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 .
Priority
The current application claims benefit of parent application PCT/IB2023/059141, filed on September 14th, 2022. Examiner acknowledges the applicant’s claim for priority.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on April 18th, 2024 and November 7th, 2024 is being considered by the examiner.
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 1-14 and 16-25 are rejected under 35 U.S.C. 103 as being unpatentable over Tuval et al. (US20200237986 referenced as Tuval ‘986) in view of Green (Pat. 6485501).
Green, like Tuval ‘986, integrates micron-sized frames into a guidewire-fed vascular system to prevent cardiac damage during cardiopulmonary surgeries. Green’s mechanisms “prevents an edge 150 of [the device] from becoming entangled in an artery or guide catheter during withdrawal from a patient” [0028] to improve the safety and efficacy of a ventricular assist device and would have been found by Tuval ‘986 as a source of the state of the art for these improvements.
Regarding claim 1, Tuval ‘986 teaches an apparatus, comprising: ([0010] In accordance with some applications of the present invention, a ventricular assist device includes” is an apparatus) an axial shaft configured for insertion into, and rotation within, a ventricle of a heart of a subject; ([0010] “The impeller, the axial shaft and the frame are disposed within a distal portion of the tube inside the subject's left ventricle. Typically, the impeller is configured to pump blood from the left ventricle into the aorta by rotating” Where the impeller is in connection with the axial shaft) an impeller coupled to the axial shaft; [0069] “the impeller is coupled to the axial shaft”) a frame surrounding the impeller; ([0010] “with a frame disposed around the impeller”) a pump-outlet tube surrounding the frame such that, as the axial shaft rotates, the impeller pumps blood proximally, from the ventricle, through the pump-outlet tube; and ([0223] “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 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.” and [0226] “Typically, along distal portion 102 of tube 24, a frame 34 is disposed within the tube around impeller 50.” Where the pump outlet tube surrounds the frame and impeller and where the impeller pumps blood form the distal tube end [i.e., form the ventricle] to the proximal end; see also [0311]’s “the rotational motion of the impeller (which is imparted via the axial shaft)” where the impeller is rotated via the axial shaft) Regarding claim 1, Tuval ‘986 does not explicitly teach, as taught by Green a flat inlet guard, which is shaped to define one or more holes, disposed around, and perpendicular to, the axial shaft and within the frame distally to the impeller, such that the blood flows to the impeller via the holes. ([Figure 2] and [para 6] “Filter membrane 20 has a fixed portion 24 which is movably attached to guidewire 10, and filter membrane 20 lies adjacent guidewire 10 proximal to fixed portion 24” where the mesh filter membrane [comprising an inlet guard with one or more holes] lays flat against or perpendicular to the guidewire [comprising an axial shaft]; see also [para 11] “The flow of blood in FIG. 2 is toward the distal end of guidewire 10. As such, the force of the flow of blood pushed on deployed filter membrane 20” where the blood flows through the filter holes to the rest of the device.) It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Tuval ‘986 with the teachings of Green, with a reasonable expectation of success, by utilizing a flat inlet guard that is disposed perpendicularly around an axial shaft. Tuval ‘986 would have incorporated Green’s teaching to prevent damage to cardiac structures.
Regarding claim 2, Tuval ‘986-Green as a combination teaches all of the limitations of claim 1. Tuval ‘986 also teaches wherein the pump-outlet tube has an open distal end. ([0226] “the frame (and thereby distal portion 102 of tube 24) … is configured to hold the distal portion of the tube in an open state.” i.e., has an open distal end)
Regarding claim 3, Tuval ‘986-Green as a combination teaches all of the limitations of claim 1. Tuval ‘986 also teaches further comprising a drive cable, wherein the axial shaft is coupled to the drive cable such that the axial shaft rotates with the drive cable. ([0311] “the rotational motion of the impeller (which is imparted via the axial shaft… is transmitted to the axial shaft via the drive cable, … the drive cable extends … to the proximal end of axial shaft 92.”)
Regarding claim 4, Tuval ‘986-Green as a combination teaches all of the limitations of claim 1. Tuval ‘986 also teaches comprising a drive cable, wherein the axial shaft is a distal portion of the drive cable. (see [0311] above, where the axial shaft is connected distally to the drive cable)
Regarding claim 5, Tuval ‘986-Green as a combination teaches all of the limitations of claim 1. Green also teaches wherein the inlet guard is Toric. ([Fig. 3] where the shape of the filter [comprising the inlet guard] is disc shaped [i.e., Toric].) It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Tuval ‘986 with the teachings of Green, with a reasonable expectation of success, by utilizing a Toric inlet guard that is disposed perpendicularly around an axial shaft. Tuval ‘986 would have incorporated Green’s teaching to prevent damage to cardiac structures.
Regarding claim 6, Tuval ‘986-Green as a combination teaches all of the limitations of claim 1. Tuval ‘986 also teaches wherein the frame comprises multiple struts, ([Tuval ‘986: figure 2] struts (37))
Regarding claim 6, Green also teaches and wherein the inlet guard is coupled to the struts. ([para 43] “FIG. 20 depicts a filter membrane 280 supported by strut wires 282” comprises an inlet guard coupled to the struts.) It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Tuval ‘986 with the teachings of Green, with a reasonable expectation of success, by utilizing a flat inlet guard that is coupled to the apparatus struts. Tuval ‘986 would have incorporated Green’s teaching to prevent damage to cardiac structures.
Regarding claim 7, Tuval ‘986-Green as a combination teaches all of the limitations of claim 1. Tuval ‘986- Green as a combination also teaches wherein the inlet guard is coupled to an inner wall of the pump-outlet tube. ([para 43] “FIG. 20 depicts a filter membrane 280 supported by strut wires 282” and [para 0033] “Filter membrane 170 can comprise a number of different metallic or nonmetallic permeable membranes… Preferably basket wires 168 are encapsulated in membrane 170.” Where the multiple permeable membranes [comprising an inner wall of the pump outlet tube and an inlet guard] encapsulates basket wires [comprising an inlet guard that the is coupled to the inner wall]) It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Tuval ‘986 with the teachings of Green, with a reasonable expectation of success, by utilizing a flat inlet guard that is coupled to the inner wall of a pump outlet tube. Tuval ‘986 would have incorporated Green’s teaching to prevent damage to cardiac structures.
Regarding claim 8, Tuval ‘986-Green as a combination teaches all of the limitations of claim 1. Tuval ‘986 also teaches further comprising a lining that lines an inside of the frame, ([0014] “For some applications, an inner lining lines at least the cylindrical portion of the frame”.) Regarding claim 8, Green also teaches wherein the inlet guard is coupled to the lining. ([para 0033] “Filter membrane 170 can comprise a number of different metallic or nonmetallic permeable membranes… Preferably basket wires 168 are encapsulated in membrane 170.” Where the multiple permeable membranes [comprising a lining and inlet guard] encapsulates basket wires [comprising an inlet guard that the is coupled to the lining].) It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Tuval ‘986 with the teachings of Green, with a reasonable expectation of success, by utilizing a flat inlet guard that is coupled to a lining inside a frame. Tuval ‘986 would have incorporated Green’s teaching to prevent damage to cardiac structures.
Regarding claim 9, Tuval-Green as a combination teaches all of the limitations of claim 1. Green also teaches wherein the inlet guard is polymeric. ([para 38] “in FIG. 16, filter membrane 170 comprises a polymeric material”.) It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Tuval ‘986 with the teachings of Green, with a reasonable expectation of success, by utilizing a flat inlet guard that is polymeric. Tuval ‘986 would have incorporated Green’s teaching to prevent damage to cardiac structures.
Regarding claim 10, Tuval ‘986-Green as a combination teaches all of the limitations of claim 1. Green also teaches wherein a thickness of the inlet guard is 40-100 microns. ([para 14] “The mesh used in the filter device of the invention can have a pore size less than 300 microns, preferably from about 50 to about 150 microns.” Wherein a single layer of porous material in the filter comprises a thickness of the inlet guard from 40-100 microns.) It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Tuval ‘986 with the teachings of Green, with a reasonable expectation of success, by utilizing a flat inlet guard that uses a micron scale thickness. Tuval ‘986 would have incorporated Green’s teaching to prevent damage to cardiac structures. Further, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the apparatus to incorporate a flat inlet guard of 40-100 microns, 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] (see MPEP 2144.05).
Regarding claim 11, Tuval ‘986-Green as a combination teaches all of the limitations of claim 1. Tuval ‘986 also teaches a thrust bearing disposed distally from the axial shaft so as to inhibit distal movement of the axial shaft beyond the thrust bearing. ([0274] “As shown in FIG. 5C, a bearing assembly typically includes a radial bearing (indicated by ellipse 200) and a thrust bearing (indicated by circle 202).” Where the bearing inhibits distal movement of the axial shaft.)
Regarding claim 12, Tuval-Green as a combination teaches all of the limitations of claim 1. Green also teaches: wherein the holes are shaped such that, for each of the holes, a span of the hole in at least one direction is less than 1 mm. ([38] “the holes 190 could be from about 50 to 300 µm in diameter.”) It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Tuval ‘986 with the teachings of Green, with a reasonable expectation of success, by making an inlet guard with holes shaped in a span of less than 1mm. Tuval ‘986 would have incorporated Green’s teaching to more precisely prevent the intrusion of cardiac structures into the impeller.
Regarding claim 13, Tuval-Green as a combination teaches all of the limitations of claim 1. Green also teaches wherein an area of each of the holes is 0.05-5 mm2. ([38] “the holes 190 could be from about 50 to 300 µm in diameter.”) It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Tuval ‘986 with the teachings of Green, with a reasonable expectation of success, by making an inlet guard with a micron-level inlet area. Tuval ‘986 would have incorporated Green’s teaching to more precisely prevent the intrusion of cardiac structures into the impeller. Further, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the apparatus to incorporate an area form .05-5 mm2, 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] (see MPEP 2144.05).
Regarding claim 15, Tuval-Green as a combination teaches all of the limitations of claim 1. Green also teaches wherein a porosity of the inlet guard is at least 40%. ([38] “ Preferably, the open area of the holes represents from about 10 to 50 percent, more preferably from about 15% to 40%, of the filter surface.”) It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Tuval ‘986 with the teachings of Green, with a reasonable expectation of success, by minimizing the inlet guard’s holes on the micron level. Tuval ‘986 would have incorporated Green’s teaching to more precisely prevent the intrusion of cardiac structures into the impeller. Further, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the apparatus to incorporate a porosity of at least 40%, 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] (see MPEP 2144.05).
Regarding claim 16, Tuval-Green as a combination teaches all of the limitations of claim 1. Green also teaches wherein a distance between each pair of adjacent ones of the holes is 0.01-0.1 mm. ([38] “the holes 190 could be from about 50 to 300 µm in diameter. The vertical separation of holes 190 can be from 1.2 to 1.4 times the hole diameter”) It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Tuval ‘986 with the teachings of Green, with a reasonable expectation of success, by minimizing the inlet guard’s holes on the micron level. Tuval ‘986 would have incorporated Green’s teaching to more precisely prevent the intrusion of cardiac structures into the impeller. Further, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the apparatus to incorporate an area from 0.01-0.1mm, 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] (see MPEP 2144.05).
Regarding claim 17, Tuval-Green as a combination teaches all of the limitations of claim 1. Tuval ‘986 also teaches a bearing configured to stabilize the axial shaft while the axial shaft rotates; and a bearing housing that houses the bearing and is coupled to ([0320] “The axial shaft itself is radially stabilized via proximal radial bearing 116 and distal radial bearing 118. Proximal and distal ends of frame 34 are rigidly coupled to the proximal and distal bearings”)
Green also teaches: the inlet guard. ([Figure 2] and [para 6] “Filter membrane 20 has a fixed portion 24 which is movably attached to guidewire 10, and filter membrane 20 lies adjacent guidewire 10 proximal to fixed portion 24” where the mesh filter membrane [comprising an inlet guard with one or more holes] is affixed to the device [comprising the housing]) It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Tuval ‘986 with the teachings of Green, with a reasonable expectation of success, by integrating an inlet guard housing within a bearing frame. This would reduce the size profile of a device and improve its maneuverability within a patient.
Regarding claim 18, Tuval-Green as a combination teaches all of the limitations of claim 17. Tuval ‘932 also teaches wherein at least 10% of a length of the bearing housing is disposed within the frame. ([Fig. 5A] “the bearing housing (116) length occupies the entire length of the frame’s coupling portion (31); see also [0276] “Typically, coupling portion 31 of frame 34 is coupled to proximal radial bearing 116, for example, via snap-fit coupling, and/or via welding.” Where a snap-fit coupling and/or welding disposes the housing entirely within the frame)
Regarding claim 19, Tuval-Green as a combination teaches all of the limitations of claim 18. Tuval ‘932 also teaches wherein at least 50% of the length of the bearing housing is disposed within the frame. (see [Fig. 5A] and [0276] above)
Regarding claim 20, Tuval-Green as a combination teaches all of the limitations of claim 19. Tuval ‘986 also teaches wherein at least 80% of the length of the bearing housing is disposed within the frame. (see [Fig. 5A] and [0276] above)
Regarding claim 21, Tuval-Green as a combination teaches all of the limitations of claim 19. Tuval ‘986 also teaches wherein the bearing housing is disposed entirely within the frame. (see [Fig. 5A] and [0276] above)
Regarding claim 22, Tuval ‘986-Green as a combination teaches all of the limitations of claim 17. Tuval ‘986 also teaches a thrust bearing disposed distally from the axial shaft so as to inhibit distal movement of the axial shaft beyond the thrust bearing. ([0274] “As shown in FIG. 5C, a bearing assembly typically includes a radial bearing (indicated by ellipse 200) and a thrust bearing (indicated by circle 202). ” Where the bearing inhibits distal movement of the axial shaft.)
Regarding claim 23, Tuval ‘986-Green as a combination teaches all of the limitations of claim 1. Tuval ‘986 also teaches: Regarding claim 23, Tuval ‘986 also teaches wherein the frame comprises a central cylindrical portion and a distal conical portion, ([0228] “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”.) Regarding claim 23, Green also teaches and wherein the inlet guard is disposed within 1 mm of a distal end of the central cylindrical portion. ([para 43] “FIG. 20 depicts a filter membrane 280 supported by strut wires 282” comprises an inlet guard coupled to the struts, where the distal part of the conical region is within 1mm of the inlet guard.) It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Tuval ‘986 with the teachings of Green, with a reasonable expectation of success, by utilizing a flat inlet guard disposed within 1mm of a distal end of the central cylinder portion. Tuval ‘986 would have incorporated Green’s teaching to prevent damage to cardiac structures. Further, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the apparatus to incorporate a flat inlet guard of within 1 mm of a distal end of the central portion, 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] (see MPEP 2144.05).
Regarding claim 24, Tuval ‘986-Green as a combination teaches all of the limitations of claim 23. Tuval ‘986 also teaches wherein the distal end of the pump-outlet tube is proximal to a distal end of the distal conical portion. ([Figure 1] blood outlet openings (109) is proximal to both conical portions of the frame (36) and (40)).
Regarding claim 25, Tuval ‘986-Green as a combination teaches all of the limitations of claim 24. Tuval ‘986 also teaches wherein the distal end of the pump-outlet tube is within 1 mm of a distal end of the central cylindrical portion. ([Figure 1c] and [0228] “ [0228] Referring again to FIG. 1C, for some applications, 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… For some applications, tube 24 extends to the end of cylindrical portion 38 (or slightly proximal or distal thereof)” where the tube extending to the end or slightly proximal to the end of the central conical portion comprises the distal end of the tube is within 1mm of the central conical portion)
Claims 15 is rejected under 35 U.S.C. 103 as being unpatentable over Tuval et al. (US20200237986 referenced as Tuval ‘986) in view of Green (Pat. 6485501) and further in view of Goslau et al. (WO 2021055826).
Like Tuval ‘986, Goslau creates another mesh filter that supports the treatment of cardiac compromised patients for various disease states. Goslau indicates “there have been many challenges to their safe implementation. For instance, it is common to introduce, cross and exchange a variety of percutaneous devices such as guide wires, catheters, sheaths, guide catheters, and adjunctive technologies to gain access to and treat a coronary vessel, coronary valve, or other vascular anatomy. These and other approaches to the repair or replacement of tissue can dislodge particles/debris (emboli)” and cause a risk during cardiac procedures ([p1, lines 25-31]. Thus, Tuval ‘986 would have found Goslau while reducing the risk of embolism in a catheter based cardiac pump.
Regarding claim 15, Tuval-Green as a combination teaches all of the limitations of claim 1. Tuval-Green does not teach, as taught by Goslau wherein each of the holes is hexagonal. ([p30, line 29] “the hexagonal cell shape” Where the inlet openings comprise each of the holes). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Tuval ‘986 and Green with the teachings of Goslau, with a reasonable expectation of success, by making an inlet guard with hexagonally shaped holes. This would reduce the resistance to blood flow, preventing embolisms.
Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
D’Ambrosio et al. (US20210236797) discloses an intravascular pump with an intake filter that reduces risk of heart tissue being sucked into an intake port of the pump. The filter defines a plurality of apertures, through which blood flows through the filter. This system teaches bearings, wire based struts, impellers, and more.
Hildebrand et al. (Pat. 12220570) discloses an intravascular blood pump containing a collapsable conduit and impeller. This system contains structures similar to this application, including axle rods, bearing housings, inlet channels, and more.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Unsu Jung can be reached at 571-272-8506. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/R.A.S/Examiner, Art Unit 3792
/UNSU JUNG/Supervisory Patent Examiner, Art Unit 3792
Prosecution Insights