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 Arguments
Applicant’s arguments with respect to claim(s) 17-30 have been considered but are moot because the new ground of rejection over Reddy US 2018/0133463 in view of To et al. US 2011/0087257 in view of Reddy US 2017/0021159 (hereafter Reddy ‘159).
Applicant argues the prior art fails to disclose wherein the needle is in a first straight inserting configuration and a second angled configuration.
However, To et al. teaches cannula configured to be transitioned between a first straight configuration for insertion into a target space of a patient and a second curved configuration in which at least a distal end portion of the needle is at an angle (for example, paragraph 0178, 0203, figures 29A-C or 31A-31C; cannula, 2910 or 3100 is straight when introduced and curved once straight stylet 2920 or 3120 is removed); an introducer configured to removably engage the needle to maintain the needle in the first configuration during insertion of the needle into the substernal space being a straight stylet (2920 or 3120) removably disposed in the lumen (paragraph 1078, figures 29A-C, stylet 2920, figures 31A, 31B, stylet 3120), configured to selectively maintain the cannula in the first configuration when disposed in the cannula lumen during insertion into the target space (for example, figure 31A, straightening stylet is inserted forming a straight insertion configuration), the transitioning includes the introducer configured to be removed or by withdrawing from the cannula lumen after insertion to allow the needle to transition to the second configuration to facilitate a biasing of at least the distal end portion of the needle toward the posterior sternal wall (paragraph 0178, figures 29A-C, paragraph 0203, figures 31A-31B), wherein the introducer is configured to removably engage the cannula to straighten a bend along a length of the needle (figures 29A-C, 31A-31B), wherein the needle in the second configuration is biased at an angle (figures 29A-C, paragraph 0178, paragraph 0203, figure 31B), the cannula-stylet assembly and straight stylet 3120 to enhance responsiveness and maneuverability while penetrating the patient’s skin, muscle, and body tissues, allowing for closer placement and more direct path (paragraph 0203), the cannula, once the stylet is removed, bends toward the desired target location.
Applicant argues the prior art fails to disclose the needle in a first configuration being straight and a second configuration being biased at an angle toward a posterior sternal wall of the patient and away from the heart, the distal end of the needle disposed in a predetermined position proximate a sternal angle of the patent.
However, Reddy ‘159 teaches a method for delivering a lead of an implantable device a distal end portion of the shaft 304 is biased at an angle toward a posterior sternal wall 312 of the patient and away from a heart 314 of the patient (paragraph 0005, 0013, figure 8B, insertion sheath near the xiphoid and beneath the sternum, biased curve back toward the sternum, passing a cannula through the sheath such that the cannula is also biased toward the sternum); inserting the device in a predetermined position proximate a sternal angle of the patient (paragraph 0012, device may be inserted in a variety of desired locations, consisting approximately at the sternal angle between the second and third ribs).
Therefore, the amendment fails to overcome the prior art, as further discussed below.
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) 17-30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Reddy US 2018/0133463 in view of To et al. US 2011/0087257 in view of Reddy US 2017/0021159 (hereafter Reddy ‘159).
Regarding claims 17, 20, 21, 22, 24, 27, 28 and 29, Reddy discloses a method for delivering a lead of an implantable device (paragraph 0004, lead for an implantable cardiac device may be implanted), the method comprising: inserting a needle 1066 into a substernal space of a patient in a first configuration (figure 22, paragraph 0045, 0105, 0135; 0146; procedure may include a xiphoid or sub-xiphoid incision and allow for tunneling along the back side of the sternum or other positions, creating a puncture with a needle or trocar, needle 1066 inserted into target location 1064 for anchoring a lead beneath the rib cage) advancing, while the needle is in a second configuration (paragraph 0077, once inserted at the desired location through intercostal space), a guidewire through a needle lumen of the needle such that a distal end portion of the guidewire is disposed beyond a distal end of the needle in the substernal space (paragraph 0077, 0105, 0106; needle inserted at the desired location through intercostal space, a guidewire can be passed through the needle and into the mediastinal space or target location 1064, figure 22); removing the needle from the guidewire while the guidewire remains in the substernal space (paragraph 0107); advancing, over the guidewire delivered via a needle lumen of the needle, a sheath 1074 to place the distal end of the sheath in a desired position, such that a distal end portion of the sheath is disposed in the substernal space (paragraph 0106, 0107, figure 25); advancing a lead 1080 through a sheath lumen of the sheath 1074 such that at least a portion of the lead is disposed in the substernal space (figure 25, paragraph 0106, 0108, lead and electrode structure of 32B may be delivered using needle 1066); and withdrawing or removing the sheath from the patient while at least the portion of the lead remains in the substernal space (paragraph 0110, guidewire and sheaths removed after placement of the lead). Examiner notes Reddy discloses the implant procedure may include a xiphoid or sub-xiphoid incision that allows for tunneling along the back side of the sternum, for example, paragraphs 0135, 0146), positioning and spacing may be adjusted or reconfigured to be optimized for a particular procedure (paragraph 0135, 140, 146).
Reddy fails to explicitly disclose the needle first configuration is straight, transitioning the needle from the first configuration to a second configuration such that at least a distal end portion of the needle is biased at an angle toward a posterior sternal wall of the patient and away from a heart of the patient; the guidewire extending through the needle lumen of the needle disposed in a predetermined position proximate a sternal angle of the patient, and at least a portion of the lead is in contact with the posterior sternal wall, an introducer configured to removably engage the needle to maintain the needle in the first configuration during insertion of the needle into the substernal space, the introducer is a straight stylet configured to straighten the portion of the needle when disposed in the needle lumen, and the transitioning the needle includes manipulating the introducer by withdrawing the stylet from the needle lumen or rotating the stylet while the stylet is in the needle lumen to facilitate a biasing of at least the distal end portion of the needle toward the posterior sternal wall to allow the needle to transition from the first configuration to the second configuration, or explicitly positioning the lead such that a first portion of the lead is disposed in the substernal space and in contact with the posterior sternal wall and a second portion of the lead is disposed in the substernal space and in contact with a pericardium of a heart of the patient.
To et al. teaches a cannula configured to be transitioned between a first straight configuration for insertion into a target space of a patient and a second curved configuration in which at least a distal end portion of the needle is at an angle (for example, paragraph 0178, 0203, figures 29A-C or 31A-31C; cannula, 2910 or 3100 is straight when introduced and curved once straight stylet 2920 or 3120 is removed); an introducer configured to removably engage the needle to maintain the needle in the first configuration during insertion of the needle into the substernal space being a straight stylet (2920 or 3120) removably disposed in the lumen (paragraph 1078, figures 29A-C, stylet 2920, figures 31A, 31B, stylet 3120), configured to selectively maintain the cannula in the first configuration when disposed in the cannula lumen during insertion into the target space (for example, figure 31A, straightening stylet is inserted forming a straight insertion configuration), the transitioning includes the introducer configured to be removed or by withdrawing from the cannula lumen after insertion to allow the needle to transition to the second configuration to facilitate a biasing of at least the distal end portion of the needle toward the posterior sternal wall (paragraph 0178, figures 29A-C, paragraph 0203, figures 31A-31B), wherein the introducer is configured to removably engage the cannula to straighten a bend along a length of the needle (figures 29A-C, 31A-31B), wherein the needle in the second configuration is biased at an angle (figures 29A-C, paragraph 0178, paragraph 0203, figure 31B), the cannula-stylet assembly and straight stylet 3120 to enhance responsiveness and maneuverability while penetrating the patient’s skin, muscle, and body tissues, allowing for closer placement and more direct path (paragraph 0203), the cannula, once the stylet is removed, bends toward the desired target location.
Reddy ‘159 teaches a method for delivering a lead of an implantable device a distal end portion of the shaft 304 is biased at an angle toward a posterior sternal wall 312 of the patient and away from a heart 314 of the patient (paragraph 0005, 0013, figure 8B, insertion sheath near the xiphoid and beneath the sternum, biased curve back toward the sternum, passing a cannula through the sheath such that the cannula is also biased toward the sternum); inserting the device in a predetermined position proximate a sternal angle of the patient (paragraph 0012, device may be inserted in a variety of desired locations, consisting approximately at the sternal angle between the second and third ribs), and at least a portion of the lead is in contact with the posterior sternal wall (paragraph 0006, 0010, 0018, 0035, figure 16, cardiac lead 330 on the back side of the sternum, placing an anchor adjacent the posterior of the sternum connecting a tension element 326, the lead using the tension element thereon to a desired location at the sternum anchor 324, anchoring a lead may be desirable in the region of the sternal angle at the junction of the manubrium and the sternal body, lead at least partially inContact with the sternal wall, figure 16), and a second portion of the lead is disposed in the substernal space and in contact with a pericardium of a heart of the patient (figure 16, at least a portion of lead 330 placed anterior or in contact to the pericardium).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Reddy with the needle first configuration is straight, transitioning the needle from the first configuration to a second configuration, as taught by To, to enhance responsiveness and maneuverability while penetrating the patient’s skin, muscle, and body tissues, allowing for closer placement and more direct path, and the distal end portion of the needle is biased at an angle toward a posterior sternal wall of the patient and away from a heart of the patient; the guidewire extending through the needle lumen of the needle disposed in a predetermined position proximate a sternal angle of the patient, and at least a portion of the lead is in contact with the posterior sternal wall, as taught by Reddy ‘159, as a known method of inserting a lead proximate a sternal angle of the patient and facing the sternal wall, the lead being in contact with the posterior sternal wall with the implanted anchor and the pericardium of the heart, as may be adjusted or reconfigured to be optimized for a particular procedure.
Regarding claims 18 and 30, Reddy discloses removing the guidewire from the sheath, prior to advancing the lead, while the distal end portion of the sheath remains in the substernal space (paragraph 192, guidewire removed after placement of sheath to allow introduction of the lead).
Regarding claims 19 and 26, Reddy discloses wherein the sheath includes a dilator, the method further comprising: withdrawing the dilator after advancing the sheath over the guidewire and prior to advancing the lead through the sheath lumen (paragraph 192, dilator removed after placement of sheath to allow introduction of the lead).
Regarding claims 23 and 25, Reddy discloses wherein the implantable device is an implantable cardioverter defibrillator (paragraph 0002, 0134, 0209, implantable defibrillator, cardiac rhythm management system), the first portion of the lead includes at least one coil capable of delivering high voltage shocks to defibrillate the heart of the patient and the second portion of the lead includes at least one pacing electrode configured to deliver low voltage shocks to pace the heart of the patient (paragraph 0053, 0055, electrodes may be used for therapy delivery, and post shock pacing therapy).
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 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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/CHRISTINA C LAUER/Examiner, Art Unit 3771
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