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 Invention I and the species of Embodiment A (directed to claims 1-6 and 8-19) in the reply filed on 07/09/2026 is acknowledged.
Information Disclosure Statement
The Information Disclosure Statements (IDS) dates 01/13/2025 and 02/07/2025 have been considered by the Examiner.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 3-5 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 3-5 recite the limitation of "the side wall”. There is insufficient antecedent basis for this limitation in the claim. Examiner is interpreting “the side wall” to be directed to “the annular side wall” as claimed in claim 2.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 6, and 8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yang et al (CN 116650825 A), with reference to the machine translation for citation purposes.
Regarding claim 1, Yang teaches a percutaneous circulatory support device (10) comprising:
a flexible elongate shaft (400);
a percutaneous blood pump (300) coupled to a distal end region of the elongate shaft at a junction (see Fig. 4; pump 300 coupled to a distal end region of the catheter shaft 400 at a junction),
the percutaneous blood pump (300) including a blood inlet (301), a blood outlet (302), an impeller assembly (330) positioned between the blood inlet and the blood outlet (see Fig. 6; impeller 330 positioned between inlet 301 and outlet 302), and
a motor housing (311) positioned proximal of the impeller (see Fig. 6; motor assembly 310 having housing 311 positioned proximal to the impeller),
the motor housing including a motor to rotationally drive an impeller of the impeller assembly to pump blood from the blood inlet to the blood outlet during use (see [Page 3, paragraph 2, machine translation]; the secondary pumping device includes a secondary motor comprising a rotating shaft, one end of the rotating shaft rotatably passes through the inner part of the secondary motor and the other end passes through the secondary impeller so that the rotating shaft can drive the secondary impeller to rotate);
wherein the motor housing includes an end cap surrounding and secured to a distal end region of the elongate shaft at the junction (see Fig. 7; fixing pin 315 and/or locating cover 317).
Regarding claim 6, Yang teaches the percutaneous circulatory support device of claim 1,
wherein the motor housing (311) includes a main body (311a) surrounding the motor (310), and
the end cap (315/317) is a separate component fixed to the main body (see [Page 10, paragraph 1, machine translation]; the proximal end of pumping device 300 is provided with a fixing pin 315, fixing pin 315 is further wrapped with a locating cover 317).
Regarding claim 8, Yang teaches the percutaneous circulatory support device of claim 1, wherein the end cap (315/317) includes a distal end region having a first outer diameter and a proximal end region having a second outer diameter, the second outer diameter being less than the first outer diameter (see Fig. 7; fixing pin 315 having a distal region having a first outer diameter and a proximal region having a second, smaller diameter). See annotated Fig. 7 below, which has been cropped to focus on the elements of interest.
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Claims 15-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Keenan et al (US 20210162195 A1).
Regarding claim 15, Keenan teaches a percutaneous circulatory support device (300) comprising:
a flexible elongate shaft (304);
a percutaneous blood pump (308) coupled to a distal end region of the elongate shaft at a junction (see Fig. 11; distal region of shaft 304 coupled to cannula 308 at junction 316),
the percutaneous blood pump configured to pump blood through a housing of the percutaneous blood pump during use (see [0004-0006]; intra-aortic balloon pumps are commonly inserted into the body and connected to the cardiovascular system to assist in the pumping function of the heart);
wherein the junction includes an end cap (336) at a proximal end of the percutaneous blood pump (see [0074]; the distal end of the ferrule 336 can be welded to the proximal end of the sleeve 368) surrounding and secured to a distal end region of the elongate shaft at the junction (see [0065]; ferrule 336 is an example of a structure to mechanically join the catheter body 304 to the cannula 308, the material of the catheter body 304 may extend into the distal zone 340 of ferrule 336, see Figs. 11 and 12 picturing junction between catheter body 304 and cannula 308).
Regarding claim 16, Keenan teaches the percutaneous circulatory support device of claim 15, wherein the junction further includes a fillet of material (316) surrounding a proximal end region of the end cap and extending proximally thereof and surrounding an exterior surface of the elongate shaft (see Figs. 11-12; fillet 316 surrounding the end cap 336 and an exterior surface of catheter shaft 304).
Regarding claim 17, Keenan teaches the percutaneous circulatory support device of claim 16, wherein the proximal end region of the end cap includes an annular side wall and one or more apertures extending into the annular side wall (see Figs. 13-14, [0067]; ferrule 336 includes proximal zone 348 which includes a plurality of recesses 352).
Regarding claim 18, Keenan teaches the percutaneous circulatory support device of claim 17, wherein the fillet of material extends into the one or more apertures (see [0067]; proximal zone 348 of ferrule 336 is preferably configured to provide an excellent fluid seal between the ferrule and the non-expandable tubular portion 316 of cannula 308, wherein portion 316 is the fillet) and is bonded to the elongate shaft (see [0063]; the tubular portion 316 plays a role in anchoring the cannula 308 to the catheter body 304).
Regarding claim 19, Keenan teaches the percutaneous circulatory support device of claim 18, wherein an outer circumferential surface of the proximal end region of the end cap includes one or more grooves (see Figs. 13-14, [0067]; outer surface of proximal zone 348 includes a plurality of recesses 352 which may take the form of a continuous helical groove in the outer surface of the ferrule 336),
wherein the fillet of material extends into the one or more grooves (see [0067]; proximal zone 348 of ferrule 336 is preferably configured to provide an excellent fluid seal between the ferrule and the non-expandable tubular portion 316 of cannula 308, wherein portion 316 is the fillet).
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.
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.
Claims 2-5 and 9-14 are rejected under 35 U.S.C. 103 as being unpatentable over Yang et al (CN 116650825 A) in view of Keenan et al (US 20210162195 A1).
Regarding claim 2, Yang teaches the percutaneous circulatory support device of claim 1 wherein the end cap (315/317) includes an annular side wall. Yang is silent regarding wherein the end cap includes one or more apertures extending into the annular side wall.
Keenan teaches a percutaneous circulatory support device (300) comprising:
a flexible elongate shaft (304);
a percutaneous blood pump (308) coupled to a distal end region of the elongate shaft at a junction (see Fig. 11; distal region of shaft 304 coupled to cannula 308 at junction 316),
the percutaneous blood pump configured to pump blood through a housing of the percutaneous blood pump during use (see [0004-0006]; intra-aortic balloon pumps are commonly inserted into the body and connected to the cardiovascular system to assist in the pumping function of the heart);
wherein the junction includes an end cap (336 or portion of housing 308 having apertures 364 in Fig. 12) at a proximal end of the percutaneous blood pump (see [0074]; the distal end of the ferrule 336 can be welded to the proximal end of the sleeve 368 or [0068]; a supplemental securement device 360 can be provided to secure catheter 304 and cannula 308 via ferrule 336 and junction 316) surrounding and secured to a distal end region of the elongate shaft at the junction (see [0065]; ferrule 336 is an example of a structure to mechanically join the catheter body 304 to the cannula 308, the material of the catheter body 304 may extend into the distal zone 340 of ferrule 336, see Figs. 11 and 12 picturing junction between catheter body 304 and cannula 308);
wherein the end cap includes an annular side wall and one or more apertures extending into the annular side wall (see Fig. 13, [0065]; a plurality of apertures 344 in distal zone 340 of ferrule 336, or Fig. 12, [0069]; a recess 364 is provided within the catheter assembly 300 to receive the securement device 360).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the junction between the percutaneous blood pump and the elongate shaft as taught by Yang with the pump housing end cap having one or more apertures in the side walls as taught by Keenan. One of ordinary skill in the art would have been motivated to make this modification in order to securely mechanically join the pump housing and catheter body together (Keenan [0065], [0068-0069]).
Regarding claim 3, Yang and Keenan teach the percutaneous circulatory support device of claim 2. Yang is silent regarding wherein the one or more apertures are through holes extending through an entire thickness of the side wall, the through holes having material of the end cap completely surrounding a periphery of the through holes.
Keenan teaches wherein the one or more apertures (344) are through holes extending through an entire thickness of the side wall, the through holes having material of the end cap completely surrounding a periphery of the through holes (see Fig. 14; where apertures 344 are pictured as extending through an entire thickness of the side wall and being completely surrounded by the ferrule material on all sides).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the junction between the percutaneous blood pump and the elongate shaft as taught by Yang with the pump housing end cap having one or more apertures in the side walls as taught by Keenan. One of ordinary skill in the art would have been motivated to make this modification in order to securely mechanically join the pump housing and catheter body together (Keenan [0065], [0068-0069]) via an interface formed at the junction including the end cap.
Regarding claim 4, Yang in view of Keenan teach the percutaneous circulatory support device of claim 2. They are silent regarding wherein the one or more apertures are blind holes extending through only a portion of a thickness of the side wall.
However, Keenan teaches securement device 360 that uses a cantilevered member which may be coupled with a corresponding recess disposed inward of the securement device (Keenan [0068]). It can be appreciated that the recesses 364 may be apertures which extend through the entire thickness of the housing, or they may be blind holes which only extend through a portion of the housing, because as long as the recesses have a sufficient depth to receive the cantilevered members of securement device 360, the depth of the aperture/recess is merely a matter of the size/shape of the aperture. Whether recess 364 extended through the entirety of the thickness of the housing or only a portion, so long as securement device 360 could couple to the recess, the size/shape of the recess would not have produced any unexpected results. MPEP 2144.04(IV)(A) states: ‘In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device.’
Regarding claim 5, Yang in view of Keenan teaches the percutaneous circulatory support device of claim 2. Yang is silent regarding wherein the one or more apertures are slots extending through an entire thickness of the side wall and opening out to a proximal end of the end cap.
Keenan teaches wherein the one or more apertures are slots (364) extending through an entire thickness of the side wall and opening out to a proximal end of the end cap (see Fig. 12, [0068-0069]; a recess 364 is provided within the catheter assembly 300 to receive the securement device 360).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the junction between the percutaneous blood pump and the elongate shaft as taught by Yang with the pump housing end cap having one or more apertures in the side walls as taught by Keenan. One of ordinary skill in the art would have been motivated to make this modification in order to securely mechanically join the pump housing and catheter body together (Keenan [0065], [0068-0069]) via an interface formed at the junction including the end cap.
Regarding claim 9, Yang teaches the percutaneous circulatory support device of claim 8, wherein the proximal end region of the end cap includes an annular side wall. Yang is silent regarding wherein the proximal end region of the end cap includes one or more apertures extending into the annular side wall.
Keenan teaches wherein the proximal end region of the end cap includes an annular side wall and one or more apertures extending into the annular side wall (see Fig. 13; apertures 344 extending into annular side wall of end cap 336, [0067]; ferrule 336 also includes zone 348 including a plurality of recesses 352).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the junction between the percutaneous blood pump and the elongate shaft as taught by Yang with the pump housing end cap having one or more apertures in the side walls as taught by Keenan. One of ordinary skill in the art would have been motivated to make this modification in order to securely mechanically join the pump housing and catheter body together (Keenan [0065], [0068-0069]) via an interface formed at the junction including the end cap.
Regarding claim 10, Yang in view of Keenan teaches percutaneous circulatory support device of claim 9, wherein the junction further includes a fillet of material (311b) surrounding the proximal end region of the end cap and extending proximally thereof and surrounding an exterior surface of the elongate shaft (see Yang Fig. 9; fillet 311b surrounds the end cap assembly 315/317 and surrounds the outside of 317 and socket portion 410 which connects the cover 317 and the socket 410 to connect the pump to the catheter 400).
Regarding claim 10, Keenan also teaches wherein the junction further includes a fillet of material (316) surrounding the proximal end region of the end cap and extending proximally thereof and surrounding an exterior surface of the elongate shaft (see Keenan [0065]; ferrule 336 is an example of a structure to mechanically join the catheter body 304 to the cannula 308, the material of the catheter body 304 may extend into the distal zone 340 of ferrule 336, see Figs. 11 and 12 picturing junction between catheter body 304 and cannula 308).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the junction between the percutaneous blood pump and the elongate shaft as taught by Yang with the pump housing end cap having one or more apertures in the side walls and configured to couple with the fillet of material as taught by Keenan. One of ordinary skill in the art would have been motivated to make this modification in order to securely mechanically join the pump housing and catheter body together (Keenan [0065], [0068-0069]) via an interface formed at the junction including the end cap and the fillet of material surrounding the end cap.
Regarding claim 11, Yang and Keenan teach the percutaneous circulatory support device of claim 10. Yang is silent regarding wherein the fillet of material extends into the one or more apertures.
Keenan teaches wherein the fillet of material extends into the one or more apertures (see Keenan [0067]; zone 348 is configured to provide an excellent fluid seal between the ferrule and the non-expandable tubular portion 316 of cannula 308).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the junction between the percutaneous blood pump and the elongate shaft as taught by Yang with the pump housing end cap having one or more apertures in the side walls and configured to couple with the fillet of material as taught by Keenan. One of ordinary skill in the art would have been motivated to make this modification in order to securely mechanically join the pump housing and catheter body together (Keenan [0065], [0068-0069]) via an interface formed at the junction including the end cap and the fillet of material surrounding the end cap.
Regarding claim 12, Yang and Keenan teach the percutaneous circulatory support device of claim 11. Yang further teaches wherein the end cap includes a shoulder between the proximal end region of the end cap and the distal end region of the end cap (see annotated Yang Fig. 9 below which has been cropped to focus on the elements of interest),
wherein the fillet of material 311b) extends distal of the shoulder and surrounds a portion of the distal end region of the end cap (see Yang Fig. 9; fillet 311b extending distal to the shoulder portion of end cap 315).
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Regarding claims 13 and 14, Yang and Keenan teach the percutaneous circulatory support device of claim 10. Yang is silent regarding wherein an outer circumferential surface of the proximal end region of the end cap includes one or more grooves,
wherein the fillet of material extends into the one or more grooves; and
wherein the one or more grooves extend circumferentially or helically around the outer circumferential surface.
Keenan teaches wherein an outer circumferential surface of the proximal end region of the end cap (see Keenan [0074]; the distal end of the ferrule 336 can be welded to the proximal end of the sleeve 368) includes one or more grooves, wherein the fillet of material extends into the one or more grooves (see Keenan [0067]; the proximal zone 348 of ferrule 336 is configured to provide a seal between fillet 316 and cannula 308, the proximal zone 348 includes a plurality of recesses 352 which may be turns of a helical groove which is configured to couple with the inner surface of the proximal portion of fillet 316); and
wherein the one or more grooves extend circumferentially or helically around the outer circumferential surface (see Keenan [0067]; the proximal zone 348 includes a plurality of recesses 352 which may be turns of a helical groove w).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the junction between the percutaneous blood pump and the elongate shaft as taught by Yang with the pump housing end cap having one or more grooved on the outer surface and configured to couple with the fillet of material as taught by Keenan. One of ordinary skill in the art would have been motivated to make this modification in order to securely mechanically join the pump housing and catheter body together (Keenan [0065], [0068-0069]) via an interface formed at the junction including the end cap and the fillet of material surrounding the end cap.
Conclusion
The following prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Yu (US 20230310834 A1) which teaches a blood pump assembly having a cannula and a catheter.
Butler (US 20230114252 A1) which teaches systems and methods for drive cable covering for a catheter pump motor assembly.
Yu (US 20230144798 A1) which teaches an interventional ventricular assist device.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALISHA J SIRCAR whose telephone number is (571)272-0450. The examiner can normally be reached Monday - Thursday 9-6:30, Friday 9-5:30 CT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin Klein can be reached at 571-270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/A.J.S./Examiner, Art Unit 3792
/Benjamin J Klein/Supervisory Patent Examiner, Art Unit 3792
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