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 30JUN2025 was filed in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
The disclosure is objected to because of the following informalities:
¶0047 of the Specification states “dashed line 221”. Other mentions of part 221 refer to an extending portion. This should be corrected to have consistent terminology for part 221.
Appropriate correction is required.
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 11-20 are 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.
Regarding Claim 11:
Claim 11 recites the limitation " the at least one impeller " in Line 6. There is insufficient antecedent basis for this limitation in the claim.
Claims 12-20 are additionally rejected for depending upon the rejected claim 11.
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.
Claims 1-2, 4-7, 9-10, & 21-22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tuval et al. (US Publication No. 20200237981).
Regarding claim 1, Tuval discloses an intravascular blood pump (Tuval ¶0428 “With regards to all aspects of ventricular assist device 20…For some applications, components of device 20 are applicable to different types of blood pumps. ” Showing device 20 placed in a blood vessel which is used to pump blood), comprising: a collapsible conduit (Tuval “Fig. 6A showing tube 24, ¶0228 “Tube 24 is typically made of a blood-impermeable collapsible material.”),having an inner lumen for passing fluid therethrough (Tuval “Fig. 6A showing tube 24, ¶0280 “pumping blood through tube 24” showing tube 24 comprises a inner lumen for passing fluid through), the conduit comprising a proximal end having a proximal opening (Tuval ¶0230 “Typically, blood outlet openings 109 are defined by tube 24, such that the openings extend at least partially along the proximal conical section of tube 24.”; Figure 1C) , and a distal end having a distal opening (Tuval ¶0224 “The tube typically defines one or more blood inlet openings 108 at the distal end of the tube” referring to the structure of tube 24; Figure 1C); at least one impeller within the conduit (Tuval Impeller 50 as shown in Figure 1C; ¶0224 “an impeller 50 is disposed within a distal portion 102 of tube 24 and is configured to pump blood from the left ventricle into the aorta by rotating.”), the at least one impeller arranged to pump fluid into the distal opening of the conduit and out of the proximal opening of the conduit (Tuval ¶0224 “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. For some applications, proximal portion 106 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.”); a plurality of metallic struts extending from the proximal end or the distal end of the conduit (Tuval struts of frame 34 extending from distal end of tube 24, Figure 1C, described in ¶0229), and a hub (Tuval Figure 6A-C showing a hub defined by distal radial bearing 118 and distal tip element 107) configured to receive the plurality of metallic struts (Tuval Figure 6A showing distal strut junctions 33 are placed between radial bearing 118 and receiving tube 126 of distal tip element 107; ¶0277) , the hub comprising at least one non-metallic layer (Tuval ¶0284 “For example, distal-tip element 107 may be made of silicone, polyethylene terephthalate (PET) and/or polyether block amide ).
Regarding claim 2, claim 1 is anticipated by Tuval. Tuval further discloses wherein the hub comprises a first layer and a second layer (Tuval ¶0017 “While heating the inner lining, the frame and the distal portion of the elongate tube, pressure is applied from outside the distal portion of the elongate tube, such as to cause the distal portion of the elongate tube to conform with a structure of the struts of the frame, and such as to cause the inner lining and the distal portion of the elongate tube to become coupled to the frame.” Showing the portion that couples the frame to the tube 107, which includes the hub portion, consists of two layers which are heated to adhere to the frame) each made of non-metallic materials (Tuval ¶0284 “ For some applications, distal-tip element 107 is configured to be soft, such that the distal-tip portion is configured not to injure tissue of the subject, even if the distal-tip portion comes into contact with the tissue (e.g., tissue of the left ventricle). For example, distal-tip element 107 may be made of silicone, polyethylene terephthalate (PET) and/or polyether block amide (e.g., PEBAX®).”) disposed around the plurality of metallic struts (Tuval ¶0237 “ Subsequently, the distal strut portions are closed around the outside of a distal bearing 118, as described in further detail hereinbelow with reference to FIGS. 5A-B. For some applications, a proximal end of distal-tip element 107 (shown in FIG. 1C) holds the distal strut portions in their closed configurations around the outside of distal bearing 118.”).
Regarding claim 4, claim 2 is anticipated by Tuval. Tuval further discloses wherein the second non-metallic layer comprises Pebax. (Tuval ¶0284 “ For some applications, distal-tip element 107 is configured to be soft, such that the distal-tip portion is configured not to injure tissue of the subject, even if the distal-tip portion comes into contact with the tissue (e.g., tissue of the left ventricle). For example, distal-tip element 107 may be made of silicone, polyethylene terephthalate (PET) and/or polyether block amide (e.g., PEBAX®).”).
Regarding claim 5, claim 1 is anticipated by Tuval. Tuval further discloses wherein the at least one non-metallic layer is configured to encompass or surround the plurality of metallic struts. (Tuval Figure 6A showing tube 126 surrounds an outer surface of the strut junctions 33; ¶0227).
Regarding claim 6, Claim 2 is anticipated by Tuval. Tuval further discloses wherein the first non-metallic layer and the second nonmetallic layer are heat treated so as to meld together around the plurality of metallic struts. (Tuval ¶0017 “While heating the inner lining, the frame and the distal portion of the elongate tube, pressure is applied from outside the distal portion of the elongate tube, such as to cause the distal portion of the elongate tube to conform with a structure of the struts of the frame, and such as to cause the inner lining and the distal portion of the elongate tube to become coupled to the frame.” Showing the portion that couples the frame to the tube 107, which includes the hub portion, consists of two layers which are heated to adhere to the frame).
Regarding claim 7, claim 1 is anticipated by Tuval. Tuval further discloses wherein the hub comprises a distal hub positioned adjacent to the distal opening. (Tuval Figure 6A showing receiving tube 126 of distal tip element 107 positioned adjacent to the distal opening).
Regarding claim 9, claim 1 is anticipated by Tuval. Tuval further discloses wherein the plurality of metallic struts comprise nitinol. (Tuval ¶0227 “Typically, along distal portion 102 of tube 24, a frame 34 is disposed within the tube around impeller 50. The frame is typically made of a shape-memory alloy, such as nitinol.”).
Regarding claim 10, claim 1 is anticipated by Tuval. Tuval further discloses wherein the plurality of metallic struts comprises 4, 5, 6, 7, or 8 struts (Tuval Figure 6A Showing the plurality of struts disposed on the pump).
Regarding claim 21, Tuval discloses method of manufacturing an intravascular blood pump (Tuval ¶0017), the method comprising: placing one or more metallic struts of a blood conduit on or near a first non-metallic hub layer; placing a second non-metallic hub layer on or over the one or more metallic struts; and applying a heat treatment to the one or more metallic struts, the first non-metallic hub layer, and the second non-metallic hub layer to meld or melt the first and second non-metallic hub layers around the one or more metallic struts (Tuval ¶0017 “While the distal portion is disposed around at least the portion of the frame, the inner lining, the frame and the distal portion of the elongate tube are heated, via the mandrel. While heating the inner lining, the frame and the distal portion of the elongate tube, pressure is applied from outside the distal portion of the elongate tube, such as to cause the distal portion of the elongate tube to conform with a structure of the struts of the frame, and such as to cause the inner lining and the distal portion of the elongate tube to become coupled to the frame.”).
Regarding claim 22, claim 21 is anticipated by Tuval. Tuval further discloses wherein, prior to the applying a heat treatment step, applying a shrink tubing over the second non-metallic hub layer. (Tuval ¶0017 “While heating the inner lining, the frame and the distal portion of the elongate tube, pressure is applied from outside the distal portion of the elongate tube, such as to cause the distal portion of the elongate tube to conform with a structure of the struts of the frame, and such as to cause the inner lining and the distal portion of the elongate tube to become coupled to the frame. For example, the pressure may be applied by means of a silicone tube that is placed outside the distal portion of the elongate tube.” Where the examiner is interpreting the silicone tubing which applies pressure during heating as the shrink tubing.).
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.
Claims 8, 11-12, & 14-20 are rejected under 35 U.S.C. 103 as being unpatentable over Tuval et al. (US Publication No. 20200237981) in view of Hildebrand et al. (WO Publication No. 2021026469).
Regarding claim 8, claim 1 is anticipated by Tovel. Tovel does not further disclose the pump further comprising a bullet-shaped tapering section extending proximally from where the plurality of metallic struts are joined to the distal hub. Hildebrand in a similar field of endeavor of blood pumps teaches a bullet-shaped tapering section extending proximally from where the plurality of metallic struts are joined to the distal hub (Hildebrand Figure 15 showing the bullet-shaped tapering of impeller 423 extending proximally). Before the effective filing date, it would have been obvious to one of ordinary skill in the art that the impeller of Tuval could have been modified as claimed in view of Hildebrand so as to replace the impeller of Tuval with the impeller of Hildebrand, to provide a shape that converges toward the impeller, which reduces turbulence (Tuval ¶0371).
Regarding claim 11, Tuval discloses an intravascular blood pump (Tuval ¶0428 “With regards to all aspects of ventricular assist device 20…For some applications, components of device 20 are applicable to different types of blood pumps. ” Showing device 20 placed in a blood vessel which is used to pump blood), comprising: a collapsible conduit (Tuval “Fig. 6A showing tube 24, ¶0228 “Tube 24 is typically made of a blood-impermeable collapsible material.”), comprising: a collapsible conduit (Tuval “Fig. 6A showing tube 24, ¶0228 “Tube 24 is typically made of a blood-impermeable collapsible material.”) having an inner lumen for passing fluid therethrough, (Tuval “Fig. 6A showing tube 24, ¶0280 “pumping blood through tube 24” showing tube 24 comprises a inner lumen for passing fluid through) the conduit comprising a proximal end having a proximal opening (Tuval ¶0230 “Typically, blood outlet openings 109 are defined by tube 24, such that the openings extend at least partially along the proximal conical section of tube 24.”; Figure 1C), and a distal end having a distal opening (Tuval ¶0224 “The tube typically defines one or more blood inlet openings 108 at the distal end of the tube” referring to the structure of tube 24; Figure 1C); the at least one impeller arranged to pump fluid into the distal opening of the conduit and out of the proximal opening of the conduit, (Tuval ¶0224 “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. For some applications, proximal portion 106 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.”) a plurality of metallic struts extending from the distal end of the conduit (Tuval struts of frame 34 extending from distal end of tube 24, Figure 1C, described in ¶0229); and a distal hub (Tuval Figure 6A-C showing a hub defined by distal radial bearing 118 and distal tip element 107) configured to receive the plurality of metallic struts (Tuval Figure 6A showing distal strut junctions 33 are placed between radial bearing 118 and receiving tube 126 of distal tip element 107; ¶0277), the hub comprising at least one non-metallic layer (Tuval ¶0284 “For example, distal-tip element 107 may be made of silicone, polyethylene terephthalate (PET) and/or polyether block amide )configured to encapsulate the plurality of metallic struts. (Tuval Figure 6A showing tube 126 surrounds an outer surface of the strut junctions 33; ¶0227).
Tuval does not disclose a proximal impeller positioned at least partially within the conduit near the proximal opening, Hildebrand in a similar field of endeavor of blood pumps teaches a a proximal impeller positioned at least partially within the conduit near the proximal opening (Hildebrand Figure 15 proximal impeller 422). Before the effective filing date, it would have been obvious to one of ordinary skill in the art that the impeller of Tuval could have been modified as claimed in view of Hildebrand to provide a impeller positioned proximally in the device, as this will provide a controlled flow rate of the impeller since the axial distance of the impeller placement will achieve various flow rate (Hildebrand ¶0098).
Regarding claim 12, claim 11 is obvious over Tovel in view of Hildebrand. Tuval further discloses a first layer and a second layer (Tuval ¶0017 “While heating the inner lining, the frame and the distal portion of the elongate tube, pressure is applied from outside the distal portion of the elongate tube, such as to cause the distal portion of the elongate tube to conform with a structure of the struts of the frame, and such as to cause the inner lining and the distal portion of the elongate tube to become coupled to the frame.” Showing the portion that couples the frame to the tube 107, which includes the hub portion, consists of two layers which are heated to adhere to the frame) each made of non-metallic materials (Tuval ¶0284 “ For some applications, distal-tip element 107 is configured to be soft, such that the distal-tip portion is configured not to injure tissue of the subject, even if the distal-tip portion comes into contact with the tissue (e.g., tissue of the left ventricle). For example, distal-tip element 107 may be made of silicone, polyethylene terephthalate (PET) and/or polyether block amide (e.g., PEBAX®).”) disposed around the plurality of metallic struts (Tuval ¶0237 “ Subsequently, the distal strut portions are closed around the outside of a distal bearing 118, as described in further detail hereinbelow with reference to FIGS. 5A-B. For some applications, a proximal end of distal-tip element 107 (shown in FIG. 1C) holds the distal strut portions in their closed configurations around the outside of distal bearing 118.”).
Regarding claim 14, claim 12 is obvious over Tovel in view of Hildebrand. Tuval further discloses wherein the second non-metallic layer comprises Pebax. (Tuval ¶0284 “ For some applications, distal-tip element 107 is configured to be soft, such that the distal-tip portion is configured not to injure tissue of the subject, even if the distal-tip portion comes into contact with the tissue (e.g., tissue of the left ventricle). For example, distal-tip element 107 may be made of silicone, polyethylene terephthalate (PET) and/or polyether block amide (e.g., PEBAX®).”).
Regarding claim 15, claim 11 is obvious over Tuval in view of Hildebrand. Tuval further discloses wherein the at least one non-metallic layer is configured to encompass or surround the plurality of metallic struts. (Tuval Figure 6A showing tube 126 surrounds an outer surface of the strut junctions 33; ¶0227).
Regarding claim 16, Claim 12 is obvious over Tovel in view of Hildebrand. Tuval further discloses wherein the first non-metallic layer and the second nonmetallic layer are heat treated so as to meld together around the plurality of metallic struts. (Tuval ¶0017 “While heating the inner lining, the frame and the distal portion of the elongate tube, pressure is applied from outside the distal portion of the elongate tube, such as to cause the distal portion of the elongate tube to conform with a structure of the struts of the frame, and such as to cause the inner lining and the distal portion of the elongate tube to become coupled to the frame.” Showing the portion that couples the frame to the tube 107, which includes the hub portion, consists of two layers which are heated to adhere to the frame).
Regarding claim 17, claim 11 is obvious over Tuval in view of Hildebrand. Tuval further discloses wherein the hub comprises a distal hub positioned adjacent to the distal opening. (Tuval Figure 6A showing receiving tube 126 of distal tip element 107 positioned adjacent to the distal opening).
Regarding claim 18, claim 11 is obvious over Tovel in view of Hildebrand. Tovel does not further disclose the pump further comprising a bullet-shaped tapering section extending proximally from where the plurality of metallic struts are joined to the distal hub. Hildebrand further teaches a bullet-shaped tapering section extending proximally from where the plurality of metallic struts are joined to the distal hub. (Hildebrand Figure 15 showing the bullet-shaped tapering of impeller 423 extending proximally). Before the effective filing date, it would have been obvious to one of ordinary skill in the art that the impeller of Tuval could have been modified as claimed in view of Hildebrand so as to replace the impeller of Tuval with the impeller of Hildebrand, to provide a shape that converges toward the impeller, which reduces turbulence (Tuval ¶0371).
Regarding claim 19, claim 11 is obvious over Tovel in view of Hildebrand. Tuval further discloses wherein the plurality of metallic struts comprise nitinol. (Tuval ¶0227 “Typically, along distal portion 102 of tube 24, a frame 34 is disposed within the tube around impeller 50. The frame is typically made of a shape-memory alloy, such as nitinol.”).
Regarding claim 20, claim 11 is obvious over Tovel in view of Hildebrand. Tuval further discloses wherein the plurality of metallic struts comprises 4, 5, 6, 7, or 8 struts. (Tuval Figure 6A Showing the plurality of struts disposed on the pump).
Claims 3 & 23 are rejected under 35 U.S.C. 103 as being unpatentable over Tuval et al. (US Publication No. 20200237981) in view of Cajamarca et al. (US Publication No. 20150119859).
Regarding claim 3, claim 2 is anticipated by Tuval. Tuval does not further disclose wherein the first non-metallic layer comprises a thermoplastic urethane. Cajamarca in a similar field of endeavor of designing blood conduits teaches wherein the first non-metallic layer comprises a thermoplastic urethane. (Cajamarca ¶0038 “The first outer layer may be constructed of a polyimide, a thermoplastic such as a polyether block amide (Pebax.RTM.), a nylon, a urethane, or combinations thereof “). Before the effective filing date, it would have been obvious to one of ordinary skill in the art that the hub of Tovel could have been modified as to consist of a layer made of thermoplastic urethane, as taught in Cajamarca, to provide a layer of the hub, which is conformable to the other components and biocompatible, to the components being encapsulated by the thermoplastic urethane layer. Thermoplastic urethane is known for its biocompatibility, shaping ability, and durability, all of which would be desirable in a blood conduit system in areas that face constant blood flow forces.
Regarding claim 23, claims 21-22 are anticipated by Tuval. Tuval does not further disclose removing the shrink tubing after applying the heat treatment. Cajamarca in a similar field of endeavor of designing blood conduits teaches removing the shrink tubing after applying the heat treatment (Cajamarca ¶0041 “ Once a suitable second outer layer material is selected, it is introduced around the exterior of the braided polyimide tube. In many embodiments, the second outer layer will be formed from a tubular material that is placed around the exterior of the braided polyimide tube (along with a heat shrink material) and subjected to a reflow process. Once the reflow process is complete and the second outer layer formed, the heat shrink material is removed.”). Before the effective filing date, it would have been obvious to one of ordinary skill in the art that the manufacturing steps of Tuval in which silicone tubing is used to apply pressure to and seal the components, could have been modified as claimed in view of Cajamarca such that the silicone is removed following the heat treatment, as to provide a seal with uniform thickness which may be evaluated after the tube is removed to confirm the device has been manufactured correctly. Since the Shrink tubing is used for forming of the device, it is not necessary to keep after the heat treatment steps of manufacturing, and one would understand this part may be removed as it is not necessary for the functioning of the blood conduit.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Tuval et al. (US Publication No. 20200237981) in view of Hildebrand et al. (WO Publication No. 2021026469) and Cajamarca et al. (US Publication No. 20150119859).
Regarding claim 13, claim 12 is obvious over Tovel in view of Hildebrand and Cajamarca. Tuval does not further disclose wherein the first non-metallic layer comprises a thermoplastic urethane. Cajamarca in a similar field of endeavor of designing blood conduits teaches wherein the first non-metallic layer comprises a thermoplastic urethane. (Cajamarca ¶0038 “The first outer layer may be constructed of a polyimide, a thermoplastic such as a polyether block amide (Pebax.RTM.), a nylon, a urethane, or combinations thereof “). Before the effective filing date, it would have been obvious to one of ordinary skill in the art that the hub of Tovel as combined with Hildebrand could have been modified as to consist of a layer made of thermoplastic urethane, as taught in Cajamarca, to provide a layer of the hub, which is conformable to the other components and biocompatible, to the components being encapsulated by the thermoplastic urethane layer. Thermoplastic urethane is known for its biocompatibility, shaping ability, and durability, all of which would be desirable in a blood conduit system in areas that face constant blood flow forces.
Conclusion
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/MEGAN T FEDORKY/Examiner, Art Unit 3796
/Jennifer Pitrak McDonald/Supervisory Patent Examiner, Art Unit 3796