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 Amendment
In response to the amendment filed on 10/17/2024, no claims have been cancelled, and Claims 1-20 are pending.
Claim Rejections - 35 USC § 102
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.
Claims 1-8, 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 6152937 A Peterson et al. (hereinafter Peterson).
Regarding claim 1, Peterson discloses a cartridge (10, Fig. 1) for an anastomotic coupler (50, Fig. 8, col. 5 line 4-12), the cartridge comprising:
a frame (11, Fig. 1-3) extending along a longitudinal axis (axis 11, Fig. 1-3);
one or more fasteners (16, Fig. 1-3) extending from the frame at an angle from the longitudinal axis (as seen in Fig. 3, 10, col. 5 line 18-19, col. 8 line 59-60), the one or more fasteners operable to at least partially puncture a wall of a tubular structure (col. 8 line 65-67); and
one or more frictional elements (18, 20, Fig. 1-3, 10-14) extending from the frame at an angle from the longitudinal axis (col. 6 line 51-57, Fig. 3), the one or more frictional elements operable to abut against the wall of the tubular structure without puncturing the wall (as seen in Fig. 10-14, body conduit (90) is pinned between frictional elements (18, 20) which abut against the body conduit without puncturing the wall).
Regarding claim 2, Peterson discloses the limitations of claim 1, and further discloses wherein the one or more fasteners each have an end that is linear, curved, bent, and/or hooked (fasteners (16) have a curved hook end that forms a sharp point as seen in Fig. 3, 10).
Regarding claim 3, Peterson discloses the limitations of claim 1, and further discloses wherein the frame includes a body (frame (11) has a physical body) that has a diameter substantially the same as a diameter of a lumen of the tubular structure so that a body outer radial surface abuts against the wall of the tubular structure to maintain the shape of the tubular structure (as seen in Fig. 14, the body of the frame (11) has a diameter substantially the same as a diameter of the lumen of tubular structure (30) and the body outer radial surface abuts the wall of the tubular structure to maintain the shape of the tubular structure).
Regarding claim 4, Peterson discloses the limitations of claim 3, and further discloses wherein the body forms a lumen to permit fluid to flow across the frame (the cartridge (10) is annular with the body forming a lumen (12, Fig. 1)).
Regarding claim 5, Peterson discloses the limitations of claim 3, and further discloses wherein at least one of the one or more frictional elements extends from the body (frictional elements (18, 20) extend outwardly from the body of the frame (11) as seen in Fig. 3).
Regarding claim 6, Peterson discloses the limitations of claim 3, and further discloses wherein the frame includes one or more columns (19, Fig. 2) that extend from the body along the longitudinal axis.
Regarding claim 7, Peterson discloses the limitations of claim 6, and further discloses wherein at least one of the one or more fasteners extends from the one or more columns (as seen in Fig. 3, fasteners (16) extend from the columns (19)).
Regarding claim 8, Peterson discloses the limitations of claim 1, and further discloses wherein the angle that the one or more fasteners extend from the longitudinal axis is between about 1 degree and about 90 degrees (as seen in Fig. 3, 10, col. 5 line 18-19, col. 8 line 59-60, fasteners (16) extend radially outward and will inherently extend from the longitudinal axis (11) at an angle between about 1 degree and about 90 degrees depending on which side of the fastener the angle is taken from).
Regarding claim 10, Peterson discloses the limitations of claim 1, and further discloses wherein the angle that the one or more frictional elements extend from the longitudinal axis is between about 1 degree and about 90 degrees (col. 6 line 51-57, Fig. 3, frictional elements (18, 20) extend from the frame (11) outwardly at angle (19) between 20 degrees and 90 degrees from the longitudinal axis (11)).
Claim Rejections - 35 USC § 103
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.
Claims 11-18, 20 are rejected under 35 U.S.C. 103 as being unpatentable over US 20060004394 A1 Amarant in view of Grudem.
Regarding claim 11, Amarant discloses an anastomotic coupler (10, Fig. 1) comprising:
a ring (24/26, Fig. 1) operable to receive a tubular structure (40/42, Fig. 4) extending along a longitudinal axis (paragraph 31); and
a cartridge (12, Fig. 1) operable to be received in the tubular structure (seen in Fig. 4, paragraph 31), the cartridge including:
a frame (entirety of cartridge 12) extending along a longitudinal axis (Fig. 1);
one or more frictional elements (18, 20, Fig. 1) extending from the frame at an angle from the longitudinal axis (frictional elements (18, 20) extend from the frame (12) outwardly at a perpendicular angle from the longitudinal axis of the frame as seen in Fig. 1), the one or more frictional elements operable to abut against the wall of the tubular structure without puncturing the wall (as seen in Fig. 4-7, frictional elements (18, 20) abut against the wall of tubular structure (40, 42) without puncturing the wall),
wherein the cartridge assists in coupling the ring with the tubular structure as the one or more frictional elements provide radial compression of the tubular structure against the ring (paragraph 13, 31-32, as the ring (24/26) is slid over the cartridge (12) it provides a radial frictional force over the frictional elements (18, 20) that pins and compresses the tubular structure between the cartridge and the ring).
Amarant is silent on one or more fasteners extending from the frame at an angle from the longitudinal axis, the one or more fasteners operable to at least partially puncture a wall of a tubular structure; and the one or more fasteners provide radial compression of the tubular structure against the ring.
However, Grudem teaches a anastomotic coupler (100, Fig. 1, abstract) comprising a cartridge (10, Fig. 2, 3), the cartridge comprising a frame (entirety of cartridge 10) extending along a longitudinal axis (12, Fig. 3) and one or more fasteners (26, 42, Fig. 3) extending from the frame at an angle from the longitudinal axis (seen in Fig. 3), the one or more fasteners operable to at least partially puncture a wall of a tubular structure (104, Fig. 1) (paragraph 12, 62, 81).
Furthermore, modifying the cartridge (12) of Amarant with the fasteners (26, 42) of Grudem which extend outwards from the frame of the cartridge at an angle would allow the ring (24/26) of Amarant to compress the fasteners (26, 42) down and over the tubular structure since the deflection of the fasteners is plastic (paragraph 60-61 of Grudem).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Amarant with the teachings of Grudem to have one or more fasteners extending from the frame at an angle from the longitudinal axis, the one or more fasteners operable to at least partially puncture a wall of a tubular structure; and the one or more fasteners provide radial compression of the tubular structure against the ring, in order to provide a stronger securement of the tubular structure to the cartridge.
Regarding claim 12, the combination of Amarant and Grudem teaches the limitations of claim 11, and Grudem further discloses wherein the one or more fasteners each have an end that is linear, curved, bent, and/or hooked (the end portions 28, 44 have a linear end that forms a sharp point as seen in Fig. 3).
Regarding claim 13, the combination of Amarant and Grudem teaches the limitations of claim 11, and Amarant further discloses wherein the frame includes a body (frame (12) has a physical body) that has a diameter substantially the same as a diameter of a lumen of the tubular structure so that a body outer radial surface abuts against the wall of the tubular structure to maintain the shape of the tubular structure (as seen in Fig. 4-7, the body has a diameter substantially the same as a diameter of the lumen of the tubular structure (40, 42) and the body outer radial surface abuts the wall of the tubular structure to maintain the shape of the tubular structure).
Regarding claim 14, the combination of Amarant and Grudem teaches the limitations of claim 13, and Amarant further discloses wherein the body forms a lumen to permit fluid to flow across the frame (paragraph 25-27, the cartridge (12) is a hollow tubular conduit and therefore has a lumen).
Regarding claim 15, the combination of Amarant and Grudem teaches the limitations of claim 13, and Amarant further discloses wherein at least one of the one or more frictional elements extends from the body (frictional elements (18, 20) extend outwardly from the body of the frame (12) as seen in Fig. 1).
Regarding claim 16, the combination of Amarant and Grudem teaches the limitations of claim 13, and Grudem further discloses wherein the frame includes one or more columns that extend from the body along the longitudinal axis (as seen in annotated Fig. 3 above).
Regarding claim 17, the combination of Amarant and Grudem teaches the limitations of claim 16, and Grudem further discloses wherein at least one of the one or more fasteners extends from the one or more columns (as seen in annotated Fig. 3 above, fasteners (26, 42) extend from the columns).
Regarding claim 18, the combination of Amarant and Grudem teaches the limitations of claim 11, and Grudem further discloses wherein the angle that the one or more fasteners extend from the longitudinal axis is between about 1 degree and about 90 degrees (as seen in Fig. 3, fasteners (26, 42) extend from the longitudinal axis at an angle between 1 degree and about 90 degrees).
Regarding claim 20, the combination of Amarant and Grudem teaches the limitations of claim 11, and Amarant further discloses wherein the angle that the one or more frictional elements extend from the longitudinal axis is between about 1 degree and about 90 degrees (frictional elements (18, 20) extend from the frame (12) outwardly at a perpendicular angle (90 degrees) from the longitudinal axis of the frame as seen in Fig. 1).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Peterson in view of US 5397345 A Lazarus.
Regarding claim 9, Peterson teaches the limitations of claim 1.
Peterson is silent on wherein the angle that the one or more fasteners (16) extend from the longitudinal axis is between about 65 degrees and about 80 degrees.
However, Lazarus teaches a cartridge 16 (Fig. 3) for anchoring into a tubular structure (col. 5 line 14-29), having fasteners 70 (Fig. 3) attached at an angle 75 (Fig. 3) that is between about 15 degrees to about 135 degrees from a longitudinal axis (67) (col. 5 line 50-53). Thus, the claimed angles of between about 65 degrees and about 80 degrees of the instant application are within the limitations taught by Lazarus.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Peterson with the teachings of Lazarus to have wherein the angle that the one or more fasteners extend from the longitudinal axis is between about 65 degrees and about 80 degrees as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Amarant in view of Grudem as applied to claim 11 above, and further in view of Lazarus.
Regarding claim 19, the combination of Grudem and Amarant teaches the limitations of claim 11.
The combination is silent on wherein the angle that the one or more fasteners extend from the longitudinal axis is between about 65 degrees and about 80 degrees.
However, Lazarus teaches a cartridge 16 (Fig. 3) for anchoring into a tubular structure (col. 5 line 14-29), having fasteners 70 (Fig. 3) attached at an angle 75 (Fig. 3) that is between about 15 degrees to about 135 degrees from a longitudinal axis (67) (col. 5 line 50-53). Thus, the claimed angles of between about 65 degrees and about 80 degrees of the instant application are within the limitations taught by Lazarus.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modification of Amarant with Grudem with the teachings of Lazarus to have wherein the angle that the one or more fasteners extend from the longitudinal axis is between about 65 degrees and about 80 degrees as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Conclusion
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/KHOA TAN LE/Examiner, Art Unit 3771 /MOHAMED G GABR/Primary Examiner, Art Unit 3771