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 .
Response to Amendment
This action is entered in response to Applicant's amendment and reply of 4/29/26. The claims 92, 94-110 are pending. The claims 92, 94, and 97 are amended. Claims 102-104 are withdrawn. Claim 93 is are cancelled.
Response to Arguments
Applicant argues the election/restriction requirement stating that claim 105 should not be withdrawn. Examiner disagrees, claim 105 is drawn to an embodiment not elected in the response filed 12/12/25. After further review, claim 105 recites “the occluder comprises a balloon”. The elected invention of Species A is toward the expandable cage with a film connected to the cage as per Figs. 9A-9G. There is no description of a balloon with this embodiment.
The drawing objection has been overcome by the amendments.
Applicant’s arguments, filed 4/29/26 with respect to the rejections of claims 92, 94-96 under 35 U.S.C. 102(a)(1) as being anticipated by Frazier (US20030191357) have been fully considered but are not persuasive. Applicant argues, Frazier discloses a temporary heart-assist system with a blood pump located outside the patient’s body. Examiner makes notice the claim recites “an implantable pump… having a fluid inlet and a fluid outlet”. Therefore, the pump includes the fluid inlet and fluid outlet and the components are implanted within the vascular system by being inserted into the vessel as stated in paragraph [0031] of Frazier. Applicant further argues, Frazier does not disclose a pump that is configured for implantation in the vascular system. Examiner disagrees, where Frazier is capable of being implanted in the vascular system in the same manner as claimed. “[A]pparatus claims cover what a device is, not what a device does.” Hewlett-Packard Co.v.Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a “recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus” if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987) (The preamble of claim 1 recited that the apparatus was “for mixing flowing developer material” and the body of the claim recited “means for mixing ..., said mixing means being stationary and completely submerged in the developer material.” The claim was rejected over a reference which taught all the structural limitations of the claim for the intended use of mixing flowing developer. However, the mixer was only partially submerged in the developer material. The Board held that the amount of submersion is immaterial to the structure of the mixer and thus the claim was properly rejected.). See MEPEP 2173.
Applicant further argues, Examiners interpretation of downstream flow being the recirculated flood flow back toward the occluder and states this goes against the ordinary meaning of the term downstream. Examiner disagrees, the claim is given its ordinary meaning, the meaning of downstream in the claim is interpreted as a flowing in a direction from one point to another. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Furthermore, the recirculated blood flow is interpreted as downstream by the blood flowing from the outlet cannula 46 and toward the inlet cannula 38 ([0035], see Fig. 3A).
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, 94-96 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 including the inlet cannula 38 and outlet cannula 46) configured for implantation in the vascular system (the inlet cannula 38 and outlet cannula 46 extend into the vascular system and are part of the implantable pump 10, [0031]]) and 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 implantation in the vascular system downstream of the fluid outlet of the implantable pump (see Fig. 1, [0043]) such that the occluder element selectively impedes blood flow from the implantable pump (blood is recirculated and flows toward the occluder 8 and is blocked, see Fig. 3A, this direction is interpreted as “downstream), 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 in the vascular system past the occluder element (see Fig. 3A), and 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 in the vascular system, 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 94, Frazier discloses the assist system according to claim 92, wherein 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 to an interior wall of 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
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas Barrett can be reached on (571)272-4746. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/M.A.M/Examiner, Art Unit 3774
/THOMAS C BARRETT/SPE, Art Unit 3799
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