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 Arguments
Applicant's arguments filed 24NOV2025 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.
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, 5-11, 25, 27, 29, and 31 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20120059213 A1 (Spence).
Regarding claims 1, 2, 5-7, 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); 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 tissue erosion thereof” 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);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].
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);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
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 HANS KALIHER whose telephone number is (303)297-4453. The examiner can normally be reached Monday-Friday 08:00-05:00 MT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached at (571) 272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HANS KALIHER/Examiner, Art Unit 3781
/SARAH AL HASHIMI/Supervisory Patent Examiner, Art Unit 3781