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 .
Priority
This application is a continuation of US Application no. 17/391,448, now US Patent no. 12,011,204, filed 2 August 2021 which is a continuation of US Application no. 16/227,610 now US Patent no. 11,076,904 filed 20 December 2018.
Response to Amendment
The preliminary amendment filed 17 May 2024 has been acknowledged. Claims 21-35 are pending.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 21-35 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The claims recite that a remote device receives a first set operating parameters, generating a second set of operating parameters, and for transmitting a control signal with the second set of operating parameters. There is no support for a “remote” device. The disclosure teaches controller 101 receiving, processing, and transmitting of operating parameters from control unit/controller 202, wherein it will be interpreted that controller 101 comprises more or more processor/controller as claimed in claims 21 and 28, and the control unit/controller 202 related to the pump assembly the second controller or remote device.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 21, 24-30, 34, and 35 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 12,011,204. Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘204 patent recites features presently claimed thereby rendering the present invention an obvious variant.
For instance, claim 1 of the ‘204 patent provides the functional limitations of the receiving a first set of operating parameters from a controller (i.e., the second controller configured to: store a set of parameters for a treatment procedure), receiving an indication of flow rate from a sensor a sensor for sensing a flow rate of the cooling fluid), generating a set of second set of operating parameters (i.e., determine whether to adjust one of the speed or the direction of rotation for the motor based on the indicated flow rate and the set of parameters, wherein the adjustment is from a first set of parameters executed by the controller and the determined adjustment being the second set), and transmitting a control signal that causes the control motor of the pump assembly based on the adjusted or second set of parameters (i.e., transmit a control signal to the first controller responsive to a determination to adjust one of the speed or the direction of rotation, the control signal causing the first controller to control the motor to adjust the speed or the direction of rotation accordingly).
In claims 1 and 35, the remote device as presently recited is considered to be comprised by the first controller recited in claim 1 of the ‘204, and the one or more processors/controller presently recited is considered to be comprised by the second controller recited in claim 1 of the ‘204 patent which is configured to perform these steps.
Claim 1 of the ‘204 is considered to read on and render obvious present claims 21, 28, and 35 and their depending claims 26 and 33, claims 2 and 3 of the ‘204 is considered to read on present claims 24 and 29, claim 4 of the ‘204 is considered to read on present claims 25 and 30, and claim 11 of the ‘204 is considered to read on present claims 27 and 34.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 21, 22, 24, 26-29, 31, and 33-35 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Arts et al. (US Publication no. 2016/0206279 – disclosed by Applicant).
In regard to claim 21, Arts et al. disclose non-transitory computer readable media having instructions stored thereon (i.e., a computer program and/or logic circuitry, para 93, 110) that when executed by one or more processors (processor 82, introduced at para 87), cause the one or more processors 82 to perform operations comprising: receiving, from a remote device (i.e, flow control 50, para 91), a first set of operating parameters for a pump assembly of a medical device for performing radiofrequency (RF) ablation (para 93, the flow control 50 is communicatively coupled to the processor unit 82, processor unit may adjust the flow rate of the flow control, and is therefore considered to obtain current operating or performance status of the flow for determining whether to make an adjustment; Para, 130, The processor unit 82 may be communicatively-coupled to the flow-control device 50, e.g., via a transmission line,);
receiving, from a sensor, an indication of a flow rate for a cooling fluid, the cooling fluid delivered by the pump assembly to a distal end of a probe assembly of the medical device through a first lumen (para 101, a flow sensor FS1 is communicatively coupled to the processor 82 and the sensor is disposed in the coolant flow path 19);
generating a second set of operating parameters for the pump assembly based the flow rate and the first set of operating parameters (para 101, Processor unit 82 may be configured to control the flow-control device 50 based on determination of a desired fluid flow rate using one or more signals received from the flow sensor; para 131, signals indicative of the rate of fluid flow into and/or out of the probe 100 and/or conduit fluidly-coupled the probe 100 received from one or more flow sensors may be used by the processor unit 82 to determine a desired fluid flow rate (i.e. considered to imply adjustment of parameters over current parameters. The desired fluid flow rate determined in this manner is considered to comprise the second set of operating parameters); and
transmitting, to the remote device (flow control 50), a control signal that causes the remote device to control a motor of the pump assembly based on the second set of operating parameters (para 132-133, processor unit 82, e.g., based on determination of a desired fluid flow rate using temperature data and/or flow data, to selectively adjust the fluid flow rate in a fluid flow path; feedback control system 14 may be adapted to control the flow-control device 50).
In regard to claim 22, Arts et al. teach that the first set of operating parameters and the second set of operating parameters comprise at least one of a speed, a rotational direction, an acceleration rate, or a deceleration rate for the pump assembly (para 84, pump speed is controlled and adjusted).
In regard to claim 25, in Arts et al., the flow sensor positioned along the first lumen between the pump assembly and the probe assembly (para 101, the flow sensor may be disposed in communication with a coolant path; figure 1 shows flow sensor FS between probe 100 and control unit 50).
In regard to claim 26, in Arts et al., remote device is a controller for the pump assembly (para 91, control unit 50 regulates or controls the rate of fluid flow).
In regard to claim 27, in Arts et al., operations comprise delivering, by the probe assembly, RF energy to a patient's body (para 73).
In regard to claim 28, Arts et al. disclose controller 82 for a radiofrequency (RF) generator 86 of a medical device (electrosurgical system 10) (para 87) controller comprising: a memory device having instructions stored thereon (para 129; para 131,The desired fluid flow rate may be selected from a look-up table or determined by a computer algorithm stored within the memory device); and one or more processors 82 configured to execute the instructions to cause the controller to (para 87; para 93, Processor unit 82 may be configured to control the flow-control device 50 … The amount of time the fluid flow is blocked or the desired fluid flow rate may additionally, or alternatively, be selected from a look-up table or determined by a computer algorithm; para 132, Processor unit 82 may be configured to execute a series of instructions such that the flow-control device 50 and the fluid-movement device 60 are cooperatively controlled by the processor unit 82, e.g., based on determination of a desired fluid flow rate using temperature data and/or flow data, to selectively adjust the fluid flow rate in a fluid flow path (e.g., first coolant path 19) of the coolant supply system 11): receive, from a second controller (flow control 50) associated with a pump assembly of the medical device, a first set of operating parameters for the pump assembly (para 93, the flow control 50 is communicatively coupled to the processor unit 82, processor unit may adjust the flow rate of the flow control, and is therefore considered to obtain current operating or performance status of the flow for determining whether to make an adjustment; Para, 130, The processor unit 82 may be communicatively-coupled to the flow-control device 50, e.g., via a transmission line,)
receiving, from a sensor positioned between the pump assembly and a probe assembly of the medical device, an indication of a flow rate for a cooling fluid, the cooling fluid delivered by the pump assembly to a distal end of the probe assembly through a first lumen (para 101, a flow sensor FS1 is communicatively coupled to the processor 82 and the sensor is disposed in the coolant flow path 19); generating a second set of operating parameters for the pump assembly based the flow rate and the first set of operating parameters (para 101, Processor unit 82 may be configured to control the flow-control device 50 based on determination of a desired fluid flow rate using one or more signals received from the flow sensor; para 131, signals indicative of the rate of fluid flow into and/or out of the probe 100 and/or conduit fluidly-coupled the probe 100 received from one or more flow sensors may be used by the processor unit 82 to determine a desired fluid flow rate (i.e. considered to imply adjustment of parameters over current parameters. The desired fluid flow rate determined in this manner is considered to comprise the second set of operating parameters); and transmitting, to the second controller (flow control 50), a control signal that causes the second controller to operate a motor of the pump assembly according to the second set of operating parameters (para 132-133, processor unit 82, e.g., based on determination of a desired fluid flow rate using temperature data and/or flow data, to selectively adjust the fluid flow rate in a fluid flow path; feedback control system 14 may be adapted to control the flow-control device 50).
In regard to claim 29, in Arts et al., the flow sensor positioned along the first lumen between the pump assembly and the probe assembly (para 101, the flow sensor may be disposed in communication with a coolant path; figure 1 shows flow sensor FS between probe 100 and control unit 50).
In regard to claim 31, Arts et al. teach that the first set of operating parameters and the second set of operating parameters comprise at least one of a speed, a rotational direction, an acceleration rate, or a deceleration rate for the pump assembly (para 84, pump speed is controlled and adjusted).
In regard to claim 33, in Arts et al., second controller is a controller for the pump assembly (para 91, control unit 50 regulates or controls the rate of fluid flow).
In regard to claim 34, in Arts et al., operations comprise delivering, by the probe assembly, RF energy to a patient's body (para 73).
In regard to claim 35, Arts et al. disclose a method of controlling an RF generator 86 of a medical device (electrosurgical system 10) comprising: receiving, from a remote device (flow control 50) associated with a pump assembly of the medical device, a first set of operating parameters for the pump assembly (para 93, the flow control 50 is communicatively coupled to the processor unit 82, processor unit may adjust the flow rate of the flow control, and is therefore considered to obtain current operating or performance status of the flow for determining whether to make an adjustment; Para, 130, The processor unit 82 may be communicatively-coupled to the flow-control device 50, e.g., via a transmission line,); receiving, from a sensor positioned between the pump assembly and a probe assembly of the medical device, an indication of a flow rate for a cooling fluid, the cooling fluid delivered by the pump assembly to a distal end of the probe assembly through a first lumen (para 101, a flow sensor FS1 is communicatively coupled to the processor 82 and the sensor is disposed in the coolant flow path 19); generating a second set of operating parameters for the pump assembly based the flow rate and the first set of operating parameters (para 101, Processor unit 82 may be configured to control the flow-control device 50 based on determination of a desired fluid flow rate using one or more signals received from the flow sensor; para 131, signals indicative of the rate of fluid flow into and/or out of the probe 100 and/or conduit fluidly-coupled the probe 100 received from one or more flow sensors may be used by the processor unit 82 to determine a desired fluid flow rate (i.e. considered to imply adjustment of parameters over current parameters. The desired fluid flow rate determined in this manner is considered to comprise the second set of operating parameters); and transmitting, to the remote device, a control signal that causes the remote device to operate a motor of the pump assembly according to the second set of operating parameters (para 132-133, processor unit 82, e.g., based on determination of a desired fluid flow rate using temperature data and/or flow data, to selectively adjust the fluid flow rate in a fluid flow path; feedback control system 14 may be adapted to control the flow-control device 50).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 23 and 32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Arts et al. (US Publication no. 2016/0206279 – disclosed by Applicant).
In regard to claims 23 and 32, Arts et al. substantially disclose the invention as claimed, however do not teach the steps of the controller to receive, from the sensor, a second indication of the flow rate for the cooling fluid after causing the second controller to control the motor of the pump assembly; determine whether to generate a third set of operating parameters based on the second indication of the flow rate and the first set of operating parameters; and responsive to determining to generate the third set of operating parameters, transmit, to the second controller, a second control signal that causes the second controller to control the motor of the pump assembly based on the third set of operating parameters. However, this is considered to be suggestive of the closed-loop control to adapt flow control and selectively adjusting one or more operational parameters of the coolant moving through the flow path (para 130). Therefore it is considered obvious to one of ordinary skill in the art to receive second and thirds indication of the flow rate since it is suggest by the control of Art et al. and would optimize the pump speed by selectively adjusting the fluid flow rate to attain a desired fluid flow rate.
Claim(s) 25 and 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Arts et al. (US Publication no. 2016/0206279 – disclosed by Applicant) in view of Drbal et al. (US Patent Application Publication 2016/0018347). In regard to claims 25 and 30, Arts et al. substantially disclose the invention as claimed, however do not teach that the flow sensor comprises a wetted surface that is made from an inert, biocompatible material. Drbal et al. is directed to a medical fluid system (para 378) with a flow sensor (para 615). Drbal et al. teaches that the flow sensor comprises a wetted surface (para 626) that is made from an inert, biocompatible material (para 521, 534, 619, and 624). It would have been obvious to one having ordinary skill in the art to use a flow sensor made of wetted surface with inert, biocompatible materials in Arts et al. since Drbal et al. teaches these are common properties of flow sensors to prevent the sensor from corroding after contact with the liquid whose properties are being sensed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN T GEDEON whose telephone number is (571)272-3447. The examiner can normally be reached M-F 8:00 am to 5:30 PM ET.
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/BRIAN T GEDEON/Primary Examiner, Art Unit 3796 30 January 2026