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 Arguments
Applicant’s arguments, see “Applicant Argument/Remarks”, filed 03/02/2026, with respect to the rejections under U.S.C. 112(b) have been fully considered and are persuasive. The rejections under U.S.C. 112(b) have been withdrawn.
Applicant’s arguments, see “Applicant Argument/Remarks”, filed 03/02/2026, with respect to the rejections under U.S.C. 102 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made under U.S.C. 103 in view of Liotta and Han.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-5, 7, 12-16, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication 20040054251 awarded to Liotta, hereinafter Liotta, as applied to the claims above, and further in view of U.S. Patent Publication 20250229077 awarded to Han et al, hereinafter Han.
Regarding Claims 1 and 13, Liotta teaches a system and method of implanting a device into a heart of a mammal (abstract), comprising: inserting a fluid conduit (receptacle 4, Para. 0072, “a receptacle (housing) (4) provided with an inlet (3) and an outlet (5) having means for connecting to the heart cavity and to the vessel (7)”) having an inflow portion (inlet 3) and an outflow portion (outlet 5) into a cardiovascular system of the mammal (abstract, Fig. 2), wherein the inflow portion is located within an atrium of the heart of the mammal and the outflow portion is located within an aorta of the cardiovascular system of the mammal (Fig. 2, abstract, “The pump inflow (3) is connected to the left atrium and the pump outflow to the descending thoracic aorta (5,7)”), and the fluid conduit passing from the atrium into the aorta (Fig. 2). Liotta does not teach providing the outflow portion with a flow-directing hood having an extending side directed toward a center of a longitudinal axis of the fluid conduit as the extending side extends longitudinally over a resulting orifice that is along an opposing side of the flow-directing hood and is not formed in the transverse plane to the longitudinal axis at terminus of the fluid conduit.
However, in the art of heart pumps (abstract), Han teaches an outflow portion (outlet portion 54 with guide vane structure 56, Fig. 3), having an extending side directed toward a center of a longitudinal axis of the fluid conduit as the extending side extends longitudinally over a resulting orifice that is along an opposing side of the flow-directing hood and is not formed in the transverse plane to the longitudinal axis at terminus of the fluid conduit (Fig. 3) to improve blood outflow and reducing the damage to the blood itself (Para. 0051).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Liotta by Han i.e. by using the outflow portion of Han in the system of Liotta, for the predictable purpose of improving blood outflow and reducing the damage to the blood itself.
Regarding Claims 2 and 14, Liotta modified by Han makes obvious the inventions above. Liotta further teaches wherein the atrium is a left atrium (abstract, “The pump inflow (3) is connected to the left atrium and the pump outflow to the descending thoracic aorta (5,7)”).
Regarding Claim 3, Liotta modified by Han makes obvious the inventions above. Liotta further teaches wherein the atrium is a left atrium and the outflow portion is into a descending portion of the aorta (abstract, “The pump inflow (3) is connected to the left atrium and the pump outflow to the descending thoracic aorta (5,7)”).
Regarding Claim 4, Liotta modified by Han makes obvious the inventions above. Liotta further teaches wherein the outflow portion includes a diffuser (Para. 0095, “Within each pneumatic variable chamber (11) a pneumatic diffuser (9) may be included, consisting of a plate which, having a plurality of holes (26), is interposed between the connection with the pulsating pneumatic auxiliary unit (8) and the circulation variable chamber (12)”).
Regarding Claims 5 and 18, Liotta modified by Han makes obvious the inventions above. Liotta further teaches wherein the fluid conduit includes a cage/structure to prevent contact of a body of the fluid conduit with a wall of the atrium (atrial prosthesis 1, Para. 0041, “Then, without removing the catheter-balloon, the surgeon sutures the atrial prosthesis to the upper end of the special designed blood inflow pump's connector. Reference 23 designates the titanium ring which is incorporated to the base of the atrial prosthesis to maintain the atriostomy area for an undetermined period of time”) to minimize thrombus formation and ingestion of thrombus into the pump (The Examiner notes that this limitation is an inherent method effect, i.e. that the anti-thrombolytic effect is tied entirely to the inlet conduit not touching the atrium. As Liotta teaches that limitation, it inherently teaches the anti-thrombolytic effect. Where a reference discloses the terms of the recited method steps, and such steps necessarily result in the desired and recited effect, that the reference does not describe the recited effect in haec verba is of no significance as the reference meets the claim under the doctrine of inherency. Ex Parte Novitski, 26 USPQ2d 1389, 1390-91 (BdPatApp & Inter 1993).
Regarding Claim 7, Liotta modified by Han makes obvious the inventions above. Liotta further teaches wherein the fluid conduit is configured to supply a flow of fluid from the outflow portion having a velocity of less than 3.0 m/s (Para. 0025, “it may maintain the unidirectional mechanical circulation of blood by means of the introduction of two valves into the pump system and in that the assembly develops parameters which may be homologized with relation to normal circulation in what concerns to blood flow and pressure in the patient's circulatory system and for an extended period of time” The Examiner notes that blood flow in the aorta is 0.4 m/s, see https://biologyinsights.com/how-fast-does-blood-travel-through-the-body/).
Regarding Claim 12, Liotta modified by Han makes obvious the inventions above. Liotta further teaches the method of claim 1, wherein the fluid conduit includes a pump (abstract).
Regarding Claim 15, Liotta modified by Han makes obvious the inventions above. Liotta further teaches wherein the controller regulates rate of blood flow through the conduit from the atrium to the aorta or fluid velocity through the conduit from the atrium to the aorta (Para. 0025, “The implantable device for mechanical circulation of blood and assistance to heart ventricles uses a blood circulation pump, and is characterized in that, being driven by the pneumatic source of power produced by an external system (driver), it may maintain the unidirectional mechanical circulation of blood by means of the introduction of two valves into the pump system and in that the assembly develops parameters which may be homologized with relation to normal circulation in what concerns to blood flow and pressure in the patient's circulatory system and for an extended period of time”).
Regarding Claim 16, Liotta modified by Han makes obvious the inventions above. Liotta further teaches wherein the aorta outflow portion includes a diffuser (Para. 0095, “Within each pneumatic variable chamber (11) a pneumatic diffuser (9) may be included, consisting of a plate which, having a plurality of holes (26), is interposed between the connection with the pulsating pneumatic auxiliary unit (8) and the circulation variable chamber (12)”).
Claims 6, 8, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication 20040054251 awarded to Liotta, hereinafter Liotta, as applied to the claims above, and further in view of U.S. Patent Publication 20250229077 awarded to Han et al, hereinafter Han, and further in view of U.S. Patent 5112200 awarded to Isaacson, hereinafter Isaacson.
Regarding Claims 6 and 19, Liotta modified by Han makes obvious the inventions above. Liotta does not teach wherein the fluid conduit is configured to supply a helical flow of fluid from the outflow portion.
However, in the art of cardiac device (abstract), Isaacson teaches wherein supplying the outflow portion with a helical flow of fluid (Col. 4, Lines 24-29, “The shear stress in the gap 60 is about 1900 dynes per square centimeter, and the shear stress in the gap 61 is about 2200 dynes per square centimeter. The rotor surface forming the gaps 60 and 61 may have helical ribs to promote the flow of blood in an axial direction) to minimize cell damage by keeping the shear stress lowered (Col. 2, Lines 40-46, “In order to minimize cell damage in the gap, shear stress should be maintained below 2500 dynes per square centimeter and residence time of cells in the gap should be below 0.1 second. However, the gap size must be kept low to minimize violent eccentric motion of the rotor with respect to the stator”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Liotta by Isaacson, i.e. by using the outflow portion of Isaacson in the system of Liotta, for the predictable purpose of improving device safety by maintaining a low shear stress as set forth in Isaacson above.
Regarding Claim 8, Liotta modified by Han makes obvious the method of Claim 1. Liotta does not teach wherein the fluid conduit is configured to supply a flow of fluid from the outflow portion having a wall shear stress of less than 4500 dynes/cm2.
However, Isaacson teaches wherein the fluid conduit is configured to supply a flow of fluid from the outflow portion having a wall shear stress of less than 4500 dynes/cm2 to minimize cell damage (Col. 2, Lines 40-46, “In order to minimize cell damage in the gap, shear stress should be maintained below 2500 dynes per square centimeter and residence time of cells in the gap should be below 0.1 second. However, the gap size must be kept low to minimize violent eccentric motion of the rotor with respect to the stator”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Liotta by Isaacson, i.e. maintaining the shear stress below 4500 dynes/cm2 in the system of Liotta as in Isaacson, for the predictable purpose of improving device safety by maintaining a low shear stress as set forth in Isaacson above.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication 20040054251 awarded to Liotta, hereinafter Liotta, as applied to claims above, and further in view of U.S. Patent Publication 20250229077 awarded to Han et al, hereinafter Han, and further in view of U.S. Patent Publication 20060167334 awarded to Anstadt et al, hereinafter Anstadt.
Regarding Claim 9, Liotta modified by Han makes obvious the method of Claim 1. Liotta does not teach wherein the atrium is a left atrium and further comprising maintaining pressure in the left atrium between 18 and 25 mm Hg to assist the mammal with HFpEF, but does teach control systems to maintain blood parameters at healthy levels (Para. 0025).
However, in the art of cardiac devices (abstract), Anstadt teaches maintaining a pressure of 20 mm Hg (Para. 0427, “Referring to FIG. 5B and FIG. 2C, method or algorithm 930 begins at the initiation of systole with step 932, wherein delivery of drive fluid into cavity 119 of DMVA device 100 begins, at a delivery pressure of 20 mm Hg as needed to safely treat someone with systolic heart failure (Para. 0006, “Specifically, DCC techniques only substantially improve the systolic function of hearts in moderate to severe heart failure… This better explains why DCC techniques require substantial degrees of LV and RV loading (i.e. increased left and right atrial pressure or "preload") to be effective, as such increases serve to augment ventricular filling”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Liotta by Anstadt, i.e. by maintaining a pressure of 20 mm Hg, for the predictable purpose of maintaining proper heart health/blood flow as set forth in both Liotta and Anstadt.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication 20040054251 awarded to Liotta, hereinafter Liotta, as applied to claims above, further in view of U.S. Patent Publication 20250229077 awarded to Han et al, hereinafter Han, and further in view of U.S. Patent Publication 20060167334 awarded to Anstadt et al, hereinafter Anstadt.
Regarding Claim 10, Liotta modified by Han makes obvious the method of Claim 1. Liotta does not teach wherein the atrium is a left atrium and further comprising reducing pressure in the left atrium to between 10 and 15 mm Hg to assist the mammal with HFrEF, but does teach control systems to maintain blood parameters at healthy levels (Para. 0025).
However, in the art of cardiac devices (abstract), Keren teaches wherein the atrium is a left atrium and further comprising reducing pressure in the left atrium to between 10 and 15 mm Hg to maintain healthy pressure (Para. 0035, “Thus for example, a chronic device can be a preventive device where when pressures rise for some reason to dangerous levels the pump goes into action and helps to lower the pressure in the left ventricle, thereby preventing the acute development of dyspnea and pulmonary edema and assures that the LVDP are always at an optimal level of no more than 15 mmHg”). The Examiner notes that this level specifically helping someone with HFrEF is an inherent method effect of maintaining the pressure between 10-15 mm Hg. Where a reference discloses the terms of the recited method steps, and such steps necessarily result in the desired and recited effect, that the reference does not describe the recited effect in haec verba is of no significance as the reference meets the claim under the doctrine of inherency. Ex Parte Novitski, 26 USPQ2d 1389, 1390-91 (BdPatApp & Inter 1993).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Liotta by Keren, i.e. by maintaining a pressure of no more than 15 mm Hg, for the predictable purpose of maintaining proper heart health/blood flow as set forth in both Liotta and Keren.
Claims 11 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication 20040054251 awarded to Liotta, hereinafter Liotta, as applied to the claims above, further in view of U.S. Patent Publication 20250229077 awarded to Han et al, hereinafter Han, and further in view of U.S. Patent Publication 20190105435 awarded to Asirvatham et al, hereinafter Asirvatham.
Regarding Claims 11 and 20, Liotta modified by Han makes obvious the inventions above. Liotta does not teach wherein there comprises a pressure sensor coupled to the atrium inflow portion, wherein the pressure sensor is configured to provide a pressure measurement signal in the atrium as feedback to the controller.
However, Asirvatham teaches the usage of a pressure sensor in the left atria to provide a pressure signal back to a feedback controller (Para. 0034, “In some cases, a pressure sensor can be connected to an assist device. Sensing and pressure electrodes can permit real-time, online calculation of variations in heart rates and relative systolic and diastolic filling times to determine an algorithm that incorporates the timing of atrial signals at two different sites (e.g., to provide inter-atrial and intra-ventricular conduction times) and the pressure signals to assess electromechanical translation times”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Liotta by Asirvatham, i.e. by using a pressure sensor to monitor and modulate the feedback as in Asirvatham, for the predictable purpose of improving the device of Liotta as in the device of Asirvatham.
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 Jess Mullins whose telephone number is (571)-272-8977. The examiner can normally be reached between the hours of 9:00 a.m. to 5:00 p.m. PST M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Unsu Jung, can be reached at (571)-272-8506. The fax number for the organization where this application or proceeding is assigned is (571)-273-8300.
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/JLM/
Examiner, Art Unit 3792
/UNSU JUNG/Supervisory Patent Examiner, Art Unit 3792