DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after 16 March 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The amendment to the claims filed 26 November 2025 has been entered. Claim(s) 1, 30 and 96 is/are currently amended. Claim(s) 2-18, 21, 23-25, 31-60, 62-74, 77-95 and 97-161 has/have been canceled. Claim(s) 1, 19-20, 22, 26-30, 61, 75-76, 96 and 162-164 is/are pending.
Rejections Withdrawn
Rejections of claim(s) under 35 U.S.C. 101, 35 U.S.C. 112(a) (pre-AIA 35 U.S.C. 112, first paragraph) and/or 35 U.S.C. 112(b) (pre-AIA 35 U.S.C. 112, second paragraph) not reproduced below has/have been withdrawn in view of Applicant's amendments to the claims and/or submitted remarks.
Claim Interpretation
As noted in the prior Office action(s), claim(s) reciting an "anchoring structure" or an "anchor structure" limitation has/have been interpreted to invoke 35 U.S.C. 112(f) (or pre-AIA 35 U.S.C. 112, sixth paragraph).
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:
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue.
Resolving the level of ordinary skill in the pertinent art.
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.
Claim(s) 1, 19, 22, 27-29, 75-76 and 96 is/are rejected under 35 U.S.C. 103 as obvious over US 2011/0213413 A1 (previously cited, Brown '413) in view of Zhu et al. (Zhu), US 2013/0085350 A1 (previously cited, previously cited, Schugt), US 2004/0199238 A1 (previously cited, Brown '238) and US 2006/0200030 A1 (previously cited, White) and.
Regarding claim 1, Brown '413 discloses/suggests an implantable sensor system (e.g., Figs. 16-17) comprising:
a sensor (sensor 144) configured to fit in and capable of being implanted in an aneurysm of a patient (e.g., ¶ [0108] implantation site; ¶ [0107] aneurysm sac; etc.), the sensor capable of detecting one or more physiological parameters of the patient and generating sensor data (e.g., ¶ [0106] flow, pressure, oxygen levels or other chemical levels or substances); and
an anchor structure configured to fit within the aneurysm and to maintain a position of the system, including the sensor thereof in the aneurysm (cage 146; ¶ [0108] cage 146 helps to hold the sensor in place at the implantation site), the anchor structure forming a structure that encloses the sensor (e.g., Fig. 17), the anchor structure capable of being compressed for loading into a delivery system and expanded upon release from the delivery system (e.g., ¶ [0108] during advancement and deployment of the sensor within a patient's body or vasculature, the cage 146 is held tight against external surfaces of the sensor 146, and, when implanted at an interventional or other site, the cage is permitted to expand to its unrestrained configuration).
The only particular type of aneurysm described by Brown '413 is an abdominal aortic aneurysm (AAA) (e.g., ¶¶ [0003]-[0005]). Accordingly, Brown '413 does not expressly disclose the aneurysm into which the sensor is implanted, or that the system is configured to fit within, is an intracranial aneurysm. However, Brown '413 broadly discloses the system/sensor may be configured to fit/be positioned within "an aneurismal sac," which one of ordinary skill in the art reasonably encompasses intracranial aneurysms, and discloses the invention can be used to sense conditions in other areas of the body, including the brain (e.g., ¶ [0013]). Accordingly, Brown '413 at least suggests the sensor is capable of being implanted, and the system is configured to fit within, an intracranial aneurysm.
Alternatively/Additionally, Brown '413 further discloses/suggests the system is useful for obtaining information regarding the success of an aneurysm repair procedure, particularly placement of an endovascular graft, e.g., by monitoring for conditions indicative of endoleak (¶¶ [0005]-[0012]). Zhu discloses placement of an endovascular graft is a repair procedure also utilized for intracranial aneurysms, in which endoleaks may similarly occur (throughout document, e.g., pgs. 287-288, Introduction). 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 system of Brown '413 with the aneurysm into which the sensor is capable of being implanted, and the system being configured to fit within, being an intracranial aneurysm in order to similarly obtain information regarding the success of a repair/treatment of said intracranial aneurysm (Brown '413, ¶¶ [0012]-[0013]).
While Brown '413/Brown '413 as modified discloses the sensor system can be used to monitor desired parameters in the area of interest (¶ [0153]; etc.), Brown '413 does not expressly disclose the system comprises an antenna in electrical communication with the sensor.
Schugt teaches/suggests an implantable sensor system comprising: a sensor capable of being implanted in an aneurysm of a patient (Figs. 1-8, IMD 14, 20, etc., such as an implantable sensor, e.g., ¶ [0023], ¶ [0026], etc.), wherein the sensor is capable of detecting one or more physiological parameters of the patient and generating sensor data (e.g., ¶ [0043] sensor 20 may comprise one or more of a pressure sensor, a pH sensor, an oxygen sensor, etc.); an anchor structure joined to the sensor for maintaining a position of the sensor in the aneurysm (fixation mechanism 24, 46, etc., mechanically coupled to the housing of the IMD for fixing the IMD relative to a target location within a patient, such as a wall of a cavity or body lumen); and an antenna in electrical communication with the sensor (e.g., ¶ [0036] where a connector electrically connects fixation mechanism 24 to a telemetry module within the housing of the IMD, such that the fixation mechanism 24 is further configured to function as a radiating element of an antenna), wherein the antenna transmits sensor data related to the one or more physiological parameters of the patient to a receiver (e.g., ¶ [0031]), wherein the antenna is capable of being compressed for loading into a delivery system and expanded upon release from the delivery system (e.g., ¶ [0051] fixation mechanism 24 may be radially compressed to aid in delivery of IMD 20 to the target location, and expanded in situ when located at the target location to securely engage the vessel wall).
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 system of Brown '413 to further comprise an antenna in electrical communication with the sensor, wherein the antenna is configured to transmit sensor data related to the one or more physiological parameters of the patient to a receiver, as taught and/or suggested by Schugt in order to facilitate retrieval of data sensed by the system for use in monitoring a desired parameter(s) within the aneurysm by a user, e.g., physician, clinician, etc. (Brown '413, ¶ [0009], ¶ [0153], etc.; Schugt, ¶ [0028]). Furthermore, 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 system of Brown '413 with the anchor structure being configured to function as the antenna, such that each of the anchor structure and antenna is capable of being compressed for loading into a delivery system and expanded upon release from the delivery system, as taught/suggested by Schugt in order to provide an antenna that is efficient and capable of wireless telemetry over larger distances than a smaller antenna, e.g., limited to the size of the sensor (Schugt, ¶ [0018]).
Brown '413 as modified discloses/suggests the sensor may measure a chemical level or substance (¶ [0106]) and/or any "desired" parameter(s) (¶ [0153]), which reasonably encompasses a glucose sensor. Alternatively/Additionally, at the time the invention was effectively filed, it would have been an obvious matter of design choice to a person of ordinary skill in the art to modify the system of Brown '413 with the sensor comprising a glucose sensor and the one or more physiological parameters comprising glucose in the blood of the patient because Applicant has not disclosed that a glucose sensor/measurement, particularly within an intracranial aneurysm, provides an advantage, is used for a particular purpose, or solves a stated problem. Rather, Applicant discloses the sensor may be any of "a blood flow sensor, a blood pressure sensor, a metabolic sensor, a glucose sensor, an oxygen sensor, or other sensor" (e.g., ¶ [0010]). As no evidence has been provided to the contrary, one of ordinary skill in the art would have expected Applicant's invention to perform equally well with the sensor(s) disclosed/suggested by Brown '413 because either arrangement permits measuring relevant parameters within the blood of the patient (Brown '413, ¶ [0106]). Further alternatively/additionally, Brown '238 teaches/suggests an implantable sensor system comprising a sensor capable of being implanted in an aneurysm of a patient (sensor 16 or 52, measuring device 202, etc.), detecting one or more physiological parameters of the patient, and generating sensor data, wherein the sensor comprises a glucose sensor and the one or more physiological parameters comprises glucose in the blood of the patient (¶ [0019], ¶ [0041], ¶ [0047]). 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 system of Brown '413 to comprise a glucose sensor, such that the one or more physiological parameters further comprise glucose in the blood of the patient, as taught and/or suggested by Brown '238 in order to facilitate sensing other/additional parameter(s) as desired (Brown '413, ¶ [0153]; Brown '238, ¶ [0019]; etc.).
Brown '413 as modified discloses/suggests the antenna/anchor structure encloses the sensor and is configured to fit, and anchor the system, within the intracranial aneurysm, as discussed above. Brown '413 as modified does not expressly disclose said antenna/anchor structure is a spherical structure. However, at the time the invention was effectively filed, it would have been an obvious matter of design choice to a person of ordinary skill in the art to modify the system of Brown '143 with the antenna/anchor structure being spherical because Applicant has not disclosed that any particular shape of antenna provides an advantage, is used for a particular purpose, or solves a stated problem. Rather, Applicant expressly discloses different shapes as suitable alternatives (e.g., ¶ [0009]). As no evidence has been provided to the contrary, one of ordinary skill in the art would have expected Applicant's invention to perform equally well with the antenna and/or anchor structure shape illustrated by Brown '413 because either arrangement enables protecting the sensor, securing the sensor at an area of interest, providing an antenna that is capable of wireless telemetry over larger distances than a smaller antenna, etc.
Alternatively/Additionally, Zhu discloses intracranial aneurysms may be saccular (e.g., spherical) (Table 3). White discloses/suggests a system (e.g., Figs. 6-8) comprising an implantable sensor (intracorporeal device 46, e.g., ¶ [0046]); an anchor structure that encloses the sensor (wire loops 44 encircling device 46), wherein the structure is spherical (see Figs. 6-8) and configured to fit, and to anchor the system, within a deployment site of the patient (e.g., ¶ [0041]); and a radiopaque marker selected to allow identification of the location of the system within the deployment site (e.g., ¶ [0044]). 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 system of Brown '413 with the antenna/anchor structure being spherical as taught/suggested by White in order to facilitate spacing the sensor from a spherical intracranial aneurismal sac (Brown '413, ¶ [0016]; Zhu, Table 3) and/or as a simple substitution of one suitable structure shape for another to yield no more than predictable results. See MPEP 2143(I)(B). Furthermore, 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 system of Brown '413 to further comprise a radiopaque marker selected to allow identification of the location of the system within the intended deployment site (e.g., intracranial space) of the patient as taught and/or suggested by White in order to facilitate fluoroscopic visualization of the device (White, ¶ [0044]), e.g., for confirming proper placement thereof.
Regarding claim 19, Brown '413 as modified discloses and/or suggests the limitations of claim 1, as discussed above, but does not disclose the system further comprises a sealing layer to hermetically seal the sensor. Schugt teaches/suggests a comparable system, as discussed above, comprising a sealing layer to hermetically seal the sensor (¶ [0033] IMD 20 includes a housing 22 hermetically enclosing components of IMD 20, such as at least a portion of a sensor). 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 system of Brown '413 to further comprise a sealing layer to hermetically seal the sensor as taught and/or suggested by Schugt in order to protect the sensor, e.g., from bodily fluids.
Regarding claim 22, Brown '413 as modified discloses and/or suggests the limitations of claim 1, as discussed above, but does not disclose the system further comprises a power source for providing power to the sensor. Schugt teaches/suggests a comparable system, as discussed above, comprising a power source for providing power to the sensor (Fig. 9, power source 116; ¶ [0086]; etc.). 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 system of Brown '413 to comprise a power source for providing power to the sensor as taught/suggested by Schugt in order to facilitate supplying power as needed or desired for taking and/or transmitting measurements.
Regarding claim 27, Brown '413 as modified discloses and/or suggests the limitations of claim 1, as discussed above, but does not disclose the system further comprises a memory device for storing sensor data. Schugt teaches and/or suggests a comparable system, as discussed above, comprising a memory device for storing sensor data (Fig. 9, memory 112; ¶ [0082]; etc.). 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 system of Brown '413 to further a memory device for storing sensor data as taught/suggested by Schugt in order to facilitate storing sensor data in raw and/or processed form (Schugt, ¶ [0082]), thereby allowing more frequently measured data to be transmitted periodically, (e.g., in batches rather than single measurements) to reduce power consumed by the sensor system.
Regarding claim 28, Brown '413 as modified discloses/suggests the limitations of claim 1, as discussed above, and further teaches/suggests the system comprises a second sensor capable of detecting a different physiological parameter than glucose (¶ [0109] plurality of sensors; ¶ [0153] monitoring desired parameters in an area of interest).
Regarding claim 29, Brown '413 as modified with respect to claim 1 discloses/suggests a kit comprising: the implantable sensor system of claim 1 (see discussion of claim 1 above); and one or more delivery systems capable of releasing the sensor in the aneurysm (¶ [0016], ¶ [0019], delivery catheter; ¶ [0018] delivery cannula; etc.).
Regarding claim 75, Brown '413 as modified with respect to claim 1 discloses/suggests a method of monitoring an aneurysm of a patient, the method comprising: detecting one or more physiological parameters of the aneurysm using an implantable sensor system of claim 1 (see rejection of claim 1 above, sensing at least blood glucose information); and transmitting sensor data related to the one or more physiological parameters to a remote location (Schugt, ¶ [0083] telemetry module 68 transmits communications to and/or receives communications from another device, such as an external device 18, via antenna 118).
Regarding claim 76, Brown '413 as modified discloses and/or suggests the method further comprises occluding the aneurysm with an anchor structure (e.g., Brown '413, ¶¶ [0003]-[0012] aneurysm repair procedure, e.g., implanting an endovascular graft; Zhu, stent-graft placement to treat the intracranial aneurysm; etc.).
Regarding claim 96, Brown '413 as modified with respect to claim 1 teaches/suggests a method of implanting a sensor system into an aneurysm of a patient, the method comprising: advancing a delivery system (e.g., ¶ [0016], ¶ [0019] delivery catheter; ¶ [0018] delivery cannula; etc.) carrying the sensor system of claim 1 to an intracranial aneurysm of the patient (¶ [0108] advancement of the sensor within a patient's body or vasculature to a site; e.g., ¶ [0107] an aneurismal sac is an implantation site, which may include an intracranial aneurysm (see discussion of claim 1 above)); releasing the sensor system inside the intracranial aneurysm; whereupon the antenna adopts a spherical structure configured to fit within the intracranial aneurysm and to anchor the sensor system within the intracranial aneurysm (¶ [0108] deployment or implantation of the sensor at the site wherein the cage is permitted to expand to its unrestrained configuration).
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as obvious over Brown '413 in view of Zhu, Schugt, Brown '238 and White as applied to claim(s) 1 above, and further in view of US 5,980,550 A (previously cited, Eder).
Regarding claim 20, Brown '413 as modified teaches/suggests the limitations of claim 1, as discussed above, but does not disclose the system further comprises a dissolving membrane layer that dissolves when in contact with blood of the patient. Brown '413, however, does disclose the system may be coated with a drug for the delivery of the same (e.g., ¶ [0135]).
Eder discloses a vasoocclusive device comprising an inner coating of a bio-active agent, such as a therapeutic agent (e.g., col. 3, lines 23-30) and an outer coating configured to dissolve when in contact with blood of a patient (e.g., col. 4, lines 27-44).
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 system of Brown '413 to comprise a dissolving membrane layer that dissolves when in contact with blood of the patient as taught/suggested by Eder in order to facilitate delivering a drug/therapeutic agent to the aneurysm while reducing the likelihood of thrombus formation on the system and/or in the aneurysm during delivery/implantation of the system (Eder, col. 4, lines 18-43).
Claim(s) 26 is/are rejected under 35 U.S.C. 103 as obvious over Brown '413 in view of Zhu, Schugt, Brown '238 and White as applied to claim(s) 1 above, and further in view of US 2017/0326355 A1 (previously cited, Koop).
Regarding claim 26, Brown '413 as modified teaches/suggests the limitations of claim 1, as discussed above, but does not disclose the system further comprises a supercapacitor to provide power to the sensor.
Koop teaches/suggests an implantable sensor system comprising a sensor (Fig. 2, sensing circuitry 32, ¶ [0045]) and a supercapacitor to provide power to the sensor (¶ [0045] circuitry 32 is operably coupled to the power source 30, which may comprise a super-capacitor).
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 system of Brown '413 to comprise a supercapacitor to provide power to the sensor as taught/suggested by Koop in order to facilitate providing the system with a rechargeable power source (Koop, ¶ [0045]) and/or as a simple substitution of one suitable means for providing the sensor with power for another to yield no more than predictable results. See MPEP 2143(I)(B).
Claim(s) 30 is/are rejected under 35 U.S.C. 103 as obvious over Brown '413 in view of Zhu, Schugt, Brown '238, White, US 2019/0336053 A1 (previously cited, Halac) and US 2006/0189926 A1 (previously cited, Hall).
Regarding claim 30, Brown '413 discloses/suggests an implantable sensor system (e.g., Figs. 16-17) comprising:
a sensor (sensor 144) configured to fit in and capable of being implanted in an aneurysm of a patient (e.g., ¶ [0108] implantation site; ¶ [0107] aneurysm sac; etc.), the sensor capable of detecting one or more physiological parameters of the patient and generating sensor data (e.g., ¶ [0106] flow, pressure, oxygen levels or other chemical levels or substances); and
an anchor structure configured to fit within the aneurysm and to maintain a position of the system, including the sensor thereof in the aneurysm (cage 146; ¶ [0108] cage 146 helps to hold the sensor in place at the implantation site), the anchor structure forming a structure that encloses the sensor (e.g., Fig. 17), the anchor structure capable of being compressed for loading into a delivery system and expanded upon release from the delivery system (e.g., ¶ [0108] during advancement and deployment of the sensor within a patient's body or vasculature, the cage 146 is held tight against external surfaces of the sensor 146, and, when implanted at an interventional or other site, the cage is permitted to expand to its unrestrained configuration).
The only particular type of aneurysm described by Brown '413 is an abdominal aortic aneurysm (AAA) (e.g., ¶¶ [0003]-[0005]). Accordingly, Brown '413 does not expressly disclose the aneurysm into which the sensor is implanted, or that the system is configured to fit within, is an intracranial aneurysm. However, Brown '413 broadly discloses the system/sensor may be configured to fit/be positioned within "an aneurismal sac," which one of ordinary skill in the art reasonably encompasses intracranial aneurysms, and discloses the invention can be used to sense conditions in other areas of the body, including the brain (e.g., ¶ [0013]). Accordingly, Brown '413 at least suggests the sensor is capable of being implanted, and the system is configured to fit within, an intracranial aneurysm.
Alternatively/Additionally, Brown '413 further discloses/suggests the system is useful for obtaining information regarding the success of an aneurysm repair procedure, particularly placement of an endovascular graft, e.g., by monitoring for conditions indicative of endoleak (¶¶ [0005]-[0012]). Zhu discloses placement of an endovascular graft is a repair procedure also utilized for intracranial aneurysms, in which endoleaks may similarly occur (throughout document, e.g., pgs. 287-288, Introduction). 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 system of Brown '413 with the aneurysm into which the sensor is capable of being implanted, and the system being configured to fit within, being an intracranial aneurysm in order to similarly obtain information regarding the success of a repair/treatment of said intracranial aneurysm (Brown '413, ¶¶ [0012]-[0013]).
While Brown '413/Brown '413 as modified discloses the sensor system can be used to monitor desired parameters in the area of interest (¶ [0153]; etc.), Brown '413 does not expressly disclose the system comprises an antenna in electrical communication with the sensor.
Schugt teaches/suggests an implantable sensor system comprising: a sensor capable of being implanted in an aneurysm of a patient (Figs. 1-8, IMD 14, 20, etc., such as an implantable sensor, e.g., ¶ [0023], ¶ [0026], etc.), wherein the sensor is capable of detecting one or more physiological parameters of the patient and generating sensor data (e.g., ¶ [0043] sensor 20 may comprise one or more of a pressure sensor, a pH sensor, an oxygen sensor, etc.); an anchor structure joined to the sensor for maintaining a position of the sensor in the aneurysm (fixation mechanism 24, 46, etc., mechanically coupled to the housing of the IMD for fixing the IMD relative to a target location within a patient, such as a wall of a cavity or body lumen); and an antenna in electrical communication with the sensor (e.g., ¶ [0036] where a connector electrically connects fixation mechanism 24 to a telemetry module within the housing of the IMD, such that the fixation mechanism 24 is further configured to function as a radiating element of an antenna), wherein the antenna transmits sensor data related to the one or more physiological parameters of the patient to a receiver (e.g., ¶ [0031]), wherein the antenna is capable of being compressed for loading into a delivery system and expanded upon release from the delivery system (e.g., ¶ [0051] fixation mechanism 24 may be radially compressed to aid in delivery of IMD 20 to the target location, and expanded in situ when located at the target location to securely engage the vessel wall).
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 system of Brown '413 to further comprise an antenna in electrical communication with the sensor, wherein the antenna is configured to transmit sensor data related to the one or more physiological parameters of the patient to a receiver, as taught and/or suggested by Schugt in order to facilitate retrieval of data sensed by the system for use in monitoring a desired parameter(s) within the aneurysm by a user, e.g., physician, clinician, etc. (Brown '413, ¶ [0009], ¶ [0153], etc.; Schugt, ¶ [0028]). Furthermore, 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 system of Brown '413 with the anchor structure being configured to function as the antenna (i.e., the antenna providing the anchor structure) as taught/suggested by Schugt in order to provide an antenna that is efficient and capable of wireless telemetry over larger distances than a smaller antenna, e.g., limited to the size of the sensor (Schugt, ¶ [0018]).
Brown '413 as modified discloses/suggests the sensor may measure a chemical level or substance (¶ [0106]) and/or any "desired" parameter(s) (¶ [0153]), which reasonably encompasses a glucose sensor. Alternatively/Additionally, at the time the invention was effectively filed, it would have been an obvious matter of design choice to a person of ordinary skill in the art to modify the system of Brown '413 with the sensor comprising a glucose sensor and the one or more physiological parameters comprising glucose in the blood of the patient because Applicant has not disclosed that a glucose sensor/measurement, particularly within an intracranial aneurysm, provides an advantage, is used for a particular purpose, or solves a stated problem. Rather, Applicant discloses the sensor may be any of "a blood flow sensor, a blood pressure sensor, a metabolic sensor, a glucose sensor, an oxygen sensor, or other sensor" (e.g., ¶ [0010]). As no evidence has been provided to the contrary, one of ordinary skill in the art would have expected Applicant's invention to perform equally well with the sensor(s) disclosed/suggested by Brown '413 because either arrangement permits measuring relevant parameters within the blood of the patient (Brown '413, ¶ [0106]). Further alternatively/additionally, Brown '238 teaches/suggests an implantable sensor system comprising a sensor capable of being implanted in an aneurysm of a patient (sensor 16 or 52, measuring device 202, etc.), detecting one or more physiological parameters of the patient, and generating sensor data, wherein the sensor comprises a glucose sensor and the one or more physiological parameters comprises glucose in the blood of the patient (¶ [0019], ¶ [0041], ¶ [0047]). 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 system of Brown '413 to comprise a glucose sensor, such that the one or more physiological parameters further comprise glucose in the blood of the patient, as taught and/or suggested by Brown '238 in order to facilitate sensing other/additional parameter(s) as desired (Brown '413, ¶ [0153]; Brown '238, ¶ [0019]; etc.).
Brown '413 as modified discloses/suggests the antenna/anchor structure encloses the sensor and is configured to fit, and anchor the system, within the intracranial aneurysm, as discussed above. Brown '413 as modified does not expressly disclose said antenna/anchor structure is a spherical structure. However, at the time the invention was effectively filed, it would have been an obvious matter of design choice to a person of ordinary skill in the art to modify the system of Brown '143 with the antenna/anchor structure being spherical because Applicant has not disclosed that any particular shape of antenna provides an advantage, is used for a particular purpose, or solves a stated problem. Rather, Applicant expressly discloses different shapes as suitable alternatives (e.g., ¶ [0009]). As no evidence has been provided to the contrary, one of ordinary skill in the art would have expected Applicant's invention to perform equally well with the antenna and/or anchor structure shape illustrated by Brown '413 because either arrangement enables protecting the sensor, securing the sensor at an area of interest, providing an antenna that is capable of wireless telemetry over larger distances than a smaller antenna, etc.
Alternatively/Additionally, Zhu discloses intracranial aneurysms may be saccular (e.g., spherical) (Table 3). White discloses/suggests a system (e.g., Figs. 6-8) comprising an implantable sensor (intracorporeal device 46, e.g., ¶ [0046]); an anchor structure that encloses the sensor (wire loops 44 encircling device 46), wherein the structure is spherical (see Figs. 6-8) and configured to fit, and to anchor the system, within a deployment site of the patient (e.g., ¶ [0041]); and a radiopaque marker selected to allow identification of the location of the system within the deployment site (e.g., ¶ [0044]). 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 system of Brown '413 with the antenna/anchor structure being spherical as taught/suggested by White in order to facilitate spacing the sensor from a spherical intracranial aneurismal sac (Brown '413, ¶ [0016]; Zhu, Table 3) and/or as a simple substitution of one suitable structure shape for another to yield no more than predictable results. See MPEP 2143(I)(B). Furthermore, 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 system of Brown '413 to further comprise a radiopaque marker selected to allow identification of the location of the system within the intended deployment site (e.g., intracranial space) of the patient as taught and/or suggested by White in order to facilitate fluoroscopic visualization of the device (White, ¶ [0044]), e.g., for confirming proper placement thereof.
Brown '413 as modified but does not teach the sensor further comprises a conductivity switch configured to detect a presence of fluid above a threshold amount.
Halac teaches/suggests a system comprising a glucose sensor (analyte sensor, ¶ [0095]) and a conductivity switch configured to detect when an analyte sensor has been deployed to trigger the system to exit a lower power state, such that the glucose sensor is configured to operate only after implantation (¶ [0246] activation detection circuit 520 and/or activation detection component 545 may include a conductivity-based sensor that may be used to trigger analyte sensor system 308 to exit a lower power state). Hall discloses a conductivity switch comprising two spaced apart conductive pads (Fig. 51, conductive sleeves 6055a and 6055b) configured to detect a presence of fluid above a threshold amount (¶ [0479] conductivity between the two conductive sleeves exceeding a predetermined threshold indicates presence of blood).
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 system of Brown '413 to comprise a conductivity switch comprising two spaced apart conductive pads configured to detect a presence of fluid above a threshold amount as taught/suggested by Hall, wherein the glucose sensor is configured to operate only when fluid above the threshold amount is detected (e.g., is in contact with blood), as taught and/or suggested by Halac, in order to enable activating the system upon detection that the system has been deployed (Halac, ¶ [0246]; Hall, ¶ [0479]) for more accurately assessing the time of sensor implantation to more accurately process sensor signal glucose values; reduce unwanted changes to the glucose sensor (e.g., deviation from calibration values); etc. (e.g., Halac, ¶¶ [0008]-[0012]).
Claim(s) 61 is/are rejected under 35 U.S.C. 103 as obvious over Brown '413 in view of Zhu, Schugt, Brown '238, White, Halac and Hall as applied to claim(s) 30 above, and further in view of US 2013/0202721 A1 (previously cited, Silver).
Regarding claim 61, Brown '413 as modified with respect to claim 30 above discloses and/or suggests a kit comprising the implantable sensor system of claim 30 (see discussion of claim 30 above); and a delivery system capable of releasing the implantable sensor system in an aneurysm (e.g., ¶ [0016], ¶ [0019] delivery catheter; ¶ [0018] delivery cannula; etc.). Brown '413 as modified further discloses at least one delivery system comprising a shaft (main catheter 313) having a shaft wall defining a lumen (e.g., Figs. 68-70), and a retention wire extending along the shaft partially within the lumen and partially outside the lumen (release wire 324), wherein portions of the retention wire outside the lumen retain the sensor system in place relative to the shaft, the retention wire capable of being moved relative to the shaft to thereby release the implantable sensor system from the shaft into the aneurysm (e.g., ¶¶ [0146]-[0147]). Brown '413 as modified does not disclose portions of the retention wire outside the lumen retain the anchor structure in place relative to the shaft.
Silver teaches/suggests a kit (e.g., Fig. 7A) comprising an implantable sensor system (¶ [0279] support structure 96 having a sensor housing 20); and a delivery system comprising a shaft (tubular body 86) having a shaft wall defining a lumen (¶ [0280] deployment wire lumen 108), and a retention wire (deployment wire 94) extending along the shaft partially within the lumen and partially outside the lumen, wherein portions of the retention wire outside the lumen retain the anchor structure in place relative to the shaft (¶ [0280] deployment wire 94 extends throughout the length of tubular body 86 through deployment wire lumen 108, wherein the distal end of deployment wire 100 exits tubular body 86 at deployment wire port 100, and loops support structure 96 in loops/slip knots 102 to restrain support structure 96 in its collapsed configuration), the retention wire capable of being moved relative to the shaft to thereby release the implantable sensor system from the shaft into the vasculature (¶ [0280] a proximal end of deployment wire 94 may be proximally retracted by the clinician, which causes loops/slip knots 102 to become untied or otherwise disengaged, releasing support structure 96 so that it expands radially outwardly from its low profile introduction configuration to its radially enlarged implanted configuration; ¶ [0308]; etc.).
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 kit of Brown '413 to comprise a delivery system including a shaft having a shaft wall defining a lumen, and a retention wire extending along the shaft partially within the lumen and partially outside the lumen, wherein portions of the retention wire outside the lumen retain the anchor structure in place relative to the shaft, wherein the retention wire is capable of being moved relative to the shaft to thereby release the implantable sensor system from the shaft into the aneurysm, as taught/suggested by Silver in order to facilitate deploying a self-expanding implantable sensor device at a desired site (Silver, ¶ [0280]; Brown '413, ¶ [0108]; etc.) and/or as a simple substitution of one suitable delivery system for another to yield no more than predictable results. See MPEP 2143(I)(B).
Claim(s) 162-164 is/are rejected under 35 U.S.C. 103 as obvious over Brown '413 in view of Zhu, Schugt, Brown '238 and White as applied to claim(s) 1 above, and further in view of Halac and Hall.
Regarding claims 162-164, Brown '413 as modified discloses/suggests the limitations of claim 1, as discussed above, but does not teach the sensor further comprises a conductivity switch configured to detect a presence of fluid above a threshold amount.
Halac teaches/suggests a system comprising a glucose sensor (analyte sensor, ¶ [0095]) and a conductivity switch configured to detect when an analyte sensor has been deployed to trigger the system to exit a lower power state, such that the glucose sensor is configured to operate only after implantation (¶ [0246] activation detection circuit 520 and/or activation detection component 545 may include a conductivity-based sensor that may be used to trigger analyte sensor system 308 to exit a lower power state). Hall discloses a conductivity switch comprising two spaced apart conductive pads (Fig. 51, conductive sleeves 6055a and 6055b) configured to detect a presence of fluid above a threshold amount (¶ [0479] conductivity between the two conductive sleeves exceeding a predetermined threshold indicates presence of blood).
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 system of Brown '413 to comprise a conductivity switch comprising two spaced apart conductive pads configured to detect a presence of fluid above a threshold amount as taught/suggested by Hall, wherein the glucose sensor is configured to operate only when fluid above the threshold amount is detected (e.g., is in contact with blood), as taught and/or suggested by Halac, in order to enable activating the system upon detection that the system has been deployed (Halac, ¶ [0246]; Hall, ¶ [0479]) for more accurately assessing the time of sensor implantation to more accurately process sensor signal glucose values; reduce unwanted changes to the glucose sensor (e.g., deviation from calibration values); etc. (e.g., Halac, ¶¶ [0008]-[0012]).
Response to Arguments
Applicant's arguments have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 extension fee 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 date of this final action.
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/Meredith Weare/Primary Examiner, Art Unit 3791
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