DETAILED ACTION
Comments
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . 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.
Claims 1-20 are pending and examined in the instant Office action.
Information Disclosure Statements
The IDSs filed have been considered.
Claim Rejections - 35 USC § 112(b) - Indefiniteness
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 1-20 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.
Independent claims 1 and 11 recite that the heart simulation model is adjusted “to account for an effect of a radiation treatment plan on simulated electrical activities of the heart of the patient, the radiation treatment plan specifying radiation doses to be applied to different regions of the heart of the patient….” In this limitation, since there is no active step of treating the heart using radiation during the simulation, it is unclear as to whether the radiation treatment plan is executed on the heart before, during, or after the simulation. While the simulation simulated a “post-radiation” state of the heart, it is unclear as to whether this “post-radiation” is after the radiation treatment plan, or a simple CT and X-ray radiation dosage to assess the state of the heart. For the purpose of the examination, the claims are interpreted such that the radiation treatment plan can be executed before, during, or after the simulation.
Claim 4 recites the limitation "the corresponding radiation dose" in line 5. There is insufficient antecedent basis for this limitation in the claim. While claim 1 recites a plurality of radiation doses, it is unclear as to which of the plurality of radiation doses in claim 1 to which “the corresponding radiation dose” refers. For the purpose of examination, it is interpreted that “the corresponding radiation dose” could refer to any of the radiation doses cited in claim 1.
Claim 14 recites the limitation "the corresponding radiation dose" in line 5. There is insufficient antecedent basis for this limitation in the claim. While claim 11 recites a plurality of radiation doses, it is unclear as to which of the plurality of radiation doses in claim 11 to which “the corresponding radiation dose” refers. For the purpose of examination, it is interpreted that “the corresponding radiation dose” could refer to any of the radiation doses cited in claim 11.
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.
Claim(s) 1-20 is/are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea/law of nature/natural phenomenon without significantly more. Claims 1-10 are drawn to methods, and claims 11-20 are drawn to systems comprising processors.
In accordance with MPEP § 2106, claims found to recite statutory subject matter (Step 1 : YES) are then analyzed to determine if the claims recite any concepts that equate to an abstract idea, law of nature or natural phenomenon (Step 2A, Prong 1). In the instant application, the claims recite the following limitations that equate to an abstract idea:
Claims 1 and 11 recite the mental step of generating a heart simulation model of a heart of a patient wherein the model is configured to simulate electrical activities of the heart.
Claims 1 and 11 recite the mental steps of determining a simulated post-radiation state of the heart of the patient by adjusting the heart simulation model to account for an effect of a radiation treatment plan on simulated electrical activities of the heart of the patient wherein the radiation treatment plan specifies radiation doses to be applied to different regions of the heart of the patient.
Claims 1 and 11 recite the mental step of simulating the post-radiation state of the heart with a stimulation to induce a heart rhythm disorder.
Claims 1 and 11 recite the mental step of determining whether the heart rhythm disorder is induces based on electrical activities generated when simulating the simulated post-radiation state of the heart with the simulation.
Claims 1 and 11 recite the mental step of outputting an indication of whether the heart rhythm disorder is induced in the simulated post-radiation state of the heart.
Claims 2 and 12 recite the mental step of constraining the type of heart rhythm disorder.
Claims 3-4 and 13-14 recite the mental and mathematical limitations using and adjusting mathematical parameters of the simulation model.
Claims 5-6 and 15-16 recite the mental and mathematical limitation of using and adjusting mathematical parameters pertaining the conduction velocity.
Claims 7 and 17 recite the mental step of identifying, in the simulation, the portion of the heart that is expected to become electrically inert in response to the radiation treatment plan.
Claims 8 and 18 recite the mental step of requiring the simulation to include simulating a virtual catheter-based stimulation in the post-radiation state of the heart.
Claims 9-10 and 19-20 recite the mental steps of modifying the radiation treatment plan upon determining that the heart rhythm disorder is induced via modifying a radiation and/or region of the heart.
These recitations are similar to the concepts of collecting information, analyzing it and displaying certain results of the collection and analysis in Electric Power Group, LLC, v. Alstom (830 F.3d 1350, 119 USPQ2d 1739 (Fed. Cir. 2016)), organizing and manipulating information through mathematical correlations in Digitech Image Techs., LLC v Electronics for Imaging, Inc. (758 F.3d 1344, 111 U.S.P.Q.2d 1717 (Fed. Cir. 2014)) and comparing information regarding a sample or test to a control or target data in Univ. of Utah Research Found. v. Ambry Genetics Corp. (774 F.3d 755, 113 U.S.P.Q.2d 1241 (Fed. Cir. 2014)) and Association for Molecular Pathology v. USPTO (689 F.3d 1303, 103 U.S.P.Q.2d 1681 (Fed. Cir. 2012)) that the courts have identified as concepts that can be practically performed in the human mind or mathematical relationships. Therefore, these limitations fall under the “Mental process” and “Mathematical concepts” groupings of abstract ideas. Merely reciting that a mental process is being performed in a generic computer environment does not preclude the steps from being performed practically in the human mind or with pen and paper as claimed. 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 if falls within the “Mental processes” grouping of abstract ideas. As such, claim(s) 1-20 recite(s) an abstract idea/law of nature/natural phenomenon (Step 2A, Prong 1 : YES).
Claims found to recite a judicial exception under Step 2A, Prong 1 are then further analyzed to determine if the claims as a whole integrate the recited judicial exception into a practical application or not (Step 2A, Prong 2). This judicial exception is not integrated into a practical application because the claims do not recite an additional element that reflects an improvement to technology or applies or uses the recited judicial exception to affect a particular treatment for a condition. Rather, the instant claims recite additional elements that amount to mere instructions to implement the abstract idea in a generic computing environment or mere instructions to apply the recited judicial exception via a generic treatment.
As such, these limitations equate to mere instructions to implement the abstract idea on a generic computer that the courts have stated does not render an abstract idea eligible in Alice Corp., 573 U.S. at 223, 110 USPQ2d at 1983. See also 573 U.S. at 224, 110 USPQ2d at 1984. As such, claims 1-20 is/are directed to an abstract idea/law of nature/natural phenomenon (Step 2A, Prong 2 : NO).
Claims found to be directed to a judicial exception are then further evaluated to determine if the claims recite an inventive concept that provides significantly more than the judicial exception itself (Step 2B). The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims recite additional elements that equate to mere instructions to apply the recited exception in a generic way or in a generic computing environment.
As discussed above, there are no additional limitations to indicate that the claimed analysis engine requires anything other than generic computer components in order to carry out the recited abstract idea in the claims. Claims that amount to nothing more than an instruction to apply the abstract idea using a generic computer do not render an abstract idea eligible. Alice Corp., 573 U.S. at 223, 110 USPQ2d at 1983. See also 573 U.S. at 224, 110 USPQ2d at 1984. MPEP 2106.05(f) discloses that mere instructions to apply the judicial exception cannot provide an inventive concept to the claims. The additional elements do not comprise an inventive concept when considered individually or as an ordered combination that transforms the claimed judicial exception into a patent-eligible application of the judicial exception. Therefore, the claims do not amount to significantly more than the judicial exception itself (Step 2B : No). As such, claims 1-20 is/are 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.
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.
35 U.S.C. 103 Rejection #1:
Claim(s) 1-3, 7-8, 11-13, and 17-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over of Mansi et al. [US PGPUB 2016/0220311 A1; on IDS] in view of Krummen et al. [US PGPUB 2019/0206127 A1].
Claim 1 is drawn to a method of simulating radiation effect for cardiac ablation. The method comprises generating, based on medical images and electrophysiology data of a patient, a heart simulation model of a heart of the patient. The heart simulation model is configured to simulate electrical activities of the heart of the patient. The method comprises determining a simulated post-radiation state of the heart of the patient by adjusting the heart simulation model to account for an effect of a radiation treatment plan on simulated electrical activities of the heart of the patient. The radiation treatment plan specifies radiation doses to be applied to different regions of the heart of the patient. The method comprises simulating, using the adjusted heart simulation model, the simulated post-radiation state of the heart with a stimulation to induce a heart rhythm disorder. The method comprises determining whether the heart rhythm disorder is induced based on electrical activities generated when simulating the simulated post-radiation state of the heart with the simulation. The method comprises outputting an indication of whether the heart rhythm disorder is induced in the simulated post-radiation state of the heart.
Claim 11 is drawn to similar subject matter as claim 1, except claim 11 is drawn to a system comprising a processor.
The document of Mansi et al. studies planning and guidance of electrophysiology therapies [title]. The abstract of Mansi et al. teaches overlaying an adjusted image of a computational model of heart after intervention over an initial model of the computational model of the heart before intervention. Figure 7 of Mansi et al. is an illustration of the overlaid image of the heart after intervention onto the image of the heart before intervention. Paragraphs 70-71 of Mansi et al. elaborate on the details of the interventions in that the intervention may involve an interventional CT system (i.e. that applies doses of radiation to the heart). Paragraph 69 of Mansi et al. teaches that an application of the system is to detect heart rhythm problems. Consequently, illustrations analogous to Figure 7 of Mansi et al. conducted using interventional CT systems determine and output whether electrical stimulations affect heart rhythm.
Mansi et al. does not teach that the adjustments to the computational model are based entirely on computations. Mansi et al. does not teach details regarding electrophysiological data.
The document of Krummen et al. studies computational localization of fibrillation sources [title]. Paragraph 42 of Krummen et al. teaches that patient-specific heart models include computational models obtained after a radiationally involved CT scan. The abstract of Krummen et al. teaches adjusting computational models of the heart based on similarities with other heart models in a library database of heart models. In other words, Krummen et al. uses a database of heart models as a training set to adjust a test heart model.
With regard to claims 2 and 12, paragraphs 2-3 of Krummen et al. teach application of the analysis to ventricular fibrillation and atrial fibrillation. Paragraph 2 of Mansi et al. teaches application of the analysis to ventricular tachycardia.
With regard to claims 3 and 13, paragraphs 53-55 of Mansi et al. and paragraph 59 of Krummen et al. teach adjusting the parameters of the electrophysiology model of the heart.
With regard to claims 7-8 and 17-18, paragraph 71 of Mansi et al. teaches using catheters in the modeling. Paragraph 42 of Krummen et al. teaches that patient-specific heart models include computational models obtained after a radiationally involved CT scan (i.e. electrophysiological modeling indicating electrically inert areas of the heart).
It would have been obvious to someone of ordinary skill in the art at the time of the effective filing date of the instant application to modify computational modeling overlays of the heart involving interventional CT systems of Mansi et al. by use of machine learning algorithms to facilitate adjusting heart models of Krummen et al. wherein the motivation would have been that Krummen et al. uses computational techniques to analyze in advance the CT interventions of Mansi et al. [abstract and paragraph 42 of Krummen et al.]. There would have been a reasonable expectation of success in combining Mansi et al. and Krummen et al. because both studies analogously use CT systems to better understand the electrophysiological modeling of the heart.
35 U.S.C. 103 Rejection #2:
Claim(s) 4-6, 9-10, 14-16, and 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over of Mansi et al. in view of Krummen et al. as applied to claims 1-3, 7-8, 11-13, and 17-18 above, in further view of Zhang et al. [Nature Communications, volume 12, 24 September 2021; 14 pages; on IDS].
Claims 4-6, 9-10, 14-16, and 19-20 recite adjusting specific parameters regarding heart modeling (e.g. parameters pertaining to conduction velocity) or updating the patient radiation therapy plan.
Mansi et al. and Krummen et al. make obvious the computational modeling and the adjustment of computational modeling of the heart pertaining to electrophysiology and radiation of the heart.
Mansi et al. and Krummen et al. do not teach the specific parameters pertaining the plans recited in the claims.
The document of Zhang et al. studies cardiac radiotherapy inducing electrical conduction reprogramming in the absence of transmural fibrosis [title]. The introduction on page 1 of Zhang et al. teaches the use of radiation therapy to analyze ventricular tachycardia. Figure 3 on page 5 of Zhang et al. illustrates conduction velocity as a function of radiation dosage. Figure 4 of Zhang et al. teaches that radiation reprograms the border zone myocardium in a model of myocardial infarction.
It would have been obvious to someone of ordinary skill in the art at the time of the effective filing date of the instant application to modify computational modeling overlays of the heart involving interventional CT systems of Mansi et al. and the machine learning algorithms to facilitate adjusting heart models of Krummen et al. by use of the parameter specific radiation therapy of the heart of Zhang et al. wherein the motivation would have been that Zhang et al. gives specific data to facilitate the modeling of radiation treatment plan [Figures 3 and 4 of Zhang et al.]. There would have been a reasonable expectation of success in combining Mansi et al., Krummen et al., and Zhang et al. because all three studies analogously apply to understanding the electrophysiological model of the heart and the effect of radiation on the heart.
Related Prior Art
The document of Zheng et al. [IEEE Transactions on Medical Imaging, volume 27, 2008, pages 1668-1681; on IDS] studies a four-chamber heart modeling and automatic segmentation for three dimensional cardiac CT volumes using marginal space learning and steerable features [title]. Zheng et al. using learning to assist with anatomical structure localization and boundary delineation.
The document of Iravanian [U.S. Patent 10,629,308 B1; on IDS] studies simulating electrophysiology of the heart involving refractory periods, conduction delays, and cycle lengths [abstract[. Iravanian also uses computational simulations of the heart to simulate ECG and IEGM signals from the heart.
E-mail Communications Authorization
Per updated USPTO Internet usage policies, Applicant and/or applicant’s representative is encouraged to authorize the USPTO examiner to discuss any subject matter concerning the above application via Internet e-mail communications. See MPEP 502.03. To approve such communications, Applicant must provide written authorization for e-mail communication by submitting the following statement via EFS-Web (using PTO/SB/439) or Central Fax (571-273-8300):
Recognizing that Internet communications are not secure, I hereby authorize the USPTO to communicate with the undersigned and practitioners in accordance with 37 CFR 1.33 and 37 CFR 1.34 concerning any subject matter of this application by video conferencing, instant messaging, or electronic mail. I understand that a copy of these communications will be made of record in the application file.
Written authorizations submitted to the Examiner via e-mail are NOT proper. Written authorizations must be submitted via EFS-Web (using PTO/SB/439) or Central Fax (571-273-8300). A paper copy of e-mail correspondence will be placed in the patent application when appropriate. E-mails from the USPTO are for the sole use of the intended recipient, and may contain information subject to the confidentiality requirement set forth in 35 USC § 122. See also MPEP 502.03.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Russell Negin, whose telephone number is (571) 272-1083. This Examiner can normally be reached from Monday through Thursday from 8 am to 3 pm and variable hours on Fridays.
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s Supervisor, Larry Riggs, Supervisory Patent Examiner, can be reached at (571) 270-3062.
/RUSSELL S NEGIN/ Primary Examiner, Art Unit 1686 7 August 2026
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