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 .
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) and under 35 U.S.C. 365(c) is acknowledged.
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 1-15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Statutory Category: YES - The claim recites a tracking system device and, therefore, is a device.
Step 2A, Prong 1, Judicial Exception: YES - The claim recites the limitation of detect real-time position of the movable sensor within the global coordinate system, set an origin of the global coordinate system as an anchor point in relation to the patient’s body; span a first reference plane, span a second reference plane, span a third reference plane, and translate any or all of the reference planes in parallel based on an expected movement path of the movable sensor (consistent with the disclosure, interpreted by examiner to be an arbitrary choice by the user, also see 112(b) rejection that follows). Courts have placed tracking systems in the mathematical concept grouping of abstracts ideas (Thales Visionix, Inc. v. United States, 850 F.3d 1343, 1348-49, 121 USPQ2d 1898, 1902-03 (Fed. Cir. 2017)).
This limitation, as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer component “controller”. That is, other than reciting “controller,” nothing in the claim element precludes the steps from practically being performed in the mind. For example, but for the “controller” language, the claim encompasses a user simply taking the position of a sensor and defining arbitrary planes relative to an origin and arbitrarily moving those planes in parallel. The mere nominal recitation of a generic controller does not take the claim limitation out of the mathematical concept grouping. Thus, the claim recites a mathematical concept.
Step 2A, Prong 2, Integrated into Practical Application: No - The claim recites additional elements: an emitting device, a movable sensor, and a first reference sensor. The sensors and emitting device are recited at a high level of generality (i.e., as a general means of emitting and detecting a tracking signal), and amounts to mere data gathering, which is a form of insignificant extra-solution activity. The controller that performs the detect, set, span, and translate steps is also recited at a high level of generality, and merely automates the mathematical steps. Each of the additional limitations is no more than mere instructions to apply the exception using a generic component.
The combination of these additional elements is no more than mere instructions to apply the exception using a generic component. Accordingly, even in combination, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. The claim is directed to the abstract idea.
Step 2B, Inventive Concept: No - As discussed with respect to Step 2A Prong Two, the additional elements in the claim amount to no more than mere instructions to apply the exception using a generic computer component and data collection sensors. The same analysis applies here in 2B, i.e., mere instructions to apply an exception on a generic computer cannot integrate a judicial exception into a practical application at Step 2A or provide an inventive concept in Step 2B. Under the 2019 PEG, a conclusion that an additional element is insignificant extra-solution activity in Step 2A should be re-evaluated in Step 2B. Here, the initial data collection steps performed by the sensors were considered to be extra-solution activity in Step 2A, and thus it is re-evaluated in Step 2B to determine if it is more than what is well-understood, routine, conventional activity in the field. The background of the specification does not provide any indication that the controller is anything other than a generic, off-the-shelf computer component, and the Symantec, TLI, and OIP Techs. court decisions cited in MPEP 2106.05(d)(II) indicate that mere collection or receipt of data over a network is a well‐understood, routine, and conventional function when it is claimed in a merely generic manner (as it is here). Accordingly, a conclusion that the collecting step is well-understood, routine, conventional activity is supported under Berkheimer Option 2. Further, as cited below in the prior art rejection with US 20200170807 to Bettenga, the sensors and emitting device are routine, well-understood and conventional in medical position tracking systems. To further support this conclusion, there is an entire classification area for patent applications that utilize this technology (i.e. A61B2034/2051 electromagnetic tracking system used in surgery in which there are tens of thousands of documents). For these reasons, there is no inventive concept in the claim, and thus it is ineligible.
Examiner has also reviewed the dependent claims for eligibility but there is nothing that amounts to an inventive concept for the same reasons as above. Claim 14 includes a display but it cannot be said to improve the underlying technology because of how generic it is claimed. However, if more specificity was given to what was being displayed (so as to amount to an improvement in guided surgery), it could make the claims patent eligible.
Applicant’s attention is directed towards MPEP 2106.05(a)(II) wherein an improvement in existing technology was demonstrated in order to make the claimed invention patent eligible. In a similar tracking system technology, a particular configuration of inertial sensors and a particular method of using the raw data from the sensors was determined to be patent eligible (Thales Visionix, Inc. v. United States, 850 F.3d 1343, 1348-49, 121 USPQ2d 1898, 1902 (Fed. Cir. 2017)). In the current claims, the sensors are not particular and there is no use of the raw data from the sensors that can be said to be an inventive concept, e.g. no visual display is made that could be used to improve guided surgery.
Claim Rejections - 35 USC § 112(b)
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 1-15 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.
Regarding Claim 1, “translate in parallel…based on an expected movement path of the movable sensor” is not understood because “expected movement path” appears to be an arbitrary determination by the user as disclosed. Further, as claimed, it does not take into account the detected position of the movable sensor, making it seem like the parallel translation is arbitrarily chosen. It is not clear what scope to give to this limitation.
Claims 2-15 are rejected due to their dependency on a rejected claim.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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 1-15 are rejected under 35 U.S.C. 103 as being unpatentable over US 20200170807 to Bettenga in view of US 20170231580 to Relan.
Regarding Claim 1, Bettenga teaches a tracking system (tracking system 100, Figure 1) comprising:
an emitting device (electromagnetic field generator 20, Figure 1) configured to establish a measurement volume within at least a part of a patient’s body (electromagnetic fields 22 are transmitted in the volume of the patient, Figure 1), the patient’s body having a median plane (sagittal plane 204, Figure 2), a transverse plane (transverse plane 206, Figure 2), and a coronal plane (coronal plane 202, Figure 2);
a movable sensor (magnetic sensor 30c, Figure 1) which is movable within the measurement volume (par. 0038, 0062);
a first reference sensor (magnetic sensor 30a, Figure 1) establishing a global coordinate system within the measurement volume (par. 0057), the global coordinate system having an origin, an x-axis, a y-axis, and a z-axis (Cartesian system is being used); and
a controller configured to:
detect real-time positions of the movable sensor within the global coordinate system (par. 0059);
set the origin of the global coordinate system as an anchor point in relation to the patient’s body (par. 0057);
span a first reference plane in direction of the x-axis and the z-axis being parallel to the median plane (third plane 620, par. 0055; median and sagittal are synonymous);
span a second reference plane in direction of the y-axis and the z-axis being parallel to the transverse plane (second plane 610, par. 0055);
span a third reference plane in direction of the x-axis and the y-axis being parallel to the coronal plane (plane 420, par. 0055).
Bettenga does not teach the controller is configured to translate in parallel at least one of the first reference plane, the second reference plane, or the third reference plane based on an expected movement path of the movable sensor. Instead, Bettenga maintains the relative positions of the planes relative to the global reference frame regardless of moving the instrument tracking sensor 30c (par. 0055-0057). That is, the planes represent the global frame of reference for the movable tracking sensor 30c.
However, Relan teaches a tracking system wherein an instrument 13 is tracked relative to coronal plane (502), axial plane (504), and sagittal/median plane (506) (par. 0048, Figure 5). The tracked location of the instrument 13 relative to the global frame of reference is used to slide the planes in parallel to their global plane, as shown in Figure 5 Image Viewer by slice images 502, 504, 506 and 3D graphical representation 500 with all three planes visible. The three planes intersect at the position of the tracked instrument that is moving within the volume. Further, the selection is made by the user to view the expected movement path or made automatically (par. 0049).
As such, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to utilize the viewing technique of Relan to translate in parallel at least one of the first reference plane, the second reference plane or the third reference plane based on an expected movement path of the movable sensor in the system of Bettenga in order to view the anatomy at the expected location of the tracked instrument (which corresponds with the movable sensor).
Regarding Claim 2, Relan further teaches wherein the first reference plane, the second reference plane and the third reference plane establish eight octants within the measurement volume, and wherein the controller is configured to adjust a partition of the eight octants based on the expected movement path of the movable sensor (as depicted in diagram 500, Figure 5, there are eight octants created by the intersection of the three planes; the partition is adjusted as the user selects the intersection point within the GUI, par. 0049).
Regarding Claim 3, Bettenga further teaches a second reference sensor and wherein the controller is further configured to detect a position and/or an orientation of the second reference sensor within the global coordinate system (locations 410a-410c, par. 0050, 0041, 0049).
Regarding Claim 4, Bettenga further teaches wherein the controller is further configured to:
align the x-axis in parallel with a line of intersection of the coronal plane and the median plane; and/or
align the y-axis in parallel with a line of intersection of the transverse plane and the coronal plane; and/or
align the z-axis in parallel with a line of intersection of the median plane and the transverse plane (par. 0051, 0053-0055, 0057; median-lateral axis 510).
Regarding Claim 5, Bettenga further teaches wherein the first reference sensor is configured to be manually aligned with the median plane and/or the transverse plane and/or the coronal plane such that the x-axis is parallel with a line of intersection of the coronal plane and the median plane, and/or such that the y-axis is parallel with a line of intersection of the transverse plane and the coronal plane, and/or such that the z-axis is parallel with a line of intersection of the median plane and the transverse plane (par. 0047, 0048, magnetic sensor 30a is attached directly to the pelvis and aligned with the planes).
Regarding Claim 6, Bettenga further teaches a third reference sensor, the controller being configured to set an orientation of the median plane, an orientation of the transverse plane, and/or an orientation of the coronal plane within the measurement volume based on the orientation of the third reference sensor (locations 410a-410c, par. 0050, 0041, 0049).
Regarding Claim 7, Bettenga further teaches wherein the controller is further configured to detect a crossing of the movable sensor with at least one of the first reference plane, the second reference plane, or the third reference plane (locations 410a-410c, par. 0050 “one or more magnetic sensors or other reference devices”, par. 0041, 0049).
Regarding Claim 8, Bettenga further teaches the controller is further configured to establish a target volume within the global coordinate system (the region of interest around the pelvis is considered as a target volume which is also displayed on the user interface 11, Figure 1).
Regarding Claim 9, Bettenga further teaches wherein the controller is further configured to establish a spatially limited auxiliary plane, the auxiliary plane indicating a unique structure within the patient’s body (par. 0058, the control unit 10 determines the orientation of an impaction axis 710; par. 0059, the impaction axis 710 indicates the pelvis, a unique structure within the patient’s body; par. 0060, the control unit 10 determines the orientation of the surgical tool 80 (i.e. another axis) relative to the impaction axis 70; the two axes define a plane, and hence, the control unit 10 is configured to establish a spatially limited auxiliary plane).
Regarding Claim 10, Bettenga does not expressly teach wherein the first reference sensor is a six degrees of freedom sensor and/or the second reference sensor is a six degrees of freedom sensor (one of ordinary skill would recognize the coils and additional sensors permit both x, y, z positions and roll, pitch, yaw orientations to be determined, par. 0038, thereby providing six degrees of freedom).
Regarding Claim 11, Bettenga further teaches a medical device, wherein the movable sensor is attached to the medical device, and wherein the medical device comprises an intravascular blood pump or a guidewire for an intravascular blood pump (Figure 8, par. 0038, 0062).
Regarding Claim 12, Bettenga further teaches wherein the emitting device is an electromagnetic field generator (par. 0032).
Regarding Claim 13, Bettenga further teaches wherein the movable sensor is an embedded electromagnetic sensor (sensor 30c does not protrude from the device 80 and so it is considered to be embedded, Figure 1) and/or wherein the movable sensor is a five degrees of freedom sensor or a six degrees of freedom sensor (one of ordinary skill would recognize the coils and additional sensors permit both x, y, z positions and roll, pitch, yaw orientations to be determined, par. 0038, thereby providing six degrees of freedom).
Regarding Claim 14, Bettenga further teaches a display device configured to display one or more of the real-time positions of the movable sensor, the first reference plane, the second reference plane, the third reference plane, a target volume, an auxiliary plane in the global coordinate system, octants within the measurement volume, or the real-time positions of the movable sensor in relation to one or more of the first reference plane, the second reference plane, the third reference plane, the target volume, the auxiliary plane in the global coordinate system or the octants ()par. 0040, Figure 1, the user interface 11 is configured to display the region of interest, i.e. the target volume; further in combination with Relan, the tracked location of the instrument 13 relative to the global frame of reference is displayed, as shown in Figure 5 Image Viewer by slice images 502, 504, 506 and 3D graphical representation 500 with all three planes and octants visible.).
Regarding Claim 15, Bettenga further teaches an input device (user interface 11) configured to communicate with the controller (par. 0040, 0058, 0068).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US 20190247130, US 20230233264, US 11464578, US 12419695 to State teaches sliding parallel planes to display octants with a tracked surgical instrument (Figure 2). US 6282437 to Franck teaches utilizing three intersecting planes and moving them parallel to track and display a surgical instrument (Figure 14a).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANGELA MARIE HOFFA whose telephone number is (571)270-7408. The examiner can normally be reached Monday - Friday 9:30 am - 6:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Keith Raymond can be reached at (571)270-1790. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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ANGELA M. HOFFA
Primary Examiner
Art Unit 3799
/Angela M Hoffa/ Primary Examiner, Art Unit 3799