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 .
Amendment Entered
In response to the amendment filed on 12/01/2025, claims 126-135 and 142-152 are cancelled, and amended claims 163-183 are entered. Claims 163-183 remain pending in the current application.
Response to Amendment
Applicant’s remarks and amendments with respect to the specification and claims have been fully considered and overcome each and every objection and rejection under 35 U.S.C. 112(b) previously set forth in the Non-Final Office Action mailed 06/04/2025. The objections and rejections are withdrawn in view of amendments to the claims.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 07/22/2025 and 05/03/2025 have been considered by the examiner.
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.
Claims 163-183 are rejected under 35 U.S.C. 103 as being unpatentable over US 2008/0275350 A1 to Liao et al. ("Liao") in view of a research article entitled "Treatment of infrapopliteal post-PTA dissection with tack implants: 12-month results from the TOBA-BTK study" by Brodmann et al. ("Brodmann"), and further in view of US 2008/0033527 A1 to Nunez et al. ("Nunez").
Regarding independent claim 163, Liao discloses an implantable sensor assembly (see Fig. 1 and [0018], "...a sensor system 10 implanted within a pulmonary artery…”, system 10 (assembly) implanted in a pulmonary artery (i.e., a body passageway of a patient)), comprising:
a first anchor and a second anchor (see Fig. 2 and [0025], "... anchors 36, 44, and/or 58 are adapted to engage the inner surface of the pulmonary artery and have an outer diameter …", two anchors (i.e., anchors 36, 44, and/or 58)), the first and second anchors configured to maintain a position of the implantable sensor assembly in a body passageway of a patient (see [0025] "…anchors 36, 44, and/or 58 are adapted to engage the inner surface of the pulmonary artery and… exert a radial expansion force against the arterial walls of the pulmonary artery or other vessel in which they are deployed, securing and stabilizing the assemblies within the artery at a desired location", anchors engage an inner surface of an artery/vessel (i.e., abut an inner wall of a body passageway) and secure/stabilize the assembly (i.e., secure the assembly in a fixed location)), the first anchor connected to the second anchor (see [0021], "… the first anchor…is at least partially engaged by the second anchor. …", first and second anchors are at least partially engaged (i.e., first anchor and second anchor are connected) wherein each of the first anchor and the second anchor is a stent (see [0026], “…stent- like anchors 36, 44, and/or 58 described above can be self-expanding or balloon expandable, and can be made from any materials, whether now known or later developed, suitable for use in cardiovascular stents or similar implantable devices…”, first and second anchors are stent-like anchors suitable for use in stent applications (i.e. stents));
a sensor system comprising a first sensor and a second sensor, wherein the first sensor is directly coupled to the first anchor and the second sensor is directly coupled to the second anchor, (see Fig. 2 and [0019], “…sensor system 10 includes at least a first assembly 24 and a second assembly 28….sensor module 32 coupled to a first anchor 36…a second sensor module 40 coupled to a second anchor 44.”, sensor system 10 (i.e., sensor system) has sensor module 32 coupled to anchor 36 (i.e., first sensor coupled to the first anchor) and sensor module 40 coupled to anchor 44 (i.e., second sensor coupled to the second anchor)) , the sensor system configured to collect sensor data related to one or more characteristics of the body passageway of the patient (see [0032], "…sensor modules 32, 40, and/or 54 may be configured to measure any known physiologic parameters such as, for example, blood pressure, temperature, blood or fluid flow, strain, electrical, chemical, or magnetic properties within the body…", sensor modules (i.e., of the sensor system) measure physiologic parameters within the body (Examiner notes that measuring a parameter within the body is indicative of detecting a parameter to be measured). see also [0022], “…sensors 32, 40 are each coupled to the anchors 36, 44 in a direction that is retrograde to the flow of blood through the pulmonary artery…”, sensors are disposed downstream of anchors (i.e., of the implanted assembly) when measuring parameters (i.e., sensors detect/measure parameters in an environment surrounding the assembly));
a communications circuitry configured to wirelessly communicate with one or more external devices (see [0031], “…sensor modules 32, 40, and/or 54 may be configured to communicate with devices external to the patient's body via wireless communication links…”, communication link of the assembly (i.e., communications circuitry) wirelessly communicates with devices external to the patient’s body), wherein the communications circuitry comprises an antenna, and the antenna extends from the first sensor to the second sensor, or wherein the antenna extends from the first anchor to the second anchor (see [0031], "… each of the assemblies…include a sensor module…coupled to anchors…sensor modules…are configured to communicate…via a communication link, which may be wired or wireless…", assemblies (i.e., sensor modules coupled to anchors) communicate via a wired communication link (i.e., a wired connection between components indicates an antenna)).
However, Liao fails to disclose “…wherein each of the first anchor and the second anchor is a tacking stent…”.
Liao further discloses stent-like anchors made of nitinol, used in cardiovascular stents or similar devices (see Figs. 1-2 and [0026], “...stent- like anchors…can be made from any materials...suitable for use in cardiovascular stents or similar implantable devices...made at least partially from...shape memory polymers and nickel-titanium shape memory alloys such as Nitinol").
Brodmann teaches an implant system for treating vascular dissections (see pg. 96, Objectives) using a self-expanding nitinol tack implant (see pg. 97 (Section 2.2) “…Tack Endovascular System…consists of self-expanding nitinol implants...designed to treat dissections by exerting a low outward radial force upon the vessel walls”). Although Liao fails to explicitly disclose a tacking stent, Liao teaches a stent-like anchor made of nitinol.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the anchors (to be tacking stents) of Liao for the purpose of reducing the metal burden, as evidence by Brodmann (see pg. 97, Section 1). Furthermore, one of ordinary skill in the art would have had predictable success combining Liao, and Brodmann since their teachings relate to the same narrow field of endeavor, i.e., utilizing sensing devices implanted in patient vasculature.
Additionally, Liao fails to disclose “…a power source configured to provide power to the sensor system…”.
Liao further discloses battery operation of the assembly (see Liao [0020], “…e.g., battery failure, decreased sensing capacity, etc.…”), but is silent regarding what components of the assembly receive power.
Nunez teaches an implant incorporating a graft with integrated sensors (see abstract), including a power source that powers a sensor system (see [0069], "...power source is operatively coupled to sensors 416 and configured to power sensors 416...", see also [0047], "Power source 130 is configured to provide an electrical current through sensors 122, 128 and transmitter 132" power source provides power to the sensor system.
Therefore, it would have been prima facie obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention to modify Liao (to include the power source of Nunez) for the purpose of generating the necessary power required to power the device, as evidence by Nunez (see [0047]). Furthermore, one of ordinary skill in the art would have had predictable success combining Liao and Nunez since both teachings relate to the same narrow field of endeavor, i.e., utilizing sensing devices implanted in patient vasculature to measure various parameters.
Regarding claim 164, the Liao/Brodmann/Nunez combination discloses the assembly as claimed in claim 163 above. However, the Liao/Brodmann/Nunez combination fails to explicitly disclose “…wherein the communications circuitry comprises a wakeup receiver configured to detect a wakeup signal from the one or more external devices and to activate the sensor assembly in response to detecting the wakeup signal”.
Liao further discloses wireless communications circuitry with a receiver (see [0031], “…transmitter/receiver configured for acoustic telemetry, which transmitter/receiver is configured to transmit and/or receive ultrasonic signals to/from a pulse generator…”).
Nunez further teaches using an external device to interrogate and activate sensors (see [0059], “…a plurality of devices coupled to or integrated with endoprosthesis 100 and a plurality of devices located externally…”, see also [0037], “…sensors…are activated at a time of interrogation”).
The Liao/Brodmann/Nunez combination above discloses communications circuitry wirelessly communicating with external devices (see Liao [0031]), and further discloses a receiver (see Liao [0031]), but fails to explicitly disclose activating the sensor assembly in response to detecting a wakeup signal from an external device. Nunez further teaches activating sensors in response to receiving a signal from an external device (see [0037] and [0059]).
Therefore, it would have been prima facie obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention to modify the Liao/Brodmann/Nunez combination (to activate the sensor assembly in response to detecting a wakeup signal at a wakeup receiver) for the purpose of improving operational reliability, as evidence by Nunez (see [0037]).
Regarding claim 165, the Liao/Brodmann/Nunez combination discloses the assembly as claimed in claim 163 above. The Liao/Brodmann/Nunez combination further discloses wherein at least one of the first sensor or the second sensor is a blood flow sensor, a blood pressure sensor, a metabolic sensor, a glucose sensor, a pressure sensor, an oxygen sensor, or a protein enzyme sensor (see Liao [0032] "The sensor modules…measure any known physiologic parameters such as, for example, blood pressure, temperature, blood or fluid flow, strain, electrical, chemical, or magnetic properties within the body…", sensor system measures blood pressure (i.e., pressure), blood or fluid flow (i.e., flow)).
Regarding claim 166, the Liao/Brodmann/Nunez combination discloses the assembly as claimed in claim 163 above. The Liao/Brodmann/Nunez combination further discloses wherein each of the first and second anchors is configured to expand from a first diameter in a delivery configuration to a second diameter in a deployed configuration (see Liao [0025], "…anchors 36, 44, and/or 58 are configured to transition between a collapsed configuration and an expanded configuration. In the collapsed configuration the anchors 36, 44, and/or 58 are configured to be delivered to a target site…”, anchors begin in a collapsed configuration (i.e., a delivery diameter) and transition to an expanded configuration (i.e., an expanded deployed diameter. “expanded” is interpreted as an increased diameter, relative to the delivery diameter),.
Regarding claim 167, the Liao/Brodmann/Nunez combination discloses the assembly as claimed in claim 163 above. However, the Liao/Brodmann/Nunez combination fails to explicitly disclose “…wherein each of the first and second anchors has a length less than or equal to 9 mm”.
Broadman further teaches self-expanding nitinol stent anchors with a length of 6mm (see pg. 97, Section 2.2, “…consists of self-expanding nitinol implants, each measuring 6 mm in length…”).
Although the Liao/Brodmann/Nunez combination fails to explicitly disclose an anchor length less than or equal to 9mm, Broadman teaches a length of 6mm, which is less than 9mm. Therefore, it would have been prima facie obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to modify the Liao/Brodmann/Nunez combination (to have a first and second anchor length less than 9mm) for the purpose of minimizing anchor contact with the artery wall, as evidence by Brodmann (see pg. 97, Section 2.2)).
Additionally, it would have been obvious to one having ordinary skill in the art at the time the invention was made to have a first and second anchor length less than 9mm, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 168, the Liao/Brodmann/Nunez combination discloses the assembly as claimed in claim 163 above. The Liao/Brodmann/Nunez combination further discloses wherein the communications circuitry is configured to wirelessly transmit raw data collected from the sensor system (see Liao [0031], “…sensor modules 32, 40, and/or 54 may be configured to communicate with devices external to the patient's body via wireless communication links…”).
Regarding claim 169, the Liao/Brodmann/Nunez combination discloses the assembly as claimed in claim 163 above. The Liao/Brodmann/Nunez combination further discloses wherein the sensor system comprises processing circuitry configured to at least partially process the sensor data collected from the first sensor and the second sensor (see Liao [0032], “…sensor modules 32, 40, and/or 54 are configured to store and/or transmit blood pressure data to a pulse generator or other device…”, sensor modules (i.e., processing circuitry) store and transmit collected data (i.e., partially process collected data)).
Regarding claim 170, the Liao/Brodmann/Nunez combination discloses the assembly as claimed in claim 169/163 above. The Liao/Brodmann/Nunez combination further discloses wherein the communications circuitry is configured to wirelessly transmit the at least partially processed sensor data (see Liao [0032], “…sensor modules 32, 40, and/or 54 are configured to store and/or transmit blood pressure data to a pulse generator or other device…”, sensor modules (i.e., processing circuitry) wirelessly transmit processed (i.e., stored) data).
Regarding claim 171, the Liao/Brodmann/Nunez combination discloses the assembly as claimed in claim 163 above. The Liao/Brodmann/Nunez combination further discloses wherein the communications circuitry is configured to wirelessly receive instructions from the one or more external devices (see Liao [0031], “…communicate with devices external to the patient's body via wireless communication links…”, communicate externally with devices (i.e., receive instructions)).
Regarding claim 172, the Liao/Brodmann/Nunez combination discloses the assembly as claimed in claim 163 above. The Liao/Brodmann/Nunez combination further discloses wherein the implantable sensor assembly is configured to receive power from the one or more external devices (see Liao [0047], "Power source 130 is configured to provide an electrical current through sensors 122, 128 and transmitter 132").
Regarding claim 173, the Liao/Brodmann/Nunez combination discloses the assembly as claimed in claim 163 above. The Liao/Brodmann/Nunez combination further discloses wherein the power source is rechargeable (see Liao [0020], “…e.g., battery failure, decreased sensing capacity, etc.…”),.
Regarding claim 174, the Liao/Brodmann/Nunez combination discloses the assembly as claimed in claim 163 above. The Liao/Brodmann/Nunez combination further discloses wherein the power source is configured to receive power from the one or more external devices (see Liao [0047], "Power source 130 is configured to provide an electrical current through sensors 122, 128 and transmitter 132"). .
Regarding claim 175, the Liao/Brodmann/Nunez combination discloses the assembly as claimed in claim 163 above. The Liao/Brodmann/Nunez combination further discloses wherein the power source comprises a battery or a capacitor (see Liao [0020], “…e.g., battery failure, decreased sensing capacity, etc.…”).
Regarding claim 176, the Liao/Brodmann/Nunez combination discloses the assembly as claimed in claim 163 above. However, the Liao/Brodmann/Nunez combination fails to explicitly disclose “…wherein the power source is hermetically sealed by wrapped with a non-permeable material”.
Nunez further teaches a power source coupled a sensor of an endoprosthesis (see abstract) where power is delivered to the sensor by the movement of an indictor and a capacitor (see [0055], “…electrically conducting material including a first capacitor plate 286 is layered or deposited on a surface of polymer substrate 280… electrically conducting material including an inductor 289 electrically connected to capacitor plate 288 is layered onto a second polymer substrate 290… membrane that is movable with respect to or toward polymer substrate 280 in response to a change in an external condition”, ) and the capacitors are positioned in a hermetically sealed cavity (see [0056], “…when attached, polymer substrate 280 and polymer substrate 290 form a hermetically sealed cavity 284…”, movement of inductor 289 toward capacitor plate 288 in response to an external change generates an electrical conduction, powering the sensor of the endoprosthesis).
Therefore, it would have been prima facie obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the Liao/Brodmann/Nunez combination (to hermetically seal the power supply) for the purpose of protecting the power supply from exposure to external conditions, as evidence by Nunez (see [0055]).
Regarding claim 177, the Liao/Brodmann/Nunez combination discloses the assembly as claimed in claim 163 above. The Liao/Brodmann/Nunez combination further discloses wherein the one or more characteristics comprises pressure, flow, sound, or vibration of the environment surrounding the implantable sensor assembly (see Liao [0032] "The sensor modules…measure any known physiologic parameters such as, for example, blood pressure, temperature, blood or fluid flow, strain, electrical, chemical, or magnetic properties within the body…", sensor system measures blood pressure (i.e., pressure), blood or fluid flow (i.e., flow)).
Regarding claim 178, the Liao/Brodmann/Nunez combination discloses the assembly as claimed in claim 163 above. Liao further discloses the sensor system is positioned in the vasculature of a patient (see Liao [0004], “…sensing module is delivered transvenously to a target vessel…and anchored in the vessel…”, positioning of a sensor within patient vasculature is indicative of the sensor being in contact with blood and/or other vascular material of a patient).
However, the Liao/Brodmann/Nunez combination is silent regarding wherein the sensor system is hermetically sealed.
Nunez further teaches a pressure sensor positioned on an endoprosthesis (see Figs. 1-2 and [0053], “…Pressure sensor 222 is positioned on endoprosthesis 100 such that changes in luminal or exterior pressure will cause a deformation of pressure sensor 222…”) including a hermetic seal (see Figs. 3-8 and [0056], “…when attached, polymer substrate 280 and polymer substrate 290 form a hermetically sealed cavity 284", attachment of substrates 280 and 290 create a hermetically sealed cavity within sensor 222 (i.e., the sensor is hermetically sealed)).
Therefore, it would have been prima facie obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the Liao//Brodmann/Nunez combination (to hermetically seal the sensor system) for the purpose of protecting the sensor system from exposure to external conditions, as evidence by Nunez (see [0055]).
Regarding claim 179, the Liao/Brodmann/Nunez combination discloses the assembly as claimed in claim 163 above. However, the Liao//Brodmann/Nunez combination fails to disclose a kit comprising the assembly of Claim 126 and a unique identification code.
Nunez further teaches, in an alternate embodiment, a system including a unique code for each signal (see Fig. 9 and [0061], "...digital signals are transmitted to microcontroller 304 and radiofrequency identification tags 306, wherein each digital signal is provided a unique code”). Therefore, it would have been prima facie obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the Liao/Brodmann/Nunez combination (to include a unique identification code) for the purpose of detecting a problem or complication with the device, as evidence by Nunez (see [0061]).
Regarding claim 180, the Liao/Brodmann/Nunez combination discloses the assembly as claimed in claim 179/163 above. The Liao/Brodmann/Nunez combination further discloses wherein the unique identification code is configured to be scanned by a barcode scanner (see Nunez [0061], “…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 181, the Liao/Brodmann/Nunez combination discloses the assembly as claimed in claim 179/163 above. The Liao/Brodmann/Nunez combination further discloses wherein the unique identification code is integrated with a RFID (see Nunez [0059]-[0060], “…System 300 may include any suitable number of radiofrequency identification tags 306…includes a radiofrequency identification tag 306 for each sensor…a radiofrequency identification reader 324…”).
Regarding claim 182, the Liao/Brodmann/Nunez combination discloses the assembly as claimed in claim 163 above. The Liao/Brodmann/Nunez combination further discloses a memory device for storing the sensor data related to the one or more characteristics (see Liao [0032], “…configured to store and/or transmit blood pressure data…”).
Regarding claim 183, the Liao/Brodmann/Nunez combination discloses the assembly as claimed in claim 163 above. The Liao/Brodmann/Nunez combination further discloses wherein the communications circuitry is configured to wirelessly communicate with the one or more external devices via a BluetoothTM protocol, WiFi, ZigBee, medical implant communication service, the medical device radio communications service, or cellular telephony (see Liao [0031], “…sensor modules 32, 40, and/or 54 may be configured to communicate with devices external to the patient's body via wireless communication links…”, communication link of the assembly (i.e., communications circuitry) wirelessly communicates with devices external to the patient’s body).
Response to Arguments
Applicant’s arguments, filed 12/01/2025, with respect to the rejection of claims 126-135 and 141-152 under 35 U.S.C. 103 have been fully considered, but they are moot in view of the cancellation of claims 126-135 and 141-152.
Applicant’s arguments, filed 12/01/2025, with respect to the prior art of record have been fully considered, but are not persuasive in view of the current combination of references that were necessitated by amendment.
Applicant argues that Liao, Nunez, Brodmann, and Drinan, taken individually or in combination, fail to teach or suggest the features recited in newly presented claim 163 (see pg. 7 of remarks). In particular, applicant argues that Liao, Nunez, Brodmann, and Drinan, fail to teach or suggest a tacking stent and antenna as claimed in newly presented claim 163, further reciting portions of the instant specification to provide technical advantages of the claimed invention (see pg. 7-8 of remarks).
Regarding applicant’s argument that Liao, Nunez, Brodmann, and Drinan fail to teach or suggest features recited in newly presented claim 163, this argument is considered not persuasive in view of the current combination of references that were necessitated by amendment, and treatment of newly presented claim 163 above.
Regarding applicant’s citations of portions of the specification describing technical advantages of the claimed invention, MPEP § 2145 (II) states that the fact that appellant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious, see Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
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 ALYSSA P NOVAK whose telephone number is (703)756-1947. The examiner can normally be reached M-F: 8-5.
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/ALYSSA PAIGE NOVAK/Examiner, Art Unit 3791
/ERIC J MESSERSMITH/Primary Examiner, Art Unit 3791