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 Objections
The Claims are objected to because of the following informalities:
In Claim 1, the term “combining the physical state of the medical device with the positions of the one or more of the plurality of magnetic elements to determine at least one of a position, a shape, and an orientation of the medical device within the patient body.” should be replaced with -- combining the physical state of the optical fiber with the positions of the one or more of the plurality of magnetic elements to determine at least one of a position, a shape, and an orientation of the medical device within the patient body.-- for claim clarity.
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 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 “combining the physical state of the medical device with the positions of the one or more of the plurality of magnetic elements to determine at least one of a position, a shape, and an orientation of the medical device within the patient body.” 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 fiber spectral width based on received incident light, and (ii) change a characteristic of the reflected light signal based on strain experienced by the optical fiber;”
“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 of the incident light by one or more of the plurality of fiber sensors;
processing the reflected light signals associated with the one or more of core fibers to determine a physical state of the optical fiber;
receiving the electrical signals from the magnetic field sensor;
processing the electrical signals to determine the positions of the one or more of the plurality of magnetic elements with respect to the magnetic field sensor;”
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 and positions of the one or more of the plurality of magnetic elements to determine at least one of a position, a shape, and an orientation 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 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, 7-9, 11, and 15-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tegg et al (US 2021/0282867) (“Tegg”) in view of Cox et al (US 2011/0015533) (“Cox”) and further in view of Oda et al (US 2007/0238922) (“Oda”).
Regarding Claim 1, while Tegg teaches a medical device 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 (Figs. 1-5 and 8, [0020], [0026]-[0027]) comprising:
an optical fiber having one or more of core fibers (Figs. 1-3, [0019], [0022] fiber core cable 112), each of the one or more core fibers including a plurality of fiber sensors distributed along a longitudinal length of a corresponding core fiber (Fig. 3, [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] the optical sensors 300a, 300b, 300c, here Fiber Bragg Gratings are distributed along a longitudinal length of a corresponding core fiber) and each fiber sensor of the plurality of fiber sensors being configured to (i) reflect a light signal of a different fiber spectral width based on received incident light, and (ii) change a characteristic of the reflected light signal based on strain experienced by the optical fiber ([0027]-[0028] FBGs detect strain experienced by the optical fiber by changing a characteristic of reflected lights signals based on strain experienced by the optical fiber, Fiber Bragg Gratings are capable of reflecting light signals of different spectral widths by their reflective capability); 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 including one or more processors and a memory having stored thereon logic, when executed by the one or more processors ([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 of the incident light by one or more of the plurality of fiber sensors ([0019], [0028]-[0029], [0047]-[0048]);
processing the reflected light signals associated with the one or more of core fibers to determine a physical state 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 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
combining the physical state of the medical device with the positions of the one or more of the plurality of magnetic elements to determine at least one of a position, a shape, and an orientation of the medical device within the patient body ([0048]-[0053]).
Tegg fails to teach:
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 logic for the operations provided by a non-transitory computer-readable medium,
the operations including:
processing the electrical signals to determine the positions of the one or more of the plurality of magnetic elements with respect to the magnetic field sensor.
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]); and
the operations including:
receiving the electrical signals from the magnetic field sensor ([0126]-[0131]);
processing the electrical signals to determine the positions of the one or more of the plurality of magnetic elements with respect to the magnetic field sensor ([0126]-[0131] a chest worn TLS sensor 50 provides electrical signals for processing to determine the positions of the one or more of the plurality of magnetic elements); and
Cox further teaches the instructions for the operations of the system by a computer-readable medium ([0302]).
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 Cox as Oda teaches that both configurations are suitable for position information tracking (Oda: [0135]-[0136]). Further, it would have been obvious to include the instructions as non-transitory computer readable media as taught by Cox as a specific example of how the instructions may be provided within a memory, enabling invention consistency across applications.
Regarding Claim 7, Tegg, Cox, and Oda 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, Cox: [0126]).
Regarding Claim 8, Tegg, Cox, and Oda teach the system according to claim 1, wherein the magnetic field sensor is applied to a chest of the patient (See Claim 1 Rejection, Cox: [0130]).
Regarding Claim 9, Tegg, Cox, and Oda teach the system according to claim 1, wherein one or more of the plurality of the magnetic elements are permanent magnets ([0002]).
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 Cox are specifically permanent magnets as taught by Cox as a way to ensure structural consistency across use of the invention, ensuring more uniform results.
Regarding Claim 11, Tegg, Cox, and Oda teach the system according to claim 1, wherein one or more of the plurality of magnetic elements are electro-magnets ([0002]).
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 Cox are specifically electro-magnets as taught by Cox as a way to ensure structural consistency across use of the invention, ensuring more uniform results.
Regarding Claim 15, Tegg, Cox, and Oda 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, Cox, and Oda 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)
Regarding Claim 17, Tegg, Cox, and Oda teach the system according to claim 1, and Cox further wherein the operations further 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 the physical state 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 processing of Cox be combined with the above ECG processing as taught by Cox to increase positioning accuracy (Cox: [0111]).
Regarding Claim 18, Tegg, Cox, and Oda teach the system according to claim 1, and Cox teaches wherein the magnetic field sensor is coupled to the patient body (See Claim 1 Rejection, TLS sensor 50 coupled to patient’s chest).
Claim(s) 2-3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tegg in view of Cox and further in view of Oda and further in view of Duval et al (US 2020/0129318) (“Duval”).
Regarding Claim 2, while Tegg, Cox, and Oda teach the system according to claim 1, wherein each magnetic element is longitudinally shaped (Fig. 5, [0127] magnetic elements are cylinders, cylinders stacked end to end along a length of the stylet, a cylinder shape being longitudinally shaped), where magnetic poles defining a magnetic field in accordance with an orientation of the magnetic element (an inherent relationship between magnetic poles and magnetic fields), their combined efforts fail to explicitly teach having a magnetic pole at each end of the cylinder.
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 magnetic poles of Cox’s magnet as at each end of the magnet as taught by Duval as a teaching on how to standardize construction of the system, ensuring consistency in results.
Regarding Claim 3, Tegg, Cox, Oda, 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, Cox’s cylinder magnets aligned with the longitudinal axis of the medical device).
Claim(s) 4-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tegg in view of Cox and further in view of Oda and further in view of Duval and further in view of Azar (US 2005/0251017).
Regarding Claim 4, while Tegg, Cox, Oda, and Duval teach the system according to claim 2, their combined efforts fail to teach wherein the operations further include processing the electrical signals to determine an orientation of each of the magnetic elements with respect to the magnetic field sensor.
However Azar teaches a magnetic field based endoscope system (Abstract) where magnets for generating an electrical field, with known poles, can be processed to give a position, an orientation, and a longitudinal distance ([0024]).
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 magnetic poles of Cox’s magnet and utilize the added knowledge of magnets to find orientations of the magnetic elements as this provides greater sensitivity to the changes in physical state of the tracked catheter, increasing the accuracy of the location tracking of Tegg, Cox, and Oda.
Regarding Claim 5, Tegg, Cox, Oda, Duval, and Azar teach the system according to claim 4, wherein the operations further include combining the positions of the magnetic elements with the orientations of the magnetic elements to determine at least one of the position, the shape, and the orientation of the medical device within the patient body (See Claim 4 Rejection, Azar: [0024] orientation of endoscope robot may be found when the poles of the magnet are known).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tegg in view of Cox and further in view of Oda and further in view of Huelman et al (US 2016/0220314) (“Huelman”).
Regarding Claim 6, while Tegg, Cox, and Oda teach the system according to claim 1, and Cox teaches wherein each magnet is shaped of a cylinder ([0127]), 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 Cox can be shaped as hollow as taught by Huelman as it enables the optical fiber to pass between the magnetic elements. Such a structure would be desired as it aligns with Tegg’s Fig. 3 (optical fiber 206 and magnetic sensors 210a, 210b) and thus requires less modification to Tegg’s original catheter structure.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tegg in view of Cox and further in view of Oda and further in view of Toyoda et al (US 2004/0143183) (“Toyoda”).
Regarding Claim 10, while Tegg, Cox, and Oda teach the system according to claim 1, 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, Cox, and Oda 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 Cox and further in view of Oda and further in view of Ludwin et al (US 2017/0065353) (“Ludwin”).
Regarding Claim 12, while Tegg, Cox, and Oda 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 first configuration of Tegg with external magnetic field generation and internal magnetic field detection and the second configuration of Cox with 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 13, while Tegg, Cox, and Oda 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 the first configuration of Tegg with external magnetic field generation and internal magnetic field detection and the second configuration of Cox with 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, Cox, and Oda 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 first configuration of Tegg with external magnetic field generation and internal magnetic field detection and the second configuration of Cox with 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.
Conclusion
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/JAIRO H. PORTILLO/
Examiner
Art Unit 3791
/JACQUELINE CHENG/Supervisory Patent Examiner, Art Unit 3791