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 .
Notice of Amendment
In response to the amendment filed on 9/11/2023, cancelled claims 1-57 and new claims 58-77 are acknowledged. Claims 58-77 remain pending.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
No claim limitation has been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 59-61 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
In particular, claim 59 recites the limitations “the sensor assembly is 2-3 cm in length” and “at least a distal portion of the sensor assembly is positioned within 25 mm of the distal tip”, which appear to disagree with the specific dimensions contemplated in the disclosure as originally filed. In particular, Figure 31 and p. 43, lines 20-25 describe a sensor assembly that is 3 mm long, p. 46, lines 4-10 describe housing 6 (which accommodates the sensors) as being between 2 mm and 5 mm in length, and p. 43, lines 20-25 describes distal end (i.e. the area between the distal tip and a distal portion of the sensor assembly) as being 3 cm long. That is, the disclosure appears to contemplate a sensor assembly that is 25 mm in length and a distal portion of the sensor assembly is positioned at least 3 cm from the distal tip. While the disclosure does contemplate other dimensions and is not specifically limited to only those listed above, the marked difference between the specifically claimed dimensions and what is described in the disclosure raise the question of whether this was intentional or merely a drafting error when the new claim set was filed. Clarification is requested.
Claims 60-61 are further rejected based on their dependence from claim 59.
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) 58, 63-66, 72, and 77 is/are rejected under 35 U.S.C. 103 as being unpatentable over Voeller et al. (US Publication No. 2014/0081244 A1) (cited by Applicant), further in view of Fleischhacker, Jr. (US Patent No. 5,984,877).
Regarding claim 58, Voeller et al. discloses a guidewire, comprising:
a solid elongated core (14, 1214) (see Figures 1 and 17);
a sensor assembly (24, 1224), wherein the sensor assembly comprises a sensor array configured to sense one or more characteristics of a biological structure contacting the sensor assembly (see [0038] – “A pressure sensor 24 may be disposed within coil 20 (e.g., at or near tip member 22). While pressure sensor 24 is shown schematically in FIG. 1, it can be appreciated that the structural form and/or type of pressure sensor 24 may vary. For example, pressure sensor 24 may include a semiconductor (e.g., silicon wafer) pressure senor, piezoelectric pressure sensor, a fiber optic or optical pressure sensor, a Fabry-Perot type pressure sensor, an ultrasound transducer and/or ultrasound pressure sensor, a magnetic pressure sensor, or the like, or any other suitable pressure sensor. To the extent applicable, any of the pressure sensors disclosed herein may be utilized in any of the medical devices disclosed herein, as appropriate”);
a plurality of wire leads (26, 28, 1226, 1228) coupled to and extending proximally from the sensor assembly (see Figures 1 and 17 and [0039] – “In at least some embodiments, one or more leads, for examples leads 26/28, may be attached to pressure sensor 24 and extend proximally therefrom. A portion of leads 26/28 may be disposed within coil 20 and/or along core wire 14”);
a coil (20, 1220), wherein the coil surrounds a distal portion of the solid elongated core, and the plurality of wire leads are positioned between the solid elongated core and the coil (see Figures 1 and 17 and [0039] – “A portion of leads 26/28 may be disposed within coil 20 and/or along core wire 14” and [0071] – “Coil 1220 may be coupled to core wire 1214. For example, coil 1220 may be disposed about distal portion 1218 and attached to core wire 1214 at a joint 1258”); and
a jacket (1236) enclosing a proximal portion of the solid elongated core, wherein the plurality of wire leads are positioned between the solid elongated core and the jacket, wherein a distal portion of the jacket and a proximal portion of the coil overlap (see Figure 17 and [0071] – “Tubular member 1236 may be coupled to core wire 1214. In at least some embodiments, tubular member 1236 may be positioned over at least a portion of coil 1220”).
It is noted Voeller et al. does not specifically teach the coil is a multi-filar coil comprising one or more wires. However, Fleischhacker, Jr. teaches the coil is a multi-filar coil comprising one or more wires (see col. 2, lines 9-15 – “The spring guide wire is wound as a multifilar structure consists of a plurality of wires, preferably four wires. At least one of the wires consists of a highly radiopaque material, such as platinum or a platinum alloy. The resulting spring guide wire shows under fluoroscopy as a relatively faint, but viewable perceptible trace along the length of the guide wire”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the guidewire of Voeller et al. to include a multi-filar coil comprising one or more wires, as disclosed in Fleischhacker, Jr., so as to provide a guidewire having a radiopaque marking that is both flexible and easily implemented while at the same time having minimum or negligible impact on the handling characteristics of the resulting guidewire (see Fleischhacker, Jr.: col. 1, line 66-col. 2, line 3).
Regarding claim 59 as best understood, Voeller et al. teaches at least a distal portion of the sensor assembly is positioned within 25 mm of the distal tip (see [0038] – “A pressure sensor 24 may be disposed within coil 20 (e.g., at or near tip member 22)”). Neither Voeller et al. nor Fleischhacker, Jr. specifically teach the sensor assembly is 2-3 cm in length. It would have been an obvious matter of design choice to make the sensor assembly have a length of 2-3 cm, since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
Regarding claim 61, Voeller et al. in view of Fleischhacker, Jr. teaches the solid elongated core is tapered at a distal end of the solid elongated core (see Voeller et al.: [0037] – “Distal portion 18 may be tapered or otherwise include one or more tapers and/or tapered sections” and Fleischhacker, Jr.: col. 4, lines 34-38 – “Along the major length of a guide wire 40, core wire 52 has a first relatively large diameter cross section 54 to facilitate control of the distal end. Core wire 52 is of a decreasing cross section 56 and tapers toward the distal tip 58”).
Regarding claim 63, Voeller et al. in view of Fleischhacker, Jr. teaches the multi-filar coil is positioned between the jacket and the solid elongated core (see Voeller et al.: Figure 17 and [0071] – “In at least some embodiments, tubular member 1236 may be positioned over at least a portion of coil 1220”).
Regarding claim 64, Voeller et al. in view of Fleischhacker, Jr. teaches the one or more wires of the multi-filar coil are wrapped around the solid elongated core in a repeating sequential pattern (see Fleischhacker, Jr.: sections 82, 90, 94, or 99, each shown repeating 3 times in Figure 4).
Regarding claim 65, Voeller et al. in view of Fleischhacker, Jr. teaches the multi-filar coil is a first multi-filar coil (104); and the guidewire further comprises a second multi-filar coil (102), wherein the first multi-filar coil is bound to an outer surface of the solid elongated core (122), and the second multi-filar coil is bound to an outer surface of the first multi-filar coil (see Fleischhacker, Jr.: Figure 5 and col. 5, lines 33-36 – “FIG. 5 is a cross sectional view of a decreasing filar spring coil 102 as utilized in a concentrically wound guide wire 100 incorporating a concentric, and oppositely wound multifilar spring coil 104”).
Regarding claim 66, Voeller et al. in view of Fleischhacker, Jr. teaches the first multi-filar coil has a first wind direction around the solid elongated core; and the second multi-filar coil has a second wind direction around the solid elongated core opposite of the first wind direction (see Fleischhacker, Jr.: Figure 5 and col. 5, lines 33-36 – “FIG. 5 is a cross sectional view of a decreasing filar spring coil 102 as utilized in a concentrically wound guide wire 100 incorporating a concentric, and oppositely wound multifilar spring coil 104”).
Regarding claim 72, Voeller et al. discloses a system, comprising:
a guidewire, comprising:
a solid elongated core (14, 1214) (see Figures 1 and 17);
a sensor assembly (24, 1224), wherein the sensor assembly comprises a sensor array configured to sense one or more characteristics of a biological structure contacting the sensor assembly (see [0038] – “A pressure sensor 24 may be disposed within coil 20 (e.g., at or near tip member 22). While pressure sensor 24 is shown schematically in FIG. 1, it can be appreciated that the structural form and/or type of pressure sensor 24 may vary. For example, pressure sensor 24 may include a semiconductor (e.g., silicon wafer) pressure senor, piezoelectric pressure sensor, a fiber optic or optical pressure sensor, a Fabry-Perot type pressure sensor, an ultrasound transducer and/or ultrasound pressure sensor, a magnetic pressure sensor, or the like, or any other suitable pressure sensor. To the extent applicable, any of the pressure sensors disclosed herein may be utilized in any of the medical devices disclosed herein, as appropriate”);
a plurality of wire leads (26, 28, 1226, 1228) coupled to and extending proximally from the sensor assembly (see Figures 1 and 17 and [0039] – “In at least some embodiments, one or more leads, for examples leads 26/28, may be attached to pressure sensor 24 and extend proximally therefrom. A portion of leads 26/28 may be disposed within coil 20 and/or along core wire 14”);
a coil (20, 1220), wherein the plurality of wire leads are positioned between the solid elongated core and the coil (see Figures 1 and 17 and [0039] – “A portion of leads 26/28 may be disposed within coil 20 and/or along core wire 14” and [0071] – “Coil 1220 may be coupled to core wire 1214. For example, coil 1220 may be disposed about distal portion 1218 and attached to core wire 1214 at a joint 1258”); and
a jacket (1236) enclosing a proximal portion of the solid elongated core, wherein the plurality of wire leads are positioned between the solid elongated core and the jacket, wherein a distal portion of the jacket and a proximal portion of the coil overlap (see Figure 17 and [0071] – “Tubular member 1236 may be coupled to core wire 1214. In at least some embodiments, tubular member 1236 may be positioned over at least a portion of coil 1220”); and
a processing unit external to the guidewire, wherein the processing unit is configured to receive and display information on the one or more characteristics of the biological structure (see [0042] – “When positioned as desired, blood may enter opening 30 of guidewire and come into contact with pressure sensor 24, which can sense pressure and communicate the appropriate signal along leads 26/28 to a suitable display or monitoring device (not shown)” and [0047] – “The fluid pressure may be transferred along guidewire 110 (e.g., along tubular member 136) by pressure transmitting fluid 138 to pressure sensor 124, which can transmit a suitable signal (e.g., using any one of a variety of different signal processing techniques) to a display or other machinery”).
It is noted Voeller et al. does not specifically teach the coil is a multi-filar coil. However, Fleischhacker, Jr. teaches the coil is a multi-filar coil (see col. 2, lines 9-15 – “The spring guide wire is wound as a multifilar structure consists of a plurality of wires, preferably four wires. At least one of the wires consists of a highly radiopaque material, such as platinum or a platinum alloy. The resulting spring guide wire shows under fluoroscopy as a relatively faint, but viewable perceptible trace along the length of the guide wire”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Voeller et al. to include a multi-filar coil , as disclosed in Fleischhacker, Jr., so as to provide a guidewire having a radiopaque marking that is both flexible and easily implemented while at the same time having minimum or negligible impact on the handling characteristics of the resulting guidewire (see Fleischhacker, Jr.: col. 1, line 66-col. 2, line 3).
Regarding claim 77, Voeller et al. in view of Fleischhacker, Jr. teaches the multi-filar coil is positioned between the jacket and the solid elongated core (see Voeller et al.: Figure 17 and [0071] – “In at least some embodiments, tubular member 1236 may be positioned over at least a portion of coil 1220”).
Claim(s) 60 is/are rejected under 35 U.S.C. 103 as being unpatentable over Voeller et al. and Fleischhacker, Jr., further in view of Burkett et al. (US Publication No. 2016/0121085 A1) (cited by Applicant).
Regarding claim 60, it is noted neither Voeller et al. nor Fleischhacker, Jr. specifically teach a radio-opaque coil wrapped around the solid elongated core and positioned distally of the sensor assembly. However, Burkett et al. teaches a radio-opaque coil (126) wrapped around the solid elongated core and positioned distally of the sensor assembly (124) (see Figure 2 and [0029] – “As shown, the distal portion 104 includes a proximal flexible element 120 and a distal flexible element 122 on each side of a housing 124 containing component 108” and [0033] – “In the illustrated embodiment, the distal flexible element 122 has an overall length of approximately 3 cm that is defined by two 4 mm radiopaque coils 126, two 4 mm non-radiopaque coils 128, and one 14 mm radiopaque coil 126 extending distally from the sensor housing 124 in an alternating pattern, as shown”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the guidewire of Voeller et al. and Fleischhacker, Jr. to include a radio-opaque coil wrapped around the solid elongated core and positioned distally of the sensor assembly, as disclosed in Burkett et al., so as to identify the exact location of the sensor based on the location of the sensor housing relative to the radio-opaque coil as well as distinguish between multiple guidewires and/or catheters positioned within a vessel (see Burkett et al.: [0037]).
Claim(s) 62 and 76 is/are rejected under 35 U.S.C. 103 as being unpatentable over Voeller et al. and Fleischhacker, Jr., further in view of Tulkki (US Publication No. 2005/0268725 A1).
Regarding claims 62 and 76, it is noted neither Voeller et al. nor Fleischhacker, Jr. specifically teach the jacket is positioned between the multi-filar coil and the solid elongated core. However, Tulkki teaches the jacket is positioned between the multi-filar coil and the solid elongated core (see Figure 3 and [0030] – “At its proximal end the jacket 25 ends in a portion 29 having a smaller diameter than the main body of the jacket 25. This end portion 29 serves as a connection piece, to which a proximal coil 30 has been attached. A similar end portion or connection piece 31, having a smaller diameter than the main body of the jacket 25, is provided at the distal end of the jacket 25, and is adapted for attachment to a distal coil 32. The connection pieces 29, 31 are not crucial for the present invention, but since the jacket 25--because of the off-centre positioning of the second opening 27 in the jacket 25--is not coaxially arranged around the core wire 21, the connection pieces 29, 31 will ensure that the jacket 25 is centred with respect to the proximal and distal coils 30, 32, something that usually is advantageous”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the guidewire of Voeller et al. and Fleischhacker, Jr. to include the jacket is positioned between the multi-filar coil and the solid elongated core, as disclosed in Tulkki, so as to ensure the jacket is centered with respect to the coil (see Tulkki: [0030]).
Claim(s) 67-69 is/are rejected under 35 U.S.C. 103 as being unpatentable over Voeller et al. and Fleischhacker, Jr., further in view of Ahmed et al. (US Patent No. 8,231,537 B2).
Regarding claim 67, it is noted neither Voeller et al. nor Fleischhacker, Jr. specifically teach a handle; and a connector assembly located at a proximal end of the solid elongated core, wherein: the connector assembly couples the solid elongated core to the handle; and the connector assembly comprises: an insulator tube mounted over the proximal end of the solid elongated core; and a conductive contact ring mounted over the insulator tube. However, Ahmed et al. teaches a handle (200); and a connector assembly (207) located at a proximal end of the solid elongated core, wherein: the connector assembly couples the solid elongated core to the handle; and the connector assembly comprises: an insulator tube (206) mounted over the proximal end of the solid elongated core; and a conductive contact ring (217) mounted over the insulator tube (see Figures 14-19 and col. 12, lines 15-40 – “FIG. 17 depicts a flow guidewire 222 with two conductive bands 227a and 227b located on the proximal end of the guidewire 222. When inserted in the connector 200, the conductive bands 227a and 227b on the flow sensor guidewire 222 make contact with a respective electrical contact 217a and 217b in the contact housing 207. Similarly, FIG. 18 depicts a standalone pressure wire 232 with three conductive bands 237a-b and 238. When inserted in the connector 200, the conductive band 237a makes contact with two electrical contacts 217c-d, the conductive band 237b makes contact with two electrical contacts 217e-f and the conductive contact 238 is grounded via contact with 217g. In FIG. 19, a combined pressure and flow sensor guidewire wherein the flow sensor conductive bands 217a-b are each in contact with a single electrical contact 217a-b in the contact housing and the pressure sensor ground wire 238 is in contact with a single grounded contact 217g, while the pressure sensor conductive bands 237a-b are each in contact with two electrical contacts 217c-d and 217e-f for redundancy. This use of redundant contacts 217c-d and 217e-f for the contact wires 237a-b from the pressure sensor ensures a more reliable electrical contact between the guide wire and the connector 200 is produced because if one dynamic contact fails at any point during rotation of the connector 200 with respect to the contact housing 207, another redundant contact is also connected to assure no lapses”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the guidewire of Voeller et al. and Fleischhacker, Jr. to include a handle; and a connector assembly located at a proximal end of the solid elongated core, wherein: the connector assembly couples the solid elongated core to the handle; and the connector assembly comprises: an insulator tube mounted over the proximal end of the solid elongated core; and a conductive contact ring mounted over the insulator tube, as disclosed in Ahmed et al., so as to ensure the reliability of the electrical connection between the guidewire and the contacts in the connector (see Ahmed et al.: col. 12, lines 52-55).
Regarding claim 68, Ahmed et al. teaches one of the plurality of wire leads are bonded to the conductive contact ring (see Figures 14-19 and col. 12, lines 15-40 – “FIG. 17 depicts a flow guidewire 222 with two conductive bands 227a and 227b located on the proximal end of the guidewire 222. When inserted in the connector 200, the conductive bands 227a and 227b on the flow sensor guidewire 222 make contact with a respective electrical contact 217a and 217b in the contact housing 207. Similarly, FIG. 18 depicts a standalone pressure wire 232 with three conductive bands 237a-b and 238. When inserted in the connector 200, the conductive band 237a makes contact with two electrical contacts 217c-d, the conductive band 237b makes contact with two electrical contacts 217e-f and the conductive contact 238 is grounded via contact with 217g. In FIG. 19, a combined pressure and flow sensor guidewire wherein the flow sensor conductive bands 217a-b are each in contact with a single electrical contact 217a-b in the contact housing and the pressure sensor ground wire 238 is in contact with a single grounded contact 217g, while the pressure sensor conductive bands 237a-b are each in contact with two electrical contacts 217c-d and 217e-f for redundancy. This use of redundant contacts 217c-d and 217e-f for the contact wires 237a-b from the pressure sensor ensures a more reliable electrical contact between the guide wire and the connector 200 is produced because if one dynamic contact fails at any point during rotation of the connector 200 with respect to the contact housing 207, another redundant contact is also connected to assure no lapses”).
Regarding claim 69, Ahmed et al. teaches the connector assembly comprises a plurality of conductive rings spaced axially from each other and mounted over the insulator tube; and each of the plurality of wire leads are bonded to a respective conductive ring of the plurality of conductive rings (see Figures 14-19 and col. 12, lines 15-40 – “FIG. 17 depicts a flow guidewire 222 with two conductive bands 227a and 227b located on the proximal end of the guidewire 222. When inserted in the connector 200, the conductive bands 227a and 227b on the flow sensor guidewire 222 make contact with a respective electrical contact 217a and 217b in the contact housing 207. Similarly, FIG. 18 depicts a standalone pressure wire 232 with three conductive bands 237a-b and 238. When inserted in the connector 200, the conductive band 237a makes contact with two electrical contacts 217c-d, the conductive band 237b makes contact with two electrical contacts 217e-f and the conductive contact 238 is grounded via contact with 217g. In FIG. 19, a combined pressure and flow sensor guidewire wherein the flow sensor conductive bands 217a-b are each in contact with a single electrical contact 217a-b in the contact housing and the pressure sensor ground wire 238 is in contact with a single grounded contact 217g, while the pressure sensor conductive bands 237a-b are each in contact with two electrical contacts 217c-d and 217e-f for redundancy. This use of redundant contacts 217c-d and 217e-f for the contact wires 237a-b from the pressure sensor ensures a more reliable electrical contact between the guide wire and the connector 200 is produced because if one dynamic contact fails at any point during rotation of the connector 200 with respect to the contact housing 207, another redundant contact is also connected to assure no lapses”)
Claim(s) 70-71 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burkett et al. (US Publication No. 2016/0303354 A1; hereinafter Burkett #2) (cited by Applicant)., further in view of Kassab et al. (US Publication No. 2017/0164857 A1) (cited by Applicant).
Regarding claim 70, Burkett #2 discloses a guidewire, comprising:
a solid elongated core (126);
a sensor assembly (124), wherein the sensor assembly comprises a sensor array (108) configured to sense one or more characteristics of a biological structure contacting the sensor assembly; and
a plurality of wire leads (129) coupled to and extending proximally from the sensor assembly, wherein:
the plurality of wire leads are attached together to form a multi-strand ribbon (see Figures 2-3 and [0050] - As discussed below, the polymer jacket is formed directly around the core member 126 and communication lines 129, which are wrapped around the core member 126. FIG. 3 provides an image of a distal portion 104 of an intravascular device 100 showing the polymer jacket 120 formed around communication lines 129 that are spiral wrapped around the core member 126” and [0058] – “In some instances, the communication lines 129 are maintained in the wrapped configuration prior to application of the polymer jacket 120 through use of a mechanical holder (e.g., clamp or other device for applying pressure to hold the communication lines in place), adhesive (e.g., using an adhesive at various points along the length of the communication lines to provide anchor points until the polymer jacket is applied), or shrink tubing applied at appropriate points, maintaining the communication lines in tension, and/or combinations thereof”); and
the multi-strand ribbon is wound around the solid elongated core (see Figures 2-3 and [0050] – “As discussed below, the polymer jacket is formed directly around the core member 126 and communication lines 129, which are wrapped around the core member 126. FIG. 3 provides an image of a distal portion 104 of an intravascular device 100 showing the polymer jacket 120 formed around communication lines 129 that are spiral wrapped around the core member 126”).
It is noted Burkett #2 does not specifically teach the multi-strand ribbon includes a ground wire positioned between two of the plurality of wire leads. However, Kassab et al. teaches the multi-strand ribbon includes a ground wire positioned between two of the plurality of wire leads (see [0088] – “Use of conductive elements 106 to provide power to the various sensors/electrodes could be, for example, handled by (a) its use as a single conductor in device 100 and the second electrode (such as excitation electrodes 126, 128 connected to circuit module 104 ground) and connected through an electrode (pad 200, for example) on the body surface to connect back to data acquisition and processing system 250 to complete the circuit, or (b) using two conductors in the wire (two conductive elements 106 or one conductive element 106 plus a conductive elongated body 102) to connect power and ground”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the guidewire of Burkett #2 to include the multi-strand ribbon includes a ground wire positioned between two of the plurality of wire leads, as disclosed in Kassab et al., so as to connect conductive elements to both power and ground (see Kassab et al.: [0088]).
Regarding claim 71, Burkett #2 teaches the multi-strand ribbon extends proximally from the sensor assembly an entire length of the solid elongated core (see Figures 7-11 and [0057] – “In this regard, enough communication line 129 needs to be provided to allow each of the communication lines 129 to be coupled to a communication line of a proximal portion of the guide wire such that signals can be transmitted along the length of the guide wire between the sensing element 108 and the connector 110. FIG. 7 illustrates such extensions of the communication lines 129 extending proximal of the core member 12”).
Claim(s) 73-75 is/are rejected under 35 U.S.C. 103 as being unpatentable over Voeller et al. and Fleischhacker, Jr., further in view of Kassab et al..
Regarding claim 73, it is noted neither Voeller et al. nor Fleischhacker, Jr. specifically teach the guidewire further comprises one or more integrated circuits electrically coupled to the sensor assembly and configured to perform analog-to-digital conversion of signals detected by the sensor assembly, wherein the sensor assembly and the one or more integrated circuits are positioned in a distal portion of the guidewire. However, Kassab et al. teaches the guidewire further comprises one or more integrated circuits electrically coupled to the sensor assembly and configured to perform analog-to-digital conversion of signals detected by the sensor assembly, wherein the sensor assembly and the one or more integrated circuits are positioned in a distal portion of the guidewire (see [0177] – “Exemplary integrated circuits (ICs or ASICs, referred to herein as exemplary circuit modules 104) may include various components contained within sensor substrates 760 of the present disclosure. Furthermore, various circuit modules 104 of the present disclosure can be configured and/or operable to perform the following tasks/functions, such as, but not limited to:” and [0189] – “Convert the analog signals coming from the sensors into a digital format (such as, for example, by way of direction and/or regulating operation of analog to digital converter 922)”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the guidewire of Voeller et al. and Fleischhacker, Jr. to include the guidewire further comprises one or more integrated circuits electrically coupled to the sensor assembly and configured to perform analog-to-digital conversion of signals detected by the sensor assembly, wherein the sensor assembly and the one or more integrated circuits are positioned in a distal portion of the guidewire, as disclosed in Kassab et al., so as to transmit sizing data and pressure data from the sensor substrate and convert the sizing data and pressure data from analog data to digital data (see Kassab et al.: [0011]).
Regarding claim 74, Kassab et al. teaches the sensor array comprises: a plurality of transmitting electrodes (126, 128) configured to be driven by the one or more integrated circuits to propagate electromagnetic waves toward the biological structure; and a plurality of receiving electrodes (122, 124) configured to receive electromagnetic waves reflected by biological structure (see [0082] – “Distal section 108, in various embodiments, would include a sizing portion 120, comprising, for example, a plurality of electrodes (such as electrodes 122, 124, 126, 128 referenced in detail herein) used to obtain cross-sectional area, diameter, and/or other measurements of luminal organ geometry when device 100 is positioned within a luminal organ. Sizing portion 120, in various embodiments, may include one or more electrodes, such as, for example, two detection electrodes (122, 124, also shown as “D” in FIG. 1) positioned in between two excitation electrodes (126, 128, also shown as “E” in FIG. 1), along distal section 108 of device 100”).
Regarding claim 75, Kassab et al. teaches two or more of the plurality of receiving electrodes are arranged in a row and positioned a different distance from one of the plurality of transmitting electrodes (see [0083] – “In such embodiments (where one connection is used to connect excitation electrodes 126, 128 and/or detection electrodes 122, 124, those pairs of electrodes would effectively act as a single electrode (as the two would be shorted together), and another electrode, such as a pad 200 (referenced in further detail below) would act as a return electrode. Such embodiments could be used for navigation (as the elements used for excitation (excitation electrodes 126, 128) and voltage recording (detection electrodes 122, 124) would be “unipolar” to the body surface), while the traditional tetrapolar embodiments (having electrodes 122, 124, 126, and 128 each connected to separate wires 150) could be used for sizing, as referenced herein. Excitation electrodes 126, 128 can, when in operation, excite an electric field within a mammalian luminal organ, which can be detected by detection electrodes 122, 124, so that conductance measurements can be obtained using impedance”).
Conclusion
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/DEVIN B HENSON/Primary Examiner, Art Unit 3791