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 .
This action is in response to the amendment filed on 10/06/25.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 and 11 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Objections
Claims 22-23 objected to because of the following informalities: the term “extravascular” is not disclosed in the specification. Appropriate correction is required.
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, 11, 19 and 21-23 is is/are rejected under 35 U.S.C. 103 as being unpatentable over Mallina (US 3,144,654) in view of Terumo (WO 2012/127888).
Regarding claim 1, Mallina discloses a device for forming an anastomosis between a first lumen (A) and a second lumen (B; Fig. 1), the device comprising: a staple receiving assembly (anvil 23) comprising a first body (bushing 52; and, bushing halves 48, 49) defining a bottom surface (89; Fig. 8) surrounding a first central opening (56a) and a plurality of staple receiving cavities (91; Figs. 5-8) positioned around the first central opening; a staple dispensing assembly (cartridge 22) comprising a second body (bushing 51; and, bushing halves 46, 47) defining a top surface (82; fig. 8) surrounding a second central opening (56b) and a plurality of staple dispensing cavities (96) positioned around the second central opening (Figs. 5-8); and a plurality staples (92) positioned within the plurality of staple dispensing cavities, wherein the staple receiving assembly and the staple dispensing assembly (22, 23, 52, 51) are configured to retain everted ends of the first and second lumens between the bottom surface and the top surface (Fig. 5), and wherein the staple dispensing assembly is configured to propel the plurality of linear staples from the plurality of staple dispensing cavities through the retained everted ends of the first and second lumens toward the plurality of staple receiving cavities in order to form an anastomosis between the first lumen and the second lumen (Figs. 7-10), but fails to disclose wherein the staples are linear. Terumo discloses an anastomosis device comprising surgical linear staples (spikes 24) for the purposes of minimize space occupied by the staples, thereby minimizing a number of applied staples and anastomosis stability. It would have been obvious to one having ordinary skills in the art before the effective filing date of the claimed invention to have provided Mallina’s staples as linear staples, as taught by Terumo, in order to minimize space occupied by the staples, thereby minimizing a number of applied staples and anastomosis stability.
Regarding claims 9 and 19, Mallina discloses a hinge (Fig. 2, hinge 24) coupled to the staple receiving assembly (Fig. 5, bushing 52) and the staple dispensing assembly (Fig. 5, staple bushing 51), and wherein the hinge (Fig. 2, hinge 24) Is configured to allow the device (Fig. 1, medical stapler; col. 2, Ins. 18-19) to transition between an open configuration (Fig. 5, hinge 24 releaseably engages sections 22, 23; col. 3, Ins. 3-16) wherein the staple receiving assembly (Fig. 5, bushing 52) and the staple dispensing assembly (Fig. 5, staple bushing 51) are spaced apart (Fig. 5, sections 22, 23 are spaced apart; col. 3, Ins. 3-16), and a closed configuration (Fig. 5, sections 22, 23; col. 3, Ins. 3-18) wherein the staple receiving assembly (Fig. 5, bushing 52) and the staple dispensing assembly (Fig. 5, staple bushing 51) retain (Fig. 5, Fig. 7, in the closed position, bushings 51, 52 retain the cuffed ends of vessels A, B) the everted ends of the first (Fig. 7, vessel A) and second lumens (Fig. 7, vessel B) between the bottom surface (Fig. 8, radial front face 88) and the top surface (Fig. 8; 82) and the plurality of staple dispensing cavities (Fig. 7, receptacles 98) are aligned with the plurality of staple receiving cavities (Fig. 7, receptacles 96 are put in juxtaposition opposite each groove 91; col. 8, Ins. 22-28).
Regarding claim 11, Mallina discloses a method (col. 8, In. 30) for forming an anastomosis between a first lumen (Fig. 7, vessel A) and a second lumen (Fig. 7, vessel B) with a device (Fig. 1, medical stapler; col. 2, Ins. 18-19) comprising a staple receiving assembly (Fig. 5, bushing 52) comprising a first body (Fig. 5, bushing halves 48, 49 define a body) defining a bottom surface (Fig. 8, radial front face 89) surrounding a first central opening (Fig. 5, passage 56a) and a plurality of staple receiving cavities (Fig. 8, grooves 91) positioned around the first central opening (Fig. 5, Fig. 8, grooves 81 are positioned around passage 56a), a staple dispensing assembly (Fig. 5, staple bushing 51) comprising a second body (Fig. 5, bushing halves 48, 47 define a body) defining a top surface (Fig. 8; rim 82) surrounding a second central opening (Fig. 5, passage 56b) and a plurality of staple dispensing cavities (Fig. 7, receptacles 96) positioned around the second central opening (Fig. 5, Fig. 7, Fig. 11, receptacles 96 are positioned around passage 56b), and a plurality of staples (Fig. 7, Fig. 8, Fig. 11, staples 92) positioned within the plurality of staple dispensing cavities (Fig. 11, staples 11 are positioned within receptacles 96), the method comprising: positioning a first end (Fig. 7, vessel A defines a first end) of the first lumen (Fig. 7, vessel A) within the first central opening (Fig. 5, passage 56a) and everting the first end (Fig. 5, Fig. 7, the surgeon will introduce the end portion of vessel A through passage 56a and overturn, In a cuffing manner, the end of vessel A over the rim portion; col. 8, Ins. 31-42) onto the bottom surface (Fig. 8, radial front face 89); positioning a second end (Fig. 7, vessel B defines a second end) of the second lumen (Fig. 7, vessel B) within the second central opening (Fig. 5, passage 56b) and everting the second end onto the top surface (Fig. 5, Fig. 7, the surgeon will Introduce the end portion of vessel A through passage 56a and overturn, in a cuffing manner, the end of vessel A over the rim portion; col. 8, Ins. 31-42; col. 9, Ins. 6-11); retaining (Fig. 1, Fig. 7, the surgeon will hinge together the two sections 22, 23, bringing together the two cuffed vessel ends; col. 9, Ins. 13-25) the first end (Fig. 7, the defined first end) and the second end (Fig. 7, the defined second end) between the top surface (Fig. 8, rim 82) and the bottom surface (Fig. 8, radial front face 89), and propelling the plurality of staples (Fig. 7, Fig. 8, Fig. 11, staples 92) from the plurality of staple dispensing cavities (Fig. 7, receptacles 96) through the retained everted ends of the first (Fig. 7, vessel A) and second lumens (Fig. 7, vessel B) toward the plurality of staple receiving cavities (Fig. 8, grooves 81) In order to form an anastomosis between the first lumen (Fig. 7, vessel A) and the second lumen (Fig. 7, Fig. 8, each staple 92 is expelled from receptacles 96 through the cuffed ends of vessels A, B to grooves 91; col. 6, Ins. 25-29; col. 6, Ins. 35-38; col. 9, Ins. 51-63), but fails to disclose a plurality of linear staples. Terumo discloses an anastomosis device (para. [0001]) and teaches a method (operation; para. [0061]-[0062]), comprising a plurality of linear staples (Fig. 3, needles 24). It would have been obvious to one of ordinary skill in the art at the time of the Invention to modify the method of Mallina to include the needles as taught by Terumo, in order to minimize space occupied by the staples, thereby maximizing a number of applied staples and thus maximizing anastomosis stability.
Regarding claims 21-23, Mallina discloses wherein the lumens are blood vessels (A, B; fig. 5; col. 1, lines 9-14); and, wherein the device is extravascular (i.e. used outside of the vascular system).
Claim(s) 2-3 and 12-13 is is/are rejected under 35 U.S.C. 103 as being unpatentable over Mallina (US 3,144,654) in view of Terumo (WO 2012/127888), as applied above in claim 1, and further in view of Drochner (2020/0205834).
Regarding claims 2 and 12, the modified invention of Mallina discloses the invention substantially as claimed comprising first and second bodies (52, 51) defining bottom and top surfaces (89, 82) surrounding first and second openings, as disclosed above, but fails to disclose wherein the first body defines a first gap connected to the first central opening to define a first open loop, wherein the second body defines a second gap connected to the second central opening to define a second open loop, and wherein the first and second gaps are configured so that after the anastomosis is formed the first lumen is removable from the first central opening through the first gap and the second lumen is removable from the second central opening through the second gap. Drochner discloses an anastomosis instrument comprising first and second bodies (110, 120; Fig. 1) defining bottom and top surfaces (Figs. 2A-2B) surrounding first and second openings (Figs. 2A, 2B), wherein the first body (110) defines a first gap (when pivoted) connected to the first central opening to define a first open loop (Fig. 5), wherein the second body defines a second gap connected to the second central opening to define a second open loop (Fig. 5), and wherein the first and second gaps are configured so that after the anastomosis is formed a first lumen is removable from the first central opening through the first gap and a second lumen is removable from the second central opening through the second gap for the purposes of facilitating removal of the fastened lumens avoiding damage to the lumens. It would have been obvious to one having ordinary skills in the art before the effective filing date of the claimed invention to have provided the modified invention of Mallina, further having gaps, as taught by Drochner, in order to facilitate removal of fastened lumens avoiding damage to the lumens.
Regarding claims 3 and 13, Mallina discloses wherein the first and second central openings are circular (Figs. 8 and 11).
Claim(s) 4-5 and 14-15 is is/are rejected under 35 U.S.C. 103 as being unpatentable over Mallina (US 3,144,654) in view of Terumo (WO 2012/127888), as applied above in claim 1, and further in view of Furukawa (JP2011206241A).
Regarding claims 4 and 14, the modified invention of Mallina discloses the device substantially as claimed, comprising first and second bodies configured to retain everted ends of lumens, but fails to disclose wherein the first body defines a first internal vacuum passage fluidically coupled to a plurality of first suction openings on the bottom surface configured to be coupled to a vacuum source in order to retain the everted end of the first lumen to the bottom surface, and wherein the second body defines a second internal vacuum passage fluidically coupled to a plurality of second suction openings on the top surface configured to be coupled to the vacuum source in order to retain the everted end of the second lumen to the top surface. Furukawa discloses an anastomosis instrument comprising first and second bodies (4, 21) with internal vacuum passage (6, 23) fluidically coupled to a plurality of first suction openings (7, 8, 30; Figs. 3 and 7) configured to be coupled to a vacuum source in order to retain everted ends of tissue during an anastomosis procedure. It would have been obvious to one having ordinary skills in the art before the effective filing date of the claimed invention to have provided the modified invention of Mallina, further comprising these features, as taught by Furukawa, in order retain tissue against the bodies surfaces and facilitating fastening of the tissue’ ends.
Regarding claims 5 and 15, Furukawa also discloses wherein the plurality of first suction openings (7, 8) are radially positioned around a first central opening (10a) on a bottom surface, and wherein the plurality of second suction openings (30; Fig. 7) are radially positioned around a second central opening (24a) on a top surface.
Claim(s) 6-7 and 16-17 is is/are rejected under 35 U.S.C. 103 as being unpatentable over Mallina (US 3,144,654) in view of Terumo (WO 2012/127888), as applied above in claim 1, and further in view of in view of Kayan (8,777,969).
Regarding claims 6 and 16, the modified invention of Mallina discloses linear staples (spikes 24 as taught by Terrumo), but fails to disclose wherein the linear staples each comprise a piercing end and a tail end on opposite sides of a longitudinal axis of the linear staple, and wherein the linear staples each further comprises a first set of barbs between the piercing end and the tail end, and a second set of barbs between the first set of bards and the tail end. Kayan discloses surgical fastener such as linear staples comprising a piercing end (14) and a tail end (16) on opposite sides of a longitudinal axis of the linear staple, and wherein each further comprises a first set of barbs (16) between the end and the tail, and a second set of barbs (28) between the first set of barbs and the tail end (Fig. 6) for the purposes of inhibiting the removal of the fastener once fastened into body tissue. It would have been obvious to one having ordinary skills in the art before the effective filing date of the claimed invention to have provided the modified invention of Mallina, further comprising staples as taught by Kayan in order to provide a fastener that is easy to apply and relatively difficult to remove after fastener into body tissue.
Regarding claims 7 and 17, the linear staples of Kayan are retain the everted end of the first lumen between the first set of barbs and the second set of barbs, and to retain the everted end of the second lumen between the second set of barbs and the tail end.
Allowable Subject Matter
Claims 8, 10, 18 and 20 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: The prior art does not disclose or make obvious the claimed combination including the following features:
Regarding claims 8 and 18, wherein the second body defines an internal pressurized air passage fluidically coupled to the plurality of staple dispensing cavities and configured to be coupled to a pressurized air source in order to pneumatically propel the staples out of the plurality of staple dispensing cavities toward the plurality of staple receiving cavities.
Regarding claims 10 and 20, a plurality of first magnets arranged around the first central opening, wherein the staple dispensing assembly comprises a plurality of second magnets arranged around the first central opening, and wherein the first and second magnets are arranged in order to be attracted and cause the plurality of staple dispensing cavities to be aligned with the plurality of staple receiving cavities.
The combinations of the claimed limitations are novel and found to be allowable over prior art. The cited references taken singly or in combination do not anticipate or make obvious the Applicant’s claimed invention.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHELLE LOPEZ whose telephone number is (571)272-4464. The examiner can normally be reached Monday thru Friday 8:30 am to 4:30 pm.
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/MICHELLE LOPEZ/ Primary Examiner, Art Unit 3731