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 (claim 5 – 13) in the reply filed on 05/12/2026 is acknowledged.
Claim 1 – 14 remain pending in the application.
Claim 1 – 4 and 14 are withdrawn from consideration.
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 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 5 – 7 and 9 – 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tuval et al. (US 2019/0209751 A1; published on 07/11/2019) (hereinafter "Tuval").
Regarding claim 5, Tuval discloses an intravascular blood pump ("Reference is also made to FIGS. 2A, 2B, and 2C, which are schematic illustrations of a blood pump portion 27 of ventricular assist device 20 …" [0447]), comprising:
a collapsible conduit having an inner lumen for passing fluid therethrough ("… of tube 24 … The tube typically defines one or more blood inlet openings 108 at the distal end of the tube, via which blood flows into the tube from the left ventricle, during operation of the impeller." [0447]; "Tube 24 is typically made of a blood-impermeable collapsible material." [0452]), the conduit comprising a proximal end having a proximal opening ("… the proximal portion of the tube defines one or more blood outlet openings 109 …" [0447]), and a distal end having a distal opening ("The tube typically defines one or more blood inlet openings 108 at the distal end of the tube …" [0447]);
at least one impeller within the conduit ("Typically, an impeller 50 is disposed within a distal portion 102 of tube 24 …" [0447]), the at least one impeller arranged to pump fluid into the distal opening of the conduit ("… and is configured to pump blood from the left ventricle into the aorta by rotating. The tube typically defines one or more blood inlet openings 108 at the distal end of the tube, via which blood flows into the tube from the left ventricle, during operation of the impeller." [0447]) and out of the proximal opening of the conduit ("… the proximal portion of the tube defines one or more blood outlet openings 109, via which blood flows from the tube into the ascending aorta, during operation of the impeller." [0447]);
a plurality of struts extending from the proximal end or the distal end of the conduit ("… a frame 34 is disposed within the tube." [0450]; "… the frame includes a plurality of rigid struts 111 …" [0451]; "… frame 34 is shaped such that the frame defines a proximal conical portion 36, a central cylindrical portion 38, and a distal conical portion 40." [0457]); and
a hub configured to receive the plurality of struts ("The axial shaft itself is radially stabilized via a proximal radial bearing 116 and a distal radial bearing 118, defined by frame 34." [0478]; see Fig.4, e.g. bearing 118 is the hub to receive 40); and
a distal tip connected to the hub, the distal tip comprising a proximal section, a central section, and a distal section ("… an axial-shaft-receiving tube 126 and a distal tip portion 120 of ventricular assist device 20 …" [0484]; see Fig.6A - 6C, the left side of 124 is the proximal section, the 124 portion is the central section, and the right side of 124 is the distal section), wherein the central section is stiffer than the proximal section and the distal section ("For some applications, the stopper comprises a rigid component that is inserted (e.g., embedded into the distal end of the shaft-receiving tube." [0485]; "For some applications, the entire tip portion is made of a material having a uniform stiffness …" [0487]; see Fig.6B and Fig.13, since only the central section is inserted with a rigid stopper 128, which cause the central section to be stiffer).
Regarding claim 6, Tuval discloses all claim limitations, as applied in claim 5, and further discloses wherein the central section has a wall thickness that is greater than a wall thickness of the proximal section and the distal section (see Fig.13, portion 124 is thicker than other portions).
Regarding claim 7, Tuval discloses all claim limitations, as applied in claim 5, and further discloses wherein the distal section is attached to the proximal section at the central section (see Fig. 13).
Regarding claim 9, Tuval discloses all claim limitations, as applied in claim 5, and further discloses an atraumatic tip coupled to the distal section ("… distal tip portion 120 of the device, being a radially-expandable atraumatic distal tip portion …" [0550]; see Fig.6A - 6C, the tip is in round shape).
Regarding claim 10, Tuval discloses all claim limitations, as applied in claim 5, and further discloses a guidewire lumen disposed within the distal tip ("… with the guidewire disposed inside lumen 122." [0484]).
Regarding claim 11, Tuval discloses all claim limitations, as applied in claim 10, and further discloses a self-sealing septum disposed at a distal end of the guidewire lumen ("For some applications, a hemostasis valve 152 is disposed at the distal end of the lumen 122 of distal tip portion 120, such that the distal tip portion becomes sealed after the guidewire is retracted from lumen 122." [0484]).
Regarding claim 12, Tuval discloses all claim limitations, as applied in claim 11, and further discloses wherein the self-sealing septum is configured to be punctured to allow a guidewire to pass through ("… guidewire 10 (FIG. 1B) is first inserted into the left ventricle, for example, in accordance with known techniques. The distal tip portion of the ventricular assist device is then guided to the left ventricle by advancing the distal tip portion over the guidewire, with the guidewire disposed inside lumen 122." [0484]; see Fig.1B, the guidewire 10 is extending out of the tip portion).
Regarding claim 13, Tuval discloses all claim limitations, as applied in claim 12, and further discloses wherein the self-sealing septum is configured to re-seal itself when the guidewire is removed ("For some applications, a hemostasis valve 152 is disposed at the distal end of the lumen 122 of distal tip portion 120, such that the distal tip portion becomes sealed after the guidewire is retracted from lumen 122." [0484]).
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.
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.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Tuval, as applied in claim 5, and further in view of Campbell et al. (US 2012/0172655 A1; published on 07/05/2012) (hereinafter "Campbell").
Regarding claim 8, Tuval teaches all claim limitations, as applied in claim 5, except wherein the proximal section includes a male shaped fitting configured to mate with a female shaped fitting of the distal section.
However, in the same field of endeavor, Campbell teaches wherein the proximal section includes a male shaped fitting configured to mate with a female shaped fitting of the distal section ("FIG. 16A shows the proximal end of the elongate body 602 advanced over the enlarged structure 632 of the hub 608." [0098]; here the structure 632 is the male shaped fitting; see Fig.15, tubular body 636 is interpreted as the proximal section, elongated body 620 is interpreted as the distal section, and portion 612 is interpreted as the central section, which is also the female shaped fitting structure of distal section).
It would have been prima facie obvious to one ordinary skilled in the art before the effective filing date of the invention to modify the distal tip of blood pump as taught by Tuval with the detailed structure of distal tip as taught by Campbell. With such connection design, it provide a mechanism "to prevent the elongate tubular member from being separated from the structural members when the catheter assembly is in use" (see Campbell; [0008]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Tuval et al. (US 2021/0178145 A1; published on 06/17/2021) teach a blood bump with atraumatic distal tip. Tuval further teaches the stiffness of different portion of the distal tip.
Siess (US 2010/0268017 A1; published on 10/21/2010) teaches an intracardiac pumping device with flexible distal tip. Siess further teaches the connection portion of the distal tip.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHAO SHENG whose telephone number is (571)272-8059. The examiner can normally be reached Monday to Friday, 8:30 am to 5:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anne M. Kozak can be reached at (571) 270-0552. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHAO SHENG/ Primary Examiner, Art Unit 3797
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