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 .
Information Disclosure Statement
Information Disclosure Statement (IDS) submitted on 04/24/2026 has been entered and fully considered by the examiner.
Response to Amendment
The amendment of 04/30/2026 has been entered and fully considered by the examiner. Claims 1, 2, 5, 7, 8, 14, and 19 have been amended. Claims 1-20 are currently pending in the application with claims 1, 14, and 19 being independent.
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.
Claims 1-20 are 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.
Claims 1 and 19 further recite: “mechanically measuring a diameter of the vessel”. This limitation is entirely unclear and indefinite since it is not clear how can the act of measurement be done “mechanically”? since the sensors are performing the task of measurement, does that intend to limit the sensors to some subset of sensors which are considered “mechanical”? or something else is intended. For the purposes of examination, the broadest reasonable interpretation has been used.
Claims 2-13, 15-18 and 20 depend upon indefinite base claims 1, 14, and 19 and are considered to be indefinite as well due to their dependency.
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:
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 1-3, 5-9, 11, 14-16, 19 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Van der Horst et al. (U.S. Publication No. 2019/0175035) hereinafter “Van der Horst” in view of Hekmat et al. (U.S. Publication No. 2009/0105799) hereinafter “Hekmat”.
Regarding claim 1, Van der Horst discloses an intravascular catheter [see [0044]; intravascular device 110 can be a catheter] comprising:
a catheter body [see [0044]; intravascular device 110 can be a catheter] with a proximal end and a distal end [see FIG. 1; it is inherent that an elongated tube such as a catheter would have a proximal end and a distal end] ; a first sensor zone comprising a first sensor group [first sensor zone 202; see FIG. 1 and [0048]; each sensor zone comprises of an array of ultrasound transducers],
and a second sensor zone comprising a second sensor group, [second sensor zone 204; see FIG. 1 and [0048]; each sensor zone comprises of an array of ultrasound transducers], the second sensor group comprising a plurality of sensors, the second sensor zone located a predetermined distance from the first sensor zone along the catheter body, [see FIG 1 and [0055]; the two zones are separated by a distance D1]
wherein the first sensor zone and the second sensor zone are adapted to make distensibility measurements of the vessel [see [0048] for example disclosing that measurements of wall dimensions are performed by the sensor zones 202 and 204] in which the catheter is inserted [see [0044]; the catheter is inserted into the renal artery 81] by mechanically measuring a diameter of the vessel [see [0083]-[0084]] through systole and diastole [see [0062] disclosing determining the vessel diameter during various phases of the cycle including systole and diastole] and simultaneously [see [0079]; the measurements of first and second sensors including diameter measurements and delay measurements are done simultaneously] to make pulse wave velocity measurements [see FIG. 9 and [0082]] by measuring a relative timing of pulse waves between the first sensor zone and the second sensor zone. [see [0075] of Van der Horst] wherein mechanically measuring [see [0083]-[0084]] the diameter of the vessel through systole and diastole comprises measuring radial contraction[see [0062] disclosing determining the vessel diameter during various phases of the cycle including systole and diastole]
Van der Horst does not expressly disclose that the first/second sensor group comprising a plurality of sensors, the first/second sensor zone extending radially from distal end of the catheter body; to cause the plurality of sensors of the first/second sensor group to contact a wall of a vessel in which the first/second sensor zone is deployed, so that the plurality of sensors of the second sensor group of the second sensor zone contact the wall of the vessel the predetermined distance from the first sensor zone; and expansion of the wall of vessel corresponding to radial movement of the plurality of sensors of the first sensor group and radial movement of the plurality of sensors of the second sensor group.
Hikmet, directed towards a branched catheter used in the renal arteries to detect physiological parameters [see abstract of Hikmet] further discloses that that the first/second sensor group comprising a plurality of sensors, the first/second sensor zone extending radially from distal end of the catheter body; [see FIG. 5E and [0072] disclosing that each branch 591 of the ballon can have sensors 599; Therefore, FIG. 5E would be considered a first/second sensor group comprising of at least 4 sensors on the balloon sections which are extending radially away from the body of the catheter] to cause the plurality of sensors of the first/second sensor group to contact a wall of a vessel in which the first/second sensor zone is deployed,[see FIGs. 5C-5E; each section of the balloon touches the wall of the vessel 578/588] so that the plurality of sensors of the second sensor group of the second sensor zone contact the wall of the vessel the predetermined distance from the first sensor zone; [see FIGs. 5C-5E and [0072]; each section of the balloon includes a sensor which is in touch with the wall of the vessel in each sensor group. Since Van der Horst discloses two sensor zones and Hekmat discloses a plurality of sensors at each zone, the two sensor groups will have the distance of the two zones between them as they contact the wall of the vessel] wherein mechanically measuring the diameter of the vessel comprises measuring radial contraction and expansion of the wall of vessel corresponding to radial movement of the plurality of sensors of the first sensor group and radial movement of the plurality of sensors of the second sensor group. [see [0064] of Hekmat; Ven der Horst discloses mechanically measuring the diameter during systole and diastole. Hikmet further discloses that such diameter measurement involves touching the walls of the vessel by the sensors]
It would have been obvious to a person of ordinary skill level at the time of the filing of the invention to modify each of the first/second sensor groups so that that the first/second sensor group comprising a plurality of sensors, the first/second sensor zone extending radially from distal end of the catheter body; to cause the plurality of sensors of the first/second sensor group to contact a wall of a vessel in which the first/second sensor zone is deployed, so that the plurality of sensors of the second sensor group of the second sensor zone contact the wall of the vessel the predetermined distance from the first sensor zone; wherein mechanically measuring the diameter of the vessel through systole and diastole comprises measuring radial contraction and expansion of the wall of vessel corresponding to radial movement of the plurality of sensors of the first sensor group and radial movement of the plurality of sensors of the second sensor group according to the teachings of Hekmat in order to provide a multi sensor group in each sensor zone which provides both the ability to locally deliver fluids or agents in a controlled manner in conjunction with the ability to perform an assessment of physiological parameters in the patients [see [0007] of Hemat]
Regarding claim 2, Van der Horst as modified by Hekmat discloses all the limitations of claim 1 [see rejection of claim 1]
Van der Horst does not disclose that the first sensor zone and the second sensor zone each comprise a plurality of smaller catheters that extend radially away from the catheter body to be in intimal contact with the vessel.
Hekmat, further discloses that the first sensor zone and the second sensor zone each comprise a plurality of smaller catheters that extend radially away from the catheter body to be in intimal contact with the vessel [see FIG. 1 and [0041]; the first sensor zone comprises of two branches 130 and 140; The examiner notes that it would have been obvious to an ordinary skilled in the art at the time of the invention to apply the same branching design to the second sensor zone as well since it has been held that duplication of the essential working parts of the device involves only routine skill in the art. ST Regis Paper Co. V. Bemis C. ,193 USPQ 8]
It would have been obvious to a person of ordinary skill level in the art at the time of the filing of the invention to modify the design of Van der Horst as modified by Hekmat such that the first sensor zone and the second sensor zone each comprise a plurality of smaller catheters that extend radially away from the catheter body to be in intimal contact with the vessel according to the teachings of Hekmat in order to perform evaluation and measurements of the vessel in close proximity of the vessel walls by branching the sensor zones into multiple sensor elements [see [0007] of Hekmat]
Regarding claim 3, Van der Horst as modified by Hekmat discloses all the limitations of claim 2 [see rejection of claim 2]
Hekmat further discloses that the plurality of sensors of the first sensor group is positioned on the plurality of smaller catheters of the first sensor zone [see FIG. 1; sensors 152 are positioned on the different branches of the smaller catheters in the first zone] and the plurality of sensors of the second sensor group is positioned on the plurality of smaller catheters of the second sensor zone. [The examiner notes that it would have been obvious to an ordinary skilled in the art at the time of the invention to apply the same branching design to the second sensor zone as well since it has been held that duplication of the essential working parts of the device involves only routine skill in the art. ST Regis Paper Co. V. Bemis C. ,193 USPQ 8]
It would have been obvious to a person of ordinary skill level in the art at the time of the filing of the invention to modify the design of Van der Horst as modified by Hekmat further such that the plurality of sensors of the first sensor group is positioned on the plurality of smaller catheters of the first sensor zone and the plurality of sensors of the second sensor group is positioned on the plurality of smaller catheters of the second sensor zone according to the teachings of Hekmat in order to perform evaluation and measurements of the vessel in close proximity of the vessel walls by branching the sensor zones into multiple sensor elements [see [0007] of Hekmat]
Regarding claim 5, Van der Horst discloses all the limitations of claim 1 [see rejection of claim 1]
Van der Horst odes not disclose that the first sensor zone and the second sensor zone each comprise a toroidal balloon that extends radially away from the body of the catheter to be in intimal contact with the vessel.
Hekmat further discloses that the first sensor zone and the second sensor zone each comprise a toroidal balloon that extends radially away from the body of the catheter to be in intimal contact with the vessel. [see FIG. 5B and [0069]; the balloon 566 is toroidal and is in intimal contact with the vessel]
It would have been obvious to a person of ordinary skill level in the art at the time of the filing of the invention to modify the design of Van der Horst such that the first sensor zone and the second sensor zone each comprise a toroidal balloon that extends radially away from the body of the catheter to be in intimal contact with the vessel according to the teachings of Hekmat in order to act as a positioning mechanism in order to bring the sensor in exact position with respect to the vessel wall [see [0069] of Hekmat]
Regarding claim 6, Van der Horst as modified by Hekmat discloses all the limitations of claim 5 [see rejection of claim 5]
Hekmat further discloses that the plurality of sensors of the first sensor group is positioned on the toroidal balloon of the first sensor zone and the plurality of sensors of the second sensor group is positioned on the toroidal balloon of the second sensor zone. [see FIG. 7 and [0076]]
It would have been obvious to a person of ordinary skill level in the art at the time of the filing of the invention to modify the design of Van der Horst as modified by Hekmat such that the plurality of sensors of the first sensor group is positioned on the toroidal balloon of the first sensor zone and the plurality of sensors of the second sensor group is positioned on the toroidal balloon of the second sensor zone according to the teachings of Hekmat in order to act as a positioning mechanism in order to bring the sensor in exact position with respect to the vessel wall [see [0069] of Hekmat]
Regarding claim 7, Van der Horst discloses all the limitations of claim 1 [see rejection of claim 1]
Van der Horst does not expressly disclose a sheath that covers at least a portion of the body of the catheter at the distal end to cover the first sensor zone and the second sensor zone.
Hekmat further discloses a sheath that covers at least a portion of the body of the catheter at the distal end to cover the first sensor zone and the second sensor zone. [see FIG. 1 and [0041] of Hekmat; guide sheath 125; The examiner notes that it would have been obvious to an ordinary skilled in the art at the time of the invention to apply the same branching design to the second sensor zone as well since it has been held that duplication of the essential working parts of the device involves only routine skill in the art. ST Regis Paper Co. V. Bemis C. ,193 USPQ 8 ]
It would have been obvious to a person of ordinary skill level in the art at the time of the filing of the invention to modify the design of Van der Horst such that it includes a sheath that covers at least a portion of the body of the catheter at the distal end to cover the first sensor zone and the second sensor zone according to the teachings of Hekmat in order to insert the device in a minimally invasive incision by keeping the branched close to the body of the catheter [see [0041] of Hekmat]
Regarding claim 8, Van der Horst as modified by Hekmat discloses all the limitations of claim 7 [see rejection of claim 7]
Hekmat further discloses that in a delivery configuration, the first sensor zone and the second sensor zone are each compressed to be adjacent to the body of the catheter, the first sensor zone and the second sensor zone held adjacent to the body of the catheter by the sheath. [see FIG. 1 and [0041] of Hekmat; guide sheath 125; The examiner notes that it would have been obvious to an ordinary skilled in the art at the time of the invention to apply the same branching design to the second sensor zone as well since it has been held that duplication of the essential working parts of the device involves only routine skill in the art. ST Regis Paper Co. V. Bemis C. ,193 USPQ 8]
It would have been obvious to a person of ordinary skill level in the art at the time of the filing of the invention to modify the design of Van der Horst as modified by Hekmat such that in a delivery configuration, the first sensor zone and the second sensor zone are each compressed to be adjacent to the body of the catheter, the first sensor zone and the second sensor zone held adjacent to the body of the catheter by the sheath according to the teachings of Hekmat in order to insert the device in a minimally invasive incision by keeping the branched close to the body of the catheter [see [0041] of Hekmat]
Regarding claim 9, Van der Horst as modified by Hekmat discloses all the limitations of claim 8 [see rejection of claim 8]
Hekmat further discloses that in a deployed configuration, the sheath is withdrawn to unsheathe the first sensor zone and the second sensor zone to allow the first sensor zone and the second sensor zone to expand radially.[see FIG. 1 and [0041]; the area outside the sheath enables the first sensor zone to expand radially; The examiner notes that it would have been obvious to an ordinary skilled in the art at the time of the invention to apply the same branching design to the second sensor zone as well since it has been held that duplication of the essential working parts of the device involves only routine skill in the art. ST Regis Paper Co. V. Bemis C. ,193 USPQ 8]
It would have been obvious to a person of ordinary skill level in the art at the time of the filing of the invention to modify the design of Van der Horst as modified by Hekmat such that in a deployed configuration, the sheath is withdrawn to unsheathe the first sensor zone and the second sensor zone to allow the first sensor zone and the second sensor zone to expand radially according to the teachings of Hekmat in order to insert the device in a minimally invasive incision by keeping the branched close to the body of the catheter [see [0041] of Hekmat]
Regarding claim 11, Van der Horst as modified by Hekmat discloses all the limitations of claim 8 [see rejection of claim 8]
Hekmat further discloses that the first sensor zone and the second sensor zone each comprise a toroidal balloon that is inflated after being unsheathed. [see FIG. 5B and [0069]-[0070]; the balloon 566 is toroidal and is in intimal contact with the vessel]
It would have been obvious to a person of ordinary skill level in the art at the time of the filing of the invention to modify the design of Van der Horst such that the first sensor zone and the second sensor zone each comprise a toroidal balloon that extends raddially away from the body of the catheter to be in intimal contact with the vessel according to the teachings of Hekmat in order to act as a positioning mechanism in order to bring the sensor in exact position with respect to the vessel wall [see [0069] of Hekmat]
Regarding claim 14, Van der Horst discloses a system for measuring vessel distensibility and pulse wave velocity [see abstract of Ven der Horst], the system comprising:
An intravascular catheter [see [0044]; intravascular device 110 can be a catheter] comprising a catheter [see [0044]; intravascular device 110 can be a catheter] having a body and a distal end [see FIG. 1] ; and a plurality of sensor zones associated with the catheter; each sensor zone comprising a sensor group having a plurality of sensors [first sensor zone 202; see FIG. 1 and [0048]; each sensor zone comprises of an array of ultrasound transducers], are radially spaced from the body of the catheter [see [0048]; the array of sensors (i.e. ultrasound transducers) extend circumferentially (radially) from the body of the catheter]] each sensor zone being spaced from an adjacent zone by a predetermined distance along the body of the catheter; [see FIG 1 and [0055]; the two zones are separated by a distance D1] and
a distensibility measurement system adapted to interface with the intravascular catheter, the distensibility measurement system comprising: [see [0048] for example disclosing that measurements of wall dimensions are performed by the sensor zones 202 and 204]
memory adapted to store computer-executable instructions; [memory 150; see FIG.,2] and
one or more processors communicably coupled to the memory and adapted to execute the computer-executable instructions to perform the following: [processor 140; see FIG. 2]
receive measurements of an inner diameter of a vessel in which the intravascular catheter is inserted, [see [0044]; the catheter is inserted into the renal artery 81] the measurements acquired by the plurality of sensor zones corresponding to a plurality of locations within the vessel;
determine a change in size of the inner diameter of the vessel at the plurality of locations within the vessel based on the measurements of the inner diameter [see [0083]-[0084]] acquired by the plurality of sensor zones determine an arrival time of a pulse wave at each sensor zone of the plurality of sensor zones; [see [0075] of Van der Horst]
determine a pulse wave velocity based on relative arrival times of the pulse wave at the plurality of sensor zones; [see FIG. 9 and [0082]] and determine vessel distensibility based on the determined changes in size of the inner diameter of the vessel and the determined pulse wave velocity. [see [0048] for example disclosing that measurements of wall dimensions are performed by the sensor zones 202 and 204] wherein mechanically measuring [see [0083]-[0084]] the diameter of the vessel through systole and diastole comprises measuring radial contraction[see [0062] disclosing determining the vessel diameter during various phases of the cycle including systole and diastole]
Van der Horst does not expressly disclose that the first/second sensor group comprising a plurality of sensors, the first/second sensor zone extending radially from distal end of the catheter body; to cause the plurality of sensors of the first/second sensor group to contact a wall of a vessel in which the first/second sensor zone is deployed, so that the plurality of sensors of the second sensor group of the second sensor zone contact the wall of the vessel the predetermined distance from the first sensor zone; and expansion of the wall of vessel corresponding to radial movement of the plurality of sensors of the first sensor group and radial movement of the plurality of sensors of the second sensor group.
Hikmet, directed towards a branched catheter used in the renal arteries to detect physiological parameters [see abstract of Hikmet] further discloses that that the first/second sensor group comprising a plurality of sensors, the first/second sensor zone extending radially from distal end of the catheter body; [see FIG. 5E and [0072] disclosing that each branch 591 of the ballon can have sensors 599; Therefore, FIG. 5E would be considered a first/second sensor group comprising of at least 4 sensors on the balloon sections which are extending radially away from the body of the catheter] to cause the plurality of sensors of the first/second sensor group to contact a wall of a vessel in which the first/second sensor zone is deployed,[see FIGs. 5C-5E; each section of the balloon touches the wall of the vessel 578/588] so that the plurality of sensors of the second sensor group of the second sensor zone contact the wall of the vessel the predetermined distance from the first sensor zone; [see FIGs. 5C-5E and [0072]; each section of the balloon includes a sensor which is in touch with the wall of the vessel in each sensor group. Since Van der Horst discloses two sensor zones and Hekmat discloses a plurality of sensors at each zone, the two sensor groups will have the distance of the two zones between them as they contact the wall of the vessel] wherein mechanically measuring the diameter of the vessel comprises measuring radial contraction and expansion of the wall of vessel corresponding to radial movement of the plurality of sensors of the first sensor group and radial movement of the plurality of sensors of the second sensor group. [see [0064] of Hekmat; Ven der Horst discloses mechanically measuring the diameter during systole and diastole. Hikmet further discloses that such diameter measurement involves touching the walls of the vessel by the sensors]
It would have been obvious to a person of ordinary skill level at the time of the filing of the invention to modify each of the first/second sensor groups so that that the first/second sensor group comprising a plurality of sensors, the first/second sensor zone extending radially from distal end of the catheter body; to cause the plurality of sensors of the first/second sensor group to contact a wall of a vessel in which the first/second sensor zone is deployed, so that the plurality of sensors of the second sensor group of the second sensor zone contact the wall of the vessel the predetermined distance from the first sensor zone; wherein mechanically measuring the diameter of the vessel through systole and diastole comprises measuring radial contraction and expansion of the wall of vessel corresponding to radial movement of the plurality of sensors of the first sensor group and radial movement of the plurality of sensors of the second sensor group according to the teachings of Hekmat in order to provide a multi sensor group in each sensor zone which provides both the ability to locally deliver fluids or agents in a controlled manner in conjunction with the ability to perform an assessment of physiological parameters in the patients [see [0007] of Hemat]
Regarding claim 15, Van der Horst discloses the distensibility measurement system is further adapted to determine vessel compliance based on the determined changes in size of the inner diameter of the vessel and the determined pulse wave velocity. [see [0048] for example disclosing that measurements of wall dimensions are performed by the sensor zones 202 and 204]
Regarding claim 16, Van der Horst further discloses an imaging system in communication with the distensibility measurement system. [see FIG. 7A-B and [0080]; the ultrasound imaging system]
Regarding claim 19, Van der Horst discloses an intravascular catheter comprising:
a catheter [see [0044]; intravascular device 110 can be a catheter having a body [see FIG. 1] ; a plurality of sensor zones associated with the catheter [first sensor zone 202; see FIG. 1 and [0048]; each sensor zone comprises of an array of ultrasound transducers], each sensor group having a plurality of sensors radially extending from the body of the catheter; [see [0048]; the array of sensors (i.e. ultrasound transducers) extend circumferentially (radially) from the body of the catheter]] ; each sensor zone being spaced from an adjacent zone by a predetermined distance along the body of the catheter, [see FIG 1 and [0055]; the two zones are separated by a distance D1] wherein each sensor zone is adapted to make a plurality of distensibility measurements [see [0048] for example disclosing that measurements of wall dimensions are performed by the sensor zones 202 and 204] of a vessel in which the catheter is inserted [see [0044]; the catheter is inserted into the renal artery 81] by mechanically measuring a diameter of the vessel at a plurality of times. [see [0062] disclosing determining the vessel diameter during various phases of the cycle including systole and diastole]
Van der Horst does not expressly disclose cause the plurality of sensors of each sensor group to contact a wall of a vessel in which the plurality of sensor zones is deployed, so that the plurality of sensors of a sensor group of a sensor zone contact the wall of the vessel the predetermined distance from the adjacent zone, wherein mechanically measuring the diameter of the vessel comprises measuring radial contraction and expansion of the wall of the vessel corresponding to radial movement of the plurality of sensors of each sensor group of the plurality of sensor zones.
Hikmet, directed towards a branched catheter used in the renal arteries to detect physiological parameters [see abstract of Hikmet] further discloses cause the plurality of sensors of the first/second sensor group to contact a wall of a vessel in which the first/second sensor zone is deployed,[see FIGs. 5C-5E; each section of the balloon touches the wall of the vessel 578/588] so that the plurality of sensors of the second sensor group of the second sensor zone contact the wall of the vessel the predetermined distance from the first sensor zone; [see FIGs. 5C-5E and [0072]; each section of the balloon includes a sensor which is in touch with the wall of the vessel in each sensor group. Since Van der Horst discloses two sensor zones and Hekmat discloses a plurality of sensors at each zone, the two sensor groups will have the distance of the two zones between them as they contact the wall of the vessel] wherein mechanically measuring the diameter of the vessel comprises measuring radial contraction and expansion of the wall of the vessel corresponding to radial movement of the plurality of sensors of each sensor group of the plurality of sensor zones. [see [0064] of Hekmat; Ven der Horst discloses mechanically measuring the diameter during systole and diastole. Hikmet further discloses that such diameter measurement involves touching the walls of the vessel by the sensors]
It would have been obvious to a person of ordinary skill level at the time of the filing of the invention to modify the teachings of Van der Horst such that to cause the plurality of sensors of each sensor group to contact a wall of a vessel in which the plurality of sensor zones is deployed, so that the plurality of sensors of a sensor group of a sensor zone contact the wall of the vessel the predetermined distance from the adjacent zone, wherein mechanically measuring the diameter of the vessel comprises measuring radial contraction and expansion of the wall of the vessel corresponding to radial movement of the plurality of sensors of each sensor group of the plurality of sensor zones according to the teachings of Hekmat in order to provide a multi sensor group in each sensor zone which provides both the ability to locally deliver fluids or agents in a controlled manner in conjunction with the ability to perform an assessment of physiological parameters in the patients [see [0007] of Hekmat]
Regarding claim 20, Van der Horst discloses wherein each sensor zone is adapted to make pulse wave velocity measurements by measuring a relative timing of pulse waves between individual sensor zones of the plurality of sensor zones. [see [0075] of Van der Horst]
Claims 4 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Van der Horst et al. (U.S. Publication No. 20190175035/) hereinafter “Van der Horst” in view of Hekmat et al. (U.S. Publication No. 2009/0105799) hereinafter “Hekmat” as applied to claims 2 and 9 above and further in view of Azamian et al. (U.S. Publication No.) hereinafter “Azamian”
Regarding claim 4, Van der Horst as modified by Hekmat discloses all the limitations of claim 2 [see rejection of claim 2]
Van der Horst as modified by Hekmat does not expressly disclose that the plurality of smaller catheters comprises a shape memory alloy.
Azaminan, directed towards a branched catheter device [see FIG. 17 and abstract of Azamian] the plurality of smaller catheters comprises a shape memory alloy. [see FIG. 17 and [0147]]
It would have been obvious to a person of ordinary skill level in the art at the time of the filing of the invention to modify the design of Van der Horst as modified by Hekmat such that the plurality of smaller catheters comprises a shape memory alloy according to the teachings of Azamian in order to allow for flexibility during the introduction of the catheter into the vessel [see [0174] of Azamian]
Regarding claim 10, Van der Horst as modified by Hekmat discloses all the limitations of claim 2 [see rejection of claim 2]
Van der Horst as modified by Hekmat does not expressly disclose that wherein the first sensor zone and the second sensor zone each comprise shape memory alloys that self-expand upon being unsheathed.
Azaminan, directed towards a branched catheter device [see FIG. 17 and abstract of Azamian] wherein the first sensor zone and the second sensor zone each comprise shape memory alloys that self-expand upon being unsheathed. [see FIG. 17 and [0147] ;The examiner notes that it would have been obvious to an ordinary skilled in the art at the time of the invention to apply the same branching design to the second sensor zone as well since it has been held that duplication of the essential working parts of the device involves only routine skill in the art. ST Regis Paper Co. V. Bemis C. ,193 USPQ 8]
It would have been obvious to a person of ordinary skill level in the art at the time of the filing of the invention to modify the design of Van der Horst as modified by Hekmat such that the wherein the first sensor zone and the second sensor zone each comprise shape memory alloys that self-expand upon being unsheathed according to the teachings of Azamian in order to allow for flexibility during the introduction of the catheter into the vessel [see [0174] of Azamian]
Claims 12 is rejected under 35 U.S.C. 103 as being unpatentable over Van der Horst et al. (U.S. Publication No. 20190175035) hereinafter “Van der Horst” in view of in view of Hekmat et al. (U.S. Publication No. 2009/0105799) hereinafter “Hekmat” as applied to claim 1 above and further in view of Goedeke et al. (U.S. Publication No. 2020/0206511) hereinafter “Goedeke”.
Regarding claim 12, Van der Horst as modified by Hekmat discloses all the limitations of claim 1 [see rejection of claim 1]
Van der Horst as modified by Hekmat does not expressly disclose that the plurality of sensors of the first sensor zone and the plurality of sensors of the second sensor zone comprise accelerometers.
Goedeke, directed towards a branched catheter with a plurality of sensors [see abstract of Goedeke], further discloses that the plurality of sensors of the first sensor zone and the plurality of sensors of the second sensor zone comprise accelerometers. [see [0901 and FIGs. 31A-31b of Goedeke; The examiner notes that it would have been obvious to an ordinary skilled in the art at the time of the invention to apply the same branching design to the second sensor zone as well since it has been held that duplication of the essential working parts of the device involves only routine skill in the art. ST Regis Paper Co. V. Bemis C. ,193 USPQ 8]
It would have been obvious to a person of ordinary skill level in the art at the time of the filing of the invention to modify the design of Van der Horst such that the plurality of sensors of the first sensor zone and the plurality of sensors of the second sensor zone comprise accelerometers according to the teachings of Goedeke in order to perform contractility measurements [see [0901] of Goedeke]
Claims 13, 17, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Van der Horst et al. (U.S. Publication No. 20190175035) hereinafter “Van der Horst” in view of in view of Hekmat et al. (U.S. Publication No. 2009/0105799) hereinafter “Hekmat as applied to claims 1 and 16 and further in view of Harrington (U.S. Publication No. 2014/0330267) hereinafter “Harrington”.
Regarding claim 13, Van der Horst discloses all the limitations of claim 1 [see rejection of claim 1]
Van der Horst does not expressly disclose that the plurality of sensors of the first sensor zone and the plurality of sensors of the second sensor zone comprise radiopaque markers.
Harrington, directed towards measurement of inner parameters of various vascular structures [see abstract of Harrington] further discloses that the plurality of sensors of the first sensor zone and the plurality of sensors of the second sensor zone comprise radiopaque markers. [see [0035] of Harrington; the radiopaque markers are attached to the balloon in the renal vessel; The examiner notes that it would have been obvious to an ordinary skilled in the art at the time of the invention to apply the same branching design to the second sensor zone as well since it has been held that duplication of the essential working parts of the device involves only routine skill in the art. ST Regis Paper Co. V. Bemis C. ,193 USPQ 8]
It would have been obvious to a person of ordinary skill level in the art at the time of the filing of the invention to modify the design of Van der Horst the plurality of sensors of the first sensor zone and the plurality of sensors of the second sensor zone comprise radiopaque markers according to the teachings of Harrington in order help in detection of various elements such as flow rate [see [0035]-[0036] of Harrington]
Regarding claim 17, Van der Horst discloses all the limitations of claim 16 [see rejection of claim 16]
Van der Horst does not expressly disclose that the imaging system is configured to acquire images of radiopaque markers at each sensor zone of the plurality of sensor zones.
Harrington further discloses that the imaging system is configured to acquire images of radiopaque markers at each sensor zone of the plurality of sensor zones. [see [0035] of Harrington; the radiopaque markers are attached to the balloon in the renal vessel and are imaged]
It would have been obvious to a person of ordinary skill level in the art at the time of the filing of the invention to modify the design of Van der Horst such that the imaging system is configured to acquire images of radiopaque markers at each sensor zone of the plurality of sensor zones according to the teachings of according to the teachings of Harrington in order help in detection of various elements such as flow rate [see [0035]-[0036] of Harrington]
Regarding claim 18, Van der Horst as modified by Harrington discloses all the limitations of claim 17 [see rejection of claim 17]
Harrington further discloses that the distensibility measurement system is further adapted to measure the size of the inner diameter using the acquired images of the radiopaque markers. [see [0035]-[0036] disclosing that the diameter of the vessel can be determined using fluoroscopy by imaging of the radiopaque markers]
It would have been obvious to a person of ordinary skill level in the art at the time of the filing of the invention to modify the design of Van der Horst such that the distensibility measurement system is further adapted to measure the size of the inner diameter using the acquired images of the radiopaque markers according to the teachings of Harrington in order help in detection of various elements such as flow rate [see [0035]-[0036] of Harrington]
Response to Arguments
Applicant’s arguments with respect to claim(s) 1, 14 and 19 have been considered but are moot because the new ground of rejection does not rely on the embodiments of 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 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.
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/MARJAN SABOKTAKIN/Examiner, Art Unit 3797
/MICHAEL J CAREY/Supervisory Patent Examiner, Art Unit 3795
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