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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 10 June 2026 has been entered.
Claim Status
Applicant’s Remarks and Amendments filed 13 May 2026 have been entered. Claims 1-4, 6, 8-14, and 21-26 are pending.
Response to Arguments
Applicant’s arguments with respect to claims 1, 11, and 21 have been considered but are moot because the new ground of rejection does not rely on any interpretation of references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “distal end of the impeller housing” of claim 1 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: Claim 1 has been amended to recite, “a cannula coupled to a distal end of the impeller housing and extending distally therefrom”. Fig. 2 of Applicant’s disclosure appears to teach this, however there is no support found in the Specification for this amendment.
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.
Claims 1-4, 8-11, 14, 21-24, and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Campbell et al. (US 2013/0331639 A1), “Campbell” in view of Salahieh et al. (US 2019/0344001 A1), “Salahieh”.
Regarding claim 1, Campbell teaches a percutaneous circulatory support device, comprising: an impeller (Fig. 2A, impeller 20) disposed within an impeller housing (Fig. 3, expandable portion 44 in which impeller 20 resides [0066]), the impeller being rotatable relative to the impeller housing (Figs. 8A-B, impeller 20 is stored within storage housing 46) to cause blood to flow through the impeller housing (Fig. 2A, rotatable drive shaft 26 imparts a rotational drive to the impeller [0059]); a cannula (Fig. 2B, cannula 40) coupled to a distal end of the impeller housing and extending distally therefrom (Figs. 8A-B, cannula 40 comprises storage housing 46 for storing impeller 20 [0068] and is moved distally to cover the impeller 20 (i.e., impeller is distal to housing) [0086]), the cannula (Fig. 2B, cannula 40) having a first portion (Fig. 2B, expandable portion 44), an intermediate portion (Fig. 3, region comprising discharge struts 58), and a second portion (Fig. 2B, non-expandable portion 42); wherein the cannula comprises a shape set curved portion within the intermediate portion of the cannula (Fig. 3, mesh 48 material within the region comprising discharge struts 58 of cannula 40 is “shape set” using heat treatment [0072] (i.e., can be shape set to be in a curved configuration)); wherein the cannula includes a plurality of slots extending around the cannula and disposed along the first portion (Fig. 7A, mesh 48 forms a continuous duct (i.e., extends 360 degrees around device) [0069]), the curved portion of the intermediate portion (Fig. 3, mesh 48 material of cannula 40 can be “shape set” using heat treatment [0072] (i.e., can be shape set to be in a curved configuration)), and the second portion of the cannula (Fig. 2B, expandable portion 44 comprises mesh 48), the plurality of slots configured such that the first portion of the cannula is defined by a first stiffness and the second portion of the cannula is defined by a second stiffness (Fig. 2B, expandable portion 44 comprises mesh 48 which defines radial stiffness and bending characteristics [0069]), the first stiffness being different than the second stiffness (Fig. 2B, non-expandable portion 42 is made from different material than expandable portion 44 (i.e., different stiffness characteristics) [0072]), but fails to teach the plurality of slots having a higher density within the first portion and the second portion relative to a density of the plurality of slots within the curved portion of the intermediate portion of the cannula.
Salahieh teaches an intravascular fluid movement device wherein the plurality of slots having a higher density within the first portion and the second portion (Fig. 17, proximal end 1128 and distal end 1126 comprise first and second expandable members 1108, 1110 which define apertures 1130) relative to a density of the plurality of slots within the curved portion of the intermediate portion of the cannula (Fig. 17, central region 1113 is axially in between expandable members 1108, 1110 (i.e., does not comprise expandable members and therefore, no apertures) [0135]; further central region 1113 is formed from material that allows for radial deformation of the region [0137]). Salahieh discloses that the conduit may be designed with a looseness that causes a greater degree of compliance to more easily adapt to heart structures [0137]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the device taught by Campbell with the proximal, distal, intermediate portions, and their slot densities in order to provide a device that minimizes point stresses in the valve by being more adaptable.
Regarding claim 2, Campbell teaches wherein the first portion (Fig. 2B, expandable portion 44) is defined as a distal portion of the cannula (Fig. 1, distal portion of blood pump 10 comprises an expandable portion 44 [0010]) and the second portion (Fig. 2B, non-expandable portion 42) is defined as a proximal portion of the cannula (Fig. 1, proximal portion of blood pump 10 includes a conduit with a fixed diameter [0010] (i.e., non-expandable portion 42)), and the first stiffness is less than the second stiffness (Fig. 2B, expandable portion 44 moves between collapsed and expanded configuration [0066] whereas non-expandable portion 42 maintains one diameter [0010]).
Regarding claim 3, Campbell teaches wherein the plurality of slots includes a plurality of openings (Figs. 14A-B, mesh 48 includes circumferential rings 51 which comprise space between them [0070-0071]), and wherein the first portion of the cannula (Fig. 2B, expandable portion 44) has a reduced density of the plurality of openings relative to a density of a plurality of openings at the second portion of the cannula (Fig. 7A, mesh 48 comprising circumferential rings 51 and axial connectors 53 can be non-uniform such as certain regions having enhanced or reduced mesh density [0071]).
Regarding claim 4, Campbell teaches the plurality of slots on the cannula (Fig. 7A, mesh 48 of cannula 40), but fails to teach a plurality of circular openings extending through the cannula.
Salahieh teaches an intravascular fluid movement device comprising a plurality of circular openings extending through the cannula (Fig. 20C, inflow openings 1522). Salahieh discloses the plurality of openings are configured to allow sufficient blood flow even when the tip is pushed against heart tissue [0168]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the cannula taught by Campbell with the circular openings taught by Salahieh in order to promote sufficient blood flow through the device.
Regarding claim 8, Campbell teaches wherein the distal portion of the cannula (Fig. 2B, expandable portion 44) comprises an atraumatic tip element (Fig. 3, cap 134).
Regarding claim 9, Campbell teaches wherein the cannula (Fig. 2B, cannula 40) includes a coating (Fig. 13D, mesh 48 comprises coating 50) configured to reduce the coefficient of friction of the cannula and create a seal over the plurality of slots (Fig. 13D, coating 50 reduces irritation to blood vessel wall by providing a smooth outer surface [0073]).
Regarding claim 10, Campbell teaches wherein the cannula (Fig. 2B, cannula 40) is composed of one of nitinol, stainless steel, Inconel and MP35N (Fig. 2B, cannula 40 is formed from nitinol [0072]).
Regarding claim 11, Campbell teaches a percutaneous circulatory support device, the device comprising: a percutaneous circulatory support device (Fig. 1, blood pump 10), the device including, an impeller (Fig. 2A, impeller 20) disposed within an impeller housing (Fig. 3, expandable portion 44 in which impeller 20 resides [0066]), the impeller being rotatable relative to the impeller housing to cause blood to flow through the impeller housing (Fig. 2A, rotatable drive shaft 26 imparts a rotational drive to the impeller [0059]), a motor configured to rotatably drive the impeller within the impeller housing (motor (not shown) imparts a rotational drive to the impeller [0059]); and a cannula (Fig. 2B, cannula 40) coupled to a distal end of the impeller housing and extending distally therefrom (Figs. 8A-B, cannula 40 comprises storage housing 46 for storing impeller 20 [0068] and is moved distally to cover the impeller 20 (i.e., impeller is distal to housing) [0086]), the cannula having a proximal portion (Fig. 2B, non-expandable portion 42), a distal portion (Fig. 2B, expandable portion 44), and an intermediate portion therebetween (Fig. 3, region comprising discharge struts 58); wherein the cannula comprises a shape set curved portion within the intermediate portion of the cannula (Fig. 3, mesh 48 material within the region comprising discharge struts 58 of cannula 40 is “shape set” using heat treatment [0072]); and wherein the cannula (Fig. 2B, cannula 40) includes a plurality of slots extending through the cannula and disposed along at least the distal portion, the proximal portion, and the curved portion of the intermediate portion of the cannula (Fig. 2B, expandable portion 44 comprises mesh 48 which defines radial stiffness and bending characteristics [0069]), wherein the plurality of slots is formed from laser cutting (Fig. 2B, mesh 48 includes laser cut voids [0070]), the distal portion (Fig. 2B, expandable portion 44) of the cannula being defined by a first stiffness (Fig. 1, distal portion of blood pump 10 comprises an expandable portion 44 [0010]), and the proximal portion (Fig. 2B, non-expandable portion 42) of the cannula being defined by a second stiffness that is different than the first stiffness (Fig. 2B, expandable portion 44 moves between collapsed and expanded configuration [0066] whereas non-expandable portion 42 maintains one diameter [0010]), but fails to teach the plurality of slots having a higher density within the proximal portion and the distal portion relative to a density of the plurality of slots in the curved portion of the intermediate portion of the cannula.
Salahieh teaches an intravascular fluid movement device wherein the plurality of slots having a higher density within the proximal portion and the distal portion (Fig. 17, proximal end 1128 and distal end 1126 comprise first and second expandable members 1108, 1110 which define apertures 1130) relative to a density of the plurality of slots in the curved portion of the intermediate portion of the cannula (Fig. 17, central region 1113 is axially in between expandable members 1108, 1110 (i.e., does not comprise expandable members and therefore, no apertures) [0135]; further central region 1113 is formed from material that allows for radial deformation of the region [0137]). Salahieh discloses that the conduit may be designed with a looseness that causes a greater degree of compliance to more easily adapt to heart structures [0137]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the device taught by Campbell with the proximal, distal, intermediate portions, and their slot densities in order to provide a device that minimizes point stresses in the valve by being more adaptable.
Regarding claim 14, Campbell teaches wherein the distal portion of the cannula (Fig. 2B, expandable portion 44) is operatively coupled to an atraumatic tip (Fig. 3, cap 134).
Regarding claim 21, Campbell teaches a percutaneous circulatory support device, comprising: a housing (Fig. 3, expandable portion 44 in which impeller 20 resides [0066]); and a cannula (Fig. 2B, cannula 40) coupled to a distal end of the impeller housing and extending distally therefrom (Figs. 8A-B, cannula 40 comprises storage housing 46 for storing impeller 20 [0068] and is moved distally to cover the impeller 20 (i.e., impeller is distal to housing) [0086]), the cannula having a first portion (Fig. 2B, expandable portion 44), an intermediate portion (Fig. 3, region comprising discharge struts 58) and a second portion (Fig. 2B, non-expandable portion 42); wherein the cannula comprises a shape set curved portion within the intermediate portion of the cannula (mesh 48 material of cannula 40 can be “shape set” using heat treatment [0072] (i.e., can be shape set to be in a curved configuration)); wherein the cannula includes a plurality of slots extending around the cannula and disposed along the first portion (Fig. 2B, expandable portion 44 comprises mesh 48 which defines radial stiffness and bending characteristics [0069]), the curved portion (Fig. 7A, mesh 48 comprising cells forms a continuous duct (i.e., extends 360 degrees around device) [0069]), and the second portion of the cannula (Fig. 2B, expandable portion 44 comprises mesh 48), the plurality of slots configured such that the first portion of the cannula is defined by a first stiffness (Fig. 1, distal portion of blood pump 10 comprises an expandable portion 44 [0010]) and the second portion of the cannula body is defined by a second stiffness, the first stiffness being different than the second stiffness (Fig. 2B, expandable portion 44 moves between collapsed and expanded configuration [0066] whereas non-expandable portion 42 maintains one diameter [0010]), but fails to teach wherein the plurality of slots extending around the cannula and disposed along the second portion of the cannula, and wherein the plurality of slots have a higher density within the first portion and the second portion relative to a density of the plurality of slots within the curved portion of the cannula.
Salahieh teaches an intravascular fluid movement device wherein the plurality of slots have a higher density within the first portion and the second portion (Fig. 17, proximal end 1128 and distal end 1126 comprise first and second expandable members 1108, 1110 which define apertures 1130) relative to a density of the plurality of slots within the curved portion of the cannula (Fig. 17, central region 1113 is axially in between expandable members 1108, 1110 (i.e., does not comprise expandable members and therefore, no apertures) [0135]; further central region 1113 is formed from material that allows for radial deformation of the region [0137]). Salahieh discloses that the conduit may be designed with a looseness that causes a greater degree of compliance to more easily adapt to heart structures [0137]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the device taught by Campbell with the proximal, distal, intermediate portions, and their slot densities in order to provide a device that minimizes point stresses in the valve by being more adaptable.
Regarding claim 22, Campbell teaches wherein the plurality of slots is formed by laser cutting (Fig. 2B, mesh 48 can be cut using a laser [0072]).
Regarding claim 23, Campbell teaches wherein the first portion (Fig. 2B, expandable portion 44) is defined as a distal portion of the cannula (Fig. 1, distal portion of blood pump 10 comprises an expandable portion 44 [0010]) and the second portion (Fig. 2B, non-expandable portion 42) is defined as a proximal portion of the cannula (Fig. 1, proximal portion of blood pump 10 includes a conduit with a fixed diameter [0010] (i.e., non-expandable portion 42)), and the first stiffness is less than the second stiffness (Fig. 2B, expandable portion 44 moves between collapsed and expanded configuration [0066] whereas non-expandable portion 42 maintains one diameter [0010]).
Regarding claim 24, Campbell teaches wherein the plurality of slots (Fig. 7A, cells of mesh 48) includes a plurality of openings extending through the cannula (Fig. 7A, mesh 48 forms a continuous duct (i.e., extends through device) [0069]).
Regarding claim 26, Campbell teaches wherein the cannula (Fig. 2B, cannula 40) includes a coating (Fig. 13D, mesh 48 comprises coating 50) configured to reduce the coefficient of friction of the cannula and create a seal over the plurality of slots (Fig. 13D, coating 50 reduces irritation to blood vessel wall by providing a smooth outer surface [0073]).
Claims 6 and 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Campbell et al. (US 2013/0331639 A1), “Campbell” in view of Stotz et al. (US 2021/0268264 A1), “Stotz”.
Regarding claim 6, Campbell teaches the plurality of slots on the cannula (Fig. 7A, mesh 48 of cannula 40), but fails to teach a spiral cut extending around and along the cannula.
Stotz teaches a line device for blood flow comprising a spiral slot extending around and along the cannula (Fig. 2, stiffening recesses 225 are disposed helically around structural section 220 [0052]). Stotz discloses that the stiffening recesses are formed to change the stiffness of the main body [0051]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the cannula taught by Campbell with the spiral slots taught by Stotz in order to alter the stiffness of the cannula as needed.
Regarding claim 12, Campbell teaches wherein the intermediate portion defines a third portion having a third stiffness.
Stotz teaches a line device for blood flow wherein the cannula comprises a curved portion in the intermediate portion (Fig. 1, line device 105), and wherein the intermediate portion defines a third portion having a third stiffness (Fig. 1, line device 105 comprises stiffening recess 225 which changes the stiffness of the main body 205 [0051] compared to head unit 110 and outlet unit 115). Stotz discloses that the stiffening recesses are formed to change the stiffness of the main body [0051]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the cannula taught by Campbell with the stiffness of the intermediate portion taught by Stotz in order to alter the stiffness of the cannula as needed.
Regarding claim 13, Campbell teaches the first stiffness (Fig. 1, distal portion of blood pump 10 comprises an expandable portion 44 [0010]) and the second stiffness (Fig. 2B, expandable portion 44 moves between collapsed and expanded configuration [0066] whereas non-expandable portion 42 maintains one diameter [0010]) but fails to teach wherein the third stiffness is different than the first stiffness and the second stiffness.
Stotz teaches a line device for blood flow wherein the third stiffness is different than the first stiffness and the second stiffness (Fig. 1, line device 105 comprises stiffening recess 225 which changes the stiffness of the main body 205 [0051] compared to head unit 110 and outlet unit 115). Stotz discloses that the stiffening recesses are formed to change the stiffness of the main body [0051]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the cannula taught by Campbell with the third stiffness taught by Stotz in order to alter the stiffness of the cannula as needed.
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Campbell et al. (US 2013/0331639 A1), “Campbell” in view of Salahieh et al. (US 2019/0344001 A1), “Salahieh” and further in view of Stotz et al. (US 2021/0268264 A1), “Stotz”.
Regarding claim 25, Campbell teaches the plurality of slots and the cannula (Fig. 7A, mesh 48 of cannula 40), but Campbell in view of Salahieh fails to teach a spiral cut extending around and along the cannula.
Stotz teaches a line device for blood flow comprising a spiral slot extending around and along the cannula (Fig. 2, stiffening recesses 225 are disposed helically around structural section 220 [0052]). Stotz discloses that the stiffening recesses are formed to change the stiffness of the main body [0051]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the cannula taught by Campbell with the spiral slots taught by Stotz in order to alter the stiffness of the cannula as needed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GABRIELLA G. B. RIOS whose telephone number is (703)756-5958. The examiner can normally be reached M-Th 9:00AM-6:00PM CST.
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/G.G.R./ Examiner, Art Unit 3774
/JERRAH EDWARDS/ Supervisory Patent Examiner, Art Unit 3774
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