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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the directional vector and model must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
Claim(s) 7-8 & 13-14 is/are 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.
Regarding Claim 7-8
Claim 7 claims a primary tip section and parent Claim 2 claims a sheath tip. The claimed relationship between the primary tip section and the sheath tip is not understood. It appears both claimed elements are referring to the same element of the primary elongated medical assembly. The Examiner is interpreting the sheath tip of parent Claim 2 and the primary tip section of Claim 7 to be the same element. Additionally it is not clear if the primary sensor device comprising the four spaced-apart electrodes are mounted to the primary tip section or only one electrode. The Examiner is interpreting the claim limitation to mean the four electrodes are mounted to the primary tip section. Similar analysis is applied to Claim 8.
Regarding Claim 13
Claim 13 claims “the sheath tip section”. The claim term is lacking antecedent basis. Further it is unclear whether the element is the same or different from the sheath tip of parent Claim 2.
Regarding Claim 14
Claim 14 claims “dilator assembly”, “dilator electrode assembly” and “sheath assembly”. These claims terms lack antecedent basis and it is confusing as to whether or not the claimed elements are different separate elements or the same elements as the primary and second elongated medical assembly. The Examiner is interpreting the listed elements above as the proper respective primary and second elongated medical assembly elements.
Claim Objections
Claim (s) 2 is/are objected to because of the following informalities:
“An system” should be --A system--.
“an outer surface the sheath” should be --an outer surface of the sheath--.
Appropriate correction is required.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 2-3, 7-8, 13-14 & 16-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Moak et al. (W/O2018/165277 A1; enclosed prior) and further in view of Markowitz et al. (U.S. Patent Application 2009/0264739 A1).
Claim 2: Markowitz teaches –
An system [apparatus] (Figure 2, Element 100) [using Carto®…, EnSite™…or another electromagnetic imaging system] (Page 6, Line 14-17), comprising:
an electro-anatomical mapping system configured to emanate an electromagnetic-transmission signal [using Carto®…, EnSite™…or another electromagnetic imaging system] (Page 6, Line 14-17) [to be used in both electrogram recording and magnetic positioning] (Page 8, Line 18-19)
a primary elongated medical assembly [sheath] (Figure 2, Element 110) configured to be positioned in, and movable along, a patient [The apparatus disclosed herein includes a sheath comprising…an outer surface having a diameter sized for introduction into a blood vessel of a subject] (Page 5, Line 16-18) [the sheath 110 is inserted into a femoral vein and routed to the right atrium under electromagnetic guidance for positioning at the foramen ovale] (Page 9, Line 31-33),
Examiner’s Note: Although the cited passages above are from different embodiments of Moak. Moak makes clear that the only differences between the embodiments is the shape and number of the electrodes (See Page 9, Line 12-28). Thus, the disclosures with regard to the dilator between the embodiments are applicable to both the dilator in Figure 2 and Figure 4.
the primary elongated medical assembly comprising a sheath [sheath] (Figure 2, Element 110) having a sheath tip [distal end of the sheath] (Page 6, Line 3) and a lumen [A lumen extending between the proximal and distal ends of the sheath] (Page 5, Line 19);
a secondary elongated medical assembly [dilator] (Figure 2, Element 120) configured to be positioned in, and movable along, the patient [The dilator 120 is positioned within the lumen of sheath 110, and can retract proximally into the sheath lumen or extend past the distal end of the sheath 110, as shown in Figure 1] (Page 5, Line 29) [The apparatus disclosed herein includes a sheath comprising…an outer surface having a diameter sized for introduction into a blood vessel of a subject] (Page 5, Line 16-18),
Examiner’s Note: The two passages support the claim limitation as the sheath is in the patient and the dilator is moveable within the sheath. Thus, the dilator is movable within the patient.
the secondary elongated medical assembly comprising a dilator [dilator] (Figure 2, Element 120) having a dilator tip [dilator includes a proximal end, a distal end, and a lumen extending between the proximal and distal ends of the dilator] (Page 2, Line 15-17),
wherein the lumen is configured to receive the secondary elongated medical assembly [A dilator is positioned within the sheath lumen] (Page 2, Line 14-15)
Examiner’s Note: The claimed lumen is the lumen from the primary elongated medical assembly and is receiving the secondary elongated medical assembly.
the primary elongated medical assembly [sheath] (Figure 2, Element 110) having a primary sensor device [electrodes] (Figure 2, Element 140c);
the secondary elongated medical assembly [dilator] (Figure 2, Element 120) having a secondary sensor device [electrodes] (Figure 2, Element 140a & 140b)
comprising a dilator electrode (Figure 2, Element 140a) positioned on the dilator tip [distal-most electrode 140a is positioned 2 millimeters from the distal end of dilator 120] (Page 9, Line 19-20)
the primary elongated medical assembly [sheath] (Figure 2, Element 110) and the secondary elongated medical assembly [dilator] (Figure 2, Element 120) each configured to be movable relative to each other in such a way that the primary sensor device [electrodes] (Figure 2, Element 140c) and the secondary sensor device [electrodes] (Figure 2, Element 140a & 104b) are movable relative to each other, once the primary elongated medical assembly [sheath] (Figure 2, Element 110) and the secondary elongated medical assembly [dilator] (Figure 2, Element 120), in use, are positioned in, and are movable along, the patient [The dilator 120 is positioned within the lumen of sheath 110, and can retract proximally into the sheath lumen or extend past the distal end of the sheath 110, as shown in Figure 1] (Page 5, Line 29) [The distance between the outer surface of the dilator 120 and the inner surface of the sheath 110 can also vary based on the needs of the particular application] (Page 6, Line 9-10).
Moak teaches the using of Carto® or EnSite™ or another electromagnetic imaging system (Page 6, Line 14-17). Moak fails to specifically teach to display spatial alignment information, the spatial alignment information including a directional vector [the navigation catheter 100 can be displayed as an icon 100i on the display 58] (Para 0042 and in Figure 3, Element 100i is a directional vector showing the catheter direction) and a model. However, Markowitz teaches display spatial alignment information (as shown in Figure 3), the spatial alignment information including a directional vector and a model [the sheath 102 can be displayed on the display 58 as an icon 102i] (Para 0045 and in Figure 3 it is shown as a model of the sheath) in order to allow for the navigation catheter to be guided in a patient in any appropriate manner (Para 0042)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Moak to include the spatial alignment as taught by Markowitz in order to allow for the navigation catheter to be guided in a patient in any appropriate manner (Para 0042)
Moak teaches multiple electrode pairs (Page 7, Line 15-16) and the additional electrodes can further improve resolution and facilitate the localization of the sheath within the cardiac chambers (Page 8, Line 21-23). Moak fails to specifically teach comprising four spaced apart electrodes positioned along an outer surface the sheath. However, Markowitz teaches primary elongated medical assembly [sheath] (Figure 4, Element 102) comprising four spaced-apart electrodes [the sheath 102 can include four electrodes 130] (Para 0045 and Figure 4, Element 130) positioned along an outer surface (as shown in Figure 4) the sheath [sheath] (Figure 4, Element 102) in order to further improve resolution and facilitate the localization of the sheath within the cardiac chambers (Page 8, Line 21-23 of Moak).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Moak to include the four electrodes as taught by Markowitz in order to further improve resolution and facilitate the localization of the sheath within the cardiac chambers (Page 8, Line 21-23 of Moak).
Claim 3/2: Moak teaches wherein:
the primary sensor device [electrodes] (Figure 2, Element 140c) is configured to receive an electromagnetic-transmission signal emanating from the electro-anatomical mapping system [Each electrode 140a/140b/140c is connected by a separate wire 145a/145b/145c] (Page 8, Line 14-15) [The wires allow each electrode to be used in both electrogram recording and magnetic positioning] (Page 8, Line 18-19), once the primary elongated medical assembly, in use, is positioned in, and is movable along, the patient [The apparatus disclosed herein includes a sheath comprising…an outer surface having a diameter sized for introduction into a blood vessel of a subject] (Page 5, Line 16-18) [the sheath 110 is inserted into a femoral vein and routed to the right atrium under electromagnetic guidance for positioning at the foramen ovale] (Page 9, Line 31-33); and
Examiner’s Note: The primary sensor device of Moak is configured by the wire as taught by Moak. The wire of Moak is disclosed as being connected to electromagnetic imaging systems of electromagnetic positioning systems (Page 6, Line 14-17). The Examiner contends that the wire is configured to perform the function of transmitting or receiving an electromagnetic-transmission signal to or from an electro-anatomical mapping system. The Examiner contends that the “electro-anatomical mapping system” is not positively claimed. The Examiner is interpreting that the claim limitation to be directed to a configuration of the primary sensor device only; which merely requires a wire for the connection.
the primary sensor device [electrodes] (Figure 2, Element 140c) is also configured to transmit a primary detected signal back to the electro-anatomical mapping system [Each electrode 140a/140b/140c is connected by a separate wire 145a/145b/145c] (Page 8, Line 14-15) [The wires allow each electrode to be used in both electrogram recording and magnetic positioning] (Page 8, Line 18-19), and the electro-anatomical mapping system is also configured to receive the primary detected signal from the primary sensor device [electrode(s) is suitable for electromagnetic positioning, for example, using Carto®…, EnSite™…or another electromagnetic imaging system] (Page 6, Line 14-17) [The electrode(s) are suitable for electrogram recording] (Page 6, Line 18-19); and
Examiner’s Note: The claim limitation is directed to the primary sensor device and how the primary sensor device is configured structurally (such as having a wire). The claim limitations directed to the electro-anatomical mapping system are indefinite as the claim limitation is not applicable to a wire. However, the Examiner points to the electro-anatomical mapping systems as disclosed by Moak is configured to receive the primary detected signal of the electrogram recording from the primary sensor device.
the secondary sensor device [electrodes] (Figure 2, Element 140c) is configured to receive the electromagnetic-transmission signal emanating from the electro-anatomical mapping system [Each electrode 140a/140b/140c is connected by a separate wire 145a/145b/145c] (Page 8, Line 14-15) [The wires allow each electrode to be used in both electrogram recording and magnetic positioning] (Page 8, Line 18-19),
Examiner’s Note: The secondary sensor device of Moak is configured by the wire as taught by Moak. The wire of Moak is disclosed as being connected to electromagnetic imaging systems of electromagnetic positioning systems (Page 6, Line 14-17). The Examiner contends that the wire is configured to perform the function of transmitting or receiving an electromagnetic-transmission signal to or from an electro-anatomical mapping system. The Examiner contends that the “electro-anatomical mapping system” is not positively claimed. The Examiner is interpreting that the claim limitation to be directed to a configuration of the primary sensor device only; which merely requires a wire for the connection.
once the secondary elongated medical assembly [dilator] (Figure 2, Element 120), in use, is positioned in, and is movable along, the patient [The dilator 120 is positioned within the lumen of sheath 110, and can retract proximally into the sheath lumen or extend past the distal end of the sheath 110, as shown in Figure 1] (Page 5, Line 29) [The apparatus disclosed herein includes a sheath comprising…an outer surface having a diameter sized for introduction into a blood vessel of a subject] (Page 5, Line 16-18); and
Examiner’s Note: The two passages support the claim limitation as the sheath is in the patient and the dilator is moveable within the sheath. Thus, the dilator is movable within the patient.
the secondary sensor device [electrodes] (Figure 2, Element 140a) is also configured to transmit a secondary detected signal back to the electro-anatomical mapping system [Each electrode 140a/140b/140c is connected by a separate wire 145a/145b/145c] (Page 8, Line 14-15) [The wires allow each electrode to be used in both electrogram recording and magnetic positioning] (Page 8, Line 18-19), and the electro-anatomical mapping system is also configured to receive the secondary detected signal from the secondary sensor device [electrode(s) is suitable for electromagnetic positioning, for example, using Carto®…, EnSite™…or another electromagnetic imaging system] (Page 6, Line 14-17) [The electrode(s) are suitable for electrogram recording] (Page 6, Line 18-19).
Examiner’s Note: The claim limitation is directed to the secondary sensor device and how the secondary sensor device is configured structurally (such as having a wire). The claim limitations directed to the electro-anatomical mapping system are indefinite as the claim limitation is not applicable to a wire. However, the Examiner points to the electro-anatomical mapping systems as disclosed by Moak is configured to receive the secondary detected signal of the electrogram recording from the secondary sensor device.
Claim 4/3/2: Moak fails to track relative movements between the primary elongated medical assembly and the secondary elongated medical assembly. However, Markowitz teaches wherein:
the electro-anatomical mapping system [LocaLisaTM Intracardiac Navigation System] (Para 0029) [perform a mapping procedure] (Para 0061) is configured to track relative movements between the primary elongated medical assembly [sheath] (Figure 4, Element 102) and the secondary elongated medical assembly [navigation catheter] (Figure 4, Element 100) based on:
the primary detected signal, of the primary sensor device, that was received by the electro-anatomical mapping system [determine a position of the sheath 102, given the impedances of the electrodes 130 of the sheath 102 and the impedances of the reference electrodes 52] (Para 0060); and
the secondary detected signal of the secondary sensor device received by the electro-anatomical mapping system [determine a position of the navigation catheter 100, given the impedances of the electrodes 112 of the navigation catheter 100 and the impedances of the reference electrodes 52] (Para 0059) in order to enable the user to know where the sheath (primary elongated assembly) relative to other instruments in the anatomy, such as the navigation catheter (secondary elongated assembly), which can provide the user with better situational awareness of the position of the sheath relative to the navigation catheter, to enable the user to more effectively manipulate the navigation catheter via the sheath.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the electrodes on the dilator and sheath of Moak to include the positioning tracking as taught by Markowitz in order to enable the user to know where the sheath (primary elongated assembly) relative to other instruments in the anatomy, such as the navigation catheter (secondary elongated assembly), which can provide the user with better situational awareness of the position of the sheath relative to the navigation catheter, to enable the user to more effectively manipulate the navigation catheter via the sheath.
Claim 7/3/2: Moak teaches wherein:
the primary elongated medical assembly [sheath] (Figure 2, Element 110) includes a primary tip section [distal end of the sheath] (Page 6, Line 3)
the primary sensor device [electrodes] (Figure 2, Element 140c) is mounted to the primary tip section (as shown in Figure 2).
Claim 8/7/3/2: Moak fails to track relative movements between the primary elongated medical assembly and the secondary elongated medical assembly. However, Markowitz teaches wherein:
the electro-anatomical mapping system [LocaLisaTM Intracardiac Navigation System] (Para 0029) [perform a mapping procedure] (Para 0061) is configured to track relative movements between the primary tip section [distal end] (Figure 4, Element 126) of the primary elongated medical assembly [sheath] (Figure 4, Element 102) and the dilator tip [tip electrode] (Figure 4, Element 112a) of the secondary elongated medical assembly [navigation catheter] (Figure 4, Element 100) based on:
the primary detected signal, of the primary sensor device, that was received by the electro-anatomical mapping system [determine a position of the sheath 102, given the impedances of the electrodes 130 of the sheath 102 and the impedances of the reference electrodes 52] (Para 0060); and
the secondary detected signal of the secondary sensor device received by the electro-anatomical mapping system [determine a position of the navigation catheter 100, given the impedances of the electrodes 112 of the navigation catheter 100 and the impedances of the reference electrodes 52] (Para 0059) in order to enable the user to know where the sheath (primary elongated assembly) relative to other instruments in the anatomy, such as the navigation catheter (secondary elongated assembly), which can provide the user with better situational awareness of the position of the sheath relative to the navigation catheter, to enable the user to more effectively manipulate the navigation catheter via the sheath.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the electrodes on the dilator and sheath of Moak to include the positioning tracking as taught by Markowitz in order to enable the user to know where the sheath (primary elongated assembly) relative to other instruments in the anatomy, such as the navigation catheter (secondary elongated assembly), which can provide the user with better situational awareness of the position of the sheath relative to the navigation catheter, to enable the user to more effectively manipulate the navigation catheter via the sheath.
Claim 13/3/2: Moak teaches wherein:
the primary sensor device [electrodes] (Figure 2, Element 140c) is configured to receive an electromagnetic-transmission signal emanating from an electro-anatomical mapping system [Each electrode 140a/140b/140c is connected by a separate wire 145a/145b/145c] (Page 8, Line 14-15) [The wires allow each electrode to be used in both electrogram recording and magnetic positioning] (Page 8, Line 18-19), once the primary elongated medical assembly, in use, is positioned in, and is movable along, the patient [The apparatus disclosed herein includes a sheath comprising…an outer surface having a diameter sized for introduction into a blood vessel of a subject] (Page 5, Line 16-18) [the sheath 110 is inserted into a femoral vein and routed to the right atrium under electromagnetic guidance for positioning at the foramen ovale] (Page 9, Line 31-33); and
Examiner’s Note: Although the cited passages above are from different embodiments of Moak. Moak makes clear that the only differences between the embodiments is the shape and number of the electrodes (See Page 9, Line 12-28). Thus, the disclosures with regard to the dilator between the embodiments are applicable to both the dilator in Figure 2 and Figure 4.
the secondary sensor device [electrodes] (Figure 2, Element 140c) is configured to receive the electromagnetic-transmission signal emanating from the electro-anatomical mapping system [Each electrode 140a/140b/140c is connected by a separate wire 145a/145b/145c] (Page 8, Line 14-15) [The wires allow each electrode to be used in both electrogram recording and magnetic positioning] (Page 8, Line 18-19 and See related Examiner’s Note in Claim 3), once the secondary elongated medical assembly, in use, is positioned in, and is movable along, the patient [The apparatus disclosed herein includes a sheath comprising…an outer surface having a diameter sized for introduction into a blood vessel of a subject] (Page 5, Line 16-18) [the sheath 110 is inserted into a femoral vein and routed to the right atrium under electromagnetic guidance for positioning at the foramen ovale] (Page 9, Line 31-33); and
Moak fails to track relative movements between the primary elongated medical assembly and the secondary elongated medical assembly. However, Markowitz teaches the electro-anatomical mapping system [LocaLisaTM Intracardiac Navigation System] (Para 0029) [perform a mapping procedure] (Para 0061) is configured to track relative movements between the dilator tip [tip electrode] (Figure 4, Element 112a) of the secondary elongated medical assembly [navigation catheter] (Figure 4, Element 100) and the sheath tip section [distal end] (Figure 4, Element 126) of the primary elongated medical assembly [navigation catheter] (Figure 4, Element 100) in order to enable the user to know where the sheath (primary elongated assembly) relative to other instruments in the anatomy, such as the navigation catheter (secondary elongated assembly), which can provide the user with better situational awareness of the position of the sheath relative to the navigation catheter, to enable the user to more effectively manipulate the navigation catheter via the sheath.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the electrodes on the dilator and sheath of Moak to include the positioning tracking as taught by Markowitz in order to enable the user to know where the sheath (primary elongated assembly) relative to other instruments in the anatomy, such as the navigation catheter (secondary elongated assembly), which can provide the user with better situational awareness of the position of the sheath relative to the navigation catheter, to enable the user to more effectively manipulate the navigation catheter via the sheath.
Claim 14/3/2: Moak teaches wherein:
the primary sensor device [electrodes] (Figure 2, Element 140c) is also configured to transmit a primary detected signal back to an electro-anatomical mapping system [Each electrode 140a/140b/140c is connected by a separate wire 145a/145b/145c] (Page 8, Line 14-15) [The wires allow each electrode to be used in both electrogram recording and magnetic positioning] (Page 8, Line 18-19), and the electro-anatomical mapping system is also configured to receive the primary detected signal from the primary sensor device [Each electrode 140a/140b/140c is connected by a separate wire 145a/145b/145c] (Page 8, Line 14-15) [The wires allow each electrode to be used in both electrogram recording and magnetic positioning] (Page 8, Line 18-19); and
the secondary sensor device [electrodes] (Figure 2, Element 140a) is also configured to transmit a secondary detected signal back to the electro-anatomical mapping system [Each electrode 140a/140b/140c is connected by a separate wire 145a/145b/145c] (Page 8, Line 14-15) [The wires allow each electrode to be used in both electrogram recording and magnetic positioning] (Page 8, Line 18-19), and the electro-anatomical mapping system is also configured to receive the secondary detected signal from the secondary sensor device [electrode(s) is suitable for electromagnetic positioning, for example, using Carto®…, EnSite™…or another electromagnetic imaging system] (Page 6, Line 14-17) [The electrode(s) are suitable for electrogram recording] (Page 6, Line 18-19); and
Moak fails to track relative movements between the primary elongated medical assembly and the secondary elongated medical assembly. However, Markowitz teaches –
the electro-anatomical mapping system [LocaLisaTM Intracardiac Navigation System] (Para 0029) [perform a mapping procedure] (Para 0061) is configured to track relative movements between the dilator tip [tip electrode] (Figure 4, Element 112a) of the dilator assembly [navigation catheter] (Figure 4, Element 100) and the sheath tip section [distal end] (Figure 4, Element 126) of the sheath assembly [sheath] (Figure 4, Element 102) based on:
the secondary detected signal of the dilator electrode assembly received by the electro-anatomical mapping system [determine a position of the navigation catheter 100, given the impedances of the electrodes 112 of the navigation catheter 100 and the impedances of the reference electrodes 52] (Para 0059); and
the primary signal detected [determine a position of the sheath 102, given the impedances of the electrodes 130 of the sheath 102 and the impedances of the reference electrodes 52] (Para 0060) from the four spaced-apart electrodes [the sheath 102 can include four electrodes 130] (Para 0045 and Figure 4, Element 130) in order to enable the user to know where the sheath (primary elongated assembly) relative to other instruments in the anatomy, such as the navigation catheter (secondary elongated assembly), which can provide the user with better situational awareness of the position of the sheath relative to the navigation catheter, to enable the user to more effectively manipulate the navigation catheter via the sheath.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the electrodes on the dilator and sheath of Moak to include the positioning tracking as taught by Markowitz in order to enable the user to know where the sheath (primary elongated assembly) relative to other instruments in the anatomy, such as the navigation catheter (secondary elongated assembly), which can provide the user with better situational awareness of the position of the sheath relative to the navigation catheter, to enable the user to more effectively manipulate the navigation catheter via the sheath.
Claim 16: Moak teaches –
A system [apparatus] (Figure 2, Element 100) [using Carto®…, EnSite™…or another electromagnetic imaging system] (Page 6, Line 14-17), comprising:
an electro-anatomical mapping system configured to emanate an electromagnetic-transmission signal [using Carto®…, EnSite™…or another electromagnetic imaging system] (Page 6, Line 14-17) [to be used in both electrogram recording and magnetic positioning] (Page 8, Line 18-19); and
a primary elongated medical assembly [sheath] (Figure 2, Element 110) configured to be positioned in, and movable along, a patient [The apparatus disclosed herein includes a sheath comprising…an outer surface having a diameter sized for introduction into a blood vessel of a subject] (Page 5, Line 16-18) [the sheath 110 is inserted into a femoral vein and routed to the right atrium under electromagnetic guidance for positioning at the foramen ovale] (Page 9, Line 31-33); and
Examiner’s Note: Although the cited passages above are from different embodiments of Moak. Moak makes clear that the only differences between the embodiments is the shape and number of the electrodes (See Page 9, Line 12-28). Thus, the disclosures with regard to the dilator between the embodiments are applicable to both the dilator in Figure 2 and Figure 4.
a secondary elongated medical assembly [dilator] (Figure 2, Element 120) configured to be positioned in, and movable along, the patient [The dilator 120 is positioned within the lumen of sheath 110, and can retract proximally into the sheath lumen or extend past the distal end of the sheath 110, as shown in Figure 1] (Page 5, Line 29) [The apparatus disclosed herein includes a sheath comprising…an outer surface having a diameter sized for introduction into a blood vessel of a subject] (Page 5, Line 16-18)
Examiner’s Note: The two passages support the claim limitation as the sheath is in the patient and the dilator is moveable within the sheath. Thus, the dilator is movable within the patient.
the secondary elongated medical assembly comprising a dilator [dilator] (Figure 2, Element 120) having a dilator tip [dilator includes a proximal end, a distal end, and a lumen extending between the proximal and distal ends of the dilator] (Page 2, Line 15-17); and
the primary elongated medical assembly [sheath] (Figure 2, Element 110) having a primary sensor device [electrodes] (Figure 2, Element 140c); and
the secondary elongated medical assembly [dilator] (Figure 2, Element 120) having a secondary sensor device [electrodes] (Figure 2, Element 140a) positioned on the dilator tip [distal-most electrode 140a is positioned 2 millimeters from the distal end of dilator 120] (Page 9, Line 19-20); and
the primary elongated medical assembly [sheath] (Figure 2, Element 110) and the secondary elongated medical assembly [dilator] (Figure 2, Element 120) each configured to be movable relative to each other in such a way that the primary sensor device and the secondary sensor device are movable relative to each other [The distance between the outer surface of the dilator 120 and the inner surface of the sheath 110 can also vary based on the needs of the particular application] (Page 6, Line 9-10), once the primary elongated medical assembly and the secondary elongated medical assembly, in use, are positioned in, and are movable along, the patient [The dilator 120 is positioned within the lumen of sheath 110, and can retract proximally into the sheath lumen or extend past the distal end of the sheath 110, as shown in Figure 1] (Page 5, Line 29).
Moak teaches the using of Carto® or EnSite™ or another electromagnetic imaging system (Page 6, Line 14-17). Moak fails to specifically teach to display spatial alignment information, the spatial alignment information including a directional vector [the navigation catheter 100 can be displayed as an icon 100i on the display 58] (Para 0042 and in Figure 3, Element 100i is a directional vector showing the catheter direction) and a model. However, Markowitz teaches display spatial alignment information (as shown in Figure 3), the spatial alignment information including a directional vector and a model [the sheath 102 can be displayed on the display 58 as an icon 102i] (Para 0045 and in Figure 3 it is shown as a model of the sheath) in order to allow for the navigation catheter to be guided in a patient in any appropriate manner (Para 0042)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Moak to include the spatial alignment as taught by Markowitz in order to allow for the navigation catheter to be guided in a patient in any appropriate manner (Para 0042)
Moak fails to track relative movements between the primary elongated medical assembly and the secondary elongated medical assembly. However, Markowitz teaches:
wherein the electro-anatomical mapping system [LocaLisaTM Intracardiac Navigation System] (Para 0029) [perform a mapping procedure] (Para 0061) is configured to track relative movements between the primary elongated medical assembly [sheath] (Figure 4, Element 102) and the secondary elongated medical assembly [navigation catheter] (Figure 4, Element 100) based on signals from primary sensor device [determine a position of the sheath 102, given the impedances of the electrodes 130 of the sheath 102 and the impedances of the reference electrodes 52] (Para 0060) and secondary sensor device [determine a position of the navigation catheter 100, given the impedances of the electrodes 112 of the navigation catheter 100 and the impedances of the reference electrodes 52] (Para 0059) in order to enable the user to know where the sheath (primary elongated assembly) relative to other instruments in the anatomy, such as the navigation catheter (secondary elongated assembly), which can provide the user with better situational awareness of the position of the sheath relative to the navigation catheter, to enable the user to more effectively manipulate the navigation catheter via the sheath.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the electrodes on the dilator and sheath of Moak to include the positioning tracking as taught by Markowitz in order to enable the user to know where the sheath (primary elongated assembly) relative to other instruments in the anatomy, such as the navigation catheter (secondary elongated assembly), which can provide the user with better situational awareness of the position of the sheath relative to the navigation catheter, to enable the user to more effectively manipulate the navigation catheter via the sheath.
Claim 17/16: Moak teaches –
the primary sensor device [electrodes] (Figure 2, Element 140c) is also configured to receive the electromagnetic-transmission signal emanating from an electro-anatomical mapping system [Each electrode 140a/140b/140c is connected by a separate wire 145a/145b/145c] (Page 8, Line 14-15) [The wires allow each electrode to be used in both electrogram recording and magnetic positioning] (Page 8, Line 18-19), once the primary elongated medical assembly, in use, is positioned in, and is movable along, the patient [The apparatus disclosed herein includes a sheath comprising…an outer surface having a diameter sized for introduction into a blood vessel of a subject] (Page 5, Line 16-18) [the sheath 110 is inserted into a femoral vein and routed to the right atrium under electromagnetic guidance for positioning at the foramen ovale] (Page 9, Line 31-33).
Examiner’s Note: The primary sensor device of Moak is configured by the wire as taught by Moak. The wire of Moak is disclosed as being connected to electromagnetic imaging systems of electromagnetic positioning systems (Page 6, Line 14-17). The Examiner contends that the wire is configured to perform the function of transmitting or receiving an electromagnetic-transmission signal to or from an electro-anatomical mapping system. The Examiner contends that the “electro-anatomical mapping system” is not positively claimed. The Examiner is interpreting that the claim limitation to be directed to a configuration of the primary sensor device only; which merely requires a wire for the connection.
Claim 18/17/16: Moak teaches –
the primary sensor device is also configured to transmit a primary detected signal back to the electro-anatomical mapping system [Each electrode 140a/140b/140c is connected by a separate wire 145a/145b/145c] (Page 8, Line 14-15) [The wires allow each electrode to be used in both electrogram recording and magnetic positioning] (Page 8, Line 18-19), and the electro-anatomical mapping system is also configured to receive the primary detected signal from the primary sensor device [electrode(s) is suitable for electromagnetic positioning, for example, using Carto®…, EnSite™…or another electromagnetic imaging system] (Page 6, Line 14-17) [The electrode(s) are suitable for electrogram recording] (Page 6, Line 18-19).
Examiner’s Note: The claim limitation is directed to the primary sensor device and how the primary sensor device is configured structurally (such as having a wire). The claim limitations directed to the electro-anatomical mapping system are indefinite as the claim limitation is not applicable to a wire. However, the Examiner points to the electro-anatomical mapping systems as disclosed by Moak is configured to receive the primary detected signal of the electrogram recording from the primary sensor device.
Claim 19/18/17/16: Moak teaches –
the secondary sensor device [electrodes] (Figure 2, Element 140c) is also configured to receive the electromagnetic-transmission signal emanating from the electro-anatomical mapping system [Each electrode 140a/140b/140c is connected by a separate wire 145a/145b/145c] (Page 8, Line 14-15) [The wires allow each electrode to be used in both electrogram recording and magnetic positioning] (Page 8, Line 18-19),
Examiner’s Note: The secondary sensor device of Moak is configured by the wire as taught by Moak. The wire of Moak is disclosed as being connected to electromagnetic imaging systems of electromagnetic positioning systems (Page 6, Line 14-17). The Examiner contends that the wire is configured to perform the function of transmitting or receiving an electromagnetic-transmission signal to or from an electro-anatomical mapping system. The Examiner contends that the “electro-anatomical mapping system” is not positively claimed. The Examiner is interpreting that the claim limitation to be directed to a configuration of the primary sensor device only; which merely requires a wire for the connection.
once the secondary elongated medical assembly [dilator] (Figure 2, Element 120), in use, is positioned in, and is movable along, the patient [The dilator 120 is positioned within the lumen of sheath 110, and can retract proximally into the sheath lumen or extend past the distal end of the sheath 110, as shown in Figure 1] (Page 5, Line 29) [The apparatus disclosed herein includes a sheath comprising…an outer surface having a diameter sized for introduction into a blood vessel of a subject] (Page 5, Line 16-18).
Examiner’s Note: The two passages support the claim limitation as the sheath is in the patient and the dilator is moveable within the sheath. Thus, the dilator is movable within the patient.
Claim 20/19/18/17/16: Moak teaches –
the secondary sensor device [electrodes] (Figure 2, Element 140c) is also configured to transmit a secondary detected signal back to the electro-anatomical mapping system [Each electrode 140a/140b/140c is connected by a separate wire 145a/145b/145c] (Page 8, Line 14-15) [The wires allow each electrode to be used in both electrogram recording and magnetic positioning] (Page 8, Line 18-19), and the electro-anatomical mapping system is also configured to receive the secondary detected signal from the secondary sensor device [electrode(s) is suitable for electromagnetic positioning, for example, using Carto®…, EnSite™…or another electromagnetic imaging system] (Page 6, Line 14-17) [The electrode(s) are suitable for electrogram recording] (Page 6, Line 18-19).
Examiner’s Note: The claim limitation is directed to the secondary sensor device and how the secondary sensor device is configured structurally (such as having a wire). The claim limitations directed to the electro-anatomical mapping system are indefinite as the claim limitation is not applicable to a wire. However, the Examiner points to the electro-anatomical mapping systems as disclosed by Moak is configured to receive the secondary detected signal of the electrogram recording from the secondary sensor device.
Response to Arguments
Applicant’s arguments, see Page 12, filed 10/02/2025, with respect to the Claim Objection have been fully considered and are persuasive. The Objection of the Claim has been withdrawn. However, as a result of the amendments new Claim Objections are pending above.
Applicant’s arguments, see Page 12, filed 10/02/2025, with respect to the Drawing Objections have been fully considered and are persuasive. The Objection of the Drawing has been withdrawn. However, as a result of the amendments new Drawing Objections are pending above.
Applicant’s arguments, see Page 13, filed 10/02/2025, with respect to the Rejection under 35 USC § 112, second paragraph have been fully considered and are persuasive. The rejection under 35 USC § 112, second paragraph of the Claim has been withdrawn. However, as a result of the amendments new rejections under 35 USC § 112, second paragraph are pending above.
Applicant’s arguments with respect to claim(s) 2-4, 7-8, 13-14 & 16-20 have been considered but are moot because the new ground of rejection does not rely on the manner in which any references were applied in the prior rejection of record. Any remaining pertinent arguments will be addressed.
The Applicant submitted arguments that Moak fails to teach “a secondary sensor device comprising a dilator electrode positioned on the dilator tip”. The Examiner respectfully disagrees. The Applicant is applying a narrow interpretation of the claim limitation. The Applicant uses the claim terms of: tip and tip section. Leading to confusion over what the term, tip, encompasses. The Examiner contends that 1-2 millimeters from the distal end is on the tip and/or tip section. The argument is unconvincing.
The rejection is deemed proper and is hereby maintained.
Conclusion
THIS ACTION IS MADE FINAL. 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.
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/Helene Bor/Examiner, Art Unit 3797
/CHRISTOPHER KOHARSKI/Supervisory Patent Examiner, Art Unit 3797