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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 11/17/2025 has been entered.
Status
This Office Action is responsive to the filing of 11/17/2025. Claims 2-17 are currently under consideration.
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”).
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), wherein the first distal electrical conductor is coupled to the first proximal electrical conductor to establish electrical communication between the connector and the sensor (they are coupled since they are different portions of the same element), … .
Smith does not appear to explicitly teach the guide wire comprising: a tubular member comprising a sidewall defining an inside and an outside, wherein the first end section and the second end section are positioned within the inside of the tubular member, wherein the first distal electrical conductor extends along the outside of the tubular member such that 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 outside 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). Reynolds teaches that the hypotube and joint are closer to the distal end than the proximal end (as shown in Figs. 7-12).
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 outside of the tubular member, the tubular member spacing the conductor from the first and second end sections. It would have been obvious to consider this portion the first distal electrical conductor since it is still coupled to the sensor (and since Reynolds suggests associating the hypotube with the distal end).
Regarding claims 3-5, Smith-Reynolds teaches all the features with respect to claim 2, as outlined above. Smith-Reynolds 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; the distal and proximal conductors/portions of Smith are thus defined).
Regarding claim 6, Smith-Reynolds teaches all the features with respect to claim 2, as outlined above. Smith-Reynolds 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 outside of the tubular member (the same conductors/portions are found in another of the signal transmitting cables 31 of Smith).
Regarding claims 12 and 13, Smith-Reynolds teaches all the features with respect to claim 2, as outlined above. Smith-Reynolds further teaches wherein the intravascular guide wire further comprises an outer layer formed directly over the first distal electrical conductor and the outside 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 teaches all the features with respect to claim 2, as outlined above. Smith-Reynolds further teaches wherein the tubular member comprises a hypotube (Reynolds: tubular connector 18 being a hypotube - ¶ 0042).
Regarding claim 15, Smith-Reynolds teaches all the features with respect to claim 2, as outlined above. Smith-Reynolds further teaches wherein the inside 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 teaches all the features with respect to claim 2, as outlined above. Smith-Reynolds 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 teaches all the features with respect to claim 2, as outlined above. Smith-Reynolds 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 in view of US Patent Application Publication 2006/0074318 (“Ahmed”).
Regarding claim 7, Smith-Reynolds teaches all the features with respect to claim 6, as outlined above. Smith-Reynolds 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 in view of US Patent Application Publication 2011/0166519 (“Nguyen”).
Regarding claims 8 and 9, Smith-Reynolds teaches all the features with respect to claim 2, as outlined above. Smith-Reynolds does not appear to explicitly teach wherein the outside 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-Nguyen in view of Ahmed.
Regarding claims 10 and 11, Smith-Reynolds-Nguyen teaches all the features with respect to claim 8, as outlined above. Smith-Reynolds-Nguyen does not appear to explicitly teach wherein the outside 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 11/17/2025 have been fully considered, but they are not persuasive. The signal transmitting cables 31 of Smith have different portions which can be considered different conductors that are coupled to each other. It is not that signal transmitting cables 31 are different portions of the same element, but that the proximal and distal conductors are different portions of the signal transmitting cables 31, and these portions are coupled to establish electrical communication between the connector and the sensor. This interpretation is consistent with the claim language.
Further, the present claims are apparatus claims and not method claims, and there is no particular coupling step or detail as to how the coupling is achieved. Two portions of a conductor can be considered as coupled together by e.g. a third portion of the same conductor.
As for the Office’s position that the signal transmitting cables 31 would be on the outside of the tubular member in combination, this is maintained. Applicant appears to disregard the teachings of Reynolds. The metal joining technique of Reynolds effectively makes the hypotube a part of the core wire. Thus, the signal transmitting cables would be on the outside of the core wire/hypotube. There is no conflation. The hypotube is a separate element that becomes part of the core wire as described in Reynolds. Two components can be joined into one component, and still be described individually. The components are not e.g. melded together so that all defining characteristics are lost.
The conductor of Smith is not being incorporated into Reynolds. Rather, the techniques of Reynolds are applied to Smith. Thus, all claims remain rejected in light of the prior art.
Conclusion
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/ANDREY SHOSTAK/Primary Examiner, Art Unit 3791