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 statement (IDS) submitted on 10/03/2024 has been considered by the examiner.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claim 4 is objected to because of the following informalities:
Claim 4 recites “wherein the intravascular guidewire comprises plurality of conductive members establish electrical communication between the sensor and the connector” in lines 1-3. This should read “wherein the intravascular guidewire comprises a plurality of conductive members establishing electrical communication between the sensor and the connector”.
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 4, 7-12, and 14 are 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.
Regarding claim 4, the claim recites “wherein the intravascular guidewire comprises plurality of conductive members establish electrical communication between the sensor and the connector” in lines 1-3. It is unclear whether the plurality of conductive members includes the conductive member recited in lines 12-14 of claim 1. The conductive member of claim 1 has similar functional limitations of the plurality of conductive members of claim 4. Clarification is requested.
For the purposes of examination, the claim is interpreted as “wherein the intravascular guidewire comprises a plurality of conductive members establishing electrical communication between the sensor and the connector, wherein the plurality of conductive members includes the conductive member”.
Regarding claim 7, the claim recites “the distal core” in line 5. There is insufficient antecedent basis for the limitation “the distal core” in the claim. Clarification is requested.
For the purposes of examination, the claim is interpreted as “the distal core wire”.
Regarding claim 14, the claim recites “wherein the electrical trace comprises at least one of a conductive ink, metal disposition, electroplating”. This recitation renders the claim indefinite as it is unclear how the electrical trace can comprise metal disposition or electroplating. It is further unclear what material or component that metal disposition refers to. Metal disposition may be a misspelling of metal deposition, a process of layering metal onto surfaces. Electroplating comprises a method of coating a metal with another metal. “Metal disposition” and electroplating may be considered to be examples of methods used to create electrical traces, but the structure of the electrical trace cannot comprise a method, and therefore the claim is rendered indefinite. Clarification is requested.
For the purposes of examination, the claim is interpreted as “wherein the electrical trace comprises at least one of a conductive ink, three-dimensional printed conductive polymer or metal, or extruded conductive material, or is formed by metal deposition or electroplating.
Further regarding claim 14, the claim recites “the apparatus of claim 11, wherein the electrical trace…”. There is insufficient antecedent basis for the limitation “the electrical trace”. The first recitation of an electrical trace is present in claim 13. Clarification is requested.
For the purposes of examination, claim 14 is interpreted as being dependent on claim 13.
All claims not explicitly addressed above are rejected under 35 U.S.C. 112(b) are rejected by virtue of their dependency on a rejected base claim.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-8, 9-10, and 12-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Patent Publication 2014/0005543 by Burkett et al., hereinafter “Burkett”.
Regarding claim 1, Burkett teaches an apparatus (Fig. 6, intravascular device 200), comprising: an intravascular guidewire (intravascular device 200) comprising: a flexible elongate member configured to be positioned within a blood vessel of a patient (Fig. 6 is a guidewire, which comprises a flexible elongate member. See par. [0032]), wherein the flexible elongate member comprises a proximal portion (proximal portion 202) and a distal portion (distal portion 206), wherein the proximal portion comprises a proximal core wire (core 246) and the distal portion comprises a distal core wire (core 226); a sensor disposed at the distal portion of the flexible elongate member ([0061]; component 220 may be a pressure sensor and is disposed at the distal portion), wherein the sensor is configured to obtain medical data related to the blood vessel while the flexible elongate member is positioned within the blood vessel ([0060]; Intravascular device 200 is configured to be inserted within human vasculature, and therefore the component 200 is configured to obtain readings related to its environment, which would be human vasculature.); a connector disposed at the proximal portion of the flexible elongate member ([0069, 0071]; Conductive bands 248 can comprise a connector, such as those discussed in Figs. 7-16) and a conductive member establishing electrical communication between the sensor and the connector ([0063]; Communication cable 232), wherein the conductive member is continuous between sensor and the connector ([0063, 0069]; Communication cable 232 is coupled to component 220 at the distal end and the proximal portion of the cable is coupled to the conductive bands (i.e., connector). [0063]; The cable 232 extends along the length of the intravascular device 200 from the proximal portion 202 to the distal portion 206, and must be continuous to provide electrical communication along this path).
Regarding claim 2, Burkett teaches the apparatus of claim 1, wherein a distal portion of the conductive member is directly coupled to the sensor ([0063]; “the distal end of the communication cable 232 is coupled to the component 220”).
Regarding claim 3, Burkett teaches the apparatus of claim 1, wherein the connector comprises a conductive band ([0069, 0071]; The proximal connectors can comprise conductive bands 248), wherein a proximal portion of the conductive member is directly coupled to the conductive band ([0069]; “Proximal portions of the communication cable 232 are coupled to the conductive bands 248.”).
Regarding claim 4, Burkett teaches the apparatus of claim 1, wherein the intravascular guidewire comprises plurality of conductive members establish electrical communication between the sensor and the connector ([0063]; “it is understood that all and/or portions of each of the proximal, middle, and/or distal portions 202, 204, 206 of the intravascular device 200 may have cross-sectional profiles as shown in FIGS. 2-5”. Figs. 2-5 teach cross-sectional profiles with a trifilar structure of cable 232. Therefore, cable 232 comprises 3 conductors or wires. See Pars. [0044 and 0053]), wherein each conductive member of the plurality of conductive members is continuous between the sensor and the connector (The three conductors or wires are a part of cable 232, which is continuous between the sensor and the connector (See the rejection of claim 1)).
Regarding claim 5, Burkett teaches the apparatus of claim 1, wherein a distal portion of the proximal core wire is coupled to a proximal portion of the distal core wire at a location along a length of the flexible elongate member ([0067, 0070] The proximal portion of core 226 is couple to the distal portion of core 246 through the core 238. Core 238 is coupled to the core 226 and core 246 in the middle portion 204 (i.e., the location along a length of the flexible elongate member)), wherein the conductive member is continuous across the location (Fig. 6 depicts the cable 232 running through the middle portion 240).
Regarding claim 6, Burkett teaches the apparatus of claim 5, wherein the location comprises a tubular member ([0063]; The proximal, middle, and distal portions may have cross-sectional profiles as shown in FIGG. 2-5. In the case that each portion has the same cross-sectional profiles as shown in FIG. 5. The tubular member can be considered layer 134, as it is circular in cross-section and has a length, defining a tube.), wherein the distal portion of the proximal core wire and the proximal portion of the distal core wire are disposed inside of the tubular member ([0067, 0070]; the cores are coupled, and if each section has the same cross section, the cores would be coupled within the tubular member, as the core of Fig. 5 (core 172) is inside the tubular member 134.), wherein the conductive member is disposed outside of the tubular member (Fig. 5, the trifilar cable 232 is outside of layer 134).
Regarding claim 7, Burkett teaches the apparatus of claim 1, wherein the flexible elongate member further comprises a first polymer layer disposed over the proximal core wire and the distal core wire ([0063]; The proximal, middle, and distal portions may have cross-sectional profiles as shown in FIGG. 2-5. In the case that each portion has the same cross-sectional profiles as shown in FIG. 5. [0059]; The lumen 133 can be filled with an adhesive such as polyurethane or silicone, which are polymers), wherein the first polymer layer is configured to provide insulation for the conductive member from the proximal core wire and the distal core ([0059]; The layer 133 can be considered an insulator between the core and the trifilar, as the polymer occupies space between the core and trifilar. Because this cross-sectional profile can be used in the proximal and distal sections, the layer 133 provides the insulation of the conductive member from the proximal core wire and the distal core wire. It is noted that silicone can act as an insulator.).
Regarding claim 8, Burkett teaches the apparatus of claim 7, wherein the intravascular guidewire further comprises a sensor mount (Fig. 6, [0061]; mounting structure 218), wherein the sensor is coupled to the sensor mount ([0061]; “The mounting structure 218 is configured to receive and securely hold a component 220.”), wherein the first polymer layer is disposed over the sensor mount (the adhesive 230 is analogous to the material within the lumen 133 (i.e., first polymer layer), as it is the adhesive within the cross section of the distal portion. [0062] teaches that the adhesive 230 may be the same as the adhesive 222, which is used to secure the mounting structure. Because the adhesive 222 secures the mounting structure, it is considered to be around (i.e., disposed over) the sensor mount).
Regarding claim 10, Burkett teaches the apparatus of claim 7, wherein the flexible elongate member further comprises a second polymer layer disposed over the conductive member (FIG. 5, [0057]; Each conductor or wire is wrapped with an insulating layer (156, 157, and 158), which may comprise polymers such as polyimide, polyurethane, nylon, polyethylene, polypropylene, etc.).
Regarding claim 12, Burkett teaches the apparatus of claim 10, wherein, in a cross-section, a perimeter of the conductive member is completely surrounded by at least one of the first polymer layer or the second polymer layer (Fig. 5, the insulating layer (156, 157, and 158) (i.e., second polymer layer) completely surrounds the trifilar (153, 154, and 155)).
Regarding claim 13, Burkett teaches the apparatus of claim 1, wherein the conductive member comprises an electrical trace. Applicant defines an electrical trace as “comprises at least one of a conductive ink, metal disposition, electroplating, three-dimensional printed conductive polymer or metal, or extruded conductive material” in par. [0007] of the published application. The conductors/wires 153, 154, and 155, which correspond to cable 232, may be formed of any suitable conductive material). Therefore, the conductive member of Burkett comprises a conductive material.
Furthermore, regarding claim 13, the term “extruded” of the claimed phrase “extruded conductive material” is being treated as a product-by-process limitation and a product-by-process claim is not limited to the manipulations of the recited steps, only the structure implied by the steps. Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. Therefore, even though Burkett is silent as to the process used to create the conductive member (i.e., extrusion), the conductive member of Burkett would be the same or similar as that claimed, since both applicant’s product and the prior art product is made of a conductive material.
Regarding claim 14, Burkett teaches the apparatus of claim 13, wherein the electrical trace comprises at least one of a conductive ink, metal disposition, electroplating, three-dimensional printed conductive polymer or metal, or extruded conductive material (See the rejection of claim 13).
Regarding claim 15, Burkett teaches the apparatus of claim 1, wherein the sensor comprises at least one of a pressure sensor or a flow sensor ([0061]; component 220 may be a pressure sensor).
Regarding claim 16, Burkett teaches an apparatus (See the rejection of claim 1), comprising: an intravascular guidewire (See the rejection of claim 1) comprising: a flexible elongate member configured to be positioned within a blood vessel of a patient (See the rejection of claim 1), wherein the flexible elongate member comprises a proximal portion and a distal portion (See the rejection of claim 1), wherein the proximal portion comprises a proximal core wire and the distal portion comprises a distal core wire (See the rejection of claim 1), wherein proximal core wire is coupled to the distal core wire at a location along a length of the flexible elongate member (See the rejection of claim 5); at least one of a pressure sensor or a flow sensor disposed at the distal portion of the flexible elongate member (See the rejection of claims 1 and 15), wherein at least one of the pressure sensor or the flow sensor is configured to obtain at least one of pressure data or flow data, respectively, related to the blood vessel while the flexible elongate member is positioned within the blood vessel (See the rejection of claims a and 15); a connector disposed at the proximal portion of the flexible elongate member (See the rejection of claim 1); and a conductive member establishing electrical communication between the sensor and the connector (See the rejection of claim 1), wherein the conductive member is continuous between sensor and the connector, including across the location (See the rejection of claim 5).
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.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Burkett, as applied to claim 8, in view of US Patent Publication 2017/0059908 by Radman et al., hereinafter “Radman”.
Regarding claim 9, Burkett teaches the apparatus of claim 8, but does not teach wherein the first polymer layer comprises an opening exposing the sensor.
Radman teaches an intravascular device comprising a guidewire and a pressure sensor disposed at the distal end of the guidewire. The guidewire comprises one or more slots (i.e., openings) that defines a path from the exterior of the device to the pressure sensor. The slots allow the length of the distal portion to be shorter than typical sensor mounts or hypotubes that would need to have a length sufficient for a suitable opening/hole (e.g., a suitable “large” opening/hole) to be formed therein that provides fluid access to the sensor ([0088]).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the apparatus of Burkett such that the intravascular device comprises a slot extending to the pressure sensor and exposing the sensor, in order to allow for a shorter distal portion while allowing fluid access to the sensor, as taught by Radman ([0088]). This modification would extend through the first polymer layer, as this layer is disposed around the sensor mount to hold the sensor in place.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Burkett, as applied to claim 10, in view of US Patent Publication 2015/0273187 by Richardson – cited by Applicant, hereinafter “Richardson”.
Burkett the apparatus of claim 10, but does not teach wherein the flexible elongate member further comprises a hydrophilic coating disposed over the second polymer layer.
Richardson teaches an intravascular device comprising a core wire and a pressure sensor. Richardson teaches applying a final coating on the outer surface of the guidewire with a suitable hydrophilic coating. The hydrophilic coating can be added in order to provide lubricity to the outer surface of the guidewire ([0035]).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the apparatus of Burkett, such that the flexible elongate member further comprises a hydrophilic coating disposed over the second polymer layer, to provide lubricity to the device, as taught by Richardson ([0035]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US Patent Publication 2019/0046118 by Burkett et al. teaches an apparatus comprising a guidewire with a plurality of conductive elements and multiple polymer layers that insulate a core wire from the conductors.
US Patent Publication 2014/0187972 by Burkett teaches an apparatus comprising a guidewire with a plurality of conductive elements and multiple polymer layers that insulate a core wire from the conductors.
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/NELSON ALEXANDER GLOVER/Examiner, Art Unit 3791
/ADAM J EISEMAN/Primary Examiner, Art Unit 3791
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