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 Objections
Claim 15 is objected to because of the following informalities:
The claim limitation “A computer program product comprising computer program code…” should be changed to “A non-transitory computer program product….” Correct is required.
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, specifically independent claims 1 & 14 are directed to an abstract idea without significantly more. Please see the below analysis providing the details as to why the invention is directed towards non-statutory subject matter.
Step 1:
Claim 1 is directed to a system, which is a product, i.e. a statutory category of invention.
Claim 14 is directed to a method, a statutory category of invention.
Step 2A, Prong 1:
Claim 1 recites the method steps of (i.e. processor system is configured to):
“…predicts a position of an electrode…”
“…generate at least one quality measure…”
“…control a user interface to provide a user-perceptible representation…”
Claim 11 recites the method steps of:
“…predicts a position of an electrode…”
“…generating at least one quality measure…”
“…controlling a user interface to provide a user-perceptible representation…”
These limitations, under their broadest interpretation, fall within the mental processes (i.e. predict, generating, controlling, etc.). It would be practical, but for the recitation “a processor system configured to” and a n “user interface,” to perform the steps in a human’s mind, or with a pen and paper, to utilize the claimed signals.
Step 2A, Prong 2:
The claims as a whole fails to integrate the abstract idea into a practical application. Claims 1 & 14 recites the following additional elements, which for the reasons set forth below, do not integrate the abstract idea into a practical application.
Claim 1
“…a processor system configured to…” which is directed to mere instructions to apply an exception, see MPEP 2106.05(f).
“…an electrode…” which is directed to data gathering, see MPEP 2106.05(f).
“…a user interface…” which is directed to data output, see MPEP 2106.05(g).
Claim 14
“…an electrode…” which is directed to data gathering, see MPEP 2106.05(f).
“…a user interface…” which is directed to data output, see MPEP 2106.05(g).
Therefore, the claims fail to integrate the abstract idea into a practical application. The examiner also notes that the additional elements recited in claims 1 & 14 do not apply or use the judicial exception to affect a particular treatment or prophylaxis for a disease or medical condition. The claims are silent to providing any treatment at all to a patient.
Step 2B:
The claims as a whole fails to recite an inventive concept. The additional elements, when considered individually and in combination, do not recite significantly more than the abstract idea for the reasons as set forth above in Step 2A, Prong 2. Upon re-evaluating the limitation that was previously identified as insignificant extra-solution activity in Step 2A, Prong 2, the following evidence to show that the limitation is well-understood, routine and conventional:
real-time discrete data obtained from a medical device/data previously collected from a medical device (i.e. body surface/unipolar electrodes) Presenting offers and gathering statistics, OIP Techs., 788 F.3d at 1362-63, 115 USPQ2d at 1092-93; Receiving or transmitting data over a network, e.g., using the Internet to gather data, Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information); TLI Communications LLC v. AV Auto. LLC, 823 F.3d 607, 610, 118 USPQ2d 1744, 1745 (Fed. Cir. 2016) (using a telephone for image transmission); OIP Techs., Inc., v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1093 (Fed. Cir. 2015) (sending messages over a network); buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014) (computer receives and sends information over a network).
producing at said computer processor a human-readable output (i.e. processor) of the analysis of the gathered data, this is also WURC, as evidenced by Electric Power Group, LLC v. Alstom S.A., 830F.3d 1350, 119 USPQ2d 1739 (Fed.Cir. 2016), which discusses “conventional computer, network, and display technology” and states that “nothing in the patent contains any suggestion that the displays needed for that purpose are anything but readily available. We have repeatedly held that such invocations of computers and networks that are not even arguably inventive are “insufficient to pass the test of an inventive concept in the application” of an abstract idea.” Similarly, there is nothing in Applicant’s specification that indicates that the device that is “producing at said computer processor a human-readable output indicating” the findings of the analysis is anything but readily available.
Therefore, the claims fail to recite significantly more than the abstract idea and claims 1-15 are rejected under 35 U.S.C 101.
The limitation of the dependent claims 2-13, 15 further defines steps obtaining predicted position, determining one or more characteristics, determining the quality measure, determining a sensitivity of the mapping function, controlling a user-perceptible representation, etc. which further limit claim limitations already indicated above as directed to an abstract idea. Therefore, the above claims are directed to patient-ineligible subject matter.
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 1-15 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.
Due to independent claims 1 & 14, it is unclear as to what is being claimed due to the claim limitation “…crossing electric fields induced within the anatomical cavity…” since the “crossing electric fields” are inferentially included and it is unclear if said limitation is being positively or functionally recited.
1.
A processing system for providing a quality measure of a mapping function, wherein the mapping function predicts a position of an electrode, within an anatomical cavity, using the electrical response of the electrode to crossing electric fields induced within the anatomical cavity, wherein the processing system is configured to:
E.G. via the disclosed ‘reconstruction’ of the body cavity based on measurements from a plurality of sensors such as electrodes, in which the reconstruction provides a process from the generation of a representation of a 3D shape of a target based on position data used as an indication of positions within a target anatomical location [(pp. 15, lines 27-31). Said measurements are measurements of crossing electromagnetic fields (pp. 7, lines 1-7).
Note: The examiner is interpreting the disclosed ‘reconstruction’ process as being the claimed mapping function.
generate at least one quality measure, each quality measure representing a quality of the electrode position predicting performed by the mapping function with respect to a particular portion of the anatomical cavity;
E.G. via the disclosed position data used to determine spatial positions of each sensor/electrode associated with an intrabody probe, i.e. a catheter, in order to ‘take’ sets of measurements of one or more parameters identifying particular locations within a body cavity for purposes of reconstruction [(pp. 16, lines 33-35) & (pp. 18, lines 7-25)].
and control a user interface to provide a user-perceptible representation of the at least one quality measure.
E.G. via step 122 in which an image of a reconstruction model is showed according to the positions of which electrodes of the probe have been mapped [(pp. 44, lines 24-32) & (Fig 1B)].
2.
The processing system of claim 1, wherein the processing system is configured to generate at least one quality measure by: obtaining, from a processor that generates the mapping function, the predicted position of two or more electrodes, mounted on an interventional device, within the anatomical cavity for different positions and/or orientations of the interventional device within the anatomical cavity;
E.G. [(pp. 16, lines 33-35) & (pp. 18, lines 7-25)].
determining one or more characteristics of the predicted positions of the two or more electrodes based on the determined predicted positions;
E.G. via the disclosed position data acquired that is based the state of voltage/spatial mapping, such as impedance changes, in order to effectively reach ‘precision’ needed for an operation based on said data [(pp. 46-47) & (pp. 50, lines 5-15)].
and determining, based on the one or more characteristics, the quality measure.
E.G. (pp. 50, lines 10-15).
3.
The processing system of claim 2, wherein the one or more characteristics comprise one or more statistical measures of the predicted positions of the two or more electrodes.
E.G. via the disclosed use of periodically-varying data to constrain a transformation of measurements into reconstruction and the ‘weighted’ combination of new position data [(pp. 31, lines 5-17) & (pp. 50, lines 11-15)].
4.
The processing system of claim 2, wherein the one or more characteristics comprises a density of the predicted positions and/or a uniformity of the distribution of the predicted positions.
E.G., [(pp. 31, lines 5-17), (pp. 50, lines 11-15) & (pp.51, lines 1-16)].
5.
The processing system of claims 1, wherein the processing system is configured to generate at least one quality measure by: obtaining, from a processor generating the mapping function, the predicted position of two or more electrodes, mounted on an interventional device, within the anatomical cavity for different positions and/or orientations of the interventional device within the anatomical cavity;
determining one or more characteristics of the different positions and/or orientations of the interventional device based on the determined predicted positions of the two or more electrodes;
and determining, based on the one or more characteristics, the quality measure.
E.G. via the disclosed method for updating reconstructed body cavity map based on data obtained from an intrabody probe 11 that is based on updated voltage/spatial mapping data in order to effectively reach ‘precision’ needed for an operation based on said data [(pp. 46-47) & (pp. 50, lines 5-15)].
6.
The processing system of claim 5, wherein: the step of determining one or more characteristics of the different positions and/or orientations of the interventional device comprises determining, for each position and/or orientation of the interventional device at which electric responses are obtained,
an orientation of the interventional device with respect to the anatomical cavity based on the predicted positions for the two or more electrodes at the position and/or orientation of the interventional device;
E.G. via the disclosed position data obtained that comprises both voltage and spatial mapping (pp. 50, lines 5-15).
and the one or more characteristics comprises a uniformity of the distribution of the
determined orientations of the interventional device.
E.G. via the disclosed anatomical data that is based on an overall shape of a voltage-measurement to fit an anatomy of a reference geometry Y derived from anatomical data, therefore providing “geometrically” located landmarks (pp. 48, line 1-13).
7.
The processing system of claim 1, wherein the processing system is configured to generate at least one quality measure by determining a sensitivity of the mapping function to changes in the obtained electrical responses.
E.G. via the disclosed ‘additional refinement’ used to obtain precision for operations of the medical procedure associated with spatial reconstruction (pp. 50, lines 5-11).
8.
The processing system of claim 7, wherein the processing system is configured to determine a sensitivity of the mapping function by: processing sample electrical responses using the mapping function to determine first sample predicted positions of the electrodes;
modifying the sample electrical responses; processing the modified sample electrical responses using the mapping function to determine second sample predicted positions of the electrodes;
and determining a sensitivity of the mapping function based on the first sample predicted positions and the second sample predicted positions.
E.G. via the disclosed sampling density used to analyze the voltage measurements in order to determine a probe position in relation to recent treatment, i.e. ablation (pp. 50, lines 1-15).
9.
The processing system of claim 1, wherein the processing system is configured to: obtain electrical responses of two or more of the electrodes;
and generate the at least one quality measure by determining an accuracy of the obtained electrical responses.
E.G. via the disclosed voltage measurements based on recent ablation (pp. 50, lines 1-15).
10.
The processing system of claim 1, wherein the step of determining a quality measure comprises determining a global quality measure representing the predicted overall quality of the mapping function for predicting the position of an electrode within the entire known anatomical cavity.
E.G. via the disclosed reconstruction process utilizing global constraints (pp. 26, lines 17-23).
11.
The processing system of claim 1, wherein the step of determining a quality measure comprises determining one or more local quality measures, each local quality measure representing a predicted quality of the mapping function for predicting a position of an electrode within only a part of the anatomical cavity.
E.G. via the disclosed use of local spatial calibration defined by the local spatial constraints utilized for the reconstruction process [(pp. 15, lines 18-26) & (pp. 24, lines 18-21)].
12.
The processing system of claim 11, wherein the processing system is further configured to generate guidance information for guiding a user to reposition the interventional device at a location of the anatomical structure based on the determined one or more local quality measures.
E.G. via the disclosed display and/or navigation that allows for the probe model to position the probe in relation to the actual target and eventually provide planning ‘revisions’ by adjusting the reconstruction at block 112 in order to update the position of the probe model [(pp. 38, lines 15-35)-(pp. 39, lines 18-33) & (pp. 40, lines 1-8)].
13.
The processing system of claim 12, wherein: the processing system is configured to identify, based on the determined one or more local quality measures, a part of the anatomical cavity associated with the lowest quality;
and the guidance information is designed for guiding a user to reposition the interventional device based on the identified part of the anatomical cavity associated with the lowest quality.
E.G. [(pp. 38, lines 15-35)-(pp. 39, lines 18-33) & (pp. 40, lines 1-8)].
14.
A computer-implemented method for providing a quality measure of a mapping function, wherein the mapping function predicts a position of an electrode, within an anatomical cavity, using the electrical response of the electrode to crossing electric fields induced within the anatomical cavity,
E.G. [(pp. 7, lines 1-7) & (pp. 15, lines 27-31)].
the computer-implemented method comprising: generating at least one quality measure, each quality measure representing a quality of the electrode position predicting performed by the mapping function with respect to a particular portion of the anatomical cavity;
E.G. [(pp. 16, lines 33-35) & (pp. 18, lines 7-25)].
and controlling a user interface to provide a user-perceptible representation of the at least one quality measure.
E.G. (pp. 44, lines 24-32).
15.
A computer program product comprising computer program code means which, when executed on a computing device having a processing system, cause the processing system to perform all of the steps of the method according to claim.
E.G. via the disclosed present invention being embodied as a computer program product (pp. 11, lines 8-14).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NICOLE F JOHNSON whose telephone number is (571)270-5040. The examiner can normally be reached Monday-Friday 8:00am-5:00pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at 571-270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NICOLE F JOHNSON/Primary Examiner, Art Unit 3796