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 December 4, 2025. Claims 1-13, 19-20 and 38-39 are currently pending.
Claim Objections
In view of the amendment filed on 12/4/2025 clarifying the language of claim 12 the objections made against claims 12-13 in the office action of 6/4/2025 has been withdrawn.
Claim 2 is objected to because of the following informalities: Claim 2, line 2 should recite similar to either –has an average diameter that is larger than an average diameter of the second impeller-- or –and the second impeller is a distal impeller, and wherein the proximal impeller has an average diameter that is larger than an average diameter of the distal impeller-- in order match the impellers recited in claim 1 and to avoid a lack of antecedent basis rejection. . Appropriate correction is required.
Claim Rejections - 35 USC § 112
In view of the amendment filed on 12/4/2025 clarifying the language of claim 13 and canceling claims 14-18 the 112 rejections made against claims 13-18 in the office action of 6/4/2025 has been withdrawn.
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 and 38-39 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) (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), and the first impeller tapers from a first diameter near a proximal end of the first impeller towards 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, respectively, that are different (e.g. impellers 3002 and 3004 have different diameters to provide a desired blood flow, para. [0192]).
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]). 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, 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 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).
Response to Arguments
Claim Rejections under 35 USC 102
Claims 1 and 10
Applicant’s arguments, see pgs. 6-7, filed 12/4/2025, with respect to the rejection(s) of claim(s) 1 and 10 under 35 USC 102 using Evans have been fully considered and are persuasive in view of the claim amendments regarding a first tapering region. Therefore, the 35 USC 102 rejection using Evans against claims 1 and 10 has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of US 2019/0143018 to Salahieh et al., see 103 rejection above. It is noted that the additional limitations within claim 1 are not identical to those recited within previous claims 14-15.
Claim Rejections under 35 USC 103
Claims 2-5,8-9 and 19-20
Regarding claims 2-5,8-9 and 19-20, applicant does not provide separate arguments for claims 2-5,8-9 and 19-20 and only states that the claims are allowable in view of the allowability of claim 1, see pg. 7 of response filed 12/4/2025. The arguments regarding claim 1 have been fully addressed above, therefore the arguments regarding claims 2-5,8-9 and 19-20 have been fully addressed within the response to the 102 rejection using Evans provided above.
Claims 6-7
Regarding claims 6-7, applicant does not provide separate arguments for claims 6-7 and only states that the claims are allowable in view of the allowability of claim 1, see pg. 7 of response filed 12/4/2025. The arguments regarding claim 1 have been fully addressed above, therefore the arguments regarding claims 6-7 have been fully addressed within the response to the 102 rejection using Evans provided above.
Claim 11
Regarding claim 11, applicant does not provide separate arguments for claim 11 and only states that the claims are allowable in view of the allowability of claim 1, see pg. 8 of response filed 12/4/2025. The arguments regarding claim 1 have been fully addressed above, therefore the arguments regarding claim 11 has been fully addressed within the response to the 102 rejection using Evans provided above.
Claims 12-13
Regarding claims 12-13, applicant does not provide separate arguments for claims 12-13 and only states that the claims are allowable in view of the allowability of claim 1, see pg. 8 of response filed 12/4/2025. The arguments regarding claim 1 have been fully addressed above, therefore the arguments regarding claims 11-12 have been fully addressed within the response to the 102 rejection using Evans provided above.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/JG/Examiner, Art Unit 3796
/Jennifer Pitrak McDonald/Supervisory Patent Examiner, Art Unit 3796
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