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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 01/05/2026 has been entered.
Response to Amendment
Applicant has amended claims 1 and 11. No new matter has been entered. Claims 1-20 remain pending.
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.
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.
Claim(s) 1, 5-13, 15-16, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yamamoto et al. (US 20040260241, henceforth Yamamoto) in view of Saal et al. (US 20090259126, henceforth Saal), Hetke et al. (US 20120078188, henceforth Hetke), and Cory et al. (US 20060085049, henceforth Cory).
Regarding claim 1, Yamamoto discloses an apparatus (catheter 20 of fig. 8, also shown in fig. 1 for an alternative embodiment, and impedance analyzers 90 and 190, fig. 8) comprising: an elongated body (catheter 20, fig. 8, see also fig. 1 for a total view) having a tapered distal end (distal end portion 62, fig. 8, is shown as tapering and coming to a point at the distal most portion of the cut) and a proximal end (proximal end portion 21, shown in fig. 1 of an exemplary alternative embodiment) that are aligned along an axis (see exemplary fig. 1, the portions are aligned along the central longitudinal axis of catheter 20; additionally, if catheter 20 was laid out in a straight line, the distal end portion 62 and proximal end portion 21 would be coaxial with each other along a straight line, or axis, as well); first and second electrical sensors (the first sensor is sensor 70, fig. 8, the second sensor is sensor 175, fig. 8, which are electrical sensors as they are electrodes which measure impedance, which is an electrical characteristic, see [0069]) disposed on the elongated body (see fig. 8, the sensors are located directly on the outside of catheter 20 at its distal end portion 62); an injection port (as shown in fig. 8, there is an opening in the radial center of injection needle 63 which is an opening at the end of a lumen; this opening is considered to be the claimed injection port) defined on the elongated body (see fig. 8, since the opening is formed in the exterior of the injection needle 63, it is considered to be defined thereon). Yamamoto additionally discloses that its first and second electrical sensors are used to determine the positioning of the injection port (see [0090], the outputs of the sensors are used as indicators to provide positioning data).
Yamamoto does not disclose that the injection port is defined on the elongated body longitudinally between the first and second electrical sensors with respect to the axis. Saal teaches an injection port (injection port 112, fig. 2A) defined on an elongated body (tubing 110, fig. 2A) longitudinally between a first and a second element provided for determining the precise location of the elongated body and the injection port (see fig. 2A, a first and second element 126 are called out directly adjacent to injection port 112; it is the Examiner’s understanding that these elements 126 as shown in fig. 2A are the one or more visualization markers 125 of [0060] as there are no elements provided with a reference number of 125 in fig. 2A and the elements 126 appear to be the visualization markers discussed in [0060]) with respect to a longitudinal axis (see fig. 2A, the longitudinal axis extends centrally within the tubing 110 and port 112 is longitudinally between the markers shown in fig. 2A).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have arranged the location of the injection port of Yamamoto to have been longitudinally between the first and second electrical sensors with respect to the axis as in Saal because Saal teaches this arrangement as beneficial for preventing the likelihood that fluid ejected from the device will cause inadvertent damage to the patient ([0060]) and because placing the positioning elements immediately adjacent to the injection port allows for an operator to precisely locate the proximity of the injection port to surrounding structures ([0060]).
Yamamoto as modified by Saal additionally teaches the apparatus comprising a pair of power sources which are electronic impedance analyzers (impedance analyzers 90 and 190, fig. 8; these analyzers are power sources as they provide the power for the system which allows the sensors to function and be read) having an input electrically coupled to the first and second electrical sensors to receive first and second output signals, respectively, from the first and second electrical sensors (input terminal 91 receives an output signal from first sensor 70, see [0114] and fig. 8, and input terminal 193 receives an output signal from second sensor 175, see [0114] and fig. 8); and being able to: analyze an electrical characteristic measured by the first and second electrical sensors (see [0098] and see [0113]-[0114], the respective impedance analyzers, by definition, analyze the impedance measured by sensors 70 and 175); and produce an output signal (see [0098], the impedance analyzers are configured to detect a puncturing; this detection is a production of an output signal) when the electrical characteristic measured by the first and second electrical sensors indicates that the injection port is aligned with a target anatomical feature (see [0089] and [0102], the detection involves use of a large discernible difference which is an indication of alignment), and that based on these output signals, a user can control the device and perform an injection (see [0102] and [0103]).
Yamamoto as modified by Saal does not disclose the apparatus comprising: a power source electrically coupled to the first and second electrical sensors; a computer having an input electrically coupled to the first and second electrical sensors to receive first and second output signals, respectively, from the first and second electrical sensors; and a non-transitory computer-readable memory operatively coupled to the computer, the non-transitory computer-readable memory storing computer-readable instructions that, when executed by the computer, cause the computer to: analyze an electrical characteristic measured by the first and second electrical sensors; and produce an output control signal when the electrical characteristic measured by the first and second electrical sensors indicates that the injection port is aligned with a target anatomical feature. Hetke teaches an apparatus which similarly delivers a fluidic treatment to a target anatomical feature (see Abstract) and includes use of a power source (voltage source 140, [0033]) which is electrically coupled to electrical sensors (see [0033], the voltage source 140 is coupled to electrode sites 160 via control instrumentation); as well as use of a computer (control instrumentation of [0020]) electrically coupled to electrical sensors (electrode sites 160, [0024]; these electrode sites must be coupled to the control instrumentation as this is how data and signals are transferred between the relative structures); having an input electrically coupled to the electrical sensors to receive output signals from the electrical sensors (see [0033], the fluidic threads which include electrode sites 160 are electrically coupled to the control instrumentation such as to allow the control instrumentation to analyze the output signals from the electrode sites 160; this coupling occurs at an input to the control instrumentation); which is able to: analyze an electrical characteristic measured by the electrical sensors (see [0024], the sensing of impedance which allows for feedback control means that an analysis of the impedance of the tissue is occurring); and create a control output signal (see [0016], [0017], and [0024]) when the electrical characteristic measured by the electrical sensors indicates that the sensors are aligned with various anatomical features (see [0016], [0019], and [0024], the impedance measurements can be used to create a feedback control signal depending on the localization, or alignment, with the electrode sites 160 in certain areas of tissue, or various anatomical features. Note also that the apparatus can be used with different kinds of tissue as taught in [0019]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the impedance analyzers of Yamamoto with the computer assembly of Hetke for the benefit of automating the control of the apparatus through the use of a feedback control signal such that a user is not needed to control the apparatus based on the output signals of the sensors as this would provide the benefit of more fine-tuned delivery to the target anatomical feature and could potentially prevent adverse effects on healthy tissues ([0017]).
Yamamoto as modified by Saal and Hetke does not disclose that the computer uses memory and commands to operate as claimed. Cory teaches the use of a computer (controller of [0045] which can be a microcontroller) electrically coupled to electrical sensors (electrodes 1 and 7, fig. 2, which can be used to determine impedance as in [0118], and are electrically coupled to the computer as [0045] discloses that the computer controls the functionality of the electrodes); having an input electrically coupled to the electrical sensors to receive output signals from the electrical sensors (this is how the disclosed controller of [0045] is able to receive the impedance readings from the sensors, especially electrode 7; see also [0137], the amplifier circuitry and cabling are at the input); and a non-transitory computer-readable memory operatively coupled to the computer (memory modules 25, [0137]), the non-transitory computer-readable memory storing computer-readable instructions that, when executed by the computer, cause the computer to: analyze an electrical characteristic measured by the electrical sensors (see [0136]); and produce an output signal (see [0136] and [0138], the signal is indicated via a visual display) when the electrical characteristic measured by the electrical sensors indicates that the sensors are aligned with various anatomical features ([0136], the data display includes the detection or location of the presence of nerves).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used memory in the computer to carry out the commands and analysis required by the computer as Cory teaches this memory as an art-effective way to have a computer operate and because use of memory and commands as taught by Cory in the modified system of Yamamoto and Hetke would have provided the same, predictable result of a computer which can analyze signals from sensors and create a response signal.
Regarding claim 5, Yamamoto as modified discloses the apparatus wherein the injection port is aligned with the target anatomical feature when the electrical characteristic measured by the first and second electrical sensors has about the same magnitude (see [0116], the indication that both of the sensors have entered cardiac tissue from the impedance analyzers occurs when the opening at the distal end of injection needle 63 is in the cardiac tissue and the sensors 70 and 175 both show having entered the cardiac tissue).
{Examiner notes that [0044] of the provided Specification clarifies that the term “about” means within 10%, and this is how the claim is being interpreted such as to make the claim definite.}
Regarding claim 6, Yamamoto as modified discloses the apparatus wherein the injection port is aligned with the target anatomical feature when the electrical characteristic measured by the first and second electrical sensors indicates that the first and second electrical sensors are in physical contact with the target anatomical feature (see [0116], the indication that both of the sensors have entered cardiac tissue from the impedance analyzers occurs when the opening at the distal end of injection needle 63 is in the cardiac tissue and the sensors 70 and 175 both show having entered the cardiac tissue).
Regarding claim 7, Yamamoto as modified discloses the apparatus wherein the injection port is aligned with the target anatomical feature when the magnitude of the electrical characteristic measured by the first and second electrical sensors is higher than a respective baseline magnitude (see [0116], the indication that both of the sensors have entered cardiac tissue from the impedance analyzers occurs when the opening at the distal end of injection needle 63 is in the cardiac tissue and the sensors 70 and 175 both show having entered the cardiac tissue; see also [0089], where the baseline measurements are for blood, which is disclosed as being lower than cardiac tissue – when the sensors are in the target anatomical feature of cardiac tissue, the impedance measurement is higher than the impedance measurement for blood at each sensor).
Regarding claim 9, Yamamoto as modified discloses the apparatus wherein the electrical characteristic comprises a resistance or an impedance (electrical characteristic is impedance, [0016]).
Regarding claim 10, Yamamoto as modified discloses the apparatus wherein the proximal end is flared (see fig. 1, the proximal end portion is considered to be flared since it has a larger radius than the body of the catheter 20 and thus spreads outwardly as compared to sheath portion 55).
Regarding claim 11, Yamamoto discloses a method comprising: inserting an apparatus (catheter 20 of fig. 8, also shown in fig. 1 for an alternative embodiment, and impedance analyzers 90 and 190, fig. 8) into a mammalian subject (living body of a person, see [0002] and [0004]), the apparatus comprising: an elongated body (catheter 20, fig. 8, see also fig. 1 for a total view) having a tapered distal end (distal end portion 62, fig. 8, is shown as tapering and coming to a point at the distal most portion of the cut) and a proximal end (proximal end portion 21, shown in fig. 1 of an exemplary alternative embodiment) that are aligned along an axis (see exemplary fig. 1, the portions are aligned along the central longitudinal axis of catheter 20; additionally, if catheter 20 was laid out in a straight line, the distal end portion 62 and proximal end portion 21 would be coaxial with each other along a straight line, or axis, as well); first and second electrical sensors (the first sensor is sensor 70, fig. 8, the second sensor is sensor 175, fig. 8, which are electrical sensors as they are electrodes which measure impedance, which is an electrical characteristic, see [0069]) disposed on the elongated body (see fig. 8, the sensors are located directly on the outside of catheter 20 at its distal end portion 62); an injection port (as shown in fig. 8, there is an opening in the radial center of injection needle 63 which is an opening at the end of a lumen; this opening is considered to be the claimed injection port) defined on the elongated body (see fig. 8, since the opening is formed in the exterior of the injection needle 63, it is considered to be defined thereon). Yamamoto additionally discloses that its first and second electrical sensors are used to determine the positioning of the injection port (see [0090], the outputs of the sensors are used as indicators to provide positioning data).
Yamamoto does not disclose that the injection port is defined on the elongated body longitudinally between the first and second electrical sensors with respect to the axis. Saal teaches an injection port (injection port 112, fig. 2A) defined on an elongated body (tubing 110, fig. 2A) longitudinally between a first and a second element provided for determining the precise location of the elongated body and the injection port (see fig. 2A, a first and second element 126 are called out directly adjacent to injection port 112; it is the Examiner’s understanding that these elements 126 as shown in fig. 2A are the one or more visualization markers 125 of [0060] as there are no elements provided with a reference number of 125 in fig. 2A and the elements 126 appear to be the visualization markers discussed in [0060]) with respect to a longitudinal axis (see fig. 2A, the longitudinal axis extends centrally within the tubing 110 and port 112 is longitudinally between the markers shown in fig. 2A).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have arranged the location of the injection port of Yamamoto to have been longitudinally between the first and second electrical sensors with respect to the axis as in Saal because Saal teaches this arrangement as beneficial for preventing the likelihood that fluid ejected from the device will cause inadvertent damage to the patient ([0060]) and because placing the positioning elements immediately adjacent to the injection port allows for an operator to precisely locate the proximity of the injection port to surrounding structures ([0060]).
Yamamoto as modified by Saal additionally teaches the apparatus comprising a pair of power sources which are electronic impedance analyzers (impedance analyzers 90 and 190, fig. 8; these analyzers are power sources as they provide the power for the system which allows the sensors to function and be read) having an input electrically coupled to the first and second electrical sensors to receive first and second output signals, respectively, from the first and second electrical sensors (input terminal 91 receives an output signal from first sensor 70, see [0114] and fig. 8, and input terminal 193 receives an output signal from second sensor 175, see [0114] and fig. 8); and being able to: analyze an electrical characteristic measured by the first and second electrical sensors (see [0098] and see [0113]-[0114], the respective impedance analyzers, by definition, analyze the impedance measured by sensors 70 and 175); and produce an output signal (see [0098], the impedance analyzers are configured to detect a puncturing; this detection is a production of an output signal) when the electrical characteristic measured by the first and second electrical sensors indicates that the injection port is aligned with a target anatomical feature (see [0089] and [0102], the detection involves use of a large discernible difference which is an indication of alignment), and that based on these output signals, a user can control the device and perform an injection (see [0102] and [0103]).
Yamamoto as modified by Saal does not disclose the apparatus comprising: a power source electrically coupled to the first and second electrical sensors; a computer having an input electrically coupled to the first and second electrical sensors to receive first and second output signals, respectively, from the first and second electrical sensors; and a non-transitory computer-readable memory operatively coupled to the computer, the non-transitory computer-readable memory storing computer-readable instructions that, when executed by the computer, cause the computer to: analyze an electrical characteristic measured by the first and second electrical sensors; and produce an output control signal when the electrical characteristic measured by the first and second electrical sensors indicates that the injection port is aligned with a target anatomical feature. Hetke teaches an apparatus which similarly delivers a fluidic treatment to a target anatomical feature (see Abstract) and includes use of a power source (voltage source 140, [0033]) which is electrically coupled to electrical sensors (see [0033], the voltage source 140 is coupled to electrode sites 160 via control instrumentation); as well as use of a computer (control instrumentation of [0020]) electrically coupled to electrical sensors (electrode sites 160, [0024]; these electrode sites must be coupled to the control instrumentation as this is how data and signals are transferred between the relative structures); having an input electrically coupled to the electrical sensors to receive output signals from the electrical sensors (see [0033], the fluidic threads which include electrode sites 160 are electrically coupled to the control instrumentation such as to allow the control instrumentation to analyze the output signals from the electrode sites 160; this coupling occurs at an input to the control instrumentation); which is able to: analyze an electrical characteristic measured by the electrical sensors (see [0024], the sensing of impedance which allows for feedback control means that an analysis of the impedance of the tissue is occurring); and create a control output signal (see [0016], [0017], and [0024]) when the electrical characteristic measured by the electrical sensors indicates that the sensors are aligned with various anatomical features (see [0016], [0019], and [0024], the impedance measurements can be used to create a feedback control signal depending on the localization, or alignment, with the electrode sites 160 in certain areas of tissue, or various anatomical features. Note also that the apparatus can be used with different kinds of tissue as taught in [0019]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the impedance analyzers of Yamamoto with the computer assembly of Hetke for the benefit of automating the control of the apparatus through the use of a feedback control signal such that a user is not needed to control the apparatus based on the output signals of the sensors as this would provide the benefit of more fine-tuned delivery to the target anatomical feature and could potentially prevent adverse effects on healthy tissues ([0017]).
Yamamoto as modified by Saal and Hetke does not disclose that the computer uses memory and commands to operate as claimed. Cory teaches the use of a computer (controller of [0045] which can be a microcontroller) electrically coupled to electrical sensors (electrodes 1 and 7, fig. 2, which can be used to determine impedance as in [0118], and are electrically coupled to the computer as [0045] discloses that the computer controls the functionality of the electrodes); having an input electrically coupled to the electrical sensors to receive output signals from the electrical sensors (this is how the disclosed controller of [0045] is able to receive the impedance readings from the sensors, especially electrode 7; see also [0137], the amplifier circuitry and cabling are at the input); and a non-transitory computer-readable memory operatively coupled to the computer (memory modules 25, [0137]), the non-transitory computer-readable memory storing computer-readable instructions that, when executed by the computer, cause the computer to: analyze an electrical characteristic measured by the electrical sensors (see [0136]); and produce an output signal (see [0136] and [0138], the signal is indicated via a visual display) when the electrical characteristic measured by the electrical sensors indicates that the sensors are aligned with various anatomical features ([0136], the data display includes the detection or location of the presence of nerves).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used memory in the computer to carry out the commands and analysis required by the computer as Cory teaches this memory as an art-effective way to have a computer operate and because use of memory and commands as taught by Cory in the modified system of Yamamoto and Hetke would have provided the same, predictable result of a computer which can analyze signals from sensors and create a response signal.
Regarding claim 12, Yamamoto as modified discloses the method further comprising injecting a chemical therapeutic agent ([0168], the fluid to be injected is a therapeutic liquid composition; though this is disclosed for an alternative embodiment, it is also understood to apply for the chosen embodiment, see [0081]), through the injection port (see [0173] for an equivalent embodiment; the injection port of the chosen embodiment is understood to serve the same purpose, see fig. 8), in response to the output control signal (see rejection of claim 11 above; the output control signal is a feedback signal which indicates that the injection port is in the target anatomical feature and that injection can begin with user input).
Yamamoto as modified does not explicitly disclose the injecting being automatic. Hetke teaches that fluid delivery as a result of sensed electrical characteristics which influence the control signal should be automated by the computer ([0024] and [0025], feedback control of fluid delivery is a part of the control signal which is determined by the sensed impedance).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have automated the injecting as in Hetke as this can provide optimized deliveries of the therapeutic agent (Hetke [0017]) and further because the step of automating a human task is within the skill of one of ordinary skill in the art and would have yielded the same, predictable result of chemical therapeutic agent being administered into the target area when the sensed electrical characteristic indicates that the injection port is in the target area for administration.
Regarding claim 13, Yamamoto as modified discloses the method where the apparatus comprises an operating unit (operating unit 60, see fig. 1; note that while the chosen embodiment is the catheter 20 of fig. 8, the operating unit 60 is understood to be the same as the operating unit shown in fig. 1).
Yamamoto as modified by Saal, Cory, and Hetke does not disclose the apparatus further comprising a reservoir disposed in the body and in fluid communication with the injection port, the reservoir configured to hold a chemical therapeutic agent. However, an alternative embodiment of Yamamoto teaches an operating unit (operating unit 620, fig. 25) further comprising a reservoir (reservoir 652, fig. 25) disposed in the body (see fig. 25, reservoir 652 is within operating unit 620) and in fluid communication with the injection port (see fig. 25, there is a fluid path shown which extends from reservoir 652 towards the catheter shaft), the reservoir configured to hold a chemical therapeutic agent (see [0204] and [0216]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have replaced the operating unit of the chosen embodiment with the operating unit of the alternative embodiment of Yamamoto since this would yield the same, predictable result of a unit which can be used to control the apparatus and allow for injection of fluid into a target anatomical feature, and further since it has been held that combining two embodiments disclosed adjacent to each other in a prior art patent does not require a leap of inventiveness and involves only routine skill in the art, Boston Scientific v. Cordis Fed. Cir. 2009.
Yamamoto as modified does not disclose the valve being opened automatically, being an electromechanical valve, or opening automatically in response to the output control signal. Hetke teaches the use of electromechanical valves (port gates 120, see [0025]) which are automatically opened and closed by the computer in response to the output control signal (see [0024] and [0025], the valves are taught to be controllable and the computer is taught to be responsible for feedback control of fluid delivery as a result of the impedance measurements, thus it is understood that the computer is responsible for the taught controlling of valves as a part of the taught feedback control signal) as a means of regulating the transfer of chemical therapeutic agent in an apparatus ([0025]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have replaced the valve of Yamamoto with the electromechanical valve of Hetke and to have automatically operated the valve using the computer as in Hetke since the valves of Hetke are controlled by a computer and can provide regulation of the transfer of fluid (see [0024] and [0025]), and further because such a substitution would have yielded the same, predictable result of openable valves placed in between the reservoir and the injection port which can allow for injection of the chemical therapeutic agent into the target anatomical feature.
Regarding claim 15, Yamamoto as modified discloses the method further comprising: determining, with the computer, when a magnitude of the electrical characteristic measured by the first and second electrical sensors is higher than the magnitude of a respective baseline output signal of the first and second electrical sensors (see [0116], the indication that both of the sensors have entered cardiac tissue from the impedance analyzers occurs when the opening at the distal end of injection needle 63 is in the cardiac tissue and the sensors 70 and 175 both show having entered the cardiac tissue; see also [0089], where the baseline measurements are for blood, which is disclosed as being lower than cardiac tissue – when the sensors are in the target anatomical feature of cardiac tissue, the impedance measurement is higher than the impedance measurement for blood at each sensor); and producing the output control signal when the magnitude of the electrical characteristic measured by the first and second electrical sensors is higher than the magnitude of the respective baseline output signal of the first and second electrical sensors (since it is taught in Hetke that the feedback control signal is a result of the impedance measurements as in Hetke [0024], and since the claimed relative magnitudes of signals are disclosed in Yamamoto [0116], this is understood to be disclosed in the modified device as the output control signal would be produced to inject therapeutic composition when the sensors indicate that they are in the target anatomical area which is when they are higher than the respective baseline magnitudes).
Regarding claim 16, Yamamoto as modified discloses the method further comprising producing the output control signal when the magnitude of the electrical characteristic measured by the first and second electrical sensors is about the same (see [0116], the indication that both of the sensors have entered cardiac tissue from the impedance analyzers occurs when the opening at the distal end of injection needle 63 is in the cardiac tissue and the sensors 70 and 175 both show having entered the cardiac tissue) and higher than the magnitude of the respective baseline output signal of the first and second electrical sensors (see rejection of claim 15 above).
Regarding claim 20, Yamamoto as modified discloses the method wherein the electrical characteristic comprises a resistance or an impedance (electrical characteristic is impedance, [0016]).
Claim(s) 2-4 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yamamoto et al. (US 20040260241, henceforth Yamamoto) in view of Saal et al. (US 20090259126, henceforth Saal), Hetke et al. (US 20120078188, henceforth Hetke), and Cory et al. (US 20060085049, henceforth Cory) as applied to claims 1 and 12, respectively, above, and further in view of Kim (US 20060206178, henceforth Kim).
Regarding claim 2, Yamamoto as modified by Saal, Cory, and Hetke discloses the apparatus comprising an operating unit (operating unit 60, see fig. 1; note that while the chosen embodiment is the catheter 20 of fig. 8, the operating unit 60 is understood to be the same as the operating unit shown in fig. 1).
Yamamoto as modified by Saal, Cory, and Hetke does not disclose the apparatus further comprising a reservoir disposed in the body and in fluid communication with the injection port, the reservoir configured to hold a chemical therapeutic agent. However, an alternative embodiment of Yamamoto teaches an operating unit (operating unit 620, fig. 25) further comprising a reservoir (reservoir 652, fig. 25) disposed in the body (see fig. 25, reservoir 652 is within operating unit 620) and in fluid communication with the injection port (see fig. 25, there is a fluid path shown which extends from reservoir 652 towards the catheter shaft), the reservoir configured to hold a chemical therapeutic agent (see [0204] and [0216]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have replaced the operating unit of the chosen embodiment with the operating unit of the alternative embodiment of Yamamoto since this would yield the same, predictable result of a unit which can be used to control the apparatus and allow for injection of fluid into a target anatomical feature, and further since it has been held that combining two embodiments disclosed adjacent to each other in a prior art patent does not require a leap of inventiveness and involves only routine skill in the art, Boston Scientific v. Cordis Fed. Cir. 2009.
Yamamoto as modified does not disclose that the chemical therapeutic agent is configured to damage one or more nerves in the target anatomical feature. Kim teaches administration of a chemical therapeutic agent (nerve block as in [0104]) into a target anatomical feature (the spine, [0104]) where the chemical therapeutic agent is configured to damage one or more nerves in the target anatomical feature (blocking a nerve by administering nerve block can include use of a lysis inducing agent, see [0104], which is a configuration for damaging of a nerve).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have administered the chemical therapeutic agent of Kim with the assembly of Yamamoto as Kim teaches this administration as being possible to relieve pain (see Kim [0095]). Additionally, since Yamamoto is disclosed as being used in cardiac tissue but the target anatomical area of Kim is the spinal cord (see Kim [0095] and [0104]), it would further be obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have made further structural changes to the apparatus of Yamamoto as needed such as to be able to be inserted into the spinal cord and its associated structures. Such modifications could include structural reinforcements of the catheter to withstand the stresses put onto the apparatus by the spinal cord as needed.
Regarding claim 3, Yamamoto as modified by Saal, Cory, Hetke, and Kim discloses the apparatus further comprising a valve (valve 661, fig. 25) disposed between the reservoir and the injection port (see fig. 25, the valve 661 is distal to the reservoir 652 but is upstream of the shaft portion of catheter 20 of the chosen embodiment).
Yamamoto as modified does not disclose that the valve is an electromechanical valve. Hetke teaches the use of electromechanical valves (port gates 120, see [0025]) which are controlled by the computer (see [0024] and [0025], the valves are taught to be controllable and the computer is taught to be responsible for feedback control of fluid delivery as a result of the impedance measurements, thus it is understood that the computer is responsible for the taught controlling of valves) as a means of regulating the transfer of chemical therapeutic agent in an apparatus ([0025]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have replaced the valve of Yamamoto with the electromechanical valve of Hetke since the valves of Hetke are controlled by a computer and can provide regulation of the transfer of fluid (see [0024] and [0025]), and further because such a substitution would have yielded the same, predictable result of openable valves placed in between the reservoir and the injection port which can allow for injection of the chemical therapeutic agent into the target anatomical feature.
Regarding claim 4, Yamamoto as modified discloses apparatus wherein the electromechanical valve is in electrical communication with the computer (see Hetke [0024] and [0025]), the electromechanical valve having a default closed state (see Hetke [0028], the default state is the closed state) in which the reservoir is fluidly decoupled from the injection port (in the modified device, since the valve added from Hetke is located between the reservoir 652 and the sheath of catheter 20 which terminates in the injection port, when the valve is in its closed state, it fluidically separates reservoir 652 and the sheath of catheter 20 which is a fluid decoupling) and an open state in which the reservoir is fluidly coupled to the injection port (when the valve of Hetke opens, reservoir 652 as shown in fig. 25 of Yamamoto is placed in fluidic connection with the sheath portion of catheter 20 which is a fluid coupling), the electromechanical valve configured to transition from the default closed state to the open state in response to the output control signal (see Hetke [0027] and [0028]).
Regarding claim 14, Yamamoto as modified by Saal, Cory, and Hetke does not disclose the method further comprising damaging at least one nerve in the target anatomical feature. Kim teaches administration of a chemical therapeutic agent (nerve block as in [0104]) into a target anatomical feature (the spine, [0104]) where the chemical therapeutic agent is damages at least one nerve in the target anatomical feature (blocking a nerve by administering nerve block can include use of a lysis inducing agent, see [0104], which is a configuration for damaging of a nerve).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have administered the chemical therapeutic agent of Kim with the assembly of Yamamoto as Kim teaches this administration as being possible to relieve pain (see Kim [0095]). Additionally, since Yamamoto is disclosed as being used in cardiac tissue but the target anatomical area of Kim is the spinal cord (see Kim [0095] and [0104]), it would further be obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have made further structural changes to the apparatus of Yamamoto as needed such as to be able to be inserted into the spinal cord and its associated structures. Such modifications could include structural reinforcements of the catheter to withstand the stresses put onto the apparatus by the spinal cord as needed.
Claim(s) 8 and 17-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yamamoto et al. (US 20040260241, henceforth Yamamoto) in view of Saal et al. (US 20090259126, henceforth Saal), Hetke et al. (US 20120078188, henceforth Hetke), and Cory et al. (US 20060085049, henceforth Cory) as applied to claims 5 and 12, respectively, above, and further in view of Sverdlik et al. (US 20120215106, henceforth Sverdlik).
Regarding claim 8, Yamamoto as modified discloses the apparatus wherein: the first electrical sensor is located closer to the tapered distal end than the second electrical sensor (see fig. 8, sensor 70 is closer to the tapered distal end of catheter 20 than sensor 175 as shown).
Yamamoto as modified does not disclose the apparatus wherein the injection port is aligned with the target anatomical feature when the electrical characteristic measured by the first electrical sensor indicates that the first electrical sensor has passed over the target anatomical feature and the electrical characteristic measured by the second electrical sensor indicates that the second electrical sensor is not in physical contact with the target anatomical feature. Sverdlik teaches an apparatus (system 1600, fig. 2) to be used for the treatment of tissue ([0162]) which has a treatment port (acoustic element 102 is a treatment port as it is an opening through which the treatment originates, see at least [0162], [0164], and [0403]) which is lateral to a distal end portion of a catheter (see fig. 2, acoustic element 102 is located on the side of catheter 1222, not at its distal end) and wherein the treatment port is aligned with a target anatomical feature when the treatment is to take place (see fig. 5). Sverdlik additionally teaches that it is important not to damage surrounding tissues when delivering a treatment (see at least [0285], [0286], and [0301]), but that in the case of treating nerve related disorders, the target anatomical feature can be a nerve which should be damaged (see Abstract and see [0043]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Yamamoto as modified when using the dveice to treat nerve related disorders by moving the injection port of Yamamoto as modified to be located laterally on the side of the catheter of Yamamoto as taught in Sverdlik as Sverdlik teaches that this arrangement can be used to deliver a highly localized treatment when damaging nerves as a part of a treatment (see at least Sverdlik [0156] and [0397]). Further, it would have been obvious to have arranged the injection port to have been between the first and second sensors in Yamamoto as modified so that the operator of the apparatus could know the exact types of tissue which the catheter, especially at its distal end portion, is passing through such as to maintain the specificity of the treatment location that Yamamoto uses its impedance sensors for (see at least Yamamoto [0069] and [0089]), as there is not shown as being enough space at the distal end portion of catheter 20 for an injection port to be placed between the beveled tip and sensor 70 as shown in fig. 8.
Thus, in the modified device of Yamamoto as modified by Saal, Hetke, Cory, and Sverdlik, Yamamoto as modified discloses the apparatus and the injection port is aligned with the target anatomical feature when the electrical characteristic measured by the first electrical sensor indicates that the first electrical sensor has passed over the target anatomical feature (depending on the thickness of the chosen nerve to be treated and depending on the exact spacing between the sensors 70 and 175 and the injection port in the modified device, in order to align the moved injection port of Yamamoto to the target anatomical feature, an operator would have to pass over the nerve as claimed, at which point the impedance sensor 70 would signal that the nerve to be treated had been passed over) and the electrical characteristic measured by the second electrical sensor indicates that the second electrical sensor is not in physical contact with the target anatomical feature (if the first sensor 70 had indicated that it was in physical contact with the nerve to be treated, and then the catheter 20 was advanced distally, but the second sensor 175 did not indicate that it was in physical contact with the nerve yet, then the injection port would be aligned with the nerve since it is between the two sensors which surround either side of the nerve and the catheter 20 has passed through the nerve).
{Examiner notes that the alignment of the injection port as claimed is a functional limitation, and thus the modified device need only be capable of providing such an indication in such a use case; the steps are not required as method steps.}
Regarding claim 17, Yamamoto as modified discloses the method further comprising: (a) determining, with the computer, when a magnitude of the electrical characteristic measured by the first electrical sensor is higher than the magnitude of a baseline output signal of the first electrical sensor (see Yamamoto [0098], [0108], the impedance level increases when the sensor 70 is initially inserted into the target anatomical area relative to a baseline in the blood) and the magnitude of the electrical characteristic measured by the second electrical sensor is about equal to the magnitude of a baseline output signal of the second electrical sensor (since there is a space between sensors 70 and 175, when sensor 70 is initially inserted into the target anatomical, sensor 175 would remain at a baseline output signal since it remains proximal to the target anatomical feature), and (c) producing the output control signal when the magnitude of the electrical characteristic measured by the first and second electrical sensors is about equal to the magnitude of the baseline output signals of the first and second electrical sensors, respectively (see [0098] and see Hetke [0016] and [0024]; in the modified method of Yamamoto, the computer is configured such as to be continuously analyzing the electrical characteristic at the two sensors when the device is in use, and the output signal which indicates the type of tissue which the sensors are positioned in is similarly continuously provided, meaning that this output control signal is also continuously provided when the apparatus is in use including at the claimed moment in time), wherein the first electrical sensor is located closer to the tapered distal end than the second electrical sensor (see Yamamoto fig. 8).
Yamamoto as modified additionally discloses that it is meant to inject a therapeutic composition to a target tissue ([0016]) in a living body ([0069]), and cites a cardiac use case as one possible diseased area of the body which the apparatus can be used for ([0078]).
Yamamoto as modified does not disclose a configuration where the apparatus is meant to treat nerve tissues. Sverdlik teaches an apparatus (system 1600, fig. 2) to be used for the treatment of tissue ([0162]) which has a treatment port (acoustic element 102 is a treatment port as it is an opening through which the treatment originates, see at least [0162], [0164], and [0403]) which is lateral to a distal end portion of a catheter (see fig. 2, acoustic element 102 is located on the side of catheter 1222, not at its distal end) and wherein the treatment port is aligned with a target anatomical feature when the treatment is to take place (see fig. 5). Sverdlik additionally teaches that it is important not to damage surrounding tissues when delivering a treatment (see at least [0285], [0286], and [0301]), but that in the case of treating nerve related disorders, the target anatomical feature can be a nerve which should be damaged (see Abstract and see [0043]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Yamamoto as modified when using the dveice to treat nerve related disorders by moving the injection port of Yamamoto as modified to be located laterally on the side of the catheter of Yamamoto as taught in Sverdlik as Sverdlik teaches that this arrangement can be used to deliver a highly localized treatment when damaging nerves as a part of a treatment (see at least Sverdlik [0156] and [0397]). Further, it would have been obvious to have arranged the injection port to have been between the first and second sensors in Yamamoto as modified so that the operator of the apparatus could know the exact types of tissue which the catheter, especially at its distal end portion, is passing through such as to maintain the specificity of the treatment location that Yamamoto uses its impedance sensors for (see at least Yamamoto [0069] and [0089]), as there is not shown as being enough space at the distal end portion of catheter 20 for an injection port to be placed between the beveled tip and sensor 70 as shown in fig. 8.
Thus, the modified method of Yamamoto as modified by Saal, Hetke, Cory, and Sverdlik discloses treatment of a nerve. {Note also that Cory in particular discloses that different impedances of different tissues types are able to be determined by a computer using memory as indicated above with respect to claim 11; thus the teachings regarding the impedances of cardiac tissues and baseline tissues are also understood to apply to nerve tissues in light of this.}
Yamamoto as modified does not explicitly disclose the method comprising step (b) after step (a), determining, with the computer, when the magnitude of the electrical characteristic measured by the first and second electrical sensors is about equal to the magnitude of the baseline output signals of the first and second electrical sensors, respectively.
However, there are a limited number of options for one of ordinary skill in the art to take after step (a); they could either remove the apparatus from the mammalian subject without treating the subject, advance the apparatus distally such that the first sensor 70 moves distally to the nerve to be treated, provide the treatment without the injection port being aligned with the target anatomical area, or leave the apparatus in the mammalian subject without administering treatment. Of these options and in order to provide the desired treatment to reduce the symptoms of the nerve related disorder, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have tried to move the catheter 20 distally such that the injection port could be aligned with the target anatomical feature and the mammalian subject could receive the treatment as desired. This distal movement of catheter 20 would involve determining, with the computer, when the magnitude of the electrical characteristic measured by the first and second electrical sensors is about equal to the magnitude of the baseline output signals of the first and second electrical sensors, respectively, at the point at which the catheter 20 is distally advanced as this would mean that sensor 70 is advanced distally to the targeted nerve while the second sensor 175 has not yet distally advanced to the targeted nerve.
Regarding claim 18, Yamamoto as modified discloses the method further comprising (d) advancing the apparatus distally in the mammalian subject between steps (a) and (b) (see rejection of claim 17 above, this distal advancement of the catheter 20 of the apparatus is what allows for the injection to continue and would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention), wherein the apparatus is in a first position in step (a) and in a second position in step (b) (see rejection of claim 17 above, the initial moment at which sensor 70 has been inserted into the targeted nerve is the claimed first position, and the claimed second position is the moment at which the first sensor 70 has passed distally through the nerve but the second senor 175 has not yet entered the proximal side of the targeted nerve).
Regarding claim 19, Yamamoto as modified discloses the method further comprising: (e) determining, with the computer, when the magnitude of the electrical characteristic measured by the second electrical sensor is higher than the magnitude of the baseline output signal of the second electrical sensor and the magnitude of the electrical characteristic measured by the first electrical sensor is about equal to the magnitude of the baseline output signal of the first electrical sensor.
However, there are a limited number of options for one of ordinary skill in the art to take after steps (a-d); they could either remove the apparatus from the mammalian subject without treating the subject, advance the apparatus distally such that the second sensor 175 moves distally to be in direct physical contact with the targeted nerve, provide the treatment without confirmation that the injection port is properly aligned with the target anatomical area, which is the targeted nerve, or leave the apparatus in the mammalian subject without administering treatment. Of these options and in order to provide the desired treatment to reduce the symptoms of the nerve related disorder, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have tried to move the catheter 20 distally such that the injection port could be confirmed to be in proper alignment with the target anatomical feature and the mammalian subject could receive the treatment as desired. This distal movement of catheter 20 would involve determining, with the computer, when the magnitude of the electrical characteristic measured by the second electrical sensor is higher than the magnitude of the baseline output signal of the second electrical sensor as this would mean that sensor 175 is in direct physical contact with the targeted nerve since this is what is indicated by the computer when this impedance change occurs. Further, this distal movement would also involve the magnitude of the electrical characteristic measured by the first electrical sensor being about equal to the magnitude of the baseline output signal of the first electrical sensor since it has been moved distally to the nerve and would show an impedance measurement being at the baseline measurement since the sensor 70 is no longer in direct physical contact with the targeted nerve. This modified method would then also involve (f) advancing the apparatus distally in the mammalian subject between steps (b) and (e) (this is the distal movement of catheter 20 which provides for sensor 175 being in direct physical contact with the targeted nerve), wherein the apparatus is in a third position in step (e) (this is a position distal to the second position where the proximally placed second sensor 175 is in direct physical contact with the targeted nerve), the second position between the first position and the third position (see above, the third position is distal to the second position and the second position was distal to the first position; thus the second position is between the first position and the third position).
Yamamoto as modified does not explicitly disclose the method including (g) retracting the apparatus proximally in the mammalian subject after step (e) to a fourth position, the fourth position between the first position and the third position.
However, there are a limited number of options for one of ordinary skill in the art to take after the previously listed steps; they could continue to advance the catheter distally knowing that the injection port, which is between the first and second sensors, is not aligned with the targeted nerve since the second sensor would be distal to the targeted nerve; they could perform the injection for treatment with the possibility that the catheter has already been advanced too far distally and the injection port is out of alignment with the targeted nerve; or they could retract the catheter 20 proximally in the mammalian subject such that the injection port might be aligned with the targeted nerve. Of these options and in order to provide the desired treatment to reduce the symptoms of the nerve related disorder, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have tried to move the catheter 20 proximally such that the injection port could be confirmed to be in proper alignment with the target anatomical feature and the mammalian subject could receive the treatment as desired. Since it is known that the injection port is between the two sensors in the modified apparatus, and since retracting the apparatus proximally would involve a fourth position at which the first sensor 70 is distal to the targeted nerve and the second sensor 175 is proximal to the targeted nerve, and thus that the injection port is aligned with the targeted nerve this would then further disclose the method as claimed including steps (h) after step (g), repeating step (b), wherein step (c) occurs after step (h) as the two sensors 70 and 175 surrounding either side of the targeted nerve would yield the resulting electrical characteristic measurements as a result of the varying impedance measurements as indicated above and since the corresponding production of the output control signal would indicate this alignment where the injection port is in the middle of the targeted nerve and where the sensors are not in direct contact with the targeted nerve since they are on either side of the targeted nerve.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 and 11 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. Examiner notes that Saal (relied upon above) was made of record in the previous Office Action.
Conclusion
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/SAMUEL J MARRISON/Examiner, Art Unit 3783 /EMILY L SCHMIDT/Primary Examiner, Art Unit 3783
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