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 .
Election/Restrictions
Applicant’s election without traverse of Group II, claims 11, 13-16 in the reply filed on 1/22/2026 is acknowledged.
Claims 1-9, 17-22 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
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 11, 13-16 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. It is unclear what “associated with the non-cardiac medical procedure” means.
Claim 11 also recites a “non-cardiac medical procedure,” the scope of this limitation is indefinite. Does a non-cardiac medical procedure include a skin biopsy? Kidney dialysis? Vascular stent implantation? Coronary artery bypass grafting? Because the scope of the limitation is not readily ascertainable, the claim is indefinite.
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.
Claims 11, 13-16 are rejected under 35 U.S.C. 103 as being unpatentable over Lee et al. (Pub. No.: US 2021/0193315) in view of Mathis et al. (Early Detection of Heart Failure with Reduced Ejection Fraction using Perioperative Data among Non-Cardiac Surgical Patients: A Machine Learning Approach) (cited in Applicant’s IDS).
Lee et al. (hereinafter, Lee) discloses a method of treating a patient, the method comprising:
receiving a decoupling prediction for a patient (para. 30) scheduled for a non-cardiac medical procedure (not disclosed), wherein the decoupling prediction is output from a trained machine learning model (e.g., para. 32) in response to providing one or more patient characteristics associated with the patient as input (e.g., para. 38);
determining, based on the decoupling prediction, a period of time when the patient would benefit from use of an intracardiac blood pump (e.g., para. 30, 33) associated with the non-cardiac medical procedure (not disclosed);
inserting the intracardiac blood pump into a heart of the patient during the determined period of time (e.g., para. 31, 33); and
performing the non-cardiac medical procedure to treat the patient (not disclosed).
As provided in italicized text above, Lee does not specify the use of a VAD within a patient undergoing a non-cardiac medical procedure. Mathis et al. (hereinafter, Mathis) teaches using a machine learning algorithm to predict heart failure in non-cardiac surgical patients (abstract) for the purpose of allowing early detection and treatment of heart failure in non-cardiac surgeries. VAD (Ventricular Assist Device) and mechanical circulatory support devices are known treatments for heart failure. It would have been obvious to one of ordinary skill in the art to have provided the Lee method with patients undergoing non-cardiac surgery as taught by Mathis for the purpose of predicting the need for a mechanical circulatory device in a non-cardiac surgical patient. This modification would have occurred using known methods and would have yielded predictable results.
For claim 13, Lee discloses the method of claim 11, wherein the one or more patient characteristics are provided as input to the trained machine learning model from an electronic medical record associated with the patient (e.g., para. 21).
For claim 14, Lee discloses the method of claim 11, wherein the trained machine learning model is trained using training data from a plurality of patients (e.g., para. 39) having undergone different types of non- cardiac medical procedures (not disclosed). Lee does not specify the patient data set is from non-cardiac medical procedures, however, in light of Mathis, it would have been obvious to have selected non-cardiac surgical patients for modeling VAD use in non-cardiac surgical patients.
For claim 15, Lee discloses the method of claim 11, wherein the period of time includes one or more of before the non-cardiac medical procedure, during the non-cardiac medical procedure, or after the non-cardiac medical procedure (e.g., para. 30, 33).
For claim 16, Lee discloses the method of claim 11, further comprising:
Tracking (e.g., para. 16) during the non-cardiac medical procedure an amount of decoupling experienced by the patient (e.g., remote monitoring data); and
retraining the trained machine learning model based, at least in part, on the amount of decoupling experienced by the patient and the one or more patient characteristics (e.g., para. 15). Lee does not specify the tracking is during a non-cardiac medical procedure, however, in light of Mathis, it would have been obvious to have selected non-cardiac surgical procedure for the purpose of modeling VAD use in non-cardiac surgical patients.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUBA GANESAN whose telephone number is (571)272-3243. The examiner can normally be reached Monday-Friday, 8 AM - 5 PM Mountain Time.
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/SUBA GANESAN/Primary Examiner, Art Unit 3774
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