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 § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 9-11 and 16-18 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 9 recites the limitation "a connection interface" in in line2. This language is indefinite as it is unclear if “a connection interface” is the same or different connection interface on the outer ring as disclosed in claim 1, line 9.
Claim 16 recites the limitation "an outer ring" on lines 6-7. This language is indefinite as it is unclear if “an outer ring” is the same or different an outer ring as disclosed in claim 1, line 5.
Claim 18 recites the limitation “an inner ring sized to slide over an outer diameter of one of the two vessels; an outer ring configured to trap an everted portion of the one of the two vessels between itself and the inner ring; interface features on the inner ring and outer ring configured to trap and hold the everted portion of the one of the two vessels between them and fix a position of the inner ring and outer ring with respect to each other; and a connection interface on the outer ring is configured, when mounted on the one of the two vessels, to join with the outer ring of the other of the two vessels to join the two vessels and complete anastomosis of the two vessels” on lines 4-13. This language is indefinite as claim 18 discloses the implantation device of claim 17, claim 17 discloses the implantation device of claim 16, claim 16 discloses the coupling device of claim 1. The language and structure of the coupling device is repeated and is unclear as to whether it is the same or different vascular anastomosis coupling device as claimed in claim 1, lines 3-12.
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.
Claim(s) 1-9 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hua et al. CN 210521037 in view of Lim et al. US 3774615.
Regarding claims 1, 4 and 8, Hua et al. discloses a vascular anastomotic coupling device (abstract, figure 5), comprising for each of two vessels prepared for anastomosis (figure 6): an inner ring 2 sized to slide over an outer diameter of one of the two vessels (figure 1); an outer ring 4 configured to trap an everted portion of the one of the two vessels between itself and the inner ring (figures 5, 6; and a connection interface on the outer ring is configured, when mounted on the one of the two vessels, to join with the outer ring of the other of the two vessels to join the two vessels and complete anastomosis of the two vessels (see annotated figure 6 below, connection interface portion of outer ring 4 facing the opposite outer ring).
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Hua et al. fails to disclose interface features on the inner ring and outer ring configured to trap and hold the everted portion of the one of the two vessels between them and fix a position of the inner ring and outer ring with respect to each other, wherein the interface features comprise features of an inner circumference of the outer ring and an outer circumference of the inner ring.
Lim et al. discloses an anastomotic coupling device (for example, figures 1-3) comprising an inner ring 1 sized to fit over a vessel 2, an outer ring 4 configured to trap an everted portion of the one of the two vessels between itself and the inner ring (figure 1-4), and interface features on the inner ring and outer ring configured to trap and hold the everted portion of the one of the two vessels between them and fix a position of the inner ring and outer ring with respect to each other (for example, groove 5 or thread 6, figures 3, 4; abstract, column 5, lines 10-25; vessel secured between by placing the outer ring 4 into groove 5), wherein the interface features comprise a circular groove and complementary ridge (figure 3, groove 5 with corresponding ridge of outer ring), wherein the interface features comprise features of an inner circumference of the outer ring and an outer circumference of the inner ring (figure 3, groove facing corresponding ridge on outer side of ring 1 and inner side of ring 4 to clamp vessel therebetween).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Hua et al. with interface features on the inner ring and outer ring configured to trap and hold the everted portion of the one of the two vessels between them and fix a position of the inner ring and outer ring with respect to each other, wherein the interface features comprise features of an inner circumference of the outer ring and an outer circumference of the inner ring, as taught by Lim et al., to further connect and secure the vessel between the inner and outer rings for anastomosis.
Regarding claim 2, Hua et al. discloses an anastomosis coupling device comprises no feature that penetrates the two vessels after complete anastomosis (figure 6, vessel everted around clamps or inner and outer rings without piercing to secure).
Regarding claim 3, Hua et al. discloses an anastomosis coupling device configured to be completely abluminal with respect to the two vessels after complete anastomosis (figure 6).
Regarding claims 5-7 and 12, Hua et al. discloses an anastomosis coupling device essentially as claimed as discussed above, but fails to disclose wherein at least a portion of one of the interface features is flexible, wherein at least the interface feature on the outer ring is flexible, wherein at least the interface feature of the outer ring is flexible to expand slightly when it traps the everted portion between it and the inner ring, wherein the inner and outer rings are formed from flexible biocompatible material.
Lim et al. discloses an anastomosis coupling device wherein at least a portion of one of the interface features is flexible material (column 2, lines 18-23; lines 47-62; inner and outer rings or ring and fastening members are made from an elastic material, Examiner notes the interface feature are integral with the inner and outer rings and would therefore be formed of the same material), and the inner and outer rings are formed from flexible biocompatible material (for example, column 2, lines 18-23; lines 47-62; inner and outer rings or ring and fastening members are made from an elastic material), wherein at least the interface feature on the outer ring is flexible (column 2, lines 18-23; inner and outer rings or ring and fastening members are made from an elastic material), wherein at least the interface feature of the outer ring is flexible to expand slightly when it traps the everted portion between it and the inner ring (column 2, lines 18-23; outer ring or fastening means 4 swells additionally at the place of application) to provide a tight connection or anastomosis and a softness of the consistency of the surrounding tissue while maintaining suitable strength (column 2, lines 47-62).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Hua et al. with at least a portion of one of the interface features is flexible, wherein at least the interface feature on the outer ring is flexible, wherein at least the interface feature of the outer ring is flexible to expand slightly when it traps the everted portion between it and the inner ring, as taught by Lim et al., since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use such as trapping a vessel, as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Regarding claim 9, Hua et al. discloses wherein the outer ring for each of the two vessels comprises a connection interface to interface with each other.
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Claim(s) 10, 11, 13 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hua et al. CN 210521037 in view of Lim et al. US 3774615 in view of Collito US 3254650.
Regarding claim 10, Hua et al. in combination discloses a connection to connect the connection interface (figure 7), but fails to disclose the connection interface comprising outward facing pins.
Collio discloses an anastomosis device (for example, figures 18-24) comprising rings comprising a connection interface (for example, figures 23-24, discs or rings 136, 138), the connection interface comprising outward facing pins 140 (figure 24) to connect the rings or discs (column 6, lines 60-67; pins are bent over the discs to secure).
Therefore, it would have been obvious to one having ordinary skill in the art to modify Hua et al. in combination with a connection interface comprising outward facing pins, as taught by Collio, to secure the rings and complete the anastomosis between the vessels.
Regarding claim 11, Hua et al. in combination discloses a connection to connect the connection interface (figure 7), but fails to disclose the connection interface comprising magnets, a mechanical capture, adhesive or suture openings.
Collio discloses an anastomosis device comprising rings comprising a connection interface (rings 30 and 32 brought together in alignment, figure 4), the connection interface comprising magnets, a mechanical capture, adhesive or suture openings (column 4, lines 27-34, adhesive to set the flanges permanently).
Therefore, it would have been obvious to one having ordinary skill in the art to modify Hua et al. in combination with a connection interface comprising magnets, a mechanical capture, adhesive or suture openings, as taught by Collio, to secure the rings and complete the anastomosis between the vessels.
Regarding claims 13 and 14, Hua et al. discloses a vascular anastomosis coupling but fails to disclose wherein one or both of the inner and outer ring are formed from a biocompatible metal or alloy, wherein the metal or alloy is selected from the group consisting of stainless steel, cobalt-chrome alloy, titanium, nickel-titanium alloy (nitinol), platinum, silver, iridium, and tungsten.
Collio teaches an anastomosis coupling comprising a ring which may be formed from any suitable material, such as stainless steel, other metal, plastic, or hard rubber (column 6, lines 70-72).
Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to provide one or both of the inner and outer ring being formed from a biocompatible metal or alloy, wherein the metal or alloy is selected from the group consisting of stainless steel, cobalt-chrome alloy, titanium, nickel-titanium alloy (nitinol), platinum, silver, iridium, and tungsten since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hua et al. CN 210521037 in view of Lim et al. US 3774615 in view of Heaton, II et al. US 2010/0114301.
Regarding claim 15, Hua et al. discloses inner and outer rings of claim 1, as discussed above, but fails to explicitly disclose a plurality of different diameter sets of inner and outer rings.
Lim et al. teaches an anastomosis coupling device comprising inner and outer rings (for example, figures 3 and 4), the device may be used in a great variety of sizes for connecting vessels from the thinnest size to larger sizes vessels, but fails to explicitly disclose a kit comprising a plurality of different diameter sets.
Heaton, II et al. teaches an anastomosis device comprising a kit 1805 comprising a plurality of rings, the plurality of rings comprising a plurality of different diameter sets (figure 18, paragraph 0230, different diameters such as different inner diameters, outer diameters, or both).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Hua et al. and Lim et al. with a kit having a plurality of rings comprising a plurality of different diameter sets, as taught by Heaton, II et al., in order to provide a kit for anastomosing a variety of sized vessels.
Claim(s) 16 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hua et al. CN 210521037 in view of Lim et al. US 3774615 in view of Plott et al. WO 2017/040884.
Regarding claims 16 and 17, Hua et al. discloses an anastomosis implantation device for implantation of the vascular anastomotic coupling device of claim 1, as discussed above, wherein the implantation device comprises: a flaring tool 3, carry an outer ring 4 (configured to carry the ring around exterior of tool 3, figure 1), and flare a portion of the vessel such that the outer ring 4 can evert the portion over the inner ring 2 (figures 4-5), wherein the flaring tool 3 comprises a tapered, conical end to flare the portion of the vessel (figure 5, conical end 32).
Hua et al. fails to disclose a vessel support mounted on a guide wire and sized to fit within the vessel, the flaring tool configured to slide along the wire guide, the flaring tool comprising a lumen to ride along the guide wire.
Plott et al. discloses an implantation device to aid in anastomosis comprising a vessel support 16 mounted on a guide wire 14 and sized to fit within the vessel (figure 8), the vessel support 16 providing support for the vessel wall when inflated to provide a holding force (paragraph 0051), the flaring tool 12 comprising a lumen configured to slide along the wire guide 14 for everting the vessel portion 29a (figures 6, 7).
Therefore, it would have been obvious to one having ordinary skill in the art to modify Hua et al. with a guidewire and vessel support, and sliding the flaring tool along the guidewire, as taught by Plott et al. for providing a holding force within the vessel as the everting or flaring tool is advanced for everting the vessel for anastomosis.
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hua et al. CN 210521037 in view of Lim et al. US 3774615 in view of Plott et al. WO 2017/040884 in view of Heaton, II et al. US 2010/0114301.
Regarding claim 18, Hua et al. in combination discloses an anastomosis implantation device of claim 17, a vascular anastomotic coupling device (abstract, figure 5), comprising for each of two vessels prepared for anastomosis (figure 6): an inner ring 2 sized to slide over an outer diameter of one of the two vessels (figure 1); an outer ring 4 configured to trap an everted portion of the one of the two vessels between itself and the inner ring (figures 5, 6; and a connection interface on the outer ring is configured, when mounted on the one of the two vessels, to join with the outer ring of the other of the two vessels to join the two vessels and complete anastomosis of the two vessels (see annotated figure 6 below, connection interface portion of outer ring 4 facing the opposite outer ring).
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Hua et al. fails to disclose interface features on the inner ring and outer ring configured to trap and hold the everted portion of the one of the two vessels between them and fix a position of the inner ring and outer ring with respect to each other, wherein the interface features comprise features of an inner circumference of the outer ring and an outer circumference of the inner ring, a kit comprising a plurality of different diameter sets.
Lim et al. discloses an anastomotic coupling device (for example, figures 1-3) comprising an inner ring 1 sized to fit over a vessel 2, an outer ring 4 configured to trap an everted portion of the one of the two vessels between itself and the inner ring (figure 1-4), and interface features on the inner ring and outer ring configured to trap and hold the everted portion of the one of the two vessels between them and fix a position of the inner ring and outer ring with respect to each other (for example, groove 5 or thread 6, figures 3, 4; abstract, column 5, lines 10-25; vessel secured between by placing the outer ring 4 into groove 5), wherein the interface features comprise a circular groove and complementary ridge (figure 3, groove 5 with corresponding ridge of outer ring), wherein the interface features comprise features of an inner circumference of the outer ring and an outer circumference of the inner ring (figure 3, groove facing corresponding ridge on outer side of ring 1 and inner side of ring 4 to clamp vessel therebetween), the device may be used in a great variety of sizes for connecting vessels from the thinnest size to larger sizes vessels, but fails to explicitly disclose a kit comprising a plurality of different diameter sets.
Heaton, II et al. teaches an anastomosis device comprising a kit 1805 comprising a plurality of rings, the plurality of rings comprising a plurality of different diameter sets (figure 18, paragraph 0230, different diameters such as different inner diameters, outer diameters, or both).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Hua et al. with interface features on the inner ring and outer ring configured to trap and hold the everted portion of the one of the two vessels between them and fix a position of the inner ring and outer ring with respect to each other, wherein the interface features comprise features of an inner circumference of the outer ring and an outer circumference of the inner ring, as taught by Lim et al., to further connect and secure the vessel between the inner and outer rings for anastomosis, and with a kit having a plurality of rings comprising a plurality of different diameter sets, as taught by Heaton, II et al., in order to provide a kit for anastomosing a variety of sized vessels.
Conclusion
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/CHRISTINA C LAUER/Examiner, Art Unit 3771