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 .
Applicant’s arguments filed in the reply on April 26, 2026 were received and fully considered. Claims 1, 5, 13, and 17 were amended. Please see below for more detail.
Claim Objections
The Claims are objected to because of the following informalities:
In Claim 1, lines 5-7, the term “an optical fiber having a plurality of core fibers, each core fiber including a plurality of fiber sensors distributed along a longitudinal length of of the core fiber” should be replaced with -- an optical fiber having a plurality of core fibers, each core fiber including a plurality of fiber sensors distributed along a longitudinal length of [[of]] the core fiber -- to address a typographical error.
Appropriate correction is required and applicant should carefully review the Claims for any other informalities.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-18 and 29-30 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Regarding Claim 1, the claim(s) recites “performing the machine-learning model to determine how closely the combination of the magnetic element positions with the wavelength shifts correlates with one or more of the historical locations of the medical device and thereby determine the location of the medical device within the vasculature” which amounts to an abstract idea (mental process).
This judicial exception is not integrated into a practical application because:
- The claims fail to outline an improvement to the technical field.
- The claims fail to apply the judicial exception to effect a particular treatment.
- The claims fail to apply the judicial exception with a particular machine.
- The claims fail to effect a transformation or reduction of a particular article to a different state or thing.
Next, the claim as a whole is analyzed to determine whether any element or a combination of elements, integrates judicial exception into a practical application.
For this part of the 101 analysis, the following additional limitations are considered:
“(i) reflect a light signal of a different spectral width based on received incident light, and (ii) define wavelength shifts of the reflected light signal based on strain experienced by the core fiber;”
“each magnetic element defining a magnetic field configured to indicate a position of the magnetic element in three-dimensional space;”
“detect one or more magnetic fields defined by one or more of the plurality of magnetic elements,”
“provide electrical signals in accordance with the detection of the one or more magnetic fields;”
“providing an incident light signal to the optical fiber;
receiving reflected light signals of different spectral widths from the plurality of fiber sensors;
processing the wavelength shifts of the reflected light signals to determine a shape of the optical fiber;
receiving the electrical signals from the magnetic field sensor;
processing the electrical signals to determine magnetic element positions of the plurality of magnetic elements with respect to the magnetic field sensor;”
“defining a combination of the magnetic element positions with the wavelength shifts,”
“the logic includes a machine-learning model trained using different historical locations of the medical device within the vasculature, each location paired with a respective combination of magnetic element locations and wavelength shifts,”
The additional elements are insufficient to amount to significantly more than the judicial exception because they seem to merely generally link the use of the judicial exception to a particular technological environment.
Moreover, the claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because they pertain merely to insignificant extrasolution data gathering activities.
Furthermore, optical fibers, fiber sensors, magnetic elements, and magnetic field sensors are general fields of use and processors and non-transitory computer-readable mediums are generic computer elements used to perform generic computer functions and don’t add significantly more and are well-understood, routine, and previously known to the industry.
None of these limitations, considered as an ordered combination provide eligibility because the claim taken as a whole, does not amount to significantly more than the underlying abstract idea of evaluating the combined inputs of reflected light signals associated with one or more core fibers, positions of the one or more of the plurality of magnetic elements, and historical locations to determine a location of the medical device within the patient body and does not purport to improve the functioning of the signal processing, or to improve any other technology or technical field. Use of a generic signal processing does not amount to significantly more than the abstract idea itself.
Dependent claims 2-18 and 29-30 also do not recite patent eligible subject matter as they merely further limit the abstract idea, recite limitations that do not integrate the claims into a practical application for similar reasons as set forth above, and/or do not recite significantly more than the identified abstract idea for substantially similar reasons as set forth above.
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.
Claim(s) 1, 7-8, 11, and 15-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tegg et al (US 2021/0282867) (“Tegg”) in view of Soper et al (US 2005/0182295) (“Soper”) and further in view of Tojo et al (US 2019/0231444) (“Tojo”) and further in view of Camarillo et al (US 2020/0297444) (“Camarillo”).
Regarding Claim 1, while Tegg teaches a medical system for detecting placement of a medical device within a patient body (Abstract, Figs. 1-2, 4, and 7), the system comprising:
the medical device disposed within a vasculature of the patient body (Figs. 1-5 and 8, [0020] “During a surgical procedure, the distal end 106 is placed within a region of interest within a patient—for example, within the vasculature of the patient—and navigated to a desired location within the body by a physician/technician via controls located on handle 108.” [0026]-[0027]) the medical device comprising:
an optical fiber having a plurality of core fibers (Figs. 1-4, [0019], [0022] fiber core cable 112, [0027] a multi-core fiber, [0033] is an example of the system with a plurality of core fibers 400a-400f),
each core fiber including a plurality of fiber sensors distributed along a longitudinal length of the core fiber (Figs. 3-4, [0027] multi-core fiber 206 where a plurality of optical sensors 300a, 300b, 300c, are included with the core fibers of the multi-core fiber 206, [0035] “As described above, in some embodiments, rather than locating the one or more optical sensors 300a, 300b, 300c (e.g., FBG) at a particular location along the length of the multi-core fiber—for example as part of the ablation tip 202 shown in FIGS. 2 and 3—one or more of the fiber cores 402a-402g may include a plurality of FBGs located along an axial length of the fiber core. For example, fiber core 400a may include a plurality of FBGs, each defined by a unique grating period. In some embodiments the plurality of FBGs are located adjacent one another (e.g., stacked end-to-end), with little or no gap between the adjacent FBGs. Each FBG provides feedback regarding the forces exerted on the FBG, wherein stacking a plurality of FBGs end-to-end provides shape information for a longer length of the catheter 102.” Each core fiber may include a plurality of fiber optical sensors, here Fiber Bragg Gratings, distributed along a longitudinal length of the corresponding core fiber) and each fiber sensor of the plurality of fiber sensors being configured to (i) reflect a light signal of a different spectral width based on received incident light, and (ii) define wavelength shifts of the reflected light signal based on strain experienced by the core fiber ([0027]-[0028] FBGs detect strain experienced by the optical fiber by changing a characteristic of reflected light corresponding to the strain experienced by the optical fiber, Fiber Bragg Gratings are capable of reflecting light signals of different spectral widths by their reflective capability, [0029] as recognized by defined wavelength shifts); and
a pair of magnetic sensors disposed along a longitudinal length of the medical device, detect one or more magnetic fields defined by one or more magnetic elements, and provide electrical signals in accordance with the detection of the one or more magnetic fields (Fig. 5, [0021], [0026] magnetic sensors 210a and 210b, disposed along a longitudinal length of the medical device, and measures in response to externally created magnetic field to indicate a position in three-dimensional space of the medical device);
one or more magnetic elements configured to:
define a magnetic field configured to indicate a position of the medical device in three-dimensional space ([0021] magnetic transmitter assembly 127 generates magnetic field);
a console coupled with the optical fiber and the magnetic field sensors, the console including one or more processors and a memory having stored thereon logic, when executed by the one or more processors (Fig. 1, [0020]-[0022] computer system 116 connects to magnetic sensors 210a, 210b and optical sensors [0024], [0043] processor and memory with instructions for performing the operations of the invention), causes operations including:
providing an incident light signal to the optical fiber ([0019], [0028], [0047]-[0048]);
receiving reflected light signals of different spectral widths from the plurality of fiber sensors ([0019], [0028]-[0029], [0047]-[0048]);
processing the wavelength shifts of the reflected light signals to determine a shape of the optical fiber ([0028]-[0029], [0047]-[0048]);
receiving the electrical signals from the magnetic field sensors ([0025]-[0026], [0047]-[0048]);
processing the electrical signals to determine the magnetic sensor’s positions of the one or more of the pair of magnetic field sensors with respect to the magnetic field generator ([0025]-[0026], [0047]-[0048]); and
defining a combination of the magnetic sensor positions with the wavelength shifts ([0025] “In some embodiments, a registration process is utilized to register the optical sensor with the magnetic sensor and generate the transformation coefficients utilized to convert positions from the optical reference frame to the magnetic reference frame. Based on the optical sensor data, the position of the magnetic sensor within the magnetic reference frame, and the stored transformation coefficients, the optical localization module 132 generates an output providing the location, orientation and/or shape of the optical sensor within the magnetic reference frame.” Shape of the optical sensor, identified from wavelength shifts in the FBG sensors, is combined with the position of the magnetic sensors in the magnetic reference frame),
Tegg fails to teach the system comprising:
the medical device comprising:
a plurality of magnetic elements disposed along a longitudinal length of the medical device, each magnetic element defining a magnetic field configured to indicate a position of the magnetic element in three-dimensional space;
a magnetic field sensor configured to:
detect one or more magnetic fields defined by one or more of the plurality of magnetic elements, and
the operations including:
processing the electrical signals to determine the magnetic element positions of the plurality of magnetic elements with respect to the magnetic field sensor.
wherein:
the logic includes a machine-learning model trained using different historical locations of the medical device within the vasculature, each location paired with a respective combination of magnetic element locations and wavelength shifts, and
the operations further include performing the machine-learning model to determine how closely the combination of the magnetic element positions with the wavelength shifts correlates with one or more of the historical locations of the medical device and thereby determine the location of the medical device within the vasculature.
However Soper teaches a medical system for detecting placement of a medical device within a patient body (Figs. 1A, 7A-7C, Abstract, [0058]-[0065]), the system comprising:
the medical device (Figs. 1A and 7B, [0063] flexible endoscope that passes within a patient body, where the flexible endoscope utilizes both optical fiber scanning 48 and electromagnetic position tracking 52, [0103] flexible endoscope) comprising a first embodiment and a second embodiment (Figs. 7A-7B, [0102]-[0103]), where the first embodiment of the medical device comprises
an optical fiber having a plurality of core fibers (Fig. 1E, [0063]-[0064], [0074]),
a single magnetic sensor disposed on the medical device, the magnetic sensor detecting one or more magnetic fields and providing electrical signals in accordance with the detection of the one or more magnetic fields (Fig. 7A, 9A, [0102], [0104]-[0105] a magnetic field sensor / internal magnetic sensor 278, a plurality of magnetic sensor sub-units / coils 406a-406c are disposed on the medical device / flexible endoscope, which is specifically shown as sensor 402 in Fig. 9A);
a single magnetic element configured to
defining a magnetic field configured to indicate a position of the magnetic element in three-dimensional space ([0102], [0104]-[0105] magnetic element / external electromagnetic field transmitter 276, a plurality of magnetic sub-elements / coils 404a-404c are disposed externally from the body, each magnetic sub-element / coil make up the external electromagnetic transmitter 276 and define a magnetic field configured to indicate a position of the magnetic element in three-dimensional space, which is specifically shown as electromagnetic field transmitter 400 in Fig. 9A),
and a second embodiment of the medical device comprises
a magnetic element disposed on the medical device, each magnetic element defining a magnetic field configured to indicate a position of the medical element in three-dimensional space (Figs. 7B, 9A, [0103]-[0105] magnetic element / internal electromagnetic field transmitter 290, a plurality of magnetic sub-elements / coils 404a-404c are disposed on the medical device / flexible endoscope, each magnetic sub-element / coil make up the internal electromagnetic transmitter 290 and define a magnetic field configured to indicate a position of the medical element in three-dimensional space, which is specifically shown as electromagnetic field transmitter 400 in Fig. 9A);
a magnetic field sensor (Fig. 7B, 9A, [0103]-[0105] a magnetic field sensor / external sensor 292, a plurality of magnetic sensor sub-units / coils 406a-406c are disposed on the medical device / flexible endoscope, which is specifically shown as sensor 402 in Fig. 9A) configured to
detect one or more magnetic fields defined by one or more of the plurality of magnetic elements ([0103]-[0105]), and
provide electrical signals in accordance with the detection of the one or more magnetic fields ([0103]-[0105]),
where either embodiment of electromagnetic position tracking can be equivalently applied ([0104])
and where the operation of the system comprises:
processing the electrical signals to determine the magnetic element positions of the plurality of magnetic elements with respect to the magnetic field sensor ([0069] coordination between magnetic elements transmitting magnetic field and magnetic sensor sensing magnetic field used to find positional relationship between magnetic elements),
and Soper further teaches applying models to improve position tracking by the medical device (Abstract, [0009], [0115]) and applying historical locations of the medical device as contextual information to improve tracking within the body ([0098] navigation in a performed procedure compared to previous procedures to evaluate completeness, [0109] create a dynamic model of breathing in relation to medical tracking to account for position changes due to breathing, [0114] perform periodic recalibrations to create navigation histories for future use).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to switch the positioning of the magnetic field generating elements and the magnetic field sensing elements of Tegg for the purpose of localizing medical equipment as taught by Soper as Soper teaches that both configurations are suitable for position information tracking ([0102]-[0105]). Further, it would have been obvious to consider historical locations of the medical device and modeling of Tegg within the vasculature as taught by Soper as this improves accuracy by accounting for confounding factors such as breathing.
Yet their combined efforts fail to teach the system comprising:
the medical device comprising a plurality of magnetic elements disposed along a longitudinal length of the medical device, and
the logic for the operations of the system provided by a non-transitory computer-readable medium.
However Tojo teaches an electromagnetic-based tracking system for an endoscope (Abstract) comprising the use of a plurality of magnetic elements disposed along a longitudinal length of an endoscope medical device used along with an external magnetic field sensor configured for position tracking (Fig. 1, [0040]-[0041] a plurality of magnetic elements / transmission coils 28 are disposed along a length of a medical device / endoscopic scope 12, with position tracking enabled by an external reception antenna 30) and further teaches the instructions for the system are provided by a non-transitory computer-readable medium ([0006]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have the added internal magnetic element of Tegg and Soper be a plurality of magnetic elements disposed along a longitudinal length of the medical device as taught by Tojo as a way to provide higher sensitivity to the system by tracking multiple positions of Tegg’s medical device along with the shape sensing provided by the optical fiber sensing. Further, it would have been obvious to include the instructions of Tegg and Soper as non-transitory computer readable media as taught by Tojo as a specific example of how the instructions may be provided within a memory, enabling invention consistency across applications.
Yet their combined efforts fail to teach the system comprising:
wherein:
the logic includes a machine-learning model trained using different historical locations of the medical device within the vasculature, each location paired with a respective combination of magnetic element locations and wavelength shifts, and
the operations further include performing the machine-learning model to determine how closely the combination of the magnetic element positions with the wavelength shifts correlates with one or more of the historical locations of the medical device and thereby determine the location of the medical device within the vasculature.
However Camarillo teaches a position-tracking medical instrument within a luminal network of a subject (Abstract) where the position tracking is performed by a machine learning approach with inputs from both fiber Bragg grating optical sensors and a magnetic position tracking system ([0054], [0063], [0072], [0116], [0118]) where the network can be trained using different historical locations ([0138]-[0140] neural network may be trained based on the organ of a human cadaver, [0146] where shape data and position data can also be processed with historical locations of the medical device during a current procedure to estimate current position) and Camarillo further teaches that the system may be applied within the vascular system of a subject ([0066]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to apply a machine learning model as taught by Camarillo, utilizing a combination of magnetic element position data, optical shape data, and historical location data, to achieve the position tracking of Tegg, Soper, and Tojo as machine learning provides a specific way to combine the dual data sources of Tegg that benefit from a model like in Tojo, and advantageously further considers historical locations of a medical achieve to achieve an optimal position tracking outcome. Finally, it would be obvious from Tegg that the optical shape data could be input as wavelength shifts.
Regarding Claim 7, Tegg, Soper, Tojo, and Camarillo teach the system according to claim 1, wherein at least one of the plurality of magnetic elements is disposed at a distal tip of the medical device (See Claim 1 Rejection, Tegg shows magnetic structure at tip and Tojo shows at least one magnetic element 28 at the distal tip).
Regarding Claim 8, Tegg, Soper, Tojo, and Camarillo teach the system according to claim 1, wherein the magnetic field sensor is applied to a chest of the patient (See Claim 1 Rejection, Soper Fig. 7B, shows the magnetic field sensor 292 applied to a chest of the patient).
Regarding Claim 11, Tegg, Soper, Tojo, and Camarillo teach the system according to claim 1, wherein one or more of the plurality of magnetic elements are electro-magnets (See Claim 1 Rejection, Soper [0103]).
Regarding Claim 15, Tegg, Soper, Tojo, and Camarillo teach the system according to claim 1, and Tegg teaches wherein the medical device is one of an introducer wire, a guidewire, a stylet, a stylet within a needle, a needle with the optical fiber inlayed into a cannula of the needle or a catheter with the optical fiber inlayed into one or more walls of the catheter (See Claim 1 Rejection, [0038] catheter 102 with optical fiber inlayed into one or more walls of the catheter by fiber tube supports 304, 306, and 308).
Regarding Claim 16, Tegg, Soper, Tojo, and Camarillo teach the system according to claim 1, and Tegg teaches wherein each of the plurality of fiber sensors is a reflective grating, where each reflective grating alters its reflected light signal by applying a wavelength shift dependent on a strain experienced by the reflective grating (See Claim 1 Rejection, Fiber Bragg Graff reflective grating)
Claim(s) 2-5 and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tegg in view of Soper and further in view of Tojo and further in view of Camarillo and further in view of Duval et al (US 2020/0129318) (“Duval”).
Regarding Claim 2, while Tegg, Soper, Tojo, and Camarillo teach the system according to claim 1, their combined efforts fail to teach wherein each magnetic element is longitudinally shaped having a magnetic pole at each, the magnetic poles defining a magnetic field in accordance with an orientation of the magnetic element.
However Duval teaches magnetic field based localization system (Abstract) comprising a cylindrical magnet with a magnetic pole at each end of the magnet (Fig. 3B, [0030], [0035]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to set the longitudinally spaced magnetic elements of Tojo as cylindrically-shaped magnets as taught by Duval as a simple substitution of one form of magnet structure for magnetic tracking with a medical device (Tojo: using coils) for another form of magnet structure for magnetic tracking with a medical device (Duval: using a cylinder) to obtain the predictable results of tracked relationship between changing magnetic fields and changing measurements of the magnetic fields. Furthermore, it would obvious that cylindrical magnets would have magnetic poles at each end as this an inherent relationship between magnetic poles within a cylindrical structure.
Regarding Claim 3, Tegg, Soper, Tojo, Camarillo, and Duval teach the system according to claim 2, wherein a longitudinal axis of each magnetic element is aligned with a longitudinal axis of the medical device (See Claim 2 Rejection, Tegg’s magnetic sensors, Soper’s position sensor in Fig. 1B, and Tojo’s coils are all shown as longitudinally aligned).
Regarding Claim 4, Tegg, Soper, Tojo, Camarillo, and Duval teach the system according to claim 2, and Tegg further teaches wherein the operations further include processing the electrical signals to determine an orientation of a magnetic element with respect to a magnetic field sensor ([0021]), Soper confirms applicability to an internal magnetic element system (See Claims 1 and 2 Rejection, [0103]), where multiple magnetic elements will have their position and orientation tracked (See Claim 2 Rejection, Tojo).
Regarding Claim 5, Tegg, Soper, Tojo, Camarillo, and Duval teach the system according to claim 4, wherein the operations further include processing the orientations of the magnetic elements to determine an orientation of the medical device within the patient body (See Claim 4 Rejection, Tegg [0022] magnetic-based system and optical fiber sensing provides position, orientation, and shape information for the catheter with Camarillo [0119] confirming their combined use increases accuracy of location and orientation tracking a medical instrument).
Regarding Claim 9, while Tegg, Soper, Tojo, and Camarillo teach the system according to claim 1, their combined efforts fail to teach wherein one or more of the plurality of the magnetic elements are permanent magnets.
However Duval teaches magnetic field based localization system (Abstract) comprising a comprising a permanent magnet as the magnet in the distal tip of a tracking system ([0024], [0030])
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, that the magnetic elements of Tegg, Soper, Tojo, and Camarillo be set as permanent magnets as taught by Duval as a simple substitution of one form of magnet for internal magnetic field tracking (Soper: dipole transmitter) for another (Duval: electromagnet) to obtain predictable results of accurately assessed magnet location.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tegg in view of Soper and further in view of Tojo and further in view of Camarillo and further in view of Huelman et al (US 2016/0220314) (“Huelman”).
Regarding Claim 6, while Tegg, Soper, Tojo, and Camarillo teach the system according to claim 1, their combined efforts fail to teach wherein each magnet is shaped of a hollow cylinder, and wherein the optical fiber is disposed within the hollow cylinder.
However Huelman teaches a surgical guidance system based on emitting a magnetic field from internal medical device (Abstract, [0035]-[0036]) comprising a magnet shaped as a hollow cylinder ([0046] where this shape allows passage of material through the magnet).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, that the implanted magnetic elements emitting a field taught by Soper can be shaped as hollow as taught by Huelman as it enables the optical fiber to pass between the magnetic elements. Such a structure ensures the position, shape, and orientation changes in the medical instrument will be equivalently applied to both sensing modalities.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tegg in view of Soper and further in view of Tojo and further in view of Camarillo and further in view of Toyoda et al (US 2004/0143183) (“Toyoda”).
Regarding Claim 10, while Tegg, Soper, Tojo, and Camarillo teach the system according to claim 1, their combined efforts fail to teach wherein one or more of the plurality of the magnetic elements are formed of a ferrous material.
However Toyoda teaches position detection of a medical insertion tool (Abstract) using magnetic field processing and teaches that a magnetic field generating component may be formed of a ferrous material (Abstract).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, that the magnetic elements of Tegg, Soper, Tojo, and Camarillo can be formed of a ferrous material as taught by Toyoda as a standardized structure that can be applied across applications of the invention, ensuring consistency across applications.
Claim(s) 12-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tegg in view of Soper and further in view of Tojo and further in view of Camarillo and further in view of Ludwin et al (US 2017/0065353) (“Ludwin”).
Regarding Claim 12, while Tegg, Soper, Tojo, and Camarillo teach the system according to claim 11, their combined efforts fail to teach wherein one or more of the plurality of magnetic elements are configured to sense a magnetic field.
However Ludwin teaches a tracking system for a medical device (Abstract) utilizing magnetic fields ([0022]) and teaches that magnetic elements in the system can be configured to both sense a magnetic field and generate a magnetic field ([0034]-[0036] external coils that are part of a magnetic field generation can also be configured to sense the fields and internal catheter components comprise both a location sensor and magnetic field generator).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, that the two configurations of Soper with one embodiment with an external magnetic field generation and internal magnetic field detection and the second configuration with an internal magnetic field generation and external magnetic field detection can reflect functionality of a single system as taught by Ludwin as this enables the system to have more flexibility. Specifically, the generation of a magnetic field can interfere with other devices and so providing control of where the magnetic field generates provides protection against that by the medical provider.
Regarding Claim 13, while Tegg, Soper, Tojo, and Camarillo teach the system according to claim 11, their combined efforts fail to teach wherein one or more of the plurality of magnetic elements are configured to selectively define a magnetic field and sense a magnetic field.
However Ludwin teaches a tracking system for a medical device (Abstract) utilizing magnetic fields ([0022]) and teaches that magnetic elements in the system can be configured to both sense a magnetic field and generate a magnetic field ([0034]-[0036] external coils that are part of a magnetic field generation can also be configured to sense the fields and internal catheter components comprise both a location sensor and magnetic field generator).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, that two configurations of Soper with one embodiment with an external magnetic field generation and internal magnetic field detection and the second configuration with an internal magnetic field generation and external magnetic field detection can reflect functionality of a single system as taught by Ludwin as this enables the system more flexibility. Specifically, the generation of a magnetic field can interfere with other devices and so providing control of where the magnetic field generates provides protection against that by the medical provider.
Regarding Claim 14, while Tegg, Soper, Tojo, and Camarillo teach the system according to claim 1, their combined efforts fail to teach wherein the magnetic field sensor includes one or more magnetic elements configured to define a magnetic field.
However Ludwin teaches a tracking system for a medical device (Abstract) utilizing magnetic fields ([0022]) and teaches that magnetic elements in the system can be configured to both sense a magnetic field and generate a magnetic field ([0034]-[0036] external coils that are part of a magnetic field generation can also be configured to sense the fields and internal catheter components comprise both a location sensor and magnetic field generator).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, that the two configurations of Soper with one embodiment with an external magnetic field generation and internal magnetic field detection and the second configuration with an internal magnetic field generation and external magnetic field detection can reflect functionality of a single system as taught by Ludwin as this enables the system more flexibility. Specifically, the generation of a magnetic field can interfere with other devices and so providing control of where the magnetic field generates provides protection against that by the medical provider.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tegg in view of Soper and further in view of Tojo and further in view of Camarillo and further in view of Cox et al (US 2011/0015533) (“Cox”).
Regarding Claim 17, while Tegg, Soper, Tojo, and Camarillo teach the system according to claim 1, their combined efforts fail to teach
receiving an ECG signal from an ECG electrode disposed at the distal tip;
processing the ECG signal to determine a position of the ECG electrode within the superior vena cava; and
combining the ECG signal with the shape of the optical fiber and the positions of the plurality of magnetic elements to determine the position of the medical device within the patient body.
However Cox teaches a magnetic-field based localization system (Abstract, Figs. 1-2 and 5, [0126]-[0131]) comprising
a medical device comprising:
a plurality of magnetic elements disposed along a longitudinal length of the medical device, each magnetic element defining a magnetic field configured to indicate a position of the magnetic element in three-dimensional space ([0126]-[0131] stylet 100 / medical device comprising a plurality of magnetic elements 106 disposed along a longitudinal length of the medical device as seen in Fig. 5, [0130] each magnetic element defining a magnetic field configured to indicate a position of the magnetic element in three-dimensional space);
a magnetic field sensor ([0002], [0126]-[0131] tip location system (“TLS”) sensor 50) configured to:
detect one or more magnetic fields defined by one or more of the plurality of magnetic elements ([0130]), and
provide electrical signals in accordance with the detection of the one or more magnetic fields ([0130]);
wherein the operations of the system include:
receiving an ECG signal from an ECG electrode disposed at the distal tip ([0111] an ECG-based guidance can be applied in addition to magnetic field guidance for higher accuracy, [0137] ECG sensor assembly disposed at the distal tip for sensing ECG signal);
processing the ECG signal to determine a position of the ECG electrode ([0137]) within the superior vena cava ([0115], [0163] where the desired position may be within the superior vena cava); and
combining the ECG signal with other sensing modalities of the medical device and the positions of the one or more of the plurality of magnetic elements to determine the position of the medical device within the patient body ([0111]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, that the magnetic-field and optical fiber shape processing of Tegg, Soper, Tojo, and Camarillo be combined with the above ECG processing as taught by Cox to increase positioning accuracy (Cox: [0111]). Furthermore, it would be obvious that the already present, third sensing modality of optical fiber shape sensing from Tegg, Soper, Tojo, and Camarillo would provide the increased accuracy and could thus obviate the need for ultrasound.
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tegg in view of Soper and further in view of Tojo and further in view of Camarillo and further in view of Malinin et al (US 2016/0367323) (“Malinin”).
Regarding Claim 18, while Tegg, Soper, Tojo, and Camarillo teach the system according to claim 1, and Soper teaches wherein a body function measuring sensor may be coupled to the patient’s body ([0041]), and applying a magnetic field sensor at a patient’s chest (Fig. 7B), their combined efforts fail to explicitly teach the magnetic field sensor is coupled to the patient body.
However Malinin teaches a medical instrument tracking system (Abstract) comprising a body function measuring sensor that couples to the patient’s chest and generates data based on characteristics of a detected magnetic field ([0023]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, that the system of Tegg, Soper, Tojo, and Camarillo can utilize two magnetic field sensors with one acting as the body function measuring sensor already present in Soper and one acting as the static magnetic field sensor as Malinin confirms that a patient reference sensor in Soper can also function based on magnetic-field measuring. Further, applying this teaching from Soper provides comparison data with which to identify respiration movement and/or movement of the patient’s entire body.
Claim(s) 29-30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tegg in view of Soper and further in view of Tojo and further in view of Camarillo and further in view of Chav (US 2021/0128250).
Regarding Claim 29, while Tegg, Soper, Tojo, and Camarillo teach the system according to claim 1, their combined efforts fail to teach wherein a subset of the plurality of fiber sensors are disposed longitudinally between adjacent ones of the plurality of magnetic elements.
However Chav teaches a position tracking instrument (Abstract) utilizing electromagnetic sensing and a multicore optical fiber (Fig. 6, [0107]-[0109]) wherein a subset of the plurality of fiber sensors are between adjacent ones of the plurality of magnetic sensors in the longitudinal direction ([0107]-[0109], [0117] fiber Bragg grating sensors 196 are shown longitudinally between adjacent ones of the plurality of magnetic elements / EM sensor 141).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to apply the structural teaching wherein a subset of the plurality of fiber sensors are disposed longitudinally between adjacent ones of the plurality of magnetic units as taught by Chav to the system of Tegg, Soper, Tojo, and Camarillo as a specific teaching on how the multicore optical fibers shown in Fig. 4 can be oriented with the multiple magnetic units taught by Tojo on the same medical instrument as taught by Soper. This enables a consistency in construction and thus consistency in measurements across applications of the invention. Furthermore, this teaching would remain applicable when switching the magnetic sensors for magnetic field generating elements as outlined in the rejections above.
Regarding Claim 30, while Tegg, Soper, Tojo, and Camarillo teach the system according to claim 1, wherein: the plurality of magnetic elements includes at least three magnetic elements, and adjacent magnetic elements include fiber sensors disposed longitudinally therebetween.
However Chav teaches a position tracking instrument (Abstract) utilizing electromagnetic sensing and a multicore optical fiber (Fig. 6, [0107]-[0109]) wherein: the plurality of magnetic elements includes at least three magnetic sensors, and adjacent magnetic sensors include fiber sensors disposed therebetween in a longitudinal direction ([0107]-[0109], [0117] fiber Bragg grating sensors 196 are shown longitudinally between adjacent ones of the plurality of magnetic elements / EM sensor 141, where there are over three EM sensors 141).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to apply the structural teaching wherein a subset of the plurality of fiber sensors are disposed longitudinally between adjacent ones of the plurality of magnetic units as taught by Chav to the system of Tegg, Soper, Tojo, and Camarillo as a specific teaching on how the multicore optical fibers shown in Fig. 4 can be oriented with the multiple magnetic units taught by Tojo on the same medical instrument as taught by Soper. This enables a consistency in construction and thus consistency in measurements across applications of the invention. Furthermore, this teaching would remain applicable when switching the magnetic sensors for magnetic field generating elements as outlined in the rejections above.
Response to Arguments
Applicant’s amendments and arguments filed 4/26/2026 with respect to the claim objection have been fully considered and are persuasive. The objection(s) is/are withdrawn.
Applicant’s amendments and arguments filed 4/26/2026 with respect to the 35 USC 101 rejection have been fully considered, but are not persuasive. Applicant argues that the amended language includes a large number of calculations that cannot be performed during a medical procedure of inserting the medical device within a vasculature within a patient body. Examiner respectfully disagrees. Examiner notes that a minimum number of the plurality of core fibers and the plurality of fiber sensors along the core fibers has not been provided. Thus, should the number of core fibers be two and the number of fiber sensors be two, this would be a very manageable number of calculations to consider along with position sensing and historical location. Further, no time limit has been provided to the system for calculation, and thus the practitioner can take time to consider the given calculations. Further still, there is no limitation of necessary accuracy and thus a practitioner making determinations based on wavelengths shifts, electromagnetic positions, and location history can be wrong and still fulfill the mental processing outlined in the claim. Finally, the broadness of the machine learning step is indistinguishable from mental processing performed by one of ordinary skill in the art when considering their field of work based on inputs and expertise.
Applicant’s amendments and arguments filed 4/26/2026 with respect to the 35 USC 103 rejection have been fully considered, and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Tegg, Soper, Tojo, and Camarillo.
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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/JAIRO H. PORTILLO/
Examiner
Art Unit 3791
/PUYA AGAHI/Primary Examiner, Art Unit 3791
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