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 § 112
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 12 and 16 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 12 recites the limitation of “using a second machine learning model” which renders the scope of the claim indefinite. The claim fails to set forth a first machine learning model.
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 12 and 16 are rejected under 35 U.S.C. 101 because the claimed invention is directed to the abstract idea of calculating survival probabilities without significantly more. The claim(s) recite(s) the steps of scanning a heart of a patient with heart failure using a MRI scanner to generate time-resolved image data, the time-resolved image data comprising a sequence of images corresponding to different time points throughout one or more complete cardiac cycles of the patient with heart failure; generating segmented images by processing the time-resolved image data; generating a time-resolved 3D model of the heart of the patient with heart failure by processing the segmented images using a second machine learning model; calculating a survival prediction across a period of future time by processing the time-resolved 3D model of the heart of the patient with heart failure using a trained machine learning model to generate survival probabilities of the patient with heart failure. This judicial exception is not integrated into a practical application because the steps generally links the use of the judicial exception to a particular technological environment, performing well-understood, routine and conventional activities previously known in the industry, specified at a high level of generality, and recite the concepts of gathering data, organizing data, performing mathematical calculations, and evaluating data which can be performed as a mental step or on pen and paper. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims recite the addition of a MRI scanner is not sufficient to amount to significantly more than the judicial exception. A conventional MRI scanner is required to acquire MRI images. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims recite the addition of a machine learning model which encompasses software per se and the addition of general purpose computer components alone to perform the abstract idea is not sufficient to transform it into a patentable invention. The components are recited at a high level of generality and perform he basic functions of a computer that would be needed to apply the abstract idea via a computer.
Claim 16 depends from claim 12 and recites the same abstract idea of gathering, organizing, and evaluating data and performing mathematical calculations which can be performed as a mental step or on pen and paper. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the steps recite mathematical operations that are well-understood, routine and conventional activities previously known to the industry specified at a high level of generality amounting to no more than the judicial exception.
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.
Claim(s) 12 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Golden et al. (US 2018/0218502) in view of Itu et al. (US 2019/0139641) and Liu et al. (US 2019/0192753).
Golden et al. discloses a method comprising scanning a heart of a patient with heart failures using a MRI scanner to generate time-resolved image data ([0002]), the time-resolved image data comprising a sequence of images corresponding to different time points throughout one or more complete cardiac cycles of the patient with heart failure ([0003]); generating segmented images by processing the time-resolved image data ([0028]; [0058]); generating a time-resolved 3D model of the heart of the patient with heart failure by processing the segmented images using a second machine learning model ([0058-0059]). Golden et al. does not teach calculating a survival prediction across a period of future time by processing the time-resolved 3D model of the heart of the patient with heart failure using a trained machine learning model to generate survival probabilities of the patient with heart failure. However, Itu et al. teaches in the same field of endeavor, using one or more trained machine learning models to predict one or more measures of interest (i.e. stroke, risk, etc.; [0021]). Therefore, it would have been obvious to one of ordinary skill in the art to have provided Golden et al. with using one or more machine learning models to predict one or more measures of interest as taught by Itu et al. as machine learned networks provides for fast patient assessment ([0020]). Liu et al. teaches in the same field of endeavor using machine learning technique to predict patient’s health status (e.g., survival probability; [0053]). Therefore, it would have been obvious to one of ordinary skill in the art to use machine learning to predict patient survival probability as it is a known measure of interest.
With respect to claim 16, Golden et al. discloses further comprising generating a reconstructed model of cardiac motion of the heart of the patient with heart failure ([0004]; [0198-0200]).
Response to Arguments
Applicant's arguments filed 9/12/2025 have been fully considered but they are not persuasive.
Applicant’s arguments with respect to claim rejections under 35 USC 101 have been considered but they are not persuasive. The newly amended limitation is not sufficient to amount to significantly more than the judicial exception. The limitations recite a conventional MRI scanner which is required to acquire MRI images. Generic components alone to perform the abstract idea is not sufficient to transform it into a patentable invention.
Applicant’s arguments with respect to claim(s) 12 and 16 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant's arguments fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PETER LUONG whose telephone number is (571)270-1609. The examiner can normally be reached M-F 9-6.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anhtuan T Nguyen can be reached at (571)272-4963. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PETER LUONG/Primary Examiner, Art Unit 3797