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 I directed to claims 87-97 in the reply filed on 05/14/2026 is acknowledged.
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.
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.
Claims 87-97 and 101-102 are rejected under 35 U.S.C. 103 as being unpatentable over Dea et al. (US 2002/0111616).
Regarding claim 87, Dea discloses a method for reducing reperfusion injury in a subject following an ischemic event [0013], the method comprising: inserting a heat exchange catheter of an intravascular temperature management system into a vasculature of the subject (fig.1); circulating a heat exchange fluid through the heat exchange catheter to lower a body temperature of the subject to a cool the temperature within a first period of time ([0080]: “twenty minutes into the occlusion, the external heat exchanger was turned on with the controller was set to remove heat via the heat exchange catheter to lower the cardiac temperature of the pig at the maximum rate”) prior to reperfusion ([0080]-[0081]); maintaining the body temperature of the subject below about 34°C for a second period of time [0081]; performing a reperfusion procedure on the subject when the body temperature of the subject is below about 34°C; and maintaining a state of hypothermia in the subject following the reperfusion procedure [0081]. Dea does not disclose lower a body temperature of the subject to a temperature below about 34°C within a first period. However, Dea teaches the controller 28 is configured to control the temperature of the heat exchange region for purposes of inducing and controlling cardiac hypothermia [0059]. The time during which the hypothermia is administered may vary according to the circumstances. For example, the heart may be cooled for a short period of time and then rewarmed, or may be cooled and maintained in a cooled condition for some period of time. For example, a heart attack victim may have the cardiac muscle cooled for an hour, while the hypothermia may be applied during beating heart surgery for several hours [0025]. Therefore, it would have been obvious to one of ordinary skill in the art at the time the Application was effectively filed to modify the duration and the temperature of treatment including during the first period of the procedure as contemplated by general teaching of Dea for the purpose of achieving the desired treatment.
Regarding claim 88, Dea discloses the method according to claim 87, wherein circulating the heat exchange fluid includes lowering the body temperature of the subject to a temperature between about 32°C and about 34°C [0014].
Regarding claim 89-90, Dea does not specifically teach wherein circulating the heat exchange fluid includes lowering the body temperature of the subject from normothermia to the body temperature below about 34°C within about 20 minutes and wherein maintaining the body temperature of the subject below about 34°C includes maintaining the body temperature of the subject below about 34°C prior to the reperfusion procedure. However, Dea generally teaches the controller 28 is configured to control the temperature of the heat exchange region for purposes of inducing and controlling cardiac hypothermia [0059]. The time during which the hypothermia is administered may vary according to the circumstances. For example, the heart may be cooled for a short period of time and then rewarmed, or may be cooled and maintained in a cooled condition for some period of time. For example, a heart attack victim may have the cardiac muscle cooled for an hour, while the hypothermia may be applied during beating heart surgery for several hours [0025]. Therefore, it would have been obvious to one of ordinary skill in the art at the time the Application was effectively filed to modify the duration of the procedure and the desired temperature as contemplated by the general teaching of Dea for the purpose of achieving the desired treatment.
Regarding claim 91, Dea discloses the method according to claim 87, wherein performing the reperfusion procedure includes performing the reperfusion procedure on a subject suffering from an evolving myocardial infarction of myocardial ischemia [0049].
Regarding claim 92, Dea discloses the method according to claim 87, wherein the ischemic event includes myocardial infarction, acute coronary syndrome, stroke, infarction or ischemia of metabolic tissue or organ including heart, lung, kidney, liver, and brain [0051].
Regarding claim 93, Dea discloses the method according to claim 87, wherein performing the reperfusion procedure on the subject includes performing percutaneous coronary intervention on the subject [0014].
Regarding claim 94, Dea discloses the method according to claim 87, wherein maintaining the state of hypothermia in the subject includes maintaining the body temperature of the subject at a temperature of about 32°C [0024].
Regarding claim 95, Dea discloses the method according to claim 94, wherein maintaining the state of hypothermia includes maintaining the body temperature of the subject at about 32°C [0024] for about three hours [0025].
Regarding claim 96, Dea discloses the method according to claim 87, further comprising warming the subject after maintaining the state of hypothermia in the subject for a third period (After the period of cooling) of time [0082].
Regarding claim 97, Dea discloses the method according to claim 96, wherein warming the subject includes circulating the heat exchange fluid at a temperature at or above about 42°C [0082].
Regarding claim 101, Dea discloses the method according to claim 87 further comprising estimating the body temperature of the subject [0059].
Regarding claim 102, Dea discloses the method according to claim 101, wherein estimating the body temperature of the subject includes estimating a temperature of tissue near a site of ischemia [0059].
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TIGIST S DEMIE whose telephone number is (571)270-5345. The examiner can normally be reached Monday-Friday 8am-5Pm.
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/TIGIST S DEMIE/Primary Examiner, Art Unit 3794
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