinafter Gladshtein).
Regarding claim 23, Soto, MIn and Ferguson disclose the invention substantially as
described in the 103 rejection above, furthermore, Soto teaches but fails to explicitly state that the geometric properties comprise a diameter of the blood vessel (col. 2, lines 44-60; col. 5, lines 39-53; col. 6, lines 13-25, col. 6, lines 57-67); but, fails to explicitly sate analyzing comprises identifying a change in the diameter of the blood vessel relative to a baseline diameter of the vessel.
Gladshtein discloses obtaining cardiovascular parameters. Gladshtein teaches
determining a diameter of the blood vessel (see abstract; par. [0017], [0069], [0089]); and
analyzing comprises identifying a change in the diameter of the blood vessel relative to a
baseline diameter of the vessel (see abstract; par. [0017], [0069], [0089]).
Therefore, it would have been obvious to one of ordinary skill in the art, before the
effective filing of the claimed invention, to have utilized the teaching of analyzing comprises
identifying a change in the diameter of the blood vessel relative to a baseline diameter of the
vessel in the invention of Soto, Min and Ferguson, as taught by Gladshtein, to provide
additional characteristics of blood in the patient to help physician further diagnosis the patient.
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Soto (US 8,888,714), in view of Min et al. (US 10,912,865), in view of Ferguson, JR. et al. (US 2013/0245456; hereinafter Ferguson) as applied to claim 1 above, and further in view of Donnelly et al. (US 2010/0130864; hereinafter Donnelly).
Regarding claim 24, Soto, Min and Ferguson discloses the invention substantially as described in the 103 rejection above, furthermore, Ferguson teaches capturing the two images of the blood vessels at different times (see abstract; par. [0114]), analyzing geometric properties in the at least two images (see par. [0114]), but fails to explicitly state, calculating a parameter indicative of fistula collapse.
Donnelly discloses evaluation of venous structures. Donnelly teaches a parameter indicative fistula collapse (see par. [0041], [0042], [0049], [0050], [0066]; the examiner has interpreted claim limitation “fistula collapse” as fistula give away and not maturing).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention, to have utilized the teaching of using image analysis to calculate a parameter indicative fistula collapse in the invention of Soto, Min and Ferguson, as taught by Donnelly, to provide optimum delivery of hemodialysis.
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Soto (US 8,888,714) in view of Min et al. (US 10,912,865), in view of Ferguson, JR. et al. (US 2013/0245456; hereinafter Ferguson), in view of Donnelly et al. (US 2010/0130864; hereinafter Donnelly) as applied to claim 24 above, and further in view of Sharma et al. (“Arteriovenous fistula (AVF) monitoring and surveillance; Clinical Queries: Nephorology (2014); hereinafter Sharma).
Regarding claim 25, Soto, Min, Ferguson and Donneley disclose the invention substantially as described in the 103 rejection above, furthermore, Sharma teaches performing an elevation test (see pages 47-49), and calculating a parameter associated with a change in the collapse of the fistula when the patient’s arm is elevated (see pages 47-49).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention, to have utilized the teaching of an elevation test, and calculating a parameter associated with a change in the collapse of the fistula when the patient’s arm is elevated in the invention of Soto, Min, Ferguson and Donneley, as taught by Sharma to provide optimum delivery of hemodialysis.
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Soto (US 8,888,714), in view of Min et al. (US 10,912,865), in view of Ferguson, JR. et al. (US 2013/0245456; hereinafter Ferguson), in view of Donnelly et al. (US 2010/0130864; hereinafter Donnelly), in view of Sharma et al. (“Arteriovenous fistula (AVF) monitoring and surveillance; Clinical Queries: Nephorology (2014); hereinafter Sharma) as applied to claim 25 above, and further in view of Kang et al. (US 2011/0103657; hereinafter Kang).
Regarding claim 26, Soto, Min, Ferguson, Donnelly and Sharma disclose the invention substantially as described in the 103 rejection above, furthermore, Sharma teaches identifying a change in the collapse of fistula when the patient’s arm is elevated (see abstract; pages 47-49), correlating the change identified in the fistula collapse when the patient’s arm is elevated with a change identified in at least one parameter indicative of development of one or more collateral vessels (see abstract; pages 47-49), but Soto, Sharma, and Donnelly fail to explicitly state determining a probability of failure of the fistula’s functionality based on the correlated changes.
Kang discloses vascular analysis method and apparatus. Kang teaches identifying a change in collapse of blood vessel (see par. [0176], 0180]) and determining a probability of failure of the blood vessel’s functional based on the change in the collapse of the blood vessel (see par. [0182]).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention, to have utilized the teaching of identifying a change in collapse of blood vessel and determining a probability of failure of the blood vessel’s functional based on the change in the collapse of the blood vessel in the invention of Soto, Min, Ferguson, Donnelly and Sharma, as taught by Kang, to provide further information to the physician to be able to diagnose the blood vessel.
Response to Arguments
The previous claim interpretation under 35 USC 112 (f) has been withdrawn in view of Applicant’s amendment to claim 20.
The previous clam rejection under 35 USC 112 (a) to claims 1, 18 and 20 has been withdrawn in view of Applicant’s amendments to the claims.
The previous clam rejection under 35 USC 112 (b) to claims 1, 18 and 20 has been withdrawn in view of Applicant’s amendments to the claims.
Applicant’s arguments with respect to prior arts have been considered but are moot because the new ground of rejection does not rely on any rejection applied in the prior office action of record for any teaching or matter specifically challenged in the argument. The examiner has provided new prior art Min.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHAHDEEP MOHAMMED whose telephone number is (571)270-3134. The examiner can normally be reached Monday to Friday, 9am to 5pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anne M Kozak can be reached at (571)270-0552. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SHAHDEEP MOHAMMED/ Primary Examiner, Art Unit 3797
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