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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 7/29/2025 has been entered. Claims 1-3 and 5 are currently pending.
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) 1-3 and 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2013/0303831 to Evans (Evans) (previously cited) in view of US Patent No. 8,777,832 to Wang et al. (Wang) and US 2017/0100527 to Schwammenthal et al. (Schwammenthal) (all previously cited).
In reference to at least claim 1
Evans discloses an intravascular blood pump (e.g. Figs. 30-35), comprising: a collapsible housing comprising a fluid lumen (e.g. cannula 1902, Fig. 30, para. [0172]; collapsible, para. [0110]), the fluid lumen having a distal end near an inlet of the blood pump and a proximal end near an outlet of the blood pump (e.g. cannula 1902 has a distal end and a proximal end, Figs. 30-35; distal end may act as on inlet and the proximal end acts as an outlet or vice versa, para. [0183]); a collapsible distal impeller axially spaced from a collapsible proximal impeller (e.g. distal and proximal impellers include impellers 3002 and 3004 and drive shafts 3010 and 3011, Figs. 30-35; collapsible, foldable, expandable etc. para. [0195]), at least a portion of the distal impeller and the proximal impeller disposed axially between the distal end and the proximal end of the fluid lumen (e.g. distal and proximal impellers includes impellers 3002 and 3004 and drive shafts 3010 and 3011 are disposed axially between the distal and proximal end of the fluid lumen, Figs. 30-35), wherein the collapsible proximal impeller has a proximal end that extends further proximally than the proximal end of the fluid lumen (e.g. drive shafts 3010 and 3011 which are part of the “impellers” extend proximally from a proximal end of fluid lumen, Figs. 30-35), wherein the distal impeller has an expanded configuration in an expanded state, and the proximal impeller has an expanded configuration in an expanded state (e.g. each impeller has an expanded configuration, Figs. 30-35), and wherein the expanded configuration of the distal impeller is different than the expanded configuration of the proximal impeller (e.g. The various segments can be the same length, or different, and they can have the same diameter or different diameters, para. [0192]). Evans further discloses wherein the proximal impeller has a distal end and the distal impeller has a proximal end (e.g. Figs. 30-35), wherein the proximal impeller is shaped, dimensioned and positioned to provide predominantly centrifugal flow near the outlet (e.g. para. [0186]-[0187]) and that the gap between the impellers can be adjusted as desired (e.g. para. [0192]), and that the impellers may have the same or different lengths, diameters, blades, materials etc. (e.g. para. [0192]). Evans further discloses that the cover or cannula 1902 may have two inlets provided on opposite ends, one inlet provided at an end of the cannula, one inlet and one outlet provided on opposite ends or multiple openings acting as inlets (e.g. “In some embodiments, the expandable heart pump of the present disclosure has two inlets that are positioned opposite from one another, at opposite ends of the cannula 1902. In other embodiments, the expandable heart pump of the present disclosure may have one inlet, such as where one end of the cannula 1902 is closed off”, para. [0183]) and that the expandable member is configured to engage with blood vessels such as the superior and inferior vena cava (e.g. para. [0076], [0173]).
However, Evans but does not explicitly disclose that the fluid lumen is impermeable to blood or wherein the distal impeller is shaped and dimensioned to provide predominantly axial flow near the inlet and a distance between the distal end of the proximal impeller and the proximal end of the distal impeller along a longitudinal axis of the collapsible housing is from 4 cm to 14cm.
Wang, within the same field of endeavor of cardiac blood flow pumps, discloses a pump that can be placed within the superior and inferior vena cava (e.g. Fig. 6b) that includes a first set of impellers near an inlet (e.g. 12 and 14, Figs. 3, 6b) which create axial fluid flow (e.g. Col. 4, ll. 19-23, 35-39) and an impeller near an outlet (e.g. 18, Figs. 3, 6b) that provides a predominately centrifugal fluid flow (e.g. Col. 4, ll. 27-30, 35-39). These pump designs provide Fontan circulation by providing satisfactory blood flow from both the superior and inferior vena cava into the pulmonary artery (e.g. Col. 2, ll. 36-39).
Schwammenthal, within the same field of endeavor of cardiac blood pumps, teaches a blood pump that includes expandable distal and proximal impellers (e.g. 24D, 24U, Fig. 1A-1C) which discloses spacing the impellers a distance of more than 3 cm and/or less than 18 cm to enhance blood flow from the renal veins into the subject’s vena cava (e.g. para. [0187]). Schwammenthal further discloses providing a blood-impermeable sleeve to provide desired blood flow (e.g. “a blood-impermeable material”, para. [0214], “a blood-impermeable sleeve”, para. [0217]).
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 pump of Evans to include the distal impeller(s) near the inlet(s) being shaped and dimensioned to provide predominantly axial flow near the inlet, as taught by Wang, while the proximal impeller near the outlet is shaped and dimensioned to provide predominantly centrifugal flow in order to provide a single pump that provides Fontan circulation by providing satisfactory blood flow from both the superior and inferior vena cava into the pulmonary artery while allowing mobility and improved comfort (e.g. Col. 2, ll. 36-39, 45-47). Further, 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 pump of Evans modified by Wang to include the cover or cannula being made of an blood-impermeable material and a distance between the distal end of the proximal impeller and the proximal end of the distal impeller along a longitudinal axis of the collapsible housing being between 4-14 cm, as taught by Schwammenthal, in order to utilize the pump to enhance blood flow into the vena cava.
In reference to at least claim 2
Evans modified by Wang and Schwammenthal renders obvious a device according to claim 1. Evans further discloses wherein the collapsible distal impeller has a distal blade and the proximal impeller has a proximal blade (e.g. distal and proximal impellers 3002 and 3004 include blades, Figs. 30-35), wherein the distal blade has a different pitch than the proximal blade (e.g. the blades of the impeller can include any desired number of blades with any desired number of impeller segments including blades with different pitches, Figs. 35A-35F, para. [0194]; further disclosed that the blade angle can be adjusted to create the desire pump flow, 3608, Fig. 36, para. [0204] and that the blade angle can vary based on position of the blade in reference to the inlet and out, para. [0098]-[0100]).
In reference to at least claim 3
Evans modified by Wang and Schwammenthal renders obvious a device according to claim 2. Evans further discloses wherein the distal blade is one of a plurality of distal blades, and wherein the proximal blade is one of a plurality of proximal blades, wherein the plurality of distal blades have a different pitch than each of the plurality of proximal blades (e.g. the blades of the impeller can include any desired number of blades with any desired number of impeller segments including blades with different pitches, Figs. 35A-35F, para. [0194]; further disclosed that the blade angle can be adjusted to create the desire pump flow, 3608, Fig. 36, para. [0204] and that the blade angle can vary based on position of the blade in reference to the inlet and out, para. [0098]-[0100]).
In reference to at least claim 5
Evans modified by Wang and Schwammenthal renders obvious a device according to claim 1. Evans further discloses wherein distal impeller and proximal impeller are adapted and configured to move fluid in the same direction (e.g. impellers 3002 and 3004 can be adjusted to achieve the desired blood flow and so can move in the same direction, para. [0192]).
Response to Arguments
Applicant's arguments filed 7/29/2025 have been fully considered but they are not persuasive. It is noted that the rejection has been modified to show where the amended claim language is taught within the references. Applicant argues “It is not clear how the Examiner’s proposed modification would create a functional blood pump that achieves the goals stated by the Examiner. For example, if the Examiner is suggesting replacing proximal impeller segment 3002 of Evans with the rotor 10 from Fig. 6b of Wang, the blood pump would cease to function. Blood would be pulled into the pump from both ends, since distal impeller segment 3004 would still pull blood in from the inlet, but due to the design of the Wang impeller, blood would also be pulled in from the former outlet of the Evans device (via blades 20). Additionally, Evans positions both impeller segments within a cannula 1902, so the central impeller segment from Wang in the modified device would be positioned within the cannula, and that centrifugal blood would not be able to flow through the cannula (which is enclosed) but instead would perpetually circulate between impeller segments 20 within the cannula. Simply put, the proposed design would not work, and in fact would produce a blood pump that ceases to function and would not pass a flow of blood from one end of the pump to the other end.”, see p. 5 of response filed 7/29/2025. This is not persuasive. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Evans discloses that the impellers may have the same or different lengths, diameters, blades, materials etc. (e.g. para. [0192]) and that the proximal impeller is shaped, dimensioned and positioned to provide predominantly centrifugal flow near the outlet (e.g. para. [0186]-[0187]). Wang is used to teach a pump that includes a first set of impellers near an inlet (e.g. 12 and 14, Figs. 3, 6b) which create axial fluid flow (e.g. Col. 4, ll. 19-23, 35-39) that is used along with an impeller near an outlet (e.g. 18, Figs. 3, 6b) that provides a predominately centrifugal fluid flow (e.g. Col. 4, ll. 27-30, 35-39). Wang is used to teach that providing blades at a distal impeller shaped and dimensioned to provide predominantly axial flow near the inlet which can be used with other impellers which have blades that provide predominately centrifugal flow. The combined teaching would provide a distal impeller shaped and dimensioned to provide predominantly axial flow near the inlet with the proximal impeller shaped, dimensioned and positioned to provide predominantly centrifugal flow near the outlet already recited within Evans. Regarding “a collapsible housing comprising a fluid lumen that is impermeable to blood”, Schwammenthal further discloses providing a blood-impermeable sleeve to provide desired blood flow (e.g. “a blood-impermeable material”, para. [0214], “a blood-impermeable sleeve”, para. [0217]). Regarding “wherein the collapsible proximal impeller has a proximal end that extends further proximally than the proximal end of the fluid lumen”, Evans discloses an intravascular blood pump (e.g. Figs. 30-35) that includes a collapsible distal impeller axially spaced from a collapsible proximal impeller (e.g. impellers include impellers 3002 and 3004 and drive shafts 3010 and 3011 are disposed axially between the distal and proximal end of the fluid lumen, Figs. 30-35; collapsible, foldable, expandable etc. para. [0195]) in which the collapsible proximal impeller has a proximal end that extends further proximally than the proximal end of the fluid lumen (e.g. drive shafts 3010 and 3011 which are part of the “impellers” extend proximally from a proximal end of fluid lumen, Figs. 30-35).
Conclusion
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/JENNIFER L GHAND/Examiner, Art Unit 3796