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 .
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
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 2, 13, and 19 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.
Claim 2 is indefinite because the claim recites a step of a method, whereas the claim is directed to a system. The claim is therefore a hybrid apparatus/method claim, which the Federal Circuit has held are indefinite under §112, second paragraph. See Rembrandt Data Techs., LP v. AOL, LLC, 641F.3d 1331, 1339 (Fed. Cir. 2011) (holding apparatus claim reciting active transmitting step indefinite). This is a critical defect because it is unclear whether the claim covers a device that is merely capable of performing the recited function or if the function must actually be performed.
Claim 2 is indefinite because there is unclear antecedent basis for “a simultaneous localization and mapping heuristic”. It is unclear if this is the heuristic in claim 1.
Claim 13 is indefinite because the claim recites an action rather than a structural feature of the claimed system. The claim is therefore a hybrid apparatus/method claim, which the Federal Circuit has held are indefinite under §112, second paragraph.
Claim 19 is indefinite because the claim recites an action rather than a structural feature of the claimed system. The claim is therefore a hybrid apparatus/method claim, which the Federal Circuit has held are indefinite under §112, second paragraph.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 5 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 5 requires the determining the position of the second point is before, during, or after another step. This fails to limit claim 1 because the determining the position of the second point must necessarily be either before, during, or after the other step, as a matter of basic temporal dynamics.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claim 17 is rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). The claim reads on a human organism because it recites instruments “positioned to hold the portion of the anatomy”, thereby requiring the anatomy to define the position of the instruments. Examiner suggests amending the claim to recite the instruments are “configured to be” positioned as recited.
Claims 1 - 2, 4 - 19, 33 and 43 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a mental-process type abstract idea) without significantly more.
Independent claim 1:
With regard to Step 1, the claim is directed to one of the four statutory categories of invention, i.e., a computer-assisted medical system.
With regard to Step 2A: Prong 1, the claim recites limitations directed towards:
determining, based on a position of the first instrument within the scene, a position of a first point on the anatomy;
determining, based on a position of the second instrument within the scene, a position of a second point on the anatomy;
determining, based on the position of the first point and the position of the second point, a first distance value representative of a physical distance between the first point and the second point;
identifying, based on an updated position of the second instrument, a position of a third point on the anatomy;
determining, based on the position of the third point, a second distance value representative of a physical distance between the third point and the second point;
tracking one or more of the first, second, or third points relative to the anatomy using a simultaneous localization and mapping heuristic, wherein the determining of at least one of the first or second distance values is further based on the tracking; and
determining, based on the first and second distance values, a cumulative measurement value representative of a distance along the anatomy between the first, second, and third points.
As drafted, these limitations amount to nothing more than steps that can practically be performed in the human mind and/or with the aid of pen/paper, and/or a mathematical process (e.g., the use a simultaneous localization and mapping heuristic). Therefore, the limitations recite a mental-process type abstract idea. See MPEP 2106.04(a)(2).
With regard to Step 2A: Prong 2, the claim recites additional elements involving:
a first repositionable manipulator arm coupled to a first instrument and configured to move the first instrument relative to an anatomy within a scene being imaged by an imaging device. However, in the context of the claim, the first arm functions solely as a means to provide data that the judicial exception acts upon1. The recitation of the first arm is therefore considered to be generic hardware for extra-solution activity, which would be required in any implementation of the judicial exception. The description of the configuration of the first arm merely limits the judicial exception to a particular technological environment or field of use.
a second repositionable manipulator arm coupled to a second instrument and configured to move the second instrument relative to the anatomy within the scene. However, in the context of the claim, the second arm functions solely as a means to provide data that the judicial exception acts upon. The recitation of the second arm is therefore considered to be generic hardware for extra-solution activity, which would be required in any implementation of the judicial exception. The description of the configuration of the second arm merely limits the judicial exception to a particular technological environment or field of use.
a computing device configured to perform the mental step, which amounts to no more than an instruction to implement the judicial exception on a computer.
Therefore, the recited additional elements do not, either individually or as a whole, integrate the judicial exception into a practical application.
With regard to Step 2B, as explained above, the additional limitations are directed towards generic hardware for extra-solution activity, limiting the judicial exception to a particular technological environment or field of use, and an instruction to implement the judicial exception on a computer. Therefore, when considered separately and in combination, the additional limitations do not result in the claim, as a whole, amounting to significantly more than the judicial exception.
Independent claim 33:
With regard to Step 1, the claim is directed to one of the four statutory categories of invention, i.e., a method.
With regard to Step 2A: Prong 1, the claim recites limitations directed towards:
determining, based on a position of the first instrument within the scene, a position of a first point on the anatomy;
determining, based on a position of the second instrument within the scene, a position of a second point on the anatomy;
determining, based on the position of the first point and the position of the second point, a first distance value representative of a physical distance between the first point and the second point;
identifying, based on an updated position of the second instrument, a position of a third point on the anatomy;
determining, based on the position of the third point, a second distance value representative of a physical distance between the third point and the second point;
tracking one or more of the first, second, or third points relative to the anatomy using a simultaneous localization and mapping heuristic, wherein the determining of at least one of the first or second distance values is further based on the tracking; and
determining, based on the first and second distance values, a cumulative measurement value representative of a distance along the anatomy between the first, second, and third points.
As drafted, these limitations amount to nothing more than steps that can practically be performed in the human mind and/or with the aid of pen/paper, and/or a mathematical process (e.g., the use a simultaneous localization and mapping heuristic). Therefore, the limitations recite a mental-process type abstract idea. See MPEP 2106.04(a)(2).
With regard to Step 2A: Prong 2, the claim recites additional elements involving:
the use of a “cumulative measurement system” to perform the mental step, which amounts to no more than an instruction to implement the judicial exception on a computer.
Therefore, the recited additional elements do not, either individually or as a whole, integrate the judicial exception into a practical application.
With regard to Step 2B, as explained above, the additional limitations are directed towards an instruction to implement the judicial exception on a computer. Therefore, when considered separately and in combination, the additional limitations do not result in the claim, as a whole, amounting to significantly more than the judicial exception.
Independent claim 43:
With regard to Step 1, the claim is directed to one of the four statutory categories of invention, i.e., a non-transitory computer-readable medium.
With regard to Step 2A: Prong 1, the claim recites limitations directed towards:
determining, based on a position of the first instrument within the scene, a position of a first point on the anatomy;
determining, based on a position of the second instrument within the scene, a position of a second point on the anatomy;
determining, based on the position of the first point and the position of the second point, a first distance value representative of a physical distance between the first point and the second point;
identifying, based on an updated position of the second instrument, a position of a third point on the anatomy;
determining, based on the position of the third point, a second distance value representative of a physical distance between the third point and the second point;
tracking one or more of the first, second, or third points relative to the anatomy using a simultaneous localization and mapping heuristic, wherein the determining of at least one of the first or second distance values is further based on the tracking; and
determining, based on the first and second distance values, a cumulative measurement value representative of a distance along the anatomy between the first, second, and third points.
As drafted, these limitations amount to nothing more than steps that can practically be performed in the human mind and/or with the aid of pen/paper, and/or a mathematical process (e.g., the use a simultaneous localization and mapping heuristic). Therefore, the limitations recite a mental-process type abstract idea. See MPEP 2106.04(a)(2).
With regard to Step 2A: Prong 2, the claim recites additional elements involving:
the mental step being configured as software stored on a storage device, which amounts to no more than an instruction to implement the judicial exception on a computer.
Therefore, the recited additional elements do not, either individually or as a whole, integrate the judicial exception into a practical application.
With regard to Step 2B, as explained above, the additional limitations are directed towards an instruction to implement the judicial exception on a computer. Therefore, when considered separately and in combination, the additional limitations do not result in the claim, as a whole, amounting to significantly more than the judicial exception.
Dependent claims:
claim 2 recites further calculations, which read on mental steps and/or mathematical functions.
claims 4 - 5 recite features characterizing the mental step, which merely limit the judicial exception to a particular technological environment or field of use.
claims 6 - 9, 12 - 13, and 18 - 19 recite limitations involving display, which are extra-solution activity.
claims 10 - 11, 14, and 16 recite features characterizing the mental step, which merely limit the judicial exception to a particular technological environment or field of use, and/or further mental steps.
claim 15 recites features characterizing the distances, which merely limit the judicial exception to a particular technological environment or field of use.
claim 17 recites features characterizing the instruments, which merely limit the judicial exception to a particular technological environment or field of use.
Therefore, when considered separately and in combination, the additional limitations do not integrate the judicial exception into a practical application, or result in the dependent claims amounting 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.
Claims 1 - 2, 4 - 19, 33, and 43 are rejected under 35 U.S.C. 103 as being unpatentable Itkowitz et al. (US 2010/0317965, of record) in view of Saur (US 2022/0175485).
Regarding claims 1, 33, and 43, Itkowitz shows a computer-assisted medical system (telesurgical therapies through minimally invasive apertures, [0012] and fig. 1) comprising:
a first repositionable manipulator arm (manipulators 23, [0040] and fig. 1) coupled to a first instrument and configured to move the first instrument (tool assembly 26, [0040] and fig. 1) relative to an anatomy within a scene being imaged by an imaging device (“two-handed instrument interaction … hand-over-hand measurement… measure a length of tissue while manipulating the tissue with two grasper instruments…”, [0012] and fig. 1);
a second repositionable manipulator arm (manipulators 23, [0040] and fig. 1) coupled to a second instrument (tool assembly 26, [0040] and fig. 1) and configured to move the second instrument relative to the anatomy within the scene (“two-handed instrument interaction … hand-over-hand measurement… measure a length of tissue while manipulating the tissue with two grasper instruments…”, [0072] and fig. 1); and
a computing device (processor 58, [0044] - [0045] and fig. 4) configured by instructions on a non-transitory computer-readable medium storing to perform a set of processes/method comprising:
determining, based on a position of the first instrument within the scene, a position of a first point on the anatomy (“… point along the grasper of each tool may be tracked … with the Euclidian distance between those points being used to measure the length of tissue currently being grasped …”, [0072]; “… measurement is initiated with the operator grasping the specimen to be measured with one hand or the other …”, [0073] and fig. 11);
determining, based on a position of the second instrument within the scene, a position of a second point on the anatomy ([0072]; “ … non-grasping hand becomes the measuring hand. The system continually computes and displays the computed distance between the tools associated with the right and left hands and master command input devices as well as a running total of prior measurements. Before releasing the grasping hand 202, the non-grasping hand is free to grasp and release multiple times before settling on the desired grasp to commit the measured length …”, [0073] and fig. 11);
determining, based on the position of the first point and the position of the second point, a first distance value representative of a physical distance between the first point and the second point ([0072]; “… Upon releasing the grasping hand 202, the measurement is committed and the relationship between the hands is switched …”, [0073] and fig. 11);
identifying, based on an updated position of the second instrument, a position of a third point on the anatomy ([0072]; “…former measuring hand is then left grasping the specimen, and the former grasping hand is now measuring tool free to designate a new location due to the switching of roles 206 …” [0073] and fig. 11);
determining, based on the position of the third point, a second distance value representative of a physical distance between the third point and the second point (see [0072] - [0073] and fig. 11+15A);
tracking one or more of the first, second, or third points relative to the anatomy, wherein the determining of at least one of the first or second distance values is further based on the tracking (“… tracks the instrument tip when in the measurement mode… point to be coincident with the anatomy to be measured, [0067]; “… point along the grasper of each tool may be tracked … with the Euclidian distance between those points being used to measure the length of tissue currently being grasped …”, [0072]); and
determining, based on the first and second distance values, a cumulative measurement value representative of a distance along the anatomy between the first, second, and third points (“sequentially accumulate the length of tissue grasped between the tools”, [0072]; “running total of prior measurements … Committing the measurement involves adding the computed distance between the two tools to a running total 204 …” [0073] and fig. 11).
Itkowitz is silent as to the tracking using a simultaneous localization and mapping heuristic.
Saur discloses surgical guidance. Saur teaches tracking using a simultaneous localization and mapping heuristic (“tracking … simultaneous localization and mapping (SLAM) method, known per se …”, [0155]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Itkowitz to include tracking one or more of first, second, or third points relative to anatomy using a simultaneous localization and mapping heuristic, wherein determining of at least one of a first or second distance values is further based on the tracking, as taught by Saur, in order to implement a robust, conventional tracking technique that is known per se, as suggested by Saur ([0155]).
Regarding claim 2, the combined invention of Itkowitz and Saur discloses the claimed invention substantially as noted above. Itkowitz further shows determining the positions of the first and second instruments based on kinematics data associated with the first and second instruments (“determine the locations of tissue and/or robotic surgical tools within the internal surgical site …”, [0039]; “making use of joint-based or kinematic robotic data to verify the image-based location information…”, [0057]).
Regarding claims 4 - 5, the combined invention of Itkowitz and Saur discloses the claimed invention substantially as noted above. Itkowitz further shows the determining the position of a select one or both of the first point or the second point is further based on a user input ([0072] - [0073]), wherein the determining the position of the second point is performed prior to, subsequent to, or concurrently with the determining the position of the first point (implicit).
Regarding claims 6 - 7, the combined invention of Itkowitz and Saur discloses the claimed invention substantially as noted above. Itkowitz further shows the computing device is further configured to instruct a display device to display a plurality of visual markers within a display of the scene, wherein each visual marker of the plurality of visual markers is representative of a location of a select one of the first point, the second point, or the third point on the anatomy, wherein the computing device is further configured to instruct the display device to display a virtual overlay between sequential visual markers of the plurality of visual markers within the display of the scene, wherein the virtual overlay is representative of a distance between the sequential visual markers (“… measurement marker or other indicia may be superimposed 114 on a measurement tool. Where only one tool will be used to perform a measurement, it is helpful for the system user to have a visual indication regarding which of the tools is the measurement tool…”, [0049] and fig. 15A).
Regarding claim 8, the combined invention of Itkowitz and Saur discloses the claimed invention substantially as noted above. Itkowitz further shows the computing device is further configured to instruct a display device to display a virtual overlay along a centerline of the anatomy within a display of the scene (see fig. 15A showing a line going through or along the centerline of the anatomy when held accordingly by the graspers).
Regarding claim 9, the combined invention of Itkowitz and Saur discloses the claimed invention substantially as noted above. Itkowitz further shows the computing device is further configured to instruct a display device to display the first and second distance values (“…Increment data may be displayed 126 during movement of the master controller, including the stretch line length, and the like. Optionally, a total length (including prior offsets between pairs of designated tissue locations) may also be superimposed on the image”, [0055]).
Regarding claim 10, the combined invention of Itkowitz and Saur discloses the claimed invention substantially as noted above. Itkowitz further shows the determining the first and second distance values include detecting when the first instrument and the second instrument are holding a portion of the anatomy between the first instrument and the second instrument ([0072] - [0073]).
Regarding claim 11, the combined invention of Itkowitz and Saur discloses the claimed invention substantially as noted above. Itkowitz further shows the determining the first and second distance values is based on detecting that the portion of the anatomy is straightened between the first instrument and the second instrument within a threshold amount (“Once the desired location along flexible tissue FT has been identified and the tissue has been appropriately straightened and/or stretched, the measurement tool 260 may remain in a closed grasping mode while grasping tool 262 is released, the action that updates the cumulative distance measurement to include the latest separation between the tools…”, [0077]).
Regarding claims 12 - 13, the combined invention of Itkowitz and Saur discloses the claimed invention substantially as noted above. Itkowitz further shows the computing device is further configured to instruct a display device to display a visual overlay between the first instrument and the second instrument within a display of the scene, the visual overlay indicative of a straightness of the portion of the anatomy between the first instrument and the second instrument (fig. 15A: the straight stretch line can be interpreted as an overlay indicating a straightness of the anatomy), wherein the visual overlay is dynamically updated as one or both of the first instrument or the second instrument move within the scene (“… stretch line is superimposed on the image of the site from the prior designated tissue location to the moving measurement tool, and more specifically to the marker which remains…”, [0055]).
Regarding claims 14 - 15, the combined invention of Itkowitz and Saur discloses the claimed invention substantially as noted above. Itkowitz further shows the determining the first and second distance values include generating segments along the anatomy between sequential points and calculating a sum of distances of the segments, wherein the distances of the segments are adjustable based on user input (offsets between pairs of designated tissue locations, [0055]; sequentially accumulate the length of tissue grasped between the tools, [0072] - [0073]).
Regarding claim 16, the combined invention of Itkowitz and Saur discloses the claimed invention substantially as noted above. Itkowitz further shows the determining the first and second distance values include generating contours along the anatomy between sequential points and determining distances associated with the contours (contour, [0057]).
Regarding claim 17, the combined invention of Itkowitz and Saur discloses the claimed invention substantially as noted above. Itkowitz further shows the first instrument and the second instrument are positioned to hold the portion of the anatomy such that the portion of the anatomy between the first instrument and the second instrument is visible within the scene (see fig. 15A).
Regarding claims 18 - 19, the combined invention of Itkowitz and Saur discloses the claimed invention substantially as noted above. Itkowitz further shows the computing device is further configured to instruct a display device to display a visual depth indicator within a display of the scene, the visual depth indicator indicative of a depth of the first and second instruments within a field of view of the imaging device, wherein the visual depth indicator is dynamically updated as one or both of the first instrument or the second instrument move within the scene (“Each pixel location effectively provides an associated X-Y location for that eye, with a parallax offset between the coordinate systems generally allowing the depth to be determined per the camera calibration data. The matching may occur while to tool is at the indication location (or if it is in the way, after it moves from between the tissue surface …” , [0054]; “superimposing markers and the like on tissue, on robotic structures (such as tools), or on other structures as shown in the image, it will often be advantageous to have the markers appear at the same depth at which the underlying structure appears in the stereoscopic images presented to the system user…”, [0056]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMELIE R DAVIS whose telephone number is (571)270-7240. The examiner can normally be reached Monday-Friday, 9:30 - 6:00 PST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Pascal Bui-Pho can be reached at (571)272-2714. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AMELIE R DAVIS/Primary Examiner, Art Unit 3798
1 Examiner note: if the claim was amended to recite limitations directed towards using the cumulative measurement value to control the first/second arms in some way, then the above interpretation would be withdrawn, and the limitations directed towards the first/second arms would be considered to provide integration and/or amount to significantly more.
