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 .
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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Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12, 433, 690. Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claim disclosed all of the claimed limitations [see column 20 lines 61-68, column 21 lines 1-24]
Claim 15 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 15 of U.S. Patent No. 12, 433, 690. Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claim disclosed all of the claimed limitations [see column 22 lines 1-20]
Claim 20 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 20 of U.S. Patent No. 12, 433, 690. Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claim disclosed all of the claimed limitations [see column 22 lines 38-60].
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-6, 9-11, 13-16, 18, 20 are rejected under 35 U.S.C. 103 as being unpatentable over Yang et al (Pub. No.: US 2013/0060146) in view of Browd et al (Pub. No.: US 2017/0099479)
Regarding claims 1, 15, 20, Yang et al disclose a system for facilitating insertion of a surgical tool or a medical device into a subject, the system comprising:
a computing device comprising:
a LIDAR scanner (laser range finding) [see 0069, 0071, 0090, 0093, 0134];
a display screen [see 0074, figs 6a-b];
and one or more processors configured to:
receive scanning data (topological image data associated with the exposed surface) from the LIDAR scanner that corresponds to an anatomical surface at a desired location (an exposed surface of the patient) of the subject [see 0010-0013, 0067];
identify one or more landmarks based on the received scanning data [see 0092] by disclosing a surface topography map of a region can be generated [see 0092];
generate a surface map of the surface of the desired location of the subject using the one or more landmarks identified based on the received scanning data [see 0010-0013, 0075, 0085-0087, 0090, 0082, 0090, 0092-0093, 0211, 0221-0222] by disclosing Using a 3D backscattered imaging device, topology maps of real-space surgical surfaces can be created for exposed regions of interest. Correspondingly, by image registration, structural information beneath the surface that is hidden from the surgeon's view is provided [see 0090] and a surface topography map of a region can be generated [see 0092];
correlate (through registration, emphasis added) the anatomical surface map (topology image data) with one or more diagnostic images (CT/MRI) of at least the desired location of the subject [see 0010-0013, 0073, 0085-0089, 0099-0100 and figs 12, 13B, 14];
determine an anatomical entry point for insertion of the surgical tool or the medical device based on the correlation [see 0073, 0103-0106, 0138, 0155, 0211, 0221, figs 4, 6A-B, 7] by disclosing the trajectories collectively define a frustum conical shape with a wider end at an entry surface of the vertebral arch [see 0104];
generate an output "cone of acceptance" indicative of the determined anatomical entry point for display [see 0073, 0103-0106, 0138, 0155, 0193, 0225, figs 6A-B, 7, 31, 34].
Yang et al don’t disclose identify one or more landmarks based on the received scanning data by applying one or more trained neural networks or machine learning models
Nonetheless, Browd et al disclose identify one or more landmarks based on the received scanning data by applying one or more trained neural networks or machine learning models [see 0034] by disclosing the system can utilize pattern recognition to assist in identification of anatomical structures [see 0034].
Therefore, it is obvious to one skilled in the art at the time the invention was filed and would have been motivated to combine Yang et al and Browd et al by identifying one or more landmarks based on the received scanning data by applying one or more trained neural networks or machine learning models; to improve surgical procedure outcomes.
Regarding claims 2, Yang et al disclose wherein the computing device further comprises an orientation sensor [see 0086, 0191] by disclosing the position and orientation of tool 17 may be determined using an additional global position sensor [see 0086]
Regarding claim 3, Yang et al disclose wherein the one or more diagnostic images (intraoperative image) comprise CT or MRI images [see 0099-0100, 0117].
Regarding claim 4, Yang et al disclose wherein the display screen of the computing device is configured to provide an augmented reality display that displays virtual digital images superimposed on a video provided by the optical camera [see 0230]
Regarding claim 5, Yang et al disclose wherein the output comprises a 2D or 3D virtual digital icon or image that is superimposed on the video presented on the display screen of the computing device [see 0230].
Regarding claim 6, Yang et al disclose wherein the virtual digital icon or image comprises: a cross-hair digital icon [see 0117]; or a 3D image of a medical instrument [see fig 34] or shape that is also indicative of a trajectory [see fig 34, 0225].
Regarding claim 9, Yang et al disclose wherein the anatomical surface at the desired location is at or adjacent to a surgically exposed surface [see 0138, 0201].
Regarding claim 10, Yang et al disclose wherein the surgically exposed surface is at least a portion of a spine [see 0024, 0107, 0116].
Regarding claim 11, Yang et al disclose wherein the anatomical surface at the desired location is a portion of an exterior surface of the subject [see 0107 and figs 6A-B].
Regarding claim 13, Yang et al disclose wherein the one or more processors are further configured to determine a surgical trajectory [see 0025, 0103-0104, 0106] by disclosing preoperative image acquisition of a spine of a subject and output including a predetermined principle axis demarcating an implantation trajectory of a surgical interventional device [see 0025].
Regarding claim 14, Yang et al disclose wherein the surgical trajectory is a 3D trajectory [see fig 34, 0225].
Regarding claim 16, Yang et al disclose wherein the one or more processors are further configured to determine a desired orientation for the surgical tool based at least on the surface map and the insertion point. [see 0086; figs 6a-b, 13b, 25, 31, 34].
Regarding claim 18, Yang et al disclose determine a current orientation of the surgical tool [see 0010, 0086, 0211] by disclosing determine a position and an orientation of said movable instrument relative to said exposed surface [see 0010-0012, 0086] and the position and orientation of tool 17 may be determined using an additional global position sensor [see 0086].
responsive to the current orientation of the surgical tool being within a threshold (cone of acceptance 25) of the desired orientation, output a notification [see 0103-0106, 0138, 0155, 0193, 0223, 0225, figs 6A-B, 7, 31, 34] and disclose the cone of acceptance 25 coordinates can then be overlaid onto the vertebrae and provided on the display 4 [see 0112].
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 7-8, 12, 19 are rejected under 35 U.S.C. 103 as being unpatentable over Yang et al (Pub. No.: US 2013/0060146) in view of in view of Browd et al (Pub. No.: US 2017/0099479) as applied to claim 1 above and further in view of Johnson et al (Pub. No.: US 2019/0254754).
Regarding claims 7-8, 12, 19, Yang et al and Browd et al don't disclose wherein the LIDAR scanner, an optical camera, and the one or more processors are housed within the computing device; an optical camera and a display screen, wherein the LIDAR scanner, the optical camera, the one or more processors, and the display screen of the computing device reside on or in a wearable augmented reality device.
Nonetheless, Johnson al disclose wherein the LIDAR scanner, an optical camera, and the one or more processors are housed within the computing device; an optical camera and a display screen, wherein the LIDAR scanner, the optical camera, the one or more processors, and the display screen of the computing device reside on or in a wearable augmented reality device [see 0008, 0102, 0105] by disclosing a head mounted display comprising an at least partially transparent display screen, at least one detector comprises at least one of an optical camera (e.g., a video camera), a LiDAR detector and a processor of a computing device [see 0008];
Johnson al disclose a head mounted display comprising an at least partially transparent display screen, at least one detector comprises at least one of an optical camera (e.g., a video camera), a LiDAR detector and a processor of a computing device [see 0008] and wherein the computing device is a mobile computing device [see 0162].
Therefore, it is obvious to one skilled in the art at the time the invention was filed and would have been motivated to combine Yang et al Browd et al and Johnson et al by having display screen is housed within a wearable augmented reality device communicatively coupled to the computing device; wherein the LIDAR scanner, the optical camera, the one or more processors, and the display screen of the computing device reside on or in a wearable augmented reality device; in order to provide a compact system.
Claim(s) 17 is rejected under 35 U.S.C. 103 as being unpatentable over Yang et al (Pub. No.: US 2013/0060146) in view of in view of Browd et al (Pub. No.: US 2017/0099479) as applied to claim 1 above and further in view of Tako et al (Pub. No.: US 2017/0367771).
Regarding claim 17, Yang et al and Browd et al don’t disclose wherein the one or more processors are further configured to generate a simulation of the desired orientation for the surgical tool.
Nonetheless, Tako al disclose generate a simulation of the desired orientation for the surgical tool [see 0106] by disclosing the instruments' location and orientation is then sent to the surgical .
simulating system. Feedback is provided to the surgeon based on the patient specific simulation and the instruments' location and orientation [see 0106].
Therefore, it is obvious to one skilled in the art at the time the invention was filed and would have been motivated to combine Yang et al, Browd et al and Tako al by generating a simulation of the desired orientation for the surgical tool; because a graphical simulation environment which enables the physician to experience, plan, perform, and navigate the intervention in full spherical virtual reality environment.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOEL F BRUTUS whose telephone number is (571)270-3847. The examiner can normally be reached Mon-Sat, 11:00 AM to 7:00 PM.
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/JOEL F BRUTUS/ Primary Examiner, Art Unit 3797
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