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 § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-6, 8-10, and 13-14 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Wapler (2021/0212767). Wapler discloses, in figures 1, 3, and 7 and [0011]-[0019], [0028]-[0029], [0057]-[0058], [0072], and [0076]; a method for determining a trajectory of an elongated tool (18), the method comprising: a) receiving positional information of a region of interest (50, via CT, according to para. [0011]-[0014]); b) receiving positional information of one or more structures (e.g., “critical anatomical structures,” according to para. [0076]) at least partially occluding or obstructing access to the region of interest; c) determining, based on positional information of an initial target point (52) in the region of interest, a sagittal plane (as shown in fig. 7) passing through an axis of an elongated imaging device (16, as shown in fig. 1 and according to para. [0056]) and the initial target point without passing through the one or more structures, wherein the elongated imaging device is configured to generate an image of an area along the sagittal plane; and (via optical tracking system 6, according to para. [0058]); d) determining, based on positional information of an entry point of the elongated tool, a trajectory of the elongated tool substantially along the sagittal plane for advancing the elongated tool to strike the initial target point without striking the one or more structures; wherein step c) further comprises automatically determining the positional information of the initial target point based on one or more target point constraints (according to para. [0072]); wherein step c) further comprises receiving the positional information of the initial target point from a user (a “surgeon,” according to para. [0076]); wherein step d) further comprises automatically determining the position information of the entry point (a “planned entry point” or a “current entry point,” according to para [0076]) of the elongated tool based on one or more entry point constraints; wherein the one or more entry point constraints comprise at least the entry point being on the sagittal plane (as shown in fig. 7); wherein the method further comprises: e) receiving updated positional information of either the initial target point or the entry point on the sagittal plane; and f) determining an updated trajectory (56) of the elongated tool substantially along the sagittal plane based on the updated positional information (according to para. [0076]); wherein the method further comprises repeating steps c) and d) for a subsequent target point (52) in the region of interest (50) different from the initial target point if no suitable trajectory exists for the initial target point (according to para. [0072]).
Wapler also discloses a system for determining a trajectory of an elongated tool (18), the system comprising: a processor (2, according to para. [0058]); a computer-readable memory (a computer-readably medium, according to para. [0029]) coupled to the processor and having instructions stored thereon that are executable by the processor to: a) receive positional information (36, according to para. [0059]) of a region of interest (50); b) receive positional information of one or more structures (“critical anatomical structures,” according to para. [0076]) at least partially occluding or obstructing access to the region of interest; c) determine, based on positional information of an initial target point (52) in the region of interest, a sagittal plane passing through an axis of an elongated imaging device (e.g. 16) and the initial target point without passing through the one or more structures, wherein the elongated imaging device is configured to generate an image (a “navigation view,” according to para. [0019]) of an area along the sagittal plane; and d) determine, based on positional information of an entry point of the elongated tool, a trajectory (56) of the elongated tool substantially along the sagittal plane for advancing the elongated tool to strike the initial target point without striking the one or more structures.
Wapler further discloses a system comprising: a processor (2); a memory (a computer-readably medium, according to para. [0029]) coupled to the processor ; and an elongated imaging device (16) coupled to the processor, the elongated imaging device configured to generate an image (a “navigation view,” according to para. [0019]) of an area along a sagittal plane passing through an axis of the elongated imaging device, wherein the memory is configured to receive positional information of a region of interest (50) and positional information of one or more structures at least partially occluding or obstructing access to the region of interest; and wherein the processor is configured to: determine, based on positional information of an initial target point (52) in the region of interest, the sagittal plane (as shown in fig. 7) passing through the axis of the elongated imaging device and the initial target point without passing through the one or more structures; and determine, based on positional information of an entry point (48) of an elongated tool, a trajectory (56) of the elongated tool substantially along the sagittal plane for advancing the elongated tool to strike the initial target point without striking the one or more structures; wherein the method further comprises displaying the trajectory (56) of the elongated tool in real-time as the elongated tool advances between the entry point and the initial target point (according to para. [0060}); and wherein the method further comprises displaying the trajectory of the elongated tool in real-time as the elongated tool advances between the entry point and the initial target point, wherein displaying comprises displaying the updated trajectory of the elongated tool (according to para. [0059] and [0060]).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 7, 11, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Wapler (2021/0212767) in view of Kumar et al. (2013/0116548). Wapler discloses the invention substantially as claimed, wherein step d) comprises receiving the positional information of the entry point from a user. However, with respect to claim 7, Wapler does not explicitly disclose that the method further comprises generating a warning if the trajectory based on said entry point is out of the sagittal plane. Kumar et al. teach, in fig. 11, and para. [0062]-[0063], a method comprising generating a warning (e.g., ruler 110) if a trajectory of elongated tool based on an entry point is out of a sagittal plane (e.g., beyond prostate boundaries). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, in view of Kumar et al., to modify the method of Wapler, so that a warning is generated if a trajectory of elongated tool based on an entry point is out of a sagittal plane. Such a modification would prevent overshooting of the elongated tool beyond the region of interest.
With respect to claim 11, Wapler also discloses that the system includes a needle guide (22, according to para. [0057], wherein the shaft is configured to receive a tool) coupled to a processor (2), and wherein the needle guide is configured to align a tool along a determined trajectory. However, Wapler does not explicitly disclose that the elongated tool comprises a needle. Kumar et al. teach, in figure 2 and para. [0041], an elongated tool comprising a needle (52). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, in view of Kumar et al., to modify the system of Wapler, so that the elongated tool comprises a needle. Such a modification would allow a biopsy or treatment of tissue with a needle in the region of interest.
With respect to claim 12, Wapler also does not explicitly disclose that the system further comprises an actuator coupled to the processor, wherein the actuator is configured to automatically rotate the elongated imaging device based on the determined sagittal plane. Kumar et al. also teach, in para. [0040], an actuator (e.g., a robotic arm or motion constraining tracker assembly) coupled to a processor, wherein the actuator is configured to automatically rotate an imaging device base on a determined sagittal plane. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, in view of Kumar et al., to modify the system of Wapler, so that it includes an actuator coupled to the processor. Such a modification would allow automated movement of the elongated image device to ensure imaging of the elongated tool and proper positioning of the elongated tool within the region of interest.
Response to Amendment
Applicant’s arguments with respect to claims 1-14 have been considered but are moot in view of new grounds of rejection.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Lieblich et al. (2019/0209130) teach sagittal plane navigation for an imaging device.
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.
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/JULIAN W WOO/Primary Examiner, Art Unit 3771