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 § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 9 & 12 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 9 recites the limitation “the display” in line 2. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 12, the claim recites “an independent ablation probe assembly” in lines 4-5 and it is unclear if this is the same ablation probe assembly as the “at least one ablation probe assembly” recited in claim 1, from which claim 12 depends, or is a different ablation probe assembly. For examination purposes, these are the same ablation probe assemblies and the limitation will be interpreted as “an independent ablation probe assembly of the at least one ablation probe assembly”.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 15, 17 & 19 are rejected under 35 U.S.C. 102(a)(1)/102(a)(2) as being anticipated by Brannan (U.S. Pub. No. 20190175270) herein referred to as “Brannan”.
Regarding claim 15, Brannan teaches a microwave ablation apparatus (Abstract: Microwave ablation systems) comprising:
a portable base unit (upper portion of cart, Fig. 1; wherein the wheels on the cart are seen as enabling the base unit to be portable) comprising a microwave generator port (port from generator 130, Fig. 1) and a coolant port (port from cooling system 140); and
an ablation probe assembly (antennas 110) comprising a probe (antenna 110), a flexible conduit (cable 105), a microwave connector and a coolant cartridge ([0036]: FIG. 2 is a block diagram of a microwave ablation system … a microwave generator 220, … two disposable ablation probes 210 coupled to the microwave generator 220 via a reusable cable assembly 200, and two fluid pumps and saline bags coupled to corresponding disposable ablation probes 210; see Fig. 2 wherein the block diagram depicts the connectivity/ports between the probes and the generator/cooling system), the microwave connector adapted to removably couple the ablation probe assembly to the microwave generator port, and the coolant cartridge adapted to removably couple the ablation probe assembly to the coolant port ([0036]: two disposable ablation probes 210 coupled to the microwave generator 220 via a reusable cable assembly 200, and two fluid pumps and saline bags coupled to corresponding disposable ablation probes 210).
Regarding claim 17, Brannan teaches wherein the microwave generator port is coupled to a microwave generator (microwave generator 130) in the portable base unit (see Fig. 1 where the generator comprises a port), the microwave generator configured to deliver a microwave signal to the probe ([0039]: the microwave signal generated by the generator 220 … The hardware controller 226 controls the microwave amplifier 225 to convert the DC power to a microwave signal, which is transmitted to the microwave probe 218).
Regarding claim 19, Brannan teaches a microwave ablation apparatus (Abstract: Microwave ablation systems) comprising:
a portable base unit comprising a housing (outer portion surrounding generator 130, Fig. 1; wherein the wheels on the cart are seen as enabling the base unit to be portable) defining an interior volume (volume in which generator 130 is occupying in Fig. 1);
at least one microwave generator (microwave generator 130) positioned in the housing configured to deliver a microwave signal to an ablation probe ([0039]: the microwave signal generated by the generator 220 … The hardware controller 226 controls the microwave amplifier 225 to convert the DC power to a microwave signal, which is transmitted to the microwave probe 218); and
at least one coolant flow generator (cooling system 140) positioned in the housing (see positioning in Fig. 1) configured to move coolant through a conduit (cable 105) to the ablation probe ([0035]: multiple disposable antennas 110, which can be coupled to the generator 130 and the cooling system 140).
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.
Claims 1-3, 5 & 11-14 are rejected under 35 U.S.C. 103 as being unpatentable over Brannan
Regarding claim 1, Brannan discloses a microwave ablation apparatus (Abstract: Microwave ablation systems) comprising:
a movable cart (see cart in Fig. 1) comprising a support surface (surface in which generator 130 & cooling system 140 are mounted, Fig. 1);
a portable base unit (upper portion of cart, Fig. 1; wherein the wheels on the cart are seen as enabling the base unit to be portable) comprising at least one microwave generator (microwave generator 130) and at least one coolant flow generator (cooling system 140), the portable base unit positioned on the support surface (Fig. 1); and
at least one ablation probe assembly (antennas 110, two shown in Fig. 1) configured to couple to the at least one microwave generator and the at least one coolant flow generator ([0035]: multiple disposable antennas 110, which can be coupled to the generator 130 and the cooling system 140).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention for the portable base unit to be removably positioned on the support surface, since it has been held that constructing a formerly integral structure in various elements involves only routine skill in the art. Nerwin v. Erlichman, 168 USPQ 177, 179.
Regarding claim 2, Brannan discloses wherein the movable cart comprises an elongated post configured to position the support surface at an elevated position (see Fig. 1 where the cart comprises an elongated post between the generator 130/cooling system 140 and the wheels such that the generator 130 and cooling system are elevated).
Regarding claim 3, Brannan discloses wherein the movable cart comprises a plurality of wheels mounted to an end of the elongated post opposite to the support surface (see Fig. 1 where the bottom of the cart comprises wheels opposite the generator 130).
Regarding claim 5, Brannan discloses wherein the portable base unit comprises a first coolant cartridge port, a first microwave signal port, and a first sensor port ([0036]: FIG. 2 is a block diagram of a microwave ablation system. The microwave ablation system includes a microwave generator 220, a remote temperature probe 232 coupled to the generator 220, two disposable ablation probes 210 coupled to the microwave generator 220 via a reusable cable assembly 200, and two fluid pumps and saline bags coupled to corresponding disposable ablation probes 210; wherein the connections of the block diagram are seen as ports).
Regarding claim 11, Brannan discloses wherein the at least one coolant flow generator comprises a pump configured to move coolant through the at least one ablation probe assembly ([0035]: a cooling system 140 including two fluid pumps. The microwave generator 130 and the cooling system are configured to operate with multiple disposable antennas 110, which can be coupled to the generator 130 and the cooling system 140).
Regarding claim 12, Brannan discloses wherein the at least one coolant flow generator comprises a first coolant flow generator and a second coolant flow generator, the first coolant flow generator and the second coolant flow generator each operable to independently generate flow of a coolant through an independent ablation probe assembly ([0036]: FIG. 2 is a block diagram of a microwave ablation system. The microwave ablation system includes a microwave generator 220, a remote temperature probe 232 coupled to the generator 220, two disposable ablation probes 210 coupled to the microwave generator 220 via a reusable cable assembly 200, and two fluid pumps and saline bags coupled to corresponding disposable ablation probes 210).
Regarding claim 13, Brannan discloses wherein the at least one ablation probe assembly comprises an ablation probe, a flexible conduit, a coolant cartridge and a connector ([0036]: FIG. 2 is a block diagram of a microwave ablation system. The microwave ablation system includes a microwave generator 220, a remote temperature probe 232 coupled to the generator 220, two disposable ablation probes 210 coupled to the microwave generator 220 via a reusable cable assembly 200, and two fluid pumps and saline bags coupled to corresponding disposable ablation probes 210).
Regarding claim 14, Brannan discloses wherein the connector is configured to connect the at least one ablation probe assembly to the at least one microwave generator and the coolant cartridge is configured to connect the at least one ablation probe assembly to the at least one coolant flow generator ([0036]: FIG. 2 is a block diagram of a microwave ablation system. The microwave ablation system includes a microwave generator 220, a remote temperature probe 232 coupled to the generator 220, two disposable ablation probes 210 coupled to the microwave generator 220 via a reusable cable assembly 200, and two fluid pumps and saline bags coupled to corresponding disposable ablation probes 210).
Claims 4, 9 & 16 are rejected under 35 U.S.C. 103 as being unpatentable over Brannan as applied to claim 1 above, and further in view of Henderson et al. (U.S. Pub. No. 20200078119), herein referred to as “Henderson”.
Regarding claim 4, Brannan fails to disclose wherein the support surface comprises a locator and the portable base unit comprises a complimentary locator, the locator and the complimentary locator configured to position the portable base unit in a desired position on the support surface.
However, Henderson discloses wherein the support surface (docking station 151, Fig. 4) comprises a locator (bracket 156) and the portable base unit (combo generator module 145) comprises a complimentary locator (side brackets 155), the locator and the complimentary locator configured to position the portable base unit in a desired position on the support surface ([0120]: the combo generator module 145 includes side brackets 155 that are configured to slidably engage with corresponding brackets 156 of the corresponding docking station 151 of the hub modular enclosure 136. The brackets cooperate to guide the docking port contacts of the combo generator module 145 into an electrical engagement with the docking port contacts of the hub modular enclosure 136). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the ablation system of Brannan to include a locator and a complimentary locator, as taught by Henderson, for the purpose of guiding the docking port contacts of the combo generator module into an electrical engagement with the docking port contacts of the hub modular enclosure (Henderson: [0120]).
Regarding claim 9, Brannan fails to disclose wherein the portable base unit comprises an adjustable display screen configured to allow user input and the display of one or more operating parameters.
However, Henderson discloses wherein the portable base unit (modules 2001) comprises an adjustable display screen (display screen 2006; [0280]: display screen 2006 can be detachably connected to the housing 2010) configured to allow user input and the display of one or more operating parameters ([0287]: a display 2006 configured for displaying a GUI 2008 … GUI 2008 displays controls and data associated with an energy module 2004 that is connected to the header module 2002; [0288]: the power button can be displayed as part of the GUI 2008). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the portable base unit of Brannan to include an adjustable display screen, as taught by Henderson, for the purpose of providing a consolidated point of control of all of the modules making up the particular configuration of the modular energy system (Henderson: [0280]).
Regarding claim 16, Brannan fails to disclose wherein the microwave generator port and the coolant port each include a colored light configured to identify the microwave connector and the coolant cartridge.
However, Henderson discloses wherein the microwave generator port and the coolant port each include a colored light configured to identify the microwave connector and the coolant cartridge ([0290]: energy module 2004 can include light assemblies 2015 disposed about each of the ports of the port assembly 2012 … For example, the light assemblies 2015 can change from a first color to a second color when a plug is fully seated within the respective port). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the ports of Brannan to include colored lights, as taught by Henderson, for the purpose of relaying information to user regarding the port according to their color or state (Henderson: [0290]). Wherein in this combination, Brannan teaches the function of the ports and Henderson is relied upon to teach that color coded lights are known in the art.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Brannan as applied to claim 5 above, and further in view of Brannan (U.S. Pat. No. 8568404), herein referred to as “Brannan 2”.
Regarding claim 6, Brannan discloses wherein the portable base unit comprises a second coolant cartridge port, and a second microwave signal port ([0036]: FIG. 2 is a block diagram of a microwave ablation system. The microwave ablation system includes a microwave generator 220, a remote temperature probe 232 coupled to the generator 220, two disposable ablation probes 210 coupled to the microwave generator 220 via a reusable cable assembly 200, and two fluid pumps and saline bags coupled to corresponding disposable ablation probes 210; wherein the connections of the block diagram are seen as ports). But Brannan fails to disclose wherein the portable base unit comprises a second sensor port.
However, Brannan 2 discloses wherein the portable base unit comprises a second sensor port (Col. 5, lines 2-7: one or more tissue sensor probes 200 that are adapted to sense one or more operative parameters, e.g., a tissue impedance. The tissue sensor probe 200 is operably connected by a cable 14 to a connector 18, which further operably connects tissue sensor probe 200 to a controller assembly 30; wherein in the block diagram shown in Fig. 2, the connectivity between the sensor probes and the controller is seen as comprising a first port and a second port). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the portable base unit of Brannan to include a second sensor port, as taught by Brannan 2, for the purpose of sensing at one or more points surrounding the ablation probe, the formation of the ablated volume of tissue may be accurately monitored (Brannan: Col. 6, lines 5-7).
Claims 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Brannan in view of Brannan 2 as applied to claim 6 above, and further in view of Berry et al. (U.S. Pub. No. 20150257814), herein referred to as “Berry”.
Regarding claim 7, Brannan in view of Brannan 2 fail to disclose wherein the first coolant cartridge port, the first microwave signal port, and the first sensor port are each marked with a first indicator, and the second coolant cartridge port, the second microwave signal port, and the second sensor port are each marked with a second indicator, the first indicator and the second indicator each configured to identify a different ablation probe assembly.
However, Berry discloses wherein the first coolant cartridge port, the first microwave signal port, and the first sensor port are each marked with a first indicator, and the second coolant cartridge port, the second microwave signal port, and the second sensor port are each marked with a second indicator, the first indicator and the second indicator each configured to identify a different ablation probe assembly ([0068]: display screen sections 440-444 and connectors 420-424 may be visually coupled via the use of color. For instance, when display screen section 440, or a portion thereof, and connector 420 may have the same color so that a user may easily identify that display screen section 440 and connector 420 are visually coupled and respectively associated with one another due to their common color; see Fig. 4 were display screen sections 442 & 443 correspond with connectors, 423 & 424, respectively, where each of the connectors comprise three ports such that Berry is seen as teaching three ports marked with a first indicator and three ports marked with a second indicator). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the portable base unit of Brannan in view of Brannan 2 to include first and second indicators, as taught by Berry, for the purpose of the indicators identifying a type of instrument or operation associated with a respective display screen section and connector (Berry: [0068]). Wherein in this combination, Brannan in view of Brannan 2 are relied upon to teach the function/connectivity of the ports and Berry is relied upon to teach the grouping and indicator.
Regarding claim 8, Brannan in view of Brannan 2 and Berry disclose wherein the first indicator is a first color and the second indicator is a second color (Berry: [0068]: display screen sections 440-444 and connectors 420-424 may be visually coupled via the use of color. For instance, when display screen section 440, or a portion thereof, and connector 420 may have the same color so that a user may easily identify that display screen section 440 and connector 420 are visually coupled and respectively associated with one another due to their common color; see Fig. 4 were display screen sections 442 & 443 correspond with connectors, 423 & 424, respectively, where each of the connectors comprise three ports such that Berry is seen as teaching three ports marked with a first indicator and three ports marked with a second indicator).
Claims 10 & 20 are rejected under 35 U.S.C. 103 as being unpatentable over Brannan as applied to claims 1 & 19, above, and further in view of Allen et al. (U.S. Pub. No. 20170312004), herein referred to as “Allen”.
Regarding claim 10, Brannan fails to disclose wherein the at least one microwave generator comprises a first microwave generator and a second microwave generator, the first microwave generator and the second microwave generator each operable to independently generate a microwave signal for an independent ablation probe.
However, Allen discloses wherein the at least one microwave generator (generator 100) comprises a first microwave generator and a second microwave generator (one or more output modules 200), the first microwave generator and the second microwave generator each operable to independently generate a microwave signal for an independent ablation probe ([0022]: FIG. 4A-4D are schematic views illustrating various surgical instruments being coupled to the generator of FIG. 2; [0035]: whereby the one or more output modules 200 can cooperate with the instrument 10 (e.g., surgical instrument 12) operatively coupled thereto so that the instrument 10 can perform one or more functions (e.g., grasping, sealing, cutting, ablating, cooling, etc.); [0037]: the one more output modules 200 may include an inverter configured to output energy at one or more of an ultrasonic frequency, a microwave frequency, a radio frequency, etc. … In some embodiments, different output modules may be configured to provide the same energy modalities.). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the microwave generator of Brannan to include two microwave generators, as taught by Allen, for the purpose of each output module may be configured to cooperate with one or more of the first and second surgical instruments when coupled to the generator to enable the respective one of the first and second surgical instruments to perform one or more functions (Allen: [0014]).
Regarding claim 20, Brannan discloses wherein the at least one coolant flow generator comprises a first coolant flow generator and a second coolant flow generator (see Fig. 1 where two cooling systems 140 are shown) but Brannan fails to disclose wherein the at least one microwave generator comprises a first microwave generator and a second microwave generator.
However, Allen discloses wherein the at least one microwave generator comprises (generator 100) a first microwave generator and a second microwave generator (one or more output modules 200; [0022]: FIG. 4A-4D are schematic views illustrating various surgical instruments being coupled to the generator of FIG. 2; [0035]: whereby the one or more output modules 200 can cooperate with the instrument 10 (e.g., surgical instrument 12) operatively coupled thereto so that the instrument 10 can perform one or more functions (e.g., grasping, sealing, cutting, ablating, cooling, etc.); [0037]: the one more output modules 200 may include an inverter configured to output energy at one or more of an ultrasonic frequency, a microwave frequency, a radio frequency, etc. … In some embodiments, different output modules may be configured to provide the same energy modalities). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the microwave generator of Brannan to include two microwave generators, as taught by Allen, for the purpose of each output module may be configured to cooperate with one or more of the first and second surgical instruments when coupled to the generator to enable the respective one of the first and second surgical instruments to perform one or more functions (Allen: [0014]).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Brannan as applied to claim 15 above, and further in view of Condie et al. (U.S. Pub. No. 20210212763, cited in IDS), herein referred to as “Condie”.
Regarding claim 18, Brannan fails to disclose wherein the coolant port includes a peristaltic pump configured to move coolant through the flexible conduit to the probe.
However, Condie discloses wherein the coolant port includes a peristaltic pump configured to move coolant through the flexible conduit to the probe ([0076]: each of pumps 148a, 148b, 148c comprises a peristaltic pump; see connection of coolant source to the ablation device via the pumps in Figs. 1A-1B). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the pump of Brannan to be a peristaltic pump, as taught by Condie, for the purpose of the pump enabling adjustment of the flow rate of coolant through the ablation device by controlling the speed of the motor (Condie: [0076]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Abigail M Ziegler whose telephone number is (571)272-1991. The examiner can normally be reached M-F 8:30 a.m. - 5 p.m. EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne Rodden can be reached at (303) 297-4276. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ABIGAIL M ZIEGLER/Examiner, Art Unit 3794
/THOMAS A GIULIANI/Primary Examiner, Art Unit 3794