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 (IDS) submitted on 02/25/26 was filed. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Amendment
The amendment filed 01/19/26 has been entered. Claims 1, 9-10, and 15 have been amended. Claims 2-8, 11-14, and 16-20 are in the original/ previously presented form. Thus, claims 1-20 remain pending in the application. Applicant’s amendments to the Specification, Drawings, and Claims have overcome each and every objection and 112(b) rejection previously set forth in the Non-Final Office Action mailed 10/17/25.
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 1-4, 6-7, 10-12, 14-15, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Williams (U.S. Patent No. 7,041,121) in view of Dahm et al. (U.S. PGPUB No. 2010/0145415), hereinafter Dahm, and Cardinal et al. (U.S. PGPUB No. 2013/0261692), hereinafter Cardinal.
Regarding claim 1, Williams discloses a catheter system for activation of a photoactive agent (see col. 2 lines 22-34: LEDs from tubular medical device activates a photosensitive agent), comprising:
a catheter (see col. 3 lines 35-43: “flexible central member” in FIGs.1-3. Needle is used in the example but can be any ‘flexible central member’) comprising:
an elongate shaft (see shaft of needle in Fig. 1 and see col 2 lines 56-59: “outer cylindrical surface” ==elongate shaft) comprising a proximal portion (a distal portion is shown and therefore the device MUST have a proximal portion. see also col. 2 lines 14-34: device such as disclosed in U.S. Patent No. 5964756 shows proximal portion comprising a handle in at least FIG.1), a distal portion (as shown and labeled in Fig. 1), and a first lumen (see col. 2 lines 62-65: one or more central lumens) extending along the elongate shaft (needle shaft), the first lumen extending through the proximal portion of the elongate shaft and through the distal portion of the elongate shaft (see col. 2 lines 62-65: needle can include one or more central lumens and therefore the lumen extends proximally and distally through needle), the first lumen configured to accept at least one of a guidewire, the photoactive agent, and a fluid to be delivered into a patient (see col. 2 lines 62-65: central lumen can be for supplying fluid to target tissue and is therefore the first lumen is “configured to” supply fluid to patient);
a first flexible circuit (see label ‘flex strip on FIG. 1) disposed about (see col. 2 line 50- col.3 line 4: flex strips “mounted to exterior or needle”) the distal portion (as labeled in FIG. 1) of the elongate shaft (needle shaft);
a plurality of first light-emitting diodes (LEDs) (see col. 2 lines 22-25: light-emitting diode is equivalent to the “laser” diode as disclosed throughout the patent disclosure) disposed along the first flexible circuit (see col. 2 line 50- col.3 line 4: each flex strip comprises laser diodes—a plurality of laser diodes as labeled in FIG. 1);
a second flexible circuit disposed about the distal portion of the elongate shaft (see col. 2 line 50- col.3 line 4: embodiment of FIG. 1 comprises 4 of the flex strips and thus discloses a “second” flexible circuit); and
a plurality of second LEDs disposed along the second flexible circuit (see col. 2 line 50- col.3 line 4: each flex strip comprises laser diodes—a plurality of laser diodes as labeled in FIG. 1);
a control unit (see col. 4 lines 28-46: controlled energy supplied to LEDs and therefore there must be a control unit for enabling such power delivery); and
a communications cable disposed within the catheter and electrically coupling the first and second LEDs with the control unit (see col. 3 lines 48-60: central conductor can pass through central longitudinal lumen of the needle to supply power such as from control unit as described in col. 4 lines 28-46); and
wherein the control unit is configured to vary power provided to the plurality of second LEDs independently of the first LEDs (see col. 4 lines 28-46: the number of LEDs activated and the amount of energy supplied to each LED is controllable. Therefore the controller is “configured to” vary power provided to the plurality of second LEDs independently of the first because Williams discloses power independently controllable to each LED).
Williams is silent to “a second lumen extending through the proximal portion of the elongate shaft but not through the distal portion of the elongate shaft;”, the control unit “coupled to the proximal end of the elongate shaft”, a communications cable disposed within the “second lumen”, “wherein the control unit comprising a battery power supply and a controller comprising an integrated circuit electrically coupled to the plurality of first and second LEDs configured to vary power provided to the plurality of first and second LEDs;”, and wherein the “controller” is configured to vary power.
However, Dahm teaches a catheter system for activation of a photoactive agent (see [0059]: catheter system for photo excitation) comprising a catheter (110, see FIG. 1) comprising an elongated shaft (116) with a proximal end (see rightward portion of shaft 116 relative to the ‘break’ in FIG. 1—extending to control system 106) and a first (138, see FIG. 2A and [0067]: one or more LEDs 138) and second plurality of LEDs (see [0073]: distal tip 114 can include matrix of LEDS instead of singular row as shown in FIG.2A. a second ‘row’ of the matrix would be the second plurality of LEDs.). Dahm further teaches the catheter system comprising a control unit (106, see [0059]) coupled to the proximal end (rightward extending end of 116) of the elongate shaft (116) and wherein the control unit (106) comprising a battery power supply (126, see [0061-0062]: power supply 126 can be battery) and a controller (124) electrically coupled (see [0068]: such as by wires 160/162, see FIG. 2a) to the plurality of first and second LEDs (see [0061]: controller supplies energy to 120 which, see [0066-0068]: comprises LEDs 138) configured to vary power provided to the plurality of first and second LEDs (see [0071-0073]: power at different wavelengths/ varying outputs is controllable to the LEDs.).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the control unit disclosed in Williams to be coupled specifically at the proximal end of the elongated shaft of the catheter as taught by Dahm (FIG. 1) for the purpose of allowing the control system to be easily operated from outside the body/ opposite of where the distal portion of the catheter is disposed (see [0060-0061]), thus achieving the control unit being coupled to “the proximal end of the elongate shaft”.
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the control unit disclosed in Williams to include a battery power source as taught by Dahm (FIG. 1) for the purpose of supplying portable power to the light delivery system (see [0062]), thus achieving “wherein the control unit comprising a battery power supply.”
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the control unit disclosed in Williams with the controller electrically coupled to the first and second plurality of LEDs as taught by Dahm (FIG. 1) for the purpose of providing the system with a controller for controlling the amount of radiant energy emitted by the light transmission system comprising the LEDs (see [0061]), thus achieving “a controller electrically coupled to the plurality of first and second LEDs configured to vary power provided to the plurality of first and second LEDs” and wherein the “controller” is configured to vary power.
Williams in view of Dahm (FIG. 1) remain silent to “a second lumen extending through the proximal portion of the elongate shaft but not through the distal portion of the elongate shaft;”, a communications cable disposed within the “second lumen”, and the controller “comprising an integrated circuit electrically coupled to” the plurality of first and second LEDs.
However, in another embodiment (see FIG. 6), Dahm teaches the controller comprising an integrated circuit electrically coupled to (see [0089-0090]: flip chip has integrated circuit with LEDs mounted thereon) the plurality of first and second LEDs (304).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the electrical coupling of the controller electrically coupled to the first and second plurality of LEDs taught by Williams in view of Dahm (FIG.1) to be electrically coupled by an integrated circuit as taught by Dahm (FIG.6) for the purpose of eliminating wire bonding to reduce the profile of the distal tip for delivery along narrow passageways (see [0090]), thus achieving the controller comprising “an integrated circuit electrically coupled to” the plurality of first and second LEDs.
Williams in view of Dahm (FIG.1) and Dahm (FIG. 6) remain silent to “a second lumen extending through the proximal portion of the elongate shaft but not through the distal portion of the elongate shaft;”, a communications cable disposed within the “second lumen”.
However, Cardinal teaches a catheter system comprising a catheter (see FIG. 4, [0026]: balloon catheter and [0044]: balloon 332 has electrodes on surface) having an elongate shaft (see ‘Modified FIG. 4’ below) with a first lumen (470) and a second lumen (462, see [0046]: 462 parallel to lumen 354 as seen in FIG. 4), the second lumen (462) extending through a proximal portion (see ‘Modified FIG. 4’ below—portion of shaft between 344 to 346)
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of the elongate shaft (see shaft in ‘Modified FIG.4’ above) but not (see [0046]: cable 351 only in proximal portion from 344 to 346) through a distal portion (see ‘Modified FIG. 4’ above) of the elongate shaft (see shaft in ‘Modified FIG.4’ above); a communications cable (351) disposed within the second lumen (462).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the elongate shaft of the catheter disclosed in Williams to include a second lumen extending through the proximal portion of the elongate shaft but not through the distal portion of the elongate shaft and housing a communications cable as taught by Cardinal for the purpose of electrically coupling a proximal control unit to the distally housed elements (see [0040] and [0046]), thus achieving “a second lumen extending through the proximal portion of the elongate shaft but not through the distal portion of the elongate shaft;” and a communications cable disposed within the “second lumen”.
Regarding claim 2, the modified system of Williams teaches the catheter system of claim 1, and Williams further discloses wherein the first flexible circuit and the second flexible circuit are disposed about the distal end of the elongate shaft (see Fig. 1 ‘flex strip’ label and col. 2 line 50- col.3 line 4: flex strips “mounted to exterior or needle”), but Williams (Fig.1) is silent to the first and second flexible circuits disposed “in a helical manner.”
However, in a second embodiment (see FIG. 2), Williams teaches a first and second flexible circuit disposed about the distal end of the elongate shaft in a helical manner (see col. 3 lines 15-35: flex circuit mounted helically around the needle and can be plurality of flex strips).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the plurality of circuits disposed about the distal end of the elongate shaft disclosed in Williams (FIG.1) to be disposed in a helical manner as taught by Williams (FIG.2) for the purpose of facilitating bending of the shaft while inhibiting bucking of the flexible circuit (see col. 3 lines 15-35), thus achieving the first and second flexible circuits disposed “in a helical manner.”
Regarding claim 3, the modified system of Williams teaches the catheter system of claim 1, but in the first embodiment (Fig.1), Williams is silent to “wherein a cross-section of the catheter system taken normal to the first lumen at an LED of the first LEDS is coincident with an LED of the second LEDs.”
However, in a second embodiment (see Fig. 2), Williams teaches wherein a cross-section of the catheter system taken normal to the first lumen at an LED (see ‘Modified Fig. 2’ below)
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of the first LEDS is coincident with an LED of the second LEDs (coincident along line labeled “l” in ‘Modified FIG. 2’ above, aligning with Applicant’s disclosure of the structure in at least [0030] and FIGs. 2A,B).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the plurality of circuits disposed about the distal end of the elongate shaft disclosed in Williams (FIG.1) to be disposed in a helical manner with longitudinally aligned LEDs as taught by Williams (FIG.2) for the purpose of facilitating bending of the shaft while inhibiting bucking of the flexible circuit (see col. 3 lines 15-35), thus achieving “wherein a cross-section of the catheter system taken normal to the first lumen at an LED of the first LEDS is coincident with an LED of the second LEDs”.
Regarding claim 4, the modified system of Williams teaches the catheter system of claim 1, and Williams further discloses wherein the control unit is configured to sequentially vary power between the plurality of first LEDs and the plurality of second LEDs (see col. 4 lines 28-46: the number of LEDs activated and the amount of energy supplied to each LED is controllable. Therefore the controller is “configured to” sequentially vary power between the plurality of first LEDs and the plurality of second LEDs because Williams discloses power independently controllable to each LED), but Williams is silent to the “controller” of the control unit.
However, Dahm teaches a catheter system for activation of a photoactive agent (see [0059]: catheter system for photo excitation) comprising a catheter (110, see FIG. 1) and a control unit (106, see [0059]), wherein the control unit (106) comprises a controller (124), and wherein the controller (124) is configured to sequentially vary power (see [0071-0073]: power at different wavelengths/ varying outputs is controllable to the LEDs and therefore the controller is “configured to” sequentially vary power between the first and second plurality of LEDs. See also [0061]: controller supplies energy to 120 which, see [0066-0068]: comprises LEDs 138) between a plurality of first LEDs (138, see FIG. 2A and [0067]: one or more LEDs 138) and a plurality of second LEDs (see [0073]: distal tip 114 can include matrix of LEDS instead of singular row as shown in FIG.2A. a second ‘row’ of the matrix would be the second plurality of LEDs.).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the control unit configured to vary power to the first and second plurality of LEDs disclosed in Williams to include a controller as taught by Dahm for the purpose of providing the system with a user operated controller for controlling the amount of radiant energy emitted by the light transmission system comprising the LEDs (see [0061]), thus achieving the “controller” of the control unit.
Regarding claim 6, the modified system of Williams teaches the catheter system of claim 1, and Williams further discloses wherein the first LEDs are configured to emit light at a first wavelength (see col. 1 lines 19-27: device is for photoactivation of Photofrin that responds to a 630nm wavelength. Therefore the device must at least supply a 630nm wavelength in order to enable the device for photoactivation as further described in col.1 line 61- col.2 line 13), but Williams is silent to “and the second LEDS are configured to emit light at a second wavelength different than the first wavelength.”
However, Dahm teaches a catheter system for activation of a photoactive agent (see [0059]: catheter system for photo excitation) comprising a catheter (110, see FIG. 1) with a plurality of first LEDs (138, see FIG. 2A and [0067]: one or more LEDs 138) and a plurality of second LEDs (see [0073]: distal tip 114 can include matrix of LEDS instead of singular row as shown in FIG.2A. a second ‘row’ of the matrix would be the second plurality of LEDs.), wherein the first LEDs are configured to emit light at a first wavelength and the second LEDS are configured to emit light at a second wavelength different than the first wavelength (see [0071-0073]: power at different wavelengths/ varying outputs is controllable to the LEDs and therefore the second LEDS are “configured to” emit light at a different wavelength than the first).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the second plurality of LEDs disclosed in Williams to be configured to emit light at a second wavelength different than the first as taught by Dahm for the purpose of emitting the appropriate wavelength suitable for use with the planned treatment of the tissue location and treatment agent (see [0071]), thus achieving “and the second LEDS are configured to emit light at a second wavelength different than the first wavelength.”
Regarding claim 7, the modified system of Williams teaches the catheter system of claim 1, and Williams further discloses wherein at least one LED of the first LEDs is configured to emit a frequency of light different than a frequency of light emitted by another LED of the first LEDs (see col. 4 lines 28-46: the number of LEDs activated and the amount of energy supplied to each LED is controllable. Therefore at least one LED of the first LEDs is “configured to” emit a frequency of light different than a frequency emitted by another LED of the first LEDs because Williams discloses power independently controllable to each LED.).
Regarding claim 10, Williams discloses a catheter for activation of a photoactive agent (see col. 2 lines 22-34: LEDs from tubular medical device activates a photosensitive agent), comprising:
an elongate shaft (see shaft of needle in Fig. 1 and see col 2 lines 56-59: “outer cylindrical surface” ==elongate shaft) comprising a proximal end (a distal portion is shown and therefore the device MUST have a proximal portion/end. see also col. 2 lines 14-34: device such as disclosed in U.S. Patent No. 5964756 shows proximal portion comprising a handle in at least FIG.1), a distal end (as shown in FIG. 1), and a lumen (see col. 2 lines 62-65: one or more central lumens);
a plurality of circuits disposed about the distal portion of the elongate shaft (see Fig. 1 and see col. 2 line 50- col.3 line 4: embodiment of FIG. 1 comprises 4 of the flex circuits);
a plurality of light-emitting diodes (LEDs) disposed along each of the plurality of circuits (see col. 2 line 50- col.3 line 4: each flex strip comprises laser diodes—a plurality of laser diodes as labeled in FIG. 1); and
a communications cable disposed within the lumen and electrically coupled to each of the plurality of circuits such that each of the plurality of circuits are independently activatable (see col. 3 lines 48-60: central conductor can pass through central longitudinal lumen of the needle to supply power such as from control unit as described in col. 4 lines 28-46: the number of LEDs activated and the amount of energy supplied to each LED is controllable).
Williams, in the embodiment of FIG. 1, is silent to the plurality of circuits disposed “helically” about the distal end of the elongate shaft, a lumen “extending through a proximal portion of the elongate shaft but not through a distal portion of the elongate shaft” and a communications cable disposed within the lumen and electrically coupled “independently” to each of the plurality of circuits such that each of the plurality of circuits are independently activatable.
However, in a second embodiment (see FIG. 2), Williams teaches a plurality of circuits disposed helically about the distal end of the elongate shaft (see col. 3 lines 15-35: flex circuit mounted helically around the needle and can be plurality of flex strips).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the plurality of circuits disposed about the distal end of the elongate shaft disclosed in Williams (FIG.1) to be disposed helically as taught by Williams (FIG.2) for the purpose of facilitating bending of the shaft while inhibiting bucking of the flexible circuit (see col. 3 lines 15-35), thus achieving the plurality of circuits disposed “helically” about the distal end of the elongate shaft.
Williams (Fig. 1 in view of Fig. 2) remain silent to a lumen “extending through a proximal portion of the elongate shaft but not through a distal portion of the elongate shaft” and the communications cable disposed within the lumen and electrically coupled “independently” to each of the plurality of circuits such that each of the plurality of circuits are independently activatable.
However, Dahm teaches a catheter system for activation of a photoactive agent (see [0059]: catheter system for photo excitation) comprising an elongated shaft (500, see FIG. 22), a plurality of circuits (see [0115]: embodiment of FIG. 22 can be formed by integrated chip in process of FIG. 7. See [0090]: FIG. 6 has integrated chip that replaces wire connectors) comprising LEDs (524 and 528), and an electrically coupling formed (see [0091]: electrical connection formed by conductive trace) independently to each of the plurality of circuits (see [0091-0093]) such that each of the plurality of circuits are independently activatable (see [0071-0073]: power at different wavelengths/ varying outputs is controllable to the LEDs.).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the communications cable electrically coupled to the plurality of circuits disclosed in Williams to be independently electrically coupled as taught by Dahm for the purpose of supplying each of the plurality of circuits comprising each set of plurality of LEDs with a desired energy output, wavelength, target area surface are, or other treatment parameters (see [0073]), thus achieving the communications cable electrically coupled “independently” to each of the plurality of circuits such that each of the plurality of circuits are independently activatable.
Williams (Fig. 1) in view of Williams (Fig. 2) and Dahm remain silent to a lumen “extending through a proximal portion of the elongate shaft but not through a distal portion of the elongate shaft”.
However, Cardinal teaches a catheter system comprising a catheter (see FIG. 4, [0026]: balloon catheter and [0044]: balloon 332 has electrodes on surface) having an elongate shaft (see ‘Modified FIG. 4’ below) with a first lumen (470) and a second lumen (462, see [0046]: 462 parallel to lumen 354 as seen in FIG. 4), the second lumen (462) extending through a proximal portion (see ‘Modified FIG. 4’ below—portion of shaft between 344 to 346)
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of the elongate shaft (see shaft in ‘Modified FIG.4’ above) but not (see [0046]: cable 351 only in proximal portion from 344 to 346) through a distal portion (see ‘Modified FIG. 4’ above) of the elongate shaft (see shaft in ‘Modified FIG.4’ above); a communications cable (351) disposed within the second lumen (462).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the elongate shaft of the catheter disclosed in Williams to include a second lumen extending through the proximal portion of the elongate shaft but not through the distal portion of the elongate shaft and housing the communications cable as taught by Cardinal for the purpose of electrically coupling a proximal control unit to the distally housed elements (see [0040] and [0046]), thus achieving a lumen “extending through a proximal portion of the elongate shaft but not through a distal portion of the elongate shaft”.
Regarding claim 11, the modified system of Williams teaches the catheter of claim 10, but in the first embodiment (Fig.1), Williams is silent to “wherein a cross-section of the catheter taken normal to the lumen at an LED of the plurality of LEDS is coincident with an LED of each of the plurality of circuits.”
However, in a second embodiment (see Fig. 2), Williams teaches wherein a cross-section of the catheter taken normal to the lumen at an LED (see ‘Modified Fig. 2’ below)
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of the plurality of LEDS is coincident with an LED of each of the plurality of circuits (see first and second circuits==a plurality of circuits in ‘Modified FIG.2’ above and see each LED of each circuit coincident along line labeled “l” in ‘Modified FIG. 2’ above, aligning with Applicant’s disclosure of the structure in at least [0030] and FIGs. 2A,B).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the plurality of circuits disposed about the distal end of the elongate shaft disclosed in Williams (FIG.1) to be disposed in a helical manner with longitudinally aligned LEDs as taught by Williams (FIG.2) for the purpose of facilitating bending of the shaft while inhibiting bucking of the flexible circuit (see col. 3 lines 15-35), thus achieving “wherein a cross-section of the catheter taken normal to the lumen at an LED of the plurality of LEDS is coincident with an LED of each of the plurality of circuits.”
Regarding claim 12, the modified system of Williams teaches the catheter of claim 10, and Williams further discloses wherein the LEDs of one circuit of the plurality of circuits are configured to emit light at a wavelength (see col. 1 lines 19-27: device is for photoactivation of Photofrin that responds to a 630nm wavelength. Therefore the device must at least supply a 630nm wavelength in order to enable the device for photoactivation as further described in col.1 line 61- col.2 line 13), but Williams is silent to the wavelength “different than a wavelength of the LEDs of the remaining plurality of circuits.”
However, Dahm teaches a catheter system for activation of a photoactive agent (see [0059]: catheter system for photo excitation) comprising a catheter (110, see FIG. 1) with a plurality of LEDs of a first circuit (138, see FIG. 2A and [0067]: one or more LEDs 138) and a plurality of second LEDs or a second circuit (see [0073]: distal tip 114 can include matrix of LEDS instead of singular row as shown in FIG.2A. a second ‘row’ of the matrix would be the second plurality of LEDs.), wherein the LEDs of one circuit of the plurality of circuits are configured to emit light at a wavelength different than a wavelength of the LEDs of the remaining plurality of circuits. (see [0071-0073]: power at different wavelengths/ varying outputs is controllable to the LEDs and therefore the second LEDS are “configured to” emit light at a different wavelength than the first).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the LEDs of the remaining plurality of circuits disclosed in Williams to be configured to emit light at a wavelength different than the wavelength of the first LEDs as taught by Dahm for the purpose of emitting the appropriate wavelength suitable for use with the planned treatment of the tissue location and treatment agent (see [0071]), thus achieving the wavelength “different than a wavelength of the LEDs of the remaining plurality of circuits.”
Regarding claim 14, the modified system of Williams teaches the catheter of claim 10, and Williams further discloses wherein the communications cable is configured to sequentially transfer power independently among each of the plurality of circuits (see col. 3 lines 48-60: central conductor/ comms cable can pass through central longitudinal lumen of the needle to supply power such as from control unit as described in col. 4 lines 28-46: the number of LEDs activated and the amount of energy supplied to each LED is controllable. Therefore the cable is “configured to” sequentially transfer power independently because it delivers power to each of the circuits).
Regarding claim 15, Williams discloses a method of activating a photoactive agent (see col. 2 lines 22-34: LEDs from tubular medical device activate a photosensitive agent), comprising:
introducing the photoactive agent into a tissue of a patient (see col. 1 line 54- col.2 line 3: drug is introduced to target area);
inserting a catheter (see FIG. 1) in accordance with claim 1 (see rejection of claim 1 above) into the patient towards the tissue (see col 4 line 56-57: insert the tubular device to the target tissue); and
illuminating the photoactive agent by sequentially varying a power supplied to the plurality of first LEDs and the plurality of second LEDs (see col. 2 lines 4-13 and col. 4 lines 28-63: desired power delivered to each of the first and second plurality of LEDs to illuminate photoactive agent).
Regarding claim 17, the modified system of Williams teaches the method of claim 15, and Williams further discloses wherein the photoactive agent comprises one of an anti-cancer compound and a photocurable or a photocrosslinkable agent (see col. 1 line 19-col. 2 line 3: Photofrin used in the treatment of cancer and thus MUST have “one of an anti-cancer compound”. Photofrin has photosensitizing agent that absorbs light and therefore must have “a photocurable or a photocrosslinkable agent”).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Williams in view of Dahm and Cardinal as applied to claim 4 above, and further in view of Chen et al. (U.S. PGPUB No. 2012/0089207), hereinafter Chen.
Regarding claim 5, the modified system of Williams teaches the catheter system of claim 4, and Williams further discloses wherein the control unit is configured to sequentially vary power to the first and second plurality of LEDs (see col. 4 lines 28-46: the number of LEDs activated and the amount of energy supplied to each LED is controllable. Therefore the controller is “configured to” sequentially vary power between the plurality of first LEDs and the plurality of second LEDs because Williams discloses power independently controllable to each LED).
Williams is silent to wherein the “controller” is configured to sequentially vary power “to a frequency of about 45 Hz.”
However, Dahm teaches a catheter system for activation of a photoactive agent (see [0059]: catheter system for photo excitation) comprising a catheter (110, see FIG. 1) and a control unit (106, see [0059]), wherein the control unit (106) comprises a controller (124), and wherein the controller (124) is configured to sequentially vary power (see [0071-0073]: power at different wavelengths/ varying outputs is controllable to the LEDs and therefore the controller is “configured to” sequentially vary power between the first and second plurality of LEDs. See also [0061]: controller supplies energy to 120 which, see [0066-0068]: comprises LEDs 138) between a plurality of first LEDs (138, see FIG. 2A and [0067]: one or more LEDs 138) and a plurality of second LEDs (see [0073]: distal tip 114 can include matrix of LEDS instead of singular row as shown in FIG.2A. a second ‘row’ of the matrix would be the second plurality of LEDs.).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the control unit configured to vary power to the first and second plurality of LEDs disclosed in Williams to include a controller as taught by Dahm for the purpose of providing the system with a user operated controller for controlling the amount of radiant energy emitted by the light transmission system comprising the LEDs (see [0061]), thus achieving wherein the “controller” is configured to sequentially vary power.
Williams in view of Dahm remain silent to wherein the controller is configured to sequentially vary power “to a frequency of about 45 Hz.”
However, Chen teaches a catheter system (see FIG.2) with a catheter (104) and a controller (114, see [0046]: controller is PLC) configured to sequentially vary power to a frequency of about 45Hz (see [0052-0053]: controller varies power to LEDs at operational frequency of 50HZ== “about 45Hz”. see structure of LEDs 140 at distal end of device in FIG. 5 and described in [0051]).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the controller taught by Modified Williams to be configured to sequentially vary power to a frequency of about 45Hz as taught by Chen for the purpose of improving tissue oxygenation during therapy (see [0053]), thus achieving wherein the controller is configured to sequentially vary power “to a frequency of about 45 Hz.”
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Williams in view of Dahm and Cardinal as applied to claim 1 above, and further in view of Ehrenreich et al. (U.S. PGPUB No. 2014/0188035), hereinafter Ehren.
Regarding claim 8, the modified system of Williams teaches the catheter system of claim 1, but Modified Williams is silent to “further comprising a photodiode disposed on the first flexible circuit configured to detect light emitted from the first LEDs.”
However, Ehren teaches a catheter system (see FIG. 1) for targeted light therapy further comprising a photodiode (26, see [0044-0045]: LEDs and photodiodes on substrate 30) disposed on a first flexible circuit (see [0046]: photodiodes provided on flex circuit) configured to detect light emitted from a first LEDs (28, see [0044-0046]: photodiodes detect light emitted by the LEDs).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the first flexible circuit disclosed in Williams to include a photodiode configured to detect light emitted from the first LEDs as taught by Ehren for the purpose of selectively producing a desired energy flux at the desired treatment site (see [0044-0045] and [0048-0052]), thus achieving “further comprising a photodiode disposed on the first flexible circuit configured to detect light emitted from the first LEDs”.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Williams in view of Dahm and Cardinal as applied to claim 1 above, and further in view of Eisenfrats et al. (U.S. PGPUB No. 2018/0185096), hereinafter Eisen.
Regarding claim 9, the modified system of Williams teaches the catheter system of claim 1, but Modified Williams is silent to “wherein the second lumen has a c-shaped or crescent-shaped cross-section.”
However, However, Eisen teaches a catheter system with an elongate shaft (see ‘Modified FIG. 5’ below—the elongate shaft extending proximally through proximal shaft and shown in the ‘expanded cross-section’ of the shaft)
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delivering light to target tissue and having a first lumen (see ‘Modified FIG. 5’ above and [0188]), wherein a second lumen extends along a proximal portion of a proximal shaft but not the distal portion of the elongate shaft (see ‘Modified FIG. 5’ above—second lumen completely separate from elongate shaft), wherein the second lumen (see second lumen as shown in ‘Modified FIG. 5’ above) has a c-shaped or crescent-shaped cross-section (as seen in ‘Modified FIG. 5’ above).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the second lumen of the catheter system taught by Modified Williams to be crescent shaped as taught by Eisen. A person of ordinary skill in the art would have been motivated to make this modification because it is a simple substitution of one known element (a second lumen taught by Modified Williams) for another known element (a crescent shaped lumen as taught in Eisen) in the art to obtain the predictable result of forming a lumen using a known lumen shape for catheters (see MPEP § 2143.I.B), thus achieving “wherein the second lumen has a c-shaped or crescent-shaped cross-section.”
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Williams in view of Dahm and Cardinal as applied to claim 1 above, and further in view of Ehren (U.S. PGPUB No. 2014/0188035).
Regarding claim 13, the modified system of Williams teaches the catheter of claim 10, but Modified Williams is silent to “further comprising a photodiode disposed on one of the plurality of circuits configured to detect light emitted from the plurality of LEDs.”
However, Ehren teaches a catheter (see FIG. 1) for targeted light therapy further comprising a photodiode (26, see [0044-0045]: LEDs and photodiodes on substrate 30) disposed on a one of a circuit (see [0046]: photodiodes provided on flex circuit in plurality of strips) configured to detect light emitted from a plurality of LEDs (28, see [0044-0046]: photodiodes detect light emitted by the LEDs).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the first flexible circuit disclosed in Williams to include a photodiode configured to detect light emitted from the first LEDs as taught by Ehren for the purpose of selectively producing a desired energy flux at the desired treatment site (see [0044-0045] and [0048-0052]), thus achieving “further comprising a photodiode disposed on the first flexible circuit configured to detect light emitted from the first LEDs”.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Williams in view of Dahm and Cardinal as applied to claim 15 above, and further in view of Keltner et al. (U.S. PGPUB No. 2009/0216300), hereinafter Keltner.
Regarding claim 16, the modified system of Williams teaches the method of claim 15, but Williams is silent to “further comprising monitoring tissue temperature and varying the power supplied based on the monitoring.”
However, Keltner teaches a method of activating a photoactive agent (see [0002]) comprising introducing the photoactive agent into a tissue of a patient (see [0038]: photoactive drug introduced into patient); inserting a catheter comprising light emitters into the patient towards the tissue (see [0038]: catheter such as shown in FIG. 1 is introduced and see [0039]: plurality of LEDs); and illuminating the photoactive agent (see [0050-0052]). Keltner teaches the method further comprising monitoring tissue temperature and varying the power supplied based on the monitoring (see [0037]: temperature monitoring unit measures temperature and then can shut off power==vary the power supplied if temperature has been exceeded).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method disclosed in Williams to include a step of monitoring tissue temperature and varying the power supplied based on the monitoring as taught by Keltner for the purpose of shutting off the treatment device if a temperature at the treatment site exceeds a predetermined value (see [0037]), which increases safety, thus achieving “further comprising monitoring tissue temperature and varying the power supplied based on the monitoring.”
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Williams in view of Dahm and Cardinal as applied to claim 15 above, and further in view of Whitehurst (U.S. PGPUB No. 2002/0029071) and De Taboada et al. (U.S. PGPUB No. 2019/0060664),hereinafter DeTabo.
Regarding claim 18, Williams discloses wherein the photoactive agent is introduced intravenously, but Williams is silent to the photoactive agent “comprises tetra(hydroxyphenyl)chlorin (mTHPC)” and “wherein the illuminating is performed between about two and about five days later.”
However, Whitehurst teaches a method of activating a photoactive agent (see [0001-0002] and see [0046] a photosensitizing drug such as 5-ALA administered—see other drugs in table 1 on page 4 between [0060] and [0061]. [0060] states table 1 has “common photosensitizers”), wherein the photoactive agent comprises tetra(hydroxyphenyl)chlorin (mTHPC) (see table 1 on page 4 between [0060] and [0061]).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the photoactive agent disclosed in Williams to be tetra(hydroxyphenyl)chlorin (mTHPC) as taught by Whitehurst for the purpose of selecting a photoactive agent that is appropriately matched to the device LED emission spectra for treatment (see [0061]), thus achieving the photoactive agent “comprises tetra(hydroxyphenyl)chlorin (mTHPC)”.
Williams in view of Whitehurst remain silent to “wherein the illuminating is performed between about two and about five days later.”
However, DeTabo teaches a method of activating a photoactive agent including illuminating the photoactive agent (see [0004-0005]), wherein the illuminating is performed between about two and about five days later (see [0074]: nanoparticles delivered intravenously and then a wait period of about 36 hours happens prior to light treatment. 36 hours is “about” two days).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify illuminating step disclosed in the method of Williams to include a wait period of about 36 hours as taught by DeTabo for the purpose of allowing the photoactive agent to diffuse into the pathological tissue (see [0074]), thus achieving “wherein the illuminating is performed between about two and about five days later.”
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Williams in view of Dahm and Cardinal as applied to claim 15 above, and further in view of Hestdal et al. (U.S. PGPUB No. 2019/0022404), hereinafter Hestdal.
Regarding claim 19, the modified system of Williams teaches the method of claim 15, but Modified Williams is silent to “wherein the tissue is bladder tissue and further comprising diagnosing cancer after illuminating based on the effects of the photoactive agent.”
However, Hestdal teaches a method of activating a photoactive agent (see [0004-0006]: method activates photoactive agent such as 5-ALA for photodynamic diagnosis via fluorescence detection) comprises introducing a photoactive agent into a tissue of a patient (see [0004-0005]); wherein the tissue is bladder tissue (see [0017]) and the method further comprising diagnosing cancer after illuminating based on the effects of the photoactive agent (see [0004-0006]: method activates photoactive agent such as 5-ALA for photodynamic diagnosis via fluorescence detection).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the tissue for treatment disclosed in the method of Williams to be bladder tissue as taught by Hestdal for the purpose of using photodynamic therapy to treat bladder tissue such as in the treatment of bladder cancer (see [0016-0020]), thus achieving “wherein the tissue is bladder tissue”.
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method including activating a photoactive agent disclosed in Williams to include diagnosing cancer after illuminating based on the effects of the photoactive agent as taught by Hestdal for the purpose of using photodynamic diagnosis of the tissue that will not miss lesions (see [0005]: benefit of PDD as taught in [0004-0006] is that the diagnosis procedure has better visibility of cancer regions), enhancing the quality of the diagnosis method, thus achieving “further comprising diagnosing cancer after illuminating based on the effects of the photoactive agent.”
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Williams in view of Dahm and Cardinal as applied to claim 15 above, and further in view of Whitehurst (U.S. PGPUB No. 2002/0029071).
Regarding claim 20, the modified system of Williams teaches the method of claim 15, but Modified Williams is silent to “wherein the photoactive agent comprises 5-aminolevulinic acid (ALA) configured for photodynamic therapy (PDT).”
However, Whitehurst teaches a method of activating a photoactive agent (see [0001-0002] and see [0046] a photosensitizing drug such as 5-ALA administered—see other drugs in table 1 on page 4 between [0060] and [0061]. [0060] states table 1 has “common photosensitizers”), wherein the photoactive agent comprises comprises 5-aminolevulinic acid (ALA) configured for photodynamic therapy (PDT) (see [0046]).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the photoactive agent disclosed in Williams to be 5-ALA as taught by Whitehurst for the purpose of selecting a photoactive agent that is appropriately matched to the device LED emission spectra for treatment (see [0061]), thus achieving “wherein the photoactive agent comprises 5-aminolevulinic acid (ALA) configured for photodynamic therapy (PDT).”
Response to Arguments
Applicant’s arguments with respect to claim(s) 1, 10, and 15 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.
A new reference, Cardinal, has been used in the 35 U.S.C. § 103 claim rejections to address the limitations as argued.
Conclusion
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.
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/KATHLEEN PAIGE FARRELL/Examiner, Art Unit 3783 /Lauren P Farrar/Primary Examiner, Art Unit 3783