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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 04 June 2026 has been entered.
Status of Claims
Claim(s) 1 is/are currently amended. Claim(s) 1-11 is/are pending.
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 pre-AIA 35 U.S.C. 112, first paragraph:
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.
Claim(s) 1-11 is/are rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 1 and claims dependent thereon, Applicant discloses a metallic core wire may include a constant diameter portion and two flattened portions with a tapered (i.e., reducing in size, e.g., diameter) transition region therebetween (e.g., Fig. 3, 6a, transition regions 312 between flattened sections 304, 306 and between flattened section 304 and reduced diameter section 302; Fig. 8, transition regions 812 disposed between the flattened sections 804, 806 and between the flattened section 804 and the reduced diameter section 802; etc.). In all disclosed embodiments, Applicant discloses the first attachment location and/or the first length defined thereby, is located entirely on a "first portion" of the core wire (e.g., Fig. 7, where joint 360 is located entirely on constant size/diameter section 306; Fig. 12, where joint 870 is located entirely on constant size section 806; Fig. 17, where joint 1370 is located entirely on constant size section 1306; etc.). Applicant fails to disclose the first attachment location and/or first length thereof is located, even in part, on the tapered transition region between constant sized section as required by amended claim 1. Accordingly, the limitation "wherein the transition region comprise[s] at least part of the first length that the metallic core wire and the metallic shaping ribbon are attached" lacks sufficient support in the application as filed, and therefore is directed to and/or encompasses new matter.
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), wherein a first portion of the metallic core wire is distal to the housing structure (e.g., Fig. 6, distal, constant diameter section), a second, proximal portion of the metallic core wire (e.g., Fig. 6, section of core wire proximal to enlarged portion), and a transition region of the metallic core wire is between the first portion and the second portion of the metallic core wire in which a diameter of the metallic core reduces (e.g., Fig. 6, portion of core wire tapered to above-noted constant-diameter distal section);
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, smaller constant diameter portion of core wire 21 on the distal end (i.e., left side of figure));
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, larger constant diameter portion of core 21 threaded through the jacket 25 and/or extending proximally (i.e., to the right) of jacket 25); and
a transition region of the metallic core wire is between the first portion and the second portion of the metallic core wire where a diameter of the metallic core wire reduces (e.g., Fig. 3, tapered region extending from above-noted smaller and larger diameter constant portions of core wire 21).
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 a metallic core wire comprising the claimed first and second regions and transition region, 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 the first portion of the metallic core wire is distal to the housing structure, and the 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 and the transition region is between the first portion and the second portion 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).
Hammarstrom as modified does not disclose the transition region comprises at least part of the first length that the metallic core wire and the metallic shaping ribbon are attached. However, at the time the invention was effectively filed, it would have been an obvious matter of design choice to a person of ordinary skill in the art to modify the apparatus of Hammarstrom with the first attachment location and/or first length being located in part on the transition region because Applicant has not disclosed that the claimed configuration provides an advantage, is used for a particular purpose, or solves a stated problem. Rather, as noted with respect to rejections under 35 U.S.C. 112(a) above, Applicant fails to disclose such an arrangement, let alone a benefit and/or criticality thereto. As no evidence has been provided to the contrary, one of ordinary skill in the art, furthermore, would have expected Applicant's invention to perform equally well with Hammarstrom as modified above, because either arrangement permits securely attaching the shaping ribbon and metallic core wire by providing multiple attachment location therebetween.
Alternatively/Additionally, Reynolds discloses/suggests a shaping structure, such a coiled or non-coiled ribbon (e.g., ¶ [0051]), may alternatively or additionally be attached on a transition (i.e., tapered) region of a core wire (e.g., Fig. 13, coil 458 can be attached to core wire 413 using, e.g., soldering, at attachment point 465) or at the meeting of a transition region and constant-diameter section (e.g., Fig. 16, attachment point 465). 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 first attachment location and/or first length being located in part on the transition region (e.g., the first attachment location or first length being comprised of separate attachment points on the first portion and on the transition region; the first attachment location and/or first length being located where the first portion and transition region meet, etc.) as taught/suggested by Reynolds as a simple substitution of one suitable distal attachment location 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 asserts, "The cited references fail to disclose such limitation of the metallic core wire much less that such transition region of the metallic core wire particularly 'compris[ing] at least part of the first length that the metallic core wire and the metallic shaping ribbon are attached' as claimed" (Remarks, pgs. 5-6).
The examiner respectfully disagrees for at least the reasons noted in the rejection of record above. Specifically, the primary reference to Hammarstrom discloses a metallic core wire comprising a transition section as claimed. Hammarstrom as modified by Tulkki discloses and/or suggests, inter alia, a metallic core wire that extends longitudinally through the housing structure, the metallic core wire comprising first and second portions, and a transition region therebetween. Reynolds at least suggests an attachment location at the meeting of a constant size/diameter section and a transition region as a suitable location at which to attach a shaping structure, such as a ribbon, and therefore would have been an obvious modification. Further, there is no/insufficient evidence of record that indicates the claimed attachment location is any more than a mere matter of design choice. Indeed, as noted in the rejections under 35 U.S.C. 112(a), the application as filed fails to even disclose the claimed arrangement, let alone any benefit (e.g., advantage provided by, purpose of use, problem solved by, etc.) thereto.
Conclusion
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
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