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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Claims 1-5, 8-12, 15-18, and 20 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7, 9, and 16 of U.S. Patent No. 12,193,768. Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims 1, 9, and 16, include elements that correspond to the limitations in claims 1, 15, and 20 of current application. Claim 1 of ‘768 is directed to a “a system for aligning a reference target and an imaging device for robotic surgery, comprising: a processor; and a memory storing instructions for execution by the processor that, when executed, cause the processor to: transmit first instructions configured to cause a robot to position a reference target proximate a body of a patient, receive image data from the imaging device, determine, using an image processing algorithm, an amount of an anatomical element that is represented in the image data, to yield a first determination, determine, using a target detection algorithm, an amount of the reference target that is represented in the image data, to yield a second determination, obtain a comparison of a position of the imaging device, a position of the anatomical element, and a position of the reference target, generate, based on the first determination, the second determination, and the comparison, a repositioning requirement for the imaging device, the reference target, or both, transmit second instructions for repositioning at least one of the imaging device and the reference target based on the repositioning requirement, receive second image data, determine, using the image processing algorithm, that the amount of the anatomical element that is represented in the second image data comprises less than all of the anatomical element to yield a third determination, generate, based on the third determination, a second repositioning requirement, transmit third instructions for repositioning the imaging device based on the second repositioning requirement, compare the image data to one or more known shapes, determine, based on the comparison of the image data to the one or more known shapes, that an object in the image data correlates to a known shape of the anatomical element, and identify the object as the anatomical element in response to determining that the object in the image data correlates to the known shape of the anatomical element, wherein the third instructions are configured to cause automatic repositioning of the imaging device” (similar to claim 1 of current application). Claim 1 of ‘768 includes more specific elements with respect to yielding a third determination where “the amount of anatomical element that is represented in the second image data comprises less than all of the anatomical element to yield a third determination…generate…a second repositioning requirement…transmit third instructions for repositioning the imaging device based on the second repositioning requirement”. Therefore, claim 1 of ‘768 anticipates claim 1 of present application.
Claim 9 of ‘768 includes elements similar to method claim 20 of present application. Claim 9 additionally includes the method steps of “receiving second image data; determining, using the image processing algorithm, that the amount of the anatomical element that is represented in the second image data comprises less than all of the anatomical element to yield a third determination; generating, based on the third determination, a second repositioning requirement; transmitting third instructions for repositioning the imaging device based on the second repositioning requirement; comparing the image data to one or more known shapes; determining, based on the comparison of the image data to the one or more known shapes, that an object in the image data correlates to a known shape of the anatomical element; and identifying the object as the anatomical element in response to determining that the object in the image data correlates to the known shape of the anatomical element, wherein the third instructions are configured to automatically cause repositioning of the imaging device”. Therefore, claim 9 is more specific and anticipates claim 20 of present application.
Claim 16 of ‘768 includes elements similar to claim 15 of present application. Claim 16 includes “a system for aligning an imaging device and a reference target for surgery, comprising :at least one communication interface for communicating with the imaging device and a robot supporting [[a]]the reference target with a robotic arm; a processor; and a memory storing instructions for execution by the processor that, when executed, cause the processor to: receive image data, via the communication interface, from the imaging device, determine, using an image processing algorithm, an amount of an anatomical element that is represented in the image data, to yield a first determination, determine, using a target detection algorithm, an amount of the reference target that is represented in the image data, to yield a second determination, obtain a comparison of a position of the imaging device, a position of the anatomical element, and a position of the reference target, generate, based on the first determination, the second determination, and the comparison, a repositioning requirement for the imaging device, the reference target, or both, transmit second instructions for repositioning at least one of the imaging device and the reference target based on the repositioning requirement, compare the image data to one or more known shapes, determine, based on the comparison of the image data to the one or more known shapes, that an object in the image data correlates to a known shape of the anatomical element, and identify the object as the anatomical element in response to determining that the object in the image data correlates to the known shape of the anatomical element”. The claim includes additional specific elements with respect to the “target detection algorithm” and the “image processing algorithm” and therefore anticipates claim 15 of present application.
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 15 and 20 recite steps to determine an amount of the reference target that is represented in the image data and the amount of anatomical element represented in the image data. However, there is no specific algorithm recited in the body of the claim that would be used to carry out these steps. It is not clear from the claim language how the steps are carried out. The specification makes reference to the “target detection algorithm” and the “image processing algorithm” [0061-0064].
Claims 1, 15, and 20 recites the step of “repositioning to include more of the known shape in a field of view of the imaging device”. However, it is not clear how this step is carried as there is no mention of the specific algorithm in the body of the claims. As per the specification, the “repositioning algorithm…determines if the imaging device 112 and/or the reference target 128 requires repositioning based on whether the imaging device 112 and/or the reference target 128 are misaligned” [0052]. The claims also do not clarify how the repositioning is conducted based on geometric comparison. “The repositioning requirement may be based on a geometric comparison of a position of the imaging device 112 (which is movable), the anatomical element (which is stationary), and a position of the reference target 128 (which is movable)” [0052].
Therefore, it is suggested claims 1, 15, and 20 include the specific algorithms (as set forth above) and the repositioning to be “based on a geometric comparison of a position of the imaging device 112 (which is movable), the anatomical element (which is stationary), and a position of the reference target 128 (which is movable)” [0052].
The corresponding dependent claims do not provide additional clarity and therefore stand rejected under 112(b).
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 20 is rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception in the form of an abstract idea, specifically a mental process, without significantly more. The claim(s) recite(s) “determining, based on the first comparison and/or second comparison, that an object in the image data correlates to a known shape and that the imaging device requires repositioning to include more of the known shape in a field of view of the imaging device”. The limitations, under broadest reasonable interpretation, cover performance of the limitation in the mind, but for the recitation of generic computer components, and/or read on analyzing an image by visual inspection by a user. In this case, “determining…that an object in the image data correlates to a known shape and that the imaging device requires repositioning to include more of the known shape in a field of view of the imaging device”, can be practically performed in the mind by a user/physician viewing an image, through visual inspection. If a claim limitation under its broadest reasonable interpretation covers performance of the limitation in the mind but for the recitation of generic computer components (i.e. a processor), then it falls within the “mental processes” grouping of abstract ideas.
Following step 2A of the two-prong analysis, these judicial exceptions are not integrated into a practical application because the claim merely provides instructions to implement an abstract idea and makes no mention of whether a generic computer (i.e. “using a computer processor”) is used to do so (See MPEP 2106.05(f)). Furthermore, the claims as written do not include elements to 1) improve the functioning of a computer (See MPEP 2105.05(a)); 2) effect a particular treatment or prophylaxis (See MPEP 2106.04(d)(2)); 3) use a particular machine (See MPEP 2106.05(b)); or 4) use the judicial exceptions in a meaningful way beyond generally linking the use to a particular technological environment (See MPEP 2106.05(h)).
Following step 2B of the two-prong analysis, the additional element(s) (i.e. transmitting instruction to reposition the imaging device) do not amount to significantly more than the judicial exception the computer is simply the tool used to perform the abstract idea of determining an object in the image data correlates to a known shape and the device requires repositioning to include the known shape in the field of view of the imaging device (See MPEP 2106.05(f)).
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.
Claim(s) 1-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Crawford et al. in view of Noonan et al. (20160324585).
With respect to claims 1-3, 15-18 and 20, Crawford et al. teach of a system and method for aligning a reference target and an imaging device (col. 2 lines 53-61). Crawford et al. teach of transmitting instructions to cause a robot 15 to position a reference target proximate a body of a patient (col. 16 lines 33-35). Crawford et al. teach of determining if the anatomical element is represented in the image data or where the system can provide feedback to the user regarding whether robot 15 is locked on target (col. 16 lines 55-60). Crawford et al. teach of moving the robot into selected position with a determination to provide warning that there is lack of alignment with respect to anatomy (col. 16 lines 33-45, col. 17 lines 31-61). Crawford et al. therefore teach of an iterative algorithm to assess the mismatch between the anatomy and reference target and the position adjustment needed to move toward the target location with respect to the image processing steps (col. 23 lines 28-45). Crawford et al. teach of processor to receive image data from an imaging device such as CT scan or MRI scan or X-ray image or another anatomical scan (col. 27 lines 28-33). Crawford et al. teach of repositioning the robot or patient based on the repositioning requirement (col. 33 lines 62-64). Crawford et al. teach of a memory for storing instructions and processor to execute the steps of alignment of the imaging device with the reference target (col. 10 lines 61-col. 13 line 9). Crawford et al. teach of the communication interface for the positioning instructions (col. 13 lines 10-17).
Crawford et al. do not explicitly teach of obtaining a comparison of the position of imaging device, the anatomical element, and the reference target and generating a repositioning requirement. In a similar field of endeavor, Noonan et al. teach of a system and method for aligning reference target and an imaging device for robotic surgery that includes a system and method for tracking a device including an intraoperative imaging system 110, with probe 146 configure to generate image of a region, a shape sensing enabled instrument 102 configured to have a portion pensionable relative to the region with a coordinate system registered with coordinate system of intraoperative imaging system with a robot configured to coordinate movement between the probe and the shape sensing enabled instrument (see abstract). Noonan et al. teach of a first feedback loop and a second feedback loop to maintain alignment or register the coordinate system or geometric relationship between the probe and the shape sensing enable instrument to maintain the shape sensing enable instrument within the image [0007, 0008]. Noonan et al. teach of registering the shape of the device to a robot coordinate frame and guiding the robot to bring those devices into a visual field of view of an imaging device and permit repositioning of the imaging device to reach the targets that are not visible in a current view [0018]. Noonan et al. teach of robotic control which can improve generation of virtual images by aligning the imaging volume to the device and allowing repositioning of the probe for the generation of a virtual volume [0020]. Noonan et al. teach of the robot visualizing all targets in a loop to verify position and status of all devices and anatomical structures and view a plurality of targets concurrently [0050]. Noonan et al. teach of registering the coordinate system of the shape sensing enabled device with coordinate system of the imaging system to obtain a geometric comparison of a position of the imaging device, anatomical element, and reference target [0059] and generate a repositioning requirement for the probe to ensure that the shape sensing enabled device and surrounding anatomical region remains in field of view being displayed [0060]. It would have therefore been obvious to one of ordinary skill in the art to use the teaching by Noonan et al. to modify Crawford et al. to permit repositioning of the imaging device to reach the targets that are not visible in the current view [Noonan, 0018] and robotically reposition the probe in accordance with movement of the shape sensing enable instrument and move the probe to maintain the shape sensing enabled instrument within the image [Noonan, 0008, 0009].
With respect to claims 4 and 5, Crawford et al. in view of Noonan et al. teach of the imaging device to be a fluoroscopy device to obtain fluoroscopy data (Crawford, col. 78 lines 62-65).
With respect to claims 6, 7, and 19, Crawford et al. in view of Noonan et al. teach of the imaging device to comprise a CT scanner or MRI scanner (col. 27 lines 29-31).
With respect to claims 8-10, Crawford et al. in view of Noonan et al. therefore teach of receiving more than one set of image data, determining if there is alignment and representation of the anatomy and transmitting instructions for repositioning the camera or the reference target (Crawford, col. 33 lines 62-64), where the repositioning would obviously involve changing the direction of the position of the anatomical element that is not represented in the image data for proper alignment. Noonan et al. additionally teach of repositioning of the imaging device to reach targets that are not visible in a current view [0018] where the probe can be controlled robotically to ensure alignment of the imaging volume to the device and allowing repositioning of the probe [0020]. Noonan et al. therefore teach of the robot to continuously track the device 214 while keeping the device 214 in the field of view [0050, 0051] where an ideal orientation is computed so that the target 402 is in the middle of the volume [0053]. Therefore, the combined teachings provide support for providing instructions for repositioning the target and/or imaging device based on repositioning requirements to optimize the field of view being displayed of the alignment [Noonan, 0060].
With respect to claims 11 and 12, Crawford et al. in view of Noonan et al. teach of transmitting third instructions to reposition the reference target toward a center of an image represented by the second image data where the reference target is represented in the second image data or with the use of parallax affecting the image symmetrically about the center of the image with two markers that in the same projected position and are at the center of the image may appear to be exactly on top of each other (Crawford, col. 82 lines 18-24 lines 43-50). Crawford et al. teach of obtaining first image data and second image data or two images where coordinates of the markers can be found on the two images and positions of the anatomy and planned trajectories relative to these reference points can be related to these reference positions (col. 78 lines 41-61). Noonan et al. additionally teach of repositioning of the imaging device to reach targets that are not visible in a current view [0018] where the probe can be controlled robotically to ensure alignment of the imaging volume to the device and allowing repositioning of the probe [0020]. Noonan et al. therefore teach of the robot to continuously track the device 214 while keeping the device 214 in the field of view [0050, 0051] where an ideal orientation is computed so that the target 402 is in the middle of the volume [0053]. Therefore, the combined teachings provide support for providing instructions for repositioning the target and/or imaging device based on repositioning requirements to optimize the field of view being displayed of the alignment [Noonan, 0060].
With respect to claims 13 and 14, Crawford et al. in view of Noonan et al. teach of the known shape to be circular provided to the user to identify the tail of the planned trajectory and could have different shapes (col. 78 lines 62-col. 79 line 5).
Conclusion
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/BAISAKHI ROY/Primary Examiner, Art Unit 3797