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 Objections
Claim 11 objected to because of the following informalities: In lines 1-2, “an thermoplastic” should read “a thermoplastic”. Appropriate correction is required.
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 1-5, 12, and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kassab et al. (US 2012/0191181).
Regarding claim 1, an invention relating to access systems, Kassab discloses (Figs. 23-25) a soft tissue access support device (2500) comprising: an elongated body (1810) extending along a longitudinal axis (see annotated figure below) between a distal end (710) and a proximal end (1820) and defining a first lumen (740) therein (Par. 0178); a sealing member (1830) coupled adjacent to the distal end of the elongated body, said sealing member structured to seal to a first surface of a pericardial tissue (Par. 0178 & 0180); a support tube (2510) extending along a longitudinal axis (see annotated figure below) between a distal end (2517) and a proximal end (2513) and defining a second lumen (2515) therein (Par. 0179), wherein the support tube is slidably arranged in the lumen of the elongated body between first and second sliding positions (Par. 0179 & 0184); a securement member (2520) coupled to the support tube and structured to engage at least a second opposing surface of the pericardial tissue (Par. 0188 & 0195); and a guidewire (1050, 1890) located in the second lumen of the support tube, said guidewire comprising a puncturing tip on a distal end of the guidewire structured to puncture the pericardial tissue (Par. 0182-0183).
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Regarding claim 2, Kassab discloses the soft tissue access support device of claim 1. Kassab further discloses wherein at least the distal end of the elongated body is steerable (Par. 0024 & 0150).
Regarding claim 3, Kassab discloses the soft tissue access support device of claim 1. Kassab further discloses wherein at least the distal end of the support tube is steerable (Par. 0219).
Regarding claim 4, Kassab discloses the soft tissue access support device of claim 1. Kassab further discloses (Fig. 23) wherein the securement member comprises an anchor (2520; Par. 0198).
Regarding claim 5, Kassab discloses the soft tissue access support device of claim 4. Kassab further discloses wherein the one or more anchors comprises an inflatable device (Par. 0179).
Regarding claim 12, Kassab discloses the soft tissue access support device of claim 1. Kassab further discloses (Fig. 23) wherein the sealing member is an O-ring (1830).
Regarding claim 15, Kassab discloses the soft tissue access support device of claim 1. Kassab discloses (Fig. 23) further comprising a dilator (3030) structured for insertion into the second lumen of the support tube and comprising a hole therethrough to receive the guidewire (Par. 0194, 0197, 0201).
Claims 1-4, 6, and 10-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Delgado et al. (US 2015/0142049).
Regarding claim 1, an invention relating to access systems, Delgado discloses (Figs. 125, 132, 134, 140, 142) a soft tissue access support device (1330) comprising: an elongated body (1200 & 1340) extending along a longitudinal axis (Par. 0304) between a distal end (1341) and a proximal end (1342) and defining a first lumen [i.e. inter-sheath lumen] therein (Par. 0318); a sealing member (1344) coupled adjacent to the distal end of the elongated body, said sealing member structured to seal to a first surface of a pericardial tissue (Par. 0321); a support tube (1406) extending along a longitudinal axis (Par. 0304) between a distal end (1421) and a proximal end (1423) and defining a second lumen [i.e. inside where element 1404 is crimped] therein (Par. 0310), wherein the support tube is slidably arranged in the lumen of the elongated body between first and second sliding positions (Par. 0330-0331); a securement member (1424 & 1404) coupled to the support tube and structured to engage at least a second opposing surface of the pericardial tissue (Par. 0331); and a guidewire [i.e. element 1410 and/or hypodermic needle] located in the second lumen of the support tube, said guidewire comprising a puncturing tip on a distal end of the guidewire structured to puncture the pericardial tissue (Par. 0330).
Regarding claim 2, Delgado discloses the soft tissue access support device of claim 1. Delgado further discloses wherein at least the distal end of the elongated body is steerable (Par. 0307).
Regarding claim 3, Delgado discloses the soft tissue access support device of claim 1. Delgado further discloses wherein at least the distal end of the support tube is steerable (Par. 0330).
Regarding claim 4, Delgado discloses the soft tissue access support device of claim 1. Delgado further discloses (Fig. 141) wherein the securement member comprises an anchor (1424; Par. 0312).
Regarding claim 6, Delgado discloses the soft tissue access support device of claim 4. Delgado further discloses (Fig. 141) wherein the one or more anchors comprises two or more reversibly collapsible-radially expanding shape-memory legs (1424; Par. 0312 & 0331).
Regarding claim 10, Delgado discloses the soft tissue access support device of claim 1. Delgado further discloses wherein the distal end of the elongated body comprises a plurality of tapered segments (1209) that coalesce and which are structured to expand outwardly away from each other upon contact with the support tube (Par. 0269 & 0317).
Regarding claim 11, Delgado discloses the soft tissue access support device of claim 1. Delgado further discloses wherein the sealing member is a thermoplastic or thermoset elastomeric, low compression set material [i.e. silicone] (Par. 0319).
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 1, 4 and 7-9 are rejected under 35 U.S.C. 103 as being unpatentable over Kassab et al. (US 2012/0191181) in view of Bonner et al. (US 2003/0093104).
Regarding claim 1, an invention relating to access systems, Kassab discloses (Figs. 23-25) a soft tissue access support device (2500) comprising: an elongated body (1810) extending along a longitudinal axis (see annotated figure below) between a distal end (710) and a proximal end (1820) and defining a first lumen (740) therein (Par. 0178); a sealing member (1830) coupled adjacent to the distal end of the elongated body, said sealing member structured to seal to a first surface of a pericardial tissue (Par. 0178 & 0180); a support tube (2510) extending along a longitudinal axis (see annotated figure below) between a distal end (2517) and a proximal end (2513) and defining a second lumen (2515) therein (Par. 0179), wherein the support tube is slidably arranged in the lumen of the elongated body between first and second sliding positions (Par. 0179 & 0184); and a guidewire (1050, 1890) located in the second lumen of the support tube, said guidewire comprising a puncturing tip on a distal end of the guidewire structured to puncture the pericardial tissue (Par. 0182-0183).
However, Kassab fails to disclose a securement member coupled to the support tube and structured to engage at least a second opposing surface of the pericardial tissue [Claim 1]; wherein the securement member comprises an anchor [Claim 4]; wherein the one or more anchors comprises a helical coil terminating in a tip structured to engage the pericardial tissue, and upon rotation, urge the anchor into the pericardial tissue [Claim 7]; wherein the helical coil of the securement member is structured to helically engage with both the first and the second surfaces of the pericardial tissue [Claim 8]; and wherein the support member is slidably received through the helical coil [Claim 9].
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In the same field of endeavor, which is access systems, Bonner teaches (Fig. 32) a securement member (904) coupled to a support tube (908) and structured to engage at least a second opposing surface of the pericardial tissue (Par. 0080-0082); wherein the securement member comprises an anchor (904); wherein the one or more anchors comprises a helical coil terminating in a tip structured to engage the pericardial tissue, and upon rotation, urge the anchor into the pericardial tissue (Par. 0080-0082); wherein the helical coil of the securement member is structured to helically engage with both the first and the second surfaces of the pericardial tissue (Par. 0080-0082); and wherein the support member is slidably received through the helical coil (Par. 0084).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kassab to have a securement member coupled to the support tube and structured to engage at least a second opposing surface of the pericardial tissue [Claim 1]; wherein the securement member comprises an anchor [Claim 4]; wherein the one or more anchors comprises a helical coil terminating in a tip structured to engage the pericardial tissue, and upon rotation, urge the anchor into the pericardial tissue [Claim 7]; wherein the helical coil of the securement member is structured to helically engage with both the first and the second surfaces of the pericardial tissue [Claim 8]; and wherein the support member is slidably received through the helical coil [Claim 9]. Doing so would provide an electrode lead which may be employed for detection of electrical signals from the heart or delivery of electrical stimulus pulses such as pacing pulses to the heart (Par. 0063 & 0080), as taught by Bonner.
Claims 13-14 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Kassab et al. (US 2012/0191181) as applied to claims 1 above, and further in view of Sterman et al. (US 6,325,067).
Regarding claims 13-14, Kassab discloses the soft tissue access support device of claim 1. However, Kassab fails to disclose further comprising a transection device coupled to a distal end of a catheter and structured for insertion into the second lumen of the support tube [Claim 13]; and wherein the transection device comprises a blade or an electrode or combination of a blade and an electrode [Claim 14].
In the same field of endeavor, which is access systems, Sterman teaches (Fig. 5) a transection device (44) coupled to a distal end of a catheter and structured for insertion into the second lumen of the support tube [i.e. trocar or sheath]; and wherein the transection device comprises a blade or an electrode or combination of a blade and an electrode (Col. 5, lines 65-67; Col. 8, lines 56-67; Col. 9, lines 1-20).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kassab to have a transection device coupled to a distal end of a catheter and structured for insertion into the second lumen of the support tube [Claim 13]; and wherein the transection device comprises a blade or an electrode or combination of a blade and an electrode [Claim 14]. Doing so would allow a coronary artery bypass graft procedure with arteries that are generally preferable since they tend to remain patent for long periods and require only one anastomosis (Col. 8, lines 1-17), as taught by Sterman.
Regarding claim 16, Kassab discloses the soft tissue access support device of claim 1. Kassab discloses (Fig. 23) further comprising: a dilator (3030) structured for insertion into the second lumen of the support tube, wherein the dilator comprises a body extending between opposing ends and having a body width that is greater than a width of a device (Par. 0194, 0197, 0201). However, Kassab fails to disclose a transection device coupled to a distal end of a catheter and structured for insertion into the second lumen of the support tube.
In the same field of endeavor, which is access devices, Sterman teaches (Fig. 5) a transection device coupled to a distal end of a catheter and structured for insertion into the second lumen of the support tube (Col. 5, lines 65-67; Col. 8, lines 56-67; Col. 9, lines 1-20).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kassab to have a transection device coupled to a distal end of a catheter and structured for insertion into the second lumen of the support tube. Doing so would allow a coronary artery bypass graft procedure with arteries that are generally preferable since they tend to remain patent for long periods and require only one anastomosis (Col. 8, lines 1-17), as taught by Sterman.
Claims 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Kassab et al. (US 2012/0191181) in view of Sterman et al. (US 6,325,067) and Bonner et al. (US 2003/0093104).
Regarding claim 17, an invention relating to access systems, Kassab discloses (Figs. 23-25) a soft tissue access support device (2500) comprising: an elongated body (1810) extending along a longitudinal axis (see annotated figure below) between a distal end (710) and a proximal end (1820) and defining a first lumen (740) therein (Par. 0178); a sealing member (1830) coupled to the distal end of the elongated body, said sealing member structured to seal to a first surface of a pericardial tissue (Par. 0178 & 0180); a support tube (2510) extending along a longitudinal axis (see annotated figure below) between a distal end (2517) and a proximal end (2513) and defining a second lumen (2515) therein (Par. 0179), wherein the support tube is slidably arranged in the lumen of the elongated body between first and second sliding positions (Par. 0179 & 0184); a guidewire (1050, 1890) located in the second lumen of the support tube, said guidewire comprising a puncturing tip on a distal end of the guidewire structured to puncture the pericardial tissue (Par. 0182-0183); and a dilator (3030) structured for insertion into the second lumen of the support tube, wherein the dilator comprises a body extending between opposing ends and having a body width that is greater than a width of a device (Par. 0194, 0197, 0207). However, Kassab fails to disclose a transection device coupled to a distal end of a catheter and structured for insertion into the second lumen of the support tube; and a securement member coupled to the support tube and structured to engage a second opposing surface of the pericardial tissue [Claim 17]; wherein the securement member comprises a helical coil terminating in a tip structured to engage the pericardial tissue, and upon rotation, urge the anchor into the pericardial tissue, wherein the helical coil of the securement member is structured to helically engage with both the first and the second surfaces of the pericardial tissue [Claim 19]; and wherein the support member is slidably received through the helical coil [Claim 20].
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In the same field of endeavor, which is access systems, Sterman teaches (Fig. 5) a transection device (44) coupled to a distal end of a catheter and structured for insertion into the second lumen of the support tube [i.e. trocar or sheath] (Col. 5, lines 65-67; Col. 8, lines 56-67; Col. 9, lines 1-20).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kassab to have a transection device coupled to a distal end of a catheter and structured for insertion into the second lumen of the support tube. Doing so would allow a coronary artery bypass graft procedure with arteries that are generally preferable since they tend to remain patent for long periods and require only one anastomosis (Col. 8, lines 1-17), as taught by Sterman.
In the same field of endeavor, which is access systems, Bonner discloses a securement member (904) coupled to a support tube (908) and structured to engage a second opposing surface of the pericardial tissue (Par. 0081); wherein the securement member comprises a helical coil terminating in a tip structured to engage the pericardial tissue, and upon rotation, urge the anchor into the pericardial tissue, wherein the helical coil of the securement member is structured to helically engage with both the first and the second surfaces of the pericardial tissue (Par. 0080-0082); and wherein the support member is slidably received through the helical coil (Par. 0084).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kassab to have a securement member coupled to a support tube and structured to engage a second opposing surface of the pericardial tissue; wherein the securement member comprises a helical coil terminating in a tip structured to engage the pericardial tissue, and upon rotation, urge the anchor into the pericardial tissue, wherein the helical coil of the securement member is structured to helically engage with both the first and the second surfaces of the pericardial tissue; and wherein the support member is slidably received through the helical coil. Doing so would provide an electrode lead which may be employed for detection of electrical signals from the heart or delivery of electrical stimulus pulses such as pacing pulses to the heart (Par. 0063 & 0080), as taught by Bonner.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Examiner Chima Igboko whose telephone number is (571)272-8422. The examiner can normally be reached on Monday-Friday 9:00am-6:00pm.
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Jackie Ho, 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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/C.U.I/ Examiner, Art Unit 3771
/ASHLEY L FISHBACK/Primary Examiner, Art Unit 3771 February 14, 2026