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 .
Election/Restrictions
Applicant’s election without traverse of Group II in the reply filed on 8/13/2025 is acknowledged. The requirement is still deemed proper and is therefore made FINAL.
Claim Objections
Claim 1 is objected to because of the following informalities: the claim appears to have a typographical error in the phrase “disposed at partially within” in line 3. Appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 16-21 and 44-54 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Salahieh et al. (Pub. No.: US 2019/0328948 A1; hereinafter “Salahieh”).
Salahieh discloses the following regarding claim 16: an intravascular blood pump, comprising: a collapsible pump (e.g., 2) (Figs. 10-11E) comprising a collapsible blood conduit (e.g., 4) (Fig. 10; para. 0160) and one or more collapsible impellers (e.g., 6, 8), the one or more impellers disposed at partially within the collapsible blood conduit when the blood conduit is in an expanded configuration (Figs. 10-11E); and a flow diverter (e.g., 16) having a flow diverting surface (surfaces of element 16) in a pump outflow when the pump is in an expanded configuration (Fig. 10; paras. 0160-0162), the flow diverting surface having configuration that increases a radial flow component of blood in the outflow, the increase relative to blood flow in the absence of the flow diverter (Figs. 10-11e; paras. 0160-0162, 0192-0198).
Salahieh discloses the following regarding claim 17: the blood pump of claim 16, wherein a distal end of the flow diverter is proximal to a proximal end (e.g., 3) of the blood conduit (Fig. 10).
Salahieh discloses the following regarding claim 18: the blood pump of claim 16, wherein the flow diverting surface has a configuration that increases in radial dimension from a flow diverter distal end towards a flow diverter proximal end (Fig. 10).
Salahieh discloses the following regarding claim 19: the blood pump of claim 16, wherein the flow diverter is rotationally uncoupled from the one or more impellers (paras. 0106-0110).
Salahieh discloses the following regarding claim 20: the blood pump of claim 16, wherein the flow diverter has an internal volume (volume of element 16) in communication with a fluid inflation pathway (lumen of element 4) such that a fluid can be delivered into the flow diverter (Figs. 10-11E; paras. 0160-0163).
Salahieh discloses the following regarding claim 21: the blood pump of claim 16, wherein the flow diverter is adapted such that the flow diverter is collapsible to a collapsed configuration within a sheath (paras. 0136, 0160-0163, 0199).
Salahieh discloses the following regarding claim 44: the blood pump of claim 21, wherein the flow diverter is adapted to at least partially self-expand when released from the sheath (paras. 0135-0136).
Salahieh discloses the following regarding claim 45: the blood pump of claim 21, wherein the flow diverter is adapted to be at least partially expanded upon the introduction of fluid into the flow diverter (para. 0102, 0136).
Salahieh discloses the following regarding claim 46: the blood pump of claim 16, wherein a distal end of the flow diverter is sealed such that fluid does not escape from the distal end of the flow diverter (Fig. 10).
Salahieh discloses the following regarding claim 47: the blood pump of claim 16, further comprising a plurality of proximal struts extending proximally from a proximal end of the blood conduit (para. 0159).
Salahieh discloses the following regarding claim 48: the blood pump of claim 16, wherein the flow diverter is coupled to the plurality of struts (para. 0159, via the expandable member).
Salahieh discloses the following regarding claim 49: the blood pump of claim 48, wherein a proximal surface of the flow diverter is coupled to the plurality of struts (Figs. 1-10), and wherein a distal surface of the flow diverter is not directly coupled to the plurality of struts (Figs. 1-10).
Salahieh discloses the following regarding claim 50: the blood pump of claim 48, wherein the flow diverter is coupled to the plurality of struts such that the plurality of struts apply a radially outward force on the flow diverter when the plurality of struts self-expand (paras. 0121-0126, 0132-0136, 0159).
Salahieh discloses the following regarding claim 51: the blood pump of claim 16, wherein the flow diverter comprises a deformable material that allows the flow diverter to at least partially self-expand when released from a sheath (paras. 0121-0126, 0132-0136).
Salahieh discloses the following regarding claim 52: the blood pump of claim 16, wherein the flow diverter has a bulbous expanded configuration (e.g., Figs. 1, 8, 10-11E).
Salahieh discloses the following regarding claim 53: the blood pump of claim 16, wherein one of the one or more impellers comprises a blade that is not completely circumferentially surrounded by the blood conduit when the blood conduit is expanded (e.g., Figs. 1-2).
Salahieh discloses the following regarding claim 54: the blood pump of claim 53, wherein a proximal end of the blade extends into the outflow further proximally than a proximal end of the blood conduit (e.g., Figs. 1-2).
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) 55 and 56 is/are rejected under 35 U.S.C. 103 as being unpatentable over Salahieh in view of Chua et al. (Pub. No.: US 2017/0296326 A1; hereinafter “Chua”).
Salahieh discloses the limitations of the claimed invention, as described above. However, it does not recite the blood conduit having a proximal end with a configuration that that includes a plurality of protrusions with peaks that extend proximally; and at least one of the plurality of protrusions extends further proximally than one or more other protrusions. Chua teaches that it is well known in the art that a blood conduit comprises a proximal end with a configuration that that includes a plurality of protrusions with peaks that extend proximally (Figs. 6A-6B, 9A-11B, 12D); and at least one of the plurality of protrusions extends further proximally than one or more other protrusions (paras. 0050-0058), for the purpose of better controlling fluid flow throughout the device. It would have been obvious to one having ordinary skill in the art to modify the device of Salahieh to comprise protrusions, as taught by Chua, in order to better controlling fluid flow throughout the device. Such a modification would be made with a reasonable expectation of success.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Ann Hu whose telephone number is (571) 272-6652. The examiner can normally be reached on Monday-Friday (9:00 am-5:30 pm EST).
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/ANN HU/Primary Examiner, Art Unit 3774