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
The Amendment filed 05/15/26 has been entered. Claims 1, 8-9, 11, 17, and 20 have been amended, claims 4-7 and 19 have been cancelled, and new claim 21 has been entered. Claims 1-3, 8-18, and 20-21 are addressed in the following office action.
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 21 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Delgado et al. (US 2015/0142049).
Regarding claim 21, 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 and movable between first and second sliding positions (Par. 0330-0331); a securement member (1404 & 1424) coupled to the support tube and structured to engage at least a second opposing surface of the pericardial tissue (Par. 0331), the securement member having at least one anchor comprising two or more reversibly collapsible-radially expanding shape-memory legs (1424), wherein the legs are deployable by sliding the support tube relative to the elongated body to expand the legs such that the legs extend distally through an opening in the pericardial tissue and into contact with the second opposing surface surrounding the opening, and wherein the legs are retractable away from the second opposing surface, proximally through the opening, and into the support tube to allow removal of the soft tissue support device from the pericardial tissue (Par. 0312, 0314, 0331, 0334); 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).
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 1-3, 8-9, 12, and 15 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), both cited in previous office action.
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 first lumen of the elongated body and movable 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 the first surface and a second opposing surface of the pericardial tissue, the securement member having an anchor comprising a helical coil terminating in a tip, wherein the helical coil is rotatable to urge the anchor into the pericardial tissue.
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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 the first surface and a second opposing surface of the pericardial tissue (Par. 0080-0082); wherein the securement member having an anchor (904) comprising a helical coil terminating in a tip [i.e. distal end], wherein the helical coil is rotatable to urge the anchor into the pericardial tissue [i.e. screwed] (Par. 0081-0082).
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 the first surface and a second opposing surface of the pericardial tissue, the securement member having an anchor comprising a helical coil terminating in a tip, wherein the helical coil is rotatable to urge the anchor into the pericardial tissue. 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.
Regarding claim 2, Kassab, as modified by Bonner, 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, as modified by Bonner, 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 8, Kassab, as modified by Bonner, discloses 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 [i.e. screwed, see Bonner paragraph 0082].
Regarding claim 9, Kassab, as modified by Bonner, discloses wherein the support member tube is slidably received through the helical coil [i.e. dilator advanced through, see Bonner figure 32 and paragraph 0084].
Regarding claim 12, Kassab, as modified by Bonner, 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, as modified by Bonner, 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 13-14 and 16 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) as applied to claims 1 above, and further in view of Sterman et al. (US 6,325,067), cited in previous office action.
Regarding claims 13-14, Kassab, as modified by Bonner, 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, in view of Bonner, 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, as modified by Bonner, 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, in view of Bonner, 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 1-3 and 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Delgado et al. (US 2015/0142049), cited in previous office action.
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 (1408) extending along a longitudinal axis between a distal end (1426) and a proximal end (1428) and defining a second lumen (1429) therein, wherein the support tube is slidably arranged in the lumen of the elongated body and movable between first and second sliding positions (Figs. 140 & 144; Par. 0304-0305); 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). However, Delgado fails to disclose a securement member coupled to the support tube and structured to engage at least the first surface and a second opposing surface of the pericardial tissue, the securement member having an anchor comprising a helical coil terminating in a tip, wherein the helical coil is rotatable to urge the anchor into the pericardial tissue.
In an alternate embodiment, Delgado teaches (Figs. 21A-B) a securement member (432) coupled to a support tube [i.e. nosecone 430 of the dilator 400] and structured to engage at least the first surface and a second opposing surface of the pericardial tissue, the securement member having an anchor comprising a helical coil terminating in a tip (see annotated figure below), wherein the helical coil is rotatable to urge the anchor into the pericardial tissue (Par. 0146).
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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 Delgado to have a securement member coupled to the support tube and structured to engage at least the first surface and a second opposing surface of the pericardial tissue, the securement member having an anchor comprising a helical coil terminating in a tip, wherein the helical coil is rotatable to urge the anchor into the pericardial tissue. Doing so would reduce and/or prevent tearing of the vessel wall as the aperture in the sidewall is expanded (Par. 0146).
Regarding claim 2, Delgado, as modified by an alternate embodiment of 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, as modified by an alternate embodiment of 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, as modified by an alternate embodiment of 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 10, Delgado, as modified by an alternate embodiment of 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, as modified by an alternate embodiment of 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).
Claims 17-18 and 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), all cited in the previous office action.
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 first lumen of the elongated body and movable 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). Also, Kassab discloses wherein at least the distal end of the support tube is steerable [Claim 18] (Par. 0219).
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 first surface and a second opposing surface of the pericardial tissue, the securement member having an anchor comprising a helical coil terminating in a tip, wherein the helical coil is rotatable to urge the anchor into the pericardial tissue [Claim 17]; and wherein the support tube 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 (Fig. 32) a securement member (904) coupled to a support tube (908) and structured to engage a second opposing surface of the pericardial tissue (Par. 0081); the securement member having an anchor (904) comprising a helical coil terminating in a tip [i.e. distal end], wherein the helical coil is rotatable to urge the anchor into the pericardial tissue [i.e. screwed] (Par. 0081-0082); and wherein the support tube 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 a first surface and a second opposing surface of the pericardial tissue, the securement member having an anchor comprising a helical coil terminating in a tip, wherein the helical coil is rotatable to urge the anchor into the pericardial tissue [Claim 17]; and wherein the support tube is slidably received through the helical coil [Claim 20]. 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.
Response to Arguments
Applicant’s arguments, see page 9, filed 05/15/26, with respect to claim 11 have been fully considered and are persuasive. The objection of claim 11 has been withdrawn.
Applicant's arguments pertaining to independent claims 1 and 17 have been fully considered but they are not persuasive. Applicant argues one of ordinary skill in the art seeking to modify Kassab would not have been motivated to adopt Bonner's helical coil because the rotating action required to secure the helical coil in the tissue would make maintaining an airtight seal for applying suction much more difficult. Examiner respectfully disagrees.
Applicant presents no evidence that the helical coil rotating would compromise the airtight seal for applying suction, so the argument only amounts to an assertion. Also, previously cited prior art references Kassab and Bonner do not teach against using a helical coil as an anchor instead of a balloon. Furthermore, Kassab discloses in paragraph 0188 that “Method 2600, in at least one embodiment and as shown in FIG. 26, may further comprise the steps of engaging the targeted tissue using skirt 1830 of engagement catheter 1810 by applying a vacuum to the engagement catheter 1810 (an exemplary tissue engagement step 2620), and piercing the targeted tissue using needle 1890 to create a tissue aperture (an exemplary piercing step 2630)”, and in paragraph 0190 that “After completion of various procedures, balloon 2520 may be deflated so that inducer sheath 2510 may be withdrawn, and vacuum may be stopped so that skirt 1830 disengages the targeted tissue to allow withdrawal of engagement catheter 1810 from the body”. Hence, Kassab’s airtight seal from applying suction would not be compromised by piercing tissue.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 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
/KATHLEEN S HOLWERDA/Primary Examiner, Art Unit 3771
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