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 1-19 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claim(s) recite(s) wherein the pre-solution receive electrical and anatomical data of a heart of a patient from a surgical system, perform a comparison of the electrical and anatomical data of the heart to the database information, generate a surgical treatment plan for the heart based on the comparison for providing the best treatment outcome.
The limitation of receive electrical and anatomical data of a heart of a patient from a surgical system, perform a comparison of the electrical and anatomical data of the heart to the database information, generate a surgical treatment plan for the heart based on the comparison for providing the best treatment outcome. 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 components. That is, other than reciting “a system for improving a cardiac ablation process” nothing in the claimed element precludes the step from being practically being performed in the mind. For example, the “receive, comparing and generate” in the context of this claim encompasses the user manually receiving the data, comparing it with a database and generating a treatment plan. Similarly, the limitation of receive electrical and anatomical data of a heart of a patient from a surgical system, perform a comparison of the electrical and anatomical data of the heart to the database information, generate a surgical treatment plan for the heart based on the comparison for providing the best treatment outcome, as drafted, is a process that, under broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components. For example the “a system for improving a cardiac ablation process” and “electrical and anatomical data” is the context of this claim that encompasses the user thinking there are different electrical and anatomical data points everytime the device is in use. 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, then it falls within “Mental processes” grouping of abstract ideas. Accordingly, the claims recite an abstract idea.
This judicial exception is not integrated into a practical application. In particular, the claims only recite one additional element – one or more processors to perform both the comparing and determining steps. The cloud server in both steps is recited at a high-level of generality (i.e., as a generic processor performing a generic computer function of ranking information based on a determined amount of use) such that it amounts no more than mere instructions to apply the exception using a generic computer component. Accordingly, this additional element does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional element of using a cloud server to perform both the ranking and determining steps amounts to no more than mere instructions to apply the exception using a generic computer component. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept. The claim is not patent eligible.
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 1-19 is rejected under 35 U.S.C 103 as being unpatentable over Ibragimov et al. (US 20210030468) herein referred to as Ibragimov in view of Chou et al. (US 20210068694) herein referred to as Chou.
Regarding Claim 1, Ibragimov discloses A system for improving a cardiac ablation procedure (Figure 2), the system comprising: a cloud server that includes a database containing information related to cardiac ablations performed by surgeons with known treatment outcomes (Figure 2, 201A; Paragraph [0103]); a local server that is communicatively coupled to the cloud server via first network (Figure 2, 222); and a surgical system that is communicatively coupled to the local server via second network (Figure 2, 220), wherein the cloud server is configured to: receive, via the local server, electrical and anatomical data of a heart of a patient from the surgical system (Paragraph [0024];Figure 1A, 104), perform a comparison of the electrical and anatomical data of the heart to the database information (Figure 1A, 108; Paragraph [0164]), generate a surgical treatment plan for the heart based on the comparison for providing the best treatment outcome (Figure 1A, 110), wherein the surgical treatment plan includes a 3D image of the heart (Figure 3), and transmit, via the local server, the surgical treatment plan to the surgical system (Figure 1A, 110). However, Ibragimov does not explicitly disclose wherein the surgical treatment plan includes a grid of the heart.
Chou discloses a system (Figure 1) wherein the surgical treatment plan includes a grid of the heart (Figure 7B). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the treatment plan taught by Ibragimov to include the grid as taught by Chou. The motivation being once the activation times are on a regular grid, learning algorithms can be trained on a large patient set to identify the conduction patterns of interest given an image of the conduction pattern. After the activation time data is evaluated for conduction patterns of interest while transformed into the image space, the labelled output can be put back and displayed (Chou, Paragraph [0245]).
Regarding claim 2, Ibragimov in view Chou disclose the system of claim 1. Ibragimov also discloses wherein one or more parameters of the surgical system are changed according to the treatment plan (Paragraph [0057]; wherein power of ablation and time of application of ablation energy are changed according to the treatment plan)
Regarding claim 3, Ibragimov in view Chou disclose the system of claim 1. Ibragimov also discloses wherein the cloud server receives the electrical and anatomical data of the heart of the patient from the surgical system while the cardiac ablation procedure is performed (Paragraph [0074]; wherein additional data is gathered during the operation, and the classifier finds that considering this new data, a change to the plan is appropriate)
Regarding claim 4, Ibragimov in view Chou disclose the system of claim 1. Ibragimov also discloses wherein ablation procedure includes a plurality of ablations, wherein the cloud server receives the electrical and anatomical data of the heart of the patient from the surgical system after each ablation (Figure 1A, 124).
Regarding claim 5, Ibragimov in view Chou disclose the system of claim 1. Ibragimov also discloses wherein the cloud server is further configured to: receive additional electrical and anatomical data of the heart after the ablation procedure is performed (Figure 1A, 124), and generate an ablation score based on the additional electrical and anatomical data (Paragraph [0236]; wherein an indication (score) is given and the indication of success of treatment (or lack of success) may be provided (and updated) post treatment).
Regarding claim 6, Ibragimov in view Chou disclose the system of claim 1. Ibragimov also discloses wherein the electrical and anatomical data of a heart of a patient from the surgical system includes at least one of a catheter position, impedance measurement, contact information, and information on an energy level delivered during the procedure (Paragraph [0019]; wherein the data contains impedance measurements; Paragraph [0220]; wherein data contains information on power of ablation)
Regarding claim 7, Ibragimov in view Chou disclose the system of claim 6. Ibragimov also discloses wherein the energy level delivered during the procedure includes at least one of a power, a generated temperature and impedance before, during and after application (Paragraph [0220]; wherein data contains information on power of ablation)
Regarding claim 8, Ibragimov in view Chou disclose the system of claim 1. Ibragimov also discloses wherein the electrical and anatomical data of a heart of a patient from the surgical system includes at least one of at least one recorded electrocardiograph (ECG), at least one ultrasound image, and at least one X-ray images (Paragraph [0108]; wherein dataset can contain images from an ultrasound machine)
Regarding claim 9, Ibragimov in view Chou disclose the system of claim 1. Ibragimov also discloses wherein the electrical and anatomical data of a heart of a patient from the surgical system includes biometric data that includes one or more of local activation times (LATs), electrical activity, topology, bipolar mapping, dominant frequency, and impedance (Paragraph [0051]; wherein data includes impedance, endocardial electrical activity and electrical activity).
Regarding claim 10, Ibragimov discloses A method for improving a cardiac ablation procedure (Figure 1A), the method comprising: receiving, via a database, information about previously performed cardiac ablations with known treatment outcomes (Figure 1A, 102; Paragraph [0103]); receiving, via a local server, electrical and anatomical data of a heart of a patient from a surgical system (Paragraph [0024]; Figure 1A, 104); performing a comparison of the electrical and anatomical data of the heart to the database information (Figure 1A, 108; Paragraph [0164]); generating a surgical treatment plan for the heart based on the comparison for providing the best treatment outcome (Figure 1A, 110), wherein the surgical treatment plan includes a 3D image of the heart (Figure 3); and transmitting, via the local server, the surgical treatment plan to the surgical system (Figure 1A, 110). However, Ibragimov does not explicitly disclose wherein the surgical treatment plan includes a grid of the heart.
Chou discloses a system (Figure 3A) wherein the surgical treatment plan includes a grid of the heart (Figure 7B). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the treatment plan taught by Ibragimov to include the grid as taught by Chou. The motivation being once the activation times are on a regular grid, learning algorithms can be trained on a large patient set to identify the conduction patterns of interest given an image of the conduction pattern. After the activation time data is evaluated for conduction patterns of interest while transformed into the image space, the labelled output can be put back and displayed (Chou, Paragraph [0245]).
Regarding claim 11, Ibragimov in view Chou disclose the method of claim 10. Ibragimov also discloses wherein one or more parameters of the surgical system are changed according to the treatment plan (Paragraph [0057]; wherein power of ablation and time of application of ablation energy are changed according to the treatment plan)
Regarding claim 12, Ibragimov in view Chou disclose the method of claim 10. Ibragimov also discloses wherein the cloud server receives the electrical and anatomical data of the heart of the patient from the surgical system while the cardiac ablation procedure is performed (Paragraph [0074]; wherein additional data is gathered during the operation, and the classifier finds that considering this new data, a change to the plan is appropriate)
Regarding claim 13, Ibragimov in view Chou disclose the method of claim 10. Ibragimov also discloses wherein ablation procedure includes a plurality of ablations, wherein the cloud server receives the electrical and anatomical data of the heart of the patient from the surgical system after each ablation (Figure 1A, 124).
Regarding claim 14, Ibragimov in view Chou disclose the method of claim 13. Ibragimov also discloses further comprising receive additional electrical and anatomical data of the heart after the ablation procedure is performed (Figure 1A, 124).
Regarding claim 15, Ibragimov in view Chou disclose the method of claim 13. Ibragimov also discloses generating an ablation score based on the additional electrical and anatomical data (Paragraph [0236]; wherein an indication (score) is given and the indication of success of treatment (or lack of success) may be provided (and updated) post treatment).
Regarding claim 16, Ibragimov in view Chou disclose the method of claim 13. Ibragimov also discloses wherein the electrical and anatomical data of a heart of a patient from the surgical system includes at least one of a catheter position, impedance measurement, contact information, and information on an energy level delivered during the procedure (Paragraph [0019]; wherein the data contains impedance measurements; Paragraph [0220]; wherein data contains information on power of ablation)
Regarding claim 17, Ibragimov in view Chou disclose the method of claim 16. Ibragimov also discloses wherein the energy level delivered during the procedure includes at least one of a power, a generated temperature and impedance before, during and after application (Paragraph [0220]; wherein data contains information on power of ablation)
Regarding claim 18, Ibragimov in view Chou disclose the method of claim 10. Ibragimov also discloses wherein the electrical and anatomical data of a heart of a patient from the surgical system includes at least one of at least one recorded electrocardiograph (ECG), at least one ultrasound image, and at least one X-ray images (Paragraph [0108]; wherein dataset can contain images from an ultrasound machine)
Regarding claim 19, Ibragimov in view Chou disclose the method of claim 10. Ibragimov also discloses wherein the electrical and anatomical data of a heart of a patient from the surgical system includes biometric data that includes one or more of local activation times (LATs), electrical activity, topology, bipolar mapping, dominant frequency, and impedance (Paragraph [0051]; wherein data includes impedance, endocardial electrical activity and electrical activity).
Conclusion
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ALYSSA M. PAPE
Examiner
Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794
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