DETAILED ACTION
Claims 1-7 are hereby the present claims under consideration.
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 .
Claim Interpretation
Claim 1 recites “an electrode” which is interpreted as any conductive region which allows the transfer of electricity. This limitation is interpreted as not implicitly requiring the “electrode” to capable of performing sensing operations since the specification is directed towards the “electrodes” being the electrical contacts in a connector assembly to connect the guidewire to an external device.
Claim Objections
Claims 1-7 are objected to because of the following informalities:
Claim 1 line 3 it appears that “a sensor” should read “the sensor”
Claims 2-7 it appears that “The guide wire with a sensor” should read “The guide wire with the sensor”
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-7 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites “a sensor in a first section in a distal end portion of the core wire” but it is unclear if this limitation requires the sensor to be in the core wire itself or merely at or on the distal end of the core wire. In particular, the limitation “in a distal end portion of the cire wire” reads as though the first section is “in” the core wire and thus the sensor in the first section would also be in the core wire. It is unclear if this limitation is intended to limit the sensor to being within the core with on merely at the end of the core wire. For the purposes of this examination, the limitation in interpreted as “a sensor in a first section at a distal end portion of the core wire” such that the sensor may be in or on the distal end portion of the core wire. Such an interpretation is in line with Figs. 5 and 11 of Applicant’s specification which show the sensor being at the distal end of the core wire but not within the core wire itself. This rejection and interpretation are similarly applied to the limitation of “an electrode in a second section in a proximal end portion of the core wire” which is interpreted as “an electrode in a second section at a proximal end portion of the core wire” which is in line with Figs. 4A-C and 13.
Claims 2-7 are rejected by virtue of their dependence on claim 1.
Claim 3 recite “further to a proximal end side than a proximal end of the tube” but it is unclear what structure is used as reference for “further to a proximal end side”. It is unclear what proximal end side is being referenced. For the purposes of this examination, the limitation is interpreted as “further to a proximal end side of the guide wire” such that the middle portion is farther up the guide wire than the proximal end of the tube.
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
Claims 1-7 are rejected under 35 U.S.C. 103 as being unpatentable over Burkett US Patent Application Publication Number US 20140187972 A1 hereinafter Burkett in view of Patil US Patent Application Publication Number US 20150074995 A1 hereinafter Patil and further in view of Meller US Patent Application Publication Number US 20120172761 A1 hereinafter Meller
Regarding Claim 1, Burkett discloses a guide wire with a sensor (Abstract; Paragraph 0042: the various sensors) comprising:
a core wire (Paragraphs 0042-0045: the core wire; Fig. 3 reference 226);
a sensor in a first section in a distal end portion of the core wire (Paragraphs 0042-0045: the sensor 220 at the distal end);
an electrode in a second section in a proximal end portion of the core wire (Paragraph 0052: the plurality of conductive bands; Fig. 3 reference 248); and
a cable including a first lead wire and a second lead wire extending from the first section to the proximal end portion of the core wire along the core wire (Paragraphs 0042-0045 and 0052: the communication cable which may be tri-filar, or having 3 conductors; Fig. 3 reference 232), wherein
the cable is electrically connected with a wiring of the sensor in the first section and is electrically connected with the electrode in the second section (Paragraphs 0042-0046 and 0052: the cable connects to the sensor and each respective line of the cable connects to one of the conductive bands),
a middle position, the middle position being between the proximal end of the first section and a distal end of the second section (Paragraph 0049: the middle portion and the beginning of the transition zone; Fig. 3 references 204 and 229)
Burkett fails to further disclose the device wherein the first lead wire and the second lead wire are not integrated with each other and are movable relatively to each other in the cable arranged between a proximal end of the first section and a middle position, and the first lead wire and the second lead wire are integrated with each other in the cable between the middle position and the distal end of the second section.
Patil teaches a guidewire assembly having pressure sensors (Abstract). Thus, Patil falls within the same field of endeavor as Applicant’s invention.
Patil teaches the use of a ribbon wire where the wires are integrated with each other from the proximal end to the distal end (Paragraph 0090; Figs. 19A-B).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to implement the ribbon wire of Patil as the communication cable of Burkett because it is a simple substitution of one known element (the communication cable of Burkett) for another known element (the ribbon wire of Patil) with no surprising technical effect (the wire performs the same purpose). Thus the ribbon wire may traverse the length of the guide wire.
Burkett in view of Patil fails to further disclose the device wherein the first lead wire and the second lead wire are not integrated with each other and are movable relatively to each other in the cable arranged between a proximal end of the first section and a middle position.
Meller teaches a guidewire including a sensor (Abstract). Thus Meller falls within the same field of endeavor as Applicant’s invention.
Meller teaches that wire bundles may be split to form individual leads for each of the conductors in the wire bundle (Paragraph 0039 and Figs. 6-8 references 45.sub.1 and 45.sub.2 and reference 54: the wiring 54 may be split into its individual conductors to connect to a sensor)
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to configure the ribbon wire of Burkett in view of Patil to split into the individual wires when transitioning from the middle portion of Burkett to the distal portion of Burkett (Burkett Fig. 3 references 204 and 206, such as in the transition zone 229) because splitting the ribbon wire into each of the individual wires may make it easier to attach each of the respective split wires to their respective conductor patches on the pressure sensor and may allow greater flexibility in the types and configurations of sensors that can be implemented into the device since the connecting wire is not limited to a specific configuration and position. Having the individual wires separate and movable relative to each other in the area leading up to the sensor such as it taught by Meller allows the system to readily adapt to different types and configurations of sensors which may have wire connection requirements that are not consistent which would preclude the use of a ribbon wire without the ability to adjust the specific positions of the individual wires that comprise it. Furthermore, it would be obvious to have the ribbon wire transition from attached to non-attached in the transition zone (Burkett Fig. 3 reference 229 and paragraph 0049) because Burkett already contemplates this region being used to transition a wire from connected to separate (Burkett: Paragraph 0050) and thus it appears to be a suitable region to separate the ribbon wire of modified Burkett.
All dependent claims are addressed with the consideration that modified Burkett as presented above teaches the ribbon wire being connected towards the proximal end of the guidewire and transitioning to separate in the transition zone of Burkett and staying separate in the distal end of Burkett.
Regarding Claim 2, Burkett in view of Patil further in view of Meller teaches the guide wire with a sensor according to claim 1. Modified Burkett further teaches the device further comprising a tube that is flexible and surrounds the core wire and the cable, wherein, in at least a part of the cable arranged inside the tube, the first lead wire and the second lead wire are not integrated with each other and are movable relatively to each other (Paragraphs 0043 and 0050: the flexible element that surrounds the communication cable. As described above, the cable transitions from connected to separate in the transition zone 229 and thus a portion of the cable is in the separated state and movable relative to each other at the end of the transition zone and in the distal region 206 of Fig. 3 where the sensor is located).
Regarding Claim 3, Burkett in view of Patil further in view of Meller teaches the guide wire with a sensor according to claim 2. Modified Burkett further teaches the device wherein the middle position is further to a proximal end side than a proximal end of the tube (Fig. 3: the middle portion 204 includes the proximal end of the flexible tube 224 and extends further proximal past its end).
Regarding Claim 4, Burkett in view of Patil further in view of Meller teaches the guide wire with a sensor according to claim 3. Modified Burkett further teaches the device wherein the cable is in a connected state at the middle portion (As described above, the cable transitions from connected to separate in the transition zone 229 and thus the cable is in the connected state at the proximal end of the transition zone and moving proximate)
Modified Burkett fails to further teach the cable is joined to the core wire at the middle position.
Patil teaches joining the cable to the core wire (Paragraph 0094; Figs. 22A-B, and 30).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to configure modified Burkett to have the cable be joined with the core wire as taught by Patil in the portions of modified Burkett where the wire is in a connected configuration because such a joining would prevent tangling, kinking, snagging, or other undesirable effects in the wire by rigidly attaching the wire along the length of the guidewire.
Regarding claims 5-7, Burkett in view of Patil further in view of Meller teaches the guide wire with a sensor according to claims 4, 3, and 2 respectively. Modified Burkett further at least suggests the device, wherein, in between the proximal end of the first section and the middle position, a length of the first lead wire and a length of the second lead wire are equal (this limitation is at least suggested by Fig. 3 and paragraphs 0046 which indicate that the cable connects to the sensor and Fig. 3 depicts all the cable terminating at the sensor component 220. Thus modified Burkett is considered to at least suggest all of the wires making up the ribbon cable being the same length since they all originate and separate in the transition region 229 and terminate at the same sensor 220. Thus they are at least suggested to be the same length since they traverse the same distance.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW ERIC OGLES whose telephone number is (571)272-7313. The examiner can normally be reached M-F 8:00AM - 5:30PM.
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/MATTHEW ERIC OGLES/Examiner, Art Unit 3791
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