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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on December 12th, 2024 and January 22nd 2025 is being considered by the examiner.
Priority
The current application claims benefit of provisional application 63540916, filed on September 27th, 2023. Examiner acknowledges the applicant’s claim for priority.
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.
(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 1-7, 9, 10, 13-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Siess et al. (US20220409852).
Regarding claim 1, Siess teaches a mechanical circulatory support system comprising ([0003] “intravascular blood pump for percutaneous insertion”): a blood pump configured to pump blood from a ventricle of a heart of a patient to vasculature of the patient ([0002] “pumping device may be inserted … into the left ventricle of a patient's heart”); an elongate tube coupled with the blood pump and extending proximally from the blood pump ([Fig. 1]; see also [0027] “The pumping device 1 is attached to the distal end 11 of the catheter 10”); and a flexible elongate shaft configured to be removably positioned within the elongate tube. ( [0033] “The rod 15 may stay in the catheter or may be removed to render the catheter 10 flexible after insertion”)
Regarding claim 2, Siess teaches all of the limitations of claim 1. Siess also teaches wherein a rigidity of the flexible elongate shaft is greater than a rigidity of the elongate tube. ([0028] “The rod 15 is particularly made of Nitinol and provides a bending stiffness sufficient to prevent the catheter 10 from kinking, while permitting the catheter 10 to bend to adapt to the shape of the blood vessel”)
Regarding claim 3, Siess teaches all of the limitations of claim 1. Siess also teaches wherein a rigidity of the flexible elongate shaft varies along a length of the flexible elongate shaft. ([0018] “A variable flexibility can also be created by providing different materials along the length of the rod or by providing a jacket to provide increased bending stiffness in desired regions”)
Regarding claim 4, Siess teaches all of the limitations of claim 1. Siess also teaches wherein: the blood pump further comprises: a motor ([0026] “An impeller (not shown) is provided in the pumping device 1 to cause the blood flow from the blood flow inlet 2 to the blood flow outlet 3” ); and a motor cable extending proximally from the motor ([0032] “an electric wire 19 for supplying electric power to the pumping device 1, may be inserted in the catheter lumen 13”), and wherein the elongate tube includes a lumen ([0027] “The catheter 10 … has a lumen 13 that extends through the catheter 10”) and the motor cable extends through the lumen. ([0032] above)
Regarding claim 5, Siess teaches all of the limitations of claim 4. Siess also teaches wherein the lumen is configured to receive the motor cable and the flexible elongate shaft. ([Fig. 4] or [0032] “an electric wire 19 for supplying electric power to the pumping device 1, may be inserted in the catheter lumen 13. The stiffening structure 15 is particularly useful for preventing the catheter 10 from kinking,”)
Regarding claim 6, Siess teaches all of the limitations of claim 4. Siess also teaches wherein: the lumen is a first lumen and the motor cable extends through the first lumen, ([Fig. 4] or [0032] “an electric wire 19 for supplying electric power to the pumping device 1, may be inserted in the catheter lumen 13. The stiffening structure 15 is particularly useful for preventing the catheter 10 from kinking,”) and the elongate tube includes a second lumen extending along the first lumen and configured to removably receive the flexible elongate shaft. ([0015] “the catheter has more than one lumen, the stiffening structure may be disposed in a lumen separate from a lumen that contains other lines”)
Regarding claim 7, Siess teaches all of the limitations of claim 6. Siess also teaches wherein the second lumen has an interior surface configured to facilitate inserting and removing the flexible elongate shaft into and from the second lumen. ([0015] “Preferably, the stiffening structure is substantially free-floating or loose, i.e. not fixed, inside the lumen of the catheter” comprises an interior surface for inserting and removing the shaft; see also [0016] “the stiffening structure… may be movable in an axial direction to be able to slide in the axial direction along the length of the catheter”)
Regarding claim 10, Siess teaches a mechanical circulatory support delivery system comprising: a blood pump comprising: a motor ([0026] “An impeller (not shown) is provided in the pumping device”); a motor cable in communication with the motor and extending proximally from the motor; ([0032] “an electric wire 19 for supplying electric power to the pumping device 1, may be inserted in the catheter lumen 13”), and an impeller in communication with the motor (see impeller in [0026] above); an elongate tube coupled with the blood pump and extending proximally from the blood pump ([Fig. 1]; see also [0027] “The pumping device 1 is attached to the distal end 11 of the catheter 10”), wherein the elongate tube comprises a lumen through which the motor cable extends ([0032] “an electric wire 19 for supplying electric power to the pumping device 1, may be inserted in the catheter lumen 13”); a housing coupled with the elongate tube [i.e., catheter] and configured to receive the elongate motor cable ([Fig. 1] pumping device (1) is coupled to the distal end of the catheter (11); see also [0032] “an electric wire 19 for supplying electric power to the pumping device 1, may be inserted in the catheter lumen 13”); and a flexible elongate shaft configured to be removably positioned within the elongate tube at a location proximate the housing. ([0015] “the stiffening structure is substantially free-floating or loose, i.e. not fixed, inside the lumen of the catheter”)
Regarding claim 9 and 15, Siess teaches all of the limitations of claim 1 and 10. Siess also teaches wherein the elongate tube comprises a bend at a location proximate a distal end of the elongate tube and the flexible elongate shaft is configured to extend through the location proximate the distal end and straighten the bend ([0015] “the catheter is bent to follow a shape of a blood vessel”; see also [Fig. 2] where the bend occurs proximate of a straight distal end).
Regarding claim 13, Siess teaches all of the limitations of claim 10. Siess also teaches wherein the lumen is configured to receive the motor cable and the flexible elongate shaft. ([0032] “an electric wire 19 for supplying electric power to the pumping device 1, may be inserted in the catheter lumen 13”)
Regarding claim 14, Siess teaches all of the limitations of claim 10. Siess also teaches wherein: the lumen is a first lumen; and the elongate tube includes a second lumen configured to receive the flexible elongate shaft. ([0015] “the catheter has more than one lumen, the stiffening structure may be disposed in a lumen separate from a lumen that contains other lines”)
Regarding claim 16, Siess teaches a method, comprising: inserting a mechanical circulatory support system into a vasculature of a patient ([0002] “pumping device may be inserted … into the left ventricle of a patient's heart”), the mechanical circulatory support system comprising: a blood pump ([Fig. 1] a blood pump); an elongate tube coupled with the blood pump and extending proximally from the blood pump ([0027] “The pumping device 1 is attached to the distal end 11 of the catheter 10”); and a flexible elongate shaft removably positioned within the elongate tube ([0033] “The rod 15 may be inserted in the catheter 10 during insertion of the pumping device 1 into the patient”); delivering the blood pump through the vasculature of the patient to a heart of the patient ([0026] the pumping device 1 is inserted into the left ventricle LV of the patient's heart H via the aorta AO”); and withdrawing the flexible elongate shaft from the elongate tube. ([0033] “The rod 15 may stay in the catheter or may be removed to render the catheter 10 flexible after insertion”)
Regarding claim 17, Siess teaches all of the limitations of claim 16. Siess also teaches wherein the withdrawing the flexible elongate shaft from within the elongate tube occurs after the blood pump is delivered to the heart of the patient. ([0033] “The rod 15 may stay in the catheter or may be removed to render the catheter 10 flexible after insertion”)
Regarding claim 18, Siess teaches all of the limitations of claim 16. Siess also teaches inserting the flexible elongate shaft into the elongate tube ([0033] “The rod 15 may be inserted in the catheter 10 during insertion of the pumping device 1 into the patient”), wherein the elongate tube includes a bend and the flexible elongate shaft is inserted into the elongate tube to at least a location of the bend such that the elongate tube straightens ([0015] “the catheter is bent to follow a shape of a blood vessel”; see also [Fig. 2] where the tube is inserted to the bend); and withdrawing the flexible elongate shaft from the elongate tube includes withdrawing a distal end of the flexible elongate shaft to at least a location proximal of the bend ([0033] “The rod 15 may stay in the catheter or may be removed to render the catheter 10 flexible after insertion”) to allow the elongate tube to re-form a shape of the bend prior to delivering the blood pump to the heart of the patient ([0007] “shape-memory material prevents the catheter from kinking while at the same time providing sufficient flexibility to enable bending so that the catheter can be directed through a blood vessel”)
Regarding claim 19, Siess teaches all of the limitations of claim 16. Siess also teaches withdrawing a distal end of flexible elongate shaft from the elongate tube; ([0033] “The rod 15 may stay in the catheter or may be removed to render the catheter 10 flexible after insertion”) and re-inserting the flexible elongate shaft into the elongate tube. ([0016] “It may be movable in an axial direction to be able to slide in the axial direction along the length of the catheter”)
Regarding claim 20, Siess teaches all of the limitations of claim 14. Siess also teaches wherein the flexible elongate shaft [i.e., rod] is a first flexible elongate shaft and the method further comprises ([0033] “The rod 15 may be inserted in the catheter”): withdrawing a distal end of first flexible elongate shaft from the elongate tube([0033] “The rod 15 may stay in the catheter or may be removed to render the catheter 10 flexible after insertion”); and inserting a second flexible elongate shaft into the elongate tube ([0031] “a plurality of rods 15B may be provided” and [0033] “The rod 15 may be inserted in the catheter 10 during insertion of the pumping device 1 into the patient”), wherein the second flexible elongate shaft has a rigidity greater than the first flexible elongate shaft ([0031] “the rods 15B add up to the desired total bending stiffness of the stiffening structure”).
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.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Siess et al. (US20220409852) as applied to claim 7 above, and further in view of Siess et al. (US20150080743), herein known as Siess 743’.
Regarding claim 8, Siess teaches all of the limitations of claim 7. Siess also teaches wherein the interior surface is formed ([0013] “shape-memory materials, such as a polymeric material having shape-memory properties may be used”). Siess does not explicitly teach, as taught by Siess 743’ from a polytetrafluoroethylene (PTFE) material. ([0014] “material is preferred for the sliding tube, which might be plastic-coated on the inside, preferably again with polytetrafluoroethylene (PTFE)”)
It would have been obvious to one having ordinary skill in the at before the effective filing date of the claimed invention to modify Siess’es device by explicitly making the interior surface out of polytetrafluoroethylene as taught and suggested by Siess 743’, with a reasonable expectation of success. This would create a lower friction surface for reduced device wear. Both inventions of Siess are within the same field of invention and may substitute the same cardiac surgical device material to use a known material design choice to obtain predictive results.
Claims 11 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Siess et al. (US20220409852) as applied to claim 10 above, and further in view of Lee et al. (US20040082935).
Fig. 1 below will be used for reference to the following limitation.
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Regarding claim 11, Siess teaches all of the limitations of claim 10. Siess does not explicitly teach, as taught by Lee wherein the elongate tube includes a side port at a location distal of the housing and the side port is configured to removably receive the flexible elongate shaft. ([Fig 1] adapter (26) contains a side port configured to receive a removable flexible elongated shaft (20))
Lee and Siess both are in the same field of endeavor for flexible catheter-based surgical equipment to access cardiac chambers. It would have been obvious to one having ordinary skill in the at before the effective filing date of the claimed invention to modify Siess’es device by configuring a side port inside the elongate tube to remove the flexible elongate shaft, as taught and suggested by Lee, with a reasonable expectation of success. This configuration would allow for simultaneous treatments with multi-lumen port access without compromising pushability, see Lee [0004].
Fig. 12 below will be used for reference to the following limitation.
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Regarding claim 12, Siess teaches all of the limitations of claim 10. Siess does not explicitly teach, as taught by Lee wherein the housing includes a side port in communication with the elongate tube and the side port is configured to removably receive the flexible elongate shaft. ([Fig 12] port (106) contains a side port configured to receive a removable flexible elongated shaft (104))
Lee and Siess both are in the same field of endeavor for flexible catheter-based surgical equipment to access cardiac chambers. It would have been obvious to one having ordinary skill in the at before the effective filing date of the claimed invention to modify Siess’es device by configuring a side port inside the elongate tube to remove the flexible elongate shaft, as taught and suggested by Lee, with a reasonable expectation of success. This configuration would allow for simultaneous treatments with multi-lumen port access without compromising pushability, see Lee [0004].
Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Siess et al. (US 20230086096) teaches an intravascular blood pump with a motor unit contained in the body.
Pieferi et al. (WO-2023107833) also contains an intravascular blood pump with multiple lumens.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT ANTHONY SKROBARCZYK whose telephone number is (571)272-3301. The examiner can normally be reached Monday thru Friday 7:30AM -5PM CST.
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/R.A.S/Examiner, Art Unit 3792
/ALLEN PORTER/Primary Examiner, Art Unit 3796
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