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 .
Election/Restrictions
Applicant’s election of claims 1-8 and 10-19 without traverse in the reply filed on 07/10/2026 is acknowledged.
Claims 9 and 20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention or species, there being no allowable generic or linking claim.
Claims 1-8 and 10-19 are hereby under examination.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 09/24/2024 has been considered by the examiner.
Claim Objections
Claims 12 and 18 are objected to because of the following informalities:
Claim 12 recites “Nitinol” in line 2. This should read “nitinol”.
Claim 18 recites “associated magnetic source. an active sensor” in lines 4-5. This should read “associated magnetic source, or an active sensor”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 19 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 19 recites the limitation “the time sequence of images of the stent” in line 5. There is insufficient antecedent basis for this limitation in the claim. Clarification is requested.
For the purposes of examination, the claim is interpreted as “a time sequence of images of the stent”.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 5, 8, 10, and 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Patent Publication 2016/0038087 by Hunter et al. – cited by Applicant, hereinafter “Hunter”.
Regarding claim 1, Fig. 1 of Hunter teaches a vascular therapy device, comprising: a stent comprising a tube having an inner surface defining a central lumen, the stent configured to be placed at a treatment site in a blood vessel of an associated patient ([0054-0055]; Fig. 1 is a representative stent, which is configured to open up and maintain the lumen of a diseased body passageway (thereby defining a treatment). A wide variety of sensors can be placed on the inner (luminal) wall of the stent, and therefore the stent must have an inner surface defining a lumen); and at least one sensor attached to or embedded in the inner surface of the stent ([0055]; “A wide variety of sensors can be placed on the inner (luminal) wall of the stent”).
Regarding claim 5, Fig. 1 of Hunter teaches the vascular therapy device of claim 1, wherein the at least one sensor comprises: a first pressure sensor and a second pressure sensor disposed at spaced apart locations along a central axis of the central lumen (See Fig. 1, the plurality of pressure sensors (denoted as triangles) are disposed at different horizontal locations along the length of the stent).
Regarding claim 8, Hunter teaches the vascular therapy device of claim 1, wherein the at least one sensor comprises a passive sensor energized by an externally applied magnetic field supplied by an associated magnetic source (As shown in Fig. 8, the interrogation signal contains power for the sensors to perform sensing. Further, the sensor 22 powers up and stores power in onboard capacitors sufficient to maintain operation during the sensing).
Regarding claim 10, Hunter teaches the vascular therapy device of claim 1, wherein the at least one sensor comprises a temperature sensor configured to measure a temperature of blood flowing through the central lumen of the stent ([0055]; Fig. 1 is an illustration of the stent, wherein the sensors may include temperature sensors. Because the temperature sensors must be in the stent which is in the blood vessel, they would measure the temperature of the blood flowing within the vessels.).
Regarding claim 12, Hunter teaches the vascular therapy device of claim 1, wherein the stent comprises a self-expanding ([0062]; stents of the present invention can be self-expanding stents) Nitinol ([0004]; typically stents are composed of metal such as nitinol) stent.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 2 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Hunter.
Regarding claim 2, Fig. 1 of Hunter teaches the vascular therapy device of claim 1, but does not teach wherein the at least one sensor includes a fluid flow resistance sensor configured to measure blood flow resistance at the treatment site in the blood vessel.
Embodiment 41 of Hunter teaches an embodiment wherein the stent comprises a sensor to measure the systemic vascular resistance of the subject ([0167]). The sensor is embedded in the stent, and therefore must measure the vascular resistance at the treatment site where the stent is placed.
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the device taught by Fig. 1 of Hunter to include a sensor to measure the systemic vascular resistance of the subject such that the at least one sensor includes a fluid flow resistance sensor configured to measure blood flow resistance at the treatment site in the blood vessel, as taught by embodiment 41 of Hunter. This modification comprises combining prior art elements according to known methods to yield predictable results. See MPEP 2143.I.A.
Regarding claim 11, Hunter teaches the vascular therapy device of claim 10, but does not teach wherein the at least one sensor comprises: a first temperature sensor and a second temperature sensor disposed at spaced apart locations along a central axis of the central lumen. Hunter teaches that the stent may comprise temperature sensors, thereby defining at least a first and second temperature sensor, and depicts other sensors such as pressure sensors spaced apart along the length of the lumen.
It would be prima facie obvious to one of ordinary skill in the art to have modified the device such that the first temperature sensor and the second temperature sensor disposed at spaced apart locations along a central axis of the central lumen, similar to the positioning of other sensors in the stent.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Hunter in view of US Patent Publication 2020/0237235 by Gong et al., hereinafter “Gong”.
Regarding claim 3, Hunter teaches the vascular therapy device of claim 2, further comprising an electronic processing device ([0092]; Fig. 8, the control unit 26 is configured to receive the data and output the data) configured to compare the readings to normative or expected values ([0076-0077]) and output data to a computer or other device for display when conditions should be brought to the doctor’s attention ([0086, 0092]). Hunter does not teach the electronic device configured to: determine whether the blood flow resistance underruns a predetermined fluid flow resistance threshold; and output, on a display device, an indication of the blood flow resistance underrunning the predetermined fluid flow resistance threshold.
Gong teaches that blood flow resistance should be minimized, as lower blood flow resistance is beneficial to microcirculation and high blood flow resistance increases the damage to the blood vessel, and thus is harmful to the microcirculation ([0019]). Therefore, a blood flow resistance over a normative or expected value (i.e., threshold) can be considered to underrun the threshold.
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the device of Hunter wherein the electronic device configured to: determine whether the blood flow resistance underruns a predetermined fluid flow resistance threshold; and output, on a display device, an indication of the blood flow resistance underrunning the predetermined fluid flow resistance threshold, in order to alert a doctor to conditions that increase the damage to the blood vessel, and thus is harmful to the microcirculation, as taught by Gong ([0019]).
Claims 4, 13, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Hunter in view of US Patent Publication 2017/0071479 by Kano et al., hereinafter “Kano”.
Regarding claim 4, Hunter teaches the vascular therapy device of claim 2, wherein the at least one sensor comprises: one or more pressure sensors (See the plurality of blood pressure sensors in Fig. 1). Hunter teaches determining vascular resistance of the subject using the sensors embedded in the stent ([0167]). Hunter does not teach the one or more pressure sensors being configured to measure the blood flow resistance caused by the stent based on at least one pressure measurement acquired by the one or more pressure sensors.
Kano teaches a method of determining blood flow resistance (i.e., vascular resistance) by using the pressure difference between sensors spaced away from each other along the vessel ([0090]). Kano teaches this as being at the resistance between the entrance and exit of the coronary artery, but the concept of the blood flow resistance can be applied at any distance between pressure sensors disposed in a blood vessel.
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the device taught by Hunter such that the one or more pressure sensors being configured to measure the blood flow resistance caused by the stent based on at least one pressure measurement acquired by the one or more pressure sensors, as taught by Kano ([0090]). This modification comprises combining prior art elements according to known methods to yield predictable results. See MPEP 2143.I.A.
Regarding claim 13, Hunter in view of Kano teaches a vascular therapy device (See the rejection of claim 1), comprising: a stent comprising a tube having an inner surface defining a central lumen (See the rejection of claim 1), the stent configured to be placed at a treatment site in a blood vessel of an associated patient (See the rejection of claim 4); and at least one pressure sensor attached to or embedded in the inner surface of the stent (See the rejection of claim 4), the at least one pressure sensor configured to acquire at least one pressure measurement comprising blood flow resistance (See the rejection of claim 4).
Regarding claim 15, Hunter in view of Kano teaches the vascular therapy device of claim 13, wherein the at least one pressure sensor comprises: a first pressure sensor and a second pressure sensor disposed at spaced apart locations along a central axis of the central lumen (See the rejection of claim 5).
Claims 6-7 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Hunter in view of US Patent Publication 2020/0397320 by Gleich et al., hereinafter “Gleich”.
Regarding claim 6, Hunter teaches the vascular therapy device of claim 1, wherein: the at least one sensor includes a pressure sensor (See Fig. 1). Hunter does not teach wherein: the at least one sensor includes at least one sensor element comprising first and second permanent magnets connected by an elastic coupler; wherein a measurement of the stent placed at the treatment site is obtainable from the at least one sensor element by inducing a resonant rotational oscillation of at least one of the permanent magnets using an externally applied magnetic field.
Figs. 1-2 of Gleich teaches a pressure sensor comprising a first and second permanent magnets 507 and 508 ([0014, 0079]). Magnet 508 is coupled to membrane 515, that is able to deflect with increased pressure ([0099]). Magnet 507 is coupled to magnet 508 through casing 502 and filament 506, and the deflectable membrane 515. The measurement is obtained from the sensor by applying an external magnetic field to start a resonance rotational oscillation, and the measurement is subsequently obtained from electrical response signals ([0081-0084]). Due to the magneto-mechanical oscillator, this pressure sensor allows for a high quality factor and high sensitivity to external influences in a very small pressure sensor ([0007]).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the pressure sensors of Hunter to be the pressure sensors of Gleich such that the at least one sensor includes at least one sensor element comprised first and second permanent magnets connected by an elastic coupler; wherein a measurement of the stent placed at the treatment site is obtainable from the at least one sensor element by inducing a resonant rotational oscillation of at least one of the permanent magnets using an externally applied magnetic field. This modification would allow for a high quality factor and high sensitivity to external influences in a very small pressure sensor, as taught by Gleich ([0007]).
Regarding claim 7, Hunter in view of Gleich teaches the vascular therapy device of claim 6, wherein the at least one sensor element comprising first and second permanent magnets connected by an elastic coupler includes: a first sensor element comprising first and second permanent magnets connected by an elastic coupler that is attached to or embedded in a first location of the inner surface of the stent; and a second sensor element comprising first and second permanent magnets connected by an elastic coupler that is attached to or embedded in a second location of the inner surface of the stent; wherein the second location is spaced apart from the first location along a central axis of the central lumen of the stent. In the modification of Hunter in view of Gleich as applied to claim 6, the pressure sensors of Hunter are replaced with the pressure sensors of Gleich. As described in the rejection of claim 5 above, Hunter comprises a plurality of pressure sensors attached to or embedded in the inner surface of the stent at a plurality of locations horizontally along the stent.
Regarding claim 18, Hunter in view of Gleich teaches the vascular therapy device of claim 6, wherein the at least one pressure sensor comprises one of: a passive sensor energized by an externally applied magnetic field supplied by an associated magnetic source (As shown in Fig. 8, the interrogation signal contains power for the sensors to perform sensing. Further, the sensor 22 powers up and stores power in onboard capacitors sufficient to maintain operation during the sensing), or an active sensor including a storage capacitor configured to inductively supply power to the at least one sensor.
Claim 14 are rejected under 35 U.S.C. 103 as being unpatentable over Hunter in view of Kano, as applied to claim 13 in view of Gong.
Regarding claim 14, Hunter in view of Kano teaches the vascular therapy device of claim 13, but does not teach the device further comprising an electronic processing device configured to: determine whether the blood flow resistance underruns a predetermined fluid flow resistance threshold; and output, on a display device, an indication of the blood flow resistance underrunning the predetermined fluid flow resistance threshold.
It would be prima facie obvious to one of ordinary skill in the art to modify the device of claim 13 in view of Gong in the same way as described with respect to claim 3 above in order to alert a doctor to conditions that increase the damage to the blood vessel, and thus is harmful to the microcirculation, as taught by Gong ([0019]).
Claims 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Hunter in view of Kano, as applied to claim 13 in view of Gleich.
Regarding claim 16, Hunter in view of Kano teaches the vascular therapy device of claim 13, but does not teach wherein: the at least one pressure sensor includes at least one pressure sensor element comprising first and second permanent magnets connected by an elastic coupler; wherein a measurement of the stent placed at the treatment site is obtainable from the at least one sensor pressure element by inducing a resonant rotational oscillation of at least one of the permanent magnets using an externally applied magnetic field.
It would be prima facie obvious to one of ordinary skill in the art to modify the device of claim 13 in view of Gleich in the same way as described with respect to claim 6 to achieve a high quality factor and high sensitivity to external influences in a very small pressure sensor, as taught by Gleich ([0007]).
Regarding claim 17, the combination of Hunter, Kano, and Gleich teaches the vascular therapy device of claim 16, wherein the at least one pressure sensor element comprising first and second permanent magnets connected by an elastic coupler includes: a first pressure sensor element comprising first and second permanent magnets connected by an elastic coupler that is attached to or embedded in a first location of the inner surface of the stent; and a second pressure sensor element comprising first and second permanent magnets connected by an elastic coupler that is attached to or embedded in a second location of the inner surface of the stent; wherein the second location is spaced apart from the first location along a central axis of the central lumen of the stent (See the rejection of claim 7).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Hunter in view of Kano, as applied to claim 13 in view of US Patent Publication 2008/0147174 by Konstantino et al., hereinafter “Konstantino”.
Regarding claim 19, Hunter in view of Kano teaches the vascular therapy device of claim 13, but does not teach wherein the stent includes one or more radiopaque markers; wherein the electronic processing device is programmed to perform an image analysis based on a change in configuration of the one or more radiopaque markers in successive images of the time sequence of images of the stent acquired during a placement procedure of the stent within the blood vessel.
Konstantino teaches a method of using a plurality of radio-opaque markers attached to the opening of the stent. Konstantino teaches that current clinical practice of stenting uses angiographic images to navigate and deploy stents ([0024]).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the device such that the stent includes one or more radiopaque markers and wherein the electronic processing device is programmed to perform an image analysis based on a change in configuration of the one or more radiopaque markers in successive images of the time sequence of images of the stent acquired during a placement procedure of the stent within the blood vessel, as this method is standard clinical practice, as taught by Konstantino ([0024]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US Patent Publication 2006/0074479 by Bailey et al. teaches an implantable stent comprising in-vivo sensors to provide volumetric, flow rate, pressure, electrical, biochemical, or temperature measurements.
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/NELSON ALEXANDER GLOVER/Examiner, Art Unit 3791
/ADAM J EISEMAN/Primary Examiner, Art Unit 3791
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