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 Arguments
Applicant's arguments filed 12/30/2025 have been fully considered but they are not persuasive.
Applicant’s first argument, that Scarf does not teach the usage of multiple temperature sensors, is unpersuasive. Scarf teaches that multiple temperatures sensors can be used, and teaches multiple placements for said temperature sensors (Para. 0045, “In some embodiments, the device further comprises a sensor, or multiple sensors. The sensor can be constructed and arranged to regulate the light delivered. The sensor can be constructed and arranged to at least one of prevent or reduce tissue damage. The sensor can be constructed and arranged to at least one of prevent or reduce mucosal dehydration. The sensor can comprise a temperature sensor. The temperature sensor can comprise at least one of a thermocouple or a thermistor. The temperature sensor can comprise at least one optical fiber constructed and arranged to gather infrared light. The sensor can be positioned at least one of on or within the shaft. The device can further comprise a balloon mounted to the shaft, and the sensor can be positioned at least one of on or within the balloon”).
Applicant’s second argument, that Scarf does not teach wherein the sensors are coupled to the external skin surface, is likewise unpersuasive. As shown above in Para. 0045, Scarf teaches the usage of a thermocouple, i.e. a contact-based temperature sensor, and Para. 0045 makes clear this is used to monitor the tissue being treated. As Para. 0180 teaches that the outer surface of the skin is a treated tissue, Scarf teaches an embodiment where a thermocouple is used to monitor the outer skin tissue.
The newly added claims are rejected below under U.S.C. 103 in view of Scharf and Victor. Newly added Claims 21 and 22 are also objected to for minor informalities.
Claim Objections
Claims 21 and 22 are objected to because of the following informalities:
i. Regarding Claims 21 and 22, the language “wherein the elongate prob is configured extension beyond…” is grammatically incorrect. It should read similar to “wherein the elongate probe is configured to extend beyond…”.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-8 and 10-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Publication 20160151639 awarded to Scharf et al, hereinafter Scharf.
Regarding Claim 1, Scharf teaches a medical system (abstract), comprising: an elongate probe configured for insertion into a patient body (abstract, device 100, Fig. 1), the elongate probe including a plurality of light disseminating devices (Para. 0143, “Device 100 can include one or more optical fibers, such as optical fibers 151a positioned within wall 117 of shaft 110. One or more fibers 151a can each be embedded in wall 117 of shaft 110”); a plurality of sensors operatively coupled with the patient body (Para. 0152, “Heating of the surrounding tissue and/or fluids (e.g. urine) can be monitored by one or more sensors of device 100, such as a temperature sensor 119”); and a system module coupled with the elongate probe, the system module including a console operatively coupled with the sensors and the light disseminating devices (Para. 0159, “Housing 120 can be configured as a handle for a user, such as a clinician or patient, to hold while using device 100. Housing 120 can be implantable or include an implantable portion. Housing 120 can comprise a first housing and a second housing separated from the first housing. Housing 120 can surround one or more components including but not limited to: power supplies such as batteries; agent reservoirs such as pharmaceutical agent reservoirs; pumping mechanisms; energy delivery circuitry such as cardiac pacing or defibrillating circuitry; electronic processing circuitry; electronic memory circuitry; and combinations of these”), the console including a processor and a memory having stored thereon logic that, when executed by the processor, causes operations of the system that include: receiving a sensor signal from the sensors and activating the light disseminating devices in response to a triggering event (Para. 0099, “I n some embodiments, the device is constructed and arranged to adjust energy delivered by the at least one energy delivery. The energy adjustment can comprise an adjustment to the field strength of the electromagnetic energy delivery. The energy adjustment can comprise an adjustment to a pulse-width modulation parameter of the energy delivery. The device can further comprise a sensor constructed and arranged to produce a signal, the device can be constructed and arranged to perform the energy adjustment based on the sensor signal”), wherein a light disseminated by the light disseminating devices is configured to denature an infectious substance adjacent the elongate probe (Para. 0070, “The shaft further comprises an outer surface and an inner surface. The functional element is constructed and arranged at least one of prevent or reduce infection. The device can be constructed and arranged for insertion into the bladder of the patient, such as to deliver light to one or more of the bladder, the urethra, and/or urine in the bladder and/or urethra”).
Regarding Claim 2, Scharf teaches the system according to claim 1, wherein light is composed of wavelengths within at least one of a blue (Para. 0295, “One or more light delivery elements 155 can be constructed and arranged to deliver blue light”), violet (Para. 0262, “Energy source 650 can be constructed and arranged to provide such as one or more wavelengths between 410 nm and 580 nm, such as between 410 nm and 420 nm”), or ultraviolet spectrum (Para. 0150, “Alternatively or additionally, light source 150 can be constructed and arranged to provide visible light and/or ultraviolet light”).
Regarding Claim 3, Scharf teaches the system according to claim 1, wherein the triggering event includes a physical manipulation of the system module by a clinician (Para. 0283, “Control 728 comprises a user interface component that can be configured to initiate energy delivery by the multiple energy delivery elements 555 and/or modify the energy delivery provided”).
Regarding Claim 4, Scharf teaches the system according to claim 1, wherein: the console is communicatively coupled with an external computing device, and the operations further include: receiving input from the external computing device, and transmitting system operational information to the external computing device (Para. 0286, “Device 500c includes external controller 891 which includes user interface 898 and electronics module 899a. Electronics module 899a comprises a wireless transmitter and one or more other electronics components for providing a user interface and controlling one or more implanted components of device 500c. Implanted housing 820 surrounds electronics module 899b which comprises a wireless receiver which receives communications from external controller 891”).
Regarding Claim 5, Scharf teaches the system according to claim 4, wherein the triggering event includes an input received from the external computing device (Para. 0286, “Implanted housing 820 surrounds electronics module 899b which comprises a wireless receiver which receives communications from external controller 891. In some embodiments, electronics module 899a and electronics module 899b are each configured as transceivers to allow two way communication between the implanted portion of device 500c and external controller 891. Controller 891 can be configured to allow adjustment of energy delivered by energy source 850 to one or more energy delivery elements 555 as has been described hereabove”).
Regarding Claim 6, Scharf teaches the system according to claim 1, wherein: the system module is configured to selectively attach to and detach from the elongate probe, and attachment of the system module to the elongate probe includes operatively coupling the console with the sensors and the light disseminating devices (Para. 0152, “Temperature sensor 119 can be positioned in or proximate balloon 125 as shown, on or in shaft 110, or at another device 100 location. Temperature sensor 119 can be operably attached to, or operably attachable to, sensor measurement assembly 200, such as via one or more conduits, not shown but typically including one or more wires or optical fibers”).
Regarding Claim 7, Scharf teaches the system according to claim 1, wherein at least a subset of the sensors are coupled with an outside surface of the elongate probe (temperature sensor 119, Fig. 1, Para. 0152, “Heating of the surrounding tissue and/or fluids (e.g. urine) can be monitored by one or more sensors of device 100, such as a temperature sensor 119”)).
Regarding Claim 8, Scharf teaches the system according to claim 1, wherein the light disseminating devices are configured to project a light radially away from the elongate probe (Para. 0155, “Light delivery elements 155a can be constructed and arranged to deliver light radially out from all or a portion of outer surface 113 of shaft 110, such as a majority portion and/or distal portion of the outer surface 113”).
Regarding Claim 10, Scharf teaches the system according to claim 1, wherein: the elongate probe includes a number of optical fibers extending along the elongate probe, the optical fibers including the light disseminating devices (Fig. 1, Para. 0143, “Device 100 can include one or more optical fibers, such as optical fibers 151a positioned within wall 117 of shaft 110. One or more fibers 151a can each be embedded in wall 117 of shaft 110”); the console includes a light source coupled with the optical fibers (Para. 0285, “Energy delivery elements 555 are connected to energy source 850 via one or more cables 851, such as one or more fiber optic cables. In some embodiments, energy source 850 transmits light energy, ultrasound energy and/or mechanical energy over cable 851 to energy delivery elements 555”); and activating the light disseminating devices includes activating the light source (Para. 0286, “Implanted housing 820 surrounds electronics module 899b which comprises a wireless receiver which receives communications from external controller 891. In some embodiments, electronics module 899a and electronics module 899b are each configured as transceivers to allow two way communication between the implanted portion of device 500c and external controller 891. Controller 891 can be configured to allow adjustment of energy delivered by energy source 850 to one or more energy delivery elements 555 as has been described hereabove”).
Regarding Claim 11, Scharf teaches the system according to claim 10, wherein: the elongate probe includes a catheter (Para. 0288, “In some embodiments, shaft 110 includes multiple lumens, such as when device 100 comprises a multi-lumen catheter for insertion into a blood vessel or other body location”), and the optical fibers are embedded within a luminal wall of the catheter (Fig. 1, Para. 0143, “Device 100 can include one or more optical fibers, such as optical fibers 151a positioned within wall 117 of shaft 110. One or more fibers 151a can each be embedded in wall 117 of shaft 110”).
Regarding Claim 12, Scharf teaches the system according to claim 11, wherein at least a subset of the sensors are coupled to an inside luminal wall surface of the catheter (Para. 0299, “Heating of the surrounding tissue and/or fluids (e.g. urine) can be monitored by one or more sensors of device 100, such as functional element 195 configured as a temperature sensor. Functional element 195 can be positioned in or proximate balloon 125 as shown, on or in shaft 110, or at another device 100 location”).
Regarding Claim 13, Scharf teaches the system according to claim 12, wherein the light disseminating devices are configured to project the light radially inward from the luminal wall (Para. 0021, “The light delivery element can be constructed and arranged to further deliver light radially inward from the at least a portion of the inner surface”).
Regarding Claim 14, Scharf teaches the system according to claim 13, wherein activating the light disseminating devices is configured to denature a biofilm disposed within the lumen (Para. 0153, “Device 100 can be constructed and arranged such that the light delivered by one or more light delivery elements 155 prevent, eliminate and/or reduces colonization of foreign material by bacteria, such as to prevent, eliminate and/or reduce a biofilm of bacteria”).
Regarding Claim 15, Scharf teaches the system according to claim 1, wherein: the operations further include comparing a magnitude of a physiological parameter of the patient based on the sensor signal (Para. 0264, “In these embodiments, sensor measurement assembly 200 comprises an infrared sensor configured to correlate the received light to a temperature. The temperature determined by assembly 200 (e.g. via thermocouple signal, thermisters signal, infrared signal or otherwise), can be used to regulate the light delivered by energy source 650 in a closed loop fashion, such as to prevent damage to tissue and/or to optimize the phototherapy and/or thermal therapy being delivered by device 500a”) with a limit of the physiological parameter stored in the memory (Para. 0272, “The energy delivery elements 555 of the present inventive concepts can be constructed and arranged to deliver a minimum amount of light and/or other energy to blood and/or other tissue. Alternatively or additionally, the energy delivery elements 555 of the present inventive concepts can be constructed and arranged to deliver a maximum of light and/or other energy to blood and/or other tissue”), and the triggering event includes a result of the comparison indicating that the magnitude exceeds the limit (Para. 0264).
Regarding Claim 16, Scharf teaches the system according to claim 1, wherein at least a subset of the plurality of sensors are coupled to an external skin surface of the patient (Para. 0152 states the temperature sensors can be thermocouples, Para. 0154 states that the outer surface of the skin can be the treated tissue being monitored).
Regarding Claim 17, Scharf teaches the system according to claim 16, wherein the physiological parameter includes at, a temperature, a pH, or a blood pressure (Para. 0099, “The sensor can comprise a sensor selected from the group consisting of: temperature sensor such as a thermocouple or thermister; oxygen sensor; glucose sensor such as an optical glucose sensor; pH sensor; physiologic sensor; pressure sensor; blood gas sensor; blood conductivity sensor; impedance sensor; motion sensor; accelerometer; and combinations thereof”).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 9 and 21-23 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication 20160151639 awarded to Scharf et al, hereinafter Scharf, in view of U.S. Patent Publication 20160038621 awarded to Victor et al, hereinafter Victor.
Regarding Claim 9, Scharf teaches the system according to Claim 1, wherein the elongate probe is a venous catheter (Para. 0160). Scharf does not teach wherein the probe includes a stylet for placement in the lumen of a catheter.
However, in the art of light-based antimicrobial catheters (abstract), Victor teaches the usage of a venous catheter with a stylet (Para. 0008).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Scharf by Victor, i.e. by using a stylet for placement in the venous catheter of Scharf as in Victor, for the predictable purpose of combining known prior art elements to improve similar catheters in the same way.
Regarding Claim 21, Scharf modified by Victor makes obvious the system according to Claim 9. Scharf further teaches wherein the catheter is a vascular catheter (Para. 0160) and the elongate probe is configured for slidable placement within the lumen (Para. 0255, “Device 500a can include one or more optical fibers, such as optical fibers 651a positioned within wall 617 of shaft 610. One or more fibers 651a can each be embedded in wall 617 of shaft 610. Alternatively or additionally, one or more fibers 651a can be insertable into (e.g. slidingly received by) a lumen, such as lumens 618 positioned within wall 617 (lumens 618 are omitted from FIG. 7 for illustrative clarity but shown in FIG. 7A and described herebelow)”).
Regarding Claim 22, Scharf modified by Victor makes obvious the system according to Claim 21. Scharf further teaches wherein the elongate probe is configured extension beyond a distal end of the catheter such that: a first subset of the plurality of sensors are disposed within the lumen, anda second subset of the plurality of sensors are disposed beyond the distal end (Para. 0255, “Device 500a can include one or more optical fibers, such as optical fibers 651a positioned within wall 617 of shaft 610. One or more fibers 651a can each be embedded in wall 617 of shaft 610. Alternatively or additionally, one or more fibers 651a can be insertable into (e.g. slidingly received by) a lumen, such as lumens 618 positioned within wall 617 (lumens 618 are omitted from FIG. 7 for illustrative clarity but shown in FIG. 7A and described herebelow)”).
Regarding Claim 23, Scharf modified by Victor makes obvious the system according to Claim 21. Scharf further teaches wherein the elongate probe is configured extension beyond a distal end of the catheter such that: a first subset of the plurality of light disseminating devices are disposed within the lumen, and a second subset of the plurality of light disseminating devices are disposed beyond the distal end (Fig. 12, Para. 0299, “Heating of the surrounding tissue and/or fluids (e.g. urine) can be monitored by one or more sensors of device 100, such as functional element 195 configured as a temperature sensor. Functional element 195 can be positioned in or proximate balloon 125 as shown, on or in shaft 110, or at another device 100 location. Functional element 195 can be operably attached to, or operably attachable to, a sensor measurement assembly (e.g. sensor measurement assembly 200 of FIG. 1), such as via one or more conduits, not shown but typically including one or more wires or optical fibers”).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication 20160151639 awarded to Scharf et al, hereinafter Scharf, in view of U.S. Patent Publication 20110144566 awarded to Dacey et al, hereinafter Dacey.
Regarding Claim 18, Scharf teaches the system of Claim 1. Scharf does not teach wherein: the sensor signal includes a detection level of the infectious substance adjacent the elongate probe, the operations further include comparing the detection level with a detection level limit stored in the memory, and the triggering event includes a result of the comparison indicating that the detection level exceeds the detection level limit.
However, in the art of light-based antimicrobial catheters, Dacey teaches the usage of a sterilizing catheter that detects infection and triggers sterilizing of the area based on the detected infection (Para. 0186, “In an embodiment, at least one of the one or more energy emitters 220 is configured to emit a pulsed thermal sterilizing stimulus of a dose sufficient to induce PCD without substantially inducing necrosis of an infectious agent within a tissue proximate the catheter device 102 in response to a detect level of an infectious agent”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Scharf by Dacey, i.e. by adding the infection detection of Dacey to the controlled feedback loop taught by Scharf, for the predictable purpose of improving the sterilization abilities of Scharf in the same manner as Dacey.
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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/JLM/
Examiner, Art Unit 3792
/UNSU JUNG/Supervisory Patent Examiner, Art Unit 3792