DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Remarks
This action is in response to the remarks filed 01/02/2026.
Claims 1-22 are pending, with claims 11-22 withdrawn. Claims 1-10 are examined in the office action below.
Response to Arguments
Applicant’s arguments, see page 5, filed 01/02/2026, with respect to the objection to the drawings have been fully considered and are persuasive. The objection to the drawings has been withdrawn.
Applicant’s arguments, see page 5, filed 01/02/2026, with respect to the rejection of claims 7 and 8 under 35 U.S.C. 112(a) have been fully considered and are persuasive. The rejection of claims 7 and 8 under 35 U.S.C. 112(a) has been withdrawn.
Applicant's arguments filed 01/02/2026 have been fully considered but they are not persuasive.
Rejection of claims 1, 2, and 4-10 under 35 U.S.C. 102(a)
Applicant argues (see Remarks, pages 6-10) that McBride does not disclose “a plurality of nitinol members defining distinct distal and proximal portions respectively configured to minimize a fracture of the mesh structure in the distal portion while the mesh structure is being collapsed”.
However, this is not found persuasive. As explained during the interview on 01/13/2026, the limitations regarding "configured to minimize fracture" are considered to be functional language. Since the prior art discloses the mesh structure and the nitinol members, McBride meets these limitations. Therefore, the rejection of the claims under 35 U.S.C. 102(a) under McBride is maintained. No additional arguments have been provided for the rejection of claim 3 under 35 U.S.C. 103. Therefore, this rejection is maintained.
It is suggested by the Examiner that additional limitations with respect to structural differences in minimizing fracture be added to the independent claims in order to distinguish these features over the prior art of record. See at least paragraphs [0065]-[0073] of the instant Specification that discuss specific ways of minimizing risk of breakage within the mesh. It is noted that any amendments must have full support in the Specification/Drawings as originally filed.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of pre-AIA 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) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
Claims 1, 2, and 4-10 are rejected under pre-AIA 35 U.S.C. 102(a) as being anticipated by McBride et al. (US Patent Application Publication 2008/0114339, of record), hereinafter McBride.
Regarding claim 1, McBride discloses a catheter pump assembly (e.g. Abstract), comprising:
an elongate body having a distal end and a proximal end opposite the distal end (e.g. Par. [0135]: a blood pump 600; Fig. 14: blood pump shown with distal and proximal ends);
a cannula coupled with the distal end of the elongate body (e.g. Par. [0137]: cannula 625), the cannula comprising:
a self-expanding mesh structure (e.g. Par. [0144]: self-expanding mesh structure) that includes a plurality of nitinol members defining distinct distal and proximal portions respectively configured to minimize a fracture of the mesh structure in the distal portion while the mesh structure is being collapsed (e.g. Par. [0148]: can be made of nitinol; Fig. 15B: mesh structure 631 with distal and proximal portions; Par. [0145]; Note: As explained above, the claim language of “configured to minimize a fracture” is considered to be functional language. Since McBride discloses the plurality of nitinol members, it meets the claimed limitation.), the proximal portion tapering from an expanded diameter to a smaller diameter at the distal end of the elongate body (e.g. Fig. 15B: the proximal portion by 660 tapers to a smaller diameter than at the distal end), and the distal portion defining a plurality of inlet spaces between the plurality of nitinol members to permit blood to enter the expandable cannula (e.g. Fig. 19: inlet spaces 642 to allow blood flow at the distal portion; Par. [0143]); and
a coating formed over the mesh structure and forming a conduit for the flow of blood from the distal portion to the proximal portion (e.g. Par. [0143]: coating may be applied for flow improvement); and
a rotatable impeller coupled with the distal end of the elongate body and extending in the proximal portion of the cannula for moving blood through the cannula while the cannula is expanded (e.g. Par. [0136]: impeller 605; Fig. 15A).
Regarding claim 2, McBride further discloses wherein the expanded diameter is at least 5 millimeters (e.g. Par. [0062]: diameter between 6-7mm).
Regarding claim 4, McBride further discloses wherein the distinct distal and proximal portions are collapsible from an expanded configuration to a delivery configuration having a delivery diameter for insertion into a patient or removal from the patient (e.g. Par. [0062]: insertion into patient; Par. [0175]: removal from patient).
Regarding claim 5, McBride further discloses wherein the coating comprises a biocompatible polymer (e.g. Par. [0143]: biocompatible coating).
Regarding claim 6, McBride further discloses wherein the plurality of nitinol members forms connection structures for securing the self-expanding mesh structure to the elongate body (e.g. Par. [0146]; Fig. 16: connectors 694).
Regarding claim 7, McBride further discloses wherein the connection structures secure the self-expanding mesh structure to the elongate body at a hub structure (e.g. Fig. 18: connector connected to structure 660, which is being considered the hub structure).
Regarding claim 8, McBride further discloses wherein the connection structures engage slots formed in the hub structure (e.g. Par. [0148]; Fig. 18).
Regarding claim 9, McBride further discloses wherein the connection structures comprise loop elements (e.g. Fig. 16: connection structures include loop elements).
Regarding claim 10, McBride further discloses McBride further discloses wherein the connection structures comprise linear elements (e.g. Fig. 16: connection structures include linear elements).
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claim 3 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over McBride et al. (US Patent Application Publication 2008/0114339, of record), hereinafter McBride.
Regarding claim 3, McBride further discloses wherein the cannula proximal portion tapers at an angle in the range of 30 degrees to 40 degrees relative to a longitudinal axis of the elongate body (e.g. Fig. 15B: proximal portion tapers at an angle relative to longitudinal axis of the elongate body). McBride discloses the claimed invention except for the angle being in the range of 30 to 40 degrees. It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention as taught by McBride with the angle being in the range of 30 to 40 degrees, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art [In re Aller, 105 USPQ 233].
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Pfeffer et al. (US 2009/0093764) is directed towards a catheter device.
Campbell et al. (US 2011/0004046) is directed towards a blood pump with an expandable cannula.
McBride et al. (US 2011/0071338) is directed towards a heart assist device with an expandable impeller pump.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHREYA P ANJARIA whose telephone number is (571)272-9083. The examiner can normally be reached M-F: 8:00-5:00 EST.
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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.
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/SHREYA ANJARIA/Examiner, Art Unit 3796
/NIKETA PATEL/Supervisory Patent Examiner, Art Unit 3792
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