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 .
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 2/12/25 has/have been acknowledged and is/are being considered by the Examiner.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1-9 and 21 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lee et al. (U.S. Pub. 2002/0161421 hereinafter “Lee”).
Regarding claim 1, Lee discloses a medical apparatus for insertion into a patient's vasculature via catheterization, comprising: a handle (e.g. ¶47) comprising: a housing configured to be slidably coupled to a guidewire (e.g. 534) when the guidewire is inserted through the housing (e.g. ¶¶5, 47); and an electrical connection assembly that is configured to be electrically connected to an electrode of an external electrical stimulation generator (e.g. Abstract; “external electrical source”) and to the guidewire to provide an electrical connection between the external electrical stimulation generator and the guidewire (e.g. ¶61), the electrical connection assembly comprising: at least one electrical contacting structure configured to maintain electrical contact with the guidewire as the guidewire moves longitudinally relative to the handle, or vice versa (e.g. ¶61; “spring piston connection”).
Regarding claim 2, Lee further discloses wherein the electrical connection assembly further comprises a stationary connector that electrically contacts the electrical contacting structure, and an electrical connector that is electrically connected to the stationary connector and that is configured to be removably coupled and electrically connected to a lead of the external electrical stimulation generator (e.g. ¶61; “spring piston connection”).
Regarding claim 3, Lee further discloses wherein the electrical connector comprises an electrical socket on an exterior of the housing that is configured to be removably coupled and electrically connected to the lead of the external electrical stimulation generator, and wherein the electrical connector further comprises an electrically conductive wire, wherein a first end of the electrically conductive wire electrically connects to the stationary connector and wherein an opposite second end of the electrically conductive wire electrically connects to the electrical socket to provide an electrical connection between the electrical socket and the electrical contacting structure (e.g. Abstract; ¶53).
Regarding claim 4, Lee further discloses wherein the electrical connector comprises an electrically conductive wire, wherein a first end of the electrically conductive wire electrically connects to the stationary connector and wherein an opposite second end of the electrically conductive wire extends outside of the housing through a socket in the housing, and wherein the second end of the electrically conductive wire is configured to be removably coupled and electrically connected to the lead of the external electrical stimulation generator (e.g. Abstract; ¶53).
Regarding claim 5, Lee further discloses wherein the housing has an internal passageway (e.g. 540) that extends through the housing and is configured to receive the guidewire (e.g. 534).
Regarding claim 6, Lee further discloses wherein the housing comprises a recess along the internal passageway, and wherein the electrical contacting structure is disposed within the recess (e.g. ¶61).
Regarding claim 7, Lee further discloses a biasing mechanism that urges the electrical contacting structure toward the guidewire (e.g. ¶61; “spring piston”).
Regarding claim 8, Lee further discloses wherein the biasing mechanism comprises a compression spring (e.g. ¶61; “spring piston”).
Regarding claim 9, Lee further discloses wherein a first end of the compression spring abuts an adjacent surface of the housing, and wherein an opposite second end of the compression spring abuts the electrical contacting structure (e.g. ¶61; “spring piston”).
Regarding claim 21, Lee further discloses a locking mechanism that is configured to be selectively adjusted by a user to prevent axial movement of the guidewire relative to the handle (e.g. 206; “Collett”).
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.
Claim(s) 10-15 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lee as applied to claims 1-9 and 21 above, and further in view of Driscoll (U.S. Pat. 3,610,877).
Regarding claims 10-15 and 20, Lee discloses the claimed invention except for the electrical contacting structure being at least cylindrical roller. However, Driscoll teaches that it is known to use opposing cylindrical rollers that have a rotating axis orthogonal to the internal passageway and are set within recesses in the handle as set forth in Figure 1 and elements 31-32 to provide a means for easily allowing the guidewire to be in inserted and retracted while still having constant contact and being held in place. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by Lee, with the opposing cylindrical rollers as taught by Driscoll, since such a modification would provide the predictable results of for easily allowing the guidewire to be in inserted and retracted while still having constant contact and being held in place.
Claim(s) 16-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lee as applied to claims 1-9 and 21 above, and further in view of Fariabi (U.S. Pat. 5,931,819).
Regarding claims 16-17, Lee discloses the claimed invention except for the electrical contacting structure being two or more spherical balls. However, Fariabi teaches that it is known to use multiple spherical balls as set forth in Column 7, lines 34-63 and elements 43-44 to provide a means for providing power to multiple electrodes of a guidewire. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by Lee, with the know system of using multiple spherical balls as taught by Fariabi, since such a modification would provide the predictable results of using a known means for providing power to multiple electrodes of a guidewire.
Claim(s) 18-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lee as applied to claims 1-9 and 21 above, and further in view of Stevenson et al. (U.S. Pub. 2010/0174349 hereinafter “Stevenson”).
Regarding claims 18-19, Lee discloses the claimed invention except for the electrical contacting structure being metal spikes that penetrate the coating of the guidewire. However, Stevenson teaches that it is known to use metal spikes as set forth in Figures 71-72 and Paragraph 212 to provide a means for providing power to wire through the insulation and coating. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by Lee, with the know system of using metal spikes as taught by Stevenson, since such a modification would provide the predictable results of using a known means for providing power to multiple electrodes of a guidewire.
Claim(s) 22-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lee as applied to claims 1-9 and 21 above, and further in view of Daniels et al. (U.S. Pub. 2017/0266434 hereinafter “Daniels”).
Regarding claims 22-23, Lee discloses the claimed invention except for explicitly stating that the guidewire system is connected to a shaft with a balloon at its distal end. However, Daniels teaches that it is known to use an electrically connected guidewire as set forth in the Abstract and Paragraphs 13, 32-33 and Figure 2 to provide stimulation to the heart and for guiding and supporting delivering of elongated treatment devices within the heart. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by Lee, with an elongated shaft with a balloon at the end as taught by Daniels, since such a modification would provide the predictable results of providing stimulation to the heart and for guiding and supporting delivering of elongated treatment devices within the heart.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REX R HOLMES whose telephone number is (571)272-8827. The examiner can normally be reached Monday-Thursday 7:00AM-5:30PM.
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/REX R HOLMES/Primary Examiner, Art Unit 3796