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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 13 Oct 2025 has been entered.
This Office Action is responsive to the amendment filed on 13 Oct 2025 . As directed by the amendment: claims 1 and 19-20 have been amended, claims 18 and 21-58 have been canceled, and no claims have been added. Thus, claims 1-17 and 19-20 are presently pending in this application.
Response to Arguments
CLAIM REJECTIONS UNDER 35 U.S.C. § 103
Applicant’s arguments, see Remarks, filed 13 Oct 2025, with respect to the rejection(s) of claim 1 under 35 U.S.C. 103 have been fully considered and are persuasive in light of the claim amendments, because Maimon does not explicitly disclose the claimed feature of the hub with a plurality of support members. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Siess et al. (US 20180228953 A1), hereinafter Siess, and Tuval et al. (US 20190209758 A1), hereinafter Tuval, as explained in further detail below.
No specific arguments were made regarding dependent claims 2-17 and 19-20 and the previously cited prior art references. Therefore claims 2-17 and 19-20 are also rejected below.
DOUBLE PATENTING
Applicant’s arguments, see Remarks, filed 13 Oct 2025, with respect to the double patenting rejection of claim 1 have been fully considered and are persuasive in light of the claim amendments. The double patenting rejection of claim 1 has been withdrawn.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claims 1, 3-9, 11-15, and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Khaw et al. (US Publication No. 20030135086 A1, previously cited), hereinafter Khaw, in view of Siess et al. (US 20180228953 A1), hereinafter Siess, and Tuval et al. (US 20190209758 A1), hereinafter Tuval.
Regarding claim 1, Khaw discloses a catheter blood pump (Fig. 1, circulation assist device 6), comprising:
an expandable pump portion (Fig. 2, paragraph [0024]) extending distally from a catheter (Fig. 2, outer sheath 18), the pump portion including:
an expandable impeller housing that includes an expandable blood conduit (Fig. 2, Abstract, stator housing 10) defining a blood lumen (Fig. 2, space between interior surface of stator housing 30 and impeller 12), and
a collapsible impeller (Fig. 2, paragraph [0052], impeller 12) comprising a collapsible and inflatable hub (Fig. 2, paragraph [0046], impeller body 14) and one or more blades extending from the hub (Fig. 2, impeller blades 16) and having a collapsed configuration and an expanded configuration (paragraph [0046], "The impeller 12 may be constructed of a plastic, such as PET or any other material that can be inflated but substantially maintains its preformed shape. ... In a preferred embodiment, both the impeller body 14 and the impeller blades 16 may be inflated."),
the inflatable hub having an internal volume to facilitate fluid delivery to the internal volume to increase fluid pressure within the internal volume of the hub (paragraph [0046]).
Khaw discloses that the inflatable hub has a ramped surface (paragraph [0036], "oval" can be interpreted as a ramped surface; paragraph [0053]), but does not explicitly disclose that the inflatable hub in the expanded configuration having a plurality of support members that define a ramped surface that is disposed at least partially proximal to a proximal end of the blood conduit, the ramped surface positioned relative to the proximal end of the blood conduit to create at least partial radial flow at an outflow of the pump portion.
However, Siess teaches a catheter pump (Fig. 33, paragraph [0097]) comprising a ramped surface that is disposed at least partially proximal to a proximal end of the blood conduit (Fig. 34, paragraph [0096], tapered impeller hub 536), the ramped surface positioned relative to the proximal end of the blood conduit to create at least partial radial flow at an outflow of the pump portion (Figs. 33-34, paragraph [0096], "Due to the tapered shape of the impeller hub 536, a blood flow is directed radially outwards from the blood flow inlet 521 to the blood flow outlet 522.").
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Khaw with the teachings of Siess to include a ramped surface that is disposed at least partially proximal to a proximal end of the blood conduit to create at least a partial radial flow at an outflow of the pump portion, because doing so helps to wash out the mating surfaces of the bearing (Siess, paragraph [0007]).
Furthermore, it would have been an obvious matter of design choice to make the hub with a ramped surface, for the purpose of redirecting blood flow, since such a modification would have involved a mere change in the form or shape of a component. A change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 149 USPQ 47 (CCPA 1976).
Siess does not explicitly disclose that the ramped surface is defined by a plurality of support members when the inflatable hub is in the expanded configuration.
However, Tuval teaches an implantable blood pump (Abstract) comprising a plurality of support members (Figs. 3A-C, paragraphs [0463], [0469], outer helical elongate elements 52, elongate elements 67) that define a ramped surface (Figs. 3B-C, paragraph [0463], film 56) when in an expanded configuration (paragraph [0477], "the impeller assumes its non-radially-constrained configuration (in which the impeller is typically disposed during operation of the impeller), as shown in FIGS. 3A-C"; Fig. 5B shows the device's radially constrained state).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Khaw and Siess with the teachings of Tuval so that the ramped surface is defined by a plurality of support members when the inflatable hub is in the expanded configuration because the support members maintain the shape of the impeller (Tuval, paragraph [0475]).
Regarding claim 3, the blood pump of claim 1 is obvious over Khaw, Siess, and Tuval, as explained above. Khaw further discloses that the ramped surface is in a bladed region of the inflatable hub (Fig. 2, paragraph [0036]).
Regarding claim 4, the blood pump of claim 1 is obvious over Khaw, Siess, and Tuval, as explained above. Khaw further discloses that the internal volume is greater in a deployed configuration than in a collapsed delivery configuration (paragraphs [0055], [0057]).
Regarding claim 5, the blood pump of claim 1 is obvious over Khaw, Siess, and Tuval, as explained above. Khaw further discloses that the one or more impeller blades are not in fluid communication with the internal volume (paragraph [0052]).
Regarding claim 6, the blood pump of claim 1 is obvious over Khaw, Siess, and Tuval, as explained above. Khaw further discloses that the impeller hub comprises at least one material such that the impeller hub is stiffer after the inflation fluid is delivered to the impeller hub (paragraph [0046]).
Regarding claim 7, the blood pump of claim 1 is obvious over Khaw, Siess, and Tuval, as explained above. Neither Khaw, nor Siess, nor Tuval discloses that the inflatable hub comprises a first section with a first thickness, and a second section with a second thickness different than the first thickness. However, it would have been an obvious matter of design choice to make the inflatable hub with different thicknesses, for the purpose of altering the compliance of different sections of the hub, which could make navigating a patient's anatomy easier, since such a modification would have involved a mere change in the form or shape of a component. A change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 149 USPQ 47 (CCPA 1976).
Regarding claim 8, the blood pump of claim 7 is obvious over Khaw, Siess, and Tuval, as explained above. Khaw further discloses that the first section and the second section comprise polymeric material (paragraph [0046]).
Regarding claim 9, the blood pump of claim 1 is obvious over Khaw, Siess, and Tuval, as explained above. Khaw further discloses that the internal volume is adapted to be in fluid communication with a purge fluid source (Fig. 2, paragraph [0046], impeller inflation tube 22), the purge fluid source adapted to be disposed outside a patient's body (paragraph [0046]).
Regarding claim 11, the blood pump of claim 1 is obvious over Khaw, Siess, and Tuval, as explained above. Khaw further discloses that the inflatable hub is inflatable in a bladed region and is inflatable in a non-bladed region (Fig. 2, paragraph [0046], "impeller body 14 may be inflated").
Regarding claim 12, the blood pump of claim 1 is obvious over Khaw, Siess, and Tuval, as explained above. Khaw further discloses that the internal volume includes a bladed internal volume and a non-bladed internal volume (see annotated Fig. 2 below).
Regarding claim 13, the blood pump of claim 12 is obvious over Khaw, Siess, and Tuval, as explained above. Neither Khaw, nor Siess, nor Tuval explicitly discloses that the bladed internal volume is greater than the internal non-bladed volume when the hub is inflated. However, it would have been an obvious matter of design choice to make a hub wherein the bladed internal volume is greater than the internal non-bladed volume when the hub is inflated, for the purpose of altering the path of blood flow in a specific direction, since such a modification would have involved a mere change in the form or shape of a component. A change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 149 USPQ 47 (CCPA 1976).
Regarding claim 14, the blood pump of claim 12 is obvious over Khaw, Siess, and Tuval, as explained above. Neither Khaw, nor Siess, nor Tuval explicitly discloses that the bladed internal volume is less than the internal non-bladed volume when the hub is inflated. However, it would have been an obvious matter of design choice to make a hub wherein the bladed internal volume is less than the internal non-bladed volume when the hub is inflated, for the purpose of altering the path of blood flow in a specific direction, since such a modification would have involved a mere change in the form or shape of a component. A change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 149 USPQ 47 (CCPA 1976).
Regarding claim 15, the blood pump of claim 1 is obvious over Khaw, Siess, and Tuval, as explained above. Khaw further discloses that the inflatable hub comprises a compliant or semi-compliant material (paragraph [0046], plastic such as PET).
Regarding claim 19, the blood pump of claim 1 is obvious over Khaw, Siess, and Tuval, as explained above. Tuval further discloses that the plurality of support members are configured to at least partially self-expand (paragraph [0449], "The retraction of the delivery catheter typically causes self-expandable components of the distal end of the device to assume non-radially-constrained configurations").
Regarding claim 20, the blood pump of claim 1 is obvious over Khaw, Siess, and Tuval, as explained above. Tuval further discloses a compliant material extending between the plurality of support members (Figs. 3B-C, paragraph [0475], "Typically film 56 of the material (e.g., silicone) changes shape to conform to the shape changes of the helical elongate elements and the axial support spring"), the compliant material adapted and configured to at least partially define the ramped surface in the expanded configuration (paragraph [0464], "Each of the helical elongate elements, together with the film extending from the helical elongate element to the spring, defines a respective impeller blade, with the helical elongate elements defining the outer edges of the blades"; paragraph [0474], "The portions of the film that extend from each of the helical elongate elements to the spring define the impeller blades").
Claims 2 and 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Khaw et al. (US Publication No. 20030135086 A1, previously cited), hereinafter Khaw, in view of Siess et al. (US 20180228953 A1), hereinafter Siess, and Tuval et al. (US 20190209758 A1), hereinafter Tuval, and further in view of Schumacher et al. (US Publication No. 20120237353 A1, previously cited), hereinafter Schumacher.
Regarding claim 2, the blood pump of claim 1 is obvious over Khaw, Siess, and Tuval, as explained above. Khaw further discloses that the inflatable hub further comprises a proximal non-bladed section, the proximal non-bladed section having an outer profile with a tapered configuration that tapers downward in a proximal direction (see annotated Fig. 2 below). Khaw does not explicitly disclose that the outer profile at least partially facilitates collapse of the inflatable hub.
However, Schumacher teaches a compressible rotor for a fluid pump (Abstract) wherein the inflatable hub further comprises a proximal non-bladed section (see annotated Fig. 2 below) having an outer profile at least partially facilitating collapse of the inflatable hub (paragraph [0068]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Khaw, Siess, and Tuval with the teachings of Schumacher to provide an outer profile that at least partially facilitates collapse of the inflatable hub, because doing so allows the blood pump to be removed from the patient percutaneously (Khaw, Abstract).
Regarding claim 16, the blood pump of claim 1 is obvious over Khaw, Siess, and Tuval, as explained above. Neither Khaw, nor Siess, nor Tuval explicitly discloses that the inflatable hub comprises at least one material such that it self-expands to an at least partially deployed configuration upon release of a sheathing force.
However, Schumacher teaches a compressible rotor for a fluid pump (Abstract) wherein the inflatable hub comprises at least one material such that it self-expands to an at least partially deployed configuration upon release of a sheathing force (paragraphs [0014], [0020], [0069]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Khaw, Siess, and Tuval with the teachings of Schumacher to provide an inflatable hub comprising at least one material such that it self-expands to an at least partially deployed configuration upon release of a sheathing force, because doing so ensures, during operation of the pump, that sudden deformations of the rotor due to irregular mechanical loading are counteracted (Schumacher, paragraph [0023]).
Furthermore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to make the inflatable hub out of at least one material such that it self-expands to an at least partially deployed configuration upon release of a sheathing force, for the purpose of improving structural integrity of the hub, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Regarding claim 17, the blood pump of claim 16 is obvious over Khaw, Siess, Tuval, and Schumacher, as explained above. Neither Khaw, nor Siess, nor Tuval discloses that the inflatable hub deforms from the self-expanded configuration after the fluid delivery. However, Schumacher further teaches that the inflatable hub deforms from the self-expanded configuration after the fluid delivery (paragraphs [0019], [0067]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Khaw, Siess, and Tuval with the teachings of Schumacher to provide an inflatable hub comprising at least one material such that it self-expands to an at least partially deployed configuration upon release of a sheathing force, because doing so ensures, during operation of the pump, that sudden deformations of the rotor due to irregular mechanical loading are counteracted (Schumacher, paragraph [0023]).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Khaw et al. (US Publication No. 20030135086 A1, previously cited), hereinafter Khaw, in view of Siess et al. (US 20180228953 A1), hereinafter Siess, and Tuval et al. (US 20190209758 A1), hereinafter Tuval, and further in view of Groß-Hardt et al. (US Publication No. 20170087288 A1, previously cited) hereinafter Groß-Hardt.
Regarding claim 10, the blood pump of claim 1 is obvious over Khaw, Siess, and Tuval, as explained above. Neither Khaw, nor Siess, nor Tuval explicitly discloses that the hub includes a bladed region with a trumpet configuration, the one or more blades disposed in the bladed region.
However, Groß-Hardt teaches a non-occluding intravascular blood pump (Abstract) wherein the hub includes a bladed region with a trumpet configuration, the one or more blades disposed in the bladed region (Fig.1, paragraph [0045], hub 33 with blades 35).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Khaw, Siess, and Tuval with the teachings of Groß-Hardt to provide a bladed region with a trumpet configuration because doing so provides a smooth transition between the impeller and stator that minimizes disruption in flow (Groß-Hardt, paragraph [0045]).
Furthermore, it would have been an obvious matter of design choice to make the hub in a trumpet configuration, for the purpose of altering the path of blood flow, since such a modification would have involved a mere change in the form or shape of a component. A change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 149 USPQ 47 (CCPA 1976).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINE SISON whose telephone number is (703)756-4661. The examiner can normally be reached 8 am - 5 pm PT, Mon - Fri.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer McDonald can be reached at (571) 270-3061. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/CHRISTINE SISON/Examiner, Art Unit 3796
/Jennifer Pitrak McDonald/Supervisory Patent Examiner, Art Unit 3796