DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 10/22/2025, 01/21/2026, and 04/22/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements have been considered by the examiner.
Claim Objections
Claim 1 objected to because of the following informalities: line 7 recites: “each the plurality of sensors”, should read as “each of the plurality of sensors”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-18 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 1 is rejected because it recites “receiving reflected light signals of different spectral widths of the received incident light by the plurality of sensor”, in lines 18-19. It is unclear if the “light signals of different spectral widths of the received incident light” is the same light signal as “the light signal of a different spectral width based on received incident light”, as previously recited in lines 9-10. For examination purposes, the examiner assumes the reflected light signal of a different spectral width based on received incident light is the same as reflected light signals of different spectral widths of the received incident light. Further, there appears to be a lack of antecedent basis regarding “the received incident light” in lines 18-19. Although the claim does refer to received incident light in lines 9-10, the examiner has interpreted this received incident light as a general configuration of the plurality of sensors, while the limitations of lines 17-21 are steps of the operation initiated by the console. Therefore, since the operation steps do not explicitly claim receiving incident light, “the” should be omitted for “the received incident light” in lines 18-19. Additionally, for consistency, the examiner suggest amending lines 18-19 to: “receiving reflected light signals of different spectral widths based on received incident light by the plurality of sensors; and”, such that the limitation is similar to that of lines 9-10, and the antecedent issue would be remedied.
Claims 2-18 are rejected because they inherit deficiencies by nature of its/their dependency on claim 1.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-3, 7, and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over US2021/0045814 to Thompson et al. “Thompson”, in view of US2003/0045798 to Hular et al. “Hular”.
Regarding claim 1, Thompson teaches a medical device system (shape-sensing system, Abstract; Paragraphs 0004, 0050, 0059), comprising:
a stylet (optical-fiber stylet, Abstract; Paragraph 0050; Paragraph 0061, Fig. 4B, Ref. 424), comprising:
an optical fiber (Paragraph 0052, multi-core optical fiber), including:
a plurality of core fibers (multi-core optical fiber, with multiple cores, which reads on a plurality of core fibers) each of the plurality of core fibers including a plurality of sensors (Paragraph 0052, each core fiber utilizes a plurality of sensors) each the plurality of sensors configured to:
reflect a light signal of a different spectral width based on received incident light (Paragraph 0052, each sensor is configured to reflect a different spectral range of the incident light (e.g., different light frequency range)); and
change a characteristic of the reflected light signal based on a condition experienced by the stylet (Paragraph 0052, Based on the type and degree of strain asserted on the each core fiber, the sensors associated with that core fiber may alter (shift) the wavelength of the reflected light to convey the type and degree of stain on that core fiber at those locations of the stylet occupied by the sensors); and
a console (Fig. 3, Ref. 240; Paragraph 0060) operatively coupled to the stylet (Paragraph 0050, the stylet is the medical device; Paragraph 0060, medical device connected to the console via the optical-fiber connector module), the console including one or more processors (Paragraphs 0047, hardware processor, and 0057, processor) and a non-transitory computer-readable medium having stored thereon logic that, when executed by the one or more processors, causes operations (Paragraphs 0047, the term logic may refer to or include software such as one or more processes, one or more instances, Application Programming Interface(s) (API), subroutine(s), function(s), applet(s), servlet(s), routine(s), source code, object code, shared library/dynamic link library (dll), or even one or more instructions. This software may be stored in any type of a suitable non-transitory storage medium, or transitory storage medium; also see Paragraph 0057) comprising:
providing an incident light signal to the optical fiber (Paragraphs 0011, 0050, optical interrogator is configured to send input optical signals into the optical-fiber stylet; Paragraph 0060, wherein the optical interrogator is integrated with the console);
receiving reflected light signals of different spectral widths of the received incident light by the plurality of sensors (Paragraph 0069, optical interrogator receive returned optical signals, namely reflected light signals received from optical fiber-based reflective gratings (sensors) fabricated within each of the core fibers deployed within a stylet, catheter, guidewire, etc… The reflected light signals associated with different spectral widths include reflected light signals provided from sensors positioned in the center core fiber of a multi-core optical fiber of the stylet); and
processing the reflected light signals associated with the plurality of core fibers to determine a physical state of the stylet (Paragraph 0064, the algorithms 246 may include shape sensing logic configured to compare wavelength shifts measured by sensors deployed in each outer core fiber at the same measurement region of the stylet, catheter or guidewire (or same spectral width) to the wavelength shift at the center core fiber positioned along central axis and operating as a neutral axis of bending. From these analytics, the shape sensing logic may determine the shape the core fibers have taken in 3D space and may further determine the current physical state of the stylet; see also Paragraph 0093).
However, Thompson does not explicitly disclose an electrically conductive concentric tube configured to transmit electrical signals; and wherein the plurality of core fibers are within the concentric tube.
Hular teaches in a similar field of endeavor of a needle with a plurality of sensors (Abstract). As see in Fig. 2B, the elongate body 200 of the needle is a concentric tube, and contains a plurality of optical fibers (210, 220, 230, and 240) (See also Paragraphs 0056 and 0060). Hular further discloses that the elongate body 200 is electrically conducting, and acts as an impedance sensor (Paragraph 0066) that measures multiple frequencies of impedance (Paragraph 0067), and implies transmitting electrical signals, since the measured electrical signal must be transmitted somewhere before being received by the controller (Paragraph 0088) [Examiner notes that Hular is not clear regarding the exact path which the electrical signals measured/received by the sensor/elongate body travels to the controller, however Hular does disclose in Paragraph 0088 that such a signal does reach the controller, and therefore the impedance sensor/elongate body does transmit the measure electrical signal).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified Thompson’s invention, wherein the stylet includes an electrically conductive concentric tube configured to transmit electrical signals; and wherein the plurality of core fibers are within the concentric tube, as taught by Hular, in order to include an impedance sensor as part of the plurality of sensors of Thompson. Having a impedance sensor as part of the plurality of sensors allow the stylet to measure the electrical properties of tissue that comes into contact with the stylet (Paragraph 0066).
Regarding claim 2, the modifications of Thompson and Hular disclose all the features of claim 1 above.
Thompson further discloses wherein the physical state of the stylet is selected from the group consisting of a three-dimensional (3D) shape of the stylet, a temperature experienced by the stylet, a pressure exerted on the stylet, a fluid flow adjacent the stylet, and combinations thereof (Paragraphs 0051, shape length, shape, and or form, which reads on the 3D shape; Paragraph 0064, shape in 3D space; Paragraphs 0024, 0066, blood flow adjacent to the stylet).
Regarding claim 3, the modifications of Thompson and Hular disclose all the features of claim 2 above.
Thompson discloses wherein: the condition experienced by the stylet is a strain (Paragraph 0051, a change in signal characteristics of the reflected light signal returned from the sensor, where wavelength shift is correlated to (mechanical) strain on the core fiber), and determining the physical state includes processing the reflected light signals associated with the plurality of core fibers to determine the 3D shape (Paragraph 0064, From these analytics, the shape sensing logic may determine the shape the core fibers have taken in 3D space and may further determine the current physical state of the stylet).
Regarding claim 7, the modifications of Thompson and Hular disclose all the features of claim 1 above.
Thompson discloses wherein the plurality of sensors are distributed along a longitudinal length of the optical fiber (Paragraph 0024, having a number of FBG sensors along at least a distal end portion of the optical fiber style; See Fig. 4B, sensors 426a, 426b, and 426c, along the length of the optical fiber stylet, and can have more sensors along the length, i.e. “n number of sensors”, see Paragraph 0075).
Regarding claim 17, the modifications of Thompson and Hular disclose all the features of claim 1 above.
Thompson further teaches a catheter, wherein the stylet is disposed in a lumen of the catheter (See Fig. 4B, stylet 424 disposed within a lumen of a catheter tube 312; see also Paragraphs 0073 and 0074).
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Thompson, in view of Hular, as applied to claim 3 above, and further in view of US2019/0059743 to Ramachandran et al. “Ramachandran”.
Regarding claim 4, the modifications of Thompson and Hular disclose all the features of claim 3 above.
Thompson discloses wherein determining the physical state of the stylet further includes processing the reflected light signals associated with the plurality of core fibers (Paragraph 0051, a change in signal characteristics of the reflected light signal returned from the sensor, where wavelength shift is correlated to (mechanical) strain on the core fiber; Paragraph 0054, Information associated with the reflected light signals may be used to determine a three-dimensional representation of the physical state of the stylet within the body of a patient).
However, the modifications of Thompson and Hular do not disclose wherein the processing of the reflected light signals is to determine the temperature experienced by the device.
Ramachandran discloses a similar fiber optic probe (optical fiber, Abstract; Paragraph 0022-23, medical device or instrument 102 with a shape/temperature sensing device 104 integrated with device 102; wherein the sensing device 104 includes fiber optics, and fiber optic Bragg grating sensors). Ramachadran teaches based on the optical fiber sensed temperature induced strain (Paragraph 0004), determining one or more temperatures of the device (Paragraphs 0004, 0005).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system as described by Thompson and Hular, wherein the processing of the reflected light signals is to determine the temperature experienced by the device, as taught by Ramachandran, in order to be able to determine temperature information such that it can be visualized relative to the subject/patient (Ramachandran, Paragraph 0005).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Thompson, in view of Hular, as applied to claim 1 above, and further in view of US2011/0137126 to French et al. “French”.
Regarding claim 5, the modifications of Thompson and Hular disclose all the features of claim 1 above.
However, the modifications of Thompson and Hular do not disclose wherein the stylet further comprises a lens, and wherein the lens is configured to focus a projected illuminating light.
French teaches in a similar field of endeavor of an endoscope with optical fibers (Abstract). French teaches a lens (Paragraph 0056, objective lens 18) at the distal end of the endoscope (See Fig. 2, position of Ref. 18; also see Paragraph 0007, objective lens translated relative to distal end) wherein the lens is for focusing (Paragraph 0007, focus adjustment) the illumination light that emerges from the distal end (Paragraphs 0056-57, 0089).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system as described by Thompson and Hular, wherein the device further comprises a lens, and wherein the lens is configured to focus a projected illuminating light, as taught by French, in order to be able to adjust (such as depth scanning) and focus the light from the light source to the region of interest (French, Paragraph 0007).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Thompson, in view of Hular, and further in view of French, as applied to claim 5 above, and further in view of US5649897 to Nakamura et al. “Nakamura”.
Regarding claim 6, the modifications of Thompson, Hular, and French disclose all the features of claim 5 above.
French further teaches wherein an imaging light is an emanation of the projected illuminating light (Abstract, Paragraph 0012, light source generate coherent incident light and transmitted to the distal end of the imaging optical fibers; Paragraph 0007, output at the distal end is relayed by the objective lens to scan a focused beam across the sample). French additionally teaches causing a phase shift between the projected illuminating light and the imaging light (spatial light modulator, SLPM, adjusts the relative phase of light for each optical fiber individually, Paragraph 0012, and enables optical wavefronts emerging from the distal end of the fiber bundle to be synthesized, controlled and scanned, Paragraph 0013; wherein the optical bundle transmits imaging light, Paragraph 0012, 0056, and illumination light, Paragraph 0056). Therefore phase shifting the relative phase of each individual fiber of the fiber bundle that consists of imaging light and illumination light would read on phase shifting between the illuminating light and imaging light.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the device as described by Thompson, Hular, and French, wherein an imaging light is an emanation of the projected illuminating light and a phase shift occurs in the light emerging/projected out of the distal end consisting of the illumination light and the imaging light, as taught by French, in order to enable optical wavefronts emerging from the distal end of the fiber bundle to be synthesized, controlled and scanned (French, Paragraph0012), which allows the light to be focused across the sample such that the sample can be imaged (French, Paragraph 0007).
However, the modifications of Thompson, Hular, and French do not teach wherein the lens is configured to cause the phase shift.
Nakamura (US5649897 to Nakamura et al. “Nakamura”) teaches a similar device of an endoscope with optical fiber (col. 2, lines 30-32) for transmitting illumination light (col. 5, and 44-48) and generate image data (col. 2, lines 26-27). Nakamura teaches wherein the lens is configured to cause a phase shift between two lights (phase shifter 101, which seen in Fig. 2 is at the distal end of endoscope 1000; as seen in a similar embodiment in Fig. 7, the phase shifter 101 is held by the lens barrel 100a, which would infer that the phase shifter 101 is part of a distal lens assembly; the phase shifter 101 is for correcting any nonuniformity of the intensities of two polarized light components, col. 10, paragraph starting at line 35).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the device as described by Thompson, Hular, and French, wherein the lens is configured to cause the phase shift, as taught by Nakamura, in order to correct for any nonuniformity in the different light components (Nakamura, col. 10, paragraph starting at line 35).
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Thompson, in view of Hular, as applied to claim 1 above, and further in view of US2004/0111020 to “Long”.
Regarding claim 8, the modifications of Thompson and Hular disclose all the features of claim 1 above.
However, the modifications of Thompson and Hular do not disclose wherein the stylet includes a seal configured to prevent fluid contact with the optical fiber.
Long teaches a medical device comprising an elongate probe configured for insertion into a patient body, the elongate probe including a lumen (Long, [0008]: elongate flexible member that "can be advanced through a body lumen" and that "can include visualization means, light means, and channels for fluids (gas or liquid) and instruments"). Long further teaches wherein the elongate probe (elongate flexible member) includes a seal configured to prevent fluid exchange between the patient body and lumens (channels) in the elongate probe (Long, Figs. 11 and 12, [0079]: "In each of the embodiments ... one or more seals may be provided, as desired, to restrict gas or liquid flow through or around the flexible member 230.... For instance ... it may desirable to provide a seal in association with guide tracks 242 and 244, and in channel 800 to prevent air from passing through the guide tracks or the channel 800.").
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified Younge incorporating Wallace to incorporate the teachings of Long to configure a seal on the elongate probe. One would be motivated to do so to prevent fluid exchange between the patient body and the lumen or lumens of the elongate probe (Long, Paragraph 0079).
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Thompson, in view of Hular, as applied to claim 1 above, and further in view of US2016/0166341 to Iordachita et al. to “Iordachita”.
Regarding claim 9, the modifications of Thompson and Hular disclose all the features of claim 1 above.
Thompson discloses wherein the stylet includes a main section coupled to a distal tip section (See Fig. 3, catheter tube section 312 reads on the distal tip section, and the portions proximal to the bifurcated hub 314, including the connecting fiber connection module 120, which allows for connection to the console 240, would read on the main section).
However, the modifications of Thompson and Hular do not disclose the distal tip section having a length between about 20 mm and 80 mm.
Iordachita, hereinafter Iordachita.) teaches an elongate medical instrument (Iordachita, Figs. 15A-15B and [0131]: dexterous continuum manipulator DCM) with shape sensors(Fig.15A, FBG optical fiber; Fig. 15B, S51 and S52), wherein the elongate medical instrument includes a main section (Fig. 15B, Proximal end) coupled with a distal tip section (Fig. 15A, Distal end; Fig. 15B, DCM bending segment), the distal tip section having a length of 35 mm ([0131], [0140]).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device as described by Thompson and Hular, to use a distal tip section having a length of about 35 mm, as taught by Iordachita, since Iordachita teaches the length as being a design choice (Paragraph 0140); other lengths can be used) and Applicant's disclosure does not give any specific reasoning for the claimed dimension. Thus, the claimed dimension is considered a design choice that would only require a change in size, which would be routine to one of ordinary skill in the art. (See MPEP 2144.04: In Gardner v. TEC Syst., Inc.).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Thompson, in view of Hular, and further in view of Iordachita, as applied to claim 9 above, and further in view of US2015/0119724 to Weber et al. “Weber”.
Regarding claim 10, the modifications of Thompson, Hular, and Iordachita disclose all the features of claim 9 above.
However the modifications of Thompson, Hular, and Iordachita do not disclose wherein the distal tip section is coupled with the main section via one or more of an adhesive, a weld, or a friction fit.
Weber teaches wherein the distal tip section is coupled with the main probe section via an adhesive or welding (Weber [0101], Fig. 1: "For example, in some instances the distal tip 24 may be secured to the inner tubular member 14, outer tubular member 13, or other portion of the catheter shaft 12, for example, by laser welding, hot jaws, or other thermal bonding method, an adhesive bonding method, or other bonding method if desired.").
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device as described by Thompson, Hular, and Iordachita, wherein the distal tip section of Thompson, is coupled with the bifurcated hub that is part of the main section, via one or more of an adhesive, a weld, or a friction fit, as taught by Weber, since Weber teaches these as being design choices (Weber, Paragraph 0101) and would require only routine skill of one of ordinary skill in the art to couple two structural elements.
Claim(s) 11-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Thompson, in view of Hular, and further in view of Iordachita, as applied to claim 9 above, and further in view of US2006/0100610 to Wallace et al. “Wallace”.
Regarding claim 11 and 12, the modifications of Thompson, Hular, and Iordachita disclose all the features of claim 9 above.
However, the modifications of Thompson, Hular, and Iordachita do not disclose wherein the distal tip section defines a greater flexibility in bending than the main section, and wherein the distal tip section includes a varying flexibility in bending along the length.
Wallace teaches (Paragraph 0346) teaches a similar elongated guide instrument (Abstract). Wallace teaches wherein the distal tip section defines a greater flexibility in bending than the main section (Paragraph 0346, working length of guide instrument catheter member is about 92 cm, and the most distal 122 mm are significantly more flexible or bendable than the proximal portions, wherein the proximal portion of the guide instrument catheter includes a guide instrument base, that does not appear to be flexible), and wherein the distal tip section includes a varying flexibility in bending along the length (Paragraph 0346, the most distal 122 mm of which are significantly more flexible or bendable than the proximal portion, and the very distal 2 mm comprises a soft tapered distal tip of an even more [plyable] polymeric material; which would read on three varying zones of flexibility).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the device as described by Thompson, Hular, and Iordachita, wherein the distal tip section defines a greater flexibility in bending than the main section, and wherein the distal tip section includes a varying flexibility in bending along the length, as taught by Wallace, in order to facilitate more dramatic bendability at the distal portion of the device (Wallace, Paragraph 0193).
Regarding claim 13, the modifications of Thompson, Hular, Iordachita, and Wallace disclose all the features of claim 12 above.
As disclosed in the claim 12 rejection above, Wallace teaches wherein the distal tip section includes a first flexibility in bending adjacent a proximal end of the distal tip section transitioning toward a second flexibility in bending adjacent a distal end of the distal tip section, and wherein the second flexibility in bending is greater than the first flexibility in bending (Paragraph 0346, the most distal 122 mm of which are significantly more flexible or bendable than the proximal portion, and the very distal 2 mm comprises a soft tapered distal tip of an even more [plyable] polymeric material; which would read on three varying zones of flexibility).
Regarding claim 14, the modifications of Thompson, Hular, and Iordachita disclose all the features of claim 9 above.
However, the modifications of Thompson, Hular, and Iordachita do not disclose the stylet includes an actuator adjacent a proximal end; the actuator is operatively coupled with the distal tip section; and the actuator is configured to laterally deflect the distal tip section between a first shape and a second shape based on manipulation of the actuator, the second shape different from the first shape.
Wallace teaches the device the includes an actuator adjacent a proximal end; the actuator is operatively coupled with the distal tip section (Paragraph 0346, four control elements fastened to a single distal ring, and connected to a servorobtoic instrument driver for omnidirectional distal tip navigation; Paragraph 0341, wherein the distal ring is located at the distal tip of the steerable instrument such as a catheter; and the control elements are located in guide instrument base, similar to what is shown in Fig. 103.1-103.6, which has the guide instrument base, located at the proximal end of the flexible device); and the actuator is configured to laterally deflect the distal tip section between a first shape and a second shape based on manipulation of the actuator, the second shape different from the first shape (the control mechanism of Paragraph 0346 allows for omnidirectional movement of the distal tip, which would include at least a first shape and a second shape).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Thompson, Hular, and Iordachita, to include an actuator adjacent a proximal end; the actuator is operatively coupled with the distal tip section; and the actuator is configured to laterally deflect the distal tip section between a first shape and a second shape based on manipulation of the actuator, the second shape different from the first shape, as taught by Wallace, in order to provide omnidirectional movement for the distal tip (Wallace, Paragraph 0346).
Claim(s) 15 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Thompson, in view of Hular, and further in view of Iordachita, as applied to claim 9 above, and further in view of US2016/0256228 to Haartsen et al. “Haartsen”, and further in view of US5653759 to Hogan et al. “Hogan”.
Regarding claim 15, the modifications of Thompson, Hular, and Iordachita disclose all the features of claim 9 above.
However, the modifications of Thompson, Hular, and Iordachita do not disclose wherein the distal tip section includes a shape memory material.
Haartsen teaches an interventional instrument, preferably a catheter (5), with a bendable portion (12) and an optical shape sensing fiber (10) (Paragraph 0038- 0040, Figs. 2-4). The bendable portion of the catheter comprises a shape memory alloy (Fig. 2, Ref. 11, SMA wire; Paragraph 0039).
Resistive heating of the SMA wire is used to cause the SMA wire to change shape and as a result to cause the catheter to bend. Haartsen also teaches that the bending is controlled based on the degree of bending that is determined using the optical shape sensing fiber, and that the degree of bending can be determined very accurately (Paragraphs 0014, 0049).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Thompson, Hular, and Iordachita to incorporate the teachings of Haartsen , wherein the distal tip section includes a shape memory material, as taught by Haartsen, in order to control the bending of the distal tip by temperature/heat (Haartsen, Paragraph 0014, 0040).
However, the modifications of Thompson, Hular, Iordachita, and Haartsen do not explicitly disclose the shape memory material having a shape transition temperature between about 20°C and 37°C.
Hogan teaches a similar device of a catheter with deformable, thermoelastic shape-memory alloy rods (Abstract). Hogan teaches the shape memory material having a shape transition temperature between about 20°C and 37°C (Col. 11, Paragraph starting at line 1, preferred temperature transition phase occurs in the range from about 30°C - 35°C; which is between the claimed range of 20°C and 37°C).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system as described by Thompson, Hular, Iordachita, and Haartsen, wherein the shape memory material having a shape transition temperature between about 20°C and 37°C, as taught by Hogan, because it is dictated by the demands of the human body which maintains a normal temperature at about 37°C and having a transition range such that the transformation of the shape of the shape-memory member occur at least by a temperature of 35°C to insure a safety margin of medical usefulness (Hogan, Col. 11, Paragraph starting at line 1).
Regarding claim 16, the modifications of Thompson, Hular, Iordachita, Haartsen, and Hogan teaches all the features of claim 15 above.
Hogan teaches wherein the distal tip section defines a first transition shape below the shape transition temperature and a second transition shape above the shape transition temperature, the second transition shape different from the first transition shape (see Figs 3A and 3B, of the shape memory wire 10, wherein in Fig. 3A at a temperature less than 25-35°C, the wire is in a first deformed shape configuration, and in Fig. 3B, the wire is transformed into a fixed memory shaped second configuration at an elevated temperature greater than 25-35°C.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the device as described by Thompson, Hular, Iordachita, Haartsen, and Hogan wherein the distal tip section defines a first transition shape below the shape transition temperature and a second transition shape above the shape transition temperature, the second transition shape different from the first transition shape, as taught by Hogan, in order to be able to insert the medical device into the body, and then based on the temperature, having the medical device transformed into a predetermined shape specific to a medical procedure.
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Thompson, in view of Hular, as applied to claim 1 above, and further in view of US2012/0321243 to Younge et al. “Younge”.
Regarding claim 18, the modifications of Thompson and Hular disclose all the features of claim 1 above.
However, the modifications of Thompson and Hular do not disclose wherein the optical fiber is attached to the stylet at an attachment point adjacent a distal end such that the optical fiber is unattached to the stylet except at the attachment point.
Younge teaches wherein the optical fiber is attached to an elongate probe at an attachment point adjacent the distal end such that the optical fiber is unattached to the elongate probe except at the attachment point (Paragraph 0077 "... in one variation of the embodiment depicted in FIG. 4A, the most distal constraint {30) may be configured to substantially constrain longitudinal or axial movement of the fiber (12) relative to the catheter body {33) at the location of such constraint {30), while the more proximal constraint {30) may merely act as a guide to lift the fiber (12) away from the walls of the lumen (31) at the location of such proximal constraint {30)."; therefore, this reads on the fiber 12 being only attached at the distal constraint 30, as seen in Fig. 4A).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the device as described by Thompson and Hular, wherein the optical fiber is attached to the stylet at an attachment point adjacent a distal end such that the optical fiber is unattached to the stylet except at the attachment point, as taught by Younge, in order to allow for free longitudinal or axial motion of the fiber relative to the proximal portion of the device/instrument (Younge, Paragraph 0077).
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 1-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. US12,318,149, in view of US2021/0045814 to Thompson et al. “Thompson”.
Regarding claim 1, ‘149 discloses a medical device system (claim 1, col. 18, line 10), comprising: an elongate probe (claim 1, col. 18, line 11), comprising: an optical fiber (claim 1, col. 18, line 15), including:
an electrically conductive concentric tube (claim 1, col. 18, line 51) configured to transmit electrical signals (claim 1, col. 18, lines 53-54); and
a plurality of core fibers (claim 1, col. 18, line 17) within the concentric tube (claim 1, col. 18, lines 16-18, wherein the plurality of core fibers are part of the optical fiber; and claim 1, col. 18, line 51, wherein the concentric tube extends along the optical fiber; the plurality of core fibers would have to be within the concentric tube), each of the plurality of core fibers including a plurality of sensors (claim 1, col. 18, line 19), each the plurality of sensors configured to:
reflect a light signal of a different spectral width based on received incident light (claim 1, col. 18, lines 21-23); and
change a characteristic of the reflected light signal based on a condition experienced by the elongate probe (claim 1, col. 18, lines 24-25); and
a console operatively coupled to the elongate probe (claim 1, col. 18, lines 26-27), the console including one or more processors and a non-transitory computer-readable medium having stored thereon logic that, when executed by the one or more processors, causes operations (claim 1, col. 18, lines 27-31) comprising:
providing an incident light signal to the optical fiber (claim 1, col. 18, line 34);
receiving reflected light signals of different spectral widths of the received incident light by the plurality of sensors (claim 1, col. 18, lines 35-37); and
processing the reflected light signals associated with the plurality of core fibers to determine a physical state (claim 1, col. 18, lines 38-40) of the elongate probe (claim 1, col. 18, lines 31-33).
However the claims of ‘149 do not explicitly disclose wherein the elongated device is a stylet.
Thompson teaches similar shape-sensing medical device (Abstract), wherein the medical device comprises an elongated body (see claim language of claim 22 wherein the medical device comprises a elongated body), and can be implemented as a stylet (see claim language of claim 24).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified ‘149 wherein the elongated device is a stylet, as taught by Thompson, in order to apply the sensing system to determine if a catheter in the vasculature such as a central venous catheter has become displaced (Paragraphs 0002, 0049-50).
The following is mapping between claims of the instant application to the claims
of the ‘149 patent:
Instant Application
‘149 Patent
1
1 + Thompson
2
2
3
3
4
4
5
5
6
6
7
1, col. 18, lines 19-20
8
12
9
7
10
8
11
9
12
10
13
11
14
13
15
14
16
15
17
16
18
1, col. 18, lines 41-44
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Milton Truong whose telephone number is (571)272-2158. The examiner can normally be reached 9AM - 5PM, MON-FRI.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Keith Raymond can be reached at (571) 270-1790. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MT/Examiner, Art Unit 3798
/KEITH M RAYMOND/Supervisory Patent Examiner, Art Unit 3798
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