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 § 103
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.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-5, 7, 9, and 13-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Curran (WO 2018/175563 A1).
Regarding claim 1, Curran discloses a method of administering medical treatment (eg. Para. 1-5), comprising: identifying a patient requiring a medical procedure (eg. Para. 3, 5, 8, 48); making a first assessment of the patient's likelihood of experiencing one or more adverse outcomes of a set of adverse outcomes if the medical procedure were to be performed without the patient receiving support from an intracardiac blood pump before, during, or after the medical procedure (eg. Para. 3, 5, 8, 48, 64-65, Fig. 8, step 914); determining the patient's suitability for the medical procedure based on the first assessment (Eg. Para. 5, 48, 51); making a second assessment of the patient's likelihood of experiencing one or more adverse outcomes of the set of adverse outcomes if the medical procedure were to be performed with the patient receiving support from an intracardiac blood pump at least before, during, or after the medical procedure (eg. Para. 6, 8, 13, 47, Para. 64-65 Fig. 8, step 916), determining the patient's suitability for the medical procedure based on the second assessment (eg. Para. 8, 48, 50, Para. 64-65); and inserting the intracardiac blood pump into the patient to provide cardiac support at least before, during, or after the medical procedure (eg. Para. 7, 10, 13, 39, 42, 50-51).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the embodiments of Curran such as providing a display like on Fig. 7, Para. 65 to the embodiments of Fig. 5 and 8 to provide a physician with the native cardiac output and other variables to allow the physician to make informed decisions about a patient’s care (eg. Para. 65).
Regarding claim 2, Curran discloses comprising determining a period of time during which the patient would benefit from receiving support from the intracardiac blood pump, wherein the determined period of time comprises one or more of before, during, or after the medical procedure (eg. Para. 3, 52-53, 55).
Regarding claim 3, Curran discloses inserting the intracardiac blood pump into the patient to provide cardiac support is performed for the determined period of time (eg. Para. 49-53, percutaneous pump 700 and cannula 720, Fig. 6).
Regarding claim 4, Curran discloses comprising performing the medical procedure on the patient eg. Para. 49-53).
Regarding claim 5, Curran discloses inserting the intracardiac blood pump into the patient is performed before, at the same time as, or after performing the medical procedure inserting the intracardiac blood pump into the patient is performed before, at the same time as, or after performing the medical procedure (eg. Fig. 8, Para. 59-65).
Regarding claim 7, Curran discloses the intracardiac blood pump is configured to provide left heart support (Eg. Para. 13, 50, left ventricle).
Regarding claim 9, Curran discloses the medical procedure requires the patient to be anesthetized (Para. 1 and 66-70 Impella catheter operations are typically done under anesthesia).
Regarding claim 13, Curran discloses the set of adverse outcomes includes one or more of hypotension, pulmonary edema, ventricular fibrillation, exacerbated ischemia, myocardial ischemia, hemodynamic collapse, cardiac arrest, stroke, heart attack, acute kidney injury, neurological decline, or death (eg. Para. 4, 33, 59-65, implied that if the native cardiac output is too low, then risk of death is higher).
Regarding claim 14, Curran discloses the first assessment or the second assessment is based on one or more of the patient's age, height, weight, body mass index, blood pressure, cholesterol levels, liver function, kidney function, existing medical conditions, personal medical history, or family medical history (eg. Para. 10, 53-56, 63 recorded historical data and blood pressure).
Claim(s) 6 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Curran (WO 2018/175563 A1) in view of Montisci (“Impella 5.0 supported oncology surgery as bridge to LVAD”, 2020).
Regarding claim 6, Curran discloses the invention of claim 1, but does not disclose the medical procedure includes a noncardiac medical procedure.
Montisci teaches applying an intracardiac blood pump support during a noncardiac oncological surgery such as rectal resection for adenocarcinoma (eg. Abstract, Pages 168-169).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the assessment and support of Curran with the noncardiac procedures as taught by Montisci as both involve hemodynamic support for high risk patients and would expand the use during noncardiac surgeries to mitigate the cardiac risks (eg. Montisci. Para. 168-169).
Regarding claim 10, the combined invention of Curran and Montisci discloses the medical procedure includes one or more of laparoscopic surgery, tumor resection, or gastrointestinal surgery (Eg. Montisci, Para. 168-169).
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Curran (WO 2018/175563 A1) in view of Simpson (“Right heart failure with left ventricular assist device implantation in children: an analysis of the pedimacs registry database, 2019”).
Regarding claim 8, Curran discloses the invention of claim 1, but does not disclose intracardiac blood pump is configured to provide right heart support.
Simpson teaches a left ventricular assist device and right assist device (eg. Page 232-233, 235, 239).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the method of Curran with RVAD support as taught by Simpson to prevent right heart failure after using a LVAD (eg. Simpson, Para. 238-239).
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Curran (WO 2018/175563 A1) in view of Fallen (US 2021/0134451 A1).
Regarding claim 11, Curran discloses the invention of claim 1, but does not disclose medical procedure includes one or more of mitral valve repair, mitral valve replacement, ventricular tachycardia ablation, or atrial fibrillation ablation.
Fallen teaches a catheter and blood pump (eg. Para. 38-42, 140-143) for use of heart valve replacements, heart transplants, ablation procedures, etc. (eg. Para. 35).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the invention of Curran with the different operations as taught by Fallen as both involve hemodynamic support for high risk patients and would expand the use of the blood pump to other applications such as valve replacements and ablation procedures.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Curran (WO 2018/175563 A1) in view of Fegley (Elective Total Knee Replacement in a Patient With a Left Ventricular Assist Device Navigating the Challenges With Spinal Anesthesia, 2021).
Regarding claim 12, Curran discloses the invention of claim 1, but does not disclose the medical procedure includes knee or hip arthroplasty.
Fegley teaches the use of LVAD devices with a knee replacement surgery (eg. Pg 664-667).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the invention to have combined the invention of Curran with the hip replacement surgery as taught by Fegley to help maintain hemodynamic stability in a patient with severe cardiac comorbidity in a noncardiac orthopedic procedure (eg. Fegley, Pg. 666).
Claim(s) 15-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Curran (WO 2018/175563 A1) in view of Vetrovec (“A Review of Bleeding Risk with Impella-supported High-risk Percutaneous Coronary Intervention”, 2020).
Regarding claim 15, Curran discloses the invention of claim 1, but does not disclose the first assessment or the second assessment is based on whether the patient has one or more of diabetes, an autoimmune disorder, or heart disease.
Vetrovec teaches informing Impella suitability using a LASH risk score which incorporates heart disease and diabetes as baseline factors.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the invention of Curran with the heart disease/diabetes LASH risk score assessment as taught by Vetrovec to provide better prevent bleeding risks and overall procedural risks (eg. Vetrovec, Page 97-98).
Regarding claim 16, the combined invention of Curran and Vetrovec discloses the invention of claim 1, but does not disclose the first assessment or the second assessment is based on statistics regarding how prevalent each adverse outcome in the set of adverse outcomes is in a given population (eg. Vetrovec, Pgs. 93, 97-98).
Regarding claim 17, the combined invention of Curran and Vetrovec discloses the given population comprises a group of people sharing one or more traits with the patient (eg. Vetrovec, Pgs. 93, 97-98).
Regarding claim 18, the combined invention of Curran and Vetrovec discloses the second assessment is based on a likelihood of the patient experiencing one or more adverse outcomes of the set of adverse outcomes as a result of implantation of the intracardiac blood pump in the patient (eg. Table 3, Fig. 1-3, Page 92 and 97-98).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL J LAU whose telephone number is (571)272-2317. The examiner can normally be reached 8-5:30 PM.
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/MICHAEL J LAU/Examiner, Art Unit 3796
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