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 6/3/2026, no claims have been cancelled, and Claims 1-20 are pending.
Amendments to claim 19 to address USC 112(b) issues has been acknowledged and the rejection has been withdrawn.
Response to Arguments
Applicant’s arguments with respect to claims 1, 8 and 16 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 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.
Claim 8-15 is 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 8 recites the limitation "a portion of the one or more fasteners" in line 3-4. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, examiner interprets this to mean “a portion of one or more fasteners”.
Claims 9-15 are rejected under USC 112(b) on the basis of being dependent on rejected claim 8.
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 1-2, 6-9, 14-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20060004394 Amarant.
Regarding claim 1, Amarant discloses a cartridge (12, Fig. 1) for an anastomotic coupler (abstract, paragraph 3, 11), the cartridge comprising:
a body (cartridge 12 has a physical body as seen in Fig. 1) operable to be received in a tubular structure (40/42, Fig. 4) extending along a longitudinal axis (paragraph 31); and
one or more fasteners (18, 20, Fig. 1) extending from the body at an angle from the longitudinal axis (as seen in Fig. 1, 4, fasteners 18, 20, extends from the body at a perpendicular angle), the one or more fasteners operable to puncture a wall of the tubular structure (paragraph 26-27, fasteners have barbs to grasp the tubular structure) so that at least a portion of the one or more fasteners are received by one or more receiving portions (32, Fig. 1) of a ring (24/26, Fig. 1) positioned external to the tubular structure (Fig. 4-5, paragraph 28-32).
Regarding claim 2, Amarant 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 18, 20 have a linear end as seen in Fig. 1).
Regarding claim 6, Amarant discloses the limitations of claim 1, and further discloses wherein at least a portion of the body has a diameter substantially the same as a diameter of a lumen of the tubular structure so that an outer radial surface abuts against the wall of the tubular structure to maintain the lumen through the tubular structure (as seen in Fig. 4-5, the body of the cartridge 12 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 7, Amarant discloses the limitations of claim 1, and further discloses wherein the body forms a body lumen to permit fluid to flow across the body (paragraph 27, cartridge 12 is a cylindrical hollow tubular conduit).
Regarding claim 8, Amarant discloses an anastomotic coupler (abstract, paragraph 3, 11), comprising:
a ring (24/26, Fig. 1) operable to receive a tubular structure (40/42, Fig. 4) extending along a longitudinal axis (paragraph 28-32), the ring including one or more receiving portions (32, Fig. 1) operable to receive at least a portion of one or more fasteners (18, 20, Fig. 1) (Fig. 4-5, paragraph 28-32); and
a cartridge (12, Fig. 1) operable to be received in the tubular structure (Fig. 4-5, paragraph 31), the cartridge including:
a body (cartridge 12 has a physical body as seen in Fig. 1) operable to be received in the tubular structure (Fig. 4-5, paragraph 31); and
one or more fasteners (18, 20, Fig. 1) extending from the body at an angle from the longitudinal axis (as seen in Fig. 1, 4, fasteners 18, 20, extends from the body at a perpendicular angle), the one or more fasteners (18, 20) operable to puncture a wall of the tubular structure (paragraph 26-27, fasteners have barbs to grasp the tubular structure) so that at least a portion of the one or more fasteners (18, 20) are received by the one or more receiving portions (32) of the ring (Fig. 4-5, paragraph 28-32).
Regarding claim 9, Amarant discloses the limitations of claim 8, and further discloses wherein the one or more fasteners each have an end that is linear, curved, bent, and/or hooked (fasteners 18, 20 have a linear end as seen in Fig. 1).
Regarding claim 14, Amarant discloses the limitations of claim 8, and further discloses wherein at least a portion of the body has a diameter substantially the same as a diameter of a lumen of the tubular structure so that an outer radial surface abuts against the wall of the tubular structure to maintain the lumen through the tubular structure (as seen in Fig. 4-5, the body of the cartridge 12 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 15, Amarant discloses the limitations of claim 8, and further discloses wherein the body forms a body lumen to permit fluid to flow across the body (paragraph 27, cartridge 12 is a cylindrical hollow tubular conduit).
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 3-5, 10-13 are rejected under 35 U.S.C. 103 as being unpatentable over Amarant in view of US 5478353 A Yoon.
Regarding claim 3, Amarant discloses the limitations of claim 1.
Amarant is silent on further including a sheath operable to receive the one or more fasteners such that the one or more fasteners are covered until the cartridge is positioned inside the tubular structure.
However, Yoon teaches an applicator for a suture tie device (abstract) that includes a sheath (11, Fig. 1-2, 5-9) operable to receive one or more fasteners (27, Fig. 1-4, 6-10) (seen in Fig. 1, 5-6, col. 4 line 29-33) such that the one or more fasteners are covered until the cartridge is positioned inside the tubular structure (as seen in Fig. 5-6, col. 4 line 46-51, col. 6 line 15-33, the sheath 11 covers the fasteners 27 of cartridge 12 until the cartridge is positioned inside the tubular structure (sheath 11 is dimensioned to allow passage through a cannula, for instance small blood vessels such as veins and arteries, or a portal sleeve)).
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 Yoon to further include a sheath operable to receive the one or more fasteners such that the one or more fasteners are covered until the cartridge is positioned inside the tubular structure, in order to protect the surrounding non targeted tissue from inadvertent damage from the fasteners.
Regarding claim 4, the combination of Amarant and Yoon teaches the limitations of claim 3, and Yoon teaches wherein when the one or more fasteners (27) are received in the sheath (11), the one or more fasteners (27) are substantially parallel to the longitudinal axis (as seen in Fig. 1, 5-6).
Regarding claim 5, the combination of Amarant and Yoon teaches the limitations of claim 3, and Yoon teaches wherein when the sheath (11) is removed to expose the one or more fasteners (27), the one or more fasteners (27) expand radially outward to be at an angle from the longitudinal axis (as seen in Fig. 6-8, col. 5 line 36-43, col. 6 line 35-43, 50-57).
Regarding claim 10, Amarant discloses the limitations of claim 8.
Amarant is silent on further including a sheath operable to receive the one or more fasteners such that the one or more fasteners are covered until the cartridge is positioned inside the tubular structure.
However, Yoon teaches an applicator for a suture tie device (abstract) that includes a sheath (11, Fig. 1-2, 5-9) operable to receive one or more fasteners (27, Fig. 1-4, 6-10) (seen in Fig. 1, 5-6, col. 4 line 29-33) such that the one or more fasteners are covered until the cartridge is positioned inside the tubular structure (as seen in Fig. 5-6, col. 4 line 46-51, col. 6 line 15-33, the sheath 11 covers the fasteners 27 of cartridge 12 until the cartridge is positioned inside the tubular structure (sheath 11 is dimensioned to allow passage through a cannula, for instance small blood vessels such as veins and arteries, or a portal sleeve)).
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 Byrum with the teachings of Yoon to further include a sheath operable to receive the one or more fasteners such that the one or more fasteners are covered until the cartridge is positioned inside the tubular structure, in order to protect the surrounding non targeted tissue from inadvertent damage from the fasteners.
Regarding claim 11, the combination of Amarant and Yoon teaches the limitations of claim 10, and Yoon teaches wherein when the one or more fasteners (27) are received in the sheath (11), the one or more fasteners (27) are substantially parallel to the longitudinal axis (as seen in Fig. 1, 5-6).
Regarding claim 12, the combination of Amarant and Yoon teaches the limitations of claim 10, and Yoon teaches wherein when the sheath (11) is removed to uncover the one or more fasteners (27), the one or more fasteners (27) expand radially outward to be at an angle from the longitudinal axis (as seen in Fig. 6-8, col. 5 line 36-43, col. 6 line 35-43, 50-57).
Regarding claim 13, the combination of Amarant and Yoon teaches the limitations of claim 10, and Yoon teaches further comprising a fixation device (10, Fig. 1-2, 5) operable to position the cartridge (12) in the tubular structure (col. 4 line 29-51, the fixation device 10 holds the cartridge 12 within the sheath 11 for positioning within the tubular structure), wherein upon actuation of the fixation device, the sheath (11) is removed (col. 6 line 38-49).
Claims 16, 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Amarant in view of US 20060149349 A1 Garbe.
Regarding claim 16, Amarant discloses a system comprising:
a first ring (84, Fig. 8) operable to receive a first tubular structure (81, Fig. 8) which extends along a first longitudinal axis (Fig. 8, paragraph 34), the first ring (84) including one or more receiving portions (first ring 84 has notches as seen in Fig. 8 that are similar to the notches 32 in an embodiment of ring 24/26 in Fig. 1);
a second ring (86, Fig. 8) operable to receive a second tubular structure (82, Fig. 8) which extends along a second longitudinal axis (Fig. 8, paragraph 34), the second ring (86) including one or more receiving portions (second ring 86 has notches as seen in Fig. 8 that are similar to the notches 32 in an embodiment of ring 24/26 in Fig. 1);
a first cartridge (78, Fig. 8) operable to be received in the first tubular structure (81) (Fig. 8), the first cartridge including:
a body (first cartridge 78 has a physical body as seen in Fig. 8); and
one or more fasteners (paragraph 34, the first cartridge 78 has barbs), the one or more fasteners operable to puncture a wall of the first tubular structure (81) (paragraph 26-27, 34, fasteners of the first cartridge 78 have barbs to grasp the tubular structure) so that at least a portion of the one or more fasteners are received by the one or more receiving portions of the first ring (84) (Fig. 8, paragraph 34);
a second cartridge (80, Fig. 8) operable to be received in the second tubular structure (82), the second cartridge including:
a body (second cartridge 80 has a physical body as seen in Fig. 8); and
one or more fasteners (paragraph 34, the second cartridge 80 has barbs), the one or more fasteners operable to puncture a wall of the second tubular structure (82) (paragraph 26-27, 34, fasteners of the second cartridge 80 have barbs to grasp the tubular structure) so that at least a portion of the one or more fasteners are received by the one or more receiving portions of the second ring (86) (Fig. 8, paragraph 34),
wherein the first ring (84) and the second ring (86) are coupled with one another (Fig. 8 shows first ring 84 and second ring 86 coupled with one another with springs 74, 75, 76, paragraph 34) to join the first tubular structure and the second tubular structure such that a lumen of the first tubular structure and a lumen of the second tubular structure are aligned in fluid communication with one another (Fig. 4-5, 8, paragraph 28-32, 34, the first tubular structure and second tubular structure are joined together to form a continuous lumen for fluid communication).
Amarant is silent on the one or more fasteners of the first cartridge and the second cartridge extending from the body at an angle from the first and second longitudinal axis.
However, Garbe teaches a system for anastomosis (abstract, paragraph 2, 10-11) that comprises a first cartridge (14-1, Fig. 4-5) and a second cartridge (14-2, Fig. 4-5) having one or more fasteners (22, 22’, Fig. 1a-b, 4-5) extending from the body at an angle from a first longitudinal axis of the first cartridge and a second longitudinal axis of the second cartridge (as seen in Fig. 1a-b, 4-5).
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 Garbe to have one or more fasteners of the first cartridge and second cartridge that extend from the body at an angle in order to perforate the tissue and to assure joining of the two parts as disclosed by Garbe (paragraph 36).
Regarding claim 18, the combination of Amarant and Garbe teaches the limitations of claim 16, and Amarant further discloses wherein at least a portion of the body of the first cartridge has a diameter substantially the same as a diameter of the lumen of the first tubular structure (the term “substantially” is a relative term that is not defined by the specification) so that an outer radial surface abuts against a wall of the first tubular structure to maintain the lumen through the first tubular structure (as seen in Fig. 8).
Regarding claim 19, the combination of Amarant and Garbe teaches the limitations of claim 16, and Amarant further discloses wherein at least a portion of the body of the second cartridge has a diameter substantially the same as a diameter of the lumen of the second tubular structure (the term “substantially” is a relative term that is not defined by the specification) so that an outer radial surface abuts against a wall of the second tubular structure to maintain the lumen through the second tubular structure (as seen in Fig. 8).
Regarding claim 20, the combination of Amarant and Garbe teaches the limitations of claim 16, and Amarant further discloses wherein the body of the first cartridge and/or the body of the second cartridge forms a body lumen to permit fluid to flow across the body (paragraph 25, 34, Fig. 8, the body of the first cartridge 78 and second cartridge 80 is a ring shape having a lumen to allow fluid to flow through in an end-to-end anastomosis).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Amarant in view of Garbe as applied to claim 16 above, and further in view of US 20080114385 Byrum et al. (hereinafter Byrum).
Regarding claim 17, the combination of Amarant and Garbe teaches the limitations of claim 16.
The combination is silent on wherein the first ring and the second ring create a seal to prevent fluid leakage.
However, Byrum teaches an anastomosis coupler (abstract) having a first ring (20, Fig. 14) and a second ring (21, Fig. 14) that create a seal to prevent fluid leakage (paragraph 54, 72, the rings 20, 21 may comprise an adhesive that cures to prevent leakage).
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 Garbe with the teachings of Byrum in order to provide a leak-free connection during anastomosis as disclosed by Byrum (paragraph 72).
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KHOA TAN LE whose telephone number is (703)756-1252. The examiner can normally be reached Monday - Friday 8am - 4:30pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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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/KHOA TAN LE/Examiner, Art Unit 3771 /MOHAMED G GABR/Primary Examiner, Art Unit 3771
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