DETAILED ACTION
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 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.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 03/23/2023 has been considered by the examiner.
Status of the Claims
The response and amendment filed 07/14/2025 is acknowledged.
Claims 1-15 are pending.
Applicant’s election without traverse of species A: aortic aneurysm and species B: establishing ECC with clamping of the aorta in the reply filed on 07/14/2025 is acknowledged.
Applicant has indicated claims 1-15 read on the elected species.
Claims 1-15 are treated on the merits in this action.
The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. Rejections not reiterated herein have been withdrawn.
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 of this title, 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.
Claims 1-6 and 8-15 are rejected under 35 U.S.C. 103 as being unpatentable over Savary, Brit J Clin Pharma, 2018 (cited on Applicant’s IDS dated 03/23/2023) and Mohebali, Journal of Vascular Surgery, 2018.
Savary teaches methods comprising administering a gas containing argon for inhalation before procedures involving aortic cross clamping (Savary, entire document, e.g., pg. 1171, e.g., Introduction and Experimental protocol). Inhaling argon protects against ischemia reperfusion injury and can attenuate multiple organ failure after aortic cross clamping (Savary, entire document, e.g., pg. 1171, e.g., Introduction). Administration of argon conferred organ protection from ischemic insult (Savary, entire document, e.g., pp. 1174-1177, Discussion). Argon has direct anti-ischemic effect (Savary, entire document, e.g., pg. 1177, c1). Argon activates protective pathways in neuronal and cardiac tissue during ischemia (Savary, entire document, e.g., pg. 1177, c1-c2). Savary suggests the method would be effective in human surgery (Savary, entire document, e.g., pg. 1175, c2) since it was known argon has similar protective effects on ischemia-reperfusion models with human atrial appendages (Savary, entire document, e.g., pg. 1177, c1). Savary concludes argon attenuated ischemia-reperfusion organ failure after aortic cross clamping (Savary, e.g., pg. 1178). Savary teaches the gaseous medicament containing argon and oxygen, e.g., 70% argon and 30% oxygen (Savary, entire document, e.g., pg. 1171, experimental protocol).
Savary does not expressly teach administering the inhalable gaseous medicament containing argon gas directly to a human patient requiring vascular surgery having an aortic aneurysm, which surgery includes clamping of the aorta and establishing extracorporeal circulation.
Mohebali teaches human subjects having an aortic aneurysm (Mohebali, entire document, e.g., Abstract) wherein said human subjects are treated surgically using aortic clamping which results in distal tissues becoming ischemic (Mohebali, entire document, e.g., pp. 941-942). Extracorporeal circulation (EC) mitigates ischemia by maintaining perfusion of tissues and organs distal to the aortic clamp (Mohebali, entire document, e.g., pg. 942, e.g., c1). Mohebali notes that although extracorporeal circulation (EC) improved survival, lowers major complication rate, and offers significant reduction in operative mortality, morbidity and costs (Mohebali, entire document, e.g., Abstract, e.g., conclusions, and pg. 942, article highlights), patients undergoing aortic clamping still suffer from a number of complications due to tissues becoming ischemic, e.g., cardiac, pulmonary, and acute renal failure even with extracorporeal circulation (Mohebali, entire document, e.g., pg. 943, e.g., Table 2).
Mohebali notes that the surgery is routinely performed with additional adjuncts that mitigate the effects of ischemia (Mohebali, entire document, e.g., pg. 946) but does not expressly teach administering an inhalable gaseous medicament containing argon to said patent.
Starting from Savary: It would have been obvious before the effective filing date of the presently claimed invention to use Savary’s known argon gas medicament to treat human subjects having an aortic aneurysm requiring aortic clamping and establishing EC known from Mohebali by administering an inhalable gaseous medicament containing argon gas before surgery with a reasonable expectation of success. The skilled artisan would have been motivated to practice a method in the manner suggested by the prior art for the ischemia protective effects of inhaled argon noted by Savary, including attenuation of ischemia-reperfusion organ failure. Since Mohebali teaches subjects having an aortic aneurysm and surgically treated with aortic clamping and EC suffer from complications mediated by tissue ischemia from reduced or interrupted blood flow as a result of the aortic clamping, e.g., complications including organ failure, e.g., renal failure, the skilled artisan would have found Savary’s argon gas administration useful to further mitigate ischemic damage and attenuate organ failure complications in Mohebali’s patients with a reasonable expectation of success. The skilled artisan would have had a reasonable expectation of success because both references are directed to solving problems stemming from ischemic events caused by aortic clamping and because Savary suggests argons protective effects would benefit humans in other surgical procedures.
Starting from Mohebali: It would have been obvious before the effective filing date of the presently claimed invention to modify Mohebali’s surgical method by directly administering an inhalable gaseous medicament containing argon as suggested in Savary to improve ischemic outcomes in the same way with a reasonable expectation of success. The skilled artisan would have been motivated to improve Mohebali’s method to obtain organ protection from ischemic insult, anti-ischemic effect, and activated protective pathways in neuronal and cardiac tissue during ischemia with argon administration before aortic clamping in the same way noted by Savary with a reasonable expectation of success. The skilled artisan would have had a reasonable expectation of success because both references are directed to solving problems stemming from ischemic events caused by aortic clamping and because Savary suggests argons protective effects would benefit humans in other surgical procedures.
The recitation of stabilizing hemodynamics and reducing the risk of cardiovascular failure by controlling blood circulation, blood pressure and diffusion of blood throughout the body of a human patient is considered met at least by Mohebali teaching the method comprising establishing extracorporeal circulation which perfuses blood throughout the body distal from the clamped aorta and by the effect of argon administered to the human subject. To the extent that the elected species read on claims 12-15: these claims do not require any further manipulative steps and recite the intended results of administering argon as set for in claim 1.
Accordingly, the subject matter of claims 1-6 and 8-15 would have been prima facie obvious before the effective filing date of the presently claimed invention, absent evidence to the contrary.
Claim(s) 7 is rejected under 35 U.S.C. 103 as being unpatentable over Savary, Brit J Clin Pharma, 2018 (cited on Applicant’s IDS dated 03/23/2023) in view of Mohebali, Journal of Vascular Surgery, 2018 as applied to claims 1-6 and 8-15 above, and further in view of Mayer, International Journal of Molecular Sciences, 2016 (cited on Applicant’s IDS dated 03/23/2023).
The combined teachings of Savary and Mohebali teach a method according to claim 1 but do not expressly teach wherein the inhalable gaseous medicament also contains nitrogen or air.
However, Mayer teaches argon mixed with nitrogen was known to have organ protective effect against ischemia insult (Mayer, entire document, e.g., Abstract, pg. 9, Fig. 6, and pg. 11, conclusions). Mayer suggests the use of the gas in clinical applications including cardiac surgery (Mayer, entire document, e.g., pg. 2).
It would have been obvious before the effective filing date of the presently claimed invention to modify a method suggested by the combined teachings of Savary and Mohebali by substituting an argon/nitrogen mixture for the argon/oxygen mixture with a reasonable expectation of success. The skilled artisan would have seen this modification as a substitution of one argon containing gas for another where each were known to have protective effect on organs during ischemic events. The skilled artisan would have had a reasonable expectation of success because Mayer teaches argon/nitrogen gas mixtures effective in surgical applications.
Accordingly, the subject matter of claim 7 would have been prima facie obvious before the effective filing date of the presently claimed invention, absent evidence to the contrary.
Conclusion
No claim is allowed.
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/WILLIAM CRAIGO/Examiner, Art Unit 1615