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
This application is a national stage entry under 35 USC 371 of PCT/EP2022/060192 filed 15 April 2022, which claims the benefit of foreign priority from European Patent Application no. EP 21305511.04 filed 16 April 2021.
Response to Amendment
The preliminary amendment filed 16 October 2023 has been acknowledged. Claims 16-30 are pending, wherein claims 16-30 are new.
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.
Claim 16 recites the limitation "the upstream extremity" in line 5. There is insufficient antecedent basis for this limitation in the claim.
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.
Claim(s) 16-18, 21, 23, and 25-28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Radman (US Publication no. 2021/0008264) in view of Schellenberg et al. (EP 3 801 277 B1 – English Translation provided by USPTO), La Rose et al. (US Publication no. 2012/0029265), and Agah et al. (WO 2017/165372).
In regard to claim 16, Radman discloses a support system aimed at securing an assist device inside a patient’s heart (a circulatory support device 100, para 49, figure 1), the assist device 100 comprising a pump 110 and a pump body 112 with an entrance 114 (i.e., fluid inlet) and an exit cylinder 104 (i.e., fluid outlet at proximal end 106 of cannula 102), the pump being situated inside the pump body 112 and being in fluidic communication with the entrance and the exit cylinder (para 49-50), the support system comprising:
an upstream support element 122, aimed at securing the upstream extremity 124 (distal end of the pump) of the pump body to the patient’s heart, and at least one fixation means 122 (expandable cage) aimed at securing the upstream extremity of the pump body (para 51, cage 122 secures the pump in a patient’s vasculature such as the left ventricle),
a downstream support element 126, aimed at securing the exit cylinder 104 (i.e., fluid outlet at proximal end 106 of cannula 102) to the patient’s heart, and the outer diameter being sized to accommodate at least one tubular shaped part of the patient’s heart in order to radially cooperate with said at least one tubular shaped part (para 51, second expandable cage 126 disposed to hold the pump in a patient’s vasculature such as the aorta),
wherein the upstream support element and the downstream support element are two independent and autonomous functional elements (elements 122, 126 are separate cage, para 51).
Radman suggests the invention as claimed, however does not teach that the upstream support element comprises at least one foldable anchoring leg aimed at anchoring the upstream support element to the patient’s heart by cooperating with some patient’s heart tissue. Schellenberg et al. describes a similar ventricular assist device 100 as shown in figure 2 comprising a pump and a stent like holding structure 115. The holding structure 115 is in the form of an anchoring structure 115 for anchoring the heart support system 100 in a blood vessel and is correspondingly provided with the same reference number 115. The anchoring structure 115 can also be referred to as a stent and can also be used to position and fix the heart support system 100 in the area of the aorta when the heart support system 100 is implanted. Furthermore, two or more legs 215 described as arched feet are present, and is shaped to fix the heart support system 100 in the blood vessel in a non-positive manner. The anchoring structure 115 can optionally be folded up to assume an insertion state of the cardiac assist system 100 and unfolded to assume an anchored state of the cardiac assist system 100, wherein the legs 215 are considered to move with the structure 115 between states and is thus considered to be foldable. The stent like structure is considered similar to the element 122 of Radman, and Schellenberg et al. Demonstrate that such a structure may bear at least one foldable anchoring leg 34.
Modification of Radman to include a foldable anchoring leg on the expandable cage 122 is considered to have been obvious to one of ordinary skill in the art since this feature was expressly taught by Schellenberg et al. to aid in supporting the pump in a blood vessel.
Radman in view of Schellenberg et al. describe the invention as claimed, however do not show the downstream support element displaying a general cylindrical shape with an inner diameter and an outer diameter, the inner diameter being sized to accommodate the exit cylinder in order to radially cooperate with said exit cylinder. La Rose et al. describes an intravascular ventricular assist device similar to those described in the art cited above. Figure 18 of La Rose et al. depicts a support element 200 displaying a general cylindrical shape 204 with an inner diameter and an outer diameter (not described but a necessary feature), the inner diameter being sized to accommodate a cylinder 10 in order to radially cooperate with said cylinder 10 and adapted to engage the interior surface of an artery (para 54).
Modification of Radman and Schellenberg et al. to one expandable cage 126 to be a general cylindrical shape with an inner diameter and an outer diameter, the inner diameter being sized to accommodate the exit cylinder in order to radially cooperate with said exit cylinder is considered to have been obvious to one of ordinary skill in the art since this feature was expressly taught by La Rose et al. to aid in supporting the pump in a blood vessel. The modification pertaining to a substitution of a known element for another to yield a predictable result motivated by choice in design.
Radman in view of Schellenberg et al. and La Rose et al. describe the invention as claimed, except that the upstream support element and the downstream support element are aimed to removably secure the assist device inside the patient’s heart. Agah et al. describe a ventricular assist device similar to those of the cited prior art. Agah et al. includes a blood pump and expandable member 151 that provides a radially expandable force to retain the pump in vasculature (para 1032 and 1048). Each of the members of the expandable member 151 has an attachment portion that allows removeable coupling of the expandable member from the pump in order to permit the pump to be removable secure inside the patient’s hears (para 1032, 1034).
Modification of Radman and Schellenberg et al. and La Rose et al. to substitute the expandable cages 122, 126 of Radman with the expandable member of Agah et al. is considered to have been obvious to one of ordinary skill in the art since Agah et al. expressly teaches an expandable member that permits effective removal of the blood pump.
In regard to claim 17, Radman in view of Schellenberg et al. teach that the upstream support element 115 displays at least three foldable anchoring legs 215 (figure 2).
In regard to claim 18, Radman in view of Schellenberg et al. teach that the upstream support element 115 displays a general circular shape, the foldable anchoring legs 215 being regularly distributed over its circumference.
In regard to claim 21, in Radman, the downstream support element displays an open design in order to allow any fluid to flow through it (expandable cage 126 permits fluid to flow through).
In regard to claim 23, in Radman, the cooperation between the downstream support element and the at least one tubular shaped part of the patient’s heart is obtained by radial forces (the force of cage 126 is considered to provide radial force on the walls of the anatomical structure).
In regard to claim 25, Radman and Schellenberg et al., La Rose et al. in view of Agah et al. teach that the downstream support element is breakable along a predetermined breaking zone defined to break when submitted to a predetermined force (Agah et al. para 1056, the attachment portions 161 or the second end portion 135 of the struts 131 can include a latch, a locking mechanism, or detent that maintains the struts 131 within the attachment portions 161 until a retrieval force threshold has been exceeded. This arrangement prevents the struts 131 from being inadvertently released or removed from the expandable member 151).
In regard to claim 26, in Radman, the downstream support element is radially expandable and can be expanded in a controlled way (para 63, expansion of expandable cage is controlled by pushing the deice through the delivery shaft of the delivery sheath).
In regard to claim 27, in Radman, the upstream support element and the downstream support element are both radially expendable elements which can be expanded in a controlled way (para 63, expansion of expandable cage is controlled by pushing the deice through the delivery shaft of the delivery sheath).
In regard to claim 28, in Radman and cited prior art, the devices described therein are intended for the left ventricular assist. The recitation that the assist device is a right ventricle assist device, the upstream support element aims at securing the pump body to the right ventricle of the patient’s heart and the downstream support element aims at securing the exit cylinder in the pulmonary artery of the patient’s heart is considered to comprise a recitation of the intended use of the device. Radman and any other of the cited references are considered capable of this use.
Claim(s) 19 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Radman (US Publication no. 2021/0008264) in view of Schellenberg et al. (EP 3 801 277 B1 – English Translation provided by USPTO), La Rose et al. (US Publication no. 2012/0029265), and Agah et al. (WO 2017/165372), further in view of Baumbach et al. (US Publication no. 2021/0290931).
In regard to claim 19, Radman in view of Schellenberg et al., La Rose, and Agah et al. substantially describe the invention as claimed except that each foldable anchoring leg is aimed at being folded outwardly. Baumbach et al. describes an apparatus for anchoring an assist system in a blood vessel comprising a foldable anchoring leg 210 comprising three feet (para 56), the leg 210 designed to unfold during transition from an insertion state (fig. 4) to the anchoring state (fig. 3) (para 56). The transition as depicted in the figures 3 and 4 is considered to depict the legs as folding outward. Therefore, modification of the leg described by Radman in view of Schellenberg et al. to unfold outwardly is considered to have been obvious to one of ordinary skill in the art since this feature is expressly taught by Baumbach et al. and would provide the benefit of folding the leg and support elements into a delivery tool for insertion into the target anatomy.
In regard to claim 20, Radman in view of Schellenberg et al., La Rose, and Agah et al. substantially describe the invention as claimed except each foldable anchoring leg is reversibly unfoldable. Baumbach et al. describes an apparatus for anchoring an assist system in a blood vessel comprising a foldable anchoring leg 210 comprising three feet (para 56), the leg 210 designed to unfold during transition from an insertion state (fig. 4) to the anchoring state (fig. 3) (para 56). The leg 210 comprising foot 215 (figure 7) is disclosed to be reversibly unfoldable (para 70, If the desired positioning is not immediately successful, the feet 215 can also be folded again, even repeatedly, for example using the sleeve, by sliding the sleeve forward again, i.e. over the feet 215, and then sliding it back to reposition the feet 215 and thus allowing the feet 215 to unfold). Therefore, modification of the leg described by Radman in view of Schellenberg et al. to be reversibly unfoldable is considered to have been obvious to one of ordinary skill in the art since this feature is expressly taught by Baumbach et al. to allow for repeated repositioning until desired positioning is achieved.
Claim(s) 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Radman (US Publication no. 2021/0008264) in view of Schellenberg et al. (EP 3 801 277 B1 – English Translation provided by USPTO), La Rose et al. (US Publication no. 2012/0029265), and Agah et al. (WO 2017/165372), further in view of Kapadia (US Publication no. 2013/0190798).
In regard to claim 22, Radman in view of Schellenberg et al., La Rose, and Agah et al. substantially describe the invention as claimed except the downstream support element is at least partly made of a meshed material. Kapadia describes an apparatus for anchoring a device in a blood vessel such as the superior vena cava using an expandable support element. As shown in figure 5, the apparatus has two expandable support members that are similar to that of the claimed upstream support element (e.g., element 52 of Kapadia) and the downstream support member (e.g., element 90 of Kapadia). These expandable members are made from a mesh material (para 40). Kapadia demonstrates that mesh is a suitable material for expandable members that serve to anchor a device in the heart. Therefore, modification of the expandable cages of Radman to be formed from mesh is considered to have been obvious to one of ordinary skill in the art since the material is expressly taught by Kapadia and that it has been held that selection of a known material on the basis of its suitability of the intended use is a matter routine skill.
Claim(s) 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Radman (US Publication no. 2021/0008264) in view of Schellenberg et al. (EP 3 801 277 B1 – English Translation provided by USPTO), La Rose et al. (US Publication no. 2012/0029265), and Agah et al. (WO 2017/165372), further in view of Nolan et al. (US Publication no. 2020/0093622). In regard to claim 24, Radman in view of Schellenberg et al., La Rose, and Agah et al. substantially describe the invention as claimed except the downstream support element further comprises at least one smooth spike aimed at reinforcing the radial cooperation between the downstream support element and the at least one tubular shaped part of the patient’s heart. Nolan et al. describes an expandable stent that is similar to the expandable cages of Radman, and as a suitable equivalent to those described in Schellenberg et al., La Rose, and Agah et al. Nolan et al. teaches that the expandable stent may include a feature such as a fixation spike (para 70). The spike prevents displacement or migration of the implant. Modification of the cited prior art to include a spike is considered to have been obvious to one of ordinary skill in the art in order to prevent migration of the pump once in the target location since this is expressly taught by Nolan et al.
Claim(s) 29 and 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Radman (US Publication no. 2021/0008264) in view of Schellenberg et al. (EP 3 801 277 B1 – English Translation provided by USPTO), La Rose et al. (US Publication no. 2012/0029265), and Agah et al. (WO 2017/165372), further in view of Pham et al. (WO 2019/241777).
In regard to claim 29, Radman in view of Schellenberg et al., La Rose, and Agah et al. substantially describe the invention as claimed. Radman discloses an introducer for delivering the circulatory support system 100 (i.e., the support system of claim 1), the introducer comprising a sheath 306 divided in a proximal flexible sheath portion 310 and a distal bendable steerable sheath portion 317, wherein the introducer and the catheter are both designed to be easily introduced and navigated in a safe and controlled way through tortuous and narrow tubular lumen or tubes, wherein the distal part of the catheter is aimed at receiving either the downstream support element or the upstream support element (para 62 and 63).
However, neither of the cited references recite an introducer comprising the handle on the sheath, a catheter comprising a handle connected to a proximal flexible catheter part further connected to a distal very flexible catheter part, wherein the introducer and the catheter are both designed to be easily introduced and navigated in a safe and controlled way through tortuous and narrow tubular lumen or tubes, wherein the catheter is designed to be navigated through the sheath of the introducer, wherein the distal part of the catheter is aimed at receiving either the downstream support element or the upstream support element.
The Pham et al. describes an introducer system comprising (see annotated figures 6-8 of Pham et al. below):
An introducer 91 (figure 6 of Pham et al.) comprising an external handle 95 connected to a sheath 93 divided in a proximal flexible sheath portion and a distal bendable 94 steerable sheath portion, the distal bendable sheath portion being controlled by the external handle 95 (via knob 96) (para 179, distal tip 94 is compliant which is capable of bending; also see para 178-180 for general discussion of introducer),
Catheter 101 (figure 7) comprising a handle 108 connected to a proximal flexible catheter part further connected to a distal very flexible catheter part (para 184, distal section 104 is compliant and driven by knob 105, wherein sheath of catheter 102 is described as steerable)
wherein the introducer 91 and the catheter 101 are both designed to be easily introduced and navigated in a safe and controlled way through tortuous and narrow tubular lumen or tubes (para 11, the introducer introduces a medical device (i.e., heart valve) into the heart via the superior vena cava, internal jugular, or femoral vein),
wherein the catheter is designed to be navigated through the sheath of the introducer (figure 8).
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Modification to deliver the support system described by Radman in view of Schellenberg et al., La Rose, and Agah et al. using the introducer of Pham et al. since it is considered to be the substitution of a known introducer for another to yield a predictable result.
In regard to claim 30, in Radman, the system further comprises a pump pusher aimed at pushing the pump inside the pump body, through the upstream support element, the catheter being further aimed at receiving the pump body (para 59, 62, and 63, the circulatory assist device is pushed into the delivery sheath.).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN T GEDEON whose telephone number is (571)272-3447. The examiner can normally be reached M-F 8:00 am to 5:30 PM ET.
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/BRIAN T GEDEON/Primary Examiner, Art Unit 3796 15 September 2025