DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Status: Claims 1-25 are pending; Claims 19-25 have been withdrawn from consideration directed to non-elected invention and species.
Election/Restrictions
Applicant’s election without traverse of Invention I, Species Y in Species Group I, and Species A in Species Group II in the reply filed on November 11, 2025 is acknowledged. Applicant has withdrawn claims 19-23, and 25 in response to the restriction requirement.
Claim 24 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species H, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on November 11, 2025.
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.
Claims 2, 3, and 5 are 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.
Re Claim 2, the limitation “the driveline wall” is indefinite, because it lacks antecedent basis.
Re Claim 3 and 5, the limitation “the first driveline pressure sensing element” is indefinite, because it is unclear whether it is referring to “a first driveline sensing element” in claim 1 or another element.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-15 and 17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zeon (JP 2019/170691 – Please refer to the translation copy provided by Applicant on 2/15/2024).
Re Claim 1, Zeon discloses an intra-aortic balloon pump assembly comprising:
an expandable member having a distal end and a proximal end (para. [0019], fig. 1, a balloon portion 3 connected to the distal end of the catheter tube 2), the expandable member configured to be positioned in a patient's descending aorta and to provide circulatory support to the patient (fig. 4, para. [0010], the balloon part is positioned at a predetermined position in the descending aorta);
a driveline having a distal end and a proximal end, the distal end of the driveline configured to be coupleable to the proximal end of the expandable member (fig. 1A, para. [0019], catheter tube 2 coupled to a ballon portion 3); and
a first driveline pressure sensor device disposed within the driveline (para. [0047], fig. 1B, the sensor unit 9 includes a pressure sensitive unit 90) and configured to generate a first driveline pressure signal communicative of the pressure of the environment external to the driveline, wherein the first driveline pressure sensor device comprises a first driveline sensing element that is sensitive to changes in ambient pressure and positioned at or proximate to the distal end of the driveline (para. [0051], [0052], The pressure sensing unit installation space S communicates with the outside through which the pressure is to be measured by the pressure sensing unit 9 through the through hole 10. The pressure sensing unit 10 is a component of the sensor unit 9 that senses the pressure of the fluid in contact with the pressure sensing unit 90 in the pressure sensing unit installation space S. fig. 1B shows the pressure sensor positioned proximate to the distal end of the driveline).
Re Claim 2, Zeon discloses that the first driveline pressure sensor device further comprises a first driveline sensor cavity (annotated fig. 1B, para. [0051], a pressure-sensitive portion installation space S) and a first driveline sensor window (annotated fig. 1B, through hole 10), the first driveline sensing element defines at least a portion of a wall of the first driveline sensor cavity (para. [0052], pressure-sensitive unit 90 is configured by a metal diaphragm), the driveline wall (fig. 1B, para. [0050], sensor storage tube 4) includes a first recess extending inward relative to the exterior of the driveline, the first recess having a shape that at least partially houses the first driveline sensor cavity (annotated fig. 1B), and the first driveline sensor window is disposed along the first recess and closes the first driveline sensor cavity (annotated fig. 1B, para. [0050], [0051]).
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Re Claim 3, Zeon discloses that the driveline includes a driveline wall, and the first driveline pressure sensing element is disposed within the driveline wall (para. [0050], pressure-sensitive unit 90 is within sensor storage tube 4, fig. 1B).
Re Claim 4, Zeon discloses that the driveline comprises a working fluid lumen (para. [0050], catheter tube 2) configured to transport a working fluid for at least one of inflation and deflation of the expandable member (para. [0027], a fluid channel 6, a fluid such as helium gas is supplied to or discharged from the inside of the balloon unit 3 so that the balloon unit 3 can be expanded or contracted), and the first driveline pressure sensing element is disposed within the working fluid lumen (para. [0052], pressure sensing unit 90 is within catheter tube 2).
Re Claim 5, Zeon discloses that the driveline includes a driveline wall (para. [0050], sensor storage tube 4, fig. 1B), the driveline comprises a working fluid lumen (para. [0050], catheter tube 2) configured to transport a working fluid for at least one of inflation and deflation of the expandable member (para. [0027], a fluid channel 6, a fluid such as helium gas is supplied to or discharged from the inside of the balloon unit 3 so that the balloon unit 3 can be expanded or contracted), and the first driveline pressure sensing element is disposed partially within the driveline wall and partially within the working fluid lumen (para. [0052], pressure sensing unit 90 is within catheter tube 2 and within sensor storage tube 4).
Re Claim 6, Zeon discloses that the first driveline sensing element is a diaphragm (para. [0052], pressure-sensitive unit 90 is configured by a metal diaphragm).
Re Claim 7, Zeon discloses that the first driveline sensor device comprises a first flexible substance disposed in the first driveline sensor cavity, the first flexible substance operative to communicate pressure to the first driveline sensing element (para. [0053], the pressure sensitive portion installation space S defined around the pressure-sensitive portion 90 in the sensor storage tube 4 may be hollow but a gel such as silicone gel, polyacrylamide gel, or polyethylene oxide gel or a pressure transmission filling material such as an oily material such as silicone oil may be filled; para. [0052], the amount of deflection of the pressure sensing unit 90 varies as the pressure of the fluid in contact with the pressure sensing unit 90 varies).
Re Claim 8, Zeon discloses that the first flexible substance is one or more of a gel, a fluid, a gas, an elastomer (para. [0052], [0053], the pressure sensitive portion installation space S defined around the pressure-sensitive portion 90 in the sensor storage tube 4 may be hollow but a gel such as silicone gel, polyacrylamide gel, or polyethylene oxide gel or a pressure transmission filling material such as an oily material such as silicone oil may be filled).
Re Claim 9, Zeon discloses that the first driveline sensor window is configured to prevent the first flexible substance from leaking out of the first driveline sensor cavity when in operation (para. [0053], the pressure sensitive portion installation space S defined around the pressure-sensitive portion 90 in the sensor storage tube 4 may be hollow but a gel such as silicone gel, polyacrylamide gel, or polyethylene oxide gel or a pressure transmission filling material such as an oily material such as silicone oil may be filled).
Re Claim 10, Zeon discloses that the first driveline sensor window is sized and shaped to plug the first recess of the driveline wall (annotated fig. 1B above, para. [0053], the window functions as a plug in order to contain a gel or an oily material).
Re Claim 11, Zeon discloses that the first driveline pressure sensor device: further comprises a first driveline pressure signal line in communication with the first driveline sensing element, is disposed within the driveline, and is configured to transmit the first driveline pressure signal (fig. 1B, para. [0052], the variation in the amount of deflection measured by pressure sensing unit 90 is transmitted through the optical fiber 13).
Re Claim 12, Zeon discloses that the first driveline pressure signal line is one of a fiber optic line and a fluid-filled line (fig. 1B, para. [0052], optical fiber 13).
Re Claim 13, Zeon discloses that a distal end of the first driveline pressure signal line is coupled to the first driveline sensing element and a proximal end of the first driveline pressure signal line is configured to be coupled to a processing module configured to control a drive unit configured to inflate the expandable member (para. [0055], The pressure sensing unit installation space S is communicated with the outside where blood pressure is to be measured via the through hole 10, the pressure in the pressure sensing unit installation space S is detected by the pressure sensing unit 90; para. [0058], an optical connector 14 is connected to the proximal end of the optical fiber 13. A blood pressure measuring device is connected to the optical connector 14. Based on the blood pressure fluctuation measured by the blood pressure measuring device, the pump device is controlled in accordance with the heart beat, and the balloon unit 3 is expanded and contracted in a short cycle of 0.4 to 1 second.).
Re Claim 14, Zeon discloses that the driveline comprises a working fluid lumen (para. [0050], catheter tube 2) configured to transport a working fluid for at least one of inflation and deflation of the expandable member (para. [0027], a fluid channel 6, a fluid such as helium gas is supplied to or discharged from the inside of the balloon unit 3 so that the balloon unit 3 can be expanded or contracted).
Re Claim 15, Zeon discloses that the driveline comprises a driveline wall (para. [0050], sensor storage tube 4, fig. 1B) that defines the working fluid lumen (para. [0050], catheter tube 2, sensor storage tube 4 defines part of catheter tube 2).
Re Claim 17, Zeon discloses that the first driveline pressure signal line (fig. 1B, para. [0052], optical fiber 13) is one of: disposed within the driveline wall (para. [0050], sensor storage tube 4, fig. 1B), disposed within the working fluid lumen (para. [0050], catheter tube 2), and partially disposed within the driveline wall and partially disposed within the working fluid lumen.
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.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Zeon (JP 2019/170691 – Please refer to the translation copy provided by Applicant on 2/15/2024) in view of Jeevanandam et al. (US 2012/0108886A1).
Re Claim 16, Zeon discloses the claimed invention substantially as set forth in claims 1, 11, and 14.
Zeon discloses that the working fluid is a fluid such as helium gas (para. [0027], a fluid channel 6, a fluid such as helium gas is supplied to or discharged from the inside of the balloon unit 3 so that the balloon unit 3 can be expanded or contracted).
Zeon is silent regarding the working fluid being ambient air.
Jeevanandam discloses internal drive line for ventricular assist device (para. [0021]) and teaches working fluid being ambient air (para. [0050], [0083], a preferred pumping medium is air, but any fluid could be used.).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Zeon, by configuring the working fluid to be ambient air, as taught by Jeevanandam, because such a modification is the result of simple substitution of one known element for another producing a predictable result. More specifically, Zeon’s helium gas and Jeevanandam’s ambient air perform the same general and predictable function, the predictable function being expanding the expandable member. Since each individual element and its function are shown in the prior art, albeit shown in separate references, the difference between the claimed subject matter and the prior art rests not on any individual element or function but in the very combination itself - that is in the substitution of Zeon’s helium gas by replacing it with Jeevanandam’s ambient air. Thus, the simple substitution of one known element for another producing a predictable result renders the claim obvious.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Zeon (JP 2019/170691 – Please refer to the translation copy provided by Applicant on 2/15/2024) in view of Mori et al. (US 2007/0005010).
Re Claim 18, Zeon discloses the claimed invention substantially as set forth in claims 1, 11, 14, and 17.
Zeon is silent regarding wherein the driveline comprises a wire lumen configured as a guidewire rail and is sized such that a guidewire may be threaded through said wire lumen.
However, Mori discloses intra-aortic balloon catheter (abstract) and teaches a driveline (fig. 1, catheter tube 8a) comprises a wire lumen configured as a guidewire rail and is sized such that a guidewire may be threaded through said wire lumen (para. [0055], fig. 1, inner tube 17 within catheter tube 8a and a second lumen 18 is formed therein along the axial direction. The second lumen 18 can be used for leading a guide wire used at the time of inserting the intra-aortic balloon catheter 1 a to the patient's aorta.).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Zeon, by configuring the driveline to comprise a wire lumen configured as a guidewire rail and is sized such that a guidewire may be threaded through said wire lumen, as taught by Mori, for the purpose of leading a guide wire used at the time of inserting the intra-aortic balloon catheter 1 a to the patient's aorta (para. [0055]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VYNN V HUH whose telephone number is (571)272-4684. The examiner can normally be reached Monday to Friday from 9 am to 5 pm.
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/Benjamin J Klein/Supervisory Patent Examiner, Art Unit 3792
/V.V.H./
Vynn Huh, March 6, 2026Examiner, Art Unit 3792