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 .
DETAILED ACTION
Election/Restrictions
Applicant’s election without traverse of group I, claims 33-40, Figs. 7-8 in the reply filed on 05/22/2026 is acknowledged. Claims 21-32 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Thus, claims 33-40 are presently pending in this application.
Claim Rejections - 35 USC § 102
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(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 33, 36 and 38 are rejected under 35 U.S.C. 102(a)(1) and 102 (a)(2) as being anticipated by Houser (5865801).
Regarding claim 33 and 38, Houser discloses a system (abstract and Fig. 17) for controlling catastrophic bleeding from vessels (the system in Fig. 17 is fully capable of performing this intended use), the system comprising: an endovascular device comprising: a stent graft 256 (Fig. 17 and col. 9, lin. 5-15); a first balloon 250 coupled to the stent graft; and a second balloon 252 coupled to the stent graft (the stent is coupled to balloon 252 which is coupled to balloon 250 and therefore the stent is coupled to both balloons); at least one sensor 82 coupled to the stent graft (sensors 82, 116, 118, 120 and 122 are coupled to the stent graft via the balloon; Figs. 6/10 and col. 5, lin. 54-55/col. 7, lin. 2-6), the at least one sensor being configured to measure at least one patient parameter (col. 7, lin. 62-67 and col. 8, lin. 1-3 disclose the sensors measure patient’s vessel obstruction hardness); and a control unit coupleable to the endovascular device and configured for delivering inflation media to at least one of the first and second balloons based on one or more signals generated by the at least one sensor (based on the obstruction hardness detection by the sensors, overinflation can be avoided by varying inflation pressure using the control unit 132 and fluid supply 76; Fig. 11 and col. 7, lin. 14-18).
Regarding claim 36, Houser discloses wherein the control unit 132 (Fig. 11) is configured to perform operations comprising (the control unit 132 is fully capable of performing this intended use): repeatedly controlling inflation or deflation of at least one of the first and second balloons (col. 9, lin. 9-14 disclose the balloons can be inflated and deflated as needed); following each inflation or deflation of the at least one of the first and second balloons, receiving, from at least one sensor coupled to the stent graft, a respective set of signals indicating at least one patient parameter; and based on the sets of signals generated by the at least one sensor, determining a preferred balloon inflation configuration for the endovascular device; and controlling inflation or deflation of the first balloon and the second balloon based on the determined preferred balloon inflation configuration (col. 7, lin. 62-67 and col. 8, lin. 1-3 disclose the inflation of the balloons can be varied to prevent overinflation based on the sensors sensing the obstruction hardness).
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.
Claims 34-35 and 39-40 are rejected under 35 U.S.C. 103 as being unpatentable over Houser (5865801) in view of Schwammenthal et al. (2017/0100527) “Shwammenthal”.
Houser discloses the claimed invention of claims 33 and 38; except for wherein the at least one sensor comprises: a first sensor located distally of the second balloon; and a second sensor located proximally of the second balloon and wherein the at least one patient parameter comprises at least one of blood pressure, blood flow rate, 02 concentration, CO2 concentration, temperature, pH, or heart rate. However, Schwammenthal teaches a similar endovascular system (abstract and Fig. 1B) comprising at least one sensor comprises: a first sensor 56 located distally of a balloon 80; and a second sensor 58 located proximally of a balloon (as shown in Fig. 5A) and wherein the at least one patient parameter comprises at least one of blood pressure, blood flow rate, 02 concentration, CO2 concentration, temperature, pH, or heart rate (par. 0215 discloses the sensors 56/58 measure blood pressure).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the endovascular system in Houser to include at least one sensor comprises: a first sensor located distally of the second balloon; and a second sensor located proximally of the second balloon and wherein the at least one patient parameter comprises at least one of blood pressure, blood flow rate, 02 concentration, CO2 concentration, temperature, pH, or heart rate, as taught and suggested by Schwammenthal, for accurately detecting blood pressure at the implantation site.
Claim 37 is rejected under 35 U.S.C. 103 as being unpatentable over Houser (5865801) in view of Anderson et al. (6148825) “Anderson”.
Houser discloses the claimed invention of claims 33 and 36; except for the endovascular device further comprises a third balloon coupled to the stent graft; and based on the sets of signals generated by the at least one sensor, the control unit is configured to control at least one of: inflating the first balloon, inflating the second balloon, inflating the third balloon, deflating the first balloon, deflating the second balloon, or deflating the third balloon. However, Anderson teaches a similar endovascular system (abstract and Fig. 1) comprising a third balloon coupled to the stent graft (Fig. 1 discloses a third balloon 3 coupled to the shunt; col. 3, lin. 18-19). The combination of the sensors and control unit in Houser and the third balloon in Anderson is fully capable of performing the intended use of based on the sets of signals generated by the at least one sensor, the control unit is configured to control at least one of: inflating the first balloon, inflating the second balloon, inflating the third balloon, deflating the first balloon, deflating the second balloon, or deflating the third balloon (col. 3, lin. 24-25 disclose the balloons in Anderson can be inflated and deflated and col. 7, lin. 62-67 and col. 8, lin. 1-3 disclose the inflation of the balloons can be varied to prevent overinflation based on the sensors sensing the obstruction hardness).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the endovascular system in Houser to include a third balloon coupled to the stent graft; and based on the sets of signals generated by the at least one sensor, the control unit is configured to control at least one of: inflating the first balloon, inflating the second balloon, inflating the third balloon, deflating the first balloon, deflating the second balloon, or deflating the third balloon, as taught and suggested by Anderson, for accurately expanding the implantation site to provide sufficient blood flow.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YASHITA SHARMA whose telephone number is (571)270-5417. The examiner can normally be reached on 8am-5pm M-Th; 8am-4pm Fri (MT).
If attempts to reach the examiner by telephone are unsuccessful, the examiner' s supervisor, Jerrah Edwards, can be reached at 408-918-7557. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from Patent Center. Status information for published applications may be obtained from Patent Center. Status information for unpublished applications is available through Patent Center to authorized users only. Should you have questions about access to the USPTO patent electronic filing system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
/YASHITA SHARMA/
Primary Examiner, Art Unit 3774
Prosecution Insights