DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election without traverse of Species C (claims 1-3, 7-20) in the reply filed on June 22, 2026 is acknowledged.
Claims 4-6 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on June 22, 2026.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 3 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 3 recites the limitation “the distal tip of the optical fiber” in line 2. There is insufficient antecedent basis for this limitation in the claim. Note that the claim recites previously in claim 1 “a location of a distal tip of the medical instrument”.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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.
Claim(s) 1, 3, 8, 10-12, 14-16 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ding et al. (US Pub No. 2020/0188036) in view of Maguire et al. (US Pub No. 2002/0019627).
With regards to claim 1, Ding et al. disclose a method for placing a medical instrument into a body of a patient, the method comprising:
providing a medical instrument (“surgical tools” or sensor (122) or “flexible endoscope”) that includes an optical fiber having one or more core fibers (124, 126, 128) (paragraph [0065], referring to the sensor (122) being inserted into the patient, wherein the sensor (122) may be included in a flexible endoscope; paragraph [0080], referring to surgical tools being tracked using a fiber optic tracking system (106); paragraphs [0008]-[0009], [0044]-[0045]; Figure 1);
providing an incident light signal to the optical fiber disposed within the medical instrument (paragraph [0049], referring to the WDM interrogator (120) providing broad spectrum light to the fibers 124-128; Figure 1);
receiving reflected light signals of different spectral widths of the incident light by the optical fiber (paragraphs [0048]-[0049], referring to the FBGs (130) in the fibers (124, 126, 128) being configured to reflect a particular wavelength of light while passing other wavelengths of light, wherein in each fiber 124-128, each FBG (130) is tuned such that the possible reflected wavelengths are different for each FBG [thus reflected light signals of different spectral widths (i.e. different wavelength ranges) are received], wherein the interrogator (120) receives lights with the wavelengths reflected by the FBGs, wherein “Because of the tuning of the FBGs 130, for each fiber 124-128 the return signal includes a differentiable wavelength corresponding to particular FBG 130”, wherein the interrogator (120) provides the measured wavelengths to the computing system (102) for analysis); Figure 1);
processing the reflected light signals associated with the optical fiber (paragraphs [0049]-[0051], referring to the measured wavelengths being provided to the computing system (102) for analysis, wherein a data point/wavelength for each of the FBGs (130) provides an indication of the strain on the fiber at the location of the corresponding FBG 130, wherein these data points can be used to generate a three-dimensional model of the sensor (122); referring to the wavelength data being used by the computing system (102) to simultaneously track the positions of the plurality of anatomical features or track positions of surgical tools, etc.);
determining a location of a distal tip of the medical instrument within the patient body (paragraphs [0051], [0053], referring to the wavelength data being used by the computing system (102) to track the positions of surgical tools and/or track the position of a probe or surgical robots and end effectors, wherein “end effectors” encompass the distal tip of a surgical tool; Figure 1); and
directing the distal tip in a particular direction by manipulating the distal tip (paragraphs [0051]-[0053], [0055], referring to the sensor (122) being coupled to various portions of a surgical robot, including an end effector, wherein a robotic device includes one or more actuators coupled to the end effector and the robotic device is configured to control the end effector (e.g., a surgical tool) in six degrees of freedom, and thus the medical instrument (i.e. surgical tool, end effector) can be manipulated/controlled in order to direct the distal tip in a particular direction; Figure 1).
However, Ding et al. do not specifically disclose that the medical instrument further includes a stiffening stylet, and an adjustment mechanism, wherein actuation of the adjustment mechanism moves the stiffening stylet in a proximal or distal direction and wherein the manipulation of the distal tip is through actuation of the adjustment mechanism.
Maguire et al. disclose a probe having a deflectable tip design to independently select a desired pulmonary vein and direct the transducer assembly toward the desired location, wherein a deflecting pull wire (i.e. stylet) is incorporated into the probe shaft (102) (Abstract; paragraph [0148]). The pull wire is attached to the atraumatic tip of the shaft (102), slidably engaged with a pull-wire lumen (198 in Figures 22 and 23) in the shaft (102) and attached to a deflection mechanism (i.e. adjustment mechanism) within the handle (120) (paragraph [0148], note that a “slidably” engagement with the pull-wire lumen means that the pull-wire is moved/slid in a proximal or distal direction; Figures 22-24). The pull wire is adapted to deflect the distal probe tip by applying tension along varied stiffness transitions along the probe’s length (paragraphs [0148]-[0149]; Figure 24, note that the distal tip is manipulated through actuation of the adjustment/deflection mechanism). The probe shaft (102; cladding of the medical instrument) may be made of Pebax or any other materials that provide adjustable shape, flexibility and maneuverability of the probe (paragraph [0142]).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to have the medical instrument of Ding et al. further include a stiffening stylet, and an adjustment mechanism, wherein actuation of the adjustment mechanism moves the stiffening stylet in a proximal or distal direction and wherein the manipulation of the distal tip is through actuation of the adjustment mechanism., as taught by Maguire et al., in order to provide a deflectable tip design to independently select a desired target and direct the medical instrument toward the desired location (paragraph [0148]).
With regards to claim 3, Ding et al. disclose generating a display indicating the location of the distal tip of the optical fiber within the patient body (paragraph [0100], referring to the positions of anatomical features/objects being determined based on the shape of the sensor (122) and updated as the shape of the sensor (122) changes, wherein the positions of the anatomical features/objects may be presented on a visual display).
With regards to claim 8, Ding et al. disclose that each of the one or more core fibers includes a plurality of sensors (130) distributed along a longitudinal length of a corresponding core fiber and each sensor of the plurality of sensors is configured to (i) reflect a particular light signal of a different spectral width based on received incident light, and (ii) change a characteristic of the reflected particular light signal for use in determining a physical state (i.e. particular amount of strain) of the optical fiber (paragraphs [0044]-[0049], referring to each optical fiber 124-128 including a series of fiber optic sensors, such as fiber Bragg gratings (FBGs) 130, distributed substantially evenly along a sensing portion 132 of the sensor (122), wherein each FBG 130 is tuned such that the possible reflected wavelengths are different for each FBG 130 and wherein the wavelength of light reflected by a particular FBG 130 shifts/changes as the stress on the fiber at the position of the particular FBG 130 changes (i.e. a particular amount of wavelength shift from a reference wavelength corresponds to a particular amount of strain); Figure 1).
With regards to claim 10, Ding et al. disclose that the optical fiber is a multi-core optical fiber including a plurality of core fibers (paragraphs [0008], [0044], Figures 1, 3, wherein there are multiple core fibers (124, 126, 128)).
With regards to claim 11, Ding et al. disclose that the medical instrument is configured for insertion within a lumen of a medical device, the method further comprising: inserting the medical instrument into a first medical device; removing the medical instrument from the first medical device; and subsequently inserting the medical instrument into a second medical device (paragraph [0065], referring to the sensor (122) may be included in a flexible endoscope (i.e. first medical device) or other minimally-invasive tool (i.e. second medical device) or robotic device (i.e. second medical device), wherein such inclusion in different medical devices would inherently require a remove of the medical instrument from one medical device and subsequent insertion into a second medical device).
With regards to claim 12, the above combined references disclose that the stiffening stylet has a flexural stiffness that is greater than a flexural stiffness of a cladding (i.e. inherent cladding of the optical fiber or cladding/housing of the flexible endoscope of Ding et al., or alternatively, the tubes/cladding (304, 306, 308, 310) as depicted in Figures 3 and 18 of Ding et al.) of the medical instrument and the optical fiber (see Ding et al., paragraph [0094], which sets forth that the optical fiber is flexible to assume different shapes and thus it would follow that the cladding of the optical fiber or cladding/housing of the flexible endoscope would have the same flexibility to assumes the different shapes, and see Maguire, paragraph [0148], which sets forth that the stiffening stylet can be tensioned to achieve a desired stiffness, and therefore the stiffening style has a flexural stiffness that is greater than a flexural stiffness of the optical fiber and see paragraph [0182] of Maguire et al., wherein the stiffening sylet/wire is made of stainless steel of a metal alloy, such as titanium or nickel; further note that the definition of “flexural stiffness” is the measure of a structural element’s resistance to bending, determined by both the material’s elasticity and the geometry of its cross section; further, with regards to the “cladding”, if the tubes (304, 306, 308, 310) are considered to correspond to the cladding, the tubes are disclosed as being made of shape memory materials, including highly elastic nitinol and PTFE (see paragraphs [0040], [0067], [0069]-[0070], [0094], [0096], of Ding et al.; Further, note that in Figures 3-4, the thickness of the tubes (310, 304, 306) appear to be similar or slightly smaller than the diameter of the optical fiber (124, 126, 128); Since the elasticity (known in the art to be defined by an elasticity modulus) of an optical fiber/cladding of optical fiber and/or nitinol or PTFE tube (i.e. cladding) are made of materials which are known in the art to have lower elastic modulus values (i.e. inherent and known elastic modulus of ~0.5 GPa/16.5 GPa) than that of a stiffening stylet made of steel/metal (i.e. inherent and known elastic modulus of stainless steel is ~193 GPA), and cladding/optical fiber have a similar geometry to that of a wire/stiffening stylet, it would follow that the flexural stiffness of the stiffening stylet of the above combined references is greater than a flexural stiffness of both of a cladding of the medical instrument and the optical fiber of the above combined references. Alternatively, since the above combined references require that the stiffening stylet assumes some rigidity/stiffness and the optical fiber/cladding is desired to be flexible, it would have been obvious to one of ordinary skill in the art, through routine experimentation, to adopt different geometries for the stiffening stylet and optical fiber/cladding, including geometries that would result in the stiffening stylet to have a flexural stiffness that is greater than a flexural stiffness of both the cladding/optical fiber, in order to determine the optimal stiffness of the stiffening stylet and optimal flexibility of the optical fiber/cladding.
With regards to claim 14, Maguire et al. disclose that the adjustment mechanism is configured to be actuated mechanically, manually, or electromechanically by a user (paragraphs [0133], [0148]-[0149], wherein the deflection/adjustment mechanism located in the handle would necessarily be actuated by the physician who handles the handle; Figure 24).
With regards to claim 15, Ding et al. disclose that the medical instrument is configured for insertion within a lumen of a medical device (paragraph [0065], referring to the sensor (122) is included (and thus inserted in the lumen/interior) in a flexible endoscope or other minimally-invasive tool).
With regards to claim 16, Ding et al. disclose that the medical instrument is reusable across multiple medical devices (paragraph [0051], referring to the sensor (122; “medical instrument”) being coupled to multiple surgical tools and/or coupled to one or more elements of additional surgical system, and therefore the medical instrument (122) is reusable (i.e. capable of being reused) across multiple medical devices).
With regards to claim 19, Ding et al. disclose that the medical instrument is configured to be sterilized between uses of the medical instrument (paragraph [0051], referring to the sterile surgical field, and hence instruments used in the surgical field would be inherently required to be sterile/sterilized; paragraph [0051], surgical tools, including cutting guides, retractors, burrs, saws, etc.; paragraph [0065], flexible endoscope or other minimally invasive tool), wherein the surgical tools are capable of being sterilized and hence is configured to have actions performed on it, including being sterilized between uses of the medical instrument).
Claim(s) 2, 7 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ding et al. and Maguire et al. as applied to claim 1 above, and further in view of Duindam et al. (US Pub No. 2013/0204124).
With regards to claims 2, 7 and 12, as discussed above, the above combined references meet the limitations of claim 1. With regards to claim 7, Ding et al. further disclose that the medical instrument is a medical instrument assembly comprising a first medical instrument (i.e. endoscope/minimally-invasive tool) including a lumen and a second medical instrument (i.e. sensor 122) including the optical sensor and that the operations further include determining that a curvature is present in a distal tip of the medical instrument assembly (paragraphs [0015], [0076], referring to determining the 3D shape/curvature of the medical instrument; paragraph [0065], referring to the sensor (122) being included in a flexible endoscope or other minimally-invasive tool or robotic device; Figure 1).
However, though Ding et al. do disclose that the medical instrument can be a surgical tool and/or an endoscope (paragraphs [0051], [0065]), they do not specifically disclose that a distal portion of the medical instrument is shaped with a predetermined curvature, and manipulating the medical instrument includes rotating the medical instrument around a longitudinal axis of the medical instrument in order to direct the distal tip in a particular direction. Further, with regards to claim 13, Ding et al. do not specifically disclose that the medical instrument 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. Additionally, with regards to claim 7, Ding et al. do not specifically disclose that the curvature is formed from the second medical instrument advancing beyond a distal end of the first medical instrument.
Duindam et al. disclose a surgical system which includes a flexible steerable needle and a shape sensor for measuring the shape of the needle, wherein the needle can include a pre-bent tip section and control inputs for insertion and shaft rotation, wherein the needle moves along an approximately circular trajectory in the direction of the pre-bent tip (the lowest energy state of the needle), wherein shape and/or trajectory direction changes can be effected via needle shaft rotation and steerability is provided by rotating the needle (Abstract; paragraphs [0014]-[0015], [0042]-[0043]; Figures 1, 3). The shape sensor (120) can be a fiber optic bend sensor that includes fiber Bragg gratings (FBGs) (paragraph [0047]). The flexible, steerable needles provide an opportunity for procedures, such as biopsy and/or therapeutic treatment and can be delivered to the target site making use of the channel of an endoscope or a catheter (paragraph [0006]). Further, as can be seen in Figure 3, the medical instrument is a needle with the optical fiber (120) inlayed into a cannula of the needle (paragraphs [0034]-[0038], [0046]-[0047]; Figure 3). The curvature of the needle (i.e. second instrument) is formed from the second medical instrument advancing beyond a distal end of the endoscope (i.e. first medical instrument) (paragraphs [0042]-[0043], referring to the actuator (130) controlling the relative rotation and extension of segments of the needle, thereby determining the shape (i.e. curvature) and orientation of the needle (110); paragraphs [0006], [0044]-[0045], referring to the steerable needle being delivered through the channel of an endoscope; Figures 2A,B).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to have a distal portion of the medical instrument of the above combined references be shaped with a predetermined curvature, and manipulating the medical instrument includes rotating the medical instrument around a longitudinal axis of the medical instrument in order to direct the distal tip in a particular direction [claim 2], have the medical instrument of Ding et al. be a needle with the optical fiber inlayed into a cannula of the needle [claim 13] and have the curvature of Ding et al. be formed from the second medical instrument advancing beyond a distal end of the first medical instrument [claim 7], as taught by Duindam et al., in order to provide the opportunity for performing biopsy and/or therapeutic treatments and provide a desired steerability to effectively change the medical instrument trajectory (paragraphs [0006], [0042]-[0043]).
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ding et al. in view of Maguire et al. as applied to claim 1 above, and further in view of Younge et al. (US Pub No. 2008/0285909).
With regards to claim 9, as discussed above, the above combined references meet the limitations of claim 1. However, Ding et al. do not specifically disclose that the optical fiber is a single-core optical fiber, and wherein the incident light is provided in pulses.
Younge et al. disclose a medical instrument system including an elongate flexible instrument body with an optical fiber which includes one or more fiber gratings, wherein the optical fiber Bragg grating system may comprise of single-core optical fiber, multi-core optical fibers or a combination of single core and multi-core optical fibers and the optical system may comprise a pulsed light source, the pulsed light source may be configured to provide substantially short pulses of light that propagate down the optical fiber to the fibre gratings (Abstract; paragraphs [0101], [0109]).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to substitute the substitute the optical fiber of the above combined references with an optical fiber comprising a single-core optical fiber and further substitute the lighting system of the above combined references with a lighting system that provides the incident light in pulses, as taught by Younge et al., as the substitution of one known optical fiber and one known lighting system for another yields predictable results (i.e. provide light) to one of ordinary skill in the art. One of ordinary skill in the art would have been able to carry out such a substitution and the results are reasonably predictable.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ding et al. in view of Maguire et al. as applied to claim 16 above, and further in view of Gill et al. (US Pub No. 2009/0253967).
With regards to claim 17, as discussed above, the above combined references meet the limitations of claim 16. However, they do not specifically disclose that the medical instrument includes a disposable cover configured to cover the medical instrument for each use of the medical instrument.
Gill et al. disclose a sterile disposable sheath (34) fitted over the illumination subsystem of an endoscope and that is inserted into a target area on a patient (Abstract; paragraph [0056]; Figure 1). The disposable sheath maintains a sterile environment of the imaging unit and eliminates the space requirements, cost of reprocessing equipment, manpower and costs associated with the time sensitive endoscope re-sterilization (paragraphs [0015], [0164]).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to have the medical instrument of the above combined references comprise a disposable cover configured to cover the medical instrument for each use of the medical instrument, as taught by Gill et al., in order to maintain a sterile environment and eliminate the space requirements, cost of reprocessing equipment, manpower and costs associated with the time sensitive endoscope re-sterilization (paragraphs [0015], [0164]).
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ding et al. in view of Maguire et al. as applied to claim 16 above, and further in view of Ryan et al. (US Pub No. 2010/0286531).
With regards to claim 18, as discussed above, the above combined references meet the limitations of claim 16. However, they do not specifically disclose that the medical instrument includes a film or coating over an outer jacket of the medical instrument, the film or coating configured to be replenishable for each use of the medical instrument.
Ryan et al. disclose coating the outside of a balloon/jacket of a catheter with one or more drugs so as to provide a therapeutic effect (Abstract; paragraph [0126]).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to have the medical instrument of the above combined references include a film or coating over an outer jacket of the medical instrument, as taught by Ryan et al., in order to provide a therapeutic effect.
With regards to the limitation that the film or coating is “configured to be replenishable for each use of the medical instrument”, the limitation or “replenishable” is directed to a capability of the film/coating to be replenished. If the film/coating is capable of being replenished, then it meets the claim. Since the coating of the above combined references is capable of being replenished as it is capable of being removed and hence replenished/replaced, the above combined references meet the above limitation.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ding et al. and Maguire et al. as applied to claim 1 above, and further in view of Leo et al. (US Pub No. 2006/0200049).
With regards to claim 20, as discussed above, the above combined references meet the limitations of claim 1. However, they do not specifically disclose that the medical instrument includes electrical circuitry and componentry configured for electrocardiography, conductance measurements or impedance measurements.
Leo et al. disclose a catheter which can comprise a deformable body (1) including electrodes (30, 31, 32) coupled to the front end (33) having irrigation ports (34) (Abstract; paragraph [0132]; Figures 1, 14). The electrodes 30-33 are provided according to the function of the specific application of the catheter, which can include electrocardiogram (paragraphs [0029]-[0030], [0132]). The electrodes can measure and map electric potentials and provides improved, less time-consuming spatial registration between the mapped values and the tissue location (paragraphs [0029]-[0030], [0138]).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to have the medical instrument of the above combined references include electrical circuitry and componentry configured for electrocardiography, as taught by Leo et al., in order to measure and map electric potential and provide improved, less time-consuming spatial registration between the mapped values and the tissue location (paragraphs [0029]-[0030], [0138]).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 8 and 13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 15 of U.S. Patent No. US Patent No. 11,622,816 in view of Ding et al. and Kugler et al. (US Pub No. 2010/0063534).
With regards to claim 1, the Patent claim 1 meets most of the limitations of claim 1 of the instant application (i.e. a medical instrument/device comprising an optical fiber having one or more core fibers, a console including one or more processors to cause operations including providing incident light signal to the optical fiber, receiving reflected light signals of different spectral widths, processing the reflected light signals, determining a location of a distal tip of the medical instrument (i.e. via determining whether the medical device has entered the vessel of the patient). However, they do not specifically disclose that the medical instrument is configured to be manipulated in order to direct the distal tip in a particular direction. Ding et al. disclose that their medical instrument, which comprises an optical fiber having one or more core fibers, is configured to be manipulated in order to direct the distal tip in a particular direction, thus controlling a surgical tool to carry out one or more surgical tasks autonomously and provide the ability to confine the surgical tool within a boundary defined related to tracked anatomy (Abstract; paragraphs [0051]-[0053], [0055], referring to the sensor (122) being coupled to various portions of a surgical robot, including an end effector, wherein a robotic device includes one or more actuators coupled to the end effector and the robotic device is configured to control the end effector (e.g., a surgical tool) in six degrees of freedom, and thus the medical instrument (i.e. surgical tool, end effector) can be manipulated/controlled in order to direct the distal tip in a particular direction; Figure 1). At the time of the invention, it would have been obvious to one of ordinary skill in the art to have the medical instrument of the Patent be configured to be manipulated in order to direct the distal tip in a particular direction, as taught by Ding et al., in order to control the medical instrument to carry out one or more surgical tasks autonomously and provide the ability to confine the medical instrument within a boundary defined related to tracked anatomy (paragraph [0052]). However, the modified patent does not specifically disclose their system further comprises a stiffening stylet; and an adjustment mechanism that moves the stiffening stylet in a proximal or distal direction. Kugler et al. disclose endovascular devices and methods which may be used to cross a chronic total occlusion and facilitate treatment of the occluded vessel by an endovascular procedure (paragraph [0003]). An orienting device (3800) may be designed to orient the device, wherein the orienting device comprises a stiffening stylet (3820, “tension member” which comprises a metallic ribbon or multifilament fiber which provides controllable tensioning/stiffening of the orienting element (3840); Figures 38A,B) and an adjustment mechanism including a proximal collar (3846), a distal collar (3844), and a pair of hinged arms (3842), wherein the proximal collar (3846) is coupled to the stiffening stylet (paragraphs [0196]-[0197], paragraph [0198], referring to the collar (3846) being slidably disposed and connected to the tension member (3820; “stiffening stylet”) by suitable means, thus the proximal collar (3846) is coupled to the stiffening stylet (3820); paragraphs [0181], [0200], referring to the wings being associated with hinge points, and therefore the pair of wings (3842) correspond to the pair of “hinged arms”); Figures 38A,B), wherein actuation of the adjustment mechanism (i.e. via releasing or pulling on the tension member (3820) relative to the shaft (3810), paragraphs [0199], [0204]) moves the proximal collar (3846) in a (i) proximal direction which moves the stiffening stylet (3820) in a proximal direction relative to a distal tip of the medical instrument (See Figure 38A, wherein the stiffening stylet (3820) which is attached to the collar (3846) is at a position that is in a proximal direction/location relative to a distal tip of the medical instrument) or (ii) a distal direction which moves the stiffening stylet (3820) in a distal direction relative to the distal tip of the medical instrument (see Figure 38B, wherein the stiffening stylet (3820) which is attached to the collar (3846) is at a position that is in a more distal direction/location relative to a distal tip of the medical instrument than its position in Figure 38A) (paragraphs [0119]-[0120]; paragraphs [0198]-[0199], referring to actuating the orienting element (3840) by longitudinal displacement of the tension member (3820; stiffening stylet), wherein pulling on the tension member relative to the shaft (3810) causes the orienting element (3840) to expand, and conversely, releasing the tension member (3820) relative to the shaft (3810) causes the orienting element (3840 to collapse by elastic recovery of the wings; Figures 38A,B). At the time of the invention, it would have been obvious to one of ordinary skill in the art to have the system of the modified Patent further comprise a stiffening stylet; and an adjustment mechanism that moves the stiffening stylet in a proximal or distal direction, as taught by Kugler et al., in order to orient the medical instrument and/or to provide orienting wings that can be controlled to expand and contract (paragraphs [0119]-[0120], [0198]-[0199]).
Claim 1 of the Patent meets the limitations of claim 8 of the instant application.
Claim 15 of the Patent meets the limitations of claim 13 of the instant application.
Claims 1, 6, 10 and 13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4 and 10 of U.S. Patent No. US Patent NO. 11,624,677 in view of Ding et al and Kugler et al.
With regards to claim 1, the Patent claim 1 meets most of the limitations of claim 1 of the instant application (i.e. a medical instrument/device comprising an optical fiber having one or more core fibers, a console including one or more processors to cause operations including providing incident light signal to the optical fiber, receiving reflected light signals of different spectral widths, processing the reflected light signals, determining a location of a distal tip of the medical instrument (i.e. via determining a location of damage along the first core fiber). However, they do not specifically disclose that the medical instrument is configured to be manipulated in order to direct the distal tip in a particular direction. Ding et al. disclose that their medical instrument, which comprises an optical fiber having one or more core fibers, is configured to be manipulated in order to direct the distal tip in a particular direction, thus controlling a surgical tool to carry out one or more surgical tasks autonomously and provide the ability to confine the surgical tool within a boundary defined related to tracked anatomy (Abstract; paragraphs [0051]-[0053], [0055], referring to the sensor (122) being coupled to various portions of a surgical robot, including an end effector, wherein a robotic device includes one or more actuators coupled to the end effector and the robotic device is configured to control the end effector (e.g., a surgical tool) in six degrees of freedom, and thus the medical instrument (i.e. surgical tool, end effector) can be manipulated/controlled in order to direct the distal tip in a particular direction; Figure 1). At the time of the invention, it would have been obvious to one of ordinary skill in the art to have the medical instrument of the Patent be configured to be manipulated in order to direct the distal tip in a particular direction, as taught by Ding et al., in order to control the medical instrument to carry out one or more surgical tasks autonomously and provide the ability to confine the medical instrument within a boundary defined related to tracked anatomy (paragraph [0052]). However, the modified patent does not specifically disclose their system further comprises a stiffening stylet; and an adjustment mechanism as claimed. Kugler et al. disclose endovascular devices and methods which may be used to cross a chronic total occlusion and facilitate treatment of the occluded vessel by an endovascular procedure (paragraph [0003]). An orienting device (3800) may be designed to orient the device, wherein the orienting device comprises a stiffening stylet (3820, “tension member” which comprises a metallic ribbon or multifilament fiber which provides controllable tensioning/stiffening of the orienting element (3840); Figures 38A,B) and an adjustment mechanism including a proximal collar (3846), a distal collar (3844), and a pair of hinged arms (3842), wherein the proximal collar (3846) is coupled to the stiffening stylet (paragraphs [0196]-[0197], paragraph [0198], referring to the collar (3846) being slidably disposed and connected to the tension member (3820; “stiffening stylet”) by suitable means, thus the proximal collar (3846) is coupled to the stiffening stylet (3820); paragraphs [0181], [0200], referring to the wings being associated with hinge points, and therefore the pair of wings (3842) correspond to the pair of “hinged arms”); Figures 38A,B), wherein actuation of the adjustment mechanism (i.e. via releasing or pulling on the tension member (3820) relative to the shaft (3810), paragraphs [0199], [0204]) moves the proximal collar (3846) in a (i) proximal direction which moves the stiffening stylet (3820) in a proximal direction relative to a distal tip of the medical instrument (See Figure 38A, wherein the stiffening stylet (3820) which is attached to the collar (3846) is at a position that is in a proximal direction/location relative to a distal tip of the medical instrument) or (ii) a distal direction which moves the stiffening stylet (3820) in a distal direction relative to the distal tip of the medical instrument (see Figure 38B, wherein the stiffening stylet (3820) which is attached to the collar (3846) is at a position that is in a more distal direction/location relative to a distal tip of the medical instrument than its position in Figure 38A) (paragraphs [0119]-[0120]; paragraphs [0198]-[0199], referring to actuating the orienting element (3840) by longitudinal displacement of the tension member (3820; stiffening stylet), wherein pulling on the tension member relative to the shaft (3810) causes the orienting element (3840) to expand, and conversely, releasing the tension member (3820) relative to the shaft (3810) causes the orienting element (3840 to collapse by elastic recovery of the wings; Figures 38A,B). At the time of the invention, it would have been obvious to one of ordinary skill in the art to have the system of the modified Patent further comprise a stiffening stylet; and an adjustment mechanism as claimed, as taught by Kugler et al., in order to orient the medical instrument and/or to provide orienting wings that can be controlled to expand and contract (paragraphs [0119]-[0120], [0198]-[0199]).
Claim 1 of the Patent meets the limitations of claim 8 of the instant application.
Claim 4 of the Patent meets the limitations of claim 10 of the instant application.
Claim 10 of the Patent meets the limitations of claim 13 of the instant application.
Claims 1, 8, 10 and 13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3 and 8 of U.S. Patent No. 11,630,009 in view of Ding et al. and Kugler et al..
With regards to claim 1, the Patent claim 1 meets most of the limitations of claim 1 of the instant application (i.e. a medical instrument/device comprising an optical fiber having one or more core fibers, a console including one or more processors to cause operations including providing incident light signal to the optical fiber, receiving reflected light signals of different spectral widths, processing the reflected light signals, determining a location of a distal tip of the medical instrument (i.e. via determining a location of the portion of the optical fiber). However, they do not specifically disclose that the medical instrument is configured to be manipulated in order to direct the distal tip in a particular direction. Ding et al. disclose that their medical instrument, which comprises an optical fiber having one or more core fibers, is configured to be manipulated in order to direct the distal tip in a particular direction, thus controlling a surgical tool to carry out one or more surgical tasks autonomously and provide the ability to confine the surgical tool within a boundary defined related to tracked anatomy (Abstract; paragraphs [0051]-[0053], [0055], referring to the sensor (122) being coupled to various portions of a surgical robot, including an end effector, wherein a robotic device includes one or more actuators coupled to the end effector and the robotic device is configured to control the end effector (e.g., a surgical tool) in six degrees of freedom, and thus the medical instrument (i.e. surgical tool, end effector) can be manipulated/controlled in order to direct the distal tip in a particular direction; Figure 1). At the time of the invention, it would have been obvious to one of ordinary skill in the art to have the medical instrument of the Patent be configured to be manipulated in order to direct the distal tip in a particular direction, as taught by Ding et al., in order to control the medical instrument to carry out one or more surgical tasks autonomously and provide the ability to confine the medical instrument within a boundary defined related to tracked anatomy (paragraph [0052]). However, the modified patent does not specifically disclose their system further comprises a stiffening stylet; and an adjustment mechanism as claimed. Kugler et al. disclose endovascular devices and methods which may be used to cross a chronic total occlusion and facilitate treatment of the occluded vessel by an endovascular procedure (paragraph [0003]). An orienting device (3800) may be designed to orient the device, wherein the orienting device comprises a stiffening stylet (3820, “tension member” which comprises a metallic ribbon or multifilament fiber which provides controllable tensioning/stiffening of the orienting element (3840); Figures 38A,B) and an adjustment mechanism including a proximal collar (3846), a distal collar (3844), and a pair of hinged arms (3842), wherein the proximal collar (3846) is coupled to the stiffening stylet (paragraphs [0196]-[0197], paragraph [0198], referring to the collar (3846) being slidably disposed and connected to the tension member (3820; “stiffening stylet”) by suitable means, thus the proximal collar (3846) is coupled to the stiffening stylet (3820); paragraphs [0181], [0200], referring to the wings being associated with hinge points, and therefore the pair of wings (3842) correspond to the pair of “hinged arms”); Figures 38A,B), wherein actuation of the adjustment mechanism (i.e. via releasing or pulling on the tension member (3820) relative to the shaft (3810), paragraphs [0199], [0204]) moves the proximal collar (3846) in a (i) proximal direction which moves the stiffening stylet (3820) in a proximal direction relative to a distal tip of the medical instrument (See Figure 38A, wherein the stiffening stylet (3820) which is attached to the collar (3846) is at a position that is in a proximal direction/location relative to a distal tip of the medical instrument) or (ii) a distal direction which moves the stiffening stylet (3820) in a distal direction relative to the distal tip of the medical instrument (see Figure 38B, wherein the stiffening stylet (3820) which is attached to the collar (3846) is at a position that is in a more distal direction/location relative to a distal tip of the medical instrument than its position in Figure 38A) (paragraphs [0119]-[0120]; paragraphs [0198]-[0199], referring to actuating the orienting element (3840) by longitudinal displacement of the tension member (3820; stiffening stylet), wherein pulling on the tension member relative to the shaft (3810) causes the orienting element (3840) to expand, and conversely, releasing the tension member (3820) relative to the shaft (3810) causes the orienting element (3840 to collapse by elastic recovery of the wings; Figures 38A,B). At the time of the invention, it would have been obvious to one of ordinary skill in the art to have the system of the modified Patent further comprise a stiffening stylet; and an adjustment mechanism as claimed as taught by Kugler et al., in order to orient the medical instrument and/or to provide orienting wings that can be controlled to expand and contract (paragraphs [0119]-[0120], [0198]-[0199]).
Claim 1 of the Patent meets the limitations of claim 8 of the instant application.
Claim 3 of the Patent meets the limitations of claim 10 of the instant application.
Claim 8 of the Patent meets the limitations of claim 13 of the instant application.
Claims 1, 8, 10 and 13 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 31-33 of US Patent No. 11,931,112 in view of Ding et al. and Kugler et al..
With regards to claim 1, claim 31 of the copending application meets most of the limitations of claim 1 of the instant application (i.e. a medical instrument/device comprising an optical fiber having one or more core fibers, a console including one or more processors to cause operations including providing incident light signal to the optical fiber, receiving reflected light signals of different spectral widths, processing the reflected light signals, determining a location of a distal tip of the medical instrument (i.e. via determining whether the medical device is positioned at the target site of the patient). However, they do not specifically disclose that the medical instrument is configured to be manipulated in order to direct the distal tip in a particular direction. Ding et al. disclose that their medical instrument, which comprises an optical fiber having one or more core fibers, is configured to be manipulated in order to direct the distal tip in a particular direction, thus controlling a surgical tool to carry out one or more surgical tasks autonomously and provide the ability to confine the surgical tool within a boundary defined related to tracked anatomy (Abstract; paragraphs [0051]-[0053], [0055], referring to the sensor (122) being coupled to various portions of a surgical robot, including an end effector, wherein a robotic device includes one or more actuators coupled to the end effector and the robotic device is configured to control the end effector (e.g., a surgical tool) in six degrees of freedom, and thus the medical instrument (i.e. surgical tool, end effector) can be manipulated/controlled in order to direct the distal tip in a particular direction; Figure 1). At the time of the invention, it would have been obvious to one of ordinary skill in the art to have the medical instrument of the copending application be configured to be manipulated in order to direct the distal tip in a particular direction, as taught by Ding et al., in order to control the medical instrument to carry out one or more surgical tasks autonomously and provide the ability to confine the medical instrument within a boundary defined related to tracked anatomy (paragraph [0052]). However, the modified copending application does not specifically disclose their system further comprises a stiffening stylet; and an adjustment mechanism as claimed. Kugler et al. disclose endovascular devices and methods which may be used to cross a chronic total occlusion and facilitate treatment of the occluded vessel by an endovascular procedure (paragraph [0003]). An orienting device (3800) may be designed to orient the device, wherein the orienting device comprises a stiffening stylet (3820, “tension member” which comprises a metallic ribbon or multifilament fiber which provides controllable tensioning/stiffening of the orienting element (3840); Figures 38A,B) and an adjustment mechanism including a proximal collar (3846), a distal collar (3844), and a pair of hinged arms (3842), wherein the proximal collar (3846) is coupled to the stiffening stylet (paragraphs [0196]-[0197], paragraph [0198], referring to the collar (3846) being slidably disposed and connected to the tension member (3820; “stiffening stylet”) by suitable means, thus the proximal collar (3846) is coupled to the stiffening stylet (3820); paragraphs [0181], [0200], referring to the wings being associated with hinge points, and therefore the pair of wings (3842) correspond to the pair of “hinged arms”); Figures 38A,B), wherein actuation of the adjustment mechanism (i.e. via releasing or pulling on the tension member (3820) relative to the shaft (3810), paragraphs [0199], [0204]) moves the proximal collar (3846) in a (i) proximal direction which moves the stiffening stylet (3820) in a proximal direction relative to a distal tip of the medical instrument (See Figure 38A, wherein the stiffening stylet (3820) which is attached to the collar (3846) is at a position that is in a proximal direction/location relative to a distal tip of the medical instrument) or (ii) a distal direction which moves the stiffening stylet (3820) in a distal direction relative to the distal tip of the medical instrument (see Figure 38B, wherein the stiffening stylet (3820) which is attached to the collar (3846) is at a position that is in a more distal direction/location relative to a distal tip of the medical instrument than its position in Figure 38A) (paragraphs [0119]-[0120]; paragraphs [0198]-[0199], referring to actuating the orienting element (3840) by longitudinal displacement of the tension member (3820; stiffening stylet), wherein pulling on the tension member relative to the shaft (3810) causes the orienting element (3840) to expand, and conversely, releasing the tension member (3820) relative to the shaft (3810) causes the orienting element (3840 to collapse by elastic recovery of the wings; Figures 38A,B). At the time of the invention, it would have been obvious to one of ordinary skill in the art to have the system of the modified copending application further comprise a stiffening stylet; and an adjustment mechanism as claimed, as taught by Kugler et al., in order to orient the medical instrument and/or to provide orienting wings that can be controlled to expand and contract (paragraphs [0119]-[0120], [0198]-[0199]).
Claim 31 of the copending application meets the limitations of claim 8 of the instant application.
Claim 32 of the copending application meets the limitations of claim 10 of the instant application.
Claim 33 of the copending meets the limitations of claim 13 of the instant application.
This is a provisional nonstatutory double patenting rejection.
Claims 1, 8, 10 and 13 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3 and 7-10 of US Patent No. 12,232,821 in view of Ding et al. and Kugler et al..
With regards to claim 1, claim 1 of the Patent meets most of the limitations of claim 1 of the instant application (i.e. a medical instrument/device comprising an optical fiber having one or more core fibers, a console including one or more processors to cause operations including providing incident light signal to the optical fiber, receiving reflected light signals of different spectral widths, processing the reflected light signals, determining a location of a distal tip of the medical instrument (i.e. via determining of the positioning and the orientation of the medical instrument). However, they do not specifically disclose that the medical instrument is configured to be manipulated in order to direct the distal tip in a particular direction. Ding et al. disclose that their medical instrument, which comprises an optical fiber having one or more core fibers, is configured to be manipulated in order to direct the distal tip in a particular direction, thus controlling a surgical tool to carry out one or more surgical tasks autonomously and provide the ability to confine the surgical tool within a boundary defined related to tracked anatomy (Abstract; paragraphs [0051]-[0053], [0055], referring to the sensor (122) being coupled to various portions of a surgical robot, including an end effector, wherein a robotic device includes one or more actuators coupled to the end effector and the robotic device is configured to control the end effector (e.g., a surgical tool) in six degrees of freedom, and thus the medical instrument (i.e. surgical tool, end effector) can be manipulated/controlled in order to direct the distal tip in a particular direction; Figure 1). At the time of the invention, it would have been obvious to one of ordinary skill in the art to have the medical instrument of the copending application be configured to be manipulated in order to direct the distal tip in a particular direction, as taught by Ding et al., in order to control the medical instrument to carry out one or more surgical tasks autonomously and provide the ability to confine the medical instrument within a boundary defined related to tracked anatomy (paragraph [0052]). However, the modified copending application does not specifically disclose their system further comprises a stiffening stylet; and an adjustment mechanism as claimed. Kugler et al. disclose endovascular devices and methods which may be used to cross a chronic total occlusion and facilitate treatment of the occluded vessel by an endovascular procedure (paragraph [0003]). An orienting device (3800) may be designed to orient the device, wherein the orienting device comprises a stiffening stylet (3820, “tension member” which comprises a metallic ribbon or multifilament fiber which provides controllable tensioning/stiffening of the orienting element (3840); Figures 38A,B) and an adjustment mechanism including a proximal collar (3846), a distal collar (3844), and a pair of hinged arms (3842), wherein the proximal collar (3846) is coupled to the stiffening stylet (paragraphs [0196]-[0197], paragraph [0198], referring to the collar (3846) being slidably disposed and connected to the tension member (3820; “stiffening stylet”) by suitable means, thus the proximal collar (3846) is coupled to the stiffening stylet (3820); paragraphs [0181], [0200], referring to the wings being associated with hinge points, and therefore the pair of wings (3842) correspond to the pair of “hinged arms”); Figures 38A,B), wherein actuation of the adjustment mechanism (i.e. via releasing or pulling on the tension member (3820) relative to the shaft (3810), paragraphs [0199], [0204]) moves the proximal collar (3846) in a (i) proximal direction which moves the stiffening stylet (3820) in a proximal direction relative to a distal tip of the medical instrument (See Figure 38A, wherein the stiffening stylet (3820) which is attached to the collar (3846) is at a position that is in a proximal direction/location relative to a distal tip of the medical instrument) or (ii) a distal direction which moves the stiffening stylet (3820) in a distal direction relative to the distal tip of the medical instrument (see Figure 38B, wherein the stiffening stylet (3820) which is attached to the collar (3846) is at a position that is in a more distal direction/location relative to a distal tip of the medical instrument than its position in Figure 38A) (paragraphs [0119]-[0120]; paragraphs [0198]-[0199], referring to actuating the orienting element (3840) by longitudinal displacement of the tension member (3820; stiffening stylet), wherein pulling on the tension member relative to the shaft (3810) causes the orienting element (3840) to expand, and conversely, releasing the tension member (3820) relative to the shaft (3810) causes the orienting element (3840 to collapse by elastic recovery of the wings; Figures 38A,B). At the time of the invention, it would have been obvious to one of ordinary skill in the art to have the system of the Patent further comprise a stiffening stylet; and an adjustment mechanism as claimed, as taught by Kugler et al., in order to orient the medical instrument and/or to provide orienting wings that can be controlled to expand and contract (paragraphs [0119]-[0120], [0198]-[0199]).
Claims 3 and 10 of the copending application meets the limitations of claim 13 of the instant application.
Claim 7 of the copending application meets the limitations of claim 8 of the instant application.
Claim 8 of the copending application meets the limitations of claim 9 of the instant application.
Claim 9 of the copending application meets the limitations of claim 10 of the instant application.
This is a provisional nonstatutory double patenting rejection.
Claims 1, 8-10 and 13 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2-4, 12 and 14 of copending Application No. 17/585,219 in view of Ding et al. and Kugler et al..
With regards to claim 1, claims 1 and 14 of the copending application meets most of the limitations of claim 1 of the instant application (i.e. a medical instrument/device comprising an optical fiber having one or more core fibers, a console including one or more processors to cause operations including providing incident light signal to the optical fiber, receiving reflected light signals of different spectral widths, processing the reflected light signals, determining a location of a distal tip of the medical instrument (i.e. via determining a shape of the medical instrument(2) within the patient body and displaying the shape on a graphical display and/or determining at least a location of the distal tip as set forth in claim 14). However, they do not specifically disclose that the medical instrument is configured to be manipulated in order to direct the distal tip in a particular direction. Ding et al. disclose that their medical instrument, which comprises an optical fiber having one or more core fibers, is configured to be manipulated in order to direct the distal tip in a particular direction, thus controlling a surgical tool to carry out one or more surgical tasks autonomously and provide the ability to confine the surgical tool within a boundary defined related to tracked anatomy (Abstract; paragraphs [0051]-[0053], [0055], referring to the sensor (122) being coupled to various portions of a surgical robot, including an end effector, wherein a robotic device includes one or more actuators coupled to the end effector and the robotic device is configured to control the end effector (e.g., a surgical tool) in six degrees of freedom, and thus the medical instrument (i.e. surgical tool, end effector) can be manipulated/controlled in order to direct the distal tip in a particular direction; Figure 1). At the time of the invention, it would have been obvious to one of ordinary skill in the art to have the medical instrument of the copending application be configured to be manipulated in order to direct the distal tip in a particular direction, as taught by Ding et al., in order to control the medical instrument to carry out one or more surgical tasks autonomously and provide the ability to confine the medical instrument within a boundary defined related to tracked anatomy (paragraph [0052]). However, the modified copending application does not specifically disclose their system further comprises a stiffening stylet; and an adjustment mechanism as claimed. Kugler et al. disclose endovascular devices and methods which may be used to cross a chronic total occlusion and facilitate treatment of the occluded vessel by an endovascular procedure (paragraph [0003]). An orienting device (3800) may be designed to orient the device, wherein the orienting device comprises a stiffening stylet (3820, “tension member” which comprises a metallic ribbon or multifilament fiber which provides controllable tensioning/stiffening of the orienting element (3840); Figures 38A,B) and an adjustment mechanism including a proximal collar (3846), a distal collar (3844), and a pair of hinged arms (3842), wherein the proximal collar (3846) is coupled to the stiffening stylet (paragraphs [0196]-[0197], paragraph [0198], referring to the collar (3846) being slidably disposed and connected to the tension member (3820; “stiffening stylet”) by suitable means, thus the proximal collar (3846) is coupled to the stiffening stylet (3820); paragraphs [0181], [0200], referring to the wings being associated with hinge points, and therefore the pair of wings (3842) correspond to the pair of “hinged arms”); Figures 38A,B), wherein actuation of the adjustment mechanism (i.e. via releasing or pulling on the tension member (3820) relative to the shaft (3810), paragraphs [0199], [0204]) moves the proximal collar (3846) in a (i) proximal direction which moves the stiffening stylet (3820) in a proximal direction relative to a distal tip of the medical instrument (See Figure 38A, wherein the stiffening stylet (3820) which is attached to the collar (3846) is at a position that is in a proximal direction/location relative to a distal tip of the medical instrument) or (ii) a distal direction which moves the stiffening stylet (3820) in a distal direction relative to the distal tip of the medical instrument (see Figure 38B, wherein the stiffening stylet (3820) which is attached to the collar (3846) is at a position that is in a more distal direction/location relative to a distal tip of the medical instrument than its position in Figure 38A) (paragraphs [0119]-[0120]; paragraphs [0198]-[0199], referring to actuating the orienting element (3840) by longitudinal displacement of the tension member (3820; stiffening stylet), wherein pulling on the tension member relative to the shaft (3810) causes the orienting element (3840) to expand, and conversely, releasing the tension member (3820) relative to the shaft (3810) causes the orienting element (3840 to collapse by elastic recovery of the wings; Figures 38A,B). At the time of the invention, it would have been obvious to one of ordinary skill in the art to have the system of the modified copending application further comprise a stiffening stylet; and an adjustment mechanism as claimed, as taught by Kugler et al., in order to orient the medical instrument and/or to provide orienting wings that can be controlled to expand and contract (paragraphs [0119]-[0120], [0198]-[0199]).
Claims 2 of the copending application meets the limitations of claim 8 of the instant application.
Claim 3 of the copending application meets the limitations of claim 9 of the instant application.
Claims 4 of the copending application meets the limitations of claim 10 of the instant application.
Claim 12 of the copending application meets the limitations of claim 13 of the instant application.
This is a provisional nonstatutory double patenting rejection.
Claims 1, 8 and 13 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 11 of US Patent No. 12,490,937 in view of Ding et al. and Kugler et al..
With regards to claim 1, claim 1 of the Patent meets most of the limitations of claim 1 of the instant application (i.e. a medical instrument/device comprising an optical fiber having one or more core fibers, a console including one or more processors to cause operations including providing incident light signal to the optical fiber, receiving reflected light signals of different spectral widths, processing the reflected light signals, determining a location of a distal tip of the medical instrument (i.e. via determining a location of the portion of the optical fiber). However, they do not specifically disclose that the medical instrument is configured to be manipulated in order to direct the distal tip in a particular direction. Ding et al. disclose that their medical instrument, which comprises an optical fiber having one or more core fibers, is configured to be manipulated in order to direct the distal tip in a particular direction, thus controlling a surgical tool to carry out one or more surgical tasks autonomously and provide the ability to confine the surgical tool within a boundary defined related to tracked anatomy (Abstract; paragraphs [0051]-[0053], [0055], referring to the sensor (122) being coupled to various portions of a surgical robot, including an end effector, wherein a robotic device includes one or more actuators coupled to the end effector and the robotic device is configured to control the end effector (e.g., a surgical tool) in six degrees of freedom, and thus the medical instrument (i.e. surgical tool, end effector) can be manipulated/controlled in order to direct the distal tip in a particular direction; Figure 1). At the time of the invention, it would have been obvious to one of ordinary skill in the art to have the medical instrument of the copending application be configured to be manipulated in order to direct the distal tip in a particular direction, as taught by Ding et al., in order to control the medical instrument to carry out one or more surgical tasks autonomously and provide the ability to confine the medical instrument within a boundary defined related to tracked anatomy (paragraph [0052]). However, the modified copending application does not specifically disclose their system further comprises a stiffening stylet; and an adjustment mechanism as claimed. Kugler et al. disclose endovascular devices and methods which may be used to cross a chronic total occlusion and facilitate treatment of the occluded vessel by an endovascular procedure (paragraph [0003]). An orienting device (3800) may be designed to orient the device, wherein the orienting device comprises a stiffening stylet (3820, “tension member” which comprises a metallic ribbon or multifilament fiber which provides controllable tensioning/stiffening of the orienting element (3840); Figures 38A,B) and an adjustment mechanism including a proximal collar (3846), a distal collar (3844), and a pair of hinged arms (3842), wherein the proximal collar (3846) is coupled to the stiffening stylet (paragraphs [0196]-[0197], paragraph [0198], referring to the collar (3846) being slidably disposed and connected to the tension member (3820; “stiffening stylet”) by suitable means, thus the proximal collar (3846) is coupled to the stiffening stylet (3820); paragraphs [0181], [0200], referring to the wings being associated with hinge points, and therefore the pair of wings (3842) correspond to the pair of “hinged arms”); Figures 38A,B), wherein actuation of the adjustment mechanism (i.e. via releasing or pulling on the tension member (3820) relative to the shaft (3810), paragraphs [0199], [0204]) moves the proximal collar (3846) in a (i) proximal direction which moves the stiffening stylet (3820) in a proximal direction relative to a distal tip of the medical instrument (See Figure 38A, wherein the stiffening stylet (3820) which is attached to the collar (3846) is at a position that is in a proximal direction/location relative to a distal tip of the medical instrument) or (ii) a distal direction which moves the stiffening stylet (3820) in a distal direction relative to the distal tip of the medical instrument (see Figure 38B, wherein the stiffening stylet (3820) which is attached to the collar (3846) is at a position that is in a more distal direction/location relative to a distal tip of the medical instrument than its position in Figure 38A) (paragraphs [0119]-[0120]; paragraphs [0198]-[0199], referring to actuating the orienting element (3840) by longitudinal displacement of the tension member (3820; stiffening stylet), wherein pulling on the tension member relative to the shaft (3810) causes the orienting element (3840) to expand, and conversely, releasing the tension member (3820) relative to the shaft (3810) causes the orienting element (3840 to collapse by elastic recovery of the wings; Figures 38A,B). At the time of the invention, it would have been obvious to one of ordinary skill in the art to have the system of the Patent further comprise a stiffening stylet; and an adjustment mechanism as claimed, as taught by Kugler et al., in order to orient the medical instrument and/or to provide orienting wings that can be controlled to expand and contract (paragraphs [0119]-[0120], [0198]-[0199]).
Claims 1 of the Patent meets the limitations of claim 8 of the Patent.
Claim 11 of the copending application meets the limitations of claim 13 of the Patent.
This is a provisional nonstatutory double patenting rejection.
Claims 1, 8 and 13 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 15 of copending Application No. 17/945,934 in view of Ding et al. and Kugler et al.
With regards to claim 1, claim 1 of the copending application meets most of the limitations of claim 1 of the instant application (i.e. a medical instrument/device comprising an optical fiber having one or more core fibers, a console including one or more processors to cause operations including providing incident light signal to the optical fiber, receiving reflected light signals of different spectral widths, processing the reflected light signals, determining a location of a distal tip of the medical instrument (i.e. via determining at least one a position, shape and an orientation of the medical device). However, they do not specifically disclose that the medical instrument is configured to be manipulated in order to direct the distal tip in a particular direction. Ding et al. disclose that their medical instrument, which comprises an optical fiber having one or more core fibers, is configured to be manipulated in order to direct the distal tip in a particular direction, thus controlling a surgical tool to carry out one or more surgical tasks autonomously and provide the ability to confine the surgical tool within a boundary defined related to tracked anatomy (Abstract; paragraphs [0051]-[0053], [0055], referring to the sensor (122) being coupled to various portions of a surgical robot, including an end effector, wherein a robotic device includes one or more actuators coupled to the end effector and the robotic device is configured to control the end effector (e.g., a surgical tool) in six degrees of freedom, and thus the medical instrument (i.e. surgical tool, end effector) can be manipulated/controlled in order to direct the distal tip in a particular direction; Figure 1). At the time of the invention, it would have been obvious to one of ordinary skill in the art to have the medical instrument of the copending application be configured to be manipulated in order to direct the distal tip in a particular direction, as taught by Ding et al., in order to control the medical instrument to carry out one or more surgical tasks autonomously and provide the ability to confine the medical instrument within a boundary defined related to tracked anatomy (paragraph [0052]). However, the modified copending application does not specifically disclose their system further comprises a stiffening stylet; and an adjustment mechanism as claimed. Kugler et al. disclose endovascular devices and methods which may be used to cross a chronic total occlusion and facilitate treatment of the occluded vessel by an endovascular procedure (paragraph [0003]). An orienting device (3800) may be designed to orient the device, wherein the orienting device comprises a stiffening stylet (3820, “tension member” which comprises a metallic ribbon or multifilament fiber which provides controllable tensioning/stiffening of the orienting element (3840); Figures 38A,B) and an adjustment mechanism including a proximal collar (3846), a distal collar (3844), and a pair of hinged arms (3842), wherein the proximal collar (3846) is coupled to the stiffening stylet (paragraphs [0196]-[0197], paragraph [0198], referring to the collar (3846) being slidably disposed and connected to the tension member (3820; “stiffening stylet”) by suitable means, thus the proximal collar (3846) is coupled to the stiffening stylet (3820); paragraphs [0181], [0200], referring to the wings being associated with hinge points, and therefore the pair of wings (3842) correspond to the pair of “hinged arms”); Figures 38A,B), wherein actuation of the adjustment mechanism (i.e. via releasing or pulling on the tension member (3820) relative to the shaft (3810), paragraphs [0199], [0204]) moves the proximal collar (3846) in a (i) proximal direction which moves the stiffening stylet (3820) in a proximal direction relative to a distal tip of the medical instrument (See Figure 38A, wherein the stiffening stylet (3820) which is attached to the collar (3846) is at a position that is in a proximal direction/location relative to a distal tip of the medical instrument) or (ii) a distal direction which moves the stiffening stylet (3820) in a distal direction relative to the distal tip of the medical instrument (see Figure 38B, wherein the stiffening stylet (3820) which is attached to the collar (3846) is at a position that is in a more distal direction/location relative to a distal tip of the medical instrument than its position in Figure 38A) (paragraphs [0119]-[0120]; paragraphs [0198]-[0199], referring to actuating the orienting element (3840) by longitudinal displacement of the tension member (3820; stiffening stylet), wherein pulling on the tension member relative to the shaft (3810) causes the orienting element (3840) to expand, and conversely, releasing the tension member (3820) relative to the shaft (3810) causes the orienting element (3840 to collapse by elastic recovery of the wings; Figures 38A,B). At the time of the invention, it would have been obvious to one of ordinary skill in the art to have the system of the modified copending application further comprise a stiffening stylet; and an adjustment mechanism as claimed, as taught by Kugler et al., in order to orient the medical instrument and/or to provide orienting wings that can be controlled to expand and contract (paragraphs [0119]-[0120], [0198]-[0199]).
Claims 1 of the copending application meets the limitations of claim 8 of the instant application.
Claim 15 of the copending application meets the limitations of claim 13 of the instant application.
This is a provisional nonstatutory double patenting rejection.
Claims 1 and 8 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 17/952,645 in view of Ding et al. and Kugler et al..
With regards to claim 1, claim 1 of the copending application meets most of the limitations of claim 1 of the instant application (i.e. a medical instrument/device comprising an optical fiber having one or more core fibers, a console including one or more processors to cause operations including providing incident light signal to the optical fiber, receiving reflected light signals of different spectral widths, processing the reflected light signals, determining a location of a distal tip of the medical instrument (i.e. via determining a live 3D shape of the elongate probe during insertion of the elongate probe within a patient body). However, they do not specifically disclose that the medical instrument is configured to be manipulated in order to direct the distal tip in a particular direction. Ding et al. disclose that their medical instrument, which comprises an optical fiber having one or more core fibers, is configured to be manipulated in order to direct the distal tip in a particular direction, thus controlling a surgical tool to carry out one or more surgical tasks autonomously and provide the ability to confine the surgical tool within a boundary defined related to tracked anatomy (Abstract; paragraphs [0051]-[0053], [0055], referring to the sensor (122) being coupled to various portions of a surgical robot, including an end effector, wherein a robotic device includes one or more actuators coupled to the end effector and the robotic device is configured to control the end effector (e.g., a surgical tool) in six degrees of freedom, and thus the medical instrument (i.e. surgical tool, end effector) can be manipulated/controlled in order to direct the distal tip in a particular direction; Figure 1). At the time of the invention, it would have been obvious to one of ordinary skill in the art to have the medical instrument of the copending application be configured to be manipulated in order to direct the distal tip in a particular direction, as taught by Ding et al., in order to control the medical instrument to carry out one or more surgical tasks autonomously and provide the ability to confine the medical instrument within a boundary defined related to tracked anatomy (paragraph [0052]). However, the modified copending application does not specifically disclose their system further comprises a stiffening stylet; and an adjustment mechanism including a proximal collar, a distal collar, and a pair of hinged arms, wherein the proximal collar is coupled to the stiffening stylet, wherein: actuation of the adjustment mechanism as claimed. Kugler et al. disclose endovascular devices and methods which may be used to cross a chronic total occlusion and facilitate treatment of the occluded vessel by an endovascular procedure (paragraph [0003]). An orienting device (3800) may be designed to orient the device, wherein the orienting device comprises a stiffening stylet (3820, “tension member” which comprises a metallic ribbon or multifilament fiber which provides controllable tensioning/stiffening of the orienting element (3840); Figures 38A,B) and an adjustment mechanism including a proximal collar (3846), a distal collar (3844), and a pair of hinged arms (3842), wherein the proximal collar (3846) is coupled to the stiffening stylet (paragraphs [0196]-[0197], paragraph [0198], referring to the collar (3846) being slidably disposed and connected to the tension member (3820; “stiffening stylet”) by suitable means, thus the proximal collar (3846) is coupled to the stiffening stylet (3820); paragraphs [0181], [0200], referring to the wings being associated with hinge points, and therefore the pair of wings (3842) correspond to the pair of “hinged arms”); Figures 38A,B), wherein actuation of the adjustment mechanism (i.e. via releasing or pulling on the tension member (3820) relative to the shaft (3810), paragraphs [0199], [0204]) moves the proximal collar (3846) in a (i) proximal direction which moves the stiffening stylet (3820) in a proximal direction relative to a distal tip of the medical instrument (See Figure 38A, wherein the stiffening stylet (3820) which is attached to the collar (3846) is at a position that is in a proximal direction/location relative to a distal tip of the medical instrument) or (ii) a distal direction which moves the stiffening stylet (3820) in a distal direction relative to the distal tip of the medical instrument (see Figure 38B, wherein the stiffening stylet (3820) which is attached to the collar (3846) is at a position that is in a more distal direction/location relative to a distal tip of the medical instrument than its position in Figure 38A) (paragraphs [0119]-[0120]; paragraphs [0198]-[0199], referring to actuating the orienting element (3840) by longitudinal displacement of the tension member (3820; stiffening stylet), wherein pulling on the tension member relative to the shaft (3810) causes the orienting element (3840) to expand, and conversely, releasing the tension member (3820) relative to the shaft (3810) causes the orienting element (3840 to collapse by elastic recovery of the wings; Figures 38A,B). At the time of the invention, it would have been obvious to one of ordinary skill in the art to have the system of the modified copending application further comprise a stiffening stylet; and an adjustment mechanism as claimed, as taught by Kugler et al., in order to orient the medical instrument and/or to provide orienting wings that can be controlled to expand and contract (paragraphs [0119]-[0120], [0198]-[0199]).
Claims 1 of the copending application meets the limitations of claim 8 of the instant application.
This is a provisional nonstatutory double patenting rejection.
Claims 1, 8 and 13 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 15 of copending Application No. 17/955,019 in view of Ding et al. and Kugler et al.
With regards to claim 1, claim 1 of the copending application meets most of the limitations of claim 1 of the instant application (i.e. a medical instrument/device comprising an optical fiber having one or more core fibers, a console including one or more processors to cause operations including providing incident light signal to the optical fiber, receiving reflected light signals of different spectral widths, processing the reflected light signals, determining a location of a distal tip of the medical instrument (i.e. via determining a 3D shape of the optical fiber and displaying an image of the 3D shape). However, they do not specifically disclose that the medical instrument is configured to be manipulated in order to direct the distal tip in a particular direction. Ding et al. disclose that their medical instrument, which comprises an optical fiber having one or more core fibers, is configured to be manipulated in order to direct the distal tip in a particular direction, thus controlling a surgical tool to carry out one or more surgical tasks autonomously and provide the ability to confine the surgical tool within a boundary defined related to tracked anatomy (Abstract; paragraphs [0051]-[0053], [0055], referring to the sensor (122) being coupled to various portions of a surgical robot, including an end effector, wherein a robotic device includes one or more actuators coupled to the end effector and the robotic device is configured to control the end effector (e.g., a surgical tool) in six degrees of freedom, and thus the medical instrument (i.e. surgical tool, end effector) can be manipulated/controlled in order to direct the distal tip in a particular direction; Figure 1). At the time of the invention, it would have been obvious to one of ordinary skill in the art to have the medical instrument of the copending application be configured to be manipulated in order to direct the distal tip in a particular direction, as taught by Ding et al., in order to control the medical instrument to carry out one or more surgical tasks autonomously and provide the ability to confine the medical instrument within a boundary defined related to tracked anatomy (paragraph [0052]). However, the modified copending application does not specifically disclose their system further comprises a stiffening stylet; and an adjustment mechanism as claimed. Kugler et al. disclose endovascular devices and methods which may be used to cross a chronic total occlusion and facilitate treatment of the occluded vessel by an endovascular procedure (paragraph [0003]). An orienting device (3800) may be designed to orient the device, wherein the orienting device comprises a stiffening stylet (3820, “tension member” which comprises a metallic ribbon or multifilament fiber which provides controllable tensioning/stiffening of the orienting element (3840); Figures 38A,B) and an adjustment mechanism including a proximal collar (3846), a distal collar (3844), and a pair of hinged arms (3842), wherein the proximal collar (3846) is coupled to the stiffening stylet (paragraphs [0196]-[0197], paragraph [0198], referring to the collar (3846) being slidably disposed and connected to the tension member (3820; “stiffening stylet”) by suitable means, thus the proximal collar (3846) is coupled to the stiffening stylet (3820); paragraphs [0181], [0200], referring to the wings being associated with hinge points, and therefore the pair of wings (3842) correspond to the pair of “hinged arms”); Figures 38A,B), wherein actuation of the adjustment mechanism (i.e. via releasing or pulling on the tension member (3820) relative to the shaft (3810), paragraphs [0199], [0204]) moves the proximal collar (3846) in a (i) proximal direction which moves the stiffening stylet (3820) in a proximal direction relative to a distal tip of the medical instrument (See Figure 38A, wherein the stiffening stylet (3820) which is attached to the collar (3846) is at a position that is in a proximal direction/location relative to a distal tip of the medical instrument) or (ii) a distal direction which moves the stiffening stylet (3820) in a distal direction relative to the distal tip of the medical instrument (see Figure 38B, wherein the stiffening stylet (3820) which is attached to the collar (3846) is at a position that is in a more distal direction/location relative to a distal tip of the medical instrument than its position in Figure 38A) (paragraphs [0119]-[0120]; paragraphs [0198]-[0199], referring to actuating the orienting element (3840) by longitudinal displacement of the tension member (3820; stiffening stylet), wherein pulling on the tension member relative to the shaft (3810) causes the orienting element (3840) to expand, and conversely, releasing the tension member (3820) relative to the shaft (3810) causes the orienting element (3840 to collapse by elastic recovery of the wings; Figures 38A,B). At the time of the invention, it would have been obvious to one of ordinary skill in the art to have the system of the modified copending application further comprise a stiffening stylet; and an adjustment mechanism including a proximal collar, a distal collar, and a pair of hinged arms, wherein the proximal collar is coupled to the stiffening stylet, wherein: actuation of the adjustment mechanism moves the proximal collar in (1) a proximal direction which moves the stiffening stylet in a proximal direction relative to a distal tip of the medical instrument, or (ii) a distal direction which moves the stiffening stylet in a distal direction relative to the distal tip of the medical instrument, as taught by Kugler et al., in order to orient the medical instrument and/or to provide orienting wings that can be controlled to expand and contract (paragraphs [0119]-[0120], [0198]-[0199]).
Claims 1 of the copending application meets the limitations of claim 8 of the instant application.
Claim 15 of the copending application meets the limitations of claim 13 of the instant application.
This is a provisional nonstatutory double patenting rejection.
Claims 1, 8 and 13 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 7 of copending Application No. 17/965,657 in view of Ding et al. and Kugler et al.
With regards to claim 1, claim 1 of the copending application meets most of the limitations of claim 1 of the instant application (i.e. a medical instrument/device comprising an optical fiber having one or more core fibers, a console including one or more processors to cause operations including providing incident light signal to the optical fiber, receiving reflected light signals of different spectral widths, processing the reflected light signals, determining a location of a distal tip of the medical instrument (i.e. via determining a first 3D shape extending along a length including at least portions of the first optical fiber and the second optical fiber). However, they do not specifically disclose that the medical instrument is configured to be manipulated in order to direct the distal tip in a particular direction. Ding et al. disclose that their medical instrument, which comprises an optical fiber having one or more core fibers, is configured to be manipulated in order to direct the distal tip in a particular direction, thus controlling a surgical tool to carry out one or more surgical tasks autonomously and provide the ability to confine the surgical tool within a boundary defined related to tracked anatomy (Abstract; paragraphs [0051]-[0053], [0055], referring to the sensor (122) being coupled to various portions of a surgical robot, including an end effector, wherein a robotic device includes one or more actuators coupled to the end effector and the robotic device is configured to control the end effector (e.g., a surgical tool) in six degrees of freedom, and thus the medical instrument (i.e. surgical tool, end effector) can be manipulated/controlled in order to direct the distal tip in a particular direction; Figure 1). At the time of the invention, it would have been obvious to one of ordinary skill in the art to have the medical instrument of the copending application be configured to be manipulated in order to direct the distal tip in a particular direction, as taught by Ding et al., in order to control the medical instrument to carry out one or more surgical tasks autonomously and provide the ability to confine the medical instrument within a boundary defined related to tracked anatomy (paragraph [0052]). However, the modified copending application does not specifically disclose their system further comprises a stiffening stylet; and an adjustment mechanism as claimed. Kugler et al. disclose endovascular devices and methods which may be used to cross a chronic total occlusion and facilitate treatment of the occluded vessel by an endovascular procedure (paragraph [0003]). An orienting device (3800) may be designed to orient the device, wherein the orienting device comprises a stiffening stylet (3820, “tension member” which comprises a metallic ribbon or multifilament fiber which provides controllable tensioning/stiffening of the orienting element (3840); Figures 38A,B) and an adjustment mechanism including a proximal collar (3846), a distal collar (3844), and a pair of hinged arms (3842), wherein the proximal collar (3846) is coupled to the stiffening stylet (paragraphs [0196]-[0197], paragraph [0198], referring to the collar (3846) being slidably disposed and connected to the tension member (3820; “stiffening stylet”) by suitable means, thus the proximal collar (3846) is coupled to the stiffening stylet (3820); paragraphs [0181], [0200], referring to the wings being associated with hinge points, and therefore the pair of wings (3842) correspond to the pair of “hinged arms”); Figures 38A,B), wherein actuation of the adjustment mechanism (i.e. via releasing or pulling on the tension member (3820) relative to the shaft (3810), paragraphs [0199], [0204]) moves the proximal collar (3846) in a (i) proximal direction which moves the stiffening stylet (3820) in a proximal direction relative to a distal tip of the medical instrument (See Figure 38A, wherein the stiffening stylet (3820) which is attached to the collar (3846) is at a position that is in a proximal direction/location relative to a distal tip of the medical instrument) or (ii) a distal direction which moves the stiffening stylet (3820) in a distal direction relative to the distal tip of the medical instrument (see Figure 38B, wherein the stiffening stylet (3820) which is attached to the collar (3846) is at a position that is in a more distal direction/location relative to a distal tip of the medical instrument than its position in Figure 38A) (paragraphs [0119]-[0120]; paragraphs [0198]-[0199], referring to actuating the orienting element (3840) by longitudinal displacement of the tension member (3820; stiffening stylet), wherein pulling on the tension member relative to the shaft (3810) causes the orienting element (3840) to expand, and conversely, releasing the tension member (3820) relative to the shaft (3810) causes the orienting element (3840 to collapse by elastic recovery of the wings; Figures 38A,B). At the time of the invention, it would have been obvious to one of ordinary skill in the art to have the system of the modified copending application further comprise a stiffening stylet; and an adjustment mechanism as claimed, as taught by Kugler et al., in order to orient the medical instrument and/or to provide orienting wings that can be controlled to expand and contract (paragraphs [0119]-[0120], [0198]-[0199]).
Claims 1 of the copending application meets the limitations of claim 8 of the instant application.
Claim 7 of the copending application meets the limitations of claim 13 of the instant application.
This is a provisional nonstatutory double patenting rejection.
Claims 1, 8 and 13 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 17 and 18 of copending Application No. 17/971,873 in view of Ding et al. and Kugler et al..
With regards to claim 1, claims 1 and 18 of the copending application meets most of the limitations of claim 1 of the instant application (i.e. a medical instrument/device comprising an optical fiber having one or more core fibers, a console including one or more processors to cause operations including providing incident light signal to the optical fiber, receiving reflected light signals of different spectral widths, processing the reflected light signals, determining a location of a distal tip of the medical instrument (i.e. via determining a 3D shape of the optical fiber and defining a reference plane in accordance with the predetermined subshape of the 3D shape, wherein an image of the 3D shape is displayed [claim 18]). However, they do not specifically disclose that the medical instrument is configured to be manipulated in order to direct the distal tip in a particular direction. Ding et al. disclose that their medical instrument, which comprises an optical fiber having one or more core fibers, is configured to be manipulated in order to direct the distal tip in a particular direction, thus controlling a surgical tool to carry out one or more surgical tasks autonomously and provide the ability to confine the surgical tool within a boundary defined related to tracked anatomy (Abstract; paragraphs [0051]-[0053], [0055], referring to the sensor (122) being coupled to various portions of a surgical robot, including an end effector, wherein a robotic device includes one or more actuators coupled to the end effector and the robotic device is configured to control the end effector (e.g., a surgical tool) in six degrees of freedom, and thus the medical instrument (i.e. surgical tool, end effector) can be manipulated/controlled in order to direct the distal tip in a particular direction; Figure 1). At the time of the invention, it would have been obvious to one of ordinary skill in the art to have the medical instrument of the copending application be configured to be manipulated in order to direct the distal tip in a particular direction, as taught by Ding et al., in order to control the medical instrument to carry out one or more surgical tasks autonomously and provide the ability to confine the medical instrument within a boundary defined related to tracked anatomy (paragraph [0052]). However, the modified copending application does not specifically disclose their system further comprises a stiffening stylet; and an adjustment mechanism as claimed. Kugler et al. disclose endovascular devices and methods which may be used to cross a chronic total occlusion and facilitate treatment of the occluded vessel by an endovascular procedure (paragraph [0003]). An orienting device (3800) may be designed to orient the device, wherein the orienting device comprises a stiffening stylet (3820, “tension member” which comprises a metallic ribbon or multifilament fiber which provides controllable tensioning/stiffening of the orienting element (3840); Figures 38A,B) and an adjustment mechanism including a proximal collar (3846), a distal collar (3844), and a pair of hinged arms (3842), wherein the proximal collar (3846) is coupled to the stiffening stylet (paragraphs [0196]-[0197], paragraph [0198], referring to the collar (3846) being slidably disposed and connected to the tension member (3820; “stiffening stylet”) by suitable means, thus the proximal collar (3846) is coupled to the stiffening stylet (3820); paragraphs [0181], [0200], referring to the wings being associated with hinge points, and therefore the pair of wings (3842) correspond to the pair of “hinged arms”); Figures 38A,B), wherein actuation of the adjustment mechanism (i.e. via releasing or pulling on the tension member (3820) relative to the shaft (3810), paragraphs [0199], [0204]) moves the proximal collar (3846) in a (i) proximal direction which moves the stiffening stylet (3820) in a proximal direction relative to a distal tip of the medical instrument (See Figure 38A, wherein the stiffening stylet (3820) which is attached to the collar (3846) is at a position that is in a proximal direction/location relative to a distal tip of the medical instrument) or (ii) a distal direction which moves the stiffening stylet (3820) in a distal direction relative to the distal tip of the medical instrument (see Figure 38B, wherein the stiffening stylet (3820) which is attached to the collar (3846) is at a position that is in a more distal direction/location relative to a distal tip of the medical instrument than its position in Figure 38A) (paragraphs [0119]-[0120]; paragraphs [0198]-[0199], referring to actuating the orienting element (3840) by longitudinal displacement of the tension member (3820; stiffening stylet), wherein pulling on the tension member relative to the shaft (3810) causes the orienting element (3840) to expand, and conversely, releasing the tension member (3820) relative to the shaft (3810) causes the orienting element (3840 to collapse by elastic recovery of the wings; Figures 38A,B). At the time of the invention, it would have been obvious to one of ordinary skill in the art to have the system of the modified copending application further comprise a stiffening stylet; and an adjustment mechanism as claimed, as taught by Kugler et al., in order to orient the medical instrument and/or to provide orienting wings that can be controlled to expand and contract (paragraphs [0119]-[0120], [0198]-[0199]).
Claims 1 of the copending application meets the limitations of claim 8 of the instant application.
Claim 17 of the copending application meets the limitations of claim 13 of the instant application.
This is a provisional nonstatutory double patenting rejection.
Claims 1 and 8 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 8 of copending Application No. 17/725,394 in view of Ding et al. and Kugler et al..
With regards to claim 1, claim 8 of the copending application meets most of the limitations of claim 1 of the instant application (i.e. a medical instrument/device comprising an optical fiber having one or more core fibers, a console including one or more processors to cause operations including providing incident light signal to the optical fiber, receiving reflected light signals of different spectral widths, processing the reflected light signals, determining a location of a distal tip of the medical instrument (i.e. via determining the physical state of the curved distal tip of the elongate probe which is inserted into a patient body). However, they do not specifically disclose that the medical instrument is configured to be manipulated in order to direct the distal tip in a particular direction. Ding et al. disclose that their medical instrument, which comprises an optical fiber having one or more core fibers, is configured to be manipulated in order to direct the distal tip in a particular direction, thus controlling a surgical tool to carry out one or more surgical tasks autonomously and provide the ability to confine the surgical tool within a boundary defined related to tracked anatomy (Abstract; paragraphs [0051]-[0053], [0055], referring to the sensor (122) being coupled to various portions of a surgical robot, including an end effector, wherein a robotic device includes one or more actuators coupled to the end effector and the robotic device is configured to control the end effector (e.g., a surgical tool) in six degrees of freedom, and thus the medical instrument (i.e. surgical tool, end effector) can be manipulated/controlled in order to direct the distal tip in a particular direction; Figure 1). At the time of the invention, it would have been obvious to one of ordinary skill in the art to have the medical instrument of the copending application be configured to be manipulated in order to direct the distal tip in a particular direction, as taught by Ding et al., in order to control the medical instrument to carry out one or more surgical tasks autonomously and provide the ability to confine the medical instrument within a boundary defined related to tracked anatomy (paragraph [0052]). However, the modified copending application does not specifically disclose their system further comprises a stiffening stylet; and an adjustment mechanism as claimed. Kugler et al. disclose endovascular devices and methods which may be used to cross a chronic total occlusion and facilitate treatment of the occluded vessel by an endovascular procedure (paragraph [0003]). An orienting device (3800) may be designed to orient the device, wherein the orienting device comprises a stiffening stylet (3820, “tension member” which comprises a metallic ribbon or multifilament fiber which provides controllable tensioning/stiffening of the orienting element (3840); Figures 38A,B) and an adjustment mechanism including a proximal collar (3846), a distal collar (3844), and a pair of hinged arms (3842), wherein the proximal collar (3846) is coupled to the stiffening stylet (paragraphs [0196]-[0197], paragraph [0198], referring to the collar (3846) being slidably disposed and connected to the tension member (3820; “stiffening stylet”) by suitable means, thus the proximal collar (3846) is coupled to the stiffening stylet (3820); paragraphs [0181], [0200], referring to the wings being associated with hinge points, and therefore the pair of wings (3842) correspond to the pair of “hinged arms”); Figures 38A,B), wherein actuation of the adjustment mechanism (i.e. via releasing or pulling on the tension member (3820) relative to the shaft (3810), paragraphs [0199], [0204]) moves the proximal collar (3846) in a (i) proximal direction which moves the stiffening stylet (3820) in a proximal direction relative to a distal tip of the medical instrument (See Figure 38A, wherein the stiffening stylet (3820) which is attached to the collar (3846) is at a position that is in a proximal direction/location relative to a distal tip of the medical instrument) or (ii) a distal direction which moves the stiffening stylet (3820) in a distal direction relative to the distal tip of the medical instrument (see Figure 38B, wherein the stiffening stylet (3820) which is attached to the collar (3846) is at a position that is in a more distal direction/location relative to a distal tip of the medical instrument than its position in Figure 38A) (paragraphs [0119]-[0120]; paragraphs [0198]-[0199], referring to actuating the orienting element (3840) by longitudinal displacement of the tension member (3820; stiffening stylet), wherein pulling on the tension member relative to the shaft (3810) causes the orienting element (3840) to expand, and conversely, releasing the tension member (3820) relative to the shaft (3810) causes the orienting element (3840 to collapse by elastic recovery of the wings; Figures 38A,B). At the time of the invention, it would have been obvious to one of ordinary skill in the art to have the system of the modified copending application further comprise a stiffening stylet; and an adjustment mechanism as claimed, as taught by Kugler et al., in order to orient the medical instrument and/or to provide orienting wings that can be controlled to expand and contract (paragraphs [0119]-[0120], [0198]-[0199]).
Claim 8 of the copending application meets the limitations of claim 8 of the instant application.
This is a provisional nonstatutory double patenting rejection.
Claims 1-3, 7-10, 12-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6, 7, 9-16 and 19 of U.S. Patent No.12,220,219. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of the instant application is generic to all that is recited in claim 1 of the Patent. That is, claim 1 of the Patent falls entirely within the scope of instant claim 1 of the Patent, or in other words, instant claim 1 is anticipated by claim 1 of the Patent. Specifically, because claim 1 of the Patent claims the same steps (i.e. providing a medical instrument, an adjustment mechanism, providing an incident light signal, receiving reflected light signals, processing the reflected light signals, determining a location and directing the distal tip), as claimed in instant claim 1, the method of instant claim 1 is anticipated by claim 1 of the Patent.
With regards to instant claim 2, claim 2 of the Patent sets forth the same limitations.
With regards to instant claim 3, claim 6 of the Patent sets forth the same limitations.
With regards to instant claim 7, claim 11 of the Patent sets forth the same limitations.
With regards to instant claim 8, claim 3 of the Patent sets forth the same limitations.
With regards to instant claim 9, claim 4 of the Patent sets forth the same limitations.
With regards to instant claim 10, claim 5 of the Patent sets forth the same limitations.
With regards to instant claim 12, claim 9 of the Patent sets forth the same limitations.
With regards to instant claim 13, claim 7 of the Patent sets forth the same limitations.
With regards to instant claim 14, claim 10 of the Patent sets forth the same limitations.
With regards to instant claim 15, claim 12 of the Patent sets forth the same limitations.
With regards to instant claim 16, claim 13 of the Patent sets forth the same limitations.
With regards to instant claim 17, claim 14 of the Patent sets forth the same limitations.
With regards to instant claim 18, claim 15 of the Patent sets forth the same limitations.
With regards to instant claim 19, claim 16 of the Patent sets forth the same limitations.
With regards to instant claim 20, claim 19 of the Patent sets forth the same limitations.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE L FERNANDEZ whose telephone number is (571)272-1957. The examiner can normally be reached Monday-Friday 9:00 AM - 5:30 PM (ET).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Pascal Bui-Pho can be reached at (571) 272-2714. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/KATHERINE L FERNANDEZ/ Primary Examiner, Art Unit 3798
Prosecution Insights