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
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 8/18/2026 has been entered. Claims 1-13, 19-20 and 38-43 are currently pending.
Claim Objections
In view of the amendment filed on 8/18/2026 clarifying the language of claim 2 the objections made against claim 2 in the office action of 4/14/2026 has been withdrawn.
Claims 1-13, 19-20 and 38-43 are objected to because of the following informalities: Claim 1, line 12 should recite similar to –wherein the first diameter at the proximal end of the first impeller is greater than the second diameter at the distal end of the impeller—in order to clarify which first diameter and second diameter applicant is referring back to. Appropriate correction is required. Claims 2-13, 19-20 and 38-43 directly or indirectly depend from claim 1 and are also objected to for the reasons stated above regarding claim 1.
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 and 8-9 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. Claims 2,8-9 recite the first and second impellers having “an average diameter” it is unclear whether the “average diameter” of the impellers recited within claims 2 and 8-9 is the same or different from the “first and second average diameters” recited within claim 1. Clarification is required.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-13, 19-20, 38-40 and 42 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2019/0143018 to Salahieh et al. (Salahieh) in view of US 2013/0303831 to Evans (Evans) (both previously cited).
In reference to at least claim 1
Salahieh discloses a catheter blood pump (e.g. pump, Figs 1-2), comprising: a pump portion (e.g. 1600 or 1100 pump portion, Figs. 1-2) that includes: an impermeable blood conduit (e.g. conduit 1604 or 1112, Figs. 1-2, “Any of the conduits herein, or at least a portion of the conduit, can be impermeable to blood.”, para. [0053]) and first and second impellers at least partially disposed in the blood conduit (e.g. impellers 1606 or 1116 and 1616 or 1118, Figs. 1-2) and wherein the first impeller is disposed in a first tapering region of the blood conduit (e.g. impeller 1606 or 1116 is located in a first tapering region of conduit 1604 or 1112, respectively, Figs. 1-2). Salahieh further discloses that the first impeller tapers from a first diameter to a second diameter near a distal end of the first impeller (e.g. impeller 1606 or 1116 taper towards the distal ends, Figs. 1-2) such that a first tip gap between an outer edge of the first impeller and an inner wall of the blood conduit is constant in the first tapering region (e.g. “each of the proximal and distal impellers are positioned within respective housings and configured to maintain a precise, consistent tip gap”, para. [0098], [0106]).
However, Salahieh does not explicitly teach wherein the first and second impellers have first and second average diameters that are different and the first impeller tapers from a first diameter at a proximal end of the first impeller towards a second diameter at a distal end of the first impeller, wherein the first diameter is greater than the second diameter.
Evans discloses a catheter blood pump (e.g. pump, Fig. 30), comprising: a pump portion (e.g. pump portion, Fig. 30) that includes: an impermeable blood conduit (e.g. conduit 1902, Fig. 30; 1902 is a cover or cannula which creates a blood conduit, para. [0110], [0172]) and first and second impellers at least partially disposed in the blood conduit (e.g. impellers 3002 and 3004 disposed in 1902, Fig. 30), wherein the first and second impellers have first and second average diameters, respectively, that are different (e.g. impellers 3002 and 3004 have different diameters, “The various segments can be the same length, or different, and they can have the same diameter or different diameters…. All of these parameters can be adjusted, as desired, so that the desired blood flow, and the desired relative amounts of blood flow, from the inlets can be calibrated and selected.”, para. [0192]) and the first impeller tapers from a first diameter at a proximal end of the first impeller towards a second diameter at a distal end of the first impeller, wherein the first diameter is greater than the second diameter (e.g. impellers 3002 and 3004 taper from a first diameter on an end to a second diameter on another end in which the first diameter is greater than a second diameter, see Figs. 30-35, “proximal” and “distal” would depend on how the device is oriented)
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the pump of Salahieh to include the first and second impellers having first and second average diameters that are different and a first impeller that tapers from a first diameter at a proximal end of the first impeller towards a second diameter at a distal end of the first impeller, wherein the first diameter is greater than the second diameter, as taught by Evans, in order to provide a desired blood flow and relative amounts of blood flow from the inlets (‘831, para. [0192]).
In reference to at least claim 2
Salahieh modified by Evans renders obvious a pump according to claim 1. Salahieh discloses wherein the first impeller is a proximal impeller (e.g. impeller 1606 or 1116 is a proximal impeller, Figs. 1-2, “wherein pump portion 1600 includes proximal impeller 1606 and distal impeller 1616”, para. [0038]) but does not explicitly teach the proximal impeller has an average diameter that is larger than an average diameter of the second impeller, wherein the second impeller is a distal impeller. Evans discloses the proximal impeller and distal impeller have different diameters (e.g. the impellers 3002 and 3004 have different diameters, “(e.g. impellers 3002 and 3004 have different diameters, “The various segments can be the same length, or different, and they can have the same diameter or different diameters…. All of these parameters can be adjusted, as desired, so that the desired blood flow, and the desired relative amounts of blood flow, from the inlets can be calibrated and selected.”, para. [0192]), but does not specifically teach which impeller diameter is larger. Accordingly, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention for the proximal impeller diameter to be larger than the distal impeller diameter to cause more blood flow in the proximal region as desired (‘831, para. [0192]).
In reference to at least claim 3
Salahieh modified by Evans renders obvious a pump according to claim 1. Salahieh discloses wherein the first impeller is a distal impeller (e.g. impeller 1616 or 1118 is a distal impeller, respectively, Figs. 1-2, “wherein pump portion 1600 includes proximal impeller 1606 and distal impeller 1616”, para. [0038]) but does not explicitly teach the distal impeller and has an average diameter that is larger than an average diameter of the proximal impeller. Evans discloses the proximal impeller and distal impeller have different diameters (the impellers 3002 and 3004 have different diameters, para [0192]) but does not specifically teach which impeller diameter is larger. Accordingly, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention for the distal impeller diameter to be larger than the proximal impeller diameter to cause more blood flow in the distal region as desired (‘831, para. [0192]).
In reference to at least claim 4
Salahieh modified by Evans renders obvious a pump according to claim 1. Salahieh discloses wherein the blood conduit includes a first section and a second section (e.g. sections located over tope the impellers, Figs. 1-2) but does not explicitly disclose one section being greater than the other. Evans discloses embodiments in which the catheter body “blood conduit” (e.g. blood conduit 900, Fig 9B; cannula 900, para [0138]) includes a first section (e.g. larger section of catheter including 906 and 914, Fig 9B) and a second section (e.g. smaller section of catheter including 904 and 912, Fig 9B) where the first section has a greater diameter than the second section (e.g. first section 906 has a greater diameter than 904, Fig 9B) and where the larger section, surrounds an impeller (e.g. section 906 surrounds an impeller 500, Fig 9B) in order to alter the rate of flow through the conduit (e.g. the different diameter sections can alter flow, para [0139]). Accordingly, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to further modify the conduit of Salahieh modified by Evans to have a first section with a greater diameter than a second section with the greater diameter section surrounding the larger impeller to alter the rate of flow through the conduit as desired (‘831, para. [0139]).
In reference to at least claim 5
Salahieh modified by Evans renders obvious a pump according to claim 4. Salahieh discloses wherein the blood conduit includes a transition section between the first and second sections (e.g. section 1622 or 1132 located between impeller 1606 or 1116 and 1616 or 1118, Figs. 1-2) the transition section having a varying diameter between the first and second section average diameters (e.g. section 1622 or 1132 located between impeller 1606 or 1116 and 1616 or 1118 has varying diameters, Figs. 1-2). Additionally, Evans discloses wherein the blood conduit includes a transition section between the first and second sections (e.g. section 908 between sections 906 and 904, Fig 9B), the transition section having a varying diameter between the first and second section average diameters (e.g. section 908 has a varying diameter between the diameter of 906 and 904, Fig 9B).
In reference to at least claim 6
Salahieh modified by Evans renders obvious a pump according to claim 1. Salahieh discloses a plurality of expandable proximal struts extending proximally from the blood conduit (e.g. “The impellers herein can be considered to be axially within an expandable member even if the expandable member includes struts extending from a central region of the expandable member towards a longitudinal axis of the working portion”, para. [0056], “The two expandable members each include a plurality of proximal struts and a plurality of distal struts.”, para. [0064]).
In reference to at least claim 7
Salahieh modified by Evans renders obvious a pump according to claim 1. Salahieh a plurality of expandable distal struts extending distally from the blood conduit (e.g. “The impellers herein can be considered to be axially within an expandable member even if the expandable member includes struts extending from a central region of the expandable member towards a longitudinal axis of the working portion”, para. [0056], “The two expandable members each include a plurality of proximal struts and a plurality of distal struts.”, para. [0064]).
In reference to at least claim 8
Salahieh modified by Evans renders obvious a pump according to claim 1. Salahieh discloses first and second impellers (e.g. impellers 1606 or 1116 and 1616 or 1118, Figs. 1-2). Evans discloses first and second impellers having different diameters (the impellers 3002 and 3004 have different diameters, para [0192]), and where the impeller parameters are adjusted to provide a desired flow of blood (para [0192]), but does not specifically teach which impeller diameter is larger. Accordingly, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention for the first impeller diameter to be larger than the second impeller diameter to cause more blood flow in the region of the first impeller as desired. Further, the size of the first and second impeller would be determined by the desired blood flow within a particular region of the pump, therefore sizing the diameter of the first impeller to be between 100% and 500% a diameter of the second impeller would have been obvious since it has been held that where the general condition of a claim are disclosed in the prior art it is not inventive to discover the optimum or workable ranges, see MPEP 2144.05.
In reference to at least claim 9
Salahieh modified by Evans renders obvious a pump according to claim 8. Salahieh discloses first and second impellers (e.g. impellers 1606 or 1116 and 1616 or 1118, Figs. 1-2). Evans discloses first and second impellers having different diameters (the impellers 3002 and 3004 have different diameters, para [0192]), and where the impeller parameters are adjusted to provide a desired flow of blood (para [0192]), but does not specifically teach which impeller diameter is larger. Accordingly, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention for the first impeller diameter to be larger than the second impeller diameter to cause more blood flow in the region of the first impeller as desired. Further, the size of the first and second impeller would be determined by the desired blood flow within a particular region of the pump, therefore sizing the diameter of the first impeller to be between 125% and 400% a diameter of the second impeller would have been obvious since it has been held that where the general condition of a claim are disclosed in the prior art it is not inventive to discover the optimum or workable ranges, see MPEP 2144.05.
In reference to at least claim 10
Salahieh modified by Evans renders obvious a pump according to claim 1. Salahieh discloses wherein the blood conduit, first impeller, and second impeller are all configured to be expandable and collapsible (e.g. “a housing (optionally collapsible) comprising a fluid lumen, the fluid lumen having a distal end (optionally adjacent an inflow) and a proximal end (optionally adjacent an outflow); a distal impeller (optionally collapsible) axially spaced from a proximal impeller (optionally collapsible),”, para. [0009], [0018], [0020]).
In reference to at least claim 11
Salahieh modified by Evans renders obvious a pump according to claim 1. Salahieh discloses wherein the blood conduit, first impeller, and second impeller are not configured to be expandable and collapsible (e.g. “optionally collapsible”, para. [0009], [0013], therefore the conduit and impellers can be designed to not be collapsible; “For example, each of the impellers may be positioned within a respective housing having relatively rigid outer wall to resist radial collapse. The sections between the impellers may be relatively rigid, in some embodiments the section is held open primarily by the fluid pressure within.”, para. [0098]).
In reference to at least claim 12
Salahieh modified by Evans renders obvious a pump according to claim 1. Salahieh discloses wherein the first impeller is adapted and configured to be expanded and collapsed (e.g. “a housing (optionally collapsible) comprising a fluid lumen, the fluid lumen having a distal end (optionally adjacent an inflow) and a proximal end (optionally adjacent an outflow); a distal impeller (optionally collapsible) axially spaced from a proximal impeller (optionally collapsible),”, para. [0009], [0018], [0020]), and wherein the second impeller is adapted and configured such that it does not expand and collapse (e.g. “optionally collapsible”, para. [0009], [0013], therefore the impellers can be designed to not be collapsible).
In reference to at least claim 13
Salahieh modified by Evans renders obvious a pump according to claim 1. Salahieh discloses a delivery sheath (e.g. “sheath”, para. [0043]), the delivery sheath and the first impeller sized so that the delivery sheath is configured to cause the collapse of the first impeller when the delivery sheath is moved distally relative to the first impeller (e.g. “Expandable member 1602 can also be collapsed by pushing an outer shaft such as a sheath over the expandable member/conduit assembly, causing the expandable member and conduit to collapse towards their collapsed delivery configuration.”, para. [0043] and any of para. [0046], [0061], [0068]).
In reference to at least claim 19
Salahieh modified by Evans renders obvious a pump according to claim 5. Evans discloses wherein the transition section has a continuously tapering configuration (e.g. section 908 has a continuously linear tapering configuration, Fig 9B).
In reference to at least claim 20
Salahieh modified by Evans renders obvious a pump according to claim 5. In another embodiment, Evans discloses the conduit may be configured to contact tissue and resist migrations (e.g. a cannula may include fixing elements to retain the pumping system with respect to an anatomical element, para [0130]). Accordingly, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the transition cannula section to comprise a feature configured to contact tissue and resist migration of the pump system.
In reference to at least claim 38
Salahieh modified by Evans renders obvious a pump according to claim 1. Salahieh discloses wherein the second impeller is disposed in a second tapering region of the blood conduit (e.g. impeller 1616 or 11118 is located in a first tapering region of conduit 1604 or 1112, respectively, Figs. 1-2), and the second impeller tapers from a third diameter near a proximal end of the second impeller towards a fourth diameter near (e.g. impeller 1616 or 1118 taper towards the distal ends, Figs. 1-2) such that a second tip gap between an outer edge of the second impeller and an inner wall of the blood conduit is constant in the second tapering region (e.g. “each of the proximal and distal impellers are positioned within respective housings and configured to maintain a precise, consistent tip gap”, para. [0098], [0106]).
In reference to at least claim 39
Salahieh modified by Evans renders obvious a pump according to claim 1. Salahieh discloses wherein the second impeller is disposed in a constant diameter region of the blood conduit (e.g. embodiments in which the impellers are located within a constant diameter region of the blood conduit, Figs. 3A-3B).
In reference to at least claim 40
Salahieh modified by Evans renders obvious a pump according to claim 1. Salahieh discloses wherein a taper of the first tapering region matches the taper of the first impeller (e.g. impeller 1606 or 1116 taper towards the distal ends, Figs. 1-2, “each of the proximal and distal impellers are positioned within respective housings and configured to maintain a precise, consistent tip gap”, para. [0098], [0106]).
In reference to at least claim 42
Salahieh modified by Evans renders obvious a pump according to claim 38. Salahieh discloses wherein a taper of the second tapering region matches the taper of the second impeller (e.g. impeller 1616 or 1118 taper towards the distal ends, Figs. 1-2, “each of the proximal and distal impellers are positioned within respective housings and configured to maintain a precise, consistent tip gap”, para. [0098], [0106]).
Allowable Subject Matter
Claims 41 and 43 are objected to as being dependent upon a rejected base claim and for the claim objections above, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims and amended as suggested to overcome the claim objections above.
Response to Arguments
Claim Rejections under 35 USC 103
Claims 1-13,19-20 and 38-39
Applicant's arguments filed 8/18/2026 have been fully considered but they are not persuasive. Applicant argues “Salahieh does not teach or suggest impellers with a first diameter at a proximal end greater than a second diameter at a distal end. Evans does not cure the deficiency of Salahieh. As such, Applicant respectfully submits that neither Salahieh nor Evans, alone or in combination, teach each and every element of claim 1, and dependent claims 2-13, 19-20 and 38-39”, see pgs. 6-7 of the response filed 8/18/2026. This is not persuasive. Evans discloses an embodiment that includes first and second impellers at least partially disposed in the blood conduit (e.g. impellers 3002 and 3004 disposed in 1902, Fig. 30), in which the first impeller tapers from a first diameter at a proximal end of the first impeller towards a second diameter at a distal end of the first impeller, wherein the first diameter is greater than the second diameter (e.g. impellers 3002 and 3004 taper from a first diameter on an end to a second diameter on another end in which the first diameter is greater than a second diameter, see Figs. 30-35, proximal” and “distal” would depend on how the device is oriented). Therefore, utilizing the teachings within Evans, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the pump of Salahieh to include the first and second impellers having first and second average diameters that are different and a first impeller that tapers from a first diameter at a proximal end of the first impeller towards a second diameter at a distal end of the first impeller, wherein the first diameter is greater than the second diameter in order to provide a desired blood flow and relative amounts of blood flow from the inlets (‘831, para. [0192]).
Conclusion
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/JENNIFER L GHAND/Examiner, Art Unit 3796
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