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 .
DETAILED ACTION
Acknowledgement is made of applicant’s amendment which was received by the office on February 3, 2026. Claims 1-21 are currently pending. Claims 2-5,9,11-12 and 15 were withdrawn during an earlier restriction requirement.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “an element…configured to cause at least a portion of the tube to become curved” in claims 1-10.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. Specifically, “an element” has been interpreted to be a shape-memory material and equivalents thereof, see para. [0396] of published application US 2022/0241576.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
Claim(s) 1,6,8,10, 13 and 17-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2019/0328948 to Salahieh et al. (Salahieh) in view of US 2011/0144633 to Govari (Govari) and US 2020/0155739 to Siess et al. (Siess ‘739) (all previously cited).
In reference to at least claim 1
Salahieh discloses an apparatus (e.g. pump Figs. 1-2) including: a left-ventricular assist device (e.g. ventricular support device, para. [0008]) configured to assist left-ventricular functioning of a subject (e.g. placed in left ventricle, Figs. 4,8), the left-ventricular assist device comprising: a collapsible tube configured to be positioned such that a proximal portion of the tube traverses an aortic valve of the subject (e.g. conduit 1112 traverses the aortic valve, Fig. 4; “the conduit and the expandable member being joined together such that as the expandable member expands or collapses, the conduit also begins to transition to a different configuration and/or size.”, therefore the conduit 1112 is “collapsible” para. [0101], Working portion 1104 is adapted and configured to be collapsed to a smaller profile than its deployed configuration (which is shown in FIG. 2)”, therefore the working portion which includes the conduit 1112 is “collapsible”, para. [0111]-[01112]), and a distal portion of the tube is disposed within a left ventricle of the subject (e.g. conduit 1112 is disposed in the left ventricle, Fig. 4), a pump disposed within the distal portion of the tube (e.g. impeller 118 disposed in distal portion, Fig. 4) and configured to pump blood through the tube from the subject's left ventricle to the subject's aorta (e.g. pump including impeller 1118 configured to pump blood from the left ventricle to the aorta, Figs. 1-2, 4), by pumping the blood through the tube (e.g. inward arrows pumping blood into the tube and outward arrows pumping blood outward, Figs. 1-2; blood outflow within the aorta, Figs. 4 and 8), such that during operation of the pump, pressure of blood flow through the tube maintains the tube in an open state (e.g. “The sections between the impellers may be relatively rigid, in some embodiments the section is held open primarily by the fluid pressure within”, para. [0149])
Salahieh discloses the tube having a curved structure (e.g. Figs. 4 and 8) and that the bend can be preformed or adjusted in situ (e.g. para. [0146]), however Salahieh does not explicitly teach an element disposed within the tube, the element being configured to cause at least a portion of the tube to become curved while pressure of blood flow through the tube maintains the tube in an open state and a separation is maintained between the collapsible tube and the element.
Govari discloses a catheter which includes a tube (e.g. distal end of insertion tube 62, Fig. 3) which includes an element 60 within the tube (e.g. Fig. 3) made from a resilient material that includes a strut, rod or tube made from a shape memory material which produces a curved shape when unconstrained (e.g. Fig. 3, “A resilient member 60 inside the distal end of insertion tube 62 is pre-formed in a bent shape. Member 60 may comprise, for example, a strut, rod or tube made from a shape memory material, such as Nitinol, which is produced so as to have this bent shape when unconstrained in its austenitic state” para. [0020], [0033]).
Further, use of an element made from a shape memory material within a left-ventricular assist device was known in the art before the effective filing date of the claimed invention as disclosed within Siess ‘739. Siess ‘739, discloses an apparatus (e.g. apparatus shown within Fig. 1) including: a left-ventricular assist device (e.g. assist device, Fig. 1) configured to assist left-ventricular functioning of a subject (e.g. device place within left ventricle, Fig. 1), the left-ventricular assist device comprising: a tube configured such that a proximal portion of the tube traverses an aortic valve of the subject, and a distal portion of the tube is disposed within a left ventricle of the subject (e.g. tube includes catheter 10 and cannula 4); and an element disposed within the tube (e.g. stiffening rod 15, Fig. 2), the element being configured to allow at least a portion of the tube to become curved (e.g. bending of the catheter, para. [0034]) and a separation maintained between the tube and the element (e.g. separation between stiffening rod 15 and catheter 10, Figs. 2-3). Siess ‘739 discloses a stiffening rod made of Nitinol provides a better bending stiffness and prevents kinking of the catheter to avoid occlusion of tubular lines (e.g. para. [0034]) while also providing sufficient flexibility to allow the catheter to be directed through a blood vessel (e.g. para. [0007]).
Utilizing the combined teachings, since Salahieh discloses the tube having a curved structure and that the bend can be preformed or adjusted in situ, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus of Salahieh to include within at least a portion of the conduit, i.e. tube, an element made from a resilient material that includes a strut, rod or tube made from a shape memory material which produces a curved shape when unconstrained, as taught by Govari, in which the element made from a resilient material that includes a strut, rod or tube is positioned within the tube such that a separation is maintained between the tube and the element, as taught by Siess, the motivation being to provide a better bending stiffness and prevent kinking of the catheter to avoid occlusion of tubular lines while also providing sufficient flexibility to allow the catheter to be directed through a blood vessel (e.g. ‘739, para. [0007], [0034]).
In reference to at least claim 6
Salahieh discloses wherein the tube defines a set of one or more blood-inlet openings that are configured to be disposed within the subject's left ventricle (e.g. tube has inlets shown by inward arrows, Figs. 1-2), and at least the portion of the tube being curved, such that a separation is maintained between the one or more blood-inlet openings and a posterior wall of the left ventricle, mitral valve leaflets of the subject, chordae tendineae of the subject, and papillary muscles of the subject (e.g. conduit is curved such that a separation is maintained between the one or more blood-inlet openings and a posterior wall of the left ventricle, mitral valve leaflets of the subject, chordae tendineae of the subject, and papillary muscles of the subject, Figs. 4 and 8). Regarding the element, as recited above, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus of Salahieh to include within the conduit “tube” an element made from a resilient material that includes a strut, rod or tube made from a shape memory material which produces a curved shape when unconstrained, as taught by Govari, the motivation being to provide a better bending stiffness and prevent kinking of the catheter to avoid occlusion of tubular lines while also providing sufficient flexibility to allow the catheter to be directed through a blood vessel (e.g. ‘739, para. [0007], [0034]).
In reference to at least claim 8
Salahieh discloses at least a portion of the tube which is proximal to the frame and which is disposed within the left ventricle to being curved (e.g. conduit is curved proximal to the frame 1110 or 154 and which is disposed within the left ventricle to being curved, Figs. 4 and 8). Regarding the element, as recited above, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus of Salahieh to include within the conduit “tube” an element made from a resilient material that includes a strut, rod or tube made from a shape memory material which produces a curved shape when unconstrained, as taught by Govari, the motivation being to provide a better bending stiffness and prevent kinking of the catheter to avoid occlusion of tubular lines while also providing sufficient flexibility to allow the catheter to be directed through a blood vessel (e.g. ‘739, para. [0007], [0034]).
In reference to at least claim 10
Salahieh discloses wherein the tube is pre-shaped such that a portion of the tube is configured to become curved during the pumping of blood through the tube (e.g. the bends may be pre-formed or adjusted in situ, Figs. 4 and 8, para. [0146]).
In reference to at least claim 13
Salahieh discloses wherein the tube is pre-shaped such that, during the pumping of blood through the tube, the portion of the tube becomes curved, such that a separation is maintained between the tube and the posterior wall of the left ventricle, mitral valve leaflets of the subject, chordae tendineae of the subject, and papillary muscles of the subject (e.g. the bends may be pre-formed or adjusted in situ, para. [0146]; the bends maintain separation between the tube and the posterior wall of the left ventricle, mitral valve leaflets of the subject, chordae tendineae of the subject, and papillary muscles of the subject, Fig. 8).
In reference to at least claim 17
Salahieh discloses wherein the pump comprises an impeller disposed within the frame (e.g. 1118 or 152), and wherein the curve is disposed proximally with respect to the impeller (e.g. curved portion(s) located proximal frame 1110 or 154 which enclose impellers 1118 or 152, Figs. 4 and 8). Regarding the element, as recited above, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus of Salahieh to include within the conduit “tube” an element made from a resilient material that includes a strut, rod or tube made from a shape memory material which produces a curved shape when unconstrained, as taught by Govari, the motivation being to provide a better bending stiffness and prevent kinking of the catheter to avoid occlusion of tubular lines while also providing sufficient flexibility to allow the catheter to be directed through a blood vessel (e.g. ‘739, para. [0007], [0034]).
In reference to at least claim 18
Salahieh discloses wherein the element is disposed proximally with respect to the frame (e.g. curved portion(s) located proximal frame 1110 or 154 which enclose impellers 1118 or 152, Figs. 4 and 8). Regarding the element, as recited above, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus of Salahieh to include within the conduit “tube” an element made from a resilient material that includes a strut, rod or tube made from a shape memory material which produces a curved shape when unconstrained, as taught by Govari, the motivation being to provide a better bending stiffness and prevent kinking of the catheter to avoid occlusion of tubular lines while also providing sufficient flexibility to allow the catheter to be directed through a blood vessel (e.g. ‘739, para. [0007], [0034]).
In reference to at least claim 19
Salahieh discloses wherein the left-ventricular assist device further comprises proximal and distal bearings disposed respectively at proximal and distal ends of the frame (e.g. providing proximal and distal bearings, para. [0115]), wherein the curved portion is disposed proximal to the proximal bearing (e.g. curved portion(s) located proximal frame 1110 or 154 which enclose impellers 1118 or 152, Figs. 4 and 8). Regarding the element, as recited above, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus of Salahieh to include within the conduit “tube” an element made from a resilient material that includes a strut, rod or tube made from a shape memory material which produces a curved shape when unconstrained, as taught by Govari, the motivation being to provide a better bending stiffness and prevent kinking of the catheter to avoid occlusion of tubular lines while also providing sufficient flexibility to allow the catheter to be directed through a blood vessel (e.g. ‘739, para. [0007], [0034]).
In reference to at least claim 20
Salahieh discloses wherein the curved portion is disposed immediately proximal to the proximal bearing (e.g. curved portion(s) located proximal frame 1110 or 154 which enclose impellers 1118 or 152, Figs. 4 and 8). Regarding the element, as recited above, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus of Salahieh to include within the conduit “tube” an element made from a resilient material that includes a strut, rod or tube made from a shape memory material which produces a curved shape when unconstrained, as taught by Govari, the motivation being to provide a better bending stiffness and prevent kinking of the catheter to avoid occlusion of tubular lines while also providing sufficient flexibility to allow the catheter to be directed through a blood vessel (e.g. ‘739, para. [0007], [0034]).
In reference to at least claim 21
Salahieh discloses wherein the left-ventricular assist device further comprises a frame disposed within the distal portion of the tube (e.g. expandable member 1110 containing a frame, Fig. 4) the frame being configured to hold the distal portion of the tube in an open state (e.g. expandable member 1110 holds the tube in an open state, Fig. 4).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2019/0328948 to Salahieh et al. (Salahieh) in view of US 2011/0144633 to Govari (Govari) and US 2020/0155739 to Siess et al. (Siess ‘739) as applied to claim 1 further in view of US 2020/0246527 to Hildebrand et al (Hildebrand) (previously cited).
In reference to at least claim 7
Salahieh modified by Govari and Siess ‘739 renders obvious an apparatus according to claim 1. Salahieh wherein the left-ventricular assist device further comprises a drive cable (e.g. 1612 or 1117, para. [0114]-[0115]) but does not explicitly teach the element comprises a hypotube disposed around a section of the drive cable.
Hildebrand, in the same field of endeavor of intravascular blood pumps, discloses an intravascular pump containing multiple pumps disposed within frames (e.g. Fig. 2) and further discloses providing a hypotube around a drive cable to prevent blood ingress (e.g. 144, para. [0279], [0284]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to further modify the apparatus of Salahieh modified by Govari and Siess ‘739 to include as part of the element a hypotube disposed around a section of the drive cable, as taught by Hildebrand, in order to prevent blood ingress (‘527, para. [0279], [0284]).
Claim(s) 14 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2019/0328948 to Salahieh et al. (Salahieh) in view of US 2011/0144633 to Govari and US 2020/0155739 to Siess et al. (Siess ‘739) as applied to claim 1 further in view of US 2014/0128659 to Heuring et al. (Heuring) (previously cited).
In reference to at least claim 14
Salahieh modified by Govari and Siess ‘739 renders obvious an apparatus according to claim 1. Salahieh further discloses wherein the tube defines a set of one or more blood-inlet openings that are configured to be disposed within the subject's left ventricle (e.g. tube has inlets shown by inward arrows, Figs. 1-2), and a set of one or more blood-outlet openings that are configured to be disposed within the subject's aorta (e.g. tube has outlets shown by outward arrows, Figs. 1-2). Siess ‘739 discloses that shape-memory material have temperature dependent properties that allows the shape memory material the ability to transform between martensite phase and austenite phase (e.g. para. [0007]). Regarding the configuration including at least one of the sets of blood- inlet openings and blood-outlet openings being disposed in a non-axi-symmetric configuration with respect to the tube, it was known in the art before the effective filing date of the claimed invention to provide various configurations for blood-inlet openings and blood-outlet openings based on the desired properties for the blood flow as evidence by Heuring (e.g. Figs. 15-18D, 20-23D), therefore it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to include any arrangement of blood-inlet and/or blood-outlet openings including of the blood-inlet and/or blood-outlet openings being disposed in a non-axi-symmetric configuration with respect to the tube such that pumping of the blood through the at least one of the sets of blood-inlet openings and blood-outlet openings causes a temperature change that transforms the “element” made from a shape-memory material such that at least a portion of the tube becomes curved. Additionally, it would have been an obvious matter of design choice to modify Salahieh modified by Govari and Siess ‘739, to have at least one of the sets of blood- inlet openings and blood-outlet openings being disposed in a non-axi-symmetric configuration with respect to the tube such that pumping of the blood through the at least one of the sets of blood-inlet openings and blood-outlet openings causes at least a portion of the tube to become curved, since applicant has not disclosed that having at least one of the sets of blood- inlet openings and blood-outlet openings being disposed in a non-axi-symmetric configuration with respect to the tube solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either designs. Furthermore, absent a teaching as to criticality that at least one of the sets of blood- inlet openings and blood-outlet openings being disposed in a non-axi-symmetric configuration with respect to the tube such that pumping of the blood through the at least one of the sets of blood-inlet openings and blood-outlet openings causes at least a portion of the tube to become curved, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement, see MPEP 2144.
In reference to at least claim 16
Salahieh modified by Govari and Siess ‘739 renders obvious an apparatus according to claim 14. Salahieh further discloses at least one of sets of blood- inlet openings and blood-outlet openings (e.g. tube has inlets shown by inward arrows and outlets shown by outward arrows, Figs. 1-2 that extend around, para. [0090]) with blood-out openings being provided in the aorta (e.g. Figs. 4 and 8). Regarding the configuration of the one or more blood-outlet openings being disposed on a side of the tube that is inside of a curve defined by the tube such that as blood exits the blood-outlet openings the blood impacts a wall of the aorta, it was known in the art to provide various configurations for blood-inlet openings and blood-outlet openings based on the desired properties for the blood flow as evidence Heuring (e.g. Figs. 15-18D, 20-23D), therefore it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to include any arrangement of blood-outlet openings including the one or more blood-outlet openings are disposed on a side of the tube that is inside of a curve defined by the tube such that as blood exits the blood-outlet openings the blood impacts a wall of the aorta causing a proximal end of the tube to be pushed in an opposite direction from the flow of the blood exiting the blood-outlet openings. Additionally, it would have been an obvious matter of design choice to modify Salahieh modified by Govari and Siess ‘739, to have the blood-outlet openings including the one or more blood-outlet openings being disposed on a side of the tube that is inside of a curve defined by the tube such that as blood exits the blood-outlet openings the blood impacts a wall of the aorta causing a proximal end of the tube to be pushed in an opposite direction from the flow of the blood exiting the blood-outlet openings, since applicant has not disclosed that having blood-outlet openings including the one or more blood-outlet openings being disposed on a side of the tube that is inside of a curve defined by the tube such that as blood exits the blood-outlet openings the blood impacts a wall of the aorta solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either designs. Furthermore, absent a teaching as to criticality that blood-outlet openings including the one or more blood-outlet openings are disposed on a side of the tube that is inside of a curve defined by the tube such that as blood exits the blood-outlet openings the blood impacts a wall of the aorta, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement, see MPEP 2144.
Response to Arguments
II. DETAILED ARGUMENTS
Applicant's arguments filed 2/3/2026 have been fully considered but they are not persuasive. It is noted that the rejection has been updated to show where Salahieh, Govari and Siess ‘739 disclose the amended claim language regarding maintaining the tube in an open state and separation being maintained between the collapsible tube and the element.
Firstly, applicant argues that “Since the bend in Salahieh is already formed in the structure provided by Salahieh, Applicant submits that there would be no reason to modify Salahieh to provide an additional resilient element of Govari in order to provide a bend between the impellers….Applicant respectfully disagrees and submits that Salahieh provides a structure that already achieves bending through its stent-like structures, and merely being adjustable in situ does not imply, suggest or motivate the addition of an element within the tube.”, see pg. 11 of response filed 2/3/2026. This is not persuasive. While Salahieh discloses that the bend may be adjusted in situ that is not the motivation provided for combining the references. The motivation, as stated within the rejection, is to provide a better bending stiffness and prevent kinking of the catheter to avoid occlusion of tubular lines while also providing sufficient flexibility to allow the catheter to be directed through a blood vessel (e.g. ‘739, para. [0007], [0034]). Further, applicant argues “the section including the bend is described by Salahieh as already being relatively rigid (this is described in paragraph [0149] in Salahieh). Therefore, since the section between the impellers is already relatively rigid in a manner that allows for providing the bend in the structure, there would be no reason or motivation to modify Salahieh to include an additional resilient/rigid element of Govari”, see pg. 11 of response filed 2/3/2026. This is not persuasive. It is unclear exactly what argument applicant is arguing regarding the combination of references. The disclosure states that sections between the impellers may be “relatively rigid” and that “the section may be held open primarily by the fluid pressure”, however there is no further disclosure regarding the “relatively rigid” including the “relatively rigid” structure maintaining the section in an open manner or providing the bending stiffness to maintain the section in an open manner. There is nothing within Salahieh which discourages or discredits the combination with Govari and Siess ‘739 which disclose the use of shape memory materials to provide a preformed or in situ curve and would have been obvious to use within the device of Salahieh. As stated above, the motivation is to provide a better bending stiffness and preventing kinking of the catheter to avoid occlusion of tubular lines while also providing sufficient flexibility to allow the catheter to be directed through a blood vessel (e.g. ‘739, para. [0007], [0034]).
Secondly, applicant argues that “Govari describes an ablation catheter having a resilient member causing a bend in the distal end of the ablation catheter. The resilient member of Govari is built into the distal end of the insertion tube and there is no separation between the resilient member and the portion of the distal end of insertion tube in which it is housed…. Applicant respectfully submits that Salahieh, having read Govari would not modify his device to include the resilient member of Govari. This is at least because the ablation catheter Govari does not have blood flow under pressure therethrough, such that Salahieh would have no reasonable expectation of success that when providing an internal element in the tube and passing fluid through the tube, that the curved element would still be able to provide the curve, under the pressure of the flow such that there is a separation between the curved element and the tube”, see pg. 12 of response filed 2/3/2026. This is not persuasive. Applicant is arguing Govari when Siess ‘739 is also used within the rejection to show that the use of an element made from a shape memory material within a left-ventricular assist device was known in the art before the effective filing date of the claimed invention as disclosed within Siess '739, see rejection above. Siess '739 discloses a stiffening rod made of Nitinol which is located within a catheter, i.e. tube, and maintains a separation between the tube and the element (e.g. separation between stiffening rod 15 and catheter 10, Figs. 2-3) and provides a better bending stiffness and prevents kinking of the catheter to avoid occlusion of tubular lines (e.g. para. [0034]) while also providing sufficient flexibility to allow the catheter to be directed through a blood vessel (e.g. para.[0007]). Absolute predictability of success is not required and applicant has not provided any evidence showing there was no reasonable expectation of success utilizing the combined references, see MPEP 2143.02. The expectation of success need only be reasonable and one having ordinary skill in the art in view of the teachings of Salahieh which discloses providing a curvature to a tubular structure and Govari and Siess ‘739 which disclose the use of a shape-memory element for providing a curvature would provide a reasonable expectation of success.
Finally, applicant argues that “Thus, Applicant submits that a person seeking to cause (i.e., create) a curvature in the tube, such as Salahieh or Govari, would not turn to the rod of Siess for a solution. This is at least because the stiffening rod described in Siess does not create the bend/curvature in the catheter but rather allows the catheter to conform to the natural curvatures in the anatomy while providing the catheter with sufficient stiffness to prevent kinking thereof…There is no indication or teaching in Siess of how the stiffening rod would create the bend in the section between the impellers in Salahieh, or the curve in the ablation catheter of Govari.”, see pg. 13 of response filed 2/3/2026. This is not persuasive. Siess ‘739 is analogous art to the claimed invention since Siess ‘739 is from the same field of endeavor as the claimed invention, i.e. intravascular blood pumps, see MPEP 2141.01(a), and is a reference that one having ordinary skill in the art would turn to for a solution. There is nothing within Salahieh which discourages or discredits the combination with Govari and Siess ‘739. Salahieh discloses providing a curvature to a tubular structure and Govari and Siess ‘739 disclose the use of a shape-memory element for providing a curvature, therefore it would have been well within the level of ordinary skill in the art to provide an element made from a resilient material that includes a strut, rod or tube made from a shape memory material which produces a curved shape when unconstrained, as taught by Govari, in which the element made from a resilient material that includes a strut, rod or tube is positioned within the tube such that a separation is maintained between the tube and the element, as taught by Siess, the motivation being to provide a better bending stiffness and prevent kinking of the catheter to avoid occlusion of tubular lines while also providing sufficient flexibility to allow the catheter to be directed through a blood vessel (e.g. ‘739, para. [0007], [0034]).
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 JENNIFER L GHAND whose telephone number is (571)270-5844. The examiner can normally be reached Mon-Fri 7:30AM - 3:30PM ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JENNIFER MCDONALD can be reached on (571)270-3061 or CARL LAYNO can be reached on (571)272-4949. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JG/Examiner, Art Unit 3796
/CARL H LAYNO/Supervisory Patent Examiner, Art Unit 3796
Prosecution Insights