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 § 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.
Claims 26-45 are rejected under 35 U.S.C. 101 because the claimed invention is directed to abstract ideas in the form of mental processes without significantly more.
The claim(s) recite(s) the following abstract ideas:
“receive shape information…” (claims 26 and 41);
“compare the receive shape information to a plurality of linked elements of a model…” (claims 26 and 41);
“generate adjusted position information…” (claims 26 and 41);
“create an adjusted image…” (claims 26 and 41); and
“generate a composite image including the model…and the adjusted instrument image…” (claims 26 and 41).
The cited limitations, under their broadest reasonable interpretation, cover performance in the mind in that nothing precludes them from being practically performed in the mind, or with the assistance of basic physical aids. See MPEP 2106.04(a)(2)(III)(B). In this case, the shape information is merely received and then compared to a model and adjusted position information is generated based on the comparison which is simply a calculation which constitutes a mental process regardless of whether performed with the assistance of pen/paper. Creating an adjusted instrument image and generating a composite image rely on a model which is provided in a pre-solution activity and the claims only disclose these steps with a high level of generality which allows for them to be practically performed in the mind, or with the assistance of basic physical aids.
The judicial exception is not integrated into a practical applications because while the cited steps (claims 26 and 41) are optionally associated with one or more processors (claim 26), this is generic computer hardware and simply represents implementing the abstract ideas with a computer. MPEP 2106.05(f) notes that “using a computer as a tool to perform the abstract idea” is not sufficient to integrate a judicial exception into a practical application as interpreted by the court(s). Gottschalk v. Benson, 409 U.S. 63, 175 USPQ 673 (1972) held that “simply implementing a mathematical principle on a physical machine, namely a computer, wave not a patentable application of that principle” and Intellectual Ventures LLC v. Symantec Corp., 838 F.3D 1307, 1318 (Fed.Cir. 2016) established that mental processes encompass acts which, absent anything beyond generic computer components, may be “performed by a human, mentally or with pen and paper.” Intellectual Ventures additionally established that if a claim, under its broadest reasonable interpretation, covers performance in the mind but for the recitation of generic computer components, then it is still in the mental processes category of abstract ideas unless the claim cannot be practically performed in the mind or with the aid of basic physical aids in the ways elaborated.
Independent claim 26 includes the additional limitations of an elongate instrument and a tracking system disposed along at least a portion of the elongate instrument at a high level of generality for the purpose of data gathering; however, these features do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the steps are based on generic data gathering and merely specifies the nature of the data exploited in executing the abstract ideas and only generally links to a particular technological environment or field of use. See MPEP 2106.05(g) on pre-solution activity and its failure to constitute significantly more. Examiner notes independent claim 41 does not disclose these structures.
Dependent claims 27-40 and 42-45 further define the mathematical concepts used to perform the steps; however, the claims are only directed to receiving, comparing, generating and creating already acquired information and do not provide any active steps or functions to amount to significantly more than the judicial exception.
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.
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) 26-32, 34-37 and 39-44 is/are rejected under 35 U.S.C. 103 as being unpatentable over Soper et al (7,901,348) in view of Homan et al (2008/0171936) and further in view of Harks et al (2013/0204134).
Regarding claim 26, Soper et al disclose a medical system comprising:
an elongate instrument (flexible endoscope 24 is inserted through a multi-function endoscopic catheter 22 – col.8, ll.58-59);
a tracking system disposed along at least a portion of the elongate instrument (a sensor provides signals through leads 54 that enable electromagnetic position tracking of the distal end of the flexile endoscope in vivo, indicating its position with up to five to six degrees of freedom – col.9, ll.25-30; touch sensors 98…which serves as reference for tracking the flexible endoscope – col.10, ll.65-67; sensor 27 – fig.7A); and
one or more processors coupled to the tracking system (computer workstation 56 – fig.1A; light source and processor 282 – fig.7A; processor – claim 1), wherein the one or more processors are configured to:
receive position information for a portion of the elongate instrument when the portion is disposed in a set of connected passageways of a patient anatomy (position and measurements made in the absolute coordinate frame (ACF), step 333 – col.19, ll.41-43; fig.8B);
compare the received position information to a plurality of linked elements of a model of the set of connected passageways (a step 350 indicates that the position data for the distal end of the flexible endoscope can be more closely related to the model coordinate frame (MCF) – col.19, ll.46-48; fig.8B);
generate adjusted position information for the portion of the elongate instrument based on the comparison (snapping the position measured to the centerline of the passage in the 3-D model for both real-time image display as well as for precisely determining navigation history relative to the centerlines that comprise the airway tree model – col.19, ll.48-52);
create an adjusted instrument image with the adjusted position information (snapping…for real-time virtual image display – col.19, ll.48-52).
Soper et al fail to explicitly disclose generate a composite image including the model of the set of connected passageways and the adjusted instrument image within the model.
However, Homan et al teach in the same medical field of endeavor, generate a composite image including a model of a set of connected passageways and an adjusted instrument image within the model (an image of the catheter can be registered with the reconstructed 3D model…based on the known current location of the catheter in the 3D model, an optical projection direction can be determined - abstract).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the adjusted instrument image and model of Soper et al with generating a composite image including a model and an adjusted instrument image within the model as it would provide real-time position of the instrument relative to the anatomy.
Soper et al as modified by Homan et al fail to explicitly disclose shape information for a portion of the elongate instrument.
However, Harks et al teach in the same medical field of endeavor, shape information for a portion of an elongate instrument ([0092]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the position information including up to six degrees of freedom of Soper et al as modified by Homan et al with shape information as multiple fiber Bragg grating sensors, at various positions, along the instrument can provide the curvature of the structure inferred at that position to provide the total three-dimensional form of the instrument.
Regarding claim 27, Soper et al disclose wherein generating the adjusted position information comprises snapping one or more points of the position information to a nearest linked element of the plurality of linked elements (col.19, ll.46-52).
Regarding claim 28, Soper et al disclose wherein snapping the one or more points of the shape information to the nearest linked element of the plurality of linked elements comprises snapping the one or more points to a wall of the nearest linked element (col.19, ll.46-52).
Regarding claim 29, Soper et al disclose wherein snapping the one or more points of the shape information to the nearest linked element of the plurality of linked elements comprises determining a distance between the one or more points and a centerline of the nearest linked element (precisely determining navigation history relative to the centerlines that comprises the airway tree model – col.19, ll.46-52).
Regarding claims 30-32, Soper et al disclose the position information is received from the tracking system and wherein the tracking system comprises a plurality of position sensors (a sensor provides signals through leads 54 that enable electromagnetic position tracking of the distal end of the flexile endoscope in vivo, indicating its position with up to five to six degrees of freedom – col.9, ll.25-30; touch sensors 98…which serves as reference for tracking the flexible endoscope – col.10, ll.65-67; sensor 27 – fig.7A), but fail to explicitly disclose wherein the tracking system comprises a shape sensor.
However, Harks et al teach in the same medical field of endeavor, a tracking system comprises a shape sensor and the shape information is received from the tracking system ([0092]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the EM tracking system of Soper et al as modified by Homan et al with comprising a shape sensor as it would provide the total three-dimensional form of the instrument positions.
Regarding claim 34, Soper et al disclose wherein the one or more processors are further configured to: change the adjusted instrument image to depict advancement or withdrawal of the elongate instrument through the model (snapping…for real-time virtual image display as well as precisely determining navigation history – col.19, ll.48-52).
Regarding claim 35, Soper et al disclose wherein the one or more processors are further configured to: generate the model of the set of connected passageways from one or more stored images (The 3-D model is preferably derived from an image of a portion of a body in which the linked passages are disposed, for example using the images produced by a CT or MRI scan – col.3, ll.62-65).
Regarding claim 36, Soper et al disclose wherein generating the adjusted position information for the portion of the elongate instrument comprises identifying a nearest linked element of the plurality of linked elements (snapping the position measured to the centerline of the passage in the 3-D model for both real-time image display as well as for precisely determining navigation history relative to the centerlines that comprise the airway tree model – col.19, ll.48-52).
Regarding claim 37, Soper et al disclose wherein generating the adjusted position information for the portion of the elongate instrument comprises determining a set of distances between the portion of the elongate instrument and centerlines of the plurality of linked elements (snapping the position measured to the centerline of the passage in the 3-D model for both real-time image display as well as for precisely determining navigation history relative to the centerlines that comprise the airway tree model – col.19, ll.48-52).
Regarding claim 39, Soper et al disclose wherein generating the adjusted position information for the portion of the elongate instrument comprises generating a projection between the portion of the elongate instrument and a centerline of a nearest linked element of the plurality of linked elements (projecting a position of the distal end of the flexible endoscope to a point on a three-dimensional path defined by the tree-dimensional model – claim 47).
Regarding claim 40, Soper et al disclose wherein the adjusted position information includes an adjusted position for the portion of the elongate instrument that is along the projection (said point representing a most likely position of the distal end of the flexible endoscope relative to the linked passages of the three-dimensional model – claim 47). Regarding claim 41, Soper et al disclose a method comprising:
receiving position information for a portion of the elongate instrument when the portion is disposed in a set of connected passageways of a patient anatomy (position and measurements made in the absolute coordinate frame (ACF), step 333 – col.19, ll.41-43; fig.8B);
comparing the received position information to a plurality of linked elements of a model of the set of connected passageways (a step 350 indicates that the position data for the distal end of the flexible endoscope can be more closely related to the model coordinate frame (MCF) – col.19, ll.46-48; fig.8B);
generating adjusted position information for the portion of the elongate instrument based on the comparison (snapping the position measured to the centerline of the passage in the 3-D model for both real-time image display as well as for precisely determining navigation history relative to the centerlines that comprise the airway tree model – col.19, ll.48-52);
creating an adjusted instrument image with the adjusted position information (snapping…for real-time virtual image display – col.19, ll.48-52).
Soper et al fail to explicitly disclose generating a composite image including the model of the set of connected passageways and the adjusted instrument image within the model.
However, Homan et al teach in the same medical field of endeavor, generating a composite image including a model of a set of connected passageways and an adjusted instrument image within the model (an image of the catheter can be registered with the reconstructed 3D model…based on the known current location of the catheter in the 3D model, an optical projection direction can be determined - abstract).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the adjusted instrument image and model of Soper et al with generating a composite image including a model and an adjusted instrument image within the model as it would provide real-time position of the instrument relative to the anatomy.
Soper et al as modified by Homan et al fail to explicitly disclose shape information for a portion of the elongate instrument.
However, Harks et al teach in the same medical field of endeavor, shape information for a portion of an elongate instrument ([0092]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the position information including up to six degrees of freedom of Soper et al as modified by Homan et al with shape information as multiple fiber Bragg grating sensors, at various positions, along the instrument can provide the curvature of the structure inferred at that position to provide the total three-dimensional form of the instrument.
Regarding claim 42, Soper et al disclose wherein generating the adjusted position information comprises snapping one or more points of the position information to a nearest linked element of the plurality of linked elements (col.19, ll.46-52).
Regarding claim 43, Soper et al disclose the position information is received from the tracking system extending along at least the portion of the elongate instrument (a sensor provides signals through leads 54 that enable electromagnetic position tracking of the distal end of the flexile endoscope in vivo, indicating its position with up to five to six degrees of freedom – col.9, ll.25-30; touch sensors 98…which serves as reference for tracking the flexible endoscope – col.10, ll.65-67; sensor 27 – fig.7A), but fail to explicitly disclose wherein the shape information is received from a tracking system extending along at least the portion of the elongate instrument.
However, Harks et al teach in the same medical field of endeavor, shape information is received from a tracking system extending along at least a portion of an elongate instrument ([0092]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the EM tracking system of Soper et al as modified by Homan et al with receiving shape information from a tracking system extending along at least the portion of the elongate instrument as it would provide the total three-dimensional form of the instrument positions.
Regarding claim 44, Soper et al disclose wherein generating the adjusted position information for the portion of the elongate instrument comprises determining a set of distances between the portion of the elongate instrument and centerlines of the plurality of linked elements (snapping the position measured to the centerline of the passage in the 3-D model for both real-time image display as well as for precisely determining navigation history relative to the centerlines that comprise the airway tree model – col.19, ll.48-52).
Allowable Subject Matter
Claims 33, 38 and 45 are allowable over the prior art but are dependent upon a rejected based claim and are currently rejected under 35 U.S.C. 101.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROCHELLE DEANNA TURCHEN whose telephone number is (571)270-7104. The examiner can normally be reached Mon - Fri 6:30-2:30.
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/ROCHELLE D TURCHEN/Primary Examiner, Art Unit 3797