DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after 16 March 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The amendment to the claims filed 26 January 2026 has been entered. Claim(s) 1 is/are currently amended. Claim(s) 1-11 is/are pending.
Claim Objections
Claim(s) 1 is/are objected to because of the following informalities: "wherein the metallic core and the metallic shaping ribbon" should be amended/corrected to "wherein the metallic core wire and the metallic shaping ribbon" for consistency with the prior limitation(s).
Appropriate correction is required.
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:
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue.
Resolving the level of ordinary skill in the pertinent art.
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) 1-7 and 9-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 6,336,906 B1 (previously cited, Hammarstrom) in view of US 2005/0268725 A1 (previously cited, Tulkki), US 2003/0069521 A1 (previously cited, Reynolds) and US 2013/0237864 A1 (previously cited, Mazar).
Regarding claims 1-5 and 10-11, Hammarstrom teaches/suggests an apparatus comprising an intravascular guidewire (col. 1, lines 8-11, sensor and guidewire assembly) comprising:
a metallic core wire (core wire 1; col. 5, lines 26-27);
a housing structure, distinct/different from the metallic core wire, and attached to a distal portion of the metallic core wire (e.g., Figs. 1-6, etc., enlarged portion 10, which may comprise a short tube segment attached to the core wire, as described in col. 4, lines 37-42);
a sensor mounted to the housing structure (sensor 12 mounted in enlarged portion 10);
an electrical conductor associated with the sensor and extending proximally from the sensor (Figs. 1-6, etc., signal transmitting cables 14);
a metallic shaping ribbon extending distal of the metallic core wire, wherein the metallic shaping ribbon comprises a proximal portion, a distal portion, and an intermediate portion between the proximal portion and the distal portion (Fig. 6, wire 200 that extends distal of core wire 1); and
coil distal of the housing structure (coil 8), wherein metallic core wire and the metallic shaping ribbon extend within the coil (e.g., Fig. 6),
wherein the metallic shaping ribbon is attached to the metallic core wire at a first attachment location (col. 6, lines 37-39, wire 200 is secured to core wire 1), and
wherein the sensor (12) is different than the metallic core wire (1), the electrical conductor (14), and the metallic shaping ribbon (200) (see above).
Hammarstrom does not expressly disclose, in embodiments in which the housing structure is different than core wire (i.e., embodiments in which the housing structure comprises a short tube segment attached to the core wire as described in col. 4, lines 37-42), that the metallic core wire extends longitudinally through the housing structure.
Tulkki teaches/suggests a similar intravascular guidewire (e.g., Fig. 3) comprising:
a metallic core wire (core wire 21);
a housing structure attached to a distal portion of the metallic core wire (jacket or sleeve 25, 35, 45, 55, 65; ¶ [0031] core wire 21 is threaded through the second through hole of the jacket and fixed therein);
a sensor mounted to the housing structure (sensor chip 22; ¶ [0031] sensor 22 is positioned in the first through hole and fixed therein);
an electrical conductor associated with the sensor and extending proximally from the sensor (at least one electrical lead 24 in contact with an electronic unit); and
a coil distal of the housing structure (distal coil 32), wherein the metallic core wire extends within the coil (e.g., Fig. 3),
wherein the metallic core wire extends longitudinally through the housing structure (e.g., Fig. 3), such that:
the metallic core wire and the housing structure are different than one another (see above, where the core wire and jacket/sleeve are distinct components attached/fixed together);
a first portion of the metallic core wire is distal to the housing structure (e.g., Fig. 3, portion of core wire 21 distal to (i.e., to the left of) jacket 25 and/or extending within coil 32); and
a second portion of the metallic core wire, proximal to the first portion of the metallic wire, that extends through and past the sensor housing (e.g., ¶ [0031], Fig. 3, portion of core 21 threaded through the jacket 25 and/or extending proximally (i.e., to the right) of jacket 25).
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 above-noted embodiment(s) of Hammarstrom with the metallic core wire extending longitudinally through the housing structure (i.e., short tube or jacket attached or fixed to the core wire) such that a first portion of the metallic core wire is distal to the housing structure, and a second portion of the metallic core wire that is proximal to the first portion of the metallic core wire extends within and proximal to the housing structure as taught/suggested by Tulkki in order to provide a guidewire with a comparable enlarged portion (Tulkki, Fig. 3) in which the sensor is virtually independent of movements of the core wire, such that bending deformations of the core wire will not be transferred to the sensor chip (Tulkki, ¶ [0013]) and/or as a simple substitution of one suitable enlarged portion configuration having a short tube segment attached on a core wire for another to yield no more than predictable results. See MPEP 2143(I)(B).
Hammarstrom as modified does not disclose the first attachment location is located on the first portion of the metallic core wire and/or within the coil, wherein the metallic core and the metallic shaping ribbon are attached for a first length and the first length is less than a length of the first portion, or the metallic shaping ribbon is attached to the housing structure at a different, second attachment location spaced from and proximal to the first attachment location.
Reynolds discloses a guidewire (Fig. 8) comprising a metallic core wire (guidewire formed of sections 114 and 116; ¶ [0032]); a metallic shaping ribbon comprising a proximal portion, a distal portion, and an intermediate portion between the proximal portion and the distal portion (ribbon 158; ¶ [0056], where the proximal portion is the end of ribbon 158 proximate rounded tip portion 169, the distal portion is the end opposite said proximal portion, and the intermediate portion therebetween); an enlarged section proximal to a distal portion of the metallic core wire (e.g., section 116); and a coil distal of the enlarged portion (distal section 170; ¶ [0061] distal section 170 may comprise radiopaque coil(s)), wherein the intermediate portion of the metallic shaping ribbon is attached to the metallic core wire at a first attachment location located within the coil (attachment point 164 located within distal section 170), wherein the metallic core wire and the metallic shaping ribbon are attached for a first length and the first length is less than a length of the first portion (e.g., Fig. 8, where attachment point 164, or, e.g., solder joint thereat (¶ [0056]), has a length less than the length of portion of the core wire to which the shaping ribbon is attached), and the proximal portion of the metallic shaping ribbon terminates at and is attached to the metallic core wire at a different, second attachment location spaced from and proximal to the first attachment location (attachment point 165 located proximal to attachment point 164).
Mazar discloses a guidewire comprising a core wire and a ribbon extending fully from a sensor housing of the guidewire to the distal tip thereof (e.g., ¶ [0157]).
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 apparatus of Hammarstrom with the intermediate portion of the metallic shaping ribbon being attached to the metallic core wire at a first attachment location located on the first portion of the metallic core wire and/or within the coil, wherein the metallic core and the metallic shaping ribbon are attached at the first attachment location for a first length that is less than a length of the first portion, and the proximal portion of the metallic shaping ribbon terminating at and attached to an enlarged portion, such as the housing structure, at a different, second attachment location spaced from and proximal to the first attachment location as taught and/or suggested by Reynolds and Mazar, such that the proximal portion of the metallic shaping ribbon is spaced from the metallic core wire (e.g., along the axial direction of the guidewire) in order to more securely attach the metallic shaping ribbon, to provide desired shaping and/or safety characteristics (e.g., Reynolds, ¶ [0056]; Mazar, ¶ [0157]) and/or as a simple substitution of one suitable shaping ribbon arrangement for another to yield no more than predictable results. See MPEP 2143(I)(B).
Regarding claim 6, Hammarstrom as modified teaches/suggests the guidewire further comprises adhesive disposed within the housing structure (e.g., Tulkki, ¶ [0031] the sensor and/or core wire are fixated in their respective through holes by means of, e.g., gluing). Hammarstrom as modified does not expressly disclose the metallic shaping ribbon is attached to the housing structure via the adhesive. However, Reynolds discloses the metallic shaping ribbon may be attached via adhesive (¶ [0056]). 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 apparatus of Hammarstrom with the metallic shaping ribbon being attached to the housing structure via the adhesive in order to facilitate fixating the sensor and/or core wire within the sensor housing and attaching the shaping ribbon to the sensor housing with the same material, in the same step and/or at the same time, thereby simplifying the device or the manufacture thereof.
Regarding claim 7, Hammarstrom as modified teaches/suggests the sensor comprises a pressure sensor (col. 4, line 20).
Regarding claim 9, Hammarstrom as modified teaches/suggests the sensor is disposed completely within the housing (e.g., Hammarstrom, Figs. 1-6; Tulkki, Fig. 3; etc.).
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hammarstrom in view of Tulkki, Reynolds and Mazar as applied to claim(s) 1 above, and further in view of US 2013/0116528 A1 (previously cited, Boye).
Regarding claim 8, Hammarstrom as modified teaches/suggests the limitations of claim 1, but does not expressly disclose the sensor comprises a flow sensor.
Boye teaches/suggests a guidewire comprising a sensor including a pressure and/or flow sensor (e.g., ¶ [0051]).
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 apparatus of Hammarstrom with the sensor alternatively or additionally comprising a flow sensor as taught/suggested by Boye in order to facilitate providing a physician or medical technician with alternate/additional critical information as to the status of a patient's condition (Boye, ¶ [0002]).
Response to Arguments
Applicant's arguments have been fully considered but they are not persuasive.
Applicant contends Hammarstrom does not disclose the newly-added limitations of claim 1, concluding, for only this reason, that "independent claim 1 is not anticipated or rendered obvious by Hammarstrom in view of Tulkki, Reynolds, and Mazar" (Remarks, pg. 5-6).
Applicant's arguments fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references. The examiner has made no contention that any individual reference alone, including Hammarstrom, anticipates the limitations of the pending claims. While Applicant appears to acknowledge the rejection(s) rely on multiple references in an obviousness rejection (pg. 5), Applicant does not specifically point out how the amended claim language patentably distinguishes the claims from a combination of applied references. Rather, as noted above, Applicant only alleges that the primary reference, Hammarstrom, alone does not disclose or suggest the newly-added limitation(s) of independent claim 1.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Meredith Weare whose telephone number is 571-270-3957. The examiner can normally be reached Monday - Friday, 9 AM - 5 PM.
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/Meredith Weare/Primary Examiner, Art Unit 3791