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 .
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 5/14/26 is acknowledged.
Claims 29-35 and 41 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 5/14/26.
Drawings
The drawings have been received on 6/17/24 and these drawings have been objected to under 37 CFR 1.84 for the following reasons: lines, numbers and letters are not uniformly thick and well defined; and numbers and reference characters are not plain and legible for all figures.
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 4 and 15 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 4 discloses wherein the pins extend in a direction towards a distal end of the inner sleeve. However, claim 4 is dependent upon claim 2, wherein the projection pins already extend transverse to a longitudinal axis of the inner sleeve.
Claim 15 recites the limitation "the radially inward force" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
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.
Claim(s) 1, 2, 4, 6, 15, 27 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Richard et al. US 2004/0054405.
Regarding claim 1, Richard et al. discloses a prosthetic anastomosis fixation device (figures 1, 2 or 15) comprising: an inner sleeve (30 or 300) sized and configured to be received within a blood vessel of a patient (figure 2 or 15, within vessels 22, 24), the inner sleeve including a projection (detents 50, 51, figures 2-4 or 308, figure 15) extending from an outer surface of the inner sleeve (detents 50, 51, see annotated figure 2 below, or figure 15, see annotated figure 15 below) and a groove provide on the outer surface spaced apart from the projection (see annotated figures 2, 15 below); a fixation ring (strap 32 or 33, see annotated figure 2 below or strap 310, see annotated figure 16 below) removably received over the inner sleeve (paragraph 0039, strap or fixation ring may be disengaged by separating the projection from the channel, 310 shown removed figure 15); wherein engagement between the projection and the fixation ring couples the fixation ring to the inner sleeve (figures 2, 6, projection fits within the recess channel 78 of the ring, paragraph 0038, figure 16, pins 308 within recess of strap 310).
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Regarding claim 2, Richard et al. discloses wherein the projection includes pins extending from the outer surface of the inner sleeve in a direction transverse to a longitudinal axis of the inner sleeve (figure 2).
Regarding claim 4, Richard et al. discloses wherein the pins extends in a direction towards a distal end of the inner sleeve (for example, figures 2-4; pins 50 extend in a direction toward the distal end toward vessel 24, Examiner notes the pins 50 alternatively point toward the opposite direction and may be considered in either configuration).
Regarding claim 6, Richard et al. discloses wherein a height of the pins is less than a wall thickness of the fixation ring such that the pins extend through a portion of a wall thickness of the fixation ring (figure 2, pins 50 within recess of wall of strap 32).
Regarding claim 15, Richard et al. discloses wherein a radially inward force provided by the fixation ring creates a liquid-tight seal between the inner sleeve and the fixation ring (Examiner notes a force provided on the fixation ring may be configured to result in a liquid tight seal when placed with the vessels there between, as no additional space between may be present).
Regarding claim 27, Richard et al. discloses wherein the inner sleeve is coupled to a prosthetic device, wherein the prosthetic device comprises at least one an arterial segment, a venous segment, an atrium structure, a graft material, a prosthetic heart valve, a heart assist pump, an artificial heart (coupled to vascular prosthesis 22 or 24, figure 2, 15).
Claim(s) 1, 2, 4, 11 and 15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Johnson et al. US 2016/0206316.
Regarding claim 1, Johnson et al. discloses a prosthetic anastomosis fixation device (paragraph 0003) comprising: an inner sleeve 10 sized and configured to be received within a blood vessel of a patient (device for vascular anastomosis, paragraph 0002), the inner sleeve including a projection (barbs 26 or ribs 30, figure 4) extending from an outer surface of the inner sleeve (figure 4) and a groove provide on the outer surface spaced apart from the projection (for example, within at least two of the ribs 30); a fixation ring 14 removably received over the inner sleeve (paragraph 0022, locking ring 14 is pushed and snapped over ribs); wherein engagement between the projection and the fixation ring couples the fixation ring to the inner sleeve (paragraph 0022, locking ring 14 is pushed and snapped over ribs, teeth on fixation ring engage projections 30 to lock together).
Regarding claims 2 and 4, Johnson et al. discloses wherein the projection includes pins extending from the outer surface of the inner sleeve (figure 4) in a direction transverse to a longitudinal axis of the inner sleeve (for example, figures 4, 5 and 7) , where in the pins extends in a direction towards a distal end of the inner sleeve (for example, figures 4, 5 and 7, Examiner notes that depending on the configuration of inner sleeve, the barbs may be facing proximally or distally).
Regarding claim 11, Johnson et al. discloses wherein the projection is provided adjacent a proximal end of the inner sleeve and the groove is provided adjacent the distal end of the inner sleeve opposite from the projection (figure 4; projections on proximal end, groove in center, but can be considered adjacent the distal end of the inner sleeve opposite the projection), wherein the groove includes V-shaped groove (V-shape within ribs 30) defined by a shoulder and a tapered surface extending from an inner edge of the shoulder toward the proximal end of the inner sleeve (see annotated figure 4 below).
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Regarding claim 15, Johnson et al. discloses wherein the radially inward force provided by the fixation ring creates a liquid-tight seal between the inner sleeve and the fixation ring (paragraph 0022, locking or fixation ring is tightened enough to ensure there will be no leakage).
Claim(s) 1 and 11 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lee KR 2012/0018640.
Regarding claims 1 and 11, Lee discloses prosthetic anastomosis fixation device comprising: an inner sleeve 10 (see annotated figure 4 below) sized and configured to be received within a blood vessel of a patient (received within vessel, see annotated figure 4 below), the inner sleeve 10 including a projection 11 extending from an outer surface of the inner sleeve (figure 4) and a groove (groove 23 or can considered groove adjacent projections 12, figure 4) provide on the outer surface spaced apart from the projection 11 (figure 4); a fixation ring 20 removably received over the inner sleeve (figures 1-4); wherein engagement between the projection and the fixation ring couples the fixation ring to the inner sleeve (figure 4, projection 11 coupled with portion 21 of outer tube), wherein the projection is provided adjacent a proximal end of the inner sleeve (see annotated figure 4 below) and the groove is provided adjacent the distal end of the inner sleeve opposite from the projection (see annotated figure 4 below), wherein the groove includes V-shaped groove defined by a shoulder (see annotated figure 4 below , formed by protrusion 12) and a tapered surface extending from an inner edge of the shoulder toward the proximal end of the inner sleeve (see annotated figure 4 below , tapered side of protrusion toward the aperture 13 and proximal end).
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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) 2, 4, 6, 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lee KR 2012/0018640 in view of Wirtel, III US 2016/0074041.
Regarding claim 2, 4, 6 and 7, Lee discloses the device essentially including a coupling of the projection with the fixation ring (figure 4, 11a with 21a of outer fixation ring), as claimed but fails to disclose the projection includes pins extending from the outer surface of the inner sleeve in a direction transverse to a longitudinal axis of the inner sleeve, wherein the pins extend in a direction towards a distal end of the inner sleeve, wherein the height of the pins is less than a wall thickness of the fixation ring such that the pins extend through a portion of a wall thickness of the fixation ring, or wherein a height of the pins is greater than a wall thickness of the fixation ring such that the pins extend through an entire wall thickness of the fixation ring.
Wirtel, III discloses a first inner ring 2 and a second ring assembly 52 (figure 6B, paragraph 0187), the first and second rings may include a variety of coupling elements including a plurality of notches, protuberances or other coupling structures or means for coupling parts together.
It would have been an obvious matter of design choice to modify Lee with pins that extend transversely or toward the proximal end, and extending within or entirely through the fixation ring, to have to provide a coupling means, since applicant has not disclosed that having pins that extend in a particular direction or partially or entirely through the fixation rings solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either designs.
Furthermore, absent a teaching as to criticality that pins that extend in a particular direction or partially or entirely through the fixation rings for coupling the inner ring and fixation ring, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. In re Kuhle, 526 F.2d 553,555,188 USPQ 7, 9 (CCPA 1975).
Claim(s) 16 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lee KR 2012/0018640 in view of Walsh et al. US 4657019.
Regarding claims 16 and 19, Johnson et al. discloses wherein the fixation ring has an inner diameter less than an outer diameter of the inner sleeve, wherein the fixation ring transitions between a non-expanded diameter, when the fixation ring is not provided on the inner sleeve, and an expanded diameter when the fixation ring is provided on the inner sleeve, where the non-expanded diameter is less than the expanded diameter, wherein the fixation ring defines a discontinuous cylindrical body portion, wherein the fixation ring includes a gap extending through an entire thickness of the cylindrical body portion, wherein a width of the gap increases from a non-expanded configuration when the fixation ring is not provided on the inner sleeve to an expanded configuration when the fixation ring is provided on the inner sleeve.
Walsh et al. teaches an inner ring 1 (figures 1-4) and a fixation ring 4 (figures 1-4), the fixation ring has an inner diameter less than an outer diameter of the inner sleeve (for example, spring clips 14, figure 9A-9B, have an inner diameter placed within the groove, the outer diameter of inner sleeve 26 or 28 is larger than the inner diameter of ring 14), wherein the fixation ring transitions between a non-expanded diameter when the fixation ring is not provided on the inner sleeve and an expanded diameter when the fixation ring is provided on the inner sleeve, where the non-expanded diameter is less than the expanded diameter (spring clip is expanded to be placed and hold the vessel, depending upon the thickness of the vessel, the spring clip would provide a non-fully closed or larger diameter when placed upon the inner sleeve, figure 9B), , wherein the fixation ring defines a discontinuous cylindrical body portion (ring 14, figure 3), wherein the fixation ring includes a gap extending through an entire thickness of the cylindrical body portion (figure 3), wherein a width of the gap increases from a non-expanded configuration when the fixation ring is not provided on the inner sleeve to an expanded configuration when the fixation ring is provided on the inner sleeve spring clip is expanded to be placed and hold the vessel, depending upon the thickness of the vessel, the spring clip would provide a non-fully closed or larger diameter when placed upon the inner sleeve, figure 9B).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to provide a fixation ring has an inner diameter less than an outer diameter of the inner sleeve, wherein the fixation ring transitions between a non-expanded diameter, when the fixation ring is not provided on the inner sleeve, and an expanded diameter when the fixation ring is provided on the inner sleeve, where the non-expanded diameter is less than the expanded diameter, wherein the fixation ring defines a discontinuous cylindrical body portion, wherein the fixation ring includes a gap extending through an entire thickness of the cylindrical body portion, wherein a width of the gap increases from a non-expanded configuration when the fixation ring is not provided on the inner sleeve to an expanded configuration when the fixation ring is provided on the inner sleeve, as taught by Walsh et al., as a known substitute fixation ring in the art to provide a fixation ring easily to be split and expandable to easily be positioned over the inner ring while providing a spring to provide a tight seal around the inner ring and hold the vessel once in place.
Claim(s) 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lee KR 2012/0018640 in view of Nevill US 3818515.
Regarding claim 23, Lee discloses a device essentially as claimed, but fails to disclose wherein the fixation ring is constructed from a fabric tape or a felt tape.
Nevill teaches a device comprising an inner ring 14 comprising a locking groove 3 (for example, figure 3), and a fixation ring 2 being a dacron knitted sleeve or cuff, the fixation ring 2 adhesively attached to the inner ring within the groove and by an adhesive or tape (column 2, lines 23-28).
Therefore, it would have been obvious to one having ordinary skill in the art to provide a fabric or felt fixation ring being attached by tape or adhesive, as taught by Nevill, as a known substitute for binding a fixation ring to an inner ring. Further, it would have been an obvious matter of design choice to modify the Lee with a fabric tape fixation ring since applicant has not disclosed that having the fabric tape solves any stated problem or is for any particular purpose and it appears that the device would perform equally well for coupling with either designs, such as with compression or barbs.
Claim(s) 24 and 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lee KR 2012/0018640 in view of Lim et al. US 3774615.
Regarding claims 24 and 25, Lee discloses the device including a wherein the groove includes V-shaped groove defined by a shoulder and a tapered surface extending from an inner edge of the shoulder toward the proximal end of the inner sleeve essentially as claimed (see annotated figure 4 below).
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Lee fails to further including a ligature extending around the inner sleeve adjacent the groove, wherein the groove includes V-shaped groove defined by a shoulder and a tapered surface extending from an inner edge of the shoulder toward the proximal end of the inner sleeve, wherein the ligature is provided adjacent the groove between the shoulder and the tapered surface.
Lim et al. teaches an anastomosis device comprising an inner ring 1 (figure 1) and a fixation ring 4 (figure 1) and further discloses a ligature 4 adjacent a groove (column 4, lines 41-52; fastening means 4 may be ligatures; Examiner notes there are two devices 4, one of which may be considered the fastening ring), wherein the ligature is provided adjacent the groove between the shoulder and the tapered surface (Examiner notes the groove is not shown, column 4, lines 41-44; however, in combination with the grooves as disclosed in Lee, the combination reads on the claim limitations), the ligature being provided for extra support for locations with greater strain (column 5, lines 3-7).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Lee with a ligature adjacent the V-shaped groove, as taught by Lim et al. to provide additional fastening means when coupling organs in locations with additional strain.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINA C LAUER whose telephone number is (571)270-5418. The examiner can normally be reached Monday-Thursday 7:00 AM-4:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at (571) 272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHRISTINA C LAUER/ Examiner, Art Unit 3771
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