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
Claims 39, 59, and 61 have been amended. Claims 39-44, 46-48, 50-54, 56-57, and 59-62 remain pending.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 39-44, 46-48, 50-54, 56-57, and 61-62 is/are rejected under 35 U.S.C. 103 as being unpatentable over Verma et al. (US 20200330112, henceforth Verma) in view of Starksen et al. (US 20050119523, henceforth Starksen).
Regarding claim 39, Verma discloses a method comprising: advancing an elongate medical instrument (lead as in [0002], which is elongated object 12, fig. 2) through vasculature of a body of a subject ([0002] and fig. 2); advancing a probe (vascular snare system 10, fig. 2) through the vasculature ([0002]) and positioning a distal longitudinal probe-portion of the probe (see annotated fig. 2 calling out the distal longitudinal probe-portion of vascular snare system 10) at least partially alongside a distal longitudinal medical-instrument-portion of the elongate medical instrument (see annotated fig. 3 calling out the distal longitudinal medical-instrument-portion of elongated object 12); thereafter, mechanically coupling the distal longitudinal probe-portion to the distal longitudinal medical-instrument-portion within the body (see figs. 2 and 4); and thereafter, using the probe to bend the elongate medical instrument within the body (see fig. 4, retraction of elements 30 causes a bending of elongated object 12). Verma additionally discloses that “The system 10 may be utilized to extract any elongated object 12 from the vasculature of a patient”, and that “The system 10 may also be used to extract any other type of foreign object, such as an inferior vena cava filter, having a hook or similar element that can be snared by a loop” ([0029]). Verma additionally discloses that the leads which it is configured for extracting can be pacing leads (Abstract).
Verma does not disclose the method comprising using the probe to navigate the elongate medical instrument through the vasculature to a targeted anatomical location within the body; and thereafter, performing a therapeutic or diagnostic procedure at the targeted anatomical location using the elongate medical instrument. Starksen teaches delivery and removal of devices to target anatomical areas of the heart (see [0015], [0016], and [0047]) where the devices can include pacemaker leads (see Abstract, [0010]) or cardiac ablation probes (see at least Abstract, [0016], and [0033]), and where delivery of cardiac ablation probes includes the use of the probes after they have been properly positioned (see at least [0016], [0026], and [0033], positioning is done to allow ablation procedures to occur at the desired locations).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used the system of Verma to have grabbed, moved, and delivered a cardiac ablation probe as its elongated object as Verma discloses that it is capable of grabbing such an elongated object ([0029]) and because Starksen teaches that medical devices meant to be used in the heart with pacemaker leads can also be used with cardiac ablation probes (see at least [0016] and [0033]).
{All subsequent references are to Verma unless otherwise specified.}
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Annotated fig. 3 from Verma calling out the claimed portions
Regarding claim 40, Verma as modified discloses the method of claim 39, wherein the distal longitudinal probe- portion includes one or more loops (first and second deployable elements 30a and 30b, fig. 4, which are considered to be loops as claimed because Merriam-Webster defines a loop to be “a curving or doubling of a line so as to form a closed or partly open curve within itself through which another line can be passed or into which a hook may be hooked”, and the curved segments of deployment elements 30 meet this definition as they are curved lines which form a partly open curve through which another line, such as elongated object 12, can be hooked), and wherein mechanically coupling comprises looping the one or more loops around the distal longitudinal medical-instrument-portion (see fig. 2, deployable elements 30 are connected and looped around the distal longitudinal medical-instrument-portion of elongated object 12).
Regarding claim 41, Verma as modified discloses the method of claim 40, wherein looping the one or more loops around the distal longitudinal medical-instrument-portion comprises: passing the one or more loops over the distal end of the distal longitudinal medical-instrument-portion (see fig. 2 and see [0032], the manipulation of deployment elements 30 is a passing over as claimed because it involves the ends of the deployable elements moving past and around object 12); and thereafter, proximally withdrawing the distal longitudinal probe-portion (see [0035], elements 30 are proximally withdrawn through sheath 22 after magnets 32 and 34 are coupled in the body), such that the one or more loops are positioned around the distal longitudinal medical-instrument-portion (see fig. 4 which shows element 30b being positioned around the distal longitudinal medical-instrument-portion of object 12).
Regarding claim 42, Verma as modified discloses the method of claim 40, wherein the distal longitudinal probe- portion includes two or more loops (see fig. 2, there are 2 loops which are deployment element 30a and 30b; these are each considered to be loops where they are used to form a loop), and wherein mechanically coupling comprises looping the two or more loops around the distal longitudinal medical-instrument-portion (see fig. 2, the deployment elements 30 each have to be initially manipulated to be looped around the elongated object 12; see also [0032] and [0035]).
Regarding claim 43, Verma as modified discloses the method of claim 40, wherein mechanically coupling the distal longitudinal probe-portion to the distal longitudinal medical-instrument-portion comprises tightening the one or more loops around the distal longitudinal medical-instrument-portion (see [0035], the coupling including the tightening of loops occurs when the deployment elements are proximally retracted) after looping the one or more loops around the distal longitudinal medical-instrument-portion (see [0032] and [0035]).
Regarding claim 44, Verma as modified discloses the method of claim 40, wherein advancing the probe through the vasculature comprises advancing the probe through the vasculature (see [0031], the system should be inserted into an access site and advanced to within close proximity to object 12 within the vasculature) while the one or more loops are in a non-radially-extended configuration (see [0031], the deployment elements are kept in sheath 22 while the sheath 22 is advanced intravascularly in the chosen method of use), and wherein mechanically coupling the distal longitudinal probe-portion to the distal longitudinal medical-instrument-portion comprises transitioning the one or more loops to a radially-extended configuration (see [0031] and [0032], the coupling requires deployment elements 30 to be advanced until they protrude out of sheath 22, which is a transitioning to a radially extended configuration as claimed).
Regarding claim 46, Verma as modified discloses the method of claim 44, wherein the one or more loops are retracted against the probe when in the non-radially-extended configuration (see [0031], deployment elements are considered to be retracted against sheath 22 of system 10 when they are held inside of it during advancing through vasculature since they are not extended and would be in direct contact with the wall of sheath 22 inside of lumen 24).
Regarding claim 47, Verma as modified discloses the method of claim 44, wherein transitioning the one or more loops to the radially-extended configuration comprises using one or more control wires (cables 50 and 62, see [0040], [0041], and fig. 7) that pass along the probe (see [0040] and [0041], cables 50 and 62 pass inside of lumens of deployment elements 30 which are a part of system 10 and thus pass along the system as claimed) to transition the one or more loops to the radially-extended configuration (see [0038], handles 44 and cables 50 and 62 are used for the manipulation of deployment elements 30 which are the claimed loops to move elements 30 into the desired configurations).
Regarding claim 48, Verma as modified discloses the method of claim 44, wherein transitioning the one or more loops to the radially-extended configuration comprises pivoting the one or more loops with respect to an external surface of the probe (see [0038], manipulation of the deployment elements 30 into the proper configuration for snaring elongated object 12 includes rotation of the elements 30, which is a pivoting of elements 30, and this rotation would occur with respect to an exterior surface of sheath 22 as claimed).
Regarding claim 50, Verma as modified discloses the method of claim 39, wherein advancing the elongate medical instrument through the vasculature comprises advancing the elongate medical instrument through the vasculature along a first route through the vasculature (see fig. 2, elongated object 12 is shown as having been moved through the heart along a first route), and wherein advancing the probe through the vasculature comprises advancing the probe through the vasculature along a second route through the vasculature (see fig. 2, system 10 is shown as having been moved through the heart along a second route), the second route different from the first route (see fig. 2, the system 10 and object 12 are shown as having been moved along different routes and meeting at a point within the heart from different directions).
Regarding claim 51, Verma as modified discloses the method of claim 39, wherein the probe includes a steerability-providing mechanism (the combination of handles 44 and cables 50 and 62 make up a steerability-providing mechanism as claimed, see at least [0045] and fig. 7), and wherein using the probe to bend the elongate medical instrument comprises activating the steerability-providing mechanism to steer the probe (see [0045] and [0035], manipulating deployment elements 30 which is required for retraction of object 12 involves bending and thus steering of system 10 which is achieved through the use of the claimed steerability-providing mechanism).
Regarding claim 52, Verma as modified discloses the method of claim 51, wherein the steerability-providing mechanism comprises one or more wires (cables 50 and 62, fig. 7) that pass through one or more channels (cables 50 and 62 pass through lumens of their respective deployment elements 30 which are channels, see [0040] and [0041]) defined by a wall of the probe (the lumens of elements 30 are defined by walls thereof, [0040] and [0041]), and wherein activating the steerability-providing mechanism comprises pulling at least one of the one or more wires proximally to bend the probe ([0040] and [0041]).
Regarding claim 53, Verma as modified discloses the method of claim 52, wherein the distal longitudinal probe-portion includes one or more loops (first and second deployable elements 30a and 30b, fig. 4, which are considered to be loops as claimed because Merriam-Webster defines a loop to be “a curving or doubling of a line so as to form a closed or partly open curve within itself through which another line can be passed or into which a hook may be hooked”, and the curved segments of deployment elements 30 meet this definition as they are curved lines which form a partly open curve through which another line, such as elongated object 12, can be hooked), wherein the one or more wires are attached to or integral with the one or more loops (see [0040] and [0041], cables 50 and 62), and wherein mechanically coupling comprises looping the one or more loops around the distal longitudinal medical-instrument-portion (see fig. 2, deployable elements 30 are connected and looped around the distal longitudinal medical-instrument-portion of elongated object 12).
Regarding claim 54, Verma as modified discloses the method of claim 39, wherein the elongate medical instrument is an intracardiac medical instrument (elongate object 12 is an intracardial ablation probe in the modified system, see rejection of claim 39), and wherein advancing the elongate medical instrument comprises advancing the intracardiac medical instrument through the vasculature into a heart chamber of the subject (see fig. 2, elongate object 12 is shown as being placed within a chamber of a heart 14).
Regarding claim 56, Verma as modified discloses the method of claim 39, wherein the elongate medical instrument does not comprise a steerability-providing mechanism (see [0002], elongated object 12 can be a broken lead which would not have a steerability-providing mechanism as claimed since it is broken).
Regarding claim 57, Verma as modified discloses the method of claim 39, wherein the elongate medical instrument is shaped so as to define at least one longitudinal channel therethrough (see Verma [0002], the elongated object 12 can be a stent, and stents have channels therethrough such as to hold blood vessels or other lumens open which is their purpose).
Regarding claim 61, Verma as modified discloses the method of claim 39, wherein the elongate medical instrument is a therapeutic medical instrument (see [0004], elongate object 12 is an intracardial ablation probe in the modified system, see rejection of claim 39, which is a medical instrument which delivers electrical therapy to the heart), and wherein performing the therapeutic or diagnostic procedure comprises performing the therapeutic procedure at the targeted anatomical location using the therapeutic medical instrument (see Starksen [0016], the cardiac ablation probe is used for cardiac ablation after positioning).
Regarding claim 62, Verma as modified discloses the method of claim 61 wherein the therapeutic medical instrument is an ablation probe (see Starksen at least [0016] and [0033] and the modifications made to claim 39 above).
Claim(s) 59-60 is/are rejected under 35 U.S.C. 103 as being unpatentable over Verma et al. (US 20200330112, henceforth Verma) as applied to claim 39 above, and further in view of Gijsbers et al. (US 20200113540, henceforth Gijsbers).
Regarding claim 59, Verma as modified discloses the method of claim 39, and additionally discloses that “The system 10 may be utilized to extract any elongated object 12 from the vasculature of a patient”, and that “The system 10 may also be used to extract any other type of foreign object, such as an inferior vena cava filter, having a hook or similar element that can be snared by a loop” ([0029]).
Verma does not explicitly disclose the method wherein the elongate medical instrument is a diagnostic medical instrument. Gijsbers teaches use of a non-steerable diagnostic medical instrument probe inserted into the vasculature as being used beneficially to provide for detailed visualization of an interventional target region while minimizing contrast injection while creating 3D roadmaps of hearts during surgeries (see at least fig. 3B, [0027]-[0033] and [0055]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used the system of Verma to have retrieved the probe of Gijsbers instead of placing the cardiac ablation probe of Starksen should the probe of Gijsbers break during use and be needed to retrieved as the probe of Gijsbers is disposable ([0042]) and simply delivered via catheter ([0055]) and because that is the intended use of the system of Verma ([0029]).
Thus, in the modified method, Verma as modified discloses the method wherein performing the therapeutic or diagnostic procedure comprises performing the diagnostic procedure at the targeted anatomical location using the diagnostic medical instrument (see Gijsbers [0022], [0037], [0080], the visualization probe is configured to provide real time imaging, which would include during retraction and moving of the devices toward a target location out of the body).
Regarding claim 60, Verma as modified discloses the method of claim 59, wherein the diagnostic medical instrument is selected from the group consisting of: an intracardiac echocardiography (ICE) probe, a biopsy probe, and an ultrasound probe (ICE probe, see Gijsbers [0055]).
Response to Arguments
Applicant’s arguments with respect to claim(s) 39 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.
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 SAMUEL J MARRISON whose telephone number is (703)756-1927. The examiner can normally be reached M-F 7:00a-3:30p ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached at (571) 272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SAMUEL J MARRISON/Examiner, Art Unit 3783
/EMILY L SCHMIDT/Primary Examiner, Art Unit 3783
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