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 .
Response to Amendment
Amendment to claim 1 of 7/30/2026 acknowledged and entered.
Response to Arguments
Applicant’s arguments, see p. 7, para. 2, filed 7/30/2026, with respect to claim 1 have been fully considered and are persuasive. The rejection of 4/30/2026 has been withdrawn.
Applicant’s arguments with respect to claim(s) 1 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 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:
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 1-9, 16-20 is/are rejected under 35 U.S.C. 103 as being obvious over Suarez (US 20230181241 A1) in view of Tarke (US 20220257093 A1).
The applied reference has a common assignee with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
Regarding claim 1, Suarez teaches An apparatus, comprising:
a shaft assembly including a proximal portion (fig. 2, element 110, [0029], handle assembly 110) and a distal portion (fig. 2, element 120, [0029], catheter 120), the distal portion being configured to enable lateral deflection of the distal end away from or toward a longitudinal axis defined by the proximal portion ([0030], deflection drive3 actuator 114 rotates to deflect end effector 140 and distal portion of catheter 120);
a distal navigation sensor (fig. 8, element 328, [0052], rings 328 may be used as reference electrodes to allow for location sensing) positioned at or near the distal end of the distal portion, the distal navigation sensor being configured to indicate a position of the distal end of the distal portion in three-dimensional space; and
a pair of proximal navigation sensors positioned at or near a proximal end of the distal portion (fig. 8, element 328, [0052], rings 328 may be used as reference electrodes to allow for location sensing), the pair of proximal navigation sensors being configured to indicate a roll orientation of the proximal end of the distal portion about the longitudinal axis.
Suarez does not explicitly teach a pair of proximal navigation sensors positioned laterally adjacent one another.
However, Tarke teaches a pair of proximal navigation sensors positioned laterally adjacent one another ([0115] In a manner similar to that described above, each concentric loop portion (230, 232, 234, 236) defines a respective navigation sensor (250, 252, 254, 256) that is operable to generate signals indicative of the position of the respective navigation sensor (250, 252, 254, 256) and thereby indicative of the position of at least a portion (e.g., flexible portion (118) of shaft assembly (104)) of instrument (100) in three-dimensional space, the underside of the flex circuit would be adjacent to the top side along a lateral face of the circuit).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the sensor of Suarez to be disposed adjacent as taught in Tarke in order to determine a position of the device in 3 dimensional space (Tarke [0115]).
Regarding claim 2, Suarez in view of Tarke teaches The apparatus of claim 1,
Further, Suarez teaches wherein the distal portion includes a linear array of articulating ribs (fig. 8, element 322, [0050], braided structure 322 is composed of interlaced rib structures).
Regarding claim 3, Suarez in view of Tarke teaches The apparatus of claim 2,
Further, Suarez teaches wherein the distal navigation sensor is positioned distal of the linear array of articulating ribs (fig. 4, element 500, distal flex circuit 500 is disposed distally to the braided structure 322).
Regarding claim 4, Suarez in view of Tarke teaches The apparatus of claim 2,
Further, Suarez teaches wherein the pair of proximal navigation sensors is positioned proximal of the linear array of articulating ribs (fig. 4, element 400, [0054, 63], proximal flex circuit 400 forms a navigation sensor and is disposed proximal to the bending section).
Regarding claim 5, Suarez in view of Tarke teaches The apparatus of claim 2,
Further, Suarez teaches wherein the articulating ribs is connected to each other by a resilient spine (fig. 8, element 326, [0065], channel 326).
Regarding claim 6, Suarez in view of Tarke teaches The apparatus of claim 5,
Further, Suarez teaches further comprising at least one electrically conductive element ([0074], flex circuits may be integrated into the same flex circuit which includes a strip extending along channel 326) extending along the resilient spine.
Regarding claim 7, Suarez in view of Tarke teaches The apparatus of claim 6,
Further, Suarez teaches wherein the at least one electrically conductive element is electrically coupled to the distal navigation sensor ([0074], flex circuits may be integrated into the same flex circuit which includes a strip extending along channel 326).
Regarding claim 8, Suarez in view of Tarke teaches The apparatus of claim 1,
Further, Suarez teaches further comprising a flexible substrate secured to the distal portion, wherein each of the proximal and distal navigation sensors is disposed on the flexible substrate to define a navigation sensor assembly ([0074], flex circuits may be integrated into the same flex circuit which includes a strip extending along channel 326).
Regarding claim 9, Suarez in view of Tarke teaches The apparatus of claim 8, wherein:
Further, Suarez teaches the navigation sensor assembly includes a plurality of proximal leads, and each of the proximal and distal navigation sensors is electrically coupled to respective proximal leads of the plurality of proximal leads ([0074], flex circuits may be integrated into the same flex circuit which includes a strip extending along channel 326).
Regarding claim 16, Suarez in view of Tarke teaches The apparatus of claim 1,
Further, Suarez teaches wherein the proximal portion of the shaft assembly is rigid (fig. 2, element 116, [0031], the proximal end of the catheter is covered by rigid nozzle member 116).
Regarding claim 17, Suarez in view of Tarke teaches The apparatus of claim 1,
Further, Suarez teaches wherein the distal portion of the shaft assembly is flexible ([0050], steerable portion 320).
Regarding claim 18, Suarez in view of Tarke teaches The apparatus of claim 1,
Further, Suarez teaches wherein the distal portion has a distal end sized and configured to fit in an anatomical passageway in an ear, nose, or throat of a patient (fig. 1, [0029], catheter is configured to be operable in the heart of a patient, which is smaller than ear, nose, and throat passages, hence it would fit in those passages as well).
Regarding claim 19, Suarez in view of Tarke teaches The apparatus of claim 1,
Further, Suarez teaches wherein the distal navigation sensor is configured to indicate a position of the distal end of the distal portion in three-dimensional space by generating signals indicative of a position of the distal end of the distal portion in three-dimensional space ([0035], 3-D map data on display 18).
Regarding claim 20, Suarez in view of Tarke teaches The apparatus of claim 1,
Further, Suarez teaches wherein the pair of proximal navigation sensors is configured to indicate a roll orientation of the proximal end of the distal portion about the longitudinal axis by generating signals indicative of a roll orientation of the proximal end of the distal portion about the longitudinal axis ([0056], orientation of distal flex circuits determinable by the field generators 20).
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
Claim(s) 10-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Suarez in view of Tarke as applied to claim 8 above, and further in view of Kuboi (US 20160081761 A1).
Regarding claim 10, Suarez in view of Tarke teaches The apparatus of claim 8,
Suarez in view of Tarke does not explicitly teach wherein the navigation sensor assembly includes at least one distal lead configured to be electrically coupled to at least one of an image sensor or an illuminating element.
However, Kuboi teaches wherein the navigation sensor assembly (fig. 1, element 3, [0026], curving direction regulation section 3) includes at least one distal lead configured to be electrically coupled to at least one of an image sensor (fig. 12, element 77b, [0107], image sensor 77b) or an illuminating element.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Suarez to include an image sensor as taught in Kuboi in order to generate a video signal of the operating site (Kuboi [0107]).
Regarding claim 11, Suarez in view of Tarke and Kuboi teaches The apparatus of claim 10,
Further, Suarez teaches wherein the at least one distal lead is positioned distal of the distal navigation sensor ([0033], electrical power supplied to the distal tip beyond the distal navigation sensor to ablate tissue, hence a distal lead must be positioned at the distal tip).
Regarding claim 12, Suarez in view of Tarke and Kuboi teaches The apparatus of claim 10,
Further Kuboi teaches further comprising at least one of an image sensor or an illuminating element (fig. 12, element 77b, [0107], image sensor 77b), wherein the at least one distal lead is electrically coupled to the at least one of an image sensor or an illuminating element (fig. 12, element 77c, [0107], signal line 77c).
Regarding claim 13, Suarez in view of Tarke and Kuboi teaches The apparatus of claim 12,
Further, Kuboi teaches wherein the at least one distal lead is angularly aligned with the at least one of an image sensor or an illuminating element relative to the longitudinal axis (fig. 12, element 77c, the signal line 77c is in line with the image sensor 77b).
Regarding claim 14, Suarez in view of Tarke and Kuboi teaches The apparatus of claim 12,
Further, Kuboi teaches wherein the at least one of an image sensor or an illuminating element includes an image sensor and an illuminating element (fig. 12, element 76a, 77b, [0106-7], image sensor 77b, light guide 76a).
Regarding claim 15, Suarez in view of Tarke and Kuboi teaches The apparatus of claim 14,
Further, Kuboi teaches wherein the at least one distal lead includes at least one first distal lead (fig. 12, element 77c, signal line 77c) electrically coupled to the image sensor and at least one second distal lead electrically coupled to the illuminating element ([0028], light source 5 may be an LED or laser, both controlled electrically).
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 TIMOTHY TUAN LUU whose telephone number is (703)756-4592. The examiner can normally be reached Monday-Tuesday, Thursday-Friday.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Carey can be reached at 5712707235. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/TIMOTHY TUAN LUU/ Examiner, Art Unit 3795
/MICHAEL J CAREY/ Supervisory Patent Examiner, Art Unit 3795
Prosecution Insights