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
Claims 2, 3, 5-7, 9-13, 17, 21, 26, 27, 32-46, and 52-57 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention groups II-VI, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 6/1/2026.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 8, 14, 15, 16, 18, 19, 20, 22, 23, and 28 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by McCully et al (US 2020/0123273 A1, hereinafter “McCully”).
Regarding claim 1, McCully discloses a method for reducing or preventing myocardial damage in a subject caused by extracorporeal membrane oxygenation (ECMO) (pars 0278-0281, the method comprising administering a cardioprotective agent to the subject and treating the subject with ECMO (par 0136, 0144; 0278-0281; 0303-0305).
Regarding claim 8, McCully discloses the cardioprotective agent is administered before, during, or after the ECMO treatment, or in any combination thereof (par 0278-0281).
Regarding claim 14, McCully discloses the myocardial damage comprises a myocardial infarction or an increase in the size of an already existing myocardial infarction (pars 0011, 0176, 0303-0305).
Regarding claim 15, McCully discloses the myocardial damage comprises left ventricular (LV) injury (pars 0278-0281).
Regarding claim 16, McCully discloses the myocardial damage is characterized by oxidative stress (pars 0119, 0161).
Regarding claim 18, McCully discloses the subject has or is at risk of developing myocardial infarction, heart failure, cardiac arrest, heart muscle disease, myocarditis, sepsis, hypothermia, post-transplant complications, cardiogenic shock, cardio-respiratory failure, respiratory failure, lung infection, acute respiratory distress syndrome, pulmonary embolism, congenital diaphragmatic hernia, influenza, pulmonary hypertension, pneumonia, respiratory failure, trauma, or Covid-19, or is subject to treatment with or by a ventricular assist device, heart transplant, lung transplant, heart surgery, or cardiac catheterization (pars 0011, 0128).
Regarding claim 19, McCully discloses the cardioprotective agent is administered by an intra-arterial, intra-coronary, intra-myocardial, intra-epicardial, pericardial, or intravenous route, or via the ECMO circuit (par 0147, 0278-0281).
Regarding claim 20, McCully discloses intravenous administration of a cardioprotective agent (pars 0147, 0278-0281; 0303-0305).
Regarding claim 22, McCully discloses the ECMO is veno-arterial ECMO or veno-venous ECMO (pars 0032, 0147-0151, 0164).
Regarding claim 23, McCully discloses the VA-ECMO is peripheral VA-ECMO (pars 0032, 0147-0151, 0164).
Regarding claim 28, McCully discloses that in instances of treatment with a cardioprotective agent, the cardioprotective agent comprises a mitochondrial protective agent, an antioxidant, or an oxygen radical scavenger, wherein the oxygen radical scavenger is optionally selected from a nitroxide, such as Tempol (4-hydroxy-2,2,6,6-tetramethylpiperydine-1-oxyl) or Tiron (4,5-dihydroxy-1,3-benzenedisulfonic acid) (par 0136, 0144; 0278-0281; 0303-0305).
Allowable Subject Matter
Claims 4, 24, 25, 29, 30, and 31 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
. [Copy provided with Office action] Edinger, Fabian, et al. "Application of alpha1-antitrypsin in a rat model of veno-arterial extracorporeal membrane oxygenation." Scientific reports 11.1 (2021): 15849. Details Extracorporeal membrane oxygenation (ECMO) which a life-saving intervention for patients suffering from respiratory or cardiac failure. The ECMO-associated morbidity and mortality depends to a large extent on the underlying disease and is often related to systemic inflammation, consecutive immune paralysis and sepsis. Tested the hypothesis that human α1-antitrypsin (SERPINA1) due to its anti-protease and anti-inflammatory functions may attenuate ECMO-induced inflammation.
[Copy provided with Office action] McCully JD, Cowan DB, Pacak CA, Toumpoulis IK, Dayalan H, Levitsky S. Injection of isolated mitochondria during early reperfusion for cardioprotection. Am J Physiol Heart Circ Physiol 296: H94-H105, 2009. Demonstrates that viable respiration-competent mitochondria, isolated from tissue unaffected by ischemia and then injected into the ischemic zone just before reperfusion, significantly enhancing postischemic functional recovery and cellular viability.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Lindsey G Wehrheim whose telephone number is (571)270-5181. The examiner can normally be reached Monday - Friday 9 a.m. - 5 p.m. EST.
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Lindsey G Wehrheim
Primary Examiner
Art Unit 3799
/LINDSEY G WEHRHEIM/Primary Examiner, Art Unit 3799
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