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 .
Claim Objections
The claims contain minor informalities.
In claim 21, the language “… wherein the substantially straight segment is configured to straddle an aortic valve [[in an execution of]] during a medical procedure for a heart condition… while the impeller is operating [[in the execution of]] during the medical procedure.” should be changed for brevity.
In claim 26, the language “… and the distal vessel contact zone [[in the execution of]] during the medical procedure.” should be changed for brevity.
In claim 28, the language “… wherein the distal tip of the sheath assembly is flexible.” should be changed for consistency.
In claim 38, the language “… to indicate a position or orientation of the catheter pump when percutaneously advanced in a blood vessel.” should be changed for clarity.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 21-40 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1 and 3-20 of Keenan; Richard L. et al. (US 11964119 B2).
Regarding pending claim 21, Keenan claims all limitations in patented claims 1 and 3, namely a catheter pump (claim 1, A catheter pump);
comprising: a percutaneously insertable impeller assembly including a cannula and an axial flow impeller disposed within the cannula (claim 1, an expandable impeller assembly, the expandable impeller assembly including an expandable impeller and an expandable cannula coupled to the distal end of the catheter body and housing the expandable impeller);
wherein the cannula has a distal inlet, a proximal inlet and a substantially straight segment in between (claim 1, the expandable cannula comprising a substantially straight segment having a distal inlet and a proximal outlet);
wherein the substantially straight segment is configured to straddle an aortic valve in an execution of a medical procedure for a heart condition (claim 1, thereby stabilizing the substantially straight segment when straddled across an aortic valve); and
a catheter body defining opposing ends and least one lumen defined therethrough (claim 1, a catheter body having at least one lumen therethrough, and comprising a distal end and a proximal end);
the percutaneously insertable impeller assembly coupled to one of the opposing ends (claim 1, the expandable impeller assembly … coupled to the distal end of the catheter body);
wherein the catheter body is configured with a variable stiffness including a proximal vessel zone and a distal vessel zone that are each proximal to the percutaneously insertable impeller assembly (claim 1, wherein the catheter body comprises a proximal vessel contact zone and a distal vessel contact zone that are each proximal to the substantially straight segment, the proximal vessel contact zone and distal vessel contact zone having a stiffness; claim 3, wherein the sheath assembly comprises a variable stiffness along a length thereof);
the proximal vessel zone and distal vessel zone each being configured to, when curved in a shape corresponding to the aortic arch, establish a restoring force (claim 1, the proximal vessel contact zone and distal vessel contact zone having a stiffness configured to, when formed in a curved shape deployed around an outer radius of the aortic arch, bear against the outer radius of the aortic arch with a restoring force);
to maintain the substantially straight segment in a stable position straddling the aortic valve (claim 1, in order to retain the catheter body in place around the outer radius of the aortic arch, thereby stabilizing the substantially straight segment when straddled across an aortic valve).
Although Keenan does not explicitly claim a percutaneously insertable impeller assembly, Keenan claims proximal and distal vessel contact zones that are configured to deploy in the aortic arch (claim 1), which implies that the impeller assembly is percutaneously insertable.
Keenan does not explicitly claim that the proximal and distal vessel contact zones establish a restoring force without bending the cannula. However, Keenan claims a substantially straight segment that straddles the aortic valve (claim 1). The segment’s name and its stable position in the aorta suggest that the substantially straight segment does not bend.
Keenan does not explicitly claim that the vessel contact zones and restoring force ensure that only the proximal outlet of the cannula is in the aorta while the impeller is operating in the execution of the medical procedure. However, Keenan suggests that the pump propels blood from its inlet to its outlet (claim 1, the expandable impeller assembly including an expandable impeller). In order for the catheter pump to partly or fully substitute the heart’s functions, it must traverse the aortic valve to propel blood in the same direction as a normally functioning heart. Placing only the proximal outlet in the aorta will lodge open the valve and permit blood to flow from the heart to the aorta.
Regarding pending claims 22-39, Keenan claims all limitations in patented claims 1 and 3-20 as shown in table 1.
Table 1: Keenan double patenting
Pending claim
Keenan
Pending claim
Keenan
Pending claim
Keenan
22
1
28
6
34
14
23
9
29
7
35
1, 15
24
10
30
8
36
16, 17
25
4
31
11
37
18
26
3
32
12
38
19
27
5
33
13
39
20
Regarding claim 40, Keenan does not claim that the heart condition is a cardiogenic shock condition. However, this claim describes a catheter pump and not necessarily a method of using the catheter pump Keenan claims all the same structures as the claimed catheter pump, therefore Keenan’s pump will be able to operate in the during any medical procedure, including a cardiogenic shock condition.
Conclusion
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/Adam Marcetich/
Primary Examiner, Art Unit 3781
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