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
The amendment submitted November 26th, 2025 has been entered and Applicant’s amendments to the claims have overcome the 112(b) rejection previously set forth in the Non-Final Office Action mailed August 26th, 2025.
Response to Arguments
In response to applicant's arguments on pages 10-11 with respect to claim 23 that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the joint being configured to “fix an axial position of an optical probe”, or language to specify the prevention of axial displacement) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
In response to applicant's argument that one would not combine Ramzipoor with Stevens-Wright on pages 11-12 with respect to claim 23, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). Additionally, while Applicant argues claim 23 under similar reasons as claim 1, the limitations argued in each claim are different such that claim 23 would need to recite the exact features of claim 1 for these arguments to have more weight.
In response to applicant's arguments against the references individually on pages 17-19, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
In response to applicant's argument on page 18 that the optical fiber 150 of Ransbury is stationary and does not focus light and that to modify Stevens-Wright to include the position of 150 would be totally useless without also incorporating component 160 to focus light, and even with them, there would be no scanning without rotation, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., details of the optical assembly, “the optical fiber 150 of Ransbury is stationary and does not focus light”) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Therefore, these arguments are not persuasive and the Examiner maintains the rejections of claims 14 & 23.
Applicant’s arguments, see pages 18-19, respect to the rejection(s) of claim(s) 18 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of newly found prior art that teaches the disclosed claim limitations.
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.
Claims 14-16 are rejected under 35 U.S.C. 103 as being unpatentable over Stevens-Wright et al. (U.S. Pub. No. 20140163360, previously cited), herein referred to as “Stevens-Wright” in view of Ransbury et al. (U.S. Pat. No. 10779904, previously cited), herein referred to as “Ransbury”.
Regarding claim 14, Stevens-Wright discloses a system ([0012]: FIG. 1A illustrates an overview of an ablation catheter system) comprising:
a catheter (irrigated catheter 1000) comprising:
an elongate tubular body (shaft portion 1002 & deflectable tip 1004, Fig. 10) having spaced apart proximal and distal ends (proximal end of shaft portion 1002/distal end of deflectable tip 1004) and a lumen extending through the elongate tubular body (lumen of shaft portion 1002/deflectable tip 1004, Fig. 11);
an ablation electrode (ablation electrode 1008) extending from the distal end of the elongate tubular body ([0074]: a shaft portion 1002 coupled to a deflectable tip 1004, which is coupled to an ablation electrode 1008 via an interface 1006) to terminate in a respective distal end of the ablation electrode (see Figs. 10 & 11 for the distal end of electrode 1008);
an optical imaging probe (imaging device 1012; see shaft of imaging probe 1012 in Fig. 11), the elongate body portion of the optical imaging probe having an elongate body portion (drive cable 1104) extending from the proximal end of the elongate tubular body through the lumen of the elongate tubular body (see Fig. 11 where imaging device 1012/drive cable 1104 extends to the proximal end of shaft portion 1002/deflectable tip 1004); and
a flexible tubing (steering column 1102) extending over a length proximal portion of the elongate body portion of the optical imaging probe ([0080]: imaging device control portion 1100 comprises a steering column 1102; see Fig. 11 where steering column extends over a proximal portion of drive cable 1104) and configured to permit at least rotational movement of the probe within and relative to the flexible tubing and the elongate tubular body ([0082]: steering column 1102 may be affixed to shaft portion 1002 such that the steering column 1102 does not rotate when drive cable 1104 rotates), a distal end portion of the flexible tubing being spaced proximally from the distal end of the elongate body portion of the optical imaging probe (see Fig. 11 where the distal end of steering column 1102 is spaced proximally from the distal end of drive cable 1104) and being held at an axial position relative to the elongate tubular body to fix the axial distance between the distal end of the optical imaging probe and the distal end of the ablation electrode ([0080]: imaging device control portion 1100 comprises a steering column 1102 and a drive cable 1104 coupled to the steering column 1102; [0081]: imaging device 1012 is coupled to the imaging device steering portion 1100 by being coupled to a distal end of the drive cable 1104 … The bearing surface 1108 may prevent any translational movement of the steering column 1102 and drive cable 1104; [0082]: steering column 1102 may be affixed to shaft portion 1002 such that the steering column 1102 does not rotate when drive cable 1104 rotates; wherein the imaging device 1012 being coupled to dive cable 1104, drive cable 1104 being coupled steering column 1102, and steering column being affixed to shaft portion 1002 describes a structure where the axial distance between the distal end of imaging device 1012 and ablation electrode 1104 is fixed);
a pulse generator (ablation energy generator 4); and
a controller (controller 8) configured to control the pulse generator to supply electrical energy to the ablation electrode to implement ablation ([0044]: When used in an ablation application, controller 8 is used to control ablation energy provided to catheter 10 by ablation energy generator 4).
But Stevens-Wright fails to disclose the optical imaging probe terminating in a distal end thereof that is spaced proximally a distance from the distal end of the ablation electrode.
However, Ransbury discloses the optical imaging probe (optical fiber 150) terminating in a distal end thereof that is spaced proximally a distance (illumination cavity 152) from the distal end of the ablation electrode (Col. 7, lines 4-7: The distal tip 148 may be provided with one or more openings 154 for exchange of light energy between the illumination cavity 152 and tissue). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the distance between the distal end of the optical imaging probe relative to the electrode of Stevens-Wright to the distance of Ransbury, for the purpose of illuminating a tissue along a longitudinal axis of the catheter (Ransbury: Col. 14, lines 39-40).
Regarding claim 15, Stevens-Wright discloses wherein the distal end of the ablation electrode (ablation electrode 1008) comprises a central aperture extending therethrough (see Fig. 11 where electrode 1008 is a ring/cylindrical electrode such that the distal end is a central aperture),
wherein the optical imaging probe comprises a forward scanning probe aligned to image through the central aperture of the ablation electrode ([0078]: the imaging device 1012 may be pitched at an angle to a longitudinal (e.g., the central longitudinal) axis of the catheter; see Fig. 11 where imaging device cover 1014 covers a distalmost end of the device such that the field of view includes a forward scanning view).
Regarding claim 16, Stevens-Wright discloses wherein the optical imaging probe is an optical coherence tomography (OCT) probe ([0077]: imaging device 1012 may be an optical coherence tomography (OCT) imaging device comprising one or multiple OCT transducers).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Stevens-Wright in view of Ransbury as applied to claim 14, above, and further in view of Jimenez et al. (U.S. Pub. No. 20210212755, previously cited), herein referred to as “Jimenez”.
Regarding claim 17, Stevens-Wright in view of Ransbury fails to explicitly disclose wherein the OCT probe is a polarization sensitive OCT probe.
However, Jimenez discloses wherein the OCT probe is a polarization sensitive OCT probe ([0007]: Some of the optical variables that can be used to determine changes in tissue properties are frequency, time of flight, polarization, and intensity; [0070]: interferometric data analysis may be associated with understanding changes in the polarization state of light reflected or scattered by the tissue, which may allow assessment of changes in the birefringence of tissue). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the imaging probe of Stevens-Wright in view of Ransbury to be the OCT probe of Jimenez for the purpose of OCT providing depth-resolved information with high axial resolution and LCI techniques can be used to determine structural characteristics of tissue and their changes when an ablation lesion occurs (Jimenez: [0007]).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Stevens-Wright in view of Ransbury as applied to claim 14, above, and further in view of Galluzzo et al. (U.S. Pub. No. 20170156705), herein referred to as “Galluzzo”.
Regarding claim 18, Stevens-Wright discloses a window (imaging device cover 1014) within the central aperture, an outer surface of the window including an optically transparent material ([0077]: an imaging device 1012, which is covered by imaging device cover 1014 … Imaging device cover may be attached to the catheter via a threaded interface; Fig. 10 where this shows an optically transparent material & where a threaded interface is seen as being inset from a distal edge of the ablation electrode since the cover is directly adjacent electrode 1008) but fails to disclose the outer surface of the window being inset proximally from a distal edge of the ablation electrode.
However, Galluzzo discloses the outer surface of the window being inset proximally from a distal edge of the ablation electrode (see bottom right image in Fig. 5). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the window of Stevens-Wright in view of Ransbury to be inset proximally from a distal edge of the ablation electrode, as taught by Galluzzo, for the purpose of obtaining more information about the shape and depth of the lesion than in the case of one static imaging element, because the surface of the imaging cone bisects the edge of the RF ablation lesion at a range of locations, permitting a greater range of ultrasound image and mechanical strain information to be acquired (Galluzzo: [0044]).
Claims 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Stevens-Wright in view of Ransbury as applied to claim 14, above, and further in view of Sharareh et al. (U.S. Pub. No. 20070287998, previously cited), herein referred to as “Sharareh”.
Regarding claim 19, Stevens-Wright discusses a channel for a temperature sensor ([0093]: ablation electrode 1008 comprises longitudinal channel 1304 for guiding a thermal sensor along the length of the catheter … the thermal sensor and conductor wire occupy a region of the catheter peripheral to the imaging device steering portion) but fails to disclose a temperature sensor mounted adjacent the distal end of the ablation electrode, a conductor coupled with the temperature sensor to carry a temperature signal from the temperature sensor toward the proximal end of the elongate tubular body.
However, Sharareh discloses a temperature sensor ([0044]: tip electrode 36 comprises a thermocouple) mounted adjacent the distal end of the ablation electrode ([0034]: a lead wire 40 and thermocouple wires 41 and 45 protected by a sheath 39; see 3A where the sheath 39 is adjacent to a distal end of electrode 36), a conductor (thermocouple wires 41, 45) coupled with the temperature sensor to carry a temperature signal from the temperature sensor toward the proximal end of the elongate tubular body ([0036]: The thermocouple wires 41 and 45 can also extend through the third lumen 34; [0044]: The wires 41 and 45 then extend out through the control handle 16 and to a connector (not shown) connectable to a temperature monitor (not shown); see Figs. 2A & 2B). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the ablation catheter of Stevens-Wright in view of Ransbury to include a temperature sensor, as taught by Sharareh, for the purpose of enabling temperature sensing for measuring lesion formation (Sharareh: [0008]).
Regarding claim 20, Stevens-Wright in view of Ransbury and Sharareh discloses a longitudinal slot (Sharareh: blind hole 33) formed in the distal end portion of ablation electrode ([0044]: a second blind hole 33 of the tip electrode 36), the temperature sensor being mounted in the longitudinal slot ([0044]: The wires 41 and 45 of the wire pair are electrically isolated from each other except at their distal ends where they contact and are twisted together, covered with a short piece of plastic tubing 63, e.g., polyimide, and covered with epoxy. The plastic tubing 63 is then attached in a second blind hole 33 of the tip electrode 36 (FIG. 3B)).
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Stevens-Wright in view of Ransbury as applied to claim 14, above, and further in view of Flanagan et al. (U.S. Pub. No. 20180271491, previously cited), herein referred to as “Flanagan”.
Regarding claim 22, Stevens-Wright in view of Ransbury fails to disclose a pressure sensor mounted adjacent the distal end of the ablation electrode.
However, Flanagan discloses a pressure sensor (optical fibers 228; [0069]: optical fibers 228 (shown in FIG. 2B) for pressure sensing, force sensing, and/or shape sensing) mounted adjacent the distal end of the ablation electrode (ablation electrode 206; see Fig. 2A where optical fibers 228 are adjacent ablation electrode 206 & Fig. 2A where the assembly 210 (which comprises optical fibers 228) are adjacent a distal end of the ablation electrode 206). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the system of Stevens-Wright in view of Ransbury to include pressure sensors, as taught by Flanagan for the purpose of detecting pressure of a heart chamber or measuring an amount of pressure applied by the tip to the tissue (Flanagan: [0070], [0081]).
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Stevens-Wright in view of Ramzipoor et al. (U.S. Pub. No. 20100185054), herein referred to as “Ramzipoor”.
Regarding claim 23, Stevens-Wright discloses an ablation catheter (Abstract: A catheter includes a fluid network for cooling the ablation electrode, surrounding blood and tissue), comprising:
an elongate tubular body (shaft portion 1002 & deflectable tip 1004, Fig. 10) having spaced apart proximal and distal ends (proximal end of shaft portion 1002/distal end of deflectable tip 1004) and a lumen extending through the elongate tubular body (lumen of shaft portion 1002/deflectable tip 1004, Fig. 11);
an ablation electrode (ablation electrode 1008) extending from the distal end of the elongate tubular body ([0074]: a shaft portion 1002 coupled to a deflectable tip 1004, which is coupled to an ablation electrode 1008 via an interface 1006) to terminate in a respective distal end of the ablation electrode (see Figs. 10 & 11 for the distal end of electrode 1008);
an optical imaging probe (imaging device 1012; see shaft of imaging probe 1012 in Fig. 11) having an elongate body portion (drive cable 1104), the elongate body portion extending from the proximal end of the elongate tubular body through the lumen of the elongate tubular body (see Fig. 11 where imaging device 1012/drive cable 1104 extends to the proximal end of shaft portion 1002/deflectable tip 1004) and terminating in a distal end that is spaced a distance from the distal end of the ablation electrode (see Fig. 11 where the distal end of imaging device 1012 is spaced a distance from the distal end of electrode 1008);
a flexible tubing (steering column 1102) extending over a proximal portion of the elongate body portion of the optical imaging probe ([0080]: imaging device control portion 1100 comprises a steering column 1102; see Fig. 11 where steering column extends over a proximal portion of drive cable 1104) and configured to permit rotational movement of the optical imaging probe within and relative to the flexible tubing ([0082]: steering column 1102 may be affixed to shaft portion 1002 such that the steering column 1102 does not rotate when drive cable 1104 rotates), a distal end portion of the flexible tubing being spaced proximally from the distal end of the elongate body portion of the optical imaging probe (see Fig. 11 where the distal end of steering column 1102 is spaced proximally from the distal end of drive cable 1104), and the distal end portion of the flexible tubing being configured to hold the elongate body portion of the optical imaging probe ([0082]: steering column 1102 may be affixed to drive cable 1104) and mitigate axial movement of the optical imaging probe relative to the elongate tubular body and thereby stabilize a distance of between the distal end of the elongate body portion of the optical imaging probe and the respective distal end of the ablation electrode (see Fig. 11; [0080]: imaging device control portion 1100 comprises a steering column 1102 and a drive cable 1104 coupled to the steering column 1102; [0081]: imaging device 1012 is coupled to the imaging device steering portion 1100 by being coupled to a distal end of the drive cable 1104 … The bearing surface 1108 may prevent any translational movement of the steering column 1102 and drive cable 1104; [0082]: steering column 1102 may be affixed to shaft portion 1002 such that the steering column 1102 does not rotate when drive cable 1104 rotates; wherein the imaging device 1012 being coupled to dive cable 1104, drive cable 1104 being coupled steering column 1102, and steering column being affixed to shaft portion 1002 describes a structure where the axial distance between the distal end of imaging device 1012 and ablation electrode 1104 is stabilized); and
a joint (bearing surface 1108),
but Stevens-Wright fails to disclose a joint coupled between an outer surface of the distal end portion of the flexible tubing to an inner surface of the elongate tubular body and configured to space the outer surface of the flexible tubing radially inwardly from the inner surface of the elongate tubular body and maintain the flexible tubing coaxially within the lumen, and the outer surface of the flexible tubing that extends through the lumen proximally from the joint being spaced apart from the inner surface the elongate tubular body.
However, Ramzipoor discloses a joint (detent 216) coupled between an outer surface (outer surface of drive shaft 204) of the distal end portion of the flexible tubing (drive shaft 204) to an inner surface (detent 212) of the elongate tubular body (elongated tubular member 104) and configured to space the outer surface of the flexible tubing radially inwardly from the inner surface of the elongate tubular body and maintain the flexible tubing coaxially within the lumen (see spacing in Fig. 2B), and the outer surface of the flexible tubing that extends through the lumen proximally from the joint being spaced apart from the inner surface the elongate tubular body ([0033]: stop device 212 includes detent 216 in inner core 106 and detent 218 on the interior surface of elongated member 104. Detents 216 and 218 are preferably positioned so that they come into contact and stop the advancement of inner core 106 once pre-determined length 214 has been reached).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the ablation catheter of Stevens-Wright to include a joint, as taught by Ramzipoor, for the purpose of limiting the advancement of the inner core/stopping the advancement of the inner core once a pre-determined length of the transducer has been reached (Ramzipoor: [0033]).
Allowable Subject Matter
The following is an examiner’s statement of reasons for allowance:
The current prior art of record, neither alone nor in combination, fail to disclose "a joint circumscribing the distal end portion of the flexible tubing and spacing apart an outer surface of the flexible tubing and an inner surface of the elongate tubular body, the joint being configured to couple the outer surface of the distal end portion of the flexible tubing to the elongate tubular body to hold the distal end portion of the flexible tubing at an axial position relative to the elongate tubular body and thereby fix an axial distance between the distal end of the optical imaging probe and the distal end of the ablation electrode" in combination with the other claim limitations.
Stevens-Wright discloses an ablation catheter (Abstract: A catheter includes a fluid network for cooling the ablation electrode, surrounding blood and tissue), comprising: an elongate tubular body (shaft portion 1002 & deflectable tip 1004, Fig. 10) having spaced apart proximal and distal ends (proximal end of shaft portion 1002/distal end of deflectable tip 1004) and a lumen extending through the elongate tubular body (lumen of shaft portion 1002/deflectable tip 1004, Fig. 11); an ablation electrode (ablation electrode 1008) extending from the distal end of the elongate tubular body ([0074]: a shaft portion 1002 coupled to a deflectable tip 1004, which is coupled to an ablation electrode 1008 via an interface 1006) to terminate in a respective distal end of the ablation electrode (see Figs. 10 & 11 for the distal end of electrode 1008); an optical imaging probe (imaging device 1012; see shaft of imaging probe 1012 in Fig. 11), the elongate body portion having an elongate body portion (drive cable 1104) extending from the proximal end of the elongate tubular body through the lumen of the elongate tubular body (see Fig. 11 where imaging device 1012/drive cable 1104 extends to the proximal end of shaft portion 1002/deflectable tip 1004) and terminating in a distal end that is spaced a distance from the distal end of the ablation electrode (see Fig. 11 where the distal end of imaging device 1012 is spaced a distance from the distal end of electrode 1008); and a flexible tubing (steering column 1102) extending over a proximal portion of the elongate body portion of the optical imaging probe ([0080]: imaging device control portion 1100 comprises a steering column 1102; see Fig. 11 where steering column extends over a proximal portion of drive cable 1104) and configured to permit rotational movement of the optical imaging probe within and relative to the flexible tubing ([0082]: steering column 1102 may be affixed to shaft portion 1002 such that the steering column 1102 does not rotate when drive cable 1104 rotates), a distal end portion of the flexible tubing being spaced proximally from the distal end of the elongate body portion of the optical imaging probe (see Fig. 11 where the distal end of steering column 1102 is spaced proximally from the distal end of drive cable 1104), and a joint (bearing surface 1108), but Stevens-Wright fails to disclose a joint circumscribing the distal end portion of the flexible tubing and spacing apart an outer surface of the flexible tubing and an inner surface of the elongate tubular body, the joint being configured to couple the outer surface of the distal end portion of the flexible tubing to the elongate tubular body to hold the distal end portion of the flexible tubing at an axial position relative to the elongate tubular body and thereby fix an axial distance between the distal end of the optical imaging probe and the distal end of the ablation electrode.
While Ramzipoor discloses a joint (see page 6 of Non-Final Office Action mailed 08/26/2025), Applicants arguments submitted 11/26/2025, see pages 10-11 are found persuasive.
Claims 1, 3-13 & 21 are allowed.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Abigail M Ziegler whose telephone number is (571) 272-1991. The examiner can normally be reached M-F 8:30 a.m. - 5 p.m. EST.
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/ABIGAIL M ZIEGLER/Examiner, Art Unit 3794
/THOMAS A GIULIANI/Primary Examiner, Art Unit 3794