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 .
Election/Restrictions
Claim 19 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group 2, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on February 10, 2026.
Claim Rejections - 35 USC § 112
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 11-18 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 11, lines 7-10 recites the phrase “wherein the elongate shaft includes a reverse curve portion curved in a second direction opposite the first direction; wherein the elongate shaft includes a reverse curve portion curved in a second direction opposite the first direction.” It is suggested to delete the duplicate phrase.
Claim Rejections - 35 USC § 102
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 following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Daniels (US 2017/0266434).
Regarding claim 1, Daniels discloses the claimed guidewire for delivering a replacement heart valve implant (e.g. as shown in Figure 9-11), comprising:
an elongate shaft including a distal section and a proximal section extending proximally from the distal section (e.g. elongated body 950 including proximal and distal section 962 extending from the proximal section);
a coiled portion disposed within the distal section (e.g. pigtail shape 990); and
one or more electrodes disposed within the coiled portion, the one or more electrodes adapted for pacing the heart (e.g. electrodes 956 and 958);
wherein the proximal section is adapted to provide an electrical connection with a pacing system (e.g. application of pacing with external pulse generator 142 as shown in Figure 1).
Regarding claim 2, Daniels additionally discloses wherein the elongate shaft includes a polymeric coating disposed on the coiled portion (e.g. PTFE coating on elongated body as disclosed in [0040]).
Regarding claim 3, Daniels additionally discloses wherein the one or more electrodes disposed within the coiled portion comprise spots in the coiled portion in which the polymeric coating has been removed to expose metal underneath the polymeric coating (e.g. removed insulative coating to expose electrodes 1758 as described in [0066].
Regarding claim 4, Daniels additionally discloses wherein at least some of the one or more electrodes are adapted to contact a ventricular wall of a heart when the coiled portion is disposed within a ventricle of the heart (e.g. electrode location as shown in Figure 1).
Regarding claim 5, Daniels additionally discloses wherein the proximal section of the elongate shaft includes a bare metal portion that is adapted to accommodate an alligator clip connecting the elongate shaft with the pacing system (e.g. proximal end of lead is connected to external pulse generator 142 as disclosed in [0036]).
Regarding claim 6, Daniels additionally discloses wherein the proximal section of the elongate shaft includes a bare metal proximal end that is adapted to accommodate an electrical connection with the pacing system (e.g. proximal end of lead is connected to external pulse generator 142 as disclosed in [0036] and will thus necessarily have a mental connecting portion).
Regarding claim 7, Daniels additionally discloses wherein the elongate shaft includes a polymeric coating over an entirety of the elongate shaft with the exception of: the one or more electrodes; and a bare metal region of the proximal section (e.g. PTFE coating as describe din [0040]).
Regarding claim 8, Daniels additionally discloses wherein at least a proximal-most region of the proximal section includes an uninsulated metal core and an insulated coil extending over the uninsulated metal core (e.g. uninsulated core wire 552 and insulated coils 1754 as shown in Figure 17 and disclosed in [0067]).
Claims 1-18 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Wang (US 2024/0058585).
Regarding claim 1, Wang discloses the claimed guidewire for delivering a replacement heart valve implant comprising:
an elongate shaft including a distal section and a proximal section extending proximally from the distal section (e.g. guidewire 100 as shown in Figure 1, 2, and 12 including proximal end 1204);
a coiled portion disposed within the distal section (e.g. pigtail portion 102a), and
one or more electrodes disposed within the coiled portion, the one or more electrodes adapted for pacing the heart (e.g. electrodes 150);
wherein the proximal section is adapted to provide an electrical connection with a pacing system (e.g. proximal end 1204 for connecting with a pacing system
Regarding claim 2, Wang additionally discloses wherein the elongate shaft includes a polymeric coating disposed on the coiled portion (e.g. PTFE insulation as disclosed in [0057]).
Regarding claim 3, Wang additionally discloses wherein the one or more electrodes disposed within the coiled portion comprise spots in the coiled portion in which the polymeric coating has been removed to expose metal underneath the polymeric coating (e.g. holes in insulation 603 that expose electrodes 650 as shown in Figure 6).
Regarding claim 4, Wang additionally discloses wherein at least some of the one or more electrodes are adapted to contact a ventricular wall of a heart when the coiled portion is disposed within a ventricle of the heart (e.g. device is capable of being implanted in the position as shown in Figure 2).
Regarding claim 5, Wang additionally discloses wherein the proximal section of the elongate shaft includes a bare metal portion that is adapted to accommodate an alligator clip connecting the elongate shaft with the pacing system (e.g. device is capable of being attached via alligator clip to the distal end of the guidewire as disclosed in [0069]).
Regarding claim 6, Wang additionally discloses wherein the proximal section of the elongate shaft includes a bare metal proximal end that is adapted to accommodate an electrical connection with the pacing system (e.g. proximal end 1320 as shown in Figure 12B that is bare metal and capable of electrical connection with the pacing electrode as disclosed in [0063]).
Regarding claim 7, Wang additionally discloses wherein the elongate shaft includes a polymeric coating over an entirety of the elongate shaft with the exception of: the one or more electrodes; and a bare metal region of the proximal section (e.g. PTFE insulation as disclosed in [0057] and as shown in Figures 1, 9, and 12).
Regarding claim 8, Wang additionally discloses wherein at least a proximal-most region of the proximal section includes an uninsulated metal core and an insulated coil extending over the uninsulated metal core (e.g. uninsulated core wire 610 and insulation core 603 as shown in Figure 8).
Regarding claim 9, Wang additionally discloses wherein the coiled portion is curved in a first direction in a first plane; the elongate shaft includes a reverse curve portion curved in a second direction opposite the first direction; and the reverse curve portion is disposed proximal of the coiled portion (e.g. reverse curved portion as shown in Figure 2 and further highlighted in the figures below).
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Magnified portion of figure 2 showing a clear opposite curve than the coiled portion.
Regarding claim 10, Wang additionally discloses wherein the reverse curve portion is curved in the second direction within the first plane (e.g. as shown in Figures above).
Regarding claim 11, Wang discloses the claimed guidewire adapted to deliver pacing pulses, comprising:
an elongate shaft including a distal section and a proximal section extending proximally from the distal section, the proximal section including an electrical contact segment adapted to make electrical contact with a pacing system (e.g. guidewire 100 as shown in Figure 1, 2, and 12 including proximal end 1204);
wherein the elongate shaft is adapted for delivering a replacement heart valve implant (e.g. background; [0002]), the elongate shaft including
a coiled portion disposed within the distal section, the coiled portion curved in a first direction in a first plane (e.g. pigtail portion 102a), and
wherein the elongate shaft includes a reverse curve portion curved in a second direction opposite the first direction; the reverse curved portion disposed proximal of the coiled portion (e.g. reverse curved portion as shown in Figure 2 and further highlighted in the figures shown in claim 9 above); and
wherein the coiled portion includes one or more electrodes electrically coupled with the electrical contact segment (e.g. electrodes 150).
Regarding claim 12, Wang additionally discloses wherein the elongate shaft includes a polymeric coating disposed on the coiled portion (e.g. PTFE insulation as disclosed in [0057]).
Regarding claim 13, Wang additionally discloses wherein the one or more electrodes electrically coupled with the electrical contact segment comprise spots in the coiled portion in which the polymeric coating has been removed to expose metal underneath the polymeric coating (e.g. holes in insulation 603 that expose electrodes 650 as shown in Figure 6).
Regarding claim 14, Wang additionally discloses wherein at least some of the one or more electrodes are adapted to contact a ventricular wall of a heart when the coiled portion is disposed within a ventricle of the heart (e.g. device is capable of being implanted in the position as shown in Figure 2).
Regarding claim 15, Wang additionally discloses wherein the electrical contact segment comprises a bare metal portion that is adapted to accommodate an alligator clip connecting the elongate shaft with the pacing system (e.g. device is capable of being attached via alligator clip to the distal end of the guidewire as disclosed in [0069]).
Regarding claim 16, Wang additionally discloses wherein the electrical contact segment comprises a bare metal proximal end that is adapted to accommodate an electrical connection with the pacing system (e.g. proximal end 1320 as shown in Figure 12B that is bare metal and capable of electrical connection with the pacing electrode as disclosed in [0063]).
Regarding claim 17, Wang additionally discloses wherein the elongate shaft includes a polymeric coating over an entirety of the elongate shaft with the exception of: the one or more electrodes; and a bare metal region of the proximal section (e.g. PTFE insulation as disclosed in [0057] and as shown in Figures 1, 9, and 12).
Regarding claim 18, Wang additionally discloses wherein the electrical contact segment comprises an uninsulated metal core and an insulated coil extending over the uninsulated metal core (e.g. uninsulated core wire 610 and insulation core 603 as shown in Figure 8).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Amanda K Hulbert whose telephone number is (571)270-1912. The examiner can normally be reached Monday - Friday 9:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Unsu Jung can be reached at 571-272-8506. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Amanda K Hulbert/Primary Examiner, Art Unit 3792
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