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 .
Response to Arguments
Applicant's arguments filed 3/2/2026 with respect to the rejection of Independent Claim 1 under 35 USC 103 as unpatentable over US 2014/0128659 A1 to Heuring et al. (“Heuring”) in view of US 2012/0178986 A1 to Campbell et al. (“Campbell ‘986”) as evidenced by Schmitz-Rode, T, Graf, J, Pfeffer, J. et al. An Expandable Percutaneous Catheter Pump for Left Ventricular Support: Proof of Concept. JACC. 2005 Jun, 45 (11) 1856–1861. (“Schmitz-Rode”) have been fully considered but they are not persuasive.
Applicant does not dispute the teachings of Heuring as applied in the Non-Final Office Action dated 11/28/205. The only point of contention is the limitation “and is configured to transfer between a rest position and an operating position, wherein, in the rest position, the diffuser is configured to abut against an outside of the housing apparatus in a folded or crimped configuration,” with respect to which the Examiner cites Campbell ‘986 as evidenced by Schmitz-Rode. Stated broadly, the Examiner’s position is that Heuring differs from the invention of Claim 1 in that Heuring’s diffuser is not collapsible, and as such is not configured in the manner required by the above-quoted limitation. The Examiner cites Campbell ‘986 as teaching a collapsible diffuser, and proposes to modify Heuring with the diffuser of Campbell ‘986 such that Heuring’s diffuser is collapsible. The Examiner acknowledges that based on the difference in positioning between the collapsible diffuser of Campbell ‘986 and that of Claim 1 (i.e., internal in Campbell ‘986 vs. external in Claim 1 and Huering), such a modification does not preclude the possibility that Campbell’s collapsed diffuser might–in its collapsed configuration–not be flush with the housing. While such non-flush positioning would defy logic, evidence is required of what logic it would defy. Accordingly, and for this limited purpose, the Examiner cites Schmitz-Rode. Applicant’s arguments miss this broader picture, and as such are not persuasive.
Applicant argues that “Schmitz-Rode is direction to compression of an expandable rotor locating within an expandable housing for sheath delivery, not to a diffuser structure and not to flow-guiding elements arranged downstream of outlet opening,” (Applicant’s Remarks at Pg. 8) and as such “does not disclose, teach, or suggest a diffuser that is folded or crimped along, or abuts, an outside surface of a housing apparatus and then transitions to an operating position to guide conveyed blood transversely to at least one outlet opening” (Applicant’s Remarks at Pg. 9). The Examiner agrees, but Applicant’s arguments miss the mark. As explained at Para. 11(a)(i) of the Non-Final Office Action dated 11/28/2025, Schmitz-Rode is pertinent only to the level of ordinary skill in the art (i.e., Schmitz-Rode is used to evidence the level of ordinary skill in the art). The Examiner states “…in modifying Heuring’s diffuser by replacing it with such a collapsible diffuser as taught by Campbell, one of ordinary skill in the art would configure the collapsible/expandable diffuser to abut against an outside of the housing apparatus to ensure the modification complies with known sizing constraints consistent with what is known to be technically feasible.” The limitations noted by Applicant are taught by Heuring and Campbell ‘986, and are not alleged to be taught by Schmitz-Rodes. Applicant’s arguments are thus not persuasive.
Applicant’s arguments to the effect that “Schmitz-Rode addresses a different technical problem than that solved by the present Application” because “Schmitz-Rode is concerned with enabling insertion of a pump by reducing the delivery configuration of the pump housing, whereas the present claims are directed to a diffused that is externally arranged around circumferential outlet openings to guide blood into a surrounding vessel region with reduced pressure loss” (Applicant’s Remarks at Pg. 9) are similarly unpersuasive. Heuring’s diffuser is precisely so-arranged for exactly the same purpose: the only difference is that Heuring’s diffuser is not collapsible. Campbell teaches a collapsible diffuser, and the Examiner states that since one of ordinary skill in the art would be privy to Schmitz-Rode’s manner of “enabling insertion of a pump by reducing the delivery configuration of the pump housing” (i.e., Schmitz-Rode is used as evidence of the level of ordinary skill in the art), modification of Heuring to include a collapsible diffuser such as that taught by Campbell ‘986 would necessarily result in the diffuser being “configured to abut against an outside of the housing apparatus in a folded or crimped configuration.” If the diffuser as-modified did not so-abut, the modification would contradict the knowledge of an ordinary artisan as evidenced by Schmitz-Rode because the device as modified would not comply with the design constraints typical of such pumps.
Applicant’s arguments regarding Independent Claims 15, 22 and 32 are similar to Applicant’s arguments regarding Claim 1. Applicant’s arguments have been fully considered but are not persuasive for the same reasons as explained above with respect to Claim 1.
Applicant’s arguments regarding dependent Claims 10, 12-13, 16-17, 19-21, 23, and 25-31 are based on Applicant’s arguments regarding Independent Claims 1, 15, 22 and 32. Applicant’s arguments have been fully considered but are not persuasive for the same reasons as explained above.
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.
Claims 1, 10, 12, 13, 14-17, 19, 20, 22, 23, 25, 26 and 28-32 are rejected under 35 U.S.C. 103 as being unpatentable over previously cited US 2014/0128659 A1 to Heuring et al. (“Heuring”) in view of previously cited US 2012/0178986 A1 to Campbell et al. (“Campbell ‘986”) as evidenced by Schmitz-Rode, T, Graf, J, Pfeffer, J. et al. An Expandable Percutaneous Catheter Pump for Left Ventricular Support: Proof of Concept. JACC. 2005 Jun, 45 (11) 1856–1861. (“Schmitz-Rode”). The rejection is maintained.
Regarding Independent Claim 1, Heuring discloses:
A cardiac pump housing device for guiding blood in a blood vessel, the device comprising: (Para. [0079], “This application describes systems and methods for using intravascular blood pumps, together with novel flow and pressure modification elements, to selectively augment, control and/or adjust the perfusion of targeted branch vessel(s) and/or end organ(s) in specific ways.”);
a housing apparatus configured to accommodate at least one component of a pump for conveying the blood through the housing apparatus, (Para. [0096], “FIG. 11 shows another embodiment of an intravascular pumping module, comprising a motor (108) driving a shaft (110) connected to an impeller (112). The impeller (112) lies inside the outlet housing (114) which is in turn connected to a flexible cannula (116) which is in turn connected to an inlet housing (118).”);
wherein the housing apparatus is configured to receive blood from an inlet hose, said inlet hose comprising at least one inlet opening configured to facilitate inflow of the blood, (Para. [0100], “Housing 114 may be provided with a top cover, or inflow cage, 118, which permits the passage of blood 81″ into housing 114, as it is drawn into, pumped, or pulled into housing 114 by the rotation of impeller 115.”);
and wherein the housing apparatus comprises at least one outlet opening arranged circumferentially around the circumference of the housing apparatus and configured to facilitate outflow of the blood received from the inlet hose and conveyed by the pump; (Fig. 23C, see Annotated Fig. 23C, below; Compare Heuring’s Fig. 23C with Fig. 1 of the Present Drawings);
and a diffuser configured to couple with the housing apparatus and/or the inlet hose, wherein the diffuser is arranged circumferentially around the at least one outlet opening of the housing apparatus, (Para. [0096], “The outlet housing comprises an intermediate flow director (122) and an outlet flow director or nozzle (124);” Para. [0120], “The following paragraphs discuss the flow and pressure modification elements and how they can be adjusted. Para. [0125], “The configuration of the outlet of the device ;”may be adjusted in a number of ways to minimize reverse bypass flow, maximize efficiency, maximize auto-entrainment and total flow, or alter other parameters of performance;” Fig. 23C shows such a configuration; see Annotated Fig. 23C, below; Para. [0129], “Elements like diffusers or porous media with certain characteristics may also be used to condition flow and pressure upstream or downstream of the nozzle;” Compare Heuring Fig. 23C with Fig. 3A of the Present Drawings);
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and wherein, in the operating position, the diffuser is configured to guide the conveyed blood transversely to the at least one outlet opening after the conveyed blood has passed through the at least one outlet opening (Para. [0128], “Further, the outlet flow enhancers may also be shaped to minimized reverse bypass flow. FIG. 23 shows examples for axial outlet ports (b) and radial outlet ports (a, c) and non-symmetric outlet ports (d).”).
The limitation “guide the conveyed blood transversely to the at least one outlet opening after the conveyed blood has passed through the at least one outlet opening” is being interpreted to mean that the direction of blood flow is guided towards the inner surface of the diffuser after the conveyed blood (i.e., the conveyed blood is guided “transversely to the at least one outlet opening” in the sense that flow towards the outlet defines a first direction, and blood is guided in a second direction that is transverse to the first direction defined by the outlet; see Annotated Fig. 3a, below)
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Heuring’s configuration of Fig. 23C is stated to “minimize reverse bypass flow,” and thus guides fluid in the “flow direction” indicated in Heuring’s Fig. 23C. This direction is “transverse[] to the at least one outlet opening.” Compare Heuring Fig. 23C with Fig. 3A of the Present Drawings.
Heuring does not disclose:
and is configured to transfer between a rest position and an operating position, wherein, in the rest position, the diffuser is configured to abut against an outside of the housing apparatus in a folded or crimped configuration,
Campbell ‘986 describes “…heart pumps that can include a catheter body and an impeller coupled with a distal end of the catheter body. The impeller can include a tip that is resealable or that includes a resealable member. The heart pump can also include a diffuser disposed between the distal end of the catheter body and the impeller, wherein the diffuser includes a flow directing surface” (Abstract). Campbell ‘986 is thus analogous art.
Campbell ‘986 discloses:
and is configured to transfer between a rest position and an operating position, wherein, in the rest position, the diffuser is configured to abut against an outside of the housing apparatus in a folded or crimped configuration (Para. [0109], “Advantageously, the collapsible diffuser 502 a, 502 b can have a deployed, expanded configuration, and a retracted, collapsed configuration.”)
Modification of Heuring’s diffuser with the teachings of Campbell such that Heuring’s diffuser is a collapsible diffuser results in Heuring’s diffuser abutting against an outside of the housing apparatus in a folded or crimped configuration in the rest position, when done in accordance with the level of ordinary skill in the art as evidenced by Schmitz-Rode.
Schmitz-Rode pertains to “An Expandable Percutaneous Catheter Pump for Left Ventricular Support” (Title). Schmitz-Rode describes the sizing constraints of percutaneously inserted ventricular support devices during deployment (Schmitz-Rode at Pg. 1859, Right Column, Fifth Paragraph through Pg. 1860, Left Column, First Paragraph), and suggests an expandable such device as a “technically feasible” solution (Schmitz-Rode at Pg. 1860, Left Column, Second Paragraph). One of ordinary skill in the art would understand the size constraints discussed by Schmitz-Rode, and be aware that an expandable/collapsible device is a “technically feasible solution” to those constraints. Accordingly, in modifying Heuring’s diffuser by replacing it with such a collapsible diffuser as taught by Campbell, one of ordinary skill in the art would configure the collapsible/expandable diffuser to abut against an outside of the housing apparatus in a folded or crimped configuration to ensure the modification complies with known sizing constraints consistent with what is known to be technically feasible.
It would have been obvious for a person or ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Heuring with the teachings of Campbell ‘986 (i.e., to modify Heuring’s diffuser such that it is collapsible, such as in the manner of Campbell ‘986’s diffuser) in order to provide a low profile for percutaneous insertion and facilitate greater flow rates post-insertion (Campbell ‘986 at Para. [0042]).
Regarding Claim 10, the combination of Heuring and Campbell ‘986 renders obvious entirety of Claim 1 as explained above.
Campbell ‘986 additionally teaches:
wherein the diffuser is configured to be unfolded from the rest position to the operating position. (Para. [0115], “The rotating infusant can exert a pressure on the inner surface 512 to thereby expand the diffuser 502 a from the collapsed configuration to the expanded configuration.”).
Regarding Claim 12, the combination of Heuring and Campbell ‘986 renders obvious the entirety of Claim 1 as explained above.
Heuring additionally discloses:
wherein the diffuser in the operating position has a shape of a truncated cone, a dome, an umbrella, or a funnel (Fig. 23C, Heuring’s diffuser has the shape of a funnel).
Regarding Claim 13, the combination of Heuring and Campbell ‘986 renders obvious the entirety of Claim 1 as explained above.
Heuring additionally discloses:
wherein the diffuser in the operating position has a cross-sectional area that increases in a flow direction of the blood (Fig. 23C, Heuring’s diffuser increases in cross sectional area in Heuring’s “flow direction”).
Regarding Claim 15, Heuring discloses:
A cardiac pump system comprising: (Para. [0084], “In some embodiments, the systems and methods provide a fully implantable cardiac assist device…”);
an axial flow pump; (Para. [0100], “Still with reference to FIGS. 1B and 1C, in this embodiment pump 110 is a rotary pump and preferably is an axial flow pump…”);
and a pump housing device configured to guide pumped blood, the pump housing device comprising: a housing apparatus accommodating at least one component of the pump for conveying the blood through the housing apparatus, (Para. [0079], “This application describes systems and methods for using intravascular blood pumps, together with novel flow and pressure modification elements, to selectively augment, control and/or adjust the perfusion of targeted branch vessel(s) and/or end organ(s) in specific ways;” Para. [0096], “FIG. 11 shows another embodiment of an intravascular pumping module, comprising a motor (108) driving a shaft (110) connected to an impeller (112). The impeller (112) lies inside the outlet housing (114) which is in turn connected to a flexible cannula (116) which is in turn connected to an inlet housing (118).”);
wherein the housing apparatus is configured to receive blood from an inlet hose, said inlet hose comprising at least one inlet opening configured to facilitate inflow of the blood, (Para. [0100], “Housing 114 may be provided with a top cover, or inflow cage, 118, which permits the passage of blood 81″ into housing 114, as it is drawn into, pumped, or pulled into housing 114 by the rotation of impeller 115.”);
and wherein the housing apparatus comprises at least one outlet opening arranged circumferentially around the circumference of the housing apparatus and configured to facilitate outflow of the blood received from the inlet hose and conveyed by the pump; (Fig. 23C, see Annotated Fig. 23C, above; Compare Heuring’s Fig. 23C with Fig. 1 of the Present Drawings);
and a diffuser configured to couple with the housing apparatus and/or the inlet hose, wherein the diffuser is arranged circumferentially around the at least one outlet opening of the housing apparatus, (Para. [0096], “The outlet housing comprises an intermediate flow director (122) and an outlet flow director or nozzle (124);” Para. [0120], “The following paragraphs discuss the flow and pressure modification elements and how they can be adjusted. Para. [0125], “The configuration of the outlet of the device ;”may be adjusted in a number of ways to minimize reverse bypass flow, maximize efficiency, maximize auto-entrainment and total flow, or alter other parameters of performance;” Fig. 23C shows such a configuration; see Annotated Fig. 23C, above; Para. [0129], “Elements like diffusers or porous media with certain characteristics may also be used to condition flow and pressure upstream or downstream of the nozzle;” Compare Heuring Fig. 23C with Fig. 3A of the Present Drawings);
and wherein, in an operating position, the diffuser is configured to guide the conveyed blood transversely to the at least one outlet opening after the conveyed blood has passed through the at least one outlet opening. (Para. [0128], “Further, the outlet flow enhancers may also be shaped to minimized reverse bypass flow. FIG. 23 shows examples for axial outlet ports (b) and radial outlet ports (a, c) and non-symmetric outlet ports (d).”).
The limitation “guide the conveyed blood transversely to the at least one outlet opening after the conveyed blood has passed through the at least one outlet opening” is being interpreted in the same manner as is explained above with respect to Claim 1.
Heuring does not disclose:
and is configured to transfer between a rest position and an operating position, wherein, in the rest position, the diffuser is configured to abut against an outside of the housing apparatus in a folded or crimped configuration
Campbell ‘986 describes “…heart pumps that can include a catheter body and an impeller coupled with a distal end of the catheter body. The impeller can include a tip that is resealable or that includes a resealable member. The heart pump can also include a diffuser disposed between the distal end of the catheter body and the impeller, wherein the diffuser includes a flow directing surface” (Abstract). Campbell ‘986 is thus analogous art.
Campbell ‘986 discloses:
and is configured to transfer between a rest position and an operating position, wherein, in the rest position, the diffuser is configured to abut against an outside of the housing apparatus in a folded or crimped configuration (Para. [0109], “Advantageously, the collapsible diffuser 502 a, 502 b can have a deployed, expanded configuration, and a retracted, collapsed configuration.”)
Modification of Heuring’s diffuser with the teachings of Campbell such that Heuring’s diffuser is a collapsible diffuser results in Heuring’s diffuser abutting against an outside of the housing apparatus in a folded or crimped configuration in the rest position, as explained above at Claim 1.
It would have been obvious for a person or ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Heuring with the teachings of Campbell ‘986 (i.e., to modify Heuring’s diffuser such that it is collapsible, such as in the manner of Campbell ‘986’s diffuser) in order to provide a low profile for percutaneous insertion and facilitate greater flow rates post-insertion (Campbell ‘986 at Para. [0042]).
Regarding Claim 16, the combination of Heuring and Campbell ‘986 renders obvious the entirety of Claim 15 as explained above.
Heuring additionally discloses:
wherein the pump and pump housing device are configured to form part of a heart support system for conveying blood, wherein the pump housing device and diffuser are configured to be delivered to the heart via a blood vessel. (Para. [0084], “In some embodiments, the systems and methods discussed herein may allow a pump to be deployed through a catheter percutaneously or by minor surgical access to the vasculature. In some embodiments, the systems and methods provide a fully implantable cardiac assist device…”).
Regarding Claim 17, the combination of Heuring and Campbell ‘986 renders obvious the entirety of Claim 15 as explained above.
Campbell ‘986 additionally discloses:
wherein the diffuser is configured to be unfolded from the rest position to the operating position. (Para. [0115], “The rotating infusant can exert a pressure on the inner surface 512 to thereby expand the diffuser 502 a from the collapsed configuration to the expanded configuration.”).
Regarding Claim 19, the combination of Heuring and Campbell ‘986 renders obvious the entirety of Claim 15 as explained above.
Heuring additionally discloses:
wherein the diffuser in the operating position has the shape of a truncated cone, a dome, an umbrella, or a funnel (Fig. 23C, Heuring’s diffuser has the shape of a funnel).
Regarding Claim 20, the combination of Heuring and Campbell ‘986 renders obvious the entirety of Claim 15 as explained above.
Heuring additionally discloses:
wherein the diffuser in the operating position has a cross-sectional area that increases in a flow direction of the blood (Fig. 23C, Heuring’s diffuser increases in cross sectional area in Heuring’s “flow direction”).
Regarding Independent Claim 22, Heuring discloses:
A method for producing a cardiac pump housing device, the method comprising: (Para. [0078], “Systems and methods for series modification of flow and/or pressure to create circulation of perfusion enhancements targeted to specific vessels and/or end organs are discussed herein.”);
coupling a diffuser with a housing apparatus, wherein the housing apparatus is configured to accommodate at least one component of a pump configured to convey blood through the housing apparatus, (Para. [0100], “Housing 114 may be provided with a top cover, or inflow cage, 118, which permits the passage of blood 81″ into housing 114, as it is drawn into, pumped, or pulled into housing 114 by the rotation of impeller 115;” Para. [0120], “The following paragraphs discuss the flow and pressure modification elements and how they can be adjusted. Para. [0125], “The configuration of the outlet of the device may be adjusted in a number of ways to minimize reverse bypass flow, maximize efficiency, maximize auto-entrainment and total flow, or alter other parameters of performance;” Fig. 23C shows such a configuration; see Annotated Fig. 23C, above; Para. [0129], “Elements like diffusers or porous media with certain characteristics may also be used to condition flow and pressure upstream or downstream of the nozzle;” Compare Heuring Fig. 23C with Fig. 3A of the Present Drawings);
wherein the housing apparatus is configured to receive blood from an inlet hose, said inlet hose comprising at least one inlet opening configured to facilitate inflow of the blood, (Para. [0100], “Housing 114 may be provided with a top cover, or inflow cage, 118, which permits the passage of blood 81″ into housing 114, as it is drawn into, pumped, or pulled into housing 114 by the rotation of impeller 115.”);
and wherein the housing apparatus comprises at least one outlet opening arranged circumferentially around the circumference of the housing apparatus and configured to facilitate outflow of the blood received from the inlet hose and conveyed by the pump, (Fig. 23C, see Annotated Fig. 23C, above; Compare Heuring’s Fig. 23C with Fig. 1 of the Present Drawings);
and wherein the diffuser is arranged circumferentially around the at least one outlet opening of the housing apparatus, (Para. [0096], “The outlet housing comprises an intermediate flow director (122) and an outlet flow director or nozzle (124);” Para. [0120], “The following paragraphs discuss the flow and pressure modification elements and how they can be adjusted. Para. [0125], “The configuration of the outlet of the device ;”may be adjusted in a number of ways to minimize reverse bypass flow, maximize efficiency, maximize auto-entrainment and total flow, or alter other parameters of performance;” Fig. 23C shows such a configuration; see Annotated Fig. 23C, above; Para. [0129], “Elements like diffusers or porous media with certain characteristics may also be used to condition flow and pressure upstream or downstream of the nozzle;” Compare Heuring Fig. 23C with Fig. 3A of the Present Drawings);
and wherein, in the operating position, the diffuser is configured to guide the conveyed blood transversely to the at least one outlet opening after the conveyed blood has passed through the at least one outlet opening. (Para. [0128], “Further, the outlet flow enhancers may also be shaped to minimized reverse bypass flow. FIG. 23 shows examples for axial outlet ports (b) and radial outlet ports (a, c) and non-symmetric outlet ports (d).”).
The limitation “guide the conveyed blood transversely to the at least one outlet opening after the conveyed blood has passed through the at least one outlet opening” is being interpreted in the same manner as is explained above with respect to Claim 1.
Heuring does not disclose:
and is configured to transfer between a rest position and an operating position, wherein, in the rest position, the diffuser is configured to abut against an outside of the housing apparatus in a folded or crimped configuration
Campbell ‘986 describes “…heart pumps that can include a catheter body and an impeller coupled with a distal end of the catheter body. The impeller can include a tip that is resealable or that includes a resealable member. The heart pump can also include a diffuser disposed between the distal end of the catheter body and the impeller, wherein the diffuser includes a flow directing surface” (Abstract). Campbell ‘986 is thus analogous art.
Campbell ‘986 discloses:
and is configured to transfer between a rest position and an operating position, wherein, in the rest position, the diffuser is configured to abut against an outside of the housing apparatus in a folded or crimped configuration (Para. [0109], “Advantageously, the collapsible diffuser 502 a, 502 b can have a deployed, expanded configuration, and a retracted, collapsed configuration.”)
Modification of Heuring’s diffuser with the teachings of Campbell such that Heuring’s diffuser is a collapsible diffuser results in Heuring’s diffuser abutting against an outside of the housing apparatus in a folded or crimped configuration in the rest position, as explained above at Claim 1.
It would have been obvious for a person or ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Heuring with the teachings of Campbell ‘986 (i.e., to modify Heuring’s diffuser such that it is collapsible, such as in the manner of Campbell ‘986’s diffuser) in order to provide a low profile for percutaneous insertion and facilitate greater flow rates post-insertion (Campbell ‘986 at Para. [0042]).
Regarding Claim 23, the combination of Heuring and Campbell ‘986 renders obvious the entirety of Claim 22 as explained above.
and wherein the diffuser is configured to be unfolded from the rest position to the operating position. (Para. [0115], “The rotating infusant can exert a pressure on the inner surface 512 to thereby expand the diffuser 502 a from the collapsed configuration to the expanded configuration.”).
Regarding Claim 25, the combination of Heuring and Campbell ‘986 renders obvious the entirety of Claim 22 as explained above.
Heuring additionally discloses:
wherein the diffuser in the operating position has a shape of a truncated cone, a dome, an umbrella, or a funnel (Fig. 23C, Heuring’s diffuser has the shape of a funnel)
Regarding Claim 26, the combination of Heuring and Campbell ‘986 renders obvious the entirety of Claim 22 as explained above.
Heuring additionally discloses:
wherein the diffuser in the operating position has a cross-sectional area that increases in a flow direction of the blood (Fig. 23C, Heuring’s diffuser increases in cross sectional area in Heuring’s “flow direction”).
Regarding Claim 28, the combination of Heuring and Campbell ‘986 renders obvious the entirety of Claim 1 as explained above.
Heuring additionally discloses:
wherein the diffuser extends radially outward from and transversely to an outer surface of the housing apparatus and/or the inlet hose in the operating position (Fig. 23C, Heuring’s diffuser extends in the manner claimed relative to Heuring’s housing apparatus; Compare Heuring Fig. 23C with Fig. 3A of the Present Drawings).
Regarding Claim 29, the combination of Heuring and Campbell ‘986 renders obvious the entirety of Claim 1 as explained above.
Heuring additionally discloses:
wherein an inner surface of the diffuser is configured to guide the conveyed blood (Fig. 23C, the inner surface of Heuring’s diffuser is configured in the manner claimed, in that conveyed blood is guided by the inner surface as opposed to its outer surface; Compare Heuring Fig. 23C with Fig. 3A of the Present Drawings).
Regarding Claim 30, the combination of Heuring and Campbell ‘986 renders obvious the entirety of Claim 15 as explained above.
Heuring additionally discloses:
wherein the diffuser extends radially outward from and transversely to an outer surface of the housing apparatus and/or the inlet hose in the operating position (Fig. 23C, Heuring’s diffuser extends in the manner claimed relative to Heuring’s housing apparatus; Compare Heuring Fig. 23C with Fig. 3A of the Present Drawings).
Regarding Claim 31, the combination of Heuring and Campbell ‘986 renders obvious the entirety of Claim 15 as explained above.
Heuring additionally discloses:
wherein an inner surface of the diffuser is configured to guide the conveyed blood (Fig. 23C, the inner surface of Heuring’s diffuser is configured in the manner claimed, in that conveyed blood is guided by the inner surface as opposed to its outer surface; Compare Heuring Fig. 23C with Fig. 3A of the Present Drawings).
Regarding Claim 32, Heuring discloses:
A method of guiding blood in a blood vessel, the method comprising: (Para. [0078], “Systems and methods for series modification of flow and/or pressure to create circulation of perfusion enhancements targeted to specific vessels and/or end organs are discussed herein.”);
providing a housing apparatus configured to accommodate at least one component of a pump for conveying the blood through the housing apparatus, (Para. [0096], “FIG. 11 shows another embodiment of an intravascular pumping module, comprising a motor (108) driving a shaft (110) connected to an impeller (112). The impeller (112) lies inside the outlet housing (114) which is in turn connected to a flexible cannula (116) which is in turn connected to an inlet housing (118).”);
wherein the housing apparatus is configured to receive blood from an inlet hose, said inlet hose comprising at least one inlet opening configured to facilitate inflow of the blood, (Para. [0100], “Housing 114 may be provided with a top cover, or inflow cage, 118, which permits the passage of blood 81″ into housing 114, as it is drawn into, pumped, or pulled into housing 114 by the rotation of impeller 115.”);
and wherein the housing apparatus comprises at least one outlet opening arranged circumferentially around the circumference of the housing apparatus and configured to facilitate outflow of the blood received from the inlet hose and conveyed by the pump; (Fig. 23C, see Annotated Fig. 23C, above; Compare Heuring’s Fig. 23C with Fig. 1 of the Present Drawings);
providing a diffuser configured to couple with the housing apparatus and/or the inlet hose; (Para. [0129], “Elements like diffusers or porous media with certain characteristics may also be used to condition flow and pressure upstream or downstream of the nozzle;” Fig. 23C, see Annotated Fig. 23C, above; Compare Heuring’s Fig. 23C with Fig. 1 of the Present Drawings);
arranging the diffuser circumferentially around the at least one outlet opening of the housing apparatus; (Para. [0096], “The outlet housing comprises an intermediate flow director (122) and an outlet flow director or nozzle (124);” Para. [0120], “The following paragraphs discuss the flow and pressure modification elements and how they can be adjusted. Para. [0125], “The configuration of the outlet of the device ;”may be adjusted in a number of ways to minimize reverse bypass flow, maximize efficiency, maximize auto-entrainment and total flow, or alter other parameters of performance;” Fig. 23C shows such a configuration; see Annotated Fig. 23C, above; Para. [0129], “Elements like diffusers or porous media with certain characteristics may also be used to condition flow and pressure upstream or downstream of the nozzle;” Compare Heuring Fig. 23C with Fig. 3A of the Present Drawings);
and in an operating position of the diffuser, guiding the conveyed blood by the diffuser transversely to the at least one outlet opening after the conveyed blood has passed through the at least one outlet opening (Para. [0128], “Further, the outlet flow enhancers may also be shaped to minimized reverse bypass flow. FIG. 23 shows examples for axial outlet ports (b) and radial outlet ports (a, c) and non-symmetric outlet ports (d).”).
The limitation “guide the conveyed blood transversely to the at least one outlet opening after the conveyed blood has passed through the at least one outlet opening” is being interpreted in the same manner as is explained above with respect to Claim 1.
Heuring does not disclose:
in a rest position of the diffuser, abutting the diffuser against an outside of the housing apparatus in a folded or crimped configuration
Campbell ‘986 describes “…heart pumps that can include a catheter body and an impeller coupled with a distal end of the catheter body. The impeller can include a tip that is resealable or that includes a resealable member. The heart pump can also include a diffuser disposed between the distal end of the catheter body and the impeller, wherein the diffuser includes a flow directing surface” (Abstract). Campbell ‘986 is thus analogous art.
Campbell ‘986 discloses:
in a rest position of the diffuser, abutting the diffuser against an outside of the housing apparatus in a folded or crimped configuration (Para. [0109], “Advantageously, the collapsible diffuser 502 a, 502 b can have a deployed, expanded configuration, and a retracted, collapsed configuration.”)
Modification of Heuring’s diffuser with the teachings of Campbell such that Heuring’s diffuser is a collapsible diffuser results in Heuring’s diffuser abutting against an outside of the housing apparatus in a folded or crimped configuration in the rest position, as explained above at Claim 1.
It would have been obvious for a person or ordinary skill in the art before the effective filing date of the claimed invention to modify Heuring with the teachings of Campbell ‘986 (i.e., to modify Heuring’s diffuser such that it is collapsible, such as in the manner of Campbell ‘986’s diffuser) in order to provide a low profile for percutaneous insertion and facilitate greater flow rates post-insertion (Campbell ‘986 at Para. [0042]).
Claims 14, 21 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over previously cited US 2014/0128659 A1 to Heuring et al. (“Heuring”) in view of previously cited US 2012/0178986 A1 to Campbell et al. (“Campbell ‘986”) as applied respectively to Claims 1, 15 and 22, and further in view of previously cited US 8,485,961 B2 to Campbell et al. (“Campbell ‘961”). The rejection is maintained.
Regarding Claim 14, the combination of Heuring and Campbell ‘986 renders obvious the entirety of Claim 1 as explained above.
The combination of Heuring and Campbell ‘986 does not disclose:
wherein the diffuser comprises a support structure comprising at least one strut and/or a flexible jacket
Campbell ‘961 describes “heart pumps that include a catheter assembly and that can be applied percutaneously” (Abstract). Campbell ‘961 is thus analogous art.
Campbell ‘961 discloses:
wherein the diffuser comprises a support structure comprising at least one strut and/or a flexible jacket (Col. 19, Lns. 12-24, “The outlet 111 has a diffuser arrangement 980 at the proximal end of the housing 202. The housing 202 of FIGS. 27 and 28 may have an outwardly flared portion 982 of the outlet 111 and optionally a crisp lip 984, e.g., a ring, at the proximal end of the coating 204. In addition to lip 984, the outlet 111 may include a plurality of leaflets 986 defined by the end wire structure of mesh 203 and filled with the material of coating 204. In some embodiments, each cell or portion of the mesh can be completely filled with the coating material such that no cell is only partially filled with the coating material. Thus, in some embodiments, the coating material can be completely surrounded by struts in the housing.”).
Campbell ‘961’s leaflets are such a strut as claimed.
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of combined Heuring and Campbell ‘986 with the teachings of Campbell ‘961 (i.e., to add Campbell ‘961’s leaflets to the device of Heuring) in order to improve structural stiffness (Campbell ‘961 at Col. 19, Lns. 7-10, “The increased thickness of coating 204 and the lip 976 improve the structural stiffness of the cannula inlet. The benefits of cannula shaping may also be applied to an outlet 111 at the proximal end of the housing 202.”).
Regarding Claim 21, the combination of Heuring and Campbell ‘986 renders obvious the entirety of Claim 15 as explained above.
The combination of Heuring and Campbell ‘986 does not disclose:
wherein the diffuser comprises a support structure comprising at least one strut and/or a flexible jacket
Campbell ‘961 describes “heart pumps that include a catheter assembly and that can be applied percutaneously” (Abstract). Campbell ‘961 is thus analogous art.
Campbell ‘961 discloses:
wherein the diffuser comprises a support structure comprising at least one strut and/or a flexible jacket (Col. 19, Lns. 12-24, “The outlet 111 has a diffuser arrangement 980 at the proximal end of the housing 202. The housing 202 of FIGS. 27 and 28 may have an outwardly flared portion 982 of the outlet 111 and optionally a crisp lip 984, e.g., a ring, at the proximal end of the coating 204. In addition to lip 984, the outlet 111 may include a plurality of leaflets 986 defined by the end wire structure of mesh 203 and filled with the material of coating 204. In some embodiments, each cell or portion of the mesh can be completely filled with the coating material such that no cell is only partially filled with the coating material. Thus, in some embodiments, the coating material can be completely surrounded by struts in the housing.”).
Campbell ‘961’s leaflets are such a strut as claimed.
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of combined Heuring and Campbell ‘986 with the teachings of Campbell ‘961 (i.e., to add Campbell ‘961’s leaflets to the device of Heuring) in order to improve structural stiffness (Campbell ‘961 at Col. 19, Lns. 7-10, “The increased thickness of coating 204 and the lip 976 improve the structural stiffness of the cannula inlet. The benefits of cannula shaping may also be applied to an outlet 111 at the proximal end of the housing 202.”).
Regarding Claim 27, the combination of Heuring and Campbell ‘986 renders obvious the entirety of Claim 22 as explained above.
The combination of Heuring and Campbell ‘986 does not disclose:
wherein the diffuser comprises a support structure comprising at least one strut and/or a flexible jacket
Campbell ‘961 describes “heart pumps that include a catheter assembly and that can be applied percutaneously” (Abstract). Campbell ‘961 is thus analogous art.
Campbell ‘961 discloses:
wherein the diffuser comprises a support structure comprising at least one strut and/or a flexible jacket (Col. 19, Lns. 12-24, “The outlet 111 has a diffuser arrangement 980 at the proximal end of the housing 202. The housing 202 of FIGS. 27 and 28 may have an outwardly flared portion 982 of the outlet 111 and optionally a crisp lip 984, e.g., a ring, at the proximal end of the coating 204. In addition to lip 984, the outlet 111 may include a plurality of leaflets 986 defined by the end wire structure of mesh 203 and filled with the material of coating 204. In some embodiments, each cell or portion of the mesh can be completely filled with the coating material such that no cell is only partially filled with the coating material. Thus, in some embodiments, the coating material can be completely surrounded by struts in the housing.”).
Campbell ‘961’s leaflets are such a strut as claimed.
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of combined Heuring and Campbell ‘986 with the teachings of Campbell ‘961 (i.e., to add Campbell ‘961’s leaflets to the device of Heuring) in order to improve structural stiffness (Campbell ‘961 at Col. 19, Lns. 7-10, “The increased thickness of coating 204 and the lip 976 improve the structural stiffness of the cannula inlet. The benefits of cannula shaping may also be applied to an outlet 111 at the proximal end of the housing 202.”).
Conclusion
THIS ACTION IS MADE FINAL. 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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/C.J.M./Examiner, Art Unit 3796
/Jennifer Pitrak McDonald/Supervisory Patent Examiner, Art Unit 3796
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