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 in response to the Applicant’s amendment filed 18 March 2026 wherein Claims 1, 19 – 20, 22, and 24 – 29 are amended, no claims are cancelled, no claims are newly added, and no claims were previously withdrawn. Therefore, Claims 1 – 6 and 19 – 32 are currently pending within the Application.
The Applicant’s amendment to the Specification and Drawings dated 18 March 2026 has overcome each Drawing Objection set forth in the Non-Final Rejection dated 18 September 2025 (hereinafter referred to as the “Non-Final Rejection”). Therefore, each Drawing Objection set forth in the Non-Final Rejection is withdrawn.
The Applicant’s amendment to the Specification has overcome some of the Specification Objections set forth in the Non-Final Rejection. The maintained Specification Objections are set forth below. The overcome Specification Objections from the Non-Final Rejection are withdrawn.
The Applicant’s amendment to the Claims dated 18 March 2026 has overcome each Claim Objection set forth in the Non-Final Rejection. Therefore, each Claim Objection set forth in the Non-Final Rejection is withdrawn.
The Applicant’s amendment to the Claims dated 18 March 2026 has overcome each Claim Rejection under 35 U.S.C. § 112(a) and (b) set forth in the Non-Final Rejection. Therefore, each Claim Rejection under 35 U.S.C. § 112(a) and (b) is withdrawn.
Response to Arguments
Applicant’s arguments, see pages 12 – 17, filed 18 March 2026, with respect to the rejection(s) of independent claims 1, 22, and 29 and their respective dependent claims under 35 U.S.C. §§ 102 and 103 have been fully considered and are persuasive. More specifically, the Applicant’s arguments that Schwammenthal et al. and Nitzan ’130 each do not disclose repeating the inflating the activating, and the deflating until achieving a target urine output is found to be persuasive. See pages 13, 14, and 16 of the Remarks dated 18 March 2026. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of the following:
Schwammenthal et al. (US 2017/0100527 A1) and Levin et al. (US 2017/0274190 A1); and
Nitzan et al. (US 2018/0126130 A1; hereinafter referred to as “Nitzan ’130”), Schwammenthal et al. (US 2017/0100527 A1), and Levin et al. (US 2017/0274190 A1).
Features Argued Not Within Claim Language
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies are not recited in the rejected claim(s). The Applicant recites a two features which are not recited within the method. First, the Applicant recites that the pumping is activated, then deactivated, then activated again in repeated cycles. See page 14 of the Remarks dated 18 March 2026. The deactivation step of the distal impeller pump is not recited in the claim unless the Applicant is implicitly reciting this deactivation within the “repeating” step of the method through the repeat activation of the distal impeller pump. Second, the Applicant’s method does not recite that the inflation of the proximal occlusion balloon fully occludes blood movement through the inferior vena cava. The Applicant repeatedly argues that the method of Schwammenthal et al. is a partial-occlusion procedure and that this is different than the currently recited claims. See pages 13 and 14 of the Applicant’s Remarks dated 18 March 2026. However, the Applicant’s claims do not recite whether the proximal occlusion balloon is a partial or full occlusion. The claims only recite “inflating the proximal occlusion balloon” or “inflating the upstream occlusive ballon against the inferior vena cava.” See Claims 1, 22, and 29 of the Claims dated 18 March 2026. The claims do not recite with enough specificity as to whether this occlusion is a full or partial occlusion to overcome the prior art of Schwammenthal with this argument.
Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Specification
The disclosure is objected to because of the following informalities:
[0045] of the Specification recites “the guidewire lumen 108.” The Examiner suggests amending this to recite “the central lumen 108” to correct what structure is being referred to by reference numeral 108.
Appropriate correction is required.
Claim Objections
Claim 22 and 27 are objected to because of the following informalities:
Claim 22 recites “a right renal vein…and a right renal vein of the patient.” The Examiner suggests amending the second recitation of a right renal vein to recite “[[a]] the right renal vein” to provide the proper antecedent basis for the claim language.
Claim 27 recites “an inflation aperture of the catheter that carries the proximal occlusive balloon.” The Examiner suggests amending this to recite “an inflation aperture of the second catheter that carries the proximal occlusive balloon.” This proposed amendment clarifies which catheter carries the proximal occlusive balloon to ensure that no ambiguity is present within the claims.
Appropriate correction is required.
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 30 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 29 recites:
A method for enhancing renal perfusion of a patient comprising:
placing an upstream occlusive balloon and a downstream impeller inside an inferior vena cava of the patient such that the downstream impeller is downstream of renal veins of the patient and the upstream occlusive balloon is upstream of the renal veins of the patient;
inflating the upstream occlusive balloon against the inferior vena cava; and
activating the downstream impeller to create a low-pressure zone;
deflating the upstream occlusive balloon while the downstream impeller remains activated; and
repeating the inflating and the deflating of the upstream occlusive balloon with the downstream impeller remains activated until achieving a target urine output.
Claim 30 recites:
The method of claim 29, repeating the inflating, the activating, and the deflating several times.
Claim 30 is rejected under 35 U.S.C. § 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention because Claim 29 recites that the downstream impeller remains activated until achieving a target urine output but Claim 30 recites repeating the activating [of the downstream impeller]. How can the downstream impeller remain activated in Claim 29 but then be repeatedly activated in Claim 30?
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 6 and 30 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 1 recites the following:
A method for enhancing renal perfusion of a patient comprising:
placing a proximal occlusion balloon and a distal impeller pump in an inferior vena cava of the patient;
inflating the proximal occlusion balloon;
activating the distal impeller pump so as to direct blood from kidneys of the patient and into the inferior vena cava in a downstream direction; thereafter deflating the proximal occlusion balloon; and
repeating the inflating, the activating, and the deflating until achieving a target urine output.
Claim 6 recites the following:
The method of claim 1, further comprising deflating the proximal occlusion balloon and subsequently reinflating the proximal occlusion balloon.
Claim 6 is rejected under 35 U.S.C. § 112(d) as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends. Claim 6 recites deflating the proximal occlusion balloon and subsequently reinflating the proximal occlusion balloon. However, Claim 1 already recites “repeating the inflating, the activating, and the deflating until achieving a target urine output.”
Claim 29 recites:
A method for enhancing renal perfusion of a patient comprising:
placing an upstream occlusive balloon and a downstream impeller inside an inferior vena cava of the patient such that the downstream impeller is downstream of renal veins of the patient and the upstream occlusive balloon is upstream of the renal veins of the patient;
inflating the upstream occlusive balloon against the inferior vena cava; and
activating the downstream impeller to create a low-pressure zone;
deflating the upstream occlusive balloon while the downstream impeller remains activated; and
repeating the inflating and the deflating of the upstream occlusive balloon with the downstream impeller remains activated until achieving a target urine output.
Claim 30 recites:
The method of claim 29, repeating the inflating, the activating, and the deflating several times.
Claim 30 is rejected under 35 U.S.C. § 112(d) as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends. Claim 30 recites repeating the inflating, the activating, and the deflating several times. However, Claim 29 already recites “repeating the inflating, the activating, and the deflating several times.”
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claim(s) 1 – 6, 22 – 26, and 29 – 31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schwammenthal et al. (US 2017/0100527 A1; hereinafter referred to as “Schwammenthal”) and Levin et al. (US 2017/0274190 A1; hereinafter referred to as “Levin”).
Schwammenthal is cited in the Notice of References Cited form dated 18 September 2025.
With regards to claim 1, Schwammenthal discloses (see Fig. 5A) a method for enhancing renal perfusion of a patient (see [0211] “Typically, by generating a region of low pressure, blood flow from the renal veins into the vena cava increases, thereby lowering renal blood pressure and enhancing renal perfusion”) comprising:
placing a proximal occlusion balloon (80) (see [0211]) and a distal impeller pump (24D) (see [0171]) in an inferior vena cava (22) (see [0170]) of the patient see [0216] “Although FIGS. 5A and 5B show the downstream blood pump and the occlusion element disposed on a catheter that is inserted into the vena cava from above the junctions of the vena cava with the subject's renal veins (e.g., via the subject's subclavian vein or jugular vein), for some applications, the downstream blood pump and the occlusion element are disposed on a catheter that is inserted into the vena cava from below the junctions of the vena cava with the subject's renal veins (e.g., via the subject's femoral vein), mutatis mutandis”);
inflating the proximal occlusion balloon (see [0215] “inflation of the balloon may be controllable”);
activating the distal impeller pump so as to direct blood from kidneys of the patient and into the inferior vena cava in a downstream direction (see [0197] “upstream and downstream pumps 24U and 24D are rotated at respective rotation rates, in order to cause the pumping of blood in the upstream and downstream directions to be performed at respective rates” and [0211] “For some applications, downstream pump is placed inside vena cava 22, downstream of the junctions of the vena cava with of the subject’s renal veins. The downstream pump pumps blood through the vena cava, in the downstream direction, away from the junctions of the vena cava with the renal veins, in the manner described hereinabove”); thereafter deflating the proximal occlusion balloon (see [0215] “inflation of the balloon may be controllable”); and
repeating the inflating, the activating, and the deflating (see [0215]);
However, Schwammenthal is silent with regards to:
repeating the inflating, the activating, and the deflating until achieving a target urine output.
Nonetheless Levin, which is within the analogous art of methods of apparatus to increase urine output (see abstract), teaches repeating the inflating, the activating, and the deflating until achieving a target urine output (see [0095] “a regiment can be proposed where the balloon is inflated for several minutes followed by several minutes of rest. These cycles will be repeated for several hours several times each day…achieve minimum additional urine output of 250 ml per day and preferably 500 ml per day. The high end of the therapeutic range may be 1,000 additional ml of urine per day…the device will require a pump component that is remotely programmable so that the therapy parameters can be adjusted using wireless communication,” [0098] “Duty cycle and frequency of inflation cycles in each therapy session,” and [0099] “Number and time of therapy sessions hourly, daily, or weekly”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the method of Schwammenthal in view of a teaching of Levin such that the method comprises repeating the inflating, the activating, and the deflating until achieving a target urine output. One of ordinary skill in the art would have been motivated to make this modification because Levin teaches that achieving the additional ml of urine per day improves the patient’s condition, allowing more exercise and preventing hospital admissions from fluid overload (see [0095] of Levin). Here, a person having ordinary skill in the art would recognize that repeating the inflating, activating, and deflating steps of the method of Schwammenthal in view of the teaching of Levin is beneficial because these steps generate a lower blood pressure region that would increase the blood flow from the renal veins into the vena cava thereby lowering renal blood pressure and enhancing renal perfusion (see [0092], [0096], and [0211] of Schwammenthal).
The method of Schwammenthal modified in view of Levin will hereinafter be referred to as the method of Schwammenthal and Levin.
With regards to claim 2, the method of Schwammenthal and Levin teaches the claimed invention of claim 1, and Schwammenthal further teaches placing the distal impeller pump (24D) within the inferior vena cava (22) downstream of a junction of the inferior vena cava and renal veins (42) (see [0175]) of the patient ([0211] “For some applications, downstream pump is placed inside vena cava 22, downstream of the junctions of the vena cava with of the subject’s renal veins. The downstream pump pumps blood through the vena cava, in the downstream direction, away from the junctions of the vena cava with the renal veins, in the manner described hereinabove”).
With regards to claim 3, the method of Schwammenthal and Levin teaches the claimed invention of claim 2, and Schwammenthal further teaches the method (see Fig. 5A) further comprising placing the proximal occlusion balloon (80) upstream of the junction of the inferior vena cava (22) and the renal veins (42) of the patient (see [0211] “As an alternative to, or in addition to using an upstream pump as described hereinabove, the occlusion element is placed inside the vena cava upstream of the junctions of the vena cava with the subject's renal veins”).
With regards to claim 4, the method of Schwammenthal and Levin teaches the claimed invention of claim 1, and Schwammenthal further teaches (see Fig. 5A) wherein the placing of the proximal occlusion balloon (80) and the distal impeller pump (24D) into the inferior vena cava (22) is performed with a single catheter (20) (see [0137] and [0211]).
With regards to claim 5, the method of Schwammenthal and Levin teaches the claimed invention of claim 1, and Schwammenthal further teaches (see Fig. 5A) wherein the placing of the proximal occlusion ballon (80) and the distal impeller pump (24D) into the inferior vena cava (22) is performed with first and second catheters, respectively (see [0216] “Alternatively or additionally, the occlusion element is disposed on a first catheter which is inserted into the vena cava from below the junctions of the vena cava with the subject's renal veins (e.g., via the subject's femoral vein), and the downstream blood pump is disposed on a second catheter, which inserted into the vena cava from above the junctions of the vena cava with the subject's renal veins (e.g., via the subject's subclavian vein, or jugular vein).”).
With regards to claim 6, the method of Schwammenthal and Levin teaches the claimed invention of claim 1, and Schwammenthal further teaches (see Fig. 5A) deflating the proximal occlusion balloon (80) and subsequently reinflating the proximal occlusion balloon (see [0211] and [0215] “For some applications, the diameter to which the occlusion element is expanded is controllable. For example, inflation of the balloon may be controllable…as well as the extent to which the occlusion element occludes the vena cava is controlled by a control unit responsively to the blood pressure” wherein this expansion control of the diameter of the occlusion element is the deflating and subsequent reinflating of the proximal occlusion balloon).
With regards to claim 22, Schwammenthal discloses (see Fig. 5A) a method for enhancing renal perfusion of a patient (see [0211] “Typically, by generating a region of low pressure, blood flow from the renal veins into the vena cava increases, thereby lowering renal blood pressure and enhancing renal perfusion”) comprising:
placing a proximal occlusive balloon (80) (see [0211]) and a distal impeller (24D) (see [0171]) inside an inferior vena cava (22) (see [0170]) of the patient such that the distal impeller is above a left renal vein and a right venal vein of the patient (42) (see [0175] and see reference numeral 42R and 42L in Figure 5A) and the proximal occlusive balloon is below the left renal vein and a right renal vein of the patient (see Fig. 5A, [0211], and [0216] “Although FIGS. 5A and 5B show the downstream blood pump and the occlusion element disposed on a catheter that is inserted into the vena cava from above the junctions of the vena cava with the subject's renal veins (e.g., via the subject's subclavian vein or jugular vein), for some applications, the downstream blood pump and the occlusion element are disposed on a catheter that is inserted into the vena cava from below the junctions of the vena cava with the subject's renal veins (e.g., via the subject's femoral vein), mutatis mutandis”);
inflating the proximal occlusive balloon (see [0215] “inflation of the balloon may be controllable”);
after inflating the proximal occlusive balloon, activating the distal impeller so as to direct blood from kidneys of the patient into the inferior vena cava (see [0197] “upstream and downstream pumps 24U and 24D are rotated at respective rotation rates, in order to cause the pumping of blood in the upstream and downstream directions to be performed at respective rates” and [0211] “For some applications, downstream pump is placed inside vena cava 22, downstream of the junctions of the vena cava with of the subject’s renal veins. The downstream pump pumps blood through the vena cava, in the downstream direction, away from the junctions of the vena cava with the renal veins, in the manner described hereinabove”);
thereafter deflating the proximal occlusive balloon (see [0215] “inflation of the balloon may be controllable”); and
repeating the inflating, the activating, and the deflating multiple times (see [0215]).
However, Schwammenthal is silent with regards to:
repeating the inflating, the activating, and the deflating multiple times until achieving a target urine output.
Nonetheless Levin, which is within the analogous art of methods of apparatus to increase urine output (see abstract), teaches repeating the inflating, the activating, and the deflating multiple times until achieving a target urine output (see [0095] “a regiment can be proposed where the balloon is inflated for several minutes followed by several minutes of rest. These cycles will be repeated for several hours several times each day…achieve minimum additional urine output of 250 ml per day and preferably 500 ml per day. The high end of the therapeutic range may be 1,000 additional ml of urine per day…the device will require a pump component that is remotely programmable so that the therapy parameters can be adjusted using wireless communication,” [0098] “Duty cycle and frequency of inflation cycles in each therapy session,” and [0099] “Number and time of therapy sessions hourly, daily, or weekly”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the method of Schwammenthal in view of a teaching of Levin such that the method comprises repeating the inflating, the activating, and the deflating multiple times until achieving a target urine output. One of ordinary skill in the art would have been motivated to make this modification because Levin teaches that achieving the additional ml of urine per day improves the patient’s condition, allowing more exercise and preventing hospital admissions from fluid overload (see [0095] of Levin). Here, a person having ordinary skill in the art would recognize that repeating the inflating, activating, and deflating steps of the method of Schwammenthal is beneficial because these steps generate a lower blood pressure region that would increase the blood flow from the renal veins into the vena cava thereby lowering renal blood pressure and enhancing renal perfusion (see [0092], [0096], and [0211] of Schwammenthal).
The method of Schwammenthal modified in view of Levin will hereinafter be referred to as the method of Schwammenthal and Levin.
With regards to claim 23, the method of Schwammenthal and Levin discloses the claimed invention of claim 22, and Schwammenthal further teaches (see Fig. 5A) placing the proximal occlusive balloon (80) and the distal impeller (24D) with a single catheter (20) (see [0137] and [0211]).
With regards to claim 24, the method of Schwammenthal and Levin discloses the claimed invention of claim 22, and Schwammenthal further teaches (see Fig. 5A) placing the distal impeller (24D) with a first catheter and placing the proximal occlusive balloon (80) with a second catheter (see [0216] “Alternatively or additionally, the occlusion element is disposed on a first catheter which is inserted into the vena cava from below the junctions of the vena cava with the subject's renal veins (e.g., via the subject's femoral vein), and the downstream blood pump is disposed on a second catheter, which inserted into the vena cava from above the junctions of the vena cava with the subject's renal veins (e.g., via the subject's subclavian vein, or jugular vein).”) (Here Schwammenthal’s first catheter is equivalent to the second catheter of the claim language and Schwammenthal’s second catheter is equivalent to the first catheter of the claim language).
With regards to claim 25, the method of Schwammenthal and Levin discloses the claimed invention of claim 24, and Schwammenthal further teaches (see Fig. 5A) wherein the proximal occlusive balloon (80) is disposed at a distal end of the second catheter (see Fig. 4 and the location of the shown upstream pump 24U wherein the occlusion element 80 would be located at this location, [0012] “For some applications, the upstream pump, or the occlusion element is disposed on a first catheter,” [0209], [0216] “Alternatively or additionally, the occlusion element is disposed on a first catheter which is inserted into the vena cava from below the junctions of the vena cava with the subject's renal veins (e.g., via the subject's femoral vein)”) (Here Schwammenthal’s first catheter is equivalent to the second catheter of the claim language and Schwammenthal’s second catheter is equivalent to the first catheter of the claim language).
With regards to claim 26, the method of Schwammenthal and Levin discloses the claimed invention of claim 25, and Schwammenthal further teaches (see Fig. 5A) wherein the distal impeller (24D) is disposed at a distal end of the first catheter (see Fig. 4, [0209], and [0216] “the downstream blood pump is disposed on a second catheter, which inserted into the vena cava from above the junctions of the vena cava with the subject's renal veins (e.g., via the subject's subclavian vein, or jugular vein).”) (Here Schwammenthal’s first catheter is equivalent to the second catheter of the claim language and Schwammenthal’s second catheter is equivalent to the first catheter of the claim language).
With regards to claim 29, Schwammenthal discloses (see Fig. 5A) a method for enhancing renal perfusion of a patient (see [0211] “Typically, by generating a region of low pressure, blood flow from the renal veins into the vena cava increases, thereby lowering renal blood pressure and enhancing renal perfusion”) comprising:
placing an upstream occlusive balloon (80) (see [0211]) and a downstream impeller (24D) (see [0171]) inside an inferior vena cava (22) (see [0170]) of the patient such that the downstream impeller is downstream of renal veins of the patient (see [0211] “For some applications, downstream pump is placed inside vena cava 22, downstream of the junctions of the vena cava with of the subject’s renal veins. The downstream pump pumps blood through the vena cava, in the downstream direction, away from the junctions of the vena cava with the renal veins, in the manner described hereinabove,” [0216], and Fig. 5A) and the upstream occlusive balloon is upstream of the renal veins of the patient (see [0211] “As an alternative to, or in addition to using an upstream pump as described hereinabove, the occlusion element is placed inside the vena cava upstream of the junctions of the vena cava with the subject's renal veins,” [0216] and Fig. 5A);
inflating the upstream occlusive balloon against the inferior vena cava (see [0215] “inflation of the balloon may be controllable”); and
activating the downstream impeller to create a low-pressure zone (see [0197] “upstream and downstream pumps 24U and 24D are rotated at respective rotation rates, in order to cause the pumping of blood in the upstream and downstream directions to be performed at respective rates” and [0211] “For some applications, downstream pump is placed inside vena cava 22, downstream of the junctions of the vena cava with of the subject’s renal veins. The downstream pump pumps blood through the vena cava, in the downstream direction, away from the junctions of the vena cava with the renal veins, in the manner described hereinabove…The occlusion element is configured to partially occlude the subject's vena cava such that, in response to the pumping of the downstream blood pump, there is not a substantial increase of blood flow from the subject's lower body toward the subject heart, but such that a region of low pressure within the vena cava is generated, between the occlusion element and the downstream blood pump, within which the blood pressure is lower than the subject's central venous pressure.”);
deflating the upstream occlusive balloon while the downstream impeller remains activated (see [0211] “The occlusion element is configured to partially occlude the subject's vena cava such that, in response to the pumping of the downstream blood pump, there is not a substantial increase of blood flow from the subject's lower body toward the subject heart, but such that a region of low pressure within the vena cava is generated, between the occlusion element and the downstream blood pump, within which the blood pressure is lower than the subject's central venous pressure” and [0215] “For some applications, the diameter to which the occlusion element is expanded is controllable. For example, inflation of the balloon may be controllable…as well as the extent to which the occlusion element occludes the vena cava is controlled by a control unit responsively to the blood pressure”); and
repeating the inflating and the deflating of the upstream occlusive balloon with the downstream impeller remains activated (see [0211] and [0215]).
However Schwammenthal is silent with regards to repeating the inflating and deflating of the upstream occlusive balloon with the downstream impeller remains activated until achieving a target urine output.
Nonetheless Levin, which is within the analogous art of methods of apparatus to increase urine output (see abstract), teaches repeating the inflating and deflating of the upstream occlusive balloon with the downstream impeller remains activated until achieving a target urine output (see [0095] “a regiment can be proposed where the balloon is inflated for several minutes followed by several minutes of rest. These cycles will be repeated for several hours several times each day…achieve minimum additional urine output of 250 ml per day and preferably 500 ml per day. The high end of the therapeutic range may be 1,000 additional ml of urine per day…the device will require a pump component that is remotely programmable so that the therapy parameters can be adjusted using wireless communication,” [0098] “Duty cycle and frequency of inflation cycles in each therapy session,” and [0099] “Number and time of therapy sessions hourly, daily, or weekly”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the method of Schwammenthal in view of a teaching of Levin such that the method comprises repeating the inflating and deflating of the upstream occlusive balloon with the downstream impeller remains activated until achieving a target urine output. One of ordinary skill in the art would have been motivated to make this modification because Levin teaches that achieving the additional ml of urine per day improves the patient’s condition, allowing more exercise and preventing hospital admissions from fluid overload (see [0095] of Levin). Here, a person having ordinary skill in the art would recognize that repeating the inflating and deflating steps of the method with the downstream impeller remaining activated of Schwammenthal is beneficial because these steps generate a lower blood pressure region that would increase the blood flow from the renal veins into the vena cava thereby lowering renal blood pressure and enhancing renal perfusion (see [0092], [0096], and [0211] of Schwammenthal).
The method of Schwammenthal modified in view of Levin will hereinafter be referred to as the method of Schwammenthal and Levin.
With regards to claim 30, the method of Schwammenthal and Levin teaches the claimed invention of claim 29, and Schwammenthal further teaches (see Fig. 5A) repeating the inflating, the activating, and the deflating several times (see [0211] and [0215] wherein the described controlling of the inflation of the balloon is the repeated inflating and deflating steps and the controlling of the rate at which pump 24D pumps blood away from the renal veins is the repeated activating step).
With regards to claim 31, the method of Schwammenthal and Levin teaches the claimed invention of claim 29, and Schwammenthal further teaches (see Fig. 5A) wherein the downstream impeller (24D) (see [0185]) is a bladed rotor (see [0185] “each of upstream and downstream pumps 24U and 24D includes an impeller 28…impeller 28 may have a single blade, two blades…three blades…or more than three blades”)..
Claim(s) 19, 20, and 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schwammenthal and Levin as applied to claims 4 and 26 above, and further in view of Collins (US 2008/0221553 A1).
Collins is previously cited in the Notice of References Cited form dated 18 September 2025.
With regards to claim 19, the method of Schwammenthal and Levin teaches the claimed invention of claim 4, however, Schwammenthal is silent with regards to wherein inflating the proximal occlusion balloon comprises introducing fluid through an inflation aperture in fluid communication with an inflation lumen of the single catheter, the inflation lumen extending to an interior of the proximal occlusion balloon.
Nonetheless Collins, which is within the analogous art of occlusion/infusion catheters (see abstract), teaches (Figs. 1 – 2) wherein inflating the proximal occlusion balloon (14) (see [0014]) comprises introducing fluid through an inflation aperture (32) (see [0021]) in fluid communication with an inflation lumen (24) (see [0021]) of the single catheter (22) (see [0020]), the inflation lumen extending to an interior (see at 32 in Fig .2) of the proximal occlusion balloon (see Fig. 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the proximal occlusion balloon of the method of Schwammenthal and Levin in view of a teaching of Collins such that inflating the proximal occlusion balloon comprises introducing fluid through an inflation aperture in fluid communication with an inflation lumen of the single catheter, the inflation lumen extending to an interior of the proximal occlusion balloon. One of ordinary skill in the art would have been motivated to make this modification because Schwammenthal teaches that the balloon inflation may be controllable (see [0215] of Schwammenthal). However, Schwammenthal is silent with regards to how this inflation occurs. Collins rectifies this deficiency by teaching how an occlusion balloon inflates (see [0021] of Collins). Furthermore, Collins teaches this inflation lumen and aperture as a means for immediately and rapidly perfusing one or more critical organs (see [0003], [0021] of Collins).
The method of Schwammenthal and Levin modified in view of a teaching of Collins will hereinafter be referred to as the method of Schwammenthal, Levin, and Collins.
With regards to claim 20, the method of Schwammenthal, Levin, and Collins teaches the claimed invention of claim 19, however, Schwammenthal is silent with regards to wherein the inflation lumen is connected to an inflation pump through a connector hub opening of the single catheter that is positioned proximally to the proximal occlusion balloon and distally to a catheter hub of the single catheter.
Nonetheless Collins, which is within the analogous art of occlusion/infusion catheters (see abstract), teaches (Figs. 1 – 2) wherein the inflation lumen (24) (see [0021]) is connected to an inflation pump (16) (see [0017]) through a connector hub opening (see Examiner annotated Fig. 1 below hereinafter referred to as “Fig. A”) of the single catheter (10) (see [0016]) that is positioned proximally to the proximal occlusion balloon and distally to a catheter hub (see Fig. A below) of the single catheter (see Fig. A below wherein the inflation lumen 24 is positioned proximally to the proximal occlusion balloon 14 and distally to a catheter hub along the single catheter).
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the method of Schwammenthal, Levin, and Collins in view of a further teaching of Collins such the inflation lumen is connected to an inflation pump through a connector hub opening of the single catheter that is positioned proximally to the proximal occlusion balloon and distally to a catheter hub of the single catheter. One of ordinary skill in the art would have been motivated to make this modification because Collins further teaches that the inflation lumen and inflation pump provides for immediate and rapid perfusion of one or more critical organs (see [0003], [0021] of Collins).
With regards to claim 27, the method of Schwammenthal and Levin teaches the claimed invention of claim 26, however, Schwammenthal is silent with regards to wherein the inflating comprises introducing fluid into the proximal occlusive balloon through an inflation aperture of the catheter that carries the proximal occlusive balloon.
Nonetheless Collins, which is within the analogous art of occlusion/infusion catheters (see abstract), teaches (Figs. 1 – 2) the inflating comprises introducing fluid into the proximal occlusive balloon (14) (see [0014]) through an inflation aperture (32)(see [0021]) of the catheter (10) (see [0012]) that carries the proximal occlusive balloon.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the second catheter of the method of Schwammenthal and Levin in view of a teaching of Collins such that the inflating comprises introducing fluid into the proximal occlusive balloon through an inflation aperture of the second catheter. One of ordinary skill in the art would have been motivated to make this modification because Schwammenthal teaches that the balloon inflation may be controllable (see [0215] of Schwammenthal). However, Schwammenthal is silent with regards to how this inflation occurs. Collins rectifies this deficiency by teaching how an occlusion balloon inflates (see [0021] of Collins). Furthermore, Collins teaches this inflation lumen and aperture as a means for immediately and rapidly perfusing one or more critical organs (see [0003], [0021] of Collins).
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schwammenthal and Levin as applied to claim 4 above, and further in view of Nitzan et al. (US 2020/0397963 A1; hereinafter referred to as “Nitzan ’963).
Nitzan ’963 is cited in the Notice of References Cited form dated 18 September 2025.
With regards to claim 21, the method of Schwammenthal, Levin, and Collins teaches the claimed invention of claim 4, however, Schwammenthal is silent with regards to wherein the placing includes advancing the proximal occlusion balloon and the distal impeller pump over a guidewire inserted in the inferior vena cava of the patient.
Nonetheless Nitzan ’963, which is within the analogous art of intravascular catheters (see abstract), teaches the placing includes advancing the proximal occlusion balloon (163) (see [0032] and [0047]) and the distal impeller pump (143) (see [0036]) over a guidewire (177) (see [0031]) inserted in the inferior vena cava of the patient (see [0003], [0012], [0013], [0044], [0046], [0048], and [0051] wherein the disclosed placement of the guidewire into the vasculature of the patient includes the inferior vena cava because the inferior vena cava is an example of a portion of the vasculature of the patient).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the method of Schwammenthal and Levin in view of a teaching of Nitzan ’963 such that the step of placing includes advancing the proximal occlusion balloon and the distal impeller pump over a guidewire inserted in the inferior vena cava of the patient. One of ordinary skill in the art would have been motivated to make this modification because Nitzan ’963 teaches that the guidewire assists with the delivery of the intravascular catheter oriented correctly, at the desired location of the patient, and in the proper position (see Abstract, [0013], and [0018] of Nitzan ’963).
Claim(s) 32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schwammenthal and Levin as applied to claim 29 above, and further in view of Mills (US 2008/0249454 A1).
Mills is cited in the Notice of References Cited form dated 18 September 2025.
With regards to claim 32, the method of Schwammenthal, Levin, and Collins teaches the claimed invention of claim 29, however, Schwammenthal is silent with regards to further comprising applying continuous pressure to a patient’s leg.
Nonetheless Mills, which is within the analogous art of compression socks (see abstract), teaches further comprising applying continuous pressure to a patient's leg (see Abstract, [0001, [0003], [0020]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the method of Schwammenthal and Levin in view of a teaching of Mills such that the method further comprises applying continuous pressure to a patient's leg. One of ordinary skill in the art would have been motivated to make this modification because Mills teaches that applying continuous pressure to a patient’s leg benefits the circulation for individuals having compromised circulation (see abstract of Mills). Furthermore, Mills teaches that it is well known for compression stockings to benefit wearers by improving venous blood flow from the foot and lower leg regions back to the heart (see [0001], [0003], and [0020] of Mills).
Claim(s) 22 and 24 – 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nitzan et al. (US 2018/0126130 A1; hereinafter referred to as “Nitzan ’130”), Schwammenthal, and Levin.
Nitzan ’130 is cited in the Notice of References Cited form dated 18 September 2025.
With regards to claim 22, Nitzan ’130 discloses (see Figs. 7 – 10B) a method for enhancing renal perfusion of a patient (see Abstract, [0005] – [0008]) comprising:
placing a proximal occlusive balloon (714) (see [0155]) and a distal impeller (715) (see [0159]) inside a vein (see [0155]);
inflating the proximal occlusive balloon (see [0156]);
after inflating the proximal occlusive balloon, activating the distal impeller so as to direct blood from kidneys of the patient into the vein (see [0159], [0160] and [0169]);
thereafter deflating the proximal occlusive balloon (see [0153]).
However Nitzan ’130 is silent with regards to placing the proximal occlusive balloon and a distal impeller inside an inferior vena cava of the patient such that the distal impeller is above a left renal vein and a right venal vein of the patient and the proximal occlusive balloon is below the left renal vein and a right renal vein of the patient;
activating the distal impeller so as to direct blood from kidneys of the patient into the inferior vena cava; and
repeating the inflating, the activating, and the deflating multiple times until achieving a target urine output amount.
Nonetheless Schwammenthal, which is within the analogous art of blood pumps (see abstract), teaches the following:
placing the proximal occlusive balloon (80) (see [0211]) and a distal impeller (24D) (see [0171]) inside an inferior vena cava (22) (see [0170]) of the patient such that the distal impeller is above a left renal vein and a right venal vein of the patient (42) (see [0175] and see reference numeral 42R and 42L in Figure 5A) and the proximal occlusive balloon is below the left renal vein and a right renal vein of the patient (see Fig. 5A, [0211], and [0216] “Although FIGS. 5A and 5B show the downstream blood pump and the occlusion element disposed on a catheter that is inserted into the vena cava from above the junctions of the vena cava with the subject's renal veins (e.g., via the subject's subclavian vein or jugular vein), for some applications, the downstream blood pump and the occlusion element are disposed on a catheter that is inserted into the vena cava from below the junctions of the vena cava with the subject's renal veins (e.g., via the subject's femoral vein), mutatis mutandis”);
activating the distal impeller so as to direct blood from kidneys of the patient into the inferior vena cava (see [0197] “upstream and downstream pumps 24U and 24D are rotated at respective rotation rates, in order to cause the pumping of blood in the upstream and downstream directions to be performed at respective rates” and [0211] “For some applications, downstream pump is placed inside vena cava 22, downstream of the junctions of the vena cava with of the subject’s renal veins. The downstream pump pumps blood through the vena cava, in the downstream direction, away from the junctions of the vena cava with the renal veins, in the manner described hereinabove”); and
repeating the inflating, the activating, and the deflating multiple times (see [0211] and [0215]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the vein in which the proximal occlusive balloon and distal impeller of the method of Nitzan ’130 are placed within in view of a teaching of Schwammenthal such that the method comprises placing the proximal occlusive balloon and a distal impeller inside an inferior vena cava of the patient such that the distal impeller is above a left renal vein and a right venal vein of the patient and the proximal occlusive balloon is below the left renal vein and a right renal vein of the patient; activating the distal impeller so as to direct blood from kidneys of the patient into the inferior vena cava; and repeating the inflating, the activating, and the deflating multiple times. One of ordinary skill in the art would have been motivated to make this modification because Schwammenthal teaches that this placement generates a region of low pressure, blood flow from the renal veins into the vena cava increase, thereby lowering renal blood pressure and enhancing renal perfusion (see [0211] of Schwammenthal).
The method of Nitzan ’130 modified in view of a teaching of Schwammenthal will hereinafter be referred to as the teaching of the method of Nitzan ’130 and Schwammenthal.
However neither Nitzan ’130 nor Schwammenthal teach repeating the inflating, the activating, and the deflating multiple times until achieving a target urine output amount.
Nonetheless Levin, which is within the analogous art of methods of apparatus to increase urine output (see abstract), teaches repeating the inflating, the activating, and the deflating multiple times until achieving a target urine output (see [0095] “a regiment can be proposed where the balloon is inflated for several minutes followed by several minutes of rest. These cycles will be repeated for several hours several times each day…achieve minimum additional urine output of 250 ml per day and preferably 500 ml per day. The high end of the therapeutic range may be 1,000 additional ml of urine per day…the device will require a pump component that is remotely programmable so that the therapy parameters can be adjusted using wireless communication,” [0098] “Duty cycle and frequency of inflation cycles in each therapy session,” and [0099] “Number and time of therapy sessions hourly, daily, or weekly”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the method of Nitzan ’130 and Schwammenthal in view of a teaching of Levin such that the method comprises repeating the inflating, the activating, and the deflating multiple times until achieving a target urine output. One of ordinary skill in the art would have been motivated to make this modification because Levin teaches that achieving the additional ml of urine per day improves the patient’s condition, allowing more exercise and preventing hospital admissions from fluid overload (see [0095] of Levin). Here, a person having ordinary skill in the art would recognize that repeating the inflating, activating, and deflating steps of the method of Schwammenthal is beneficial because these steps generate a lower blood pressure region that would increase the blood flow from the renal veins into the vena cava thereby lowering renal blood pressure and enhancing renal perfusion (see [0092], [0096], and [0211] of Schwammenthal).
The method of Nitzan ’130 and Schwammenthal modified in view of Levin will hereinafter be referred to as the method of Nitzan ’130, Schwammenthal, and Levin.
With regards to claim 24, the method of Nitzan ’130, Schwammenthal, and Levin teaches the claimed invention of claim 22, and Nitzan ’130 further teaches placing the distal impeller (715) (see [0159] and see Fig. 8) with a first catheter (702) (see [0155]) and placing the proximal occlusive balloon (714) (see [0155]) with a second catheter (720) (see [0158] and Fig. 8).
With regards to claim 25, the method of Nitzan ’130, Schwammenthal, and Levin teaches the claimed invention of claim 24, and Nitzan ’130 further teaches wherein the proximal occlusive balloon (714) (see [0155]) is disposed at a distal end of the second catheter (720) (see [0158] and Fig. 8).
With regards to claim 26, the method of Nitzan ’130, Schwammenthal, and Levin teaches the claimed invention of claim 25, and Nitzan ’130 further teaches wherein the distal impeller (715) (see [0159] and Figures 8 – 9A) is disposed at a distal end of the first catheter (702) (see [0155] and [0158]).
With regards to claim 27, the method of Nitzan ’130, Schwammenthal, and Levin teaches the claimed invention of claim 26, and Nitzan ’130 further teaches wherein the inflating comprises introducing fluid into the proximal occlusive balloon (714) through an inflation aperture (742) of the catheter (720) (see [0166] and Fig. 10B) that carries the proximal occlusive balloon.
Claim(s) 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nitzan ’130, Schwammenthal, and Levin as applied to claim 27 above, and further in view of Jang et al. (US 2006/0041304 A1; hereinafter referred to as “Jang”).
Jang is cited in the Notice of References Cited form dated 18 September 2025.
With regards to claim 28, the method of Nitzan ’130, Schwammenthal, and Levin teaches the claimed invention of claim 27, however, Nitzan ’130 is silent with regards to wherein the placing includes advancing at least one of the first catheter and the second catheter over a guidewire extending into inferior vena cava and advancing the other catheter into the inferior vena cava to position the catheters alongside each other within the inferior vena cava.
Nonetheless Jang, which is within the analogous art of catheter systems (see abstract), teaches (see Figs. 2 – 4A) the placing includes advancing at least one of the first catheter and the second catheter (30) over a guidewire (10) (see [0036]) extending into inferior vena cava (100) (see [0008], [0036], and Figures 2 – 3) and advancing the other catheter (20) (see [0037]) into the inferior vena cava to position the catheters alongside each other within the inferior vena cava (see Fig. 4a).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the method of Nitzan ’130, Schwammenthal, and Levin in view of a teaching of Jang such that the placing includes advancing at least one of the first catheter and the second catheter over a guidewire extending into inferior vena cava and advancing the other catheter into the inferior vena cava to position the catheters alongside each other within the inferior vena cava. One of ordinary skill in the art would have been motivated to make this modification because Jang teaches that this configuration allows for the proper placement and positioning of the components of the device (see [0012] of Jang). Furthermore, one of ordinary skill in the art would have been motivated to make this modification because guidewires improve the navigation of the device through the tortuous vasculature.
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.
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/ROBERT F ALLEN/Examiner, Art Unit 3783
/WILLIAM R CARPENTER/Primary Examiner, Art Unit 3783
05/04/2026
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