DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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.
Notice of Amendment
In response to the amendment(s) filed on 1/29/26, amended claim(s) 21 and 34, and canceled claim(s) 33 is/are acknowledged. The following new and/or reiterated ground(s) of rejection is/are set forth:
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claim(s) 21-23, 27, 29-32, and 34 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over U.S. Patent No. 4,985,022 to Fearnot et al. (hereinafter “Fearnot”) in view of U.S. Patent Application Publication No. 2007/0270679 to Nguyen et al. (hereinafter “Nguyen”) and U.S. Patent Application Publication No. 2011/0066057 to Zdeblick.
For claim 21, Fearnot discloses a medical device (Abstract) comprising:
a shaft (101, 102) (Fig. 1) comprising a first segment (101) (as can be seen in Fig. 1) and a second segment (102) (as can be seen in Fig. 1), wherein the first segment is configured to (Examiner’s Note: functional language, i.e., capable of) buckle upon application of a first critical force thereto (col. 3, line 61 – col. 4, line 15) and the second segment is configured to (Examiner’s Note: functional language, i.e., capable of) buckle upon application of a second critical force thereto (col. 3, lines 61-63, col. 4, line 58 – col. 5, line 1, and col. 6, lines 17-23), wherein the second critical force is lower than the first critical force (col. 3, lines 61-63, col. 4, line 58 – col. 5, line 1, and col. 6, lines 17-23);
a coil (109) (Figs. 1 and/or 2) disposed within an inner surface of the second segment (as can be seen in Fig. 2).
Fearnot does not expressly disclose that the coil is disposed radially inwardly of the inner surface of the second segment.
However, Nguyen teaches a coil (“second compression coil,” para [0008]) disposed radially inwardly of an inner surface of the second segment (para [0008]) (also see [0036] and [0069]-[0070]).
It would have been obvious to a skilled artisan to modify Fearnot such that the coil is disposed radially inwardly of the inner surface of the second segment, in view of the teachings of Nguyen, for the obvious advantage of improving the topography of the outer surface of the second segment (i.e., by making it smoother without bumps from the coil) so that the luminal wall is not snagged or damaged while the device is in use.
Fearnot does not expressly disclose a first pair of electrodes and a second pair of electrodes disposed on the second segment, wherein the second pair of electrodes are located distal to the first pair of electrodes, wherein the second pair of electrodes comprises a first electrode and a second electrode, and wherein the first electrode is a tip electrode and the second electrode is a ring electrode, and wherein coil is positioned between the first pair of electrodes and the second pair of electrodes.
However, Nguyen teaches a first pair of electrodes and a second pair of electrodes (7, also see 1) (Figs. 1A-B) (para [0044]-[0045]) disposed on a shaft (as can be seen in Figs. 1A-B) (para [0044]), wherein the second pair of electrodes are located distal to the first pair of electrodes (as can be seen in Figs. 1A-B), wherein the second pair of electrodes comprises a first electrode and a second electrode (as can be seen in Fig. 1B) (para [0045]), and wherein the first electrode is a tip electrode (1) and the second electrode is a ring electrode (7), and wherein coil is positioned between the first pair of electrodes and the second pair of electrodes (para [0008]) (also see [0036] and [0069]-[0070]).
It would have been obvious to a skilled artisan to modify Fearnot to include a first pair of electrodes and a second pair of electrodes disposed on the second segment, wherein the second pair of electrodes are located distal to the first pair of electrodes, wherein the second pair of electrodes comprises a first electrode and a second electrode, and wherein the first electrode is a tip electrode and the second electrode is a ring electrode, and wherein coil is positioned between the first pair of electrodes and the second pair of electrodes, in view of the teachings of Nguyen, for the obvious advantage mapping the vasculature through which Fearnot’s device is being inserted at multiple points.
Fearnot and Nguyen do not expressly disclose wherein the medical device facilitates monitoring a bend angle of the coil within the second segment between the first pair of electrodes and the second pair of electrodes using at least one of a magnetic-based positioning system and an electrical-based positioning system.
However, Zdeblick teaches wherein a first electrode and a second electrode are configured to generate a signal indicative of a bend angle between two sections of the second segment using at least one of a magnetic-based positioning system and an electrical-based positioning system (para [0042] and [0049]) (also see para [0028] and [0039]).
It would have been obvious to a skilled artisan to modify Fearnot wherein the medical device facilitates monitoring a bend angle of the coil within the second segment between the first pair of electrodes and the second pair of electrodes using at least one of a magnetic-based positioning system and an electrical-based positioning system, in view of the teachings of Zdeblick, for the obvious advantage of monitoring the position, orientation, and motion of Fearnot’s catheter.
For claim 22, Fearnot, as modified, further discloses wherein the bend angle of the coil is defined between a first axial line passing through the first pair of electrodes and a second axial line passing through the second pair of electrodes (see Fig. 4 and para [0049] of Zdeblick) (also see Fig. 3 and para [0042] of Zdeblick).
For claim 23, Fearnot, as modified, further discloses wherein the first pair of electrodes and the second pair of electrodes are configured to (Examiner’s Note: functional language) output electrical signals to an external computer or processor (see para [0077] of Nguyen).
For claim 27, Fearnot, as modified, further disclose wherein the magnetic-based positioning system is configured to apply an alternating current (AC) magnetic field (Examiner’s Note: the alternative being relied upon to satisfied the previous claim language and therefore this resultant not needing to be anticipated to anticipate the whole scope of the claim language) (alternatively, see para [0027] of Zdeblick).
For claim 29, Fearnot, as modified, further discloses wherein each of first pair of electrodes and the second pair of electrodes comprises a positioning electrode configured to (Examiner’s Note: functional language, i.e., capable of) produce representation signals indicative of at least one of a position and orientation thereof (see para [0077] of Nguyen).
For claim 30, Fearnot, as modified, further discloses wherein each of the first pair of electrodes and the second pair of electrodes is further configured to (Examiner’s Note: functional language, i.e., capable of) output the representative signals to an external computer or processor (see para [0077] of Nguyen).
For claim 31, Fearnot does not expressly disclose wherein at least two electrodes of the first pair of electrodes and the second pair of electrodes are configured to sense an impedance.
However, Nguyen teaches wherein at least two electrodes of the first pair of electrodes and the second pair of electrodes are configured (Examiner’s Note: functional language, i.e., capable of) sense an impedance (para [0040]) (also see para [0039]).
It would have been obvious to a skilled artisan to modify Fearnot wherein at least two electrodes of the first pair of electrodes and the second pair of electrodes are configured to sense an impedance, in view of the teachings of Nguyen, for the obvious advantage of sensing a property of the tissue to characterize the tissue in case it needs treatment.
For claim 32, Fearnot does not expressly disclose wherein the at least one electrode of the second pair of electrodes is configured to sense an impedance and to ablate tissue.
However, Nguyen teaches wherein the at least one electrode of the second pair of electrodes is configured to (Examiner’s Note: functional language, i.e., capable of) sense an impedance and to ablate tissue (para [0040]).
It would have been obvious to a skilled artisan to modify Fearnot wherein the at least one electrode of the second pair of electrodes is configured to sense an impedance and to ablate tissue, in view of the teachings of Nguyen, for the obvious advantage of sensing a property of the tissue to characterize the tissue and then treating it if it’s unhealthy tissue.
For claim 34, Fearnot, as modified, further discloses wherein the first pair of electrodes and the second pair of electrodes are configured to (Examiner’s Note: functional language, i.e., capable of) sense an impedance (para [0040] of Nguyen) and the first electrode is further configured to (Examiner’s Note: functional language, i.e., capable of) ablate tissue (para [0040] of Nguyen).
Response to Arguments
Applicant's arguments filed 1/29/26 have been fully considered but they are not persuasive. The main issue is that the rejection is Fearnot in view of Nguyen and then Zdeblick, not Fearnot in view of Zdeblick and then Nguyen. That is, Fearnot is modified by Nguyen to include the two pairs of electrodes and also uses the relative spacing of those electrodes to modify Fearnot. Then Fearnot is modified by Zdeblick to have the capability of monitoring a bend angle of the coil. So nowhere in the rejection is Zdeblick being modified by Nguyen. If anything, Zdeblick’s electrodes would be placed into Fearnot, but even then, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference (See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981)), and the claim language does not recite that the electrodes must be quadrant electrodes. So, all in all, the arguments presented in the response do not appear to be addressing the rejection of record and how the skilled artisan would have modified the reference(s).
Conclusion
THIS ACTION IS MADE FINAL. 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL LEE CERIONI whose telephone number is (313) 446-4818. The examiner can normally be reached M - F 8:00 AM - 5:00 PM PT.
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/DANIEL L CERIONI/Primary Examiner, Art Unit 3791