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 § 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 1-17 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.
In claim 1, “based on a change in the physiological data representative of an efficacy of the reperfusion therapy in improving the blood flow to the myocardium” is vague, inferentially included, and makes the claim incomplete for omitting an element to perform this function. The previous claim 1 had the determination “based on the physiological data”, which the previously claim 1 stated was sensed by the sensor. However, amended claim 1 now has the determination based on a change, that is representative of an efficacy. No element has been set forth to calculate this change and/or calculate the efficacy of the therapy in improving blood flow in order for the determination to be “based on” this change and representation of efficacy. It is unclear if all that is needed is a system/method that determines a progression of the reperfusion therapy, such as by receiving data and making that determination, of if the system and method also requires another element to calculate this change/efficacy.
As claim 2 states that the determination is just done by determining a derivative of the physiological data, the examiner has interpreted claim 1 as just requiring determining a derivative. In addition, since claim 1 states it is data “representative” of an efficacy, this derivative in claim 2 is data “representative of an efficacy of the reperfusion therapy in improving the blood flow to the myocardium” as claim 2 states this is how the determination of the progression is done.
Similarly, claim 17 uses similar language as claim 1 and is therefore vague and indefinite.
Claim Rejections - 35 USC § 102
Claim(s) 1-4,6,7,8,11,13,16,17 is/are rejected under 35 U.S.C. 102(a)(1),102(a)(2) as being anticipated by Mohl (2011/0295302).
1. A system, comprising:
an intravascular reperfusion therapy device configured to be positioned within a coronary vein of a patient to deliver reperfusion therapy to a myocardium of a heart of the patient associated with the coronary vein, wherein the intravascular reperfusion therapy device comprises a flexible elongate member, a sensor, and a balloon, wherein the balloon is configured to generate back pressure within the coronary vein to deliver the reperfusion therapy; (see at least ¶23 and figures 4,5 which teach a catheter 120 and balloon 122,and ¶31,50 which teach a sensor)
and
a processor circuit in communication with the intravascular reperfusion therapy device and
configured to: (see at least ¶25)
receive, from the sensor, physiological data associated with blood flow through the
coronary vein; (see at least ¶25)
determine, a progression of the reperfusion therapy
delivered to the myocardium of the heart; (at least ¶5 teaches reperfusion or redistributing blood flow to a heart, and ¶6 teaches a GUI that indicates progress)
--For the new claim limitation of “based on a change in the physiological data representative of an efficacy of the reperfusion therapy in improving the blood flow to the myocardium”, Mohl teaches this in at least paragraph 42 as Mohl takes a derivative of the sensor signal. As claim 2 states that the determination is just done by determining a derivative of the physiological data, the examiner has interpreted claim 1 as just requiring determining a derivative. In addition, claim 1 does not positively recite/claim calculating the change or efficacy. Claim 1 also states it is data “representative” of an efficacy, and the determination of the derivative by Mohl is data “representative” of an efficacy of the reperfusion therapy in improving the blood flow to the myocardium as Applicant’s claim 2 states that is how the progression is determined. Mohl also states in paragraph 44 that the sensor readings are used to determine efficacy of the therapy. Similarly, Mohl meets the same limitation as set forth in claim 17.
--control, based on the progression of the reperfusion therapy, inflation of the balloon
while the intravascular reperfusion therapy device is positioned within the coronary vein such that the back pressure within the coronary vein is controlled. (see at least ¶6)
2. The system of claim 1, wherein, to determine the progression of the reperfusion therapy, the processor circuit is configured to:
determine a derivative of the physiological data with respect to time. (see at least ¶42)
3. The system of claim 1, wherein the inflation of the balloon comprises an oscillation between
first degree of inflation and a different, second degree of inflation, and wherein, to control the inflation of the balloon, the processor circuit is configured to control the oscillation. (see at least ¶43 which teaches oscillation between inflated and deflated states controlled by a processor which uses coronary sinus pressure measurements)
4. The system of claim 3, wherein the processor circuit is configured to control a frequency of the oscillation. (see at least ¶43. The frequency is dependent upon the patient’s sinus pressure measurement values and heat condition)
6. The system of claim 1, wherein the inflation of the balloon comprises a degree of inflation, and wherein, to control the inflation of the balloon, the processor circuit is configured to control the degree of inflation. (see at least ¶43 which teaches a processor which can cause inflation or deflation, and hence the degree of inflation)
7. The system of claim 1, wherein, to control the inflation of the balloon, the processor circuit is configured to:
deflate the balloon responsive to determining, based on the progression of the reperfusion
therapy, that the reperfusion therapy is complete. (see at least ¶43,44 which teaches clinical end point of therapy)
8. The system of claim 1, wherein the processor circuit is further configured to:
output, to display in communication with the processor circuit, a visual representation of the
progression of the reperfusion therapy. (see at least ¶25 and figure 2)
11. The system of claim 1, wherein the sensor comprises a pressure sensor, wherein the physiological data comprises pressure data. (see at least ¶36)
13. The system of claim 1, wherein the flexible elongate member comprises a catheter, wherein the balloon is positioned at a distal portion of the catheter. (see at least figure 5)
16. The system of claim 1, wherein the coronary vein comprises a coronary sinus. (see at least the abstract)
17. A system, comprising:
an intravascular reperfusion therapy device configured to be positioned within a coronary vein of a patient to deliver reperfusion therapy to a myocardium of a heart of the patient associated with the coronary vein, wherein the intravascular reperfusion therapy device comprises:
one or more flexible elongate members, wherein the one or more flexible elongate
members comprises a catheter and/or a guidewire; a flow sensor positioned at a distal portion of the one or more flexible elongate members; a balloon positioned at the distal portion of the one or more flexible elongate members, (see at least ¶23 and figures 4,5 of Mohl which teach a catheter 120 and balloon 122, and ¶31,50 which teach a sensor)
wherein the balloon is configured to deliver the reperfusion therapy by obstructing blood flow in
a first direction in the coronary vein to generate back pressure in an opposite, second direction
within the coronary vein; (see at least abstract and ¶5-9 of Mohl)
a processor circuit (see at least ¶25 of Mohl) in communication with the intravascular reperfusion therapy device and configured to:
receive, from the flow sensor, flow data representative of blood flow through the
coronary vein; (see at least abstract and ¶25 of Mohl)
determine a progression of the reperfusion therapy delivered to
the myocardium; (See at least ¶20 of Mohl which teaches measuring flow in the form of pressure in the coronary sinus. Also see at least ¶25 of Mohl which teaches detecting progress of procedure and sensing coronary flow)
--For the new claim limitation of “based on a change in the physiological data representative of an efficacy of the reperfusion therapy in improving the blood flow to the myocardium”, see the above explanation in claim 1.
--control, based on the progression of the reperfusion therapy, inflation of the balloon
while the intravascular reperfusion therapy device is positioned within the coronary vein such that the back pressure within the coronary vein is controlled. (see at least ¶6 of Mohl)
Claim Rejections - 35 USC § 103
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mohl (2011/0295302) and Kassab (2011/0196282).
10. The system of claim 1, wherein the sensor comprises a flow sensor, wherein the physiological data comprises a blood flow rate. (Kassab teaches measuring blood flow rate, see at least ¶76. It would have been obvious to measure such with the device of Mohl since it is an important parameter that reveals information re the patient’s condition)
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mohl (2011/0295302) and Tansley et al (2021/0379354).
5. The system of claim 3, wherein the processor circuit is configured to control a duty cycle of the oscillation. (Tansley describes various inflation parameters such as duty cycle, see at least ¶114. To control duty cycle, as in Tansley, would have been obvious since it would allow the user to adjust the oscillation in the most appropriate way for the patient)
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mohl (2011/0295302) and Schiff (4,016,871).
9. The system of claim 1, wherein the processor circuit is further configured to:
output, to display in communication with the processor circuit, a visual representation of the
inflation of the balloon. (at least col. 5:53-55 of Schiff teaches display of visual indications of inflation of balloon. It would have been obvious to use such with the device of Mohl since it would give the user valuable information re the procedure)
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mohl (2011/0295302) and Yair (2006/0206029).
12. The system of claim 1, wherein the physiological data comprises flow data and pressure data associated with the blood flow through the coronary vein, and wherein, to determine the progression of the reperfusion therapy, the processor circuit is configured to:
determine an impedance associated with the blood flow through the coronary vein based on the
flow data and the pressure data; and
determine the progression of the reperfusion therapy based on the impedance. (Yair teaches measuring blood pressure and blood flow rate using impedance, see at least ¶49. It would have been obvious to use such parameters to determine reperfusion progress with the device of Mohl since it would provide predictable results such as an accurate assessment of whether the patient is improving or not)
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mohl (2011/0295302) and Mohl (2013/0165736).
14. The system of claim 13, wherein the sensor comprises an ultrasound transducer positioned at the distal portion of the catheter. (Mohl ‘736 teaches ultrasound sensing, see at least ¶36. It would have been obvious to use such at the distal end of the catheter since it would detect movement of the coronary sinus in a predictable manner)
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mohl (2011/0295302) and Van Der Horst et al (2019/0082978).
15. The system of claim 13, wherein the intravascular reperfusion therapy device further comprises a guidewire, wherein the sensor is positioned at distal portion of the guidewire. (Van Der Horst teaches a guidewire with a distal sensor, see at least ¶110. It would have been obvious to use such with the device of Mohl since it would facilitate accurately sensing flow and pressure in a predictable manner)
Response to Arguments
Applicant's arguments filed 6/4/26 have been fully considered but they are not persuasive and are addressed above in the 102 rejection.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to George Robert Evanisko whose telephone number is (571)272-4945. The examiner can normally be reached M-F 8AM-5PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin Klein can be reached at 571-270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/George R Evanisko/Primary Examiner, Art Unit 3792 9/5/26
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