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 .
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 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.
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 1-7, 9-15, and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Brannan (US PGPUB: 2011/0208177) in view of Allison (US PGPUB: 2017/0105798), further in view of Carr et al (US PGPUB: 2004/0243004).
Regarding independent claim 1, Brannan discloses a microwave ablation system for ablating target tissue (Fig. 1: 10; abstract, [0035]), the system comprising: a catheter having a proximal region and a distal region (Fig. 1-2; [0042]); a main antenna (Fig. 1-2: 12) comprising one or more (105 and 140) microwave radiating elements disposed at the distal region of the catheter (Fig. 1), configured to emit microwave energy ([0040], [0046]); a junction (130) of the main antenna between a proximal end of the main antenna and a distal end of the main antenna (Fig. 1; [0046]); and a processor ([0065]).
While Brannan discloses a main antenna comprising one or more microwave radiating elements, Brannan does not explicitly disclose a system comprising: the main antenna further configured to measure a radiometer temperature generated as a result of the energy emission; a reference termination disposed at a junction of the main antenna between a proximal end of the main antenna and a distal end of the main antenna, the reference termination configured to measure a reference temperature at the distal region; a switch electrically coupled to the main antenna and the reference termination, the switch configured to switch between an ablation state where the main antenna emits the microwave energy and a measurement state where a radiometer receives signals indicative of the measured radiometer temperature from the main antenna and/or signals indicative of the measured reference temperature from the reference termination via a cable coupled to the main antenna at a location proximal to the switch and the reference termination; and a processor configured to direct the switch to move between the ablation state and the measurement state.
However, Allison discloses a main antenna (Fig. 5, [0025]-[0026], [0028]; antenna and switching diodes) configured to measure a radiometer temperature generated as a result of the energy emission ([0012], [0028], [0031] discuss the radiometer configured to measure temperature and provide feedback (i.e. a single) based on the measured temperature); a reference termination (Fig. 5: "termination resistor") disposed at a junction of the main antenna between a proximal end of the main antenna and a distal end of the main antenna (Fig. 5: “termination resistor” is between a proximal end and distal end of the antenna), the reference termination configured to measure a reference temperature at the distal region ([0012], [0028] discuss the reference termination for measuring a reference temperature); a switch (Dicke switch; Fig. 5 "switching diodes") electrically coupled to the main antenna and the reference termination, the switch configured to switch between an ablation state where the main antenna emits the microwave energy and a measurement state where a radiometer receives signals indicative of the measured radiometer temperature from the main antenna and/or signals indicative of the measured reference temperature from the reference termination via a cable coupled to the main antenna at a location proximal to the switch and the reference termination ([0012], [0026], [0028] "A "Dicke switch" is the front end switch in a radiometer, and switches between the antenna input and a reference termination"). The system further comprises a generator ([0029]-[0030] refers to the ablation energy generator where Fig. 5 displays where generator connected at "generator input" which is in the proximal region of the catheter) coupled to the main antenna at a location proximal to the switch and the reference termination (Fig. 5 displays coax cable proximal the switch and reference termination and coupled to the main antenna); and a processor configured to direct the switch to move between the ablation state and the measurement state (Fig. 3, [0011], [0012], [0048]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the system of Brannan so that the main antenna is further configured to measure a radiometer temperature generated as a result of the energy emission; a reference termination disposed at a junction of the main antenna between a proximal end of the main antenna and a distal end of the main antenna, the reference termination configured to measure a reference temperature at the distal region; and a switch electrically coupled to the main antenna and the reference termination, the switch configured to switch between an ablation state where the main antenna emits the microwave energy and a measurement state where a radiometer receives signals indicative of the measured radiometer temperature from the main antenna and/or signals indicative of the measured reference temperature from the reference termination via a cable coupled to the main antenna at a location proximal to the switch and the reference termination; the generator coupled to the main antenna at a location proximal to the switch and the reference termination of Allison; and a processor configured to direct the switch to move between the ablation state and the measurement state. This configuration provides the benefit of improved accuracy and sensitivity of radiometric sensing in catheter systems ([0008]-[0009]), the ability to handle high power delivery due to a continuous center conductor path out of the antenna ([0006]), and simple technology ([0006]).
Further, the combination does not explicitly disclose the processor further configured to calculate a target tissue temperature based on the signals indicative of the measured radiometer temperature and the signals indicative of the measured reference temperature.
However, Carr discloses a microwave antenna (Fig. 1: 32) comprising a radiometer (38). The radiometer includes a Dicke Switch (40) and is connected to a processor (44). The processor is configured to receive and process the signals from the radiometer ([0036]). The temperature is measured via a resistive termination (42; [0034]). This temperature signal is supplied to input 40a of the switch and a reference temperature signal is supplied to input 40a of the switch ([0034]). The actual temperature is calculated based on these signals ([0034]-[0037]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the assembly of Brannan to incorporate the processor configured to calculate a target tissue temperature based on the signals indicative of the measured radiometer temperature and the signals indicative of the measured reference temperature of Carr. This configuration provides the befit of improving the radiometer sensitivity and performance by comparing an unknown temperature to a known temperature ([0034]).
Regarding dependent claim 2, in view of the combination of claim 1, Brannan further discloses wherein the one or more microwave radiating elements are configured to emit microwave energy within a range of 1-5 GHz to the target tissue ([0035], [0037], [0044]).
Regarding dependent claim 3, in view of the combination of claim 1, Brannan further discloses wherein the one or more microwave radiating elements comprise a basic dipole comprising first and second microwave radiating elements ([0038]).
Regarding dependent claim 4, in view of the combination of claim 3, Brannan further discloses wherein the basic dipole comprises a cylindrical configuration (Fig. 1 displays the dipole antenna as cylindrical).
Regarding dependent claim 5, in view of the combination of claim 1, Brannan further discloses wherein the one or more microwave radiating elements comprise one or more balun transformers (B1), the one or more balun transformers configured to transform a single ended transmission line system to a balanced system ([0047], [0069]).
Regarding dependent claim 6, in view of the combination of claim 5, Brannan further discloses wherein a second balun transformer (B2) of the one or more balun transformers is positioned adjacent a first balun transformer of the one or more balun transformers (See Fig. 2 where B2 is positioned adjacent to B1).
Regarding dependent claim 7, in view of the combination of claim 5, Brannan further discloses wherein the one or more balun transformers each comprise a thin, flexible dielectric substrate (220; [0049]-[0048]) having a top surface and a bottom surface (Fig. 2), and wherein the main antenna is configured to be flexible in at least one plane of the thin, flexible dielectric substrate ([0046] discusses at least portion 130 of the antenna 12 as elastic).
Regarding dependent claim 9, in view of the combination of claim 1, Brannan further discloses a junction of the main antenna between the proximal end of the main antenna and the distal end of the main antenna (130). Brann does not explicitly disclose wherein the switch and the reference termination are disposed at the junction. As outlined above, Allison discloses a reference termination and switch. Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the assembly of Brannan to incorporate the reference termination and switch of Allison disposed on the rigid section since it has been held that rearranging parts of an invention involves only routine skill in the art. MPEP 2144.04(VI)(C).
Regarding dependent claim 10, in view of the combination of claim 9, Allison further discloses wherein the switch comprises one or more switching diodes configured to be actuated by biasing the one or more switching diodes to an ON state or an OFF state ([0011],[0027], [0028] refer to the switch bias source coupled to the first and second diodes).
Regarding dependent claim 11, in view of the combination of claim 10, Allison further discloses wherein the one or more switching diodes are operatively coupled to a bias source via the cable ([0027], [0028] refer to the switch bias source coupled to the first and second diodes), the bias source configured to apply a forward current in the ON state and a negative voltage in the OFF state ([0016]).
Regarding dependent claim 12, in view of the combination of claim 10, Allison further discloses wherein the one or more switching diodes comprise a first switching diode in series connection with a second switching diode ([0011], [0028] refers to the switch comprising a first and second diode).
Regarding dependent claim 13, in view of the combination of claim 12, Allison further discloses wherein the first and second switching diodes are configured to be biased to the ON state or the OFF state in unison ([0011]).
Regarding dependent claim 14, in view of the combination of claim 10, Allison further discloses wherein the one or more switching diodes comprise microwave PIN diodes ([0028]).
Regarding dependent claim 15, in view of the combination of claim 10, Allison further discloses wherein the reference termination comprises a bias blocking capacitor configured to prevent bias current from dissipating in a resistor of the reference termination (Fig. 3; [0011]-[0012], [0016], [0028]).
Regarding dependent claim 19, in view of the combination of claim 1, Brannan further discloses further comprising a generator (28; [0040]) coupled to the proximal region of the catheter (Fig. 1), the generator configured to provide power to the first and second microwave radiating elements ([0040]-[0041]) via the cable (transmission line 15 coupled to feedline 110).
Regarding independent claim 20, Brannan discloses method for ablating target tissue (Fig. 1: 10; abstract, [0035]), the method comprising: emitting, by one or more microwave radiating elements (105 and 140) of a main antenna (Fig. 1-2: 12) disposed at a distal region of a catheter (Fig. 1-2; [0042]), microwave energy to target tissue ([0040], [0046]); a junction (130) of the main antenna between a proximal end of the main antenna and a distal end of the main antenna (Fig. 1; [0046]); and a processor ([0065]).
While Brannan discloses a method for ablating tissue, Brannan does not explicitly disclose a method comprising: measuring, by the main antenna, a radiometer temperature generated as a result of the energy emission; measuring, by a reference termination disposed at a junction of the main antenna between a proximal end of the main antenna and a distal end of the main antenna, a reference temperature at the distal region; and directing, via a processor, a switch to switch between an ablation state where the main antenna emits the microwave energy and a measurement state where a radiometer receives signals indicative of the measured radiometer temperature from the main antenna and/or signals indicative of the measured reference temperature from the reference termination via a cable coupled to the main antenna at a location proximal to the switch and the reference termination.
However, Allison discloses a method comprising: measuring, by the main antenna (Fig. 5, [0025]-[0026], [0028]; antenna and switching diodes), a radiometer temperature generated as a result of the energy emission ([0012], [0028], [0031] discuss the radiometer configured to measure temperature and provide feedback (i.e. a single) based on the measured temperature); measuring, by a reference termination (Fig. 5: "termination resistor") disposed at a junction of the main antenna between a proximal end of the main antenna and a distal end of the main antenna (Fig. 5: “termination resistor” is between a proximal end and distal end of the antenna), a reference temperature at the distal region ([0012], [0028] discuss the reference termination for measuring a reference temperature); and directing, via a processor (Fig. 3, [0048]), a switch (Dicke switch; Fig. 5 "switching diodes") to switch between an ablation state where the main antenna emits the microwave energy and a measurement state where a radiometer receives signals indicative of the measured radiometer temperature from the main antenna and/or signals indicative of the measured reference temperature from the reference termination via a cable coupled to the main antenna at a location proximal to the switch and the reference termination ([0012], [0026], [0028] "A "Dicke switch" is the front end switch in a radiometer, and switches between the antenna input and a reference termination"). The system further comprises a generator ([0029]-[0030] refers to the ablation energy generator where Fig. 5 displays where generator connected at "generator input" which is in the proximal region of the catheter) coupled to the main antenna at a location proximal to the switch and the reference termination (Fig. 5 displays coax cable proximal the switch and reference termination and coupled to the main antenna).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the method of Brannan so that further comprises measuring, by the main antenna, a radiometer temperature generated as a result of the energy emission; measuring, by a reference termination disposed at a junction of the main antenna between a proximal end of the main antenna and a distal end of the main antenna, a reference temperature at the distal region; directing, via a processor, a switch to switch between an ablation state where the main antenna emits the microwave energy and a measurement state where a radiometer receives signals indicative of the measured radiometer temperature from the main antenna and/or signals indicative of the measured reference temperature from the reference termination via a cable coupled to the main antenna at a location proximal to the switch and the reference termination of Allison. This configuration provides the benefit of improved accuracy and sensitivity of radiometric sensing in catheter systems ([0008]-[0009]), the ability to handle high power delivery due to a continuous center conductor path out of the antenna ([0006]), and simple technology ([0006]).
Further, the combination does not explicitly disclose calculating, by the processor, a target tissue temperature based on the signals indicative of the measured radiometer temperature and the signals indicative of the measured reference temperature.
However, Carr discloses method (Fig. 1: 32) comprising a radiometer (38). The radiometer includes a Dicke Switch (40) and is connected to a processor (44). The processor is configured to receive and process the signals from the radiometer ([0036]). The temperature is measured via a resistive termination (42; [0034]). This temperature signal is supplied to input 40a of the switch and a reference temperature signal is supplied to input 40a of the switch ([0034]). The actual temperature is calculated based on these signals ([0034]-[0037]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the method of Brannan to incorporate calculating, by the processor, a target tissue temperature based on the signals indicative of the measured radiometer temperature and the signals indicative of the measured reference temperature of Carr. This configuration provides the befit of improving the radiometer sensitivity and performance by comparing an unknown temperature to a known temperature ([0034]).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Brannan (US PG/PUB: 2011/0208177) in view of Allison (US PGPUB: 2017/0105798), and Carr et al (US PGPUB: 2004/0243004), further in view of Sterzer et al (US PGPUB: 2012/0029359).
Regarding dependent claim 8, in view of the combination of claim 7, the combination does not explicitly disclose further comprising foam dielectric disposed between regions above and below the thin, flexible dielectric substrate, and the one or more microwave radiating elements.
However, Sterzer discloses an antenna (Fig. 5B) comprising a foam dielectric (409) disposed between an outer (407) and inner (408) conductor ([0077]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the assembly of Brannan to incorporate further comprising foam dielectric disposed between regions above and below the thin, flexible dielectric substrate, and the first and second microwave radiating elements of Sterzer because Sterzer discloses that foam is a suitable dielectric to give the desired characteristic impedance for the feedline ([0077]).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Brannan (US PG/PUB: 2011/0208177) in view of Allison (US PGPUB: 2017/0105798) and Carr et al (US PGPUB: 2004/0243004), further in view of Mashiach (US PGPUB: 2015/0290465).
Regarding dependent claim 16, in view of the combination of claim 10, while Allison discloses a first and second switching diode, Allison does not explicitly disclose wherein the wherein the one or more switching diodes are unpackaged and encapsulated.
However, Mashiach discloses an antenna system (Fig. 4) comprising a diode 156 that is encapsulated ([0119]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the assembly of Brannan to incorporate wherein the first and second switching diodes are unpackaged and encapsulated, thereby preventing damage as the switching antenna flexes of Mashiach. This configuration provides the benefit of protecting the diode from the environment in the patient's body and preventing corrosion ([0119]).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Brannan (US PG/PUB: 2011/0208177) in view of Allison (US PGPUB: 2017/0105798) and Carr et al (US PGPUB: 2004/0243004), further in view of Thiel (US PGPUB: 2017/0112571).
Regarding dependent claim 17, in view of the combination of claim 1, while Brannan discloses a catheter, Brannan does not explicitly disclose wherein the distal region of the catheter is configured to be introduced through a mouth, into a trachea, and into a lung to the target tissue for ablation.
However, Thiel teaches a microwave ablation system wherein the distal region of the catheter (Fig. 4A) is configured to be introduced through a mouth, into a trachea, and into a lung to the target tissue for ablation ([0125]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the assembly of Brannan to incorporate wherein the distal region of the catheter is configured to be introduced through a mouth, into a trachea, and into a lung to the target tissue for ablation of Thiel. This configuration provides the benefit of enabling the system to perform endobronchial or transbronchial therapies ([0007]).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Brannan (US PG/PUB: 2011/0208177) in view of Allison (US PGPUB: 2017/0105798) and Carr et al (US PGPUB: 2004/0243004), further in view of Cronin (US Patent No.: 6,635,055).
Regarding dependent claim 18, in view of the combination of claim 1, while the combination discloses measuring temperature, it fails to disclose further comprising a thermocouple circuit formed by an outer conductor of the cable and a thin dissimilar wire terminating adjacent a resistor of the reference termination.
However, Cronin discloses a microwave application (Fig. 1: 1) comprising a thermocouple circuit (10) formed by an outer conductor (17) of the cable (5) and a wire (8; Col. 3, Lines 12-18). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the assembly of Brannan to incorporate further comprising a thermocouple circuit formed by an outer conductor of the cable and a thin dissimilar wire terminating adjacent a resistor of the reference termination of Cronin. This configuration provides the benefit of reducing the number of wires (Col. 3, Lines 13), thereby simplifying the device.
Conclusion
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/NORA W RHODES/Examiner, Art Unit 3794
/SEAN W COLLINS/Primary Examiner, Art Unit 3794
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