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
Claim 102-104 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/12/25. In addition, claim 105 has been withdrawn from consideration as being directed to a non-elected species.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the implantable pump, the occluder element, and the actuator element forming a unitary structure as claimed in claim 93 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
Claims 92-96 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Frazier (US20030191357).
Regarding claim 92, Frazier discloses an assist system for assisting blood flow in a vascular system (see Figs. 1 and 3A), the assist system comprising:
an implantable pump (10) having a fluid inlet (38) and a fluid outlet (46), each of the fluid inlet and the fluid outlet configured for being in fluid communication with the vascular system ([0031], [0035], see Fig. 1);
an occluder element (8) configured for being implanted in the vascular system downstream of the fluid outlet of the implantable pump (see Fig. 1, [0043]), the occluder element having an occluded configuration in which the occluder element occludes the vascular system so that blood flowing downstream in the vascular system from the fluid outlet of the implantable pump (blood flow is circulated by returning to the outlet cannula 46, see Fig. 3A) toward the occluder element (blood is recirculated and flows toward the occluder 8 and is blocked, see Fig. 3A, this direction is interpreted as “downstream”) is at least partially blocked from flowing further downstream past the occluder element (see Fig. 3A), and the occluder element having a flow configuration in which blood flowing downstream in the vascular system from the fluid outlet of the implantable pump toward the occluder element is capable of flowing further downstream past the occluder element (balloon 8 is adjustable to and is capable of allowing blood flow past it, [0028]); and
an actuator element (20) operatively connected to the occluder element for actuating the occluder element between the occluded configuration and the flow configuration ([0028]).
Regarding claim 93, Frazier discloses the assist system according to claim 92, wherein the implantable pump, the occluder element, and the actuator element together form a unitary structure (10, 8, and 20 are interpreted as unitary by forming a single unit for blood flow operation).
Regarding claim 94, Frazier discloses the assist system according to claim 93, wherein the unitary structure is an implantable unitary structure in which the actuator element comprises an end portion configured for connecting to an extracorporeal controller (9) for actuating the occluder element between the occluded configuration and the flow configuration ([0030], see Fig. 3A).
Regarding claim 95, Frazier discloses the assist system according to claim 92, wherein the implantable pump is an intravascular pump ([0027]).
Regarding claim 96, Frazier discloses the assist system according to claim 95, wherein the intravascular pump comprises an anchor (surface of the inlet 38 and outlet tubes 46) configured for anchoring the intravascular pump within the vascular system (intended to be held within the vessel and therefore would anchor the pump within the vascular system).
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.
Claims 97-101 and 106-110 are rejected under 35 U.S.C. 103 as being unpatentable over Frazier (US20030191357) in view of Hays (US2019/0117230).
Regarding claim 97, Frazier discloses the assist system according to claim 92; yet, is silent regarding wherein the occluder element comprises a cage configured for anchoring the assist system within the vascular system. Hays teaches an occlusion device for a vascular system having a profile balloon 10 ([0052]). Where the balloon 10 includes a support 24 made of semi-stiff wires (claimed cage) that help maintain the shape of the wall 18 as balloon 10 is tensioned ([0053]). The balloon 10 is actuated by a tension wire 22 from a narrow to expanded configuration that rest against wall of vessel ([0054], see Figs. 1-3)) It would have been obvious to one having ordinary skill in the art at the effective filing date of the claimed invention to have substituted the occluder element and actuation mechanism of Frazier for the occluder element and actuation mechanism of Hays, since the substitution would have yielded the same predictable result of an actuatable occluder device for occluding blood blow between a portion of the vascular system.
Regarding claim 98, Frazier/Hays makes obvious the assist system according to claim 97, Hays further teaches wherein the cage is overcomeably biased toward the occluded configuration (the wall 18 and support 24 is folded and therefore would be biased to the folded configuration at least by the bend formed but is intended to hold the wall configuration before tension is applied, [0053]-[0054]).
Regarding claim 99, Frazier discloses the assist system according to claim 92, yet is silent regarding wherein the occluder element comprises a cage and an occlusion film connected to the cage, and the actuator element comprises a control wire operatively connected to the cage for actuating the occluder element between the occluded configuration and the flow configuration. Hays teaches an occlusion device for a vascular system having a profile balloon 10 ([0052]). Where the balloon 10 includes a support 24 made of semi-stiff wires (claimed cage) that help maintain the shape of the wall 18 as balloon 10 is tensioned and the wall of balloon material 18 (claimed occlusion film) is on the outside of the support ([0053]). The balloon 10 is actuated by a tension wire 22 (claimed control wire) from a narrow to expanded configuration that rest against wall of vessel ([0054], see Figs. 1-3)) It would have been obvious to one having ordinary skill in the art at the effective filing date of the claimed invention to have substituted the occluder element and actuation mechanism of Frazier for the occluder element and actuation mechanism of Hays, since the substitution would have yielded the same predictable result of an actuatable occluder device for occluding blood blow between a portion of the vascular system.
Regarding claim 100, Frazier/Hays makes obvious the assist system according to claim 99, Hays further teaches wherein the occlusion film is connected to a proximal end portion of the cage (see Fig. 4, [0053]).
Regarding claim 101, Frazier/Hays makes obvious the assist system according to claim 99, Hays further teaches wherein the occlusion film is connected to a distal end portion of the cage (see Fig. 4, [0053]).
Regarding claim 106, Frazier discloses the assist system according to claim 92; yet, is silent regarding wherein the occluder element comprises a first occluder operatively connected to the actuator element for actuating the first occluder between the occluded configuration and the flow configuration, and a second occluder operatively connected to the actuator element for actuating the second occluder between the occluded configuration and the flow configuration. Hays teaches an occlusion device for a vascular system having a profile balloon 10 or occluder ([0052]). Hays further teaches a first occluder (B1, [0062]) operatively connected to the actuator element (tension wire 22) for actuating the first occluder between the occluded configuration and the flow configuration, and a second occluder (B2, [0062]) operatively connected to the actuator element for actuating the second occluder between the occluded configuration and the flow configuration ([0064]).
It would have been obvious to one having ordinary skill in the art at the effective filing date of the claimed invention to have substituted the occluder element and actuation mechanism of Frazier for the first and second occluder elements with respective actuation mechanisms of Hays, since the substitution would have yielded the same predictable result of an actuatable occluder device for occluding blood blow between a portion of the vascular system.
Regarding claim 107, Frazier/Hays makes obvious the assist system according to claim 106, Hays further teaches wherein the first occluder and the second occluder are actuatable in the flow configuration independently ([0064]).
Regarding claim 108, Frazier/Hays makes obvious the assist system according to claim 106, Hays further teaches wherein the first occluder and the second occluder are actuatable in the flow configuration simultaneously (tension wires 22 are independently operable and could be actuated simultaneous, [0064]).
Regarding claim 109, Frazier/Hays makes obvious the assist system according to claim 106, Hays further teaches wherein the first occluder and the second occluder are actuatable in the flow configuration sequentially (tension wires 22 are independently operable and could be actuated sequentially, [0064]).
Regarding claim 110, Frazier/Hays makes obvious the assist system according to claim 106, Hays further teaches wherein the actuator element comprises a first actuator (tension wire 22 of B1) operatively connected to the first occluder for actuating the first occluder between the occluded configuration and the flow configuration, and a second actuator (separate tension wire 22 of B2) operatively connected to the second occluder for actuating the second occluder between the occluded configuration and the flow configuration ([0064]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MIKAIL A MANNAN whose telephone number is (571)270-1879. The examiner can normally be reached M-F 10-6.
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/M.A.M/Examiner, Art Unit 3774
/THOMAS C BARRETT/SPE, Art Unit 3799