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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-10 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Cotter et al. US Patent Application Publication 2016/0121033 in view of Jimenez et al. US Patent Application Publication 2016/0067395.
As to claim 1, Cotter teaches a system for transabdominal or transthoracic direct cardiac or direct vascular access, comprising:
a compression assembly 200 (Figure 2) comprising:
an axial compression ring 206 having a plurality of anchor openings 213 passing axially through the axial compression ring, the axial compression ring have a central axial opening passing therethrough (Figure 2).
Cotter teaches the present invention substantially as claimed, but does not teach an attachment skirt comprising a material capable of imparting hemostasis when compressed against anatomical tissue. Jimenez teaches a device for direct vascular access including a port, anchoring device, and a coupler device (Jimenez Abstract). The device of Jimenez further comprises an attachment skirt, sealing element 158 configured for contacting and sealing against the first surface of the tissue wall upon advancing the anchoring device therethrough (Figure 1B, paragraphs 0107-0108). Jimenez teaches the sealing element is beneficial I providing a secondary fluid tight seal about the conduit or medical device which may be in addition to the primary fluid tight seal provided by the anchoring device (Jimenez paragraph 0108). It would have been obvious to one having ordinary skill in the art before the invention was originally filed to modify the system of Cotter with an attachment skirt for the benefits taught in Jimenez.
Cotter/Jimenez teach the attachment skirt having a central annular opening configured to be in axial alignment with the central axial (Jimenez Figures 1A and 1B) opening of the axial compression ring when the attachment skirt and the axial compression ring are in an adjacent relationship (Jimenez Figures 1A and 1B);
a plurality of tissue anchors 211 (Cotter Figure 2; paragraph 0061) configured to cooperate with the plurality of anchor openings 213, pass through the attachment skirt, and apply an axial compressive force to the axial compression ring, bear against the attachment skirt, and pass into anatomical tissue, thereby axially compressing the compression assembly against the anatomical tissue in a substantially hemostatic manner (Cotter paragraphs 0006-0007; 0057-0061); and
an access cap 400 configured to sealingly engage with the axial compression ring, the access cap comprising an annular member having a central opening 462 configured to be in axial alignment with the central axial opening AC of the axial compression ring (Figures 2, 4A, and 4B) and the central annular opening of the attachment skirt engaged with the axial compression ring and a seal projecting into the central opening of the annular member.
As to claim 2, the axial compression ring 206 is a unitary ring member (Figure 2).
As to claim 3, the axial compression ring 206 is a segmented ring member (Figures 1 and 2).
As to claim 4, the axial compression ring 206 further comprises a plurality of arcuate members 213.
As to claim 5, the plurality of arcuate members are interdigitated (Figure 2).
As to claim 6, each of the plurality of arcuate members 213 further include at least one of a projection or a recess that interdigitates with at least one of a projection or a recess on an adjacent one of the plurality of arcuate members – where 213 has a hexagonal head that cooperates with the projections in the anchor 209, which may include coil 11, pins, prongs, bar, hook, or staple (paragraph 0061).
As to claim 7, the axial compression ring is further comprised of a rigid, semi-rigid, or flexible material selected from the group of metals and polymers (Jimenez paragraph 0108).
As to claim 8, the tissue anchors 209 further comprise helical tissue screws 211 having a driver opening passing through a tissue screw head 213 and in axial alignment with a central rotational axis of the helical tissue screws 211 (Cotter Figure 2).
As to claim 9, the axial compression ring 206 further comprises a projection that mates with a mating projection on the access cap – where Cotter teaches a secondary anchoring device 207 may include one or more tissue anchors 209 configured for extending through mating apertures defined in the port 206 (paragraph 0061).
As to claim 10, the access cap 400 further comprises a first annular member 470 and a second annular member 402 (Cotter Figure 4A), wherein the seal is retained between the first annular member and the second annular member (Cotter Figure 4B).
As to claim 17, Cotter/Jimenez teach the system further comprising a plug configured to couple to the compression assembly in a hemostatic manner – where Cotter teaches a valve positioned within the cannula configured for controlling fluid communication therethrough (Cotter paragraph 0031); and Jimenez teaches the connector may further include a hemostasis valve configured for closing a fluid communication through the connector (Jimenez paragraph 0017).
Claims 11-16 and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Cotter et al. US Patent Application Publication 2016/0121033 in view of Jimenez et al. US Patent Application Publication 2016/0067395 and further in view of Mitchell et al. US Patent Application Publication 20200253606.
As to claim 11, Cotter/Jimenez teach the present invention substantially as claimed. Cotter/Jimenez do not teach the system further comprising an access graft coupled to the compression assembly of claim 1. Mitchell teaches an access graft is generally configured to enable a practitioner to quickly and easily make an end-to-side connection between a graft conduit and a hollow cardiovascular vessel (Mitchell paragraph 0066). It would have been obvious to one having ordinary skill in the art before the invention was originally filed to modify the system of Cotter/Jimenez with an access graft for the benefits taught in Mitchell.
As to claim 12, Cotter/Jimenez/Mitchell teach the access graft further comprises a tubular graft 132 having a radially projecting flange 134 at one end of the tubular graft 132 (Mitchell Figure 3A).
As to claim 13, Cotter/Jimenez/Mitchell teach the tubular graft 132 passes into and through a central opening of the compression assembly formed by the axial alignment of the central axial opening of the axial compression ring and the central annular opening of the attachment skirt (Mitchell Figures 1, 3A, and 7A).
As to claim 14, Cotter/Jimenez/Mitchell teach the radially projecting flange 134 is positioned between the axial compression ring 137 and the attachment skirt (Cotter Figure 2; Jimenez Figure 1A, 1B; Mitchell Figure A).
As to claim 15, Cotter/Jimenez/Mitchell teach the access graft further comprises a tubular graft 132 having a first connector and the radially projecting flange further comprises a discrete member having a second connector configured to removably couple with the first connector (Mitchell Figure 7A; Cotter Figures 4A, 4B).
As to claim 16, Cotter teaches a dual lumen cannula configured to pass into and through the central lumen of the access graft, the central opening of the axial compression ring and into cardiac or vascular tissue (Cotter Figures 4A, 4B; paragraphs 0029-0030; 0067-0068).
As to claim 18, Cotter/Jimenez/Mitchell teach a system for transabdominal or transthoracic direct cardiac or direct vascular access, comprising:
an access cuff comprising a tubular graft having a central lumen that communicates between proximal and distal ends of the tubular graft 132 (Mitchell Figures 1, 3a, and 7A);
a compression assembly 200 (Cotter Figure 2) comprising:
an axial compression ring 206 having a plurality of anchor openings 213 passing axially through the axial compression ring, the axial compression ring have a central axial opening passing therethrough (Cotter Figure 2).
Cotter teaches the present invention substantially as claimed, but does not teach an attachment skirt comprising a material capable of imparting hemostasis when compressed against anatomical tissue. Jimenez teaches a device for direct vascular access including a port, anchoring device, and a coupler device (Jimenez Abstract). The device of Jimenez further comprises an attachment skirt, sealing element 158 configured for contacting and sealing against the first surface of the tissue wall upon advancing the anchoring device therethrough (Figure 1B, paragraphs 0107-0108). Jimenez teaches the sealing element is beneficial I providing a secondary fluid tight seal about the conduit or medical device which may be in addition to the primary fluid tight seal provided by the anchoring device (Jimenez paragraph 0108). It would have been obvious to one having ordinary skill in the art before the invention was originally filed to modify the system of Cotter with an attachment skirt for the benefits taught in Jimenez.
Cotter/Jimenez teach the attachment skirt having a central annular opening configured to be in axial alignment with the central axial (Jimenez Figures 1A and 1B) opening of the axial compression ring when the attachment skirt and the axial compression ring are in an adjacent relationship (Jimenez Figures 1A and 1B);
a plurality of tissue anchors 211 (Cotter Figure 2; paragraph 0061) configured to cooperate with the plurality of anchor openings 213, pass through the attachment skirt, and apply an axial compressive force to the axial compression ring, bear against the attachment skirt, and pass into anatomical tissue, thereby axially compressing the compression assembly against the anatomical tissue in a substantially hemostatic manner (Cotter paragraphs 0006-0007; 0057-0061); and
As to claim 19, Cotter/Jimenez/Mitchell teach the system of Claim 18, further comprising an attachment skirt 158 positioned on a distal surface of the radial flange (Jimenez Figures 1A and 1B).
As to claim 20, Cotter/Jimenez/Mitchell the plurality of tissue anchors 209 in combination with the axial compression ring 206 are configured to exert an axially compressive force about an entire circumference of the attachment skirt against heart or vascular tissue (Cotter paragraphs 0061-0062).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JACQUELINE F STEPHENS whose telephone number is (571)272-4937. The examiner can normally be reached 8:30-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Nicholas Weiss can be reached at 571-270-1775. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JACQUELINE F STEPHENS/ Primary Examiner, Art Unit 3781