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 .
DETAILED ACTION
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) 1-3, 6, 7, 9-12, 15, 16, 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ueda as applied to claim Ueda US5,681,260 and Wang US2022/0047150 .
Ueda discloses for claim 1, “A catheter (14:28-30 describes different embodiments can be formed from parts of the described embodiments; as such, parts of different embodiments will be referred to as comprising a distinct embodiment; catheters are described at 14:51), comprising:
a catheter shaft (endoscope 101; fig 16; 13:15) having a proximal end, a distal end, and one or more lumens therebetween (instrument channel 140; fig 25; 17:35); and
wherein the catheter shaft has varying degrees of flexibility so as to be more flexible from the proximal end to the distal end (11:62-65 describes insertion part with two different flexibilities);
a distal tip (tip part 8a; fig 2) disposed at the distal end of the catheter shaft and defining an illumination cavity (lumen/cavity occupied by light guide 16; fig 2),
at least one optical fiber (light guide 16; fig 2) configured to transmit light between a light source and a tissue at a wavelength between 250 nm and 450 nm for facilitating excitation of nicotinamide adenine dinucleotide hydrogen (NADH) fluorescence from the tissue, and to detect emitted fluorescence from the tissue at a wavelength between 400 nm and 520 nm, the at least one optical fiber extending through the one or more lumens of the catheter shaft into the illumination cavity (fig 2),
a plurality of tubular (fig 14 shows magnetic bodies 95 are tubular) magnetic bodies (knobs 102a, 102b, …; fig 16; 13:26-27 describes knobs formed of a permanent magnet) positioned along a length of and circumferentially around the catheter shaft, wherein the plurality of tubular magnetic bodies are spaced apart from one another, and the plurality of tubular magnetic bodies being responsive to an applied magnetic field, at least one of the plurality of tubular magnetic bodies located at or near the distal end of the catheter shaft so that the distal end of the catheter can be manipulated with a magnetic field (fig 16)”.
Ueda does not disclose:
wherein the illumination cavity comprises one or more fluid ports and one or more optical ports,
wherein the one or more fluid ports in the illumination cavity are configured to allow fluid to flow out of the one or more lumens of the catheter shaft;
wherein the one or more optical ports in the illumination cavity are configured to exchange light energy between the at least one optical fiber and the tissue”.
Wang teaches in the same field of endeavor, a sheath cap (fig 6) with a main lumen/cavity (fig 6) as the claimed illumination cavity and multiple outlet channels (water spray channel 3, multiple oblique holes 4.x, 15, 16, etc.; fig 6-10) which can be used for any number of purposes requiring an outlet port/channel, including but not limited to irrigation, suction, illumination, imaging, etc. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the modification of Wang into the invention of Ueda in order to configure the catheter e.g. as claimed, including providing a central common shared working channel because it provides multifunctionality and allows the outlet ports to provide a variety of functions and does not limit the port to a specific use/function.
Ueda discloses for claim 2, “The catheter of claim 1, wherein a distal-most magnetic body of the plurality of tubular magnetic bodies is configured to determine the position of the distal end of the catheter shaft (15:58-66 describes position detection for the tip)”.
Ueda discloses for claim 3, “The catheter of claim 1, wherein plurality of tubular magnetic bodies are configured to prevent kinking of the catheter shaft (Applicant is functionally claiming the proximal magnetic bodies and does not further structurally define how this function is implemented in the claims or in the specification. As such, this limitation will be deemed to be met by the tubular magnets configured as in fig 6A, i.e. a serially configured set of ring magnets, which Ueda discloses in fig 16, a serially configured set of ring magnets)”.
Ueda discloses for claim 6, “The catheter of claim 1, wherein spacing of the plurality of tubular magnetic bodies within the distal end of the catheter shaft is configured to modify how the catheter shaft is positioned and navigated (again, it is considered that Applicant is functionally claiming the spacing of the magnetic bodies and does not further structurally define how this function is implemented in the claims or in the specification outside of fig 6A, i.e. a serially configured set of ring magnets. As such, Ueda discloses such a configuration in fig 16)”.
Ueda discloses for claim 7, “The catheter of claim 1, where each of the plurality of tubular magnetic bodies is configured to respond to the magnetic field in which it is placed to impact navigation of the catheter shaft (magnetic knobs 102a, 102b, …; fig 17, 18;)”.
Ueda discloses for claim 9, “The catheter of claim 1, wherein the distal end is configured to deliver ablation energy to tissue, the ablation energy being selected from a group consisting of radiofrequency (RF) energy, microwave energy, electrical energy, electromagnetic energy, cryoenergy, laser energy, ultrasound energy, acoustic energy, chemical energy, thermal energy and combinations thereof (instrument channel 140 opening allows the distal end to deliver ablation energy to tissue, i.e. configures the distal end to perform such a function)”.
Ueda discloses for claim 10, “A catheter (14:28-30 describes different embodiments can be formed from parts of the described embodiments; as such, parts of different embodiments will be referred to as comprising a distinct embodiment; catheters are described at 14:51), comprising:
a steerable magnetic catheter shaft (endoscope 101; fig 16; 13:15) having a proximal end, a distal end, and one or more lumens therebetween (instrument channel 140; fig 25; 17:35), the catheter shaft having regions of differing flexibility along a length thereof so as to be more flexible from the proximal end to the distal end (11:62-65 describes insertion part with two different flexibilities); and
one or more magnetic bodies (knobs 102a, 102b, …; fig 16; 13:26-27 describes knobs formed of a permanent magnet) positioned along a length of the catheter body and being responsive to an applied magnetic field, at least one of the one or more magnetic bodies located at or near the distal end of the catheter body so that the distal end of the catheter can be manipulated with a magnetic field having practical strength (fig 16)”.
Ueda discloses for claim 11, “The catheter of claim 10, wherein a distal-most magnetic body of the one or more magnetic bodies is configured to determine the position of the distal end of the catheter (15:58-66 describes position detection for the tip)”.
Ueda discloses for claim 12, “The catheter of claim 10, wherein the proximal magnetic bodies are configured to prevent kinking of the catheter (Applicant is functionally claiming the proximal magnetic bodies and does not further structurally define how this function is implemented in the claims or in the specification. As such, this limitation will be deemed to be met by the tubular magnets configured as in fig 6A, i.e. a serially configured set of ring magnets, which Ueda discloses in fig 16, a serially configured set of ring magnets)”.
Ueda discloses for claim 15, “The catheter of claim 10, wherein spacing of the one or more magnetic bodies within a distal end of the catheter body is configured to modify how the catheter body is positioned and navigated (Applicant is functionally claiming the spacing of the magnetic bodies and does not further structurally define how this function is implemented in the claims or in the specification outside of fig 6A, i.e. a serially configured set of ring magnets. As such, Ueda discloses such a configuration in fig 16)”.
Ueda discloses for claim 16, “The catheter of claim 10, where each of the one or more magnetic bodies is configured to respond to the magnetic field in which it is placed to impact navigation of the catheter body (magnetic knobs 102a, 102b, …; fig 17, 18)”.
Ueda discloses for claim 18, “The catheter of claim 10, wherein the distal end is configured to deliver ablation energy to tissue, the ablation energy being selected from a group consisting of radiofrequency (RF) energy, microwave energy, electrical energy, electromagnetic energy, cryoenergy, laser energy, ultrasound energy, acoustic energy, chemical energy, thermal energy and combinations thereof (instrument channel 140 opening allows the distal end to deliver ablation energy to tissue, i.e. configures the distal end to perform such a function)”.
Claim(s) 19 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ueda and Wang and further in view of Amirana US2013/0079645.
Ueda discloses for claim 19, “A method for visualizing ablated tissue, comprising:
advancing a catheter to a tissue in need of ablation, the catheter comprising a catheter shaft (endoscope 101; fig 16; 13:15) having a proximal end, a distal end, and one or more lumens therebetween (instrument channel 140; fig 25; 17:35);
the catheter shaft having regions of differing flexibility along a length thereof so as to be more flexible from the proximal end to the distal end (11:62-65 describes insertion part with two different flexibilities);
a distal tip (tip part 8a; fig 2) disposed at the distal end of the catheter shaft and defining an illumination cavity (lumen/cavity occupied by light guide 16; fig 2),
at least one optical fiber (light guide 16; fig 2) configured to transmit light between a light source and a tissue at a wavelength between 250 nm and 450 nm for facilitating excitation of nicotinamide adenine dinucleotide hydrogen (NADH) fluorescence from the tissue, and to detect emitted fluorescence from the tissue at a wavelength between 400 nm and 520 nm, the at least one optical fiber extending through the one or more lumens of the catheter shaft up into the illumination cavity (fig 2),
and a plurality of tubular (fig 14 shows magnetic bodies 95 are tubular) magnetic bodies (knobs 102a, 102b, …; fig 16; 13:26-27 describes knobs formed of a permanent magnet) positioned along a length of and circumferentially around the catheter shaft, wherein the plurality of tubular magnetic bodies are spaced apart from one another, and the plurality of tubular magnetic bodies being responsive to an applied magnetic field, at least one of the plurality of tubular magnetic bodies located at or near the distal end of the catheter shaft so that the distal end of the catheter can be manipulated with a magnetic field (fig 16)”.
Ueda does not disclose:
“wherein the illumination cavity comprises one or more fluid ports and one or more optical ports,
wherein the one or more fluid ports in the illumination cavity are configured to allow fluid to flow out of the one or more lumens of the catheter shaft;
wherein the one or more optical ports in the illumination cavity are configured to exchange light energy between the at least one optical fiber and the tissue;”
Wang teaches in the same field of endeavor, a sheath cap (fig 6) with a main lumen/cavity (fig 6) as the claimed illumination cavity and multiple outlet channels (water spray channel 3, multiple oblique holes 4.x, 15, 16, etc.; fig 6-10) which can be used for any number of purposes requiring an outlet port/channel, including but not limited to irrigation, suction, illumination, imaging, etc. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the modification of Wang into the invention of Ueda in order to configure the catheter e.g. as claimed, including providing a central common shared working channel because it provides multifunctionality and allows the outlet ports to provide a variety of functions and does not limit the port to a specific use/function.
Ueda does not disclose:
directing light energy from the at least one optical fiber through the one or more optical ports to excite (NADH) in an area of the tissue including ablated tissue and non-ablated tissue;
imaging the area of the tissue to detect NADH emitted fluorescence of the area of the tissue; and
producing a display of the imaged, illuminated tissue, the display illustrating the ablated tissue as having less fluorescence than non-ablated tissue ”.
Amirana teaches in the same field of endeavor, imaging ablated and nonablated tissue using UV light for exciting mitochondrial NADH and detecting the fluorescence and gaps in fluorescence (0128). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the modification of Amirana into the invention of Ueda in order to configure the method e.g. as claimed because it allows viewing of tissue not normally visible with white illumination light, thereby detecting ischemic or injured tissue (0128).
Ueda discloses for claim 20, “A method for visualizing ablated tissue, comprising:
advancing a catheter (endoscope 101; fig 16; 13:15) to a tissue in need of ablation, the catheter comprising a steerable magnetic catheter shaft having a proximal end, a distal end, and one or more lumens therebetween (instrument channel 140; fig 25; 17:35),
the catheter shaft (endoscope 101; fig 16; 13:15) having regions of differing flexibility along a length thereof so as to be more flexible from the proximal end to the distal end; (11:62-65 describes insertion part with two different flexibilities);
a distal tip (tip part 8a; fig 2) disposed at the distal end of the catheter and defining an illumination cavity (lumen/cavity occupied by light guide 16; fig 2),
at least one optical fiber (light guide 16; fig 2) configured to transmit light between a light source and a tissue at a wavelength between 250 nm and 450 nm for facilitating excitation of nicotinamide adenine dinucleotide hydrogen (NADH) fluorescence from the tissue, and to detect emitted fluorescence from the tissue at a wavelength between 400 nm and 520 nm, the at least one optical fiber extending through the one or more lumens of the catheter shaft up into the illumination cavity (fig 2);
a plurality of tubular (fig 14 shows magnetic bodies 95 are tubular) magnetic bodies (knobs 102a, 102b, …; fig 16; 13:26-27 describes knobs formed of a permanent magnet) positioned along a length of and circumferentially around the catheter shaft, wherein the plurality of tubular magnetic bodies are spaced apart from one another, and the plurality of tubular magnetic bodies being responsive to an applied magnetic field, at least one of the plurality of tubular magnetic bodies located at or near the distal end of the catheter shaft so that the distal end of the catheter can be manipulated with a magnetic field (fig 16)”.
Ueda does not disclose:
“wherein the illumination cavity comprises one or more fluid ports and one or more optical ports,
wherein the one or more fluid ports in the illumination cavity are configured to allow fluid to flow out of the one or more lumens of the catheter shaft;
wherein the one or more optical ports in the illumination cavity are configured to exchange light energy between the at least one optical fiber and the tissue;”
Wang teaches in the same field of endeavor, a sheath cap (fig 6) with a main lumen/cavity (fig 6) as the claimed illumination cavity and multiple outlet channels (water spray channel 3, multiple oblique holes 4.x, 15, 16, etc.; fig 6-10) which can be used for any number of purposes requiring an outlet port/channel, including but not limited to irrigation, suction, illumination, imaging, etc. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the modification of Wang into the invention of Ueda in order to configure the catheter e.g. as claimed, including providing a central common shared working channel because it provides multifunctionality and allows the outlet ports to provide a variety of functions and does not limit the port to a specific use/function.
Ueda does not disclose:
directing light energy from the at least one optical fiber through the one or more optical ports to excite (NADH) in an area of the tissue including ablated tissue and non-ablated tissue;
imaging the area of the tissue to detect NADH emitted fluorescence of the area of the tissue; and
producing a display of the imaged, illuminated tissue, the display illustrating the ablated tissue”.
Amirana teaches in the same field of endeavor, imaging ablated and nonablated tissue using UV light for exciting mitochondrial NADH and detecting the fluorescence and gaps in fluorescence (0128). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the modification of Amirana into the invention of Ueda in order to configure the method e.g. as claimed because it allows viewing of tissue not normally visible with white illumination light, thereby detecting ischemic or injured tissue (0128).
Response to Arguments
Applicant’s arguments with respect to the claims 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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO892.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 JAE K WOO whose telephone number is (571)272-0837. The examiner can normally be reached M-F 8:30-2:30p, 6p-9p.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anhtuan Nguyen can be reached at (571) 272-4963. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Jae Woo/Examiner, Art Unit 3795
/ANH TUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795
3/27/26