DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 4/29/2026 has been entered.
Response to Arguments
Applicant's amendments filed 4/29/2026 merit new grounds for rejection in view of Korkuch et al. (U.S. Patent Application Publication No. 2023/0085812).
The Korkuch reference teaches wherein a shroud itself has material properties causing the regions to have different stiffnesses (¶[0224], and specifically ¶[0193] coating over a proximal portion and “(t)he material for coating the frame can be varied specific to the performance requirements of the expandable sheath body”). Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the expansible and collapsible shroud of Campbell as modified to use a frame and coating construction for varying material properties, as taught by Korkuch, because it provides an advantage of thin-walled construction while retaining axial stiffness and bending flexibility with kink resistance that is not possible with other constructions (Korkuch ¶[0194]).
Applicant’s arguments appear to be moot as they because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Applicant’s remarks appear to be confined to whether Campbell and Keenan teach newly amended subject matter.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 49-59, 61-63, and 68-70 is/are rejected under 35 U.S.C. 103 as being unpatentable over Campbell et al. (U.S. Patent Application Publication No. 2019/0184078) hereinafter referred to as Campbell; in view of Keenan et al. (U.S. Patent Application Publication No. 2018/0064862) hereinafter referred to as Keenan; in view of Korkuch et al. (U.S. Patent Application Publication No. 2023/0085812) hereinafter referred to as Korkuch
Regarding claim 49, Campbell teaches a blood pump (¶[0006] heart pump), comprising:
a shroud that defines a blood lumen (¶[0039], ¶[0052]) impeller assembly conveys blood), the shroud comprising a proximal impeller region (Fig. 2, proximal region of impeller section) and a central region positioned distally to the proximal impeller region (Fig. 2, any of the space distal to the most proximal region of the impeller section).
a proximal impeller disposed at least partially within the proximal impeller region of the shroud (Fig. 13A-B, impeller hub element 208).
Campbell does not teach that the shroud is expandable and collapsible with a proximal region that has a first stiffness greater than the stiffness of a central region.
Attention is brought to the Keenan reference, which teaches a shroud, which is expandable and collapsible (¶[0068] expandible and collapsible cannula) with a proximal region that has a first stiffness greater than the stiffness of a central region (Fig. 15, ¶[0088] support member 328).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the blood pump of Campbell to include an expansible and collapsible shroud with different stiffness along the length of the shroud, as taught by Keenan, because it prevents unacceptable variance in the gap between the tip of the impeller and the inside surface of the cannula (Keenan ¶[0088]).
Campbell as modified does not teach wherein the shroud itself has material properties causing the regions to have different stiffnesses.
Attention is brought to the Korkuch reference, which teaches wherein a shroud itself has material properties causing the regions to have different stiffnesses (¶[0224], and specifically ¶[0193] coating over a proximal portion and “(t)he material for coating the frame can be varied specific to the performance requirements of the expandable sheath body”).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the expansible and collapsible shroud of Campbell as modified to use a frame and coating construction for varying material properties, as taught by Korkuch, because it provides an advantage of thin-walled construction while retaining axial stiffness and bending flexibility with kink resistance that is not possible with other constructions (Korkuch ¶[0194]).
Regarding claim 50, Campbell as modified teaches the blood pump of claim 49.
Keenan further teaches wherein the expandable and collapsible shroud includes a plurality of helical arms to define at least one helical region (Fig. 4, 15, helical arms structure, ¶[0071]).
Regarding claim 51, Campbell as modified teaches the blood pump of claim 50.
Keenan further teaches wherein at least one helical region axially overlaps with the proximal impeller (Fig. 4, 15, impeller element 112).
Regarding claim 52, Campbell as modified teaches the blood pump of claim 50.
Keenan further teaches wherein a plurality of helical regions axially overlaps with the proximal impeller (Fig. 4, 15, impeller element 112, coaxial helical structure of cannula has plurality of helical regions).
Regarding claim 53, Campbell as modified teaches the blood pump of claim 50.
Keenan further teaches wherein at least one of the plurality of helical arms extends between adjacent non-helical regions (Fig. 4, 11, 15, the helical portion extends through all regions of, e.g. non helical support member 328).
Regarding claim 54, Campbell as modified teaches the blood pump of claim 50.
Keenan as modified further teaches wherein at least one helical region extends between adjacent non-helical regions of the expandable and collapsible shroud (Fig. 4, 11, 15, the helical portion extends through all regions of, e.g. non helical support member 328).
Regarding claim 55, Campbell as modified teaches the blood pump of claim 49.
Keenan further teaches wherein the proximal impeller region of the expandable and collapsible shroud includes a plurality of helical arms to define at least one helical region (Fig. 4, plurality of helical arms overlapping proximal impeller region).
Regarding claim 56, Campbell as modified teaches the blood pump of claim 55.
Keenan further teaches wherein at least one helical region axially overlaps with the proximal impeller (Fig. 4, plurality of helical arms coaxial and overlapping proximal impeller region).
Regarding claim 57, Campbell as modified teaches the blood pump of claim 55.
Keenan further teaches wherein a plurality of helical regions axially overlaps with the proximal impeller (Fig. 4, plurality of helical arms coaxial and overlapping proximal impeller region).
Regarding claim 58, Campbell as modified teaches the blood pump of claim 55.
Keenan further teaches wherein at least one of the plurality of helical arms extends between adjacent non-helical regions (Fig. 4, 11, 15, the helical portion extends through all regions of, e.g. non helical support member 328).
Regarding claim 59, Campbell as modified teaches the blood pump of claim 50.
Keenan further teaches wherein the proximal impeller region comprises at least one helical region (Fig. 4, 11, 15, helical arms form a plurality of helical regions) and the central region comprises at least one non-helical region (Fig. 11, 15, support member 328 is not helical and more distal than the proximal impeller region therefore meeting the requirement of the central region).
Regarding claim 61, Campbell as modified teaches the blood pump of claim 49.
Keenan further teaches wherein the expandable and collapsible shroud comprises nitinol (¶[0084] expandable nitinol structure).
Regarding claim 62, Campbell as modified teaches the blood pump of claim 49.
Keenan further teaches wherein the expandable and collapsible shroud comprises a polymeric structure (¶[0087] polymeric structure).
Regarding claim 63, Campbell as modified teaches the blood pump of claim 62.
Keenan further teaches wherein a first durometer of the proximal impeller region is greater than a second durometer of the central region (Fig. 15, ¶[0088] support member 328 greater stiffness in reinforced region).
Regarding claim 68, Campbell as modified teaches the blood pump of claim 49.
Keenan further teaches wherein the greater stiffness of the proximal impeller region is configured to maintain concentricity between the proximal impeller and the expandable and collapsible shroud (Fig. 15, ¶[0080], ¶[0088] support member 328).
Regarding claim 69, Campbell as modified teaches the blood pump of claim 49.
Keenan further teaches the proximal impeller region has a first shroud pattern (Fig. 15, ¶[0088] support member 328 has a first pattern) and the central region has a second shroud pattern (Fig. 15, shroud beyond support member 328 has a second pattern), the first shroud pattern causing the proximal impeller region to have greater stiffness than the central region (¶[0088] pattern of support member provides the support).
Regarding claim 70, Campbell as modified teaches the blood pump of claim 49.
Korkuch further teaches wherein the proximal impeller region has different material properties than the central region (¶[0224], and specifically ¶[0193] coating over a proximal portion and “(t)he material for coating the frame can be varied specific to the performance requirements of the expandable sheath body”).
Claim(s) 60 and 64-65 is/are rejected under 35 U.S.C. 103 as being unpatentable over Campbell, Keenan, and Korkuch as applied to claim 49 above, and further in view of Schwammenthal et al. (U.S. Patent Application Publication No. 2020/0254161) hereinafter referred to as Schwammenthal.
Regarding claim 60, Campbell as modified teaches the blood pump of claim 49.
Campbell as modified does not teach comprising a membrane coupled to the expandable and collapsible shroud to define a fluid conduit that is impermeable to blood.
Attention is brought to the Schwammenthal reference, which teaches a membrane coupled to an expandable and collapsible shroud to define a fluid conduit that is impermeable to blood (¶[0357]).
It would have been obvious to one of ordinary skill in the art at the time of filing to include a membrane coupled to a shroud, as taught by Schwammenthal, because it lowers a blood pressure when necessary while allowing significant blood flow (Schwammenthal ¶[0354]).
Regarding claims 64-65, Campbell as modified teaches the blood pump of claim 49.
Campbell as modified does not teach wherein the expandable and collapsible shroud comprises a distal impeller region positioned distally to the central region, wherein the distal impeller region has a third stiffness that is greater than the second stiffness of the central region, the blood pump further comprising a distal impeller disposed at least partially within the distal impeller region of the shroud.
However, Keenan further teaches a shroud, which is expandable and collapsible (¶[0068] expandible and collapsible cannula) with an impeller region that has a first stiffness greater than the stiffness of a central region (Fig. 15, ¶[0088] support member 328).
Keenan does not teach two impellers or two impeller regions separated by a central region.
Attention is brought to the Schwammenthal reference, which teaches the expandable and collapsible shroud comprises a distal impeller region positioned distally to the central region, the blood pump further comprising a distal impeller disposed at least partially within the distal impeller region of the shroud (Fig. 1C, two impellers, two shrouds, ¶[0313]), therefore showing that two substantially identical impeller regions are known in the art.
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the catheter of Campbell as modified to include a duplication of the impeller, impeller region, and shroud properties of Keenan, therefore the distal impeller region has a third stiffness that is greater than the second stiffness of the central region wherein the first stiffness of the proximal impeller region is substantially similar to the third stiffness of the distal impeller region, because the courts have held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960).
Claim(s) 66-67 is/are rejected under 35 U.S.C. 103 as being unpatentable over Campbell, Keenan, and Korkuch as applied to claim 49 above, and further in view of Korakianitis et al. (U.S. Patent Application Publication No. 2019/0321529) hereinafter referred to as Korakinitis.
Regarding claims 66-67, Campbell as modified teaches the blood pump of claim 49.
Campbell as modified does not teach a tip gap between the proximal impeller and the expandable and collapsible shroud ranging from 0.01 mm to 1 mm.
Keenan teaches that the tip gap between the impeller and expandable and collapsible shroud is critical and should be maintained.
Attention is brought to the Korakinitis reference, which teaches wherein a proximal impeller region is configured to maintain a tip gap between the proximal impeller and a shroud ranging from 0.5 mm to 1 mm (¶[0233] 710 µm, e.g.).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the catheter of Campbell as modified to include a tip gap range of 0.5 mm to 1 mm as taught by Korakinitis, because a minimal but stable gap reduces backflow and may improve the efficiency of the device (Korakinitis ¶[0318]).
Conclusion
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/AMANDA L STEINBERG/ Examiner, Art Unit 3792
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