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 § 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) 1-7 and 10-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2004/0054405 (Richard).
Richard discloses an anastomotic coupler (connector 20) comprising:
a ring (first and/or second straps 32, 33);
a cartridge (connector body 30) including a body portion (body of 30) and one or more fasteners (detents 50, 51) extending from the body at an angle (see angle of FIG. 2),
wherein the ring is aligned with the cartridge in that at least a portion of the cartridge is disposed within a lumen of a first tubular structure (prosthesis 22) and the ring is positioned externally of the first tubular structure (FIG. 2; P0036),
wherein the at least one of the one or more fasteners are operable to engage with the ring such that the tubular structure is coupled with the ring (FIG. 2; P0036-P0037).
2. The tubular structure is disposed between the ring and the body of the cartridge (FIG. 2).
3. The ring is coupled with the tubular structure such that the ring creates a seal (e.g., interior surface) against a wall of the tubular structure (FIG. 2; P0009).
4. At least one of the one or more fasteners is operable to engage with the tubular structure to engage with the ring (FIG. 2; P0036 and P0038).
5. At least one of the one or more fasteners is operable to push radially outward against the tubular structure (FIG. 2; P0036 and P0038).
6. At least one of the one or more fasteners is operable to expand radially away from the body against the tubular structure to engage with the ring (FIG. 2; P0036 and P0038).
7. At least one of the one or more fasteners is operable to (or at least capable of operating to) rotate in relation to the tubular structure to engage with the ring (e.g., rotation of body 30 as whole including detents 50, 51 in relation to prosthesis 22, 24).
10. The body of the cartridge is operable to (or at least capable of operating to) expand radially against the tubular structure (e.g., capability at least due to the body being plastic at P0043).
11. The angle of the fasteners in relation to the body is greater than 0 degrees and less than or equal to about 90 degrees (e.g., see acute angle of detents 50, 51 in FIG. 2).
12. One row of fasteners is provided on the cartridge (FIG. 2-3).
13. Two rows of fasteners are provided on the cartridge (FIG. 2-3).
14. At least one of the one or more fasteners is operable to at least partially puncture the tubular structure (FIG. 2; P0042).
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) 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over US 2004/0054405 (Richard), as applied to claim 1 above, and further in view of US 2011/0270287 (Borghi).
Richard discloses the invention substantially as claimed as discussed above but does not disclose a sheath. Borghi teaches an anastomosis coupler in the same field of endeavor having a sheath (22) for the purpose of sequentially deploying the coupler (FIG. 4a-4d; P0044). The sheath is provided to cover the fasteners until the cartridge is positioned inside the tubular structure and the sheath is removed to uncover the one or more fasteners after the cartridge is positioned inside the tubular structure (4a-4d; P0044). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the coupler of Richard to include a sheath as taught by Borghi in order to sequentially deploy the coupler.
Claim(s) 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over US 2004/0054405 (Richard), as applied to claim 1 above, and further in view of US 2002/0082625 (Huxel).
Richard discloses the invention substantially as claimed as discussed above but does not disclose the receiving portion including a gasket. Huxel teaches an anastomotic coupler in the same field of endeavor where the receiving portion has a gasket (16) for the purpose of distributing compressive forces exerted by the opposed rings (P0018). The fasteners are operable to directly puncture the one or more gaskets upon puncturing the tubular structure (FIG. 8). The fasteners are compressed between two gaskets (segments 42 of gasket 16) of the one or more gaskets (FIG. 1; P0018). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the anastomotic coupler of Richard to include a receiving portion gasket as taught by Huxel in order to distribute the compressive forces exerted by the opposed rings.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TODD J SCHERBEL whose telephone number is (571)270-7085. The examiner can normally be reached Mon - Fri 9:00-6:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at 571-272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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TJ SCHERBEL
Primary Examiner
Art Unit 3771
/TODD J SCHERBEL/Primary Examiner, Art Unit 3771
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