DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim 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.
Claims 1-20 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.
Claims 1, 9, and 13 are indefinite because it is unclear what the electrical signal is. It is unclear if the tracking is by electric field or by other tracking that generates data as an electric signal.
Claims 2-4 and 11 are indefinite because it is unclear where the tangent is placed on the device. For example, it is unclear if the tangent is based on the sensors, the center of the device, or the exterior of the device.
Regarding claim 5, it is unclear what sheath detection is and what structures perform the sheath detection.
Claims 6 and 7 are indefinite because it is unclear for what the confidence value provides confidence.
Claim 12 is indefinite because it is unclear what is protruding and what correction is made based on sheath detection. It is unclear what sheath detection is and what structures perform the sheath detection.
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.
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.
Claims 1, 5, 8, 9, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. PG Pub. No. 2022/0249172 A1 to Adawi et al. in view of U.S. PG Pub. No. 2021/0113822 A1 Beeckler et al.
Regarding claim 1, Adawi discloses a system for use with an electrophysiological procedure, the system comprising: an elongated catheter assembly including a plurality of coaxially disposed catheter elements, the catheter elements including a first catheter element and a second catheter element, the first catheter element forming an elongated lumen and the second catheter element disposed within the lumen, the first and second catheter elements movable with respect to each other along an axis, wherein the first catheter element includes a first tracking sensor and the second catheter element includes a second tracking sensor (see Figs. 2, 3, 5, 6, and 9-11, abstract, and para 16-23, 37-31, and 36-45); and a controller configured to: determine an anatomical map of a heart of the electrophysiological procedure and track a catheter assembly position within the organ based on a first electrical signal from the first tracking sensor and based on a second electrical signal from the second tracking sensor (see Figs. 2, 3, 5, 6, and 9-11, abstract, and para 16-23, 37-31, and 36-45); generate a first position of the first catheter element based on the first electrical signal and generate a second position of the second catheter element based on the second electrical signal (see Figs. 2, 3, 5, 6, and 9-11, abstract, and para 16-23, 37-31, and 36-45); laterally align the first position with the second position based on a lateral displacement and a rotational displacement determined from the first position and the second position (see Figs. 2, 3, 5, 6, and 9-11, abstract, and para 16-23, 37-31, and 36-45); and longitudinally adjust the first location with respect to the second location based on a detection of the first tracking sensor of the second tracking sensor (see Figs. 2, 3, 5, 6, and 9-11, abstract, and para 16-23, 37-31, and 36-45).
It appears Adawi discloses the use of an electric signal, but it is unclear because of the lack of clarity in the claims.
However, Beeckler discloses a similar heart mapping catheter that is tracked by electrical signals (see Figs. 1 and 3 and para 42-44 and 50-52). Examiner notes that Beeckler also discloses the same tracking as Adawi and also longitudinal adjustments (see Figs. 1 and 3 and para 42-44 and 50-52).
It would have been obvious and predictable to have combined the teachings of Adawi and Beeckler because doing so would be a mere substitution of one tracking system for another to achieve predictable device tracking already taught in the primary reference.
Regarding claim 5, Adawi discloses a device, wherein the controller is configured to longitudinally adjust the first location with respect to the second location based on a sheath detection (see Figs. 2, 3, 5, 6, and 9-11, abstract, and para 16-23, 37-31, and 36-45).
Regarding claim 8, Adawi discloses a device, wherein the first catheter element is a sheath and the second catheter element is a catheter disposed within the sheath (see Figs. 2, 3, 5, 6, and 9-11, abstract, and para 16-23, 37-31, and 36-45).
Regarding claim 9, Adawi discloses a process for use with an elongate catheter assembly during an electrophysiological procedure on the heart, the catheter assembly including a plurality of coaxially disposed catheter elements, the catheter elements including a first catheter element and a second catheter element, the first catheter element forming an elongated lumen and the second catheter element disposed within the lumen, the first and second catheter elements movable with respect to each other along an axis, wherein the first catheter element includes a first tracking sensor and the second catheter element includes a second tracking sensor (see Figs. 2, 3, 5, 6, and 9-11, abstract, and para 16-23, 37-31, and 36-45), the process comprising: tracking a catheter assembly position within the heart based on a first electrical signal from the first tracking sensor and based on a second electrical signal from the second tracking sensor (see Figs. 2, 3, 5, 6, and 9-11, abstract, and para 16-23, 37-31, and 36-45); generating a first position of the first catheter element based on the first electrical signal and generate a second position of the second catheter element based on the second electrical signal (see Figs. 2, 3, 5, 6, and 9-11, abstract, and para 16-23, 37-31, and 36-45); laterally aligning the first position with the second position based on a lateral displacement and a rotational displacement determined from the first position and the second position (see Figs. 2, 3, 5, 6, and 9-11, abstract, and para 16-23, 37-31, and 36-45); and longitudinally adjusting the first location with respect to the second location based on a detection of the first tracking sensor of the second tracking sensor (see Figs. 2, 3, 5, 6, and 9-11, abstract, and para 16-23, 37-31, and 36-45).
It appears Adawi discloses the use of an electric signal, but it is unclear because of the lack of clarity in the claims.
However, Beeckler discloses a similar heart mapping catheter that is tracked by electrical signals (see Figs. 1 and 3 and para 42-44 and 50-52). Examiner notes that Beeckler also discloses the same tracking as Adawi and also longitudinal adjustments (see Figs. 1 and 3 and para 42-44 and 50-52).
It would have been obvious and predictable to have combined the teachings of Adawi and Beeckler because doing so would be a mere substitution of one tracking system for another to achieve predictable device tracking already taught in the primary reference.
Regarding claim 12 both Adawi and Beeckler disclose a device, wherein the longitudinally adjusting includes correcting a protrusion via sheath detection of the first catheter element and the second catheter element (see Adawi Figs. 2, 3, 5, 6, and 9-11, abstract, and para 16-23, 37-31, and 36-45 and Beeckler Figs. 1 and 3 and para 42-44 and 50-52).
It would have been obvious and predictable to provide a protrusion adjustment so that a user could place the device at a specific target in the body.
Claims 13, 16, 17, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. PG Pub. No. 2022/0249172 A1 to Adawi et al., in view of U.S. PG Pub. No. 2021/0113822 A1 Beeckler et al., and in view of U.S. PG Pub. No. 2014/0275989 A1 to Jacobsen et al.
Regarding claim 13, Adawi discloses a system for use with an electrophysiological procedure, the system comprising (see Figs. 2, 3, 5, 6, and 9-11, abstract, and para 16-23, 37-31, and 36-45): an elongated catheter assembly having a tracking sensor (see Figs. 2, 3, 5, 6, and 9-11, abstract, and para 16-23, 37-31, and 36-45); and a controller configured to: track a plurality of catheter assembly positions within the organ based on a plurality of electrical signals from the tracking sensor (see Figs. 2, 3, 5, 6, and 9-11, abstract, and para 16-23, 37-31, and 36-45); determine a first catheter assembly position based on a first electrical signal of the plurality of electrical signals and determine a second catheter assembly position based on a second electrical signal of the plurality of electrical signals (see Figs. 2, 3, 5, 6, and 9-11, abstract, and para 16-23, 37-31, and 36-45); and generate an anatomical map of an organ of the electrophysiological procedure with a visualization of the catheter assembly having the second position constrained with the first position (see Figs. 2, 3, 5, 6, and 9-11, abstract, and para 16-23, 37-31, and 36-45).
It appears Adawi discloses the use of an electric signal, but it is unclear because of the lack of clarity in the claims.
However, Beeckler discloses a similar heart mapping catheter that is tracked by electrical signals (see Figs. 1 and 3 and para 42-44 and 50-52). Examiner notes that Beeckler also discloses the same tracking as Adawi and also longitudinal adjustments (see Figs. 1 and 3 and para 42-44 and 50-52).
It would have been obvious and predictable to have combined the teachings of Adawi and Beeckler because doing so would be a mere substitution of one tracking system for another to achieve predictable device tracking already taught in the primary reference.
Jacobsen discloses a similar tracked sheath catheter device, wherein tracking of the second position is constrained with the first position (see Figs. 2 and 3 and para 63-85).
It would have been obvious and predictable to constrain the two positions with each other and based on the mechanical properties of the device because doing so would alert a user to any impossible or clearly wrong position readings and would also provide for more efficient tracking of the two devices relative to each other.
Regarding claim 20, Adawi discloses a system, wherein the catheter assembly including a plurality of coaxially disposed catheter elements, the catheter elements including a first catheter element and a second catheter element, the first catheter element forming an elongated lumen and the second catheter element disposed within the lumen, the first and second catheter elements movable with respect to each other along an axis, wherein the first catheter element includes a first tracking sensor and the second catheter element includes a second tracking sensor; and wherein the controller is configured to: generate a first position of the first catheter element based on a first electrical signal of the plurality of electrical signals and generate a second position of the second catheter element based on a second electrical signal of the plurality of electrical signals; laterally align the first position with the second position based on a lateral displacement and a rotational displacement determined from the first position and the second position; and longitudinally adjust the first position with respect to the second position based on a detection of the first tracking sensor of the second tracking sensor (see Figs. 2, 3, 5, 6, and 9-11, abstract, and para 16-23, 37-31, and 36-45).
Regarding claim 16, Adawi discloses a device, wherein the controller is configured to track the plurality of catheter assembly positions of the catheter assembly via the tracking sensor using a tracking methodology as a function of time as it passes through the heart (see Figs. 2, 3, 5, 6, and 9-11, abstract, and para 16-23, 37-31, and 36-45).
Regarding claim 17, Jacobsen discloses a similar tracked sheath catheter device, wherein the controller is configured to constrain the first position to the second position via bending energy data regarding bending energy of the catheter assembly (see Figs. 2 and 3 and para 63-85).
It would have been obvious and predictable to constrain the two positions with each other and based on the mechanical properties of the device because doing so would alert a user to any impossible or clearly wrong position readings and would also provide for more efficient tracking of the two devices relative to each other.
Claims 2-4, 10, and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Adawi and Beeckler as applied to claims 1 and 9 above, and further in view of Jacobsen.
Regardings claim 2 and 10, Jacobsen discloses a similar tracked sheath catheter device, further including the controller configured to generate a visualization with the catheter elements with respect to the anatomical map of the heart after laterally aligning and longitudinally adjusting; and further comprising generating an electroanatomical map of the heart and providing the catheter elements with respect to the electroanatomical map of the heart in a visualization. (see Fig. 4 and para 28-37 and 123).
It would have been obvious and predictable to have displayed the catheter in the body because doing so would show the user relative positional information so the catheter could be better guided to the target.
Regarding claim 3, Jacobsen in combination with Adawi discloses a similar tracked sheath catheter device, wherein the first catheter assembly position includes a first location in space and a first tangent, and the second catheter assembly position includes a second location in space and a second tangent (see para 92-94 and 98-106).
It would have been obvious and predictable to have utilized tangents of the device because doing so would increase accuracy of tracking and modeling of the device in the body.
Regarding claim 4, Jacobsen in combination with Adawi discloses a similar tracked sheath catheter device, wherein the first location and the first tangent are laterally aligned with the second location and the second tangent based on a lateral departure and a rotational deflection determined from the first tangent and the second tangent (see para 92-94 and 98-106).
It would have been obvious and predictable to have utilized tangents of the device because doing so would increase accuracy of tracking and modeling of the device in the body.
Regarding claim 11, Jacobsen in combination with Adawi discloses a similar tracked sheath catheter device, wherein the first catheter assembly position includes a first location in space and a first tangent, and the second catheter assembly position includes a second location in space and a second tangent, and wherein the first location and the first tangent are laterally aligned with the second location and the second tangent based on a lateral departure and a rotational deflection determined from the first tangent and the second tangent (see para 92-94 and 98-106).
It would have been obvious and predictable to have utilized tangents of the device because doing so would increase accuracy of tracking and modeling of the device in the body.
Claims 6 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Adawi and Beeckler as applied to claims 1 and 9 above, and further in view of U.S. PG Pub. No. 2018/0042683 A1 to Cohen et al.
Regarding claim 6, Cohen discloses a similar catheter tracking system, wherein the controller is configured to apply a confidence value to the second position (see abstract and para 89).
It would have been obvious and predictable to have used confidence levels to weight the quality of tracking measurements because doing so would predictably mark low quality readings as erroneous and in need of adjustment.
Regarding claim 7, it would have been a mere matter of obvious design to set the confidence value to 1.0 if the second catheter element is magnetically tracked in an electrophysiology system because doing so would optimize the tracking of low-quality readings. Further, it would have not mattered what the confidence values were scaled to as long as the values are consistent.
Claims 14 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Adawi and Beeckler as applied to claim 13 above, and further in view of U.S. PG Pub. No. 2013/0296845 A1 to Bar-Tal et al.
Regarding claim 14, Bar-Tal discloses a similar guided surgical process, wherein the controller is configured to place a tag on the anatomical map of the organ at the first catheter assembly position representing an anatomical landmark (see para 3).
It would have been obvious and predictable to have marked anatomical locations with a tag because doing so would keep track of location where the device has been and where the device has treated or sensed tissue.
Regarding claim 15, Adawi discloses a method, wherein the controller is configured to track the catheter assembly independent of the anatomical landmark (see Figs. 2, 3, 5, 6, and 9-11, abstract, and para 16-23, 37-31, and 36-45).
Claims 18 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Adawi and Beeckler as applied to claim 13 above, and further in view of U.S. PG Pub. No. 2016/0008074 A1 to Glossop.
Regarding claims 18 and 19, Glossop discloses a similar guided surgical process, wherein the controller is configured to constrain the first position to the second position via a path; and wherein the controller is configured to highlight the path in the visualization (see para 115 and 175-189).
It would have been obvious and predictable to use a constrained path such a blood vessel because doing so would predictably allow the device of Adawi to reach the heart with minimal damage to surrounding tissue.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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Claims 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-20 of copending Application No. 19/000061 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference application claims the same device and method as the present claims but merely adds a further limitation pertaining to historical correction.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
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/RAJEEV P SIRIPURAPU/Primary Examiner, Art Unit 3798