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 .
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
“the first tracking element is configured to…” in Claim 1, line 9;
“the second tracking element is configured to…” in Claim 1, lines 10-11.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
Here:
“the first tracking element” corresponding structure is described to be a positioning sensing system that includes one or more position or orientation sensors (e.g., a first/second/third magneto-resistive sensor) (see, e.g., Claim 5; Para. 0007).
“the second tracking element” corresponding structure is described as an EM-based sensor (Para. 0025).
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 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:
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.
Claim(s) 1-9, and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over US2020/0129318 to Duval et al. “Duval”, in view of US2017/0059361 to Nagarkar et al.” Nagarkar”, further in view of US20210059700A1 of Algawi et al. “Algawi”, and further in view of US2021/0077180 to Govari et al. “Govari”.
Regarding claim 1, Duval discloses a medical system (Paragraph 0012, “system for performing a medical procedure”), comprising:
a first medical device (Paragraph 0041-0043, device 14; wherein further descriptions of device 14 is found in Paragraph 0025), wherein the first medical device includes a handle (Paragraph 0025, recites that device 14 has hand-held controls external to the body, and thus infers a portion that is hand-held, and would read on a handle) and an insertion portion (Paragraph 0025, member 30; also see Figs. 1 and 6, Ref. 30), wherein a distal portion of the insertion portion of the first medical device includes a first tracking element (Paragraph 0026, magnetic field sensor 36, also see Ref. 36 in Figs. 1 and 6) and at least one camera (“distal portion 32 may include…a camera, Paragraph 0025); and
a second medical device (Paragraph 0041, device 202, which comprises all the features of device 12, described in Paragraph 0023-24), wherein the second medical device includes a handle (Paragraph 0031, handle of the operation portion of device 12; Paragraph 0023, recites that device 12 has hand-held controls external to the body, and thus infers a portion that is hand-held, and would read on a handle) and an insertion portion (Paragraph 0041, member 204), wherein a distal portion of the insertion portion of the second medical device includes a second tracking element (Paragraph 0041, magnetic device 210), and
wherein the second tracking element is configured to provide a signal that indicates a position or orientation of the distal portion of the second medical device (Paragraph 0026, “The compared parameters may be used to identify a location or position of magnet 26, as described herein (e.g., by use of a direction of a magnetic field of magnet 26 or a magnitude of a direction of a magnetic field of magnet 26”).
However, Duval does not disclose wherein the first tracking element is configured to provide a signal that indicates a position or orientation of the distal portion of the first medical device.
Nagarkar teaches a similar medical device (Paragraph 0035, Fig. 7) with a handle 106 (Paragraph 0036), a tracking element (Paragraph 0035), sensor package 10, wherein the sensor package 10 is a magneto-resistance sensor), and a camera (inherent in the device being an intrabody camera device, Paragraph 0035), wherein the tracking element is used for tracking a position and orientation of the device (Paragraph 0019, the EM sensors may be a one one-axis or two-axis magneto-resistance sensors configured to generate position and orientation information in the presence of an externally applied magnetic field).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system as described by Duval, wherein the first tracking element is configured to provide a signal that indicates a position or orientation of the distal portion of the first medical device, as taught by Nagarkar, in order to be able to determine the position and orientation of the probe (which would read on the first medical device).
Therefore, in the combination of Duval and Nagarkar, the first and second tracking element allows for determining the position and orientation of both the first and second medical device.
However, the modifications of Duval and Nagarkar do not disclose wherein the first device contains a working channel.
Algawi teaches a similar medical device (sinuplasty tool, Abstract), with a handle, and the device has an elongated tube with a distal end configured to be inserted into a cavity of a living subject (Abstract). Algawi teaches the medical device contains a working channel (working channel 132, Paragraph 0109, Fig. 3A).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system as described by Duval and Nagarkar wherein the first device contains a working channel, as taught by Algawi, in order to allow transport of tools needed for the specific procedure, for example a balloon or a ultrasonic camera, to the region of interest (Paragraphs 0109, 0110).
However, the modifications of Duval, Nagarkar, and Algawi do not disclose wherein the first medical device further includes a pressure sensor positioned at the distal portion of the first medical device, wherein the pressure sensor and the first tracking element are mounted to a same substrate within the distal portion of the first medical device.
Govari teaches a similar catheter configured to be inserted into a body-part of a living subject (Abstract). Govari teaches wherein the catheter includes a force sensor positioned at the distal, insertion portion (Paragraph 0093 and Fig. 9, distal tip 304 of insertion tube 302 with force sensor 312; wherein the force sensor 312 comprises the flexible circuit 110), wherein the force sensor and the first tracking element are mounted to a same substrate within the distal portion of the first medical device (Paragraph 0073 and Fig. 2, flexible-circuit 110 of the catheter 14 provide signals indicative of location and force to the processor 22 in console 24, wherein flexible circuit 110 includes substrate 112, with portions 114, 116, 130, and 142, See Paragraphs 0073-0076; Paragraph 0075 and Fig. 2, coils 118, 170, and 172 are the force sensing coils on portion 114; Paragraph 0076 and Fig. 2, coils at portion 116, including coils 120 and 128, and coils at portion 130, including coils 138 and 140 are the location coils). The force sensor of Govari would read on the claimed pressure sensor, and at minimum are capable of measuring pressure, since the force sensors senses the magnitude and a direction of the force, such as the force applied on the balloon by the heart tissue (Paragraph 00055) or forces or sub-gram forces exerted on the tip of the catheter (Paragraph 0082), and pressure is equal to such a measured force times a surface area where the force is obtained, such as a predefined area measurement of the sensor size.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system as described by Duval, Nagarkar, and Algawi, wherein the first medical device further includes a pressure sensor positioned at the distal portion of the first medical device, wherein the pressure sensor and the first tracking element are mounted to a same substrate within the distal portion of the first medical device, as taught by Govari, in order to be able to pack a force/pressure sensor and position sensor into a small inner diameter space such as that of the distal tip of a catheter (Govari, Paragraph 0072).
Regarding claim 2, the modifications of Duval, Nagarkar, Algawi, and Govari disclose all the features of claim 1 above.
Duval teaches wherein the distal portion of the first medical device further includes one or more lighting elements (Paragraph 0013, the distal portion of the first device may further include a light emitting source”, also see Paragraph 0025).
Regarding claim 3, the modifications of Duval, Nagarkar, Algawi, and Govari disclose all the features of claim 2 above.
Algawi teaches wherein the first tracking element, the at least one camera, and the one or more lighting elements are coupled to a substrate within the distal portion of the first medical device (Paragraphs 0111-0113 and Fig. 3A, LEDs 148, magnetic single axis sensor 152, and camera are all attached to the strip 120, wherein the magnetic single axis sensor 152 would read on the first tracking element, and the strip 120 would read on the substrate).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system as described by Duval, Nagarkar, Algawi, and Govari, wherein the first tracking element, the at least one camera, and the one or more lighting elements are coupled to a substrate within the distal portion of the first medical device, as taught by Algawi, in order to facilitate assembly by affixing the elements onto the strip 20, and then positioning the strip 20 into the device (Paragraph 0113).
Regarding claims 4-6, the modifications of Duval, Nagarkar, Algawi, and Govari disclose all the features of claim 3 above.
As disclosed in the claim 1 rejection above, Duval teaches wherein the distal portion of the insertion portion of the first medical device includes a first tracking element (Paragraph 0026, magnetic field sensor 36, also see Ref. 36 in Figs. 1 and 6), and as disclosed in the claim 3 rejection above, Algawi teaches wherein the first tracking element is coupled to a substrate.
However, Duval and Algawi does not teach wherein the substrate includes a first face and a second face, wherein the first face and the second face are arranged approximately orthogonally to each other, wherein the first tracking element includes a position sensing system that includes one or more position or orientation sensors, wherein the position sensing system includes a first magneto-resistive sensor, a second magneto-resistive sensor, and a third magneto-resistive sensor, wherein the first magneto-resistive sensor, the second magneto-resistive sensor, and the third magneto-resistive sensor are coupled to the substrate, and wherein a proximal portion of the substrate includes a plurality of contact pads.
Nagarkar teaches wherein the substrate (See Figs. 5 and 6 Ref. 42) includes a first face (face of substrate portion 44, Fig. 5) and a second face (face of substrate portion 46, See Fig. 5), wherein the first face and the second face are arranged approximately orthogonally to each other (See Fig. 5, face of portion 44 and 46 are orthogonal to each other) and wherein a proximal portion of the substrate includes a plurality of contact pads (See Fig. 1A, Ref. 20, Paragraph 0021). As see in in Fig. 5, each sensor chip circuit 24 is coupled to the substrate (either portion 44 or 46), that is labeled as 48, 50, 52 is a single axis sensor (Paragraph, 0032) where the axis is defined by the arrow indicated for each sensor circuit (See Fig. 5), and each sensor chip is a magneto-resistance sensor chip (Paragraph 0032). This reads on wherein the position sensing system includes a first magneto-resistive sensor, a second magneto-resistive sensor, and a third magneto-resistive sensor, wherein the first magneto-resistive sensor, the second magneto-resistive sensor, and the third magneto-resistive sensor are coupled to the substrate.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system as described by Duval, Nagarkar, Algawi, and Govari, wherein the first face and the second face are arranged approximately orthogonally to each other, wherein the first tracking element includes a position sensing system that includes one or more position or orientation sensors, wherein the position sensing system includes a first magneto-resistive sensor, a second magneto-resistive sensor, and a third magneto-resistive sensor, wherein the first magneto-resistive sensor, the second magneto-resistive sensor, and the third magneto-resistive sensor are coupled to the substrate, and wherein a proximal portion of the substrate includes a plurality of contact pads, as taught by Nagarkar, in order to be able to use a plurality of 1 axis sensor chips to form a magneto-resistance sensor package such that the magneto-resistance sensor package can measure in three directions (Nagarkar, Paragraph 0032).
Regarding claim 7, the modifications of Duval, Nagarkar, Algawi, and Govari disclose all the features of claim 6 above.
As disclosed in the claims 4-6 rejection above, Nagarkar teaches as see in in Fig. 5, each sensor chip circuit 24 is coupled to the substrate (either portion 44 or 46), that is labeled as 48, 50, 52 is a single axis sensor (Paragraph, 0032) wherein the axis of the single axis sensor chip is defined by the arrow indicated for each sensor circuit (See Fig. 5, three distinct directions indicated by the arrows), and each sensor chip is a magneto-resistance sensor chip (Paragraph 0032). This reads on the claim wherein the first magneto-resistive sensor has a first primary sensing direction, wherein the second magneto-resistive sensor has a second primary sensing direction, wherein the third magneto-resistive sensor has a third primary sensing direction. Further, as seen in Fig. 5, sensor 48’s sensing direction is parallel with the longitudinal axis of the substrate.
However, Nagarkar does not explicitly disclose wherein a second primary sensing direction is approximately parallel with a longitudinal axis of the substrate
However, Nagarkar does disclose that the sensors do not all have to be arranged such that the sensing direction are orthogonal to each other (Paragraph 0032, it is recognized that the sensor circuits 24 of chips 48, 50, 52 could be oriented relative to one another at angles other than 90°)..
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system as described by Duval, Nagarkar, Algawi, and Govari, wherein a second primary sensing direction is approximately parallel with a longitudinal axis of the substrate, since it would be an obvious matter of design choice to optimize the sensing directions of the magneto-resistive sensors.
Regarding claim 8, the modifications of Duval, Nagarkar, Algawi, and Govari disclose all the features of claim 7 above.
As disclosed in the claim 4 rejection above, Nagarkar teaches the sensing directions of the magneto-resistive sensor, as illustrated in Fig. 5. As seen in Fig. 5, sensor 46’s sensing direction is transverse to the longitudinal axis of the substrate, which would read on the claimed third primary sensing direction is transverse to the longitudinal axis of the substrate.
Regarding claim 9, the modifications of Duval, Nagarkar, Algawi, and Govari disclose all the features of claim 7 above.
Nagarkar teaches wherein the position sensing system is configured to measure at least five degrees of freedom (Paragraph 0005, such a position and orientation sensor assembly would still provide position and orientation information with adequate precision and accuracy and with sensing in six degrees of freedom).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system as described by Duval, Nagarkar, Algawi, and Govari, wherein the position sensing system is configured to measure at least five degrees of freedom, as taught by Nagarkar, in order to provide the desired position and orientation information useable in applications in neural, cardia, and orthopedic spaces (Paragraph 0004).
Regarding claim 12, the modifications of Duval, Nagarkar, Algawi, and Govari disclose all the features of claim 1 above.
Algawi teaches wherein the first medical device includes an optical fiber (fiber optic 150, See Fig. 3A) extending from the handle portion to the distal portion of the insertion portion of the first medical device (extends from distal end all the way to the fiber optic module, which has to extend from the distal end to handle portion, since the fiber optic module is beyond the handle portion, Paragraph 0125, and Fig. 1), wherein a distal end of the optical fiber is adjacent to the at least one camera (See Fig. 3A, fiber optic 150 is next to camera 160).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system as described by Duval, Nagarkar, Algawi, and Govari, wherein the first medical device includes an optical fiber extending from the handle portion to the distal portion of the insertion portion of the first medical device, wherein a distal end of the optical fiber is adjacent to the at least one camera, and wherein the first medical device further includes a pressure sensor positioned at the distal portion of the first medical device, as taught by Algawi, in order to be able to transmit light via the fiber optic and retrieve the reflected illumination to be analyzed (Paragraph 0126).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Duval, in view of Nagarkar, further in view of Algawi, and further in view of Govari, as applied to claim 6 above, and further in view of US2019/0217059 to “Meyer”.
Regarding claim 10, the modifications of Duval, Nagarkar, Algawi, and Govari disclose all the features of claim 6 above.
However, the modifications of Duval, Nagarkar, Algawi, and Govari do not disclose wherein the distal portion of the first medical device further includes one or more diodes and one or more capacitors, wherein the one or more diodes and the one or more capacitors are coupled to the substrate.
Meyer teaches a multilayer circuit assembly 302 (Paragraph 0073) comprising of a flexible substrate 312 (Paragraph 0073), that includes first, second, third magnetic field sensors, and diodes and capacitors (Paragraph 0074).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system as described by Duval, Nagarkar, Alga, and Govari, wherein the distal portion of the first medical device further includes one or more diodes and one or more capacitors, wherein the one or more diodes and the one or more capacitors are coupled to the substrate, as taught by Meyer, in order to form the sensing circuit (Paragraph 0074).
Claim(s) 11, 13, and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Duval, in view of Nagarkar, further in view of Algawi, and further in view of Govari, as applied to claim 1 above, and further in view of US2021/0236204 to Tower et al. “Tower”.
Regarding claim 11, the modifications of Duval, Nagarkar, Algawi, and Govari disclose all the features of claim 1 above.
However, the modifications of Duval, Nagarkar, Algawi, and Govari do not disclose wherein the handle of the first medical device includes a lever configured to control an articulation or deflection of the distal portion of the first medical device, wherein the handle of the first medical device includes a port connected to the first working channel, and wherein the handle of the first medical device includes a suction valve to control suction applied through the first working channel.
Tower teaches a similar endoscopic device (Paragraph 0017) with a flexible distal portion (Abstract). Tower teaches wherein the handle of the medical device includes a lever configured to control an articulation or deflection of the distal portion of the medical device (articular controller 114 can be deploy or release a locking mechanism for articulation via a lever on a grippable proximal portion 104, Paragraph 0031-32, wherein locking the distal end in a particular articulated position would broadly read on controlling the articulation),
wherein the handle of the first medical device includes a port (proximal end of the suction lumen 136 can connect, via a suitable connector, Paragraph 0051, wherein the connector reads on a port; See Fig. 2, proximal end of suction lumen) connected to the working channel (suction lumen, Paragraph 0051), and
wherein the handle of the first medical device includes a suction valve to control suction applied through the first working channel (flushing controller 138, see Fig. 2, Paragraph 0052, also cycles the various levels of suction).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system as described by Duval, Nagarkar, Algawi, and Govari, wherein the handle of the first medical device includes a lever configured to control an articulation or deflection of the distal portion of the first medical device, wherein the handle of the first medical device includes a port connected to the first working channel, and wherein the handle of the first medical device includes a suction valve to control suction applied through the first working channel, as taught by Tower, in order to control the articulated position of the device (Paragraph 0031-0032) and irrigate and also remove the irrigation agent from a treatment site (Paragraph 0049).
Regarding claim 13, the modifications of Duval, Nagarkar, Algawi, and Govari disclose all the features of claim 1 above.
However, the modifications of Duval, Nagarkar, Algawi, and Govari do not teach wherein the second medical device is a nephroscope, and wherein the nephroscope includes a working channel.
Tower teaches a nephroscope (Paragraph 0004) with a working channel (Paragraph 0042).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system as described by Duval, Nagarkar, Algawi, and Govari, wherein the second medical device is a nephroscope, and wherein the nephroscope includes a working channel, as taught by Tower, in order to be able to use the tracking system of Duval, Nagarkar, and Algawi, to locate a kidney stone and remove the kidney stone (Tower, Abstract).
Regarding claim 14, the modifications of Duval, Nagarkar, Algawi, Govari, and Tower disclose all the features of claim 13 above, including a nephroscope.
Tower further teaches a retrieval device configured to be delivered through the working channel (Fig. 4 and Paragraph 0053, working channel or passage 140, to deploy a separate tool or instrument such as a stone retrieval basket).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system as described by Duval, Nagarkar, Algawi, Govari, and Tower, wherein the system includes a retrieval device configured to be delivered through the working channel, as taught by Tower, in order to be able to remove/retrieve stone fragments (Tower, Paragraph 0048).
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Duval, in view of Nagarkar, further in view of Algawi, and further in view of Govari, as applied to claim 1 above, and further in view of US20200297190 to Weldon et al. “Weldon”.
Regarding claim 15, the modifications of Duval, Nagarkar, Algawi, and Govari do not disclose all the features of claim 1 above.
However, Duval, Nagarkar, Algawi, and Govari do not wherein the first medical device includes an end cap at the distal portion, wherein the end cap at least partially surrounds the first tracking element.
Weldon teaches the first medical device includes an end cap at the distal portion, and wherein the end cap at least partially surrounds the first tracking element. (See Paragraph 0008 and Fig. 5A, Cap 500).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system as described by Duval, Nagarkar, Algawi, and Govari, includes an end cap at the distal portion, and wherein the end cap at least partially surrounds the first tracking element, as taught by Weldon, in order to provide space for a distal tip of a tool (Paragraph 0008).
Claim(s) 16-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Duval, in view of Nagarkar, further in view of Tower, and further in view of Govari.
Regarding claim 16, Duval discloses a medical device (Paragraph 0041-0043, device 14; wherein further descriptions of device 14 is found in Paragraph 0025), comprising:
a handle (Paragraph 0025, recites that device 14 has hand-held controls external to the body, and thus infers a portion that is hand-held, and would read on a handle),
an insertion portion (Paragraph 0025, member 30; also see Figs. 1 and 6, Ref. 30), wherein a distal portion of the insertion portion includes a tracking element (Paragraph 0026, magnetic field sensor 36, also see Ref. 36 in Figs. 1 and 6) and at least one camera (“distal portion 32 may include…a camera, Paragraph 0025),
wherein the tracking element includes a magneto-resistive sensor (Paragraph 0013, 0026).
However, Duval does not explicitly disclose wherein the magneto-resistive sensor is a plurality of magneto-resistive sensors, and wherein the first tracking element is configured to provide a signal that indicates a position or orientation of the distal portion of the first medical device.
Nagarkar teaches a similar medical device (Paragraph 0035, Fig. 7) with a handle 106 (Paragraph 0036), a tracking element (Paragraph 0035), sensor package 10, wherein the sensor package 10 is a magneto-resistance sensor, and includes a plurality of magneto-resistance sensor chips, See Fig. 5, Ref. 48, 50, 52), and a camera (inherent in the device being an intrabody camera device, Paragraph 0035), wherein the tracking element is used for tracking a position and orientation of the device (Paragraph 0019, the EM sensors may be a one one-axis or two-axis magneto-resistance sensors configured to generate position and orientation information in the presence of an externally applied magnetic field).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system as described by Duval, wherein the first tracking element is a plurality of sensors and is configured to provide a signal that indicates a position or orientation of the distal portion of the first medical device, as taught by Nagarkar, in order to be able to determine the position and orientation of the probe (which would read on the first medical device).
Therefore, in the combination of Duval and Nagarkar, the first and second tracking element allows for determining the position and orientation of both the first and second medical device.
However, the combination of Duval and Nagarkar do not teach the handle includes a port.
Tower teaches a similar endoscopic device (Paragraph 0017) with a flexible distal portion (Abstract). Towers teaches wherein the handle includes a port (proximal end of the suction lumen 136 can connect, via a suitable connector, Paragraph 0051, wherein the connector reads on a port; and the suction lumen extends along the body 102, Paragraph 0051, which includes the handle, See Fig. 2, and as seen in Fig. 2, the proximal end of the body 102 is the proximal/bottom end of the handle; therefore the proximal end of the suction lumen would read on the on the proximal end of the handle, and therefore the handle would include the connector/port; Additionally, Tower also teaches an electrical port 124, See Fig. 2, Paragraph 0041). Tower additionally teaches that the camera (Fig. 4, Ref. 122) is located at on a substrate (Fig. 4, Ref. 116) (also see Paragraph 0039) at the distal tip (Paragraph 0024, Fig. 4 shows an end-on view of the distal tip).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system as described by Duval and Nagarkar, wherein the handle includes a port, as taught by Tower, in order to allow connection to suitable devices such as a suction or vacuum source for the connection/port to the suction lumen (Tower, Paragraph 0051), or to a power source or digital video device to receive power and to provide a wired connection between the endoscopic device and a display device (Tower, Paragraph 0041).
However, the modifications of Duval, Nagarkar, and Tower do not disclose wherein the tracking element and the pressure sensor are on a same substrate within a distal portion of the insertion portion.
Govari teaches a similar catheter configured to be inserted into a body-part of a living subject (Abstract). Govari teaches wherein the catheter includes a force sensor positioned at the distal, insertion portion (Paragraph 0093 and Fig. 9, distal tip 304 of insertion tube 302 with force sensor 312; wherein the force sensor 312 comprises the flexible circuit 110), wherein the force sensor and the first tracking element are mounted to a same substrate within the distal portion of the first medical device (Paragraph 0073 and Fig. 2, flexible-circuit 110 of the catheter 14 provide signals indicative of location and force to the processor 22 in console 24, wherein flexible circuit 110 includes substrate 112, with portions 114, 116, 130, and 142, See Paragraphs 0073-0076; Paragraph 0075 and Fig. 2, coils 118, 170, and 172 are the force sensing coils on portion 114; Paragraph 0076 and Fig. 2, coils at portion 116, including coils 120 and 128, and coils at portion 130, including coils 138 and 140 are the location coils). The force sensor of Govari would read on the claimed pressure sensor, and at minimum are capable of measuring pressure, since the force sensors senses the magnitude and a direction of the force, such as the force applied on the balloon by the heart tissue (Paragraph 00055) or forces or sub-gram forces exerted on the tip of the catheter (Paragraph 0082), and pressure is equal to such a measured force times a surface area where the force is obtained, such as a predefined area measurement of the sensor size.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system as described by Duval, Nagarkar, and Tower, wherein the medical device further includes a pressure sensor positioned at the distal portion of the medical device, wherein the pressure sensor and the tracking element are mounted to a same substrate within the distal portion of the first medical device, as taught by Govari, in order to be able to pack a force/pressure sensor and position sensor into a small inner diameter space such as that of the distal tip of a catheter (Govari, Paragraph 0072).
Further, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system as described by Duval, Nagarkar, Tower, and Govari, wherein the camera is also on the same substrate as the pressure sensor and the tracking, since as stated above, Tower teaches the camera is also on a substrate at the distal portion of the device (Tower: camera, Fig. 4, Ref. 122, is located at on a substrate, Fig. 4, Ref. 116, Paragraph 0039, at the distal tip, Paragraph 0024, Fig. 4 shows an end-on view of the distal tip). Therefore, it would have been obvious to have the camera, pressure sensor, and tracking element all on one substrate since doing so is merely combing prior art elements according to known methods to yield predictable results (See MPEP 2143.I.A), since Govari teaches the pressure sensor and tracking element are located on the same substrate, and Tower teaches the camera is also located on a substrate, and combining prior art elements would merely be combining the camera, tracking element, and pressure sensor onto one substrate.
Additionally, the combination of Duval, Nagarkar, Tower, and Govari would teach wherein the at least one camera and the pressure sensor are distal to the tracking element, since Govari teaches that the pressure sensor is distal to the tracking element (See Fig. 10D and Paragraph 0101-0102, force sensor 312 is distal of the location sensor coils 322, 324; See also Paragraph 0082 and Fig. 6, wherein the beam coupling member 190 contains first portion 114 of flexible circuit 110 and forms a force sensor sub-assembly, and wherein the beam coupling member 190 is distal of the coil segment 124, which is part of one of the location sensors) and Tower teaches the camera (Fig. 4, Ref. 122) is also located on a substrate (Fig. 4, Ref. 116) (also see Paragraph 0039) at the distal tip (Paragraph 0024, Fig. 4 shows an end-on view of the distal tip). The teaching of Tower, of the camera located at the distal tip, and not just the distal portion infers that the camera must be distal to that of the location sensor of Govari, since Govari’s location sensors are not located at the distal tip, but instead just proximal to the distal tip within what is still a distal portion.
Regarding claims 17-18, the modifications of Duval, Nagarkar, Tower, and Govari disclose all the features of claim 16 above.
As disclosed in the claim 16 rejection above, Duval teaches wherein the distal portion of the insertion portion of the first medical device includes a first tracking element (Paragraph 0026, magnetic field sensor 36, also see Ref. 36 in Figs. 1 and 6), and Govari teaches wherein the first tracking element is coupled to a substrate.
However, Duval and Govari does not teach explicitly teach wherein the substrate includes a first face and a second face, wherein the first face and the second face are arranged approximately orthogonally to each other, wherein the first tracking element includes a position sensing system that includes one or more position or orientation sensors, wherein the position sensing system includes a first magneto-resistive sensor, a second magneto-resistive sensor, and a third magneto-resistive sensor, wherein the first magneto-resistive sensor, the second magneto-resistive sensor, and the third magneto-resistive sensor are coupled to the substrate, and wherein a proximal portion of the substrate includes a plurality of contact pads.
Nagarkar teaches wherein the substrate (See Figs. 5 and 6 Ref. 42) includes a first face (face of substrate portion 44, Fig. 5) and a second face (face of substrate portion 46, See Fig. 5), wherein the first face and the second face are arranged approximately orthogonally to each other (See Fig. 5, face of portion 44 and 46 are orthogonal to each other) and wherein a proximal portion of the substrate includes a plurality of contact pads (See Fig. 1A, Ref. 20, Paragraph 0021). As see in in Fig. 5, each sensor chip circuit 24 is coupled to the substrate (either portion 44 or 46), that is labeled as 48, 50, 52 is a single axis sensor (Paragraph, 0032) where the axis is defined by the arrow indicated for each sensor circuit (See Fig. 5), and each sensor chip is a magneto-resistance sensor chip (Paragraph 0032). This reads on wherein the position sensing system includes a first magneto-resistive sensor, a second magneto-resistive sensor, and a third magneto-resistive sensor, wherein the first magneto-resistive sensor, the second magneto-resistive sensor, and the third magneto-resistive sensor are coupled to the substrate.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system as described by Duval, Duval, Nagarkar, Tower, and Govari, wherein the first face and the second face are arranged approximately orthogonally to each other, wherein the first tracking element includes a position sensing system that includes one or more position or orientation sensors, wherein the position sensing system includes a first magneto-resistive sensor, a second magneto-resistive sensor, and a third magneto-resistive sensor, wherein the first magneto-resistive sensor, the second magneto-resistive sensor, and the third magneto-resistive sensor are coupled to the substrate, and wherein a proximal portion of the substrate includes a plurality of contact pads, as taught by Nagarkar, in order to be able to use a plurality of 1 axis sensor chips to form a magneto-resistance sensor package such that the magneto-resistance sensor package can measure in three directions (Nagarkar, Paragraph 0032).
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Duval, in view of US2023/0097906 to Shelton, IV et al. “Shelton”, and further in view of Govari.
Regarding claim 19, Duval teaches a method (Title), comprising:
delivering a first medical device into a subject (advancing a first device through a first body lumen, Paragraph 0006), wherein the first medical device includes a handle (Paragraph 0025, recites that device 14 has hand-held controls external to the body, and thus infers a portion that is hand-held, and would read on a handle) and an insertion portion (Paragraph 0025, member 30; also see Figs. 1 and 6, Ref. 30),
wherein a distal portion of the insertion portion includes a camera (“distal portion 32 may include…a camera, Paragraph 0025) and a tracking element (Paragraph 0026, magnetic field sensor 36, also see Ref. 36 in Figs. 1 and 6), and wherein the tracking element includes one or more magneto-resistive sensors (Paragraph 0013, magnetic field sensor may be a magneto-resistive sensor);
delivering the distal portion of the insertion portion the first medical device into a body lumen or body cavity of the subject (advancing a first device through a first body lumen, Paragraph 0006);
identifying and/or mapping one or more objects within the body lumen or the body cavity with the camera (Paragraph 0043, illumination portions of the body to identify interests).
However, Duval does not disclose the insertion portion includes a working channel, and determining whether the one or more objects can be removed from the body lumen or body cavity with the working channel of the first medical device; upon determining that the one or more objects cannot be removed with the working channel of the first medical device, providing a proposed access path for a second medical device to the body lumen or body cavity of the subject; aiming and inserting the second medical device to the body lumen or the body cavity of the subject; tracking a position of the second medical device within the subject; and removing or otherwise treating the one or more objects within the body lumen or body cavity with the second medical device.
Shelton teaches the insertion portion includes a working channel (Paragraph 0229, endoscope with a working channel) and determining whether the one or more objects can be removed from the body lumen or body cavity with the working channel of the first medical device (predicting the size, location, shape, orientation of a tumor or other critical structure, Paragraph 00244; Paragraph , from imaging data to determine removal process);
upon determining that the one or more objects cannot be removed with the working channel of the first medical device, providing a proposed access path for a second medical device to the body lumen or body cavity of the subject (from the second imaging device, which reads on the first imaging device, determining anatomic aspects, and facilitate the positioning of the at least one instrument at the surgical site, Paragraph 0241);
aiming and inserting the second medical device to the body lumen or the body cavity of the subject (guiding a second surgical instrument, Paragraph 0007);
tracking a position of the second medical device within the subject (Paragraph 0291, detecting the location of the flexible location scope base on the signal between the flexible scope and the rigid scope)
removing or otherwise treating the one or more objects within the body lumen or body cavity with the second medical device (treating the region using the flexible scope 1295, while under the view of scope 1298, through the release of a ablation device through the working channel of scope 1295, and would read on the insertion portion includes a working channel).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system as described by Duval, wherein the insertion portion includes a working channel, and the method includes determining whether the one or more objects can be removed from the body lumen or body cavity with the working channel of the first medical device; upon determining that the one or more objects cannot be removed with the working channel of the first medical device, providing a proposed access path for a second medical device to the body lumen or body cavity of the subject; aiming and inserting the second medical device to the body lumen or the body cavity of the subject; tracking a position of the second medical device within the subject; and removing or otherwise treating the one or more objects within the body lumen or body cavity with the second medical device, as taught by Shelton, in order to collocate the treatment site using two endoscopic devices for better localization, deliver
the treatment device via the working channel (Paragraph 0308), and locally visualize the treatment and monitor for inadvertent damage (Paragraph 0310).
However, the modifications of Duval and Shelton do not disclose wherein the first medical device further includes a pressure sensor positioned at the distal portion of the first medical device, wherein the pressure sensor and the first tracking element are mounted to a same substrate within the distal portion of the first medical device.
Govari teaches a similar catheter configured to be inserted into a body-part of a living subject (Abstract). Govari teaches wherein the catheter includes a force sensor positioned at the distal, insertion portion (Paragraph 0093 and Fig. 9, distal tip 304 of insertion tube 302 with force sensor 312; wherein the force sensor 312 comprises the flexible circuit 110), wherein the force sensor and the first tracking element are mounted to a same substrate within the distal portion of the first medical device (Paragraph 0073 and Fig. 2, flexible-circuit 110 of the catheter 14 provide signals indicative of location and force to the processor 22 in console 24, wherein flexible circuit 110 includes substrate 112, with portions 114, 116, 130, and 142, See Paragraphs 0073-0076; Paragraph 0075 and Fig. 2, coils 118, 170, and 172 are the force sensing coils on portion 114; Paragraph 0076 and Fig. 2, coils at portion 116, including coils 120 and 128, and coils at portion 130, including coils 138 and 140 are the location coils). The force sensor of Govari would read on the claimed pressure sensor, and at minimum are capable of measuring pressure, since the force sensors senses the magnitude and a direction of the force, such as the force applied on the balloon by the heart tissue (Paragraph 00055) or forces or sub-gram forces exerted on the tip of the catheter (Paragraph 0082), and pressure is equal to such a measured force times a surface area where the force is obtained, such as a predefined area measurement of the sensor size.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system as described by Duval and Shelton, wherein the first medical device further includes a pressure sensor positioned at the distal portion of the first medical device, wherein the pressure sensor and the first tracking element are mounted to a same substrate within the distal portion of the first medical device, as taught by Govari, in order to be able to pack a force/pressure sensor and position sensor into a small inner diameter space such as that of the distal tip of a catheter (Govari, Paragraph 0072).
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Duval, in view of Shelton, and further in view of Govari, as applied to claim 19 above, and further in view of US20190298300 to “Lu”.
Regarding claim 20, the modifications of Duval, Shelton, and Govari disclose all the features of claim 19 above.
However, the modifications of Duval and Shelton do not disclose preparing the subject for a procedure by performing one or more of an ultrasound, a CT scan, or an MRI scan of a kidney of the subject; and before providing the access path for the second medical device, overlaying one or more aspects of the kidney or one or more kidney stones on the subject.
Lu teaches using Doppler ultrasound (Paragraph 0004) and overlaying the imaging data with B0 mode image data in a kidney stone detection interface (Paragraph 0004, 0029).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system as described by Duval and Shelton, preparing the subject for a procedure by performing one or more of an ultrasound, a CT scan, or an MRI scan of a kidney of the subject; and before providing the access path for the second medical device, overlaying one or more aspects of the kidney or one or more kidney stones on the subject, as taught by Lu, in order to be able to determine the location of the kidney stones (Paragraph 0036).
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-20 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. Applicant’s arguments are directed toward prior art to Tah, which was previously used to teach the pressure sensor. However, applicant amend the independent claims to include newly supported limitations of the pressure sensor and the tracking element being mounted on the same substrate which is taught by newly found prior to Govari and addressed above.
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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/MT/Examiner, Art Unit 3798
/KEITH M RAYMOND/Supervisory Patent Examiner, Art Unit 3798
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