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 . 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 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.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 05/27/2026 has been entered.
Response to Amendment
This Office Action is responsive to the amendment filed 05/27/2026 (“Amendment”). Claims 2-17 are currently under consideration. The Office acknowledges the amendments to claims 2, 6, 8, 10, 12, and 15.
The objection(s) to the drawings, specification, and/or claims, the interpretation(s) under 35 USC 112(f), and/or the rejection(s) under 35 USC 101 and/or 35 USC 112 not reproduced below has/have been withdrawn in view of the corresponding amendments.
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.
Claims 2-6 and 12-17 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Application Publication 2007/0255145 (“Smith”) in view of US Patent Application Publication 2006/0122537 (“Reynolds”), US Patent Application Publication 2013/0296692 (“Vanney’), and US Patent Application Publication 2002/0177783 (“Khalil”).
Regarding claim 2, Smith teaches [a]n apparatus, comprising: an intravascular guide wire (Abstract, Fig. 2, sensor and guide wire assembly 21), comprising: a proximal core comprising a first end section (Fig. 2, core wire 28 including a proximal end having an end section); a distal core comprising a second end section (Fig. 2, core wire 28 including a distal end having an end section); …; a sensor disposed at a distal portion of the guide wire (Fig. 2, sensor element 22); a connector disposed at a proximal portion of the intravascular guide wire (Fig. 2, male connector at the proximal (right) end as described in ¶ 0024); a first proximal electrical conductor in electrical communication with the connector (Fig. 2, signal transmitting cables 31 at the proximal end); and a first distal electrical conductor in electrical communication with the sensor (Fig. 2, signal transmitting cables 31 at the distal end), … .
Smith does not appear to explicitly teach the guide wire comprising: a tubular member comprising a sidewall defining an interior and an exterior, wherein the first end section and the second end section are positioned within the interior of the tubular member, wherein the first distal electrical conductor is spaced from the first end section and the second end section by the sidewall of the tubular member (although Smith does teach both portions/conductors extending along the exterior of the core – Fig. 2).
Reynolds teaches a composite guidewire (Title) made from a proximal core having a first end section and a distal core having a second end section, the end sections coupled inside a tubular member which itself has a sidewall (Fig. 2, cores 14 and 16 (proximal and distal guidewire sections) coupled inside tubular connector 18 (hypotube - ¶ 0042) at joint 12 (¶ 0038), the tubular connector 18 including a sidewall as shown in cross-section).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the guide wire of Smith of two separate cores, joined via a hypotube, as in Reynolds, for the purpose of achieving different performance features at different parts of the guide wire (Reynolds: ¶¶s 0003, 0038, 0040, etc.). Thus, the combination includes a conductor extending along the exterior of the tubular member, the tubular member spacing the conductor from the first and second end sections.
Smith-Reynolds does not appear to explicitly teach wherein the first distal electrical conductor is different from the first proximal electrical conductor, wherein an end of the first distal electrical conductor is coupled to an end of the first proximal electrical conductor outside of the tubular member to establish electrical communication between the connector and the sensor.
Vanney teaches a well-known method for connecting wires together. Leads 72 from a sensor assembly 74 are soldered to distal end leads of wiring 74 at solder joints 80 (Fig. 4, ¶ 0073). In this configuration, the distal electrical conductor associated with the sensor is different from the proximal electrical conductor associated with the connector (Abstract), and the two are joined at their ends via soldering.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use different conductors and a solder connection such as that taught by Vanney in the combination, according to a known method of manufacture (Vanney: ¶ 0073), and for the purpose of enabling e.g. separate manufacture of the sensor (so that it would not need to be manufactured with incredibly long wires/leads) to make assembly easier with shorter distal conductors (Vanney: ¶¶s 0052, 0053).
Smith-Reynolds-Vanney is not explicit that the first distal electrical conductor extends along the exterior of the tubular member (although Reynolds does contemplate the hypotube and joint being closer to the distal end than the proximal end (as shown in Figs. 7-12)).
Khalil teaches joining a distal electrical conductor to a proximal one at a relatively proximal location (Fig. 3b, e.g. lead wire 36 and extension cable 72).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to extend the first distal electrical conductor of the combination towards the proximal end along the exterior of the tubular member (which itself is associated with the distal end as shown in Reynolds), as in Khalil, for the purpose of increasing the number of guidewire shaft configurations possible (Khalil: Figs. 1b, 3a, etc.), as well as joining options for the sensor (Khalil: ¶¶s 0039 and 0040, e.g. via extension cables).
Regarding claims 3-5, Smith-Reynolds-Vanney-Khalil teaches all the features with respect to claim 2, as outlined above. Smith-Reynolds-Vanney-Khalil further teaches wherein the first distal electrical conductor extends from distal of the tubular member to proximal of the tubular member, wherein the first distal electrical conductor extends across the tubular member, wherein the first proximal electrical conductor is disposed only proximal of the tubular member (from the sensor of Smith, across the joint of Reynolds, towards the proximal end, as taught by Khalil).
Regarding claim 6, Smith-Reynolds-Vanney-Khalil teaches all the features with respect to claim 2, as outlined above. Smith-Reynolds-Vanney-Khalil further teaches wherein the intravascular guide wire further comprises: a second proximal electrical conductor in electrical in electrical communication with the connector; and a second distal electrical conductor in electrical communication with the sensor, wherein the second distal electrical conductor is coupled to the second proximal electrical conductor to establish the electrical communication between the connector and the sensor, wherein the second distal electrical conductor extends along the exterior of the tubular member (the same configuration being established for another of the signal transmitting cables 31 of Smith).
Regarding claims 12 and 13, Smith-Reynolds-Vanney-Khalil teaches all the features with respect to claim 2, as outlined above. Smith-Reynolds-Vanney-Khalil further teaches wherein the intravascular guide wire further comprises an outer layer formed directly over the first distal electrical conductor and the exterior of the tubular member (Smith: Fig. 2, tube 29), wherein the outer layer is formed indirectly over the first end section and the second end section (based on the end sections being inside the hypotube of Reynolds).
Regarding claim 14, Smith-Reynolds-Vanney-Khalil teaches all the features with respect to claim 2, as outlined above. Smith-Reynolds-Vanney-Khalil further teaches wherein the tubular member comprises a hypotube (Reynolds: tubular connector 18 being a hypotube - ¶ 0042).
Regarding claim 15, Smith-Reynolds-Vanney-Khalil teaches all the features with respect to claim 2, as outlined above. Smith-Reynolds-Vanney-Khalil further teaches wherein the interior of the tubular member further comprises at least one of a solder or an adhesive configured to fixedly secure the first end section and the second end section to one another (Reynolds: ¶ 0048).
Regarding claim 16, Smith-Reynolds-Vanney-Khalil teaches all the features with respect to claim 2, as outlined above. Smith-Reynolds-Vanney-Khalil further teaches wherein the sensor comprises at least one of a pressure sensor or a flow sensor (Smith: ¶¶s 0002, 0005, 0006, 0022, 0024, etc., a pressure sensor being obvious to use for the purpose of measuring pressure in the coronary tree (¶¶s 0005 and 0006), which is a relevant physiological variable (¶ 0001)).
Regarding claim 17, Smith-Reynolds-Vanney-Khalil teaches all the features with respect to claim 2, as outlined above. Smith-Reynolds-Vanney-Khalil further teaches wherein the intravascular guide wire comprises an outer diameter of approximately 0.014", 0.018", or 0.035" (Smith: ¶ 0031).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Smith-Reynolds-Vanney-Khalil in view of US Patent Application Publication 2006/0074318 (“Ahmed”).
Regarding claim 7, Smith-Reynolds-Vanney-Khalil teaches all the features with respect to claim 6, as outlined above. Smith-Reynolds-Vanney-Khalil further teaches wherein the tubular member comprises a first side and an opposite, second side (Reynolds: Fig. 2, top or bottom sides, left or right sides), wherein the first distal electrical conductor extends on the first side (Smith: as shown in Fig. 2, extending along the top), but does not appear to explicitly teach wherein the second distal electrical conductor extends on the second side.
Ahmed teaches using a combination pressure and flow sensor with a guidewire (Abstract, ¶ 0012, etc.), the sensor including conductors extending along opposite sides of a core (¶ 0052, Fig. 4 and 5, conductors 107 – also see Figs. 8, 9, ¶ 0064, etc.).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate a combination sensor into the combination (e.g., by adding a flow sensor), as in Ahmed (thus requiring conductors in addition to those found in Smith – see Ahmed: ¶ 0055), for the purpose improving diagnostic accuracy of ischemic testing (Ahmed: ¶ 0068). It would have been obvious to extend conductors on opposite sides of the hypotube for the purpose of ensuring the conductors remained isolated from each other (Ahmed: ¶¶s 0052, 0064).
Claims 8 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Smith-Reynolds-Vanney-Khalil in view of US Patent Application Publication 2011/0166519 (“Nguyen”).
Regarding claims 8 and 9, Smith-Reynolds-Vanney-Khalil teaches all the features with respect to claim 2, as outlined above. Smith-Reynolds-Vanney-Khalil does not appear to explicitly teach wherein the exterior of the tubular member comprises a first flat on a first side of the tubular member, wherein the first distal electrical conductor extends along the first flat.
Nguyen teaches a hypotube including a flat (Fig. 5, portion 166 of hypotube 150), with a conductor extending along the flat (Fig. 5, proximal electrode conductor 154, ¶ 0105).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a hypotube with a flat in the combination, and to extend the first distal electrical conductor along the flat, as in Nguyen, for the purpose of locating a conductor thereon without burdening the radial dimension of the guidewire (Nguyen: ¶ 0117, Fig. 5).
Claims 10 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Smith-Reynolds-Vanney-Khalil-Nguyen in view of Ahmed.
Regarding claims 10 and 11, Smith-Reynolds-Vanney-Khalil-Nguyen teaches all the features with respect to claim 8, as outlined above. Smith-Reynolds-Vanney-Khalil-Nguyen does not appear to explicitly teach wherein the exterior of the tubular member comprises a second flat on an opposite, second side of the tubular member, wherein the intravascular guide wire further comprises a second distal electrical conductor in electrical communication with the sensor, wherein the second distal electrical conductor extends along the second flat.
Ahmed teaches using a combination pressure and flow sensor with a guidewire (Abstract, ¶ 0012, etc.), the sensor including conductors extending along opposite sides of a core (¶ 0052, Fig. 4 and 5, conductors 107 – also see Figs. 8, 9, ¶ 0064, etc.).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate a combination sensor into the combination (e.g., by adding a flow sensor), as in Ahmed (thus requiring conductors in addition to those found in Smith – see Ahmed: ¶ 0055), for the purpose improving diagnostic accuracy of ischemic testing (Ahmed: ¶ 0068). Then, it would have been obvious to create another flat in the hypotube of the combination (opposite the first flat, as suggested by Ahmed), and to run the additional conductors of the sensor along this flat, for the purpose of locating additional conductors without burdening the radial dimension of the guidewire (Nguyen: ¶ 0117, Fig. 5). It further would have been obvious to extend conductors on opposite sides of the hypotube for the purpose of ensuring the conductors remained isolated from each other (Ahmed: ¶¶s 0052, 0064).
Response to Arguments
Applicant’s arguments filed 05/27/2026 have been fully considered. In response to the arguments and amendments regarding the rejections under 35 USC 103, they are persuasive to the extent that the previous combination did not address the first distal electrical conductor being different from the first proximal electrical conductor, with an end of one being coupled to an end of the other. Therefore, a new grounds of rejection is made in further view of Vanney and Khalil, and all claims remain rejected in light of the prior art.
Conclusion
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/ANDREY SHOSTAK/Primary Examiner, Art Unit 3791
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