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 .
Response to Arguments
Applicant’s arguments, see “Applicant Arguments/Remarks”, filed 02/05/2026, with respect to the rejections under U.S.C. 112(b) have been fully considered and are persuasive. The prior rejections under U.S.C. 112(b) have been withdrawn.
The objection to Claim 41 is maintained and updated, as the new amendments cause further grammatical errors. The Amendments to Claim 1 likewise necessitate an Objection for grammatical errors.
Applicant’s arguments regarding the 103 rejection to modified Nunez, that Nunez does not teach the usage of the sensors in system separate from the graft, is unpersuasive. Nunez explicitly teaches that the sensor structure can be a separate system, both physically and in the manner of deployment (Para. 0049, “In one embodiment, sensors 122 are deployed as a separate system. In this embodiment, separate sensors 122 occupy a unique space. Methods or techniques for deploy sensors 122 include deployment utilizing a small French catheter left behind after the modular graft pieces are properly positioned within the body lumen. The catheters may be positioned through a separate stick site adjacent an endograft introducer. In a particular embodiment, sensors 122 may be pushed out in a coil configuration. For example, a coil system includes sensors 122, which are introduced with a coil to promote thrombosis of the aneurysmal sac if there is an apparent endoleak”, Para. 0075, “Although the apparatus and methods described herein are described in the context of monitoring an endoprosthesis with sensors, it is understood that the apparatus and methods are not limited to sensors or endoprosthetics. Likewise, the endoprosthetic and sensor components illustrated are not limited to the specific embodiments described herein, but rather, components of both the endoprosthesis and the sensors can be utilized independently and separately from other components described herein”). Nunez also teaches the amended limitations regarding the electronic circuity, as Nunez teaches a power supply (power source 316); a memory (microprocessor 304, Para. 0059, “Referring further to FIG. 9, system 300 also includes a microcontroller 304 electronically coupled to and in signal communication with analog to digital converter 302”, Examiner notes that microprocessors have built-in memory) to store data from the sensor (Para. 0061, “Sensors 122 detect and measure pressure within endoprosthetic 100, as described above, and transmit alternating current signals to analog to digital converter 302, wherein the alternating current signals are converted to corresponding digital signals. The digital signals are transmitted to microcontroller 304”), and additional components of an electronics assembly comprising circuitry powered by the power supply (Para. 0061), the electronics assembly additionally comprising one or more components selected from a controller (processing circuitry of microprocessor 304, Para. 0059).
For these reasons, the rejections under U.S.C. 103 to modified Nunez are maintained. The rejections have been updated below to account for the claim amendments.
Claim Objections
Claims 1 and 41 is objected to because of the following informalities:
Regarding Claim 1, the limitation “conforms to a size and shape of a or stent graft” should read “conforms to a size and shape of a stent graft”.
Regarding Claim 41, the limitation “A system comprising a graft the the sensing attachment of Claim 1 in combination with the graft” should read “A system comprising the sensing attachment of Claim 1 in combination with the graft”.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
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 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.
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, 5, 14, 28, 38, 40, 42, 51, 57-61, and 63 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication 20080033527 awarded to Nunez et al, hereinafter Nunez.
Regarding Claim 1, Nunez teaches a sensing attachment for a medical device, the attachment consisting of: a sensor (sensors 122 in FIG 9); a communication interface comprising an antenna (Para. 0059, “Referring further to FIG. 9, system 300 also includes a microcontroller 304 electronically coupled to and in signal communication with analog to digital converter 302 and also coupled to one or more radiofrequency identification tags 306, each having an antenna 308”), configured to provide intra-body communication to another device (Para. 0061, “The codes are transmitted through antennas 308 to radiofrequency identification reader 324 and the codes are decoded such that the signals can be read by and/or viewed on an integrated monitoring device (not shown), such as an integrated external computing system including a display screen”); a power supply (power source 316); a memory (microprocessor 304, Para. 0059, “Referring further to FIG. 9, system 300 also includes a microcontroller 304 electronically coupled to and in signal communication with analog to digital converter 302”, Examiner notes that microprocessors have built-in memory) to store data from the sensor (Para. 0061, “Sensors 122 detect and measure pressure within endoprosthetic 100, as described above, and transmit alternating current signals to analog to digital converter 302, wherein the alternating current signals are converted to corresponding digital signals. The digital signals are transmitted to microcontroller 304”), and additional components of an electronics assembly comprising circuitry powered by the power supply (Para. 0061), the electronics assembly additionally comprising one or more components selected from a controller (processing circuitry of microprocessor 304, Para. 0059); a size-adjustable body in the shape of a spring (Para. 0050, “Alternatively, sensors 122 are deployed as a sheet of sensors in a linear configuration or in a spiral configuration”) that fits around and conforms to a size and shape of a stent graft (Para. 0050, “The sheet of sensors may be deployed along with the endograft body and limb as a separate system”), wherein the sensing attachment is implantable but is not a component of an implanted or implantable stent or graft or stent graft (Para. 0049, “In one embodiment, sensors 122 are deployed as a separate system. In this embodiment, separate sensors 122 occupy a unique space. Methods or techniques for deploy sensors 122 include deployment utilizing a small French catheter left behind after the modular graft pieces are properly positioned within the body lumen. The catheters may be positioned through a separate stick site adjacent an endograft introducer. In a particular embodiment, sensors 122 may be pushed out in a coil configuration. For example, a coil system includes sensors 122, which are introduced with a coil to promote thrombosis of the aneurysmal sac if there is an apparent endoleak”, Para. 0075, “Although the apparatus and methods described herein are described in the context of monitoring an endoprosthesis with sensors, it is understood that the apparatus and methods are not limited to sensors or endoprosthetics. Likewise, the endoprosthetic and sensor components illustrated are not limited to the specific embodiments described herein, but rather, components of both the endoprosthesis and the sensors can be utilized independently and separately from other components described herein”). Nunez does not teach wherein the attachment embodiment is formed of nitinol, but Nunez does teach another embodiment of the sensing attachment that is formed of nitinol (Para. 0051).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Nunez, i.e. by forming the spiral sensor embodiment of nitinol, as Nunez teaches the usage of nitinol for shaping the device appropriately, and as Nunez teaches in Para. 0064 that nitinol is a suitable for its properties as a biocompatible shape-memory material.
Regarding Claims 5 and 14, modified Nunez makes obvious the sensing attachment of Claim 1, wherein the size-adjustable body is in a form of a hollow monofilament comprising nitinol in the shape of a spiral, where the hollow monofilament has a lumen (see rejection above, the examiner notes that nitinol is a hollow monofilament).
Regarding Claim 28, modified Nunez makes obvious the sensing attachment of Claim 1. Nunez further teaches wherein the sensor is selected from a fluid pressure sensor (Para. 0045), fluid volume sensor (Para. 0019), contact sensor (Para. 0019), position sensor (Para. 0019), pulse pressure sensor (Para. 0071), blood flow sensor (Para. 0019), chemistry sensor (Para. 0044), metabolic sensor (Para. 0044), accelerometer (Para. 0019), mechanical stress sensor (Para. 0067), and temperature sensor (Para. 0019).
Regarding Claim 38, modified Nunez makes obvious a kit comprising the sensing attachment of Claim 1 (see rejection above), and a stent graft (stent 120).
Regarding Claim 40, modified Nunez makes obvious a system comprising a stent graft and the sensing attachment of Claim 1 (see rejection to Claim 1 above) in combination with the stent graft (stent 120 and graft 108).
Regarding Claim 42, modified Nunez makes obvious an apparatus comprising a delivery catheter and the sensing attachment of Claim 1 (see rejection to Claim 1 above) positioned within the delivery catheter (Para. 0027, “The catheter is inserted into the femoral artery and guided to the deployment site using fluoroscopic or intravascular imaging, where endoprosthesis 100 is then deployed”).
Regarding Claim 51, modified Nunez makes obvious a method comprising: implanting a stent graft into a patient during a medical procedure to provide an implanted stent graft (Para. 0027); and implanting a sensing attachment of Claim 1 into the patient during the medical procedure to provide an implanted sensing attachment (Para. 0049); where the implanted sensing attachment is adjacent to the implanted stent graft (Fig. 1, Para. 0049), and where the implanting the stent graft into the patient does not also achieve the implanting the sensing attachment into the patient (Para. 0049 states that the sensing system is implanted separately).
Regarding Claim 57, modified Nunez makes obvious a method for monitoring a patient (abstract), the method comprising: obtaining information using a sensor secured (sensors 122) to a sensing attachment of Claim 1 (see rejection to Claim 1 above), the sensing attachment physically associated with, but not a component of, a medical device that is implanted in the patient, the medical device selected from a stent graft (stent 120 and graft 108, Para. 0050, “The sheet of sensors may be deployed along with the endograft body and limb as a separate system”); and transmitting the information or a modified form thereof to a device located outside of the patient (Para. 0061, “The codes are transmitted through antennas 308 to radiofrequency identification reader 324 and the codes are decoded such that the signals can be read by and/or viewed on an integrated monitoring device (not shown), such as an integrated external computing system including a display screen”).
Regarding Claim 58, modified Nunez makes obvious the method of Claim 57. Nunez further teaches wherein the sensing attachment is associated with an abdominal aortic aneurysm stent graft (Para. 0022, “Aneurysmal sac 104 may be categorized as an abdominal aortic aneurysm (AAA)”).
Regarding Claim 59, modified Nunez makes obvious the method of Claim 57. Nunez further teaches wherein the sensor obtains information characteristic of a pressure within an aneurysm sac (Para. 0033, “The sensor provides real time feedback during implantation to facilitate accurately positioning the endoprosthesis at or within the aneurysm site. The wall tension of the endoprosthesis and/or the stent applied to the aortic wall provides real time feedback indicating a maximum wall tension within the endoprosthesis and/or the stent, while at the same time there is a simultaneous drop in the sac pressure as well as angiographic confirmation”).
Regarding Claim 60, modified Nunez makes obvious the method of Claim 57. Nunez further teaches wherein the sensor obtains information of a pressure within a stent graft (Para. 0033, “The sensor provides real time feedback during implantation to facilitate accurately positioning the endoprosthesis at or within the aneurysm site. The wall tension of the endoprosthesis and/or the stent applied to the aortic wall provides real time feedback indicating a maximum wall tension within the endoprosthesis and/or the stent, while at the same time there is a simultaneous drop in the sac pressure as well as angiographic confirmation”) located within an abdominal aortic aneurysm of the patient (Para. 0022, “Aneurysmal sac 104 may be categorized as an abdominal aortic aneurysm (AAA)”).
Regarding Claim 61, modified Nunez makes obvious the method of Claim 57. Nunez further teaches wherein the sensor is a plurality of sensors (Para. 0035, “As shown in FIG. 1, one or more sensors 122 are coupled to or integrated with endoprosthesis 100”).
Regarding Claim 63, modified Nunez makes obvious the method of Claim 57. Nunez further teaches wherein transmitting the information is by way of radiofrequency transmission from the sensing attachment (Para. 0060, “A power source 316 is provided outside body lumen 102. Power source 316 includes an oscillator 318 electronically coupled to an amplifier 320 and an inductor 322. Further, a radiofrequency identification reader 324 is also provided outside body lumen 102”).
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication 20080033527 awarded to Nunez et al, hereinafter Nunez, as applied to claim 1 above, and further in view of NPL “Corrosion Resistance of Polyurethane-Coated Nitinol Cardiovascular Stents” by Mazumder et al, hereinafter Mazumder.
Regarding Claim 25, modified Nunez makes obvious the sensing attachment of Claim 1. Nunez discloses where the frame of the heart valve device can be a polymeric material (Para. 0064), Nunez does not teach wherein the size-adjustable body of the sensor device comprises a polymeric coating on the surface of the body.
However, in the art of implantable devices, Mazumder teaches that the necessity to prevent corrosion of Nitinol in an artery (see Abstract) by coating the surface of the nitinol with a polyurethane polymer to extend the service life of the implant (see Conclusions).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Nunez by Mazumder, i.e. by coating the sensor body of Nunez with a polymeric coating as taught in Mazumder, for the predictable purpose of extending the service life of the device and increasing the safety of the device as set forth in Mazumder.
Claims 39 and 41 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication 20080033527 awarded to Nunez et al, hereinafter Nunez, as applied to claim 1 above, and further in view of U.S. Patent Publication 20140316513 awarded to Tang, hereinafter Tang.
Regarding Claims 39 and 41, modified Nunez makes obvious the sensing attachment of Claim 1 (see the rejection of Claim 1 above. Nunez also teaches the usage of other aortic grafts (Para. 0021) but does not explicitly disclose that a graft without a stent is used.
However, in the field of grafts, Tang teaches the usage of an aortic graft with or without a stent (Para. 0085).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Nunez by Tang, i.e. by using the device of Nunez in a graft without a stent, as Nunez teaches the usage of their system with other grafts and Tang discloses that aortic systems are known to be used with or without a stent.
Claim 50 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication 20080033527 awarded to Nunez et al, hereinafter Nunez, in view of U.S. Patent Publication 20110071624 awarded to Finch et al, hereinafter Finch.
Regarding Claim 50, modified Nunez makes obvious a method comprising: providing a first apparatus comprising a stent graft contained within a first delivery catheter (Para. 0027, “The apparatus may include various actuation mechanisms for retracting sheaths and where desired, inflating balloons of balloon catheters. Endoprosthesis 100 may be delivered to the deployment site using any suitable method and/or apparatus”); providing a second apparatus comprising a sensing attachment of Claim 1 (see rejection to Claim 1 above) contained within a second delivery catheter (Para. 0049, “In one embodiment, sensors 122 are deployed as a separate system. In this embodiment, separate sensors 122 occupy a unique space. Methods or techniques for deploy sensors 122 include deployment utilizing a small French catheter left behind after the modular graft pieces are properly positioned within the body lumen”); inserting the first apparatus into a patient during a medical procedure, and implanting the stent graft into the patient (Para. 0027); inserting the second apparatus into the patient during the medical procedure (Para. 0049), and implanting the sensing attachment into the patient, the sensing attachment being implanted at a location adjacent to the stent graft (Para. 0049); removing the first delivery catheter from the patient (Para. 0028, “With a distal end of the catheter sheath located at the deployment site, the catheter sheath is retracted to deploy endoprosthesis 100”). Nunez does not teach wherein the second catheter is removed from the patient.
However, in the art of catheter-based implantations (abstract), Finch teaches that it is well known in the art to remove catheters after implantation has been determined to be effective (Para. 0291).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed to modify Nunez by Finch, i.e. by removing the second catheter after implantation of the sensing attachment as taught in Finch, as Finch teaches that one of ordinary skill understands the necessity of when a catheter should be removed once physician determines successful deployment of an implant.
Claim 62 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication 20080033527 awarded to Nunez et al, hereinafter Nunez, as applied to claim 57 above, and further in view of U.S. Patent 5967986 to Cimochowski et al, hereinafter Cimochowski.
Regarding Claim 62, modified Nunez makes obvious method of Claim 57, wherein the sensor is a plurality of sensors located within an abdominal aortic aneurysm stent graft (Para. 0035, “As shown in FIG. 1, one or more sensors 122 are coupled to or integrated with endoprosthesis 100”). Nunez does not teach wherein where the plurality of sensors obtain information characteristic of a first blood pressure at an entrance to the stent graft and information characteristic of a second blood pressure at an exit to the stent graft.
However, in the art of endoluminal implants (Col. 3, Lines 15-17), Cimochowski teaches the usage of distal and proximal pressure transducers to monitor the pressures in an endoluminal implant (Col. 4, Lines 9-20, “In another form of the invention, the sensor comprises a distal and a proximal pressure transducer. The distal pressure transducer is exposed to a fluid pressure of the fluid flow through an interior portion of the member adjacent to where the fluid exits the member, and the proximal pressure transducer is exposed to a fluid pressure of the fluid flow through the interior portion of the member adjacent to where the fluid enters the member. The signal produced by the sensor is thus indicative of a differential pressure corresponding to a difference between the proximal and distal pressures respectively sensed by the proximal and distal pressure transducers”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Nunez by Chimochowski, i.e. by using the pressure system of Chimochowski in the system of Nunez, for the predictable purpose of using the known technique of Chimochowski in the similar system of Nunez for improving the pressure monitoring of Nunez in the same way as Chimochowski.
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 Jess Mullins whose telephone number is (571)-272-8977. The examiner can normally be reached between the hours of 9:00 a.m. to 5:00 p.m. PST M-F.
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/JLM/
Examiner, Art Unit 3792
/UNSU JUNG/Supervisory Patent Examiner, Art Unit 3792