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 .
Response to Amendment
This office action is responsive to the amendment filed on 04/23/2026. As directed by the amendment: claims 106 and 108 have been amended, claims 1-105 have been cancelled and claim 125 has been withdrawn. Thus, claims 106-125 are presently pending in this application.
Election/Restrictions
Claim 125 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 04/23/2026.
Applicant’s election without traverse of Invention I, claims 106-124, drawn to a method of treatment of a cardiovascular disease in the reply filed on 04/23/2026 is acknowledged.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 113 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 113 recites the limitation "wherein positioning the tip of the first catheter at or near the renal vein" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim as this limitation is not positively recited in claim 106, which 113 is dependent on. For the purpose of prior art examination, claim 113 will be interpreted as dependent on claim 107 instead of claim 106. Appropriate correction is required.
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.
Claim(s) 106, 114-118, 120-122 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lane et al (US 20200038575 A1), herein referenced to as Lane in view of Kokish et al (US 6485500 B1), herein referenced to as “Kokish”.
Claim 106
Lane discloses: A method for treatment of a cardiovascular disease (see [0028], cardiac failure, [0003]) of a subject, the method comprising using a catheter system 22 + 24 (see Figs. 3-4, 6, and 13, [0164]) comprising: a first catheter there are at least 3 catheters, a first of which 22 (see Figs. 3-4, 6, and 13, [0164]) comprising: a first balloon a first 24 associated with first 22 (see Figs. 3-4, 6, and 13, [0164]), a first lumen each balloon has a inflation channel, the inflation channel with a first 24 (see [0175]), configured to inflate the first balloon (see [0175]-[0176], the inflation lumen is used to inflate a balloon), a second catheter a second 22 (see Figs. 3-4, 6, and 13, [0164]) comprising a second balloon a second 24 associated with second 22 (see Figs. 3-4, 6, and 13, [0164]) and an inflation lumen each balloon has a inflation channel, the inflation channel with a second 24 (see [0175]) configured to inflate the second balloon (see [0175]-[0176], the inflation lumen is used to inflate a balloon), and, a third catheter a third 22 (see Figs. 3-4, 6, and 13, [0164]) comprises a third balloon a third 24 associated with third 22 (see Figs. 3-4, 6, and 13, [0164]) and an inflation lumen each balloon has a inflation channel, the inflation channel with a third 24 (see [0175]) configured to inflate the third balloon (see [0175]-[0176], the inflation lumen is used to inflate a balloon), wherein the third balloon a third 24 is configured to be positioned at or near a pulmonary artery (see Fig. 13, [0209], occlusion of the pulmonary artery) of the subject.
Lane does not explicitly teach: the first balloon having a second lumen and a third lumen, the second lumen of the first catheter is configured to accept the second catheter for advancement and retraction therethrough, and wherein the third lumen of the first catheter is configured to accept the third catheter for advancement and retraction therethrough.
However, Kokish in a similar field of invention teaches a method of temporary isolating a section of a blood vessel for treating cardiovascular disease (see col. 1, lines 43-60) with a first catheter 50 with a first balloon 51 (see Figs. 2-4), with an inflation lumen 64 (see Figs. 2-4, a second catheter 44 with a second balloon 46 (see Figs. 2-4) with an inflation lumen 48, and a third catheter 32 with a third balloon 40 (see Figs. 2-4) with an inflation lumen 43 (see Figs. 2-4). Kokish further teaches: the first balloon 51 having a second lumen 62 (see Fig. 3, col. 11, lines 9-14) and a third lumen the shared lumen of 51 and 46 which 40 extends through (see Figs. 2-4), the second lumen 62 of the first catheter 50 is configured to accept the second catheter 46 for advancement and retraction therethrough (see Figs. 2-4, 46 can be extended and retraced through 50), and wherein the third lumen the shared lumen of 51 and 46 which 40 extends through (see Figs. 2-4) of the first catheter 50 is configured to accept the third catheter for advancement and retraction therethrough (see Figs. 3-4, the 32 + 34 can extend through 50, see col. 10, lines 42-59, the catheter 44 and 50 can be placed over 32 and col. 11, lines 27-39 and withdrawing is possible).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Lane to incorporate the teachings of Kokish and teach a method for treatment of a cardiovascular disease with the first balloon having a second lumen and a third lumen, the second lumen of the first catheter is configured to accept the second catheter for advancement and retraction therethrough, and wherein the third lumen of the first catheter is configured to accept the third catheter for advancement and retraction therethrough. Motivation for such can be found in Kokish as this allows for flushing of a targeted area with reduced risk of emboli migrating from the targeted area (see col. 9, lines 49-67, and col. 10, lines 1-4).
Claim 114
The combination of Lane and Kokish teaches: The method of claim 106, see 103 rejection above. Lane further discloses: wherein positioning the second balloon a second 24 associated with second 22 at or near the subclavian vein (see Figs. 3-4, [0174], subclavian venous system) of the subject comprises advancing the second catheter a second 22 through vasculature (see [0174]-[0176], through vasculature over guidewire) of the subject over a guidewire (see [0075] and [0174]-[0176]).
Claim 115
The combination of Lane and Kokish teaches: The method of claim 106, see 103 rejection above. Lane further discloses: further comprising: positioning the third balloon a third 24 associated with third 22 of the third catheter third 22 at or near the pulmonary artery 103 (see Fig. 13, [0209], occlusion of the pulmonary artery 103); inflating the third balloon (see Fig. 13, [0209]); and measuring a pulmonary artery pressure (see [0208]-[0209], pulmonary pressure, [0026], the region which the balloons are introduced and used to occlude have the pressure measured by instruments of the catheter system) of the subject with the catheter system 22 + 24.
Kokish further teaches: inserting the third catheter 32 comprising the third balloon 40 into the third lumen the shared lumen of 51 and 46 which 40 extends through (see Figs. 2-4, 40 is inserted through 51 and 46) of the catheter system (see Figs. 2-4).
Claim 116
The combination of Lane and Kokish teaches: The method of claim 115, see 103 rejection above. Lane further discloses: wherein positioning the third balloon a third 24 associated with third 22 of the third catheter third 22 at or near the pulmonary artery 103 (see Fig. 13, [0209], occlusion of the pulmonary artery 103) comprises advancing the third catheter third 22 through vasculature of the subject over a guidewire (see [0075] and [0174]-[0176], through vasculature over guidewire).
Claim 117
The combination of Lane and Kokish teaches: The method of claim 116, see 103 rejection above. Lane further discloses: further comprising monitoring at least one hemodynamic parameter (see [0208]-[0209], pulmonary pressure, [0026], the region which the balloons are introduced and used to occlude have the pressure measured by instruments of the catheter system) of the subject with the third catheter third 22.
Claim 118
The combination of Lane and Kokish teaches: The method of claim 117, see 103 rejection above. Lane further discloses: wherein the at least one hemodynamic parameter is one or more of heart rate (the alternatives to “blood pressure” will not be examined here due to being optional claim limitations), blood pressure (see [0208]-[0209], pulmonary pressure, [0026], the region which the balloons are introduced and used to occlude have the pressure measured by instruments of the catheter system), stroke volume, cardiac output, or total peripheral resistance.
Claim 120
The combination of Lane and Kokish teaches: The method of claim 106, see 103 rejection above. Lane further discloses: further comprising monitoring pressure at a pulmonary artery (see [0208]-[0209], pulmonary pressure, [0026], the region which the balloons are introduced and used to occlude have the pressure measured by instruments of the catheter system) of the subject with the catheter system.
Claim 121
The combination of Lane and Kokish teaches: The method of claim 106, see 103 rejection above. Lane further discloses: further comprising monitoring pressure at one or more of an inferior vena cava or femoral vein (see [0179], inferior vena cava, [0195], femoral vein, [0026], the region which the balloons are introduced and used to occlude have the pressure measured by instruments of the catheter system) with the catheter system.
Claim 122
The combination of Lane and Kokish teaches: The method of claim 106, see 103 rejection above. Lane further discloses: wherein the cardiovascular disease is heart failure (see [0028], congestive heart failure) or acute heart failure (will not be examined due to being an optional claim limitation).
Claim(s) 107-108 and 113 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lane in view of Kokish as applied to claim 106 above, and further in view of Keating et al (US 20220104828 A1), herein referenced to as “Keating”.
Claim 107
The combination of Lane and Kokish teaches: The method of claim 106, see 103 rejection above. Lane further discloses: wherein the method comprises inserting the catheter system 22 + 24 into a femoral vein (see [0192]-[0195], origin is in the common femoral vessels, including the femoral vein) of the subject.
Lane and Kokish does not explicitly teach: positioning the tip of the first catheter of the catheter system at or near a renal vein of the subject; positioning the second balloon of the second catheter of the catheter system at or near a subclavian vein of the subject; and inflating the first balloon and the second balloon; wherein inflation of the second balloon creates a low-pressure area at the left internal jugular vein and thoracic duct of the subject, and wherein inflation of the first balloon creates a low-pressure area at the renal vein of the subject.
However, Keating in a similar field of invention teaches a method of treatment of a cardiovascular disease (see Fig. 14, [0003], heart failure) with a catheter system 800 (see Fig. 14) with a first catheter 807 (see Fig. 14) with a first balloon 821a (see Fig. 14) and a second catheter 810 (see Fig. 14, [0178]) with a second balloon 821b (see Fig. 14). Keating further teaches: positioning the tip of the first catheter 807 of the catheter system 800 at or near a renal vein (see Fig. 14, the tip of 821a positioned near the renal vein at 806, [0178]) of the subject; positioning the second balloon 821b of the second catheter 810 of the catheter system 800 at or near a subclavian vein (see Fig. 14, 821b positioned near the subclavian vein, see table 1, subclavian vein) of the subject; and inflating the first balloon and the second balloon (see Fig. 14, [0178]-[0179], the restrictor/balloons are inflated); wherein inflation of the second balloon 821b creates a low-pressure area (see Fig. 14, [0178]-[0179], [0084], reduce pressure, thus creating a low-pressure area adjacent to the balloon, in this case near the subclavian vein includes the left jugular vein and the thoracic duct) at the left internal jugular vein and thoracic duct of the subject, and wherein inflation of the first balloon 821a creates a low-pressure area (see Fig. 14, [0178]-[0179], [0084], reduce pressure, thus creating a low-pressure area adjacent to the balloon, in this case near the IVC at this position is the renal vein, 806) at the renal vein of the subject.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Lane to incorporate the teachings of Keating and teach a method of treatment of a cardiovascular disease with positioning the tip of the first catheter of the catheter system at or near a renal vein of the subject; positioning the second balloon of the second catheter of the catheter system at or near a subclavian vein of the subject; and inflating the first balloon and the second balloon; wherein inflation of the second balloon creates a low-pressure area at the left internal jugular vein and thoracic duct of the subject, and wherein inflation of the first balloon creates a low-pressure area at the renal vein of the subject. Motivation for such can be found in Keating as this allows reduced blood flow to an area of the body to focus blood flow to another portion of the body, for example to remedy insufficiency of cardiac output to meet tissue and organ demand, such as redirecting fluid to the kidneys for ADHF patients (see [0084]).
Claim 108
The combination of Lane and Kokish teaches: The method of claim 106, see 103 rejection above. Lane further discloses: wherein the method comprises advancing the first catheter a first 22 into a femoral vein (see [0192]-[0195], origin is in the common femoral vessels, including the femoral vein) of the subject.
Kokish further teaches: advancing the second catheter 46 through the first catheter 50 (see Figs. 2-4, 46 is extracted and advanced through 50, by being advanced over 40 and through 50).
Lane and Kokish does not explicitly teach: positioning the first balloon at an inferior vena cava (IVC) of the subject or near a renal vein of the subject; positioning the second balloon of the second catheter at a subclavian vein of the subject; and inflating the second balloon, thereby creating a low-pressure area at one or more of the left internal jugular vein or the thoracic duct of the subject.
However, Keating in a similar field of invention teaches a method of treatment of a cardiovascular disease (see Fig. 14, [0003], heart failure) with a catheter system 800 (see Fig. 14) with a first catheter 807 (see Fig. 14) with a first balloon 821a (see Fig. 14) and a second catheter 810 (see Fig. 14, [0178]) with a second balloon 821b (see Fig. 14). Keating further teaches: positioning the first balloon 821a at inferior vena cava (IVC) of the subject (see Fig. 14, [0178], 821a is placed within the inferior vena cava) or near a renal vein (see Fig. 14, the tip of 821a positioned near the renal vein at 806, [0178]) of the subject; positioning the second balloon 821b of the second catheter 810 of the catheter system 800 at subclavian vein (see Fig. 14, 821b positioned at the subclavian vein, see table 1, subclavian vein) of the subject; and inflating the second balloon (see Fig. 14, [0178]-[0179], the restrictor/balloons are inflated), thereby creating a low-pressure area (see Fig. 14, [0178]-[0179], [0084], reduce pressure, thus creating a low-pressure area adjacent to the balloon, in this case near the subclavian vein includes the left jugular vein and the thoracic duct) at the left internal jugular vein and thoracic duct of the subject.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Lane to incorporate the teachings of Keating and teach a method of treatment of a cardiovascular disease with positioning the first balloon at an inferior vena cava (IVC) of the subject or near a renal vein of the subject; positioning the second balloon of the second catheter at a subclavian vein of the subject; and inflating the second balloon, thereby creating a low-pressure area at one or more of the left internal jugular vein or the thoracic duct of the subject. Motivation for such can be found in Keating as this allows reduced blood flow to an area of the body to focus blood flow to another portion of the body, for example to remedy insufficiency of cardiac output to meet tissue and organ demand, such as redirecting fluid to the kidneys for ADHF patients (see [0084]).
Claim 113
The combination of Lane, Kokish, and Keating teaches: The method of claim 106 (see 112b rejection above, interpreted as being dependent on claim 107 instead). The combination of Lane and Keating further teaches: positioning the tip of the first catheter 807 (Keating) of the catheter system 800 (Keating) at or near a renal vein (see Fig. 14, the tip of 821a positioned near the renal vein at 806, [0178], Keating) comprises advancing the first catheter (Lane as modified with Keating, directs the location that first catheter is directed to, the first catheter still being directed over a guide wire as disclosed by Lane) through vasculature of the subject over a guidewire (see [0075] and [0174]-[0176])..
Claim(s) 109-112 and 124 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lane in view of Kokish as applied to claim 106 above, and further in view of Kapur et al (US 20220401718 A1), herein referenced to as “Kapur”.
Claim 109
The combination of Lane and Kokish teaches: The method of claim 106, see 103 rejection above. Lane and Kokish does not explicitly teach: wherein inflation of the second balloon stimulates a vagus nerve of the subject.
However, Kapur in a similar field of invention teaches a method of treatment of a cardiovascular disease (see Fig. 48, [0041]) with a first balloon 142 (see Fig. 48) and a second balloon 143 (see Fig. 48) and inflation of the first and second balloon (see Fig. 45, inflated state). Kapur further teaches: wherein inflation of the second balloon stimulates a vagus nerve (see [0041], actuation of the flow limiting element stimulate the vagal nerve) of the subject.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Lane and Kokish to incorporate the teachings of Kapur and teach a method of treatment of a cardiovascular disease with inflation of the second balloon stimulates a vagus nerve of the subject. Motivation for such can be found in Kapur as this allows for an increase of urine flow of the patient which benefits patients with heart failure and promotes decongestion (see [0041] and [0112]).
Claim 110
The combination of Lane and Kokish teaches: The method of claim 106, see 103 rejection above. Lane and Kokish does not explicitly teach: wherein inflation of the first balloon stimulates a vagus nerve of the subject.
However, Kapur in a similar field of invention teaches a method of treatment of a cardiovascular disease (see Fig. 48, [0041]) with a first balloon 142 (see Fig. 48) and a second balloon 143 (see Fig. 48) and inflation of the first and second balloon (see Fig. 45, inflated state). Kapur further teaches: wherein inflation of the first balloon stimulates a vagus nerve (see [0041], actuation of the flow limiting element stimulate the vagal nerve) of the subject.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Lane and Kokish to incorporate the teachings of Kapur and teach a method of treatment of a cardiovascular disease with inflation of the second balloon stimulates a vagus nerve of the subject. Motivation for such can be found in Kapur as this allows for an increase of urine flow of the patient which benefits patients with heart failure and promotes decongestion (see [0041] and [0112]).
Claim 111
The combination of Lane and Kokish teaches: The method of claim 106, see 103 rejection above. Lane and Kokish does not explicitly teach: wherein inflating the first balloon comprises maintaining inflation of the first balloon for 20-40 seconds before deflating the first balloon.
However, Kapur in a similar field of invention teaches a method of treatment of a cardiovascular disease (see Fig. 48, [0041]) with a first balloon 142 (see Fig. 48) and a second balloon 143 (see Fig. 48) and inflation of the first and second balloon (see Fig. 45, inflated state). Kapur further teaches: wherein inflating the first balloon comprises maintaining inflation of the first balloon before deflating the first balloon (see [0234]-[0235], intermittently inflating and deflating the balloon).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Lane and Kokish to incorporate the teachings of Kapur and teach a method of treatment of a cardiovascular disease with inflating the first balloon comprises maintaining inflation of the first balloon before deflating the first balloon. Motivation for such can be found in Kapur as this can used to offload the overloaded right ventricle and reduce the volume of fluid in the right ventricle (see [0235]).
The combination of Lane, Kokish, and Kapur does not explicitly teach: maintaining inflation of the first balloon for 20-40 seconds.
As noted in Kapaur it is necessary for the timing of the holding inflation and deflation to maintain a reduction of volume of fluid in the right ventricle to offload the overloaded right ventricle, and to maintain critical measured parameters of the heart (e.g., pressure, volume, load) (see [0235]). This correlates to inflation of the first balloon and as such maintaining inflation of the first balloon for 20-40 seconds is considered to be a result effective variable since that the amount of time the balloon is inflated directly affects the measured parameters of the heart and reducing the volume of fluid in the right ventricle. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Lane, Kokish, and Kapur by causing maintaining inflation of the first balloon for 20-40 seconds as a matter of routine optimization since it has been held that ‘where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235, (CCPA 1955).
Claim 112
The combination of Lane and Kokish teaches: The method of claim 106, see 103 rejection above. Lane and Kokish does not explicitly teach: wherein inflating the second balloon comprises maintaining inflation of the second balloon for 10-30 seconds before deflating the second balloon.
However, Kapur in a similar field of invention teaches a method of treatment of a cardiovascular disease (see Fig. 48, [0041]) with a first balloon 142 (see Fig. 48) and a second balloon 143 (see Fig. 48) and inflation of the first and second balloon (see Fig. 45, inflated state). Kapur further teaches: wherein inflating the second balloon comprises maintaining inflation of the second balloon before deflating the second balloon (see [0234]-[0235], intermittently inflating and deflating the balloon).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Lane and Kokish to incorporate the teachings of Kapur and teach a method of treatment of a cardiovascular disease with inflating the first balloon comprises maintaining inflation of the first balloon before deflating the first balloon. Motivation for such can be found in Kapur as this can used to offload the overloaded right ventricle and reduce the volume of fluid in the right ventricle (see [0235]).
The combination of Lane, Kokish, and Kapur does not explicitly teach: maintaining inflation of the second balloon for 10-30 seconds.
As noted in Kapaur it is necessary for the timing of the holding inflation and deflation to maintain a reduction of volume of fluid in the right ventricle to offload the overloaded right ventricle, and to maintain critical measured parameters of the heart (e.g., pressure, volume, load) (see [0235]). This correlates to inflation of the first balloon and as such maintaining inflation of the second balloon for 10-30 seconds is considered to be a result effective variable since that the amount of time the balloon is inflated directly affects the measured parameters of the heart and reducing the volume of fluid in the right ventricle. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Lane, Kokish, and Kapur by causing maintaining inflation of the second balloon for 10-30 seconds as a matter of routine optimization since it has been held that ‘where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235, (CCPA 1955).
Claim 124
The combination of Lane, Kokish, and Kapur teaches: The method of claim 109, see 103 rejection above. Kapur further teaches: wherein stimulating the vagus nerve of the subject reduces venous blood backflow to the heart of the subject, reduces heart pumping burden of the subject, or both (see [0041], stimulating the vagal nerve increases urine flow of the patient, which reduces venous blood backflow to the heart of the subject by reducing fluid and offload the ventricle, [0235]).
Claim(s) 123 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lane in view of Kokish and Kapur as applied to claim 109 above, and further in view of Cakmak et al (US 20190070417 A1), herein referenced to as “Cakmak”.
Claim 123
The combination of Lane, Kokish, and Kapur teaches: The method of claim 109, see 103 rejection above. Kapur further teaches: wherein stimulating the vagus nerve of the subject (see [0041], actuation of the flow limiting element stimulate the vagal nerve).
The combination of Lane, Kokish, and Kapur does not explicitly teach: causes one or more of a subclavian vein (the alternatives to “a renal vein” will not be examined here due to being optional claim limitations), a left internal jugular vein or thoracic duct, an inferior vena cava, or a renal vein to expand.
However, Cakmak in a similar field of invention teaches a method of treatment of a cardiovascular disease (see [0001], decreasing blood pressure in order to treat hypertension) with stimulating the vagus nerve of the subject (see [0017]). Cakmak further teaches: causes a renal vein to expand (see [0015] and [0017], the additional stimulation of the vagus nerve can contribute in lowering blood pressure, including expanding the renal artery of the patient).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Lane, Kokish, and Kapur to incorporate the teachings of Cakmak and teach a method of treatment of a cardiovascular disease with stimulating the vagus nerve of the subject causes a renal vein to expand. Motivation for such can be found in Cakmak as this can additionally block autonomic activation of the kidney and/or adrenal gland which would increase blood pressure with the neuroendocrine response otherwise (see [0015]).
Claim(s) 119 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lane in view of Kokish as applied to claim 106 above, and further in view of Quadri et al (US 20230414360 A1), herein referenced to as “Quadri”.
Claim 119
The combination of Lane and Kokish teaches: The method of claim 106, see 103 rejection above.
Lane further discloses: further comprising monitoring pressure (see [0208]-[0209], pulmonary pressure, [0026], the region which the balloons are introduced and used to occlude have the pressure measured by instruments of the catheter system) of the subject with the catheter system.
Lane and Kokish does not explicitly teach: further comprising monitoring pressure at a right atria.
However, Quadri in a similar field of invention teaches a method of treatment of a cardiovascular disease (see Figs. 41-46b) with an occlusive system (see Figs. 41b-46b) and monitoring pressure (see [0196], pressure sensors). Quadri further teaches: further comprising monitoring pressure (see [0196], right atrial pressure) at a right atria.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Lane to incorporate the teachings of Quadri and teach a method of treatment of a cardiovascular disease with monitoring pressure at a right atria. Motivation for such can be found in Quadri as monitoring this pressure can contribute to controlling selective occlusion to reduce cardiac preload and enhance renal circulation (see [0196]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Cedeno (US 20100331876 A1), teaches a balloon catheter for dynamic regulation of venous retrun to the heart for patients with HF via occlusion of the IVC
Caparso et al (US 20060259107 A1) teaches stimulating the vagus nerve to alter systolic/diastolic pressure
Azamian et al (US 20160128767 A1) teaches vagus stimulation to treat congestive heart failure via mechanical neuromodulation
Barbut et al (US 20020115982 A1) teaches using cyclical inflation + deflation to treat cardiovascular disease
Lane et al (US 20110257577 A1) teaches that a vagal response can induce a reduction heart rate
Keren et al (US 20040064091 A1), teaches using cyclical inflation and deflation to treat congestive heart disease by placing balloons adjacent to the renal vein
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RAIHAN R. KHANDKER
Examiner
Art Unit 3771
/RAIHAN R KHANDKER/Examiner, Art Unit 3771
Prosecution Insights