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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 23JUN2026 has been entered.
Response to Arguments
Applicant's arguments filed 21MAY2026 have been fully considered but they are not persuasive.
Regarding the conformation to tissue wall geometry, Applicant’s arguments are not persuasive. Both sides of the device which are used to retain the device in position would necessarily conform to the geometry of the tissue wall in at least some way in order to maintain the structure and integrity of the wall. It is unclear from the amendments and associated arguments if a certain level of conformity is desired, a specific level of pressure applied to result in the claimed configuration, etc. Without any significant and readily apparent changes to the affected tissue wall, the geometry of the tissue wall is considered to be substantially maintained.
Regarding Claim 7, Spence is considered to teach an initial funnel shape (as seen in cited figures) and is further considered to teach being flattened against the tissue wall during deployment as no obvious gaps are created. The arguments appear to be directed towards a system where the upper and lower planes created by the device around the tissue wall are parallel after deployment, but the structure is not claimed in a way which clearly reflects a “flat” surface as argued.
Claim Rejections - 35 USC § 102
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 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.
Claim(s) 1, 2, 6-11, 25, 27, 29, 31, and 33 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20120059213 A1 (Spence).
Regarding claims 1, 2, 6, 7, and 11, Spence teaches an inflow or outflow cannula apparatus (100) (Figs. 4E-4F), the apparatus comprising:
a conduit (110) having an exterior surface (the body-facing side of the conduit) and an interior surface (where lumen 117 is located);
an inlet portion (114) arranged at a first end of the conduit (113) including a plurality of elongate members (127) arranged about a circumference of the inlet portion, the plurality of elongate members configured to deploy against a tissue wall (50) (Fig. 4E) and conform to a geometry of the tissue wall (necessarily conforming around the thickness of the tissue wall which is penetrated in order to form a barrier) such that the geometry of the tissue wall is substantially maintained (the wall not being significantly altered in shape); and
a graft portion (124) covering and arranged between the plurality of elongate members and extending along the interior surface of the conduit [0075]; and
the graft portion is arranged on an exterior surface and an interior surface of the plurality of elongate members (the graft portion preventing the elongate members from being exposed and therefore being considered to cover both the interior and exterior surfaces [0075]); wherein
the inlet portion is configured to conform to the tissue wall [0075]; wherein
the exterior surface of the conduit is configured to lessen thrombus formation (reducing risk of clots [0092]);
wherein the inlet portion includes a funnel shape (Fig. 4B) in an initial configuration and is configured to flatten and deploy against the tissue wall (as seen in Fig. 4F); wherein
the inlet portion is configured to deploy against the tissue wall in response to fluid flow pressure with a heart chamber [0089-0090].
“[L]essen thrombus formation” , in claim 6, is a statement of intended use that does not further limit the claimed invention. While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function. In re Schreiber, 128 F.3d 1473, 1477-78, 44 USPQ2d 1429, 1431-32 (Fed. Cir. 1997) [MPEP 2114]. Since the structure of the prior art teaches all structural limitations of the claim, the same is considered capable of meeting the intended use limitations.
Regarding claims 8 and 9, Spence further teaches a constraining ring (400) (Fig. 4B) arranged about the plurality of elongate members (127) to maintain the inlet portion in a substantially cylindrical configuration (as seen in Fig. 4B prior to deployment) and allow release of the inlet portion to flatten and deploy against the tissue wall [0090] (shown in Fig. 4E), wherein the constraining ring is configured to slide away from the first end of the conduit in response to contact with an epicardial surface of the heart to allow release of the inlet portion (the constraining ring moving outwardly away when the device expands to the delivered configuration shown in Fig. 4E).
Regarding claim 10, Spence further teaches a plurality of ring structures (400) arranged along the exterior surface of an outflow portion (117) of the conduit (Fig. 4E).
Regarding claim 25, Spence is considered to teach the graft portion (124) stretches and recovers in response to forces acting on the graft portion as the forces acting on the graft portion affect the shape and deployment (thereby stretching), as seen in Fig. 4E.
Regarding claim 27, Spence further teaches the plurality of elongate members (127) are configured to move from a stored configuration (seen in Fig. 4B) to a deployed configuration upon deployment (as seen in Fig. 4E) and the plurality of elongate members move to conform to irregular topography of a heart of a patient upon deployment (the device seen conforming in Fig. 4E.
Regarding claims 29, Spence teaches an inflow or outflow cannula apparatus (100) (Figs. 4E-4F), the apparatus comprising:
a conduit (110) having an exterior surface (the body-facing side of the conduit) and an interior surface (where lumen 117 is located);
an inlet portion (114) arranged at a first end of the conduit (113) including a plurality of elongate members (127) arranged about a circumference of the inlet portion configured to deploy against a tissue wall (50) (Fig. 4E) and conform to the tissue wall (necessarily conforming around the thickness of the tissue wall which is penetrated in order to form a barrier) such that the geometry of the tissue wall is substantially maintained (the wall not being significantly altered in shape);and
a graft portion (124) arranged on an exterior surface and an interior surface of the plurality of elongate members such that the graft portion is covering and arranged between the plurality of elongate members (the graft portion preventing the elongate members from being exposed and therefore being considered to cover both the interior and exterior surfaces [0075]) and extending along the interior and exterior surfaces of the conduit (the portion forming the graft portion extending interior lumen (117).
Regarding claim 31, Spence is considered to teach each elongate member (109) of the plurality of elongate members defines an atraumatic tip at the second end, as the tips are rounded and fold to form a blunt tip which allows for smooth passage without catching tissue [0106].
Regarding claim 33, Spence further teaches the inlet portion (114) includes a funnel shape (seen in Fig. 4E) in an initial configuration and is configured to flatten against the tissue wall during use (appearing flush against the wall in Fig. 4E).
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.
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.
Claim(s) 3, 4, 26, 28, and 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Spence.
Regarding claims 3 and 4, Spence teaches the graft portion (124) is arranged on an exterior surface and an interior surface of the plurality of elongate members (the graft portion preventing the elongate members from being exposed and therefore being considered to cover both the interior and exterior surfaces [0075]), but fails to explicitly teach the graft portion extends along the interior surface of the conduit to a second end of the conduit in the embodiment of Figs. 4E and 4F.
Spence further teaches the graft portion extends along the interior surface of the conduit to a second end of the conduit as seen in the embodiments of Figs. 9-11.
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 the length of the graft portion to allow the device to be properly located based on the intended treatment and patient biology [0071].
Regarding claim 26, in the embodiment of Claim 1, Spence fails to teach the plurality of elongate members are coupled to one another at a first end and are spaced apart from one another at a second end.
Spence teaches an alternate embodiment (Fib. 12B) wherein the plurality of elongate members (109) are coupled to one another at a first end (the end opposite 204) and are spaced apart from one another at a second end (at 14).
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 the shape of the elongate members with that taught in the alternate embodiment of Spence to improve delivery [0106].
Regarding claim 28, in the embodiment of Claim 1, Spence fails to teach the graft portion has an exterior surface and is configured to allow tissue ingrowth along at least a portion of the exterior surface when the exterior surface is in contact with the tissue wall.
Spence teaches the use of a textured surface to promote tissue ingrowth [0016].
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 the device of Claim 1 to incorporate the fabric of Spence alternate embodiment, thereby resulting in tissue ingrowth in order to improve biologic compatibility [0127].
Regarding claim 30, in the embodiment of Claim 29, Spence fails to teach the plurality of elongate members are coupled to one another at a first end and are spaced apart from one another at a second end.
Spence teaches an alternate embodiment (Fib. 12B) wherein the plurality of elongate members (109) are coupled to one another at a first end (the end opposite 204) and are spaced apart from one another at a second end (at 14).
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 the shape of the elongate members with that taught in the alternate embodiment of Spence to improve delivery [0106].
Claim(s) 12 and 32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Spence in view of US 20140371676 A1 (Leeflang et al.).
Regarding claim 12, Spence fails to teach the conduit includes an adjustable cannula portion having a threaded surface and a stop, and the stop is configured to travel along a length of the threaded surface to adjust a position of the inlet portion relative to the tissue wall.
Leeflang teaches a cannula (260c) (Fig. 9C) wherein the conduit (240c) includes an adjustable cannula portion having a threaded surface (284c) and a stop (249c), and the stop is configured to travel along a length of the threaded surface [0073] to adjust a position of the inlet portion (245c) relative to the tissue 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 the conduit of Spence to include the threaded surface and related stop of Leeflang to allow the user to control the placement of the inlet portion [0073].
“[T]o adjust a position of the inlet portion relative to the tissue wall” is a statement of intended use that does not further limit the claimed invention. While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function. In re Schreiber, 128 F.3d 1473, 1477-78, 44 USPQ2d 1429, 1431-32 (Fed. Cir. 1997) [MPEP 2114]. Since the structure of the prior art teaches all structural limitations of the claim, the same is considered capable of meeting the intended use limitations.
Regarding claims 32, Spence teaches an inflow or outflow cannula apparatus (100) (Figs. 4E-4F), the apparatus comprising:
a conduit (110) having an exterior surface (the body-facing side of the conduit) and an interior surface (where lumen 117 is located);
an inlet portion (114) arranged at a first end of the conduit (113) including a plurality of elongate members (127) arranged about a circumference of the inlet portion configured to deploy against a tissue wall (50) (Fig. 4E) and conform to the tissue wall (necessarily conforming around the thickness of the tissue wall which is penetrated in order to form a barrier) such that the geometry of the tissue wall is substantially maintained (the wall not being significantly altered in shape);and
a graft portion (124) covering and arranged between the plurality of elongate members and extending along the interior surface of the conduit [0075]; and
Spence fails to teach the conduit includes an adjustable cannula portion having a threaded surface and a stop, and the stop is configured to travel along a length of the threaded surface to adjust a position of the inlet portion relative to the tissue wall.
Leeflang teaches a cannula (260c) (Fig. 9C) wherein the conduit (240c) includes an adjustable cannula portion having a threaded surface (284c) and a stop (249c), and the stop is configured to travel along a length of the threaded surface [0073] to adjust a position of the inlet portion (245c) relative to the tissue 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 the conduit of Spence to include the threaded surface and related stop of Leeflang to allow the user to control the placement of the inlet portion [0073].
“[T]o adjust a position of the inlet portion relative to the tissue wall” is a statement of intended use that does not further limit the claimed invention. While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function. In re Schreiber, 128 F.3d 1473, 1477-78, 44 USPQ2d 1429, 1431-32 (Fed. Cir. 1997) [MPEP 2114]. Since the structure of the prior art teaches all structural limitations of the claim, the same is considered capable of meeting the intended use limitations.
Conclusion
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/HANS KALIHER/Examiner, Art Unit 3781
/JACQUELINE F STEPHENS/Primary Examiner, Art Unit 3781
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