]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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 1 recites the broad recitation wherein the first slot has a first shape and the second slot has a second shape different from the first shape, and the claims 5 and 6 also recites “wherein the first slot has a first shape” and “wherein the second slot has a second shape different from the first shape” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
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.
(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.
Claim(s) 18 and 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mayer (US 20150105701 A1).
Regrading claim 18, Mayer teaches a method for providing therapy to a patient using a single-use RF device, the method comprising: providing a single-use RF device ([590] this configuration can also provide systems in which the therapeutic device is a single-use device, but the cable may be re-used. This can substantially reduce expense of materials when lengthy cabling is needed to connect the console to the operational head) having one or more electrodes ([0047] Optionally, the connector comprises an operable linkage (e.g. electrical terminals for conducting RF output) connecting the energy generator to one or more electrodes of the operational head of the therapeutic device); joining the single-use RF device to a connector ([0490] The reversible connector provides housing for the energy operable linkage (e.g. electrically conductive members that transmit RF signals) that connects the energy generator to the energy delivery head), wherein the connector includes a first slot configured for receiving a first removable memory ([0200] Optionally, the memory device is removable connected to the therapeutic device. Optionally, the memory device comprises a personal computer type connector (e.g. USB, firewire, or serial connection)), the first removable memory being configured for authentication of a treatment plan; authenticating the treatment plan ([0223] the memory device can comprise…updates of keys (symmetric or asymmetric) which when authenticated by another operator action (such as entering a code) allow the console to be used for a specific number of treatments, updates of the number of uses which the console may perform before requiring a further authorization, or scripts or instructions to copy diagnostic or historical data from the console to the memory device); and delivering energy to the patient using the one or more electrodes ([0283] Optionally, the control instructions comprise one or more calibration parameters of a wave energy delivery head (e.g. electrode), e.g. one or more calibration parameters for energy delivery).
Regrading claim 20, Mayer teaches the method of claim 18, wherein delivering energy to the patient using the one or more electrodes includes delivering energy to the one or more electrodes to ablate tissue ([0091] Optionally, the system comprises an energy generator configured to heat or ablate a target biological tissue).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-2, 4-15, 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mayer (US 20150105701 A1).
Regrading claim 1, Mayer teaches a reusable connector for use with a single-use RF device ([590] this configuration can also provide systems in which the therapeutic device is a single-use device, but the cable may be re-used. This can substantially reduce expense of materials when lengthy cabling is needed to connect the console to the operational head) ([0011] a reversible connector configured for operably linking the energy generator to the operational head) for delivering therapy to a patient ([0044] According to the present invention, at least one connector is provided for reversibly connecting a therapeutic device to a console), the connector comprising: a housing having a proximal end and an opposite distal end ([0490] The reversible connector provides housing for the energy operable linkage (e.g. electrically conductive members that transmit RF signals) that connects the energy generator to the energy delivery head), the proximal end being configured for connection to a control system for controlling delivery of energy to the single-use RF device ([0072] a. a processor, e.g. microprocessor configured for use as the RF generator controller or a microprocessor in communication with the RF generator controller), and the distal end being configured for connection to the single-use RF device ([0490] The reversible connector provides housing for the energy operable linkage (e.g. electrically conductive members that transmit RF signals) that connects the energy generator to the energy delivery head); a first slot configured for receiving a first removable memory ([0200] Optionally, the memory device is removable connected to the therapeutic device. Optionally, the memory device comprises a personal computer type connector (e.g. USB, firewire, or serial connection)), the first removable memory being configured for authentication of a treatment plan to be performed by the single-use RF device ([0223] the memory device can comprise…updates of keys (symmetric or asymmetric) which when authenticated by another operator action (such as entering a code) allow the console to be used for a specific number of treatments, updates of the number of uses which the console may perform before requiring a further authorization, or scripts or instructions to copy diagnostic or historical data from the console to the memory device); and a second slot configured for receiving a second removable memory ([0359] Optionally, the first memory device comprises the control instructions for controlling the secondary device. Additionally or alternatively, the secondary device optionally comprises a second memory device comprising control instructions for controlling the secondary device, optionally wherein the second memory device is reversibly linked to the first controller) (Optionally, the secondary device is reversibly linked to the first console (e.g. the irrigation device depicted in FIG. 8). Optionally, the secondary device comprises a second memory device that is reversibly linked to the first console (e.g. the second memory device depicted in FIG. 8 or FIG. 9, noting that the second memory device in FIG. 9 is indirectly linked to the first console through the second console)), the second removable memory being configured for modification of the treatment plan ([0216] the control instructions optionally comprise parameters that are input into executable instructions (e.g. general algorithms that reference the parameters) stored on the therapeutic device memory, an optional console memory device, or an optional secondary device memory)) ([0217] Optionally, the control instructions comprise one or more parameters. Optionally, the parameters comprise one or more of output parameters (e.g. energy output parameters and/or UI output parameters), input parameters (e.g. monitored parameters), calibration parameters, verification parameters, and capability parameters); wherein the first slot has a first shape and the second slot has a second shape different from the first shape ([0200] Optionally, the memory device is removable connected to the therapeutic device. Optionally, the memory device comprises a personal computer type connector (e.g. USB, firewire, or serial connection)).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to include a second slot configured for receiving a second removable memory on the connector in addition to the first slot, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70.
Further, it would have been an obvious matter of design choice to make the different portions of the first slot with a first shape and the second slot with a second shape of whatever form or shape was desired or expedient. A change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47.
Regrading claim 2, Mayer teaches the connector of claim 1, wherein the treatment plan includes delivering energy to one or more electrodes of the single-use RF device ([0047] Optionally, the connector comprises an operable linkage (e.g. electrical terminals for conducting RF output) connecting the energy generator to one or more electrodes of the operational head of the therapeutic device).
Regrading claim 4, Mayer teaches the connector of claim 2, wherein delivering energy to one or more electrodes of the single-use RF device includes delivering energy to the one or more electrodes to ablate tissue ([0091] Optionally, the system comprises an energy generator configured to heat or ablate a target biological tissue).
Regrading claim 5, Mayer teaches the connector of claim 1, wherein the first slot has a first shape ([0200] Optionally, the memory device is removable connected to the therapeutic device. Optionally, the memory device comprises a personal computer type connector (e.g. USB, firewire, or serial connection)).
It would have been an obvious matter of design choice to make the different portions of the first slot with a first shape of whatever form or shape was desired or expedient. A change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47.
Regrading claim 6, Mayer teaches the connector of claim 5, wherein the second slot has a second shape different from the first shape ([0359] Optionally, the first memory device comprises the control instructions for controlling the secondary device. Additionally or alternatively, the secondary device optionally comprises a second memory device comprising control instructions for controlling the secondary device, optionally wherein the second memory device is reversibly linked to the first controller) (Optionally, the secondary device is reversibly linked to the first console (e.g. the irrigation device depicted in FIG. 8). Optionally, the secondary device comprises a second memory device that is reversibly linked to the first console (e.g. the second memory device depicted in FIG. 8 or FIG. 9, noting that the second memory device in FIG. 9 is indirectly linked to the first console through the second console))
It would have been an obvious matter of design choice to make the different portions of the second slot with a second shape different from the first shape of whatever form or shape was desired or expedient. A change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47.
Regrading claim 7, Mayer teaches the connector of claim 1, wherein the first removable memory and the second removable memory include eeprom, flash, SD, MMC, XD, or SDHC ([0196] Optionally, the memory device comprises EEPROM).
Regrading claim 8, Mayer teaches the connector of claim 1, wherein the modification of the treatment plan includes changing a sequence of RF energy delivery ([0264] Optionally, the algorithm can provide a step of controlling the console based on the parameter, e.g. by providing the step of controlling the console (e.g. reducing power of energy output) as a dependent variable of an independent variable defined by the parameter or value thereof (e.g. maximum temperature or impedance change). Additionally or alternatively, the parameter can define a trigger (e.g. a sensed conduction such as parameter value) that initiates a step of control (e.g. discontinuing energy output or outputting an alarm to a user output device)) ([0278] Optionally, the control instructions comprise one or more UI output parameters, e.g. stored on therapeutic device memory or secondary device memory. Optionally, the one or more UI output parameters comprise notification parameters and/or display parameters. Useful notification parameters include data displayed (e.g. screens, triggers, ranges of accepted values, or any parameter or value thereof sensed (e.g. monitored) or stored on a memory device) or alerts (e.g. warnings or alarms)).
Regrading claim 9, Mayer teaches the connector of claim 1, wherein the modification of the treatment plan includes receiving control signals from an additional control system ([0296] The values of parameters stored on the memory device can be used, e.g. as triggers or dependent variables in algorithms of the controller or can be used for comparison with sensed or monitored parameter values of a sensor as well as outputted parameters of energy out) ([0308] the control instructions comprise a predictive algorithm. Useful predictive algorithms include any a sequence of energy delivery events which are driven by the controller to produce a certain outcome (i.e. lesion size), based on an equation, computerized model, simulation which is calculated by the console and informed by the occurrence of or change in sensed or stored parameters) ([0309] Optionally, the control instructions comprise a control algorithm. Useful control algorithms include any sequence of adjustments in the energy delivered by the console made by the controller which are calculated to maintain a sensed parameter, or multiple sensed parameters, at a predefined level or vector, based on sensory inputs. Examples useful control algorithm structures include a control law or a feedback control system, as is known in the art).
Regrading claim 10, Mayer teaches the connector of claim 1, wherein the proximal end configured for connection to a control system includes a communication bus ([0048] Optionally, the connector comprises an operable linkage (e.g. communication bus) connecting the controller of the console to the memory device of a therapeutic device).
Regrading claim 11, Mayer teaches the connector of claim 1, wherein the proximal end configured for connection to a control system includes a terminal pin ([0046] Optionally, the connector comprises a plurality of terminals, e.g. a pin connector).
Regrading claim 12, Mayer teaches the connector of claim 1, wherein the proximal end configured for connection to a control system or the distal end configured for connection to the single-use RF device includes a male connector or a female connector ([0054] mechanical alignment and coupling (e.g. male/female couplers)).
Regrading claim 13, Mayer teaches the connector of claim 1, wherein the distal end configured for connection to the single-use RF device includes an over the wire connector ([0199] the connector comprises communication wires for connecting the memory device to the controller. Optionally, the connector comprises powered wires for powering the memory device) ([0015] Optionally, the reversible connector comprises the reversible memory operable linkage, e.g. a wired communications linkage. Alternatively, the reversible memory operable linkage comprises a wireless communications linkage (e.g. electromagnetic or optical)).
Regrading claim 14, Mayer teaches the connector of claim 1, further comprising one or more leads extending from the proximal end of the housing to the distal end of the housing ([0283] Useful calibration parameters for energy delivery include…impedance between channels or wiring leads).
Regrading claim 15, Mayer teaches the system for applying energy to a patient, the system comprising: a single-use RF device ([590] this configuration can also provide systems in which the therapeutic device is a single-use device, but the cable may be re-used. This can substantially reduce expense of materials when lengthy cabling is needed to connect the console to the operational head) having one or more electrodes ([0047] Optionally, the connector comprises an operable linkage (e.g. electrical terminals for conducting RF output) connecting the energy generator to one or more electrodes of the operational head of the therapeutic device); and a reusable connector ([0011] a reversible connector configured for operably linking the energy generator to the operational head), the connector comprising: a housing having a proximal end and an opposite distal end ([0490] The reversible connector provides housing for the energy operable linkage (e.g. electrically conductive members that transmit RF signals) that connects the energy generator to the energy delivery head), the proximal end being configured for connection to a control system for controlling delivery of energy to the single-use RF device, and the distal end being configured for connection to the single-use RF device ([0072] a. a processor, e.g. microprocessor configured for use as the RF generator controller or a microprocessor in communication with the RF generator controller) ([0490] The reversible connector provides housing for the energy operable linkage (e.g. electrically conductive members that transmit RF signals) that connects the energy generator to the energy delivery head); a first slot configured for receiving a first removable memory ([0200] Optionally, the memory device is removable connected to the therapeutic device. Optionally, the memory device comprises a personal computer type connector (e.g. USB, firewire, or serial connection)), the first removable memory being configured for authentication of a treatment plan to be performed by the single-use RF device ([0223] the memory device can comprise…updates of keys (symmetric or asymmetric) which when authenticated by another operator action (such as entering a code) allow the console to be used for a specific number of treatments, updates of the number of uses which the console may perform before requiring a further authorization, or scripts or instructions to copy diagnostic or historical data from the console to the memory device); and a second slot configured for receiving a second removable memory ([0359] Optionally, the first memory device comprises the control instructions for controlling the secondary device. Additionally or alternatively, the secondary device optionally comprises a second memory device comprising control instructions for controlling the secondary device, optionally wherein the second memory device is reversibly linked to the first controller) (Optionally, the secondary device is reversibly linked to the first console (e.g. the irrigation device depicted in FIG. 8). Optionally, the secondary device comprises a second memory device that is reversibly linked to the first console (e.g. the second memory device depicted in FIG. 8 or FIG. 9, noting that the second memory device in FIG. 9 is indirectly linked to the first console through the second console)), the second removable memory being configured for modification of the treatment plan ([0216] the control instructions optionally comprise parameters that are input into executable instructions (e.g. general algorithms that reference the parameters) stored on the therapeutic device memory, an optional console memory device, or an optional secondary device memory)) ([0217] Optionally, the control instructions comprise one or more parameters. Optionally, the parameters comprise one or more of output parameters (e.g. energy output parameters and/or UI output parameters), input parameters (e.g. monitored parameters), calibration parameters, verification parameters, and capability parameters) ([0264] Optionally, the algorithm can provide a step of controlling the console based on the parameter, e.g. by providing the step of controlling the console (e.g. reducing power of energy output) as a dependent variable of an independent variable defined by the parameter or value thereof (e.g. maximum temperature or impedance change)).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to include a second slot configured for receiving a second removable memory on the connector in addition to the first slot, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70.
Regrading claim 17, Mayer teaches the system of claim 15, wherein the treatment plan includes delivering energy to the one or more electrodes to ablate tissue ([0091] Optionally, the system comprises an energy generator configured to heat or ablate a target biological tissue).
Claim(s) 3, 16, and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mayer (US 20150105701 A1) in view of Highsmith (US 20210401483 A1).
Regrading claim 3, Mayer teaches the connector of claim 2, wherein delivering energy to one or more electrodes of the single-use RF device includes delivering energy to a distal tip electrode in order to perforate tissue ([0047] Optionally, the connector comprises an operable linkage (e.g. electrical terminals for conducting RF output) connecting the energy generator to one or more electrodes of the operational head of the therapeutic device), but fails to teach during a transseptal crossing procedure.
However, Highsmith teaches during a transseptal crossing procedure ([0011] The RF ablation system can further include a transseptal needle having an ablation electrode in electrical communication with the electrical ablation output terminal). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Mayer to include during a transseptal crossing procedure. Doing so allows for ablating the tissue for a specific operation.
Regrading claim 16, Mayer teaches the wherein the treatment plan includes delivering energy to a distal tip electrode of the single-use RF device in order to perforate tissue ([0047] Optionally, the connector comprises an operable linkage (e.g. electrical terminals for conducting RF output) connecting the energy generator to one or more electrodes of the operational head of the therapeutic device), but fails to teach during a transseptal crossing procedure.
However, Highsmith teaches during a transseptal crossing procedure ([0011] The RF ablation system can further include a transseptal needle having an ablation electrode in electrical communication with the electrical ablation output terminal). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Mayer to include during a transseptal crossing procedure. Doing so allows for ablating the tissue for a specific operation.
Regrading claim 19, Mayer teaches the method of claim 18, wherein delivering energy to the patient using the one or more electrodes includes delivering energy to a distal tip electrode ([0179] For example the operational head can be an irrigated catheter (e.g. open loop or closed loop) comprising an energy delivery (e.g. RF) electrode on the outer tip of the catheter and optionally one or more sensors in or on the catheter tip), but fails to teach in order to perforate tissue during a transseptal crossing procedure.
However, Highsmith teaches during a transseptal crossing procedure ([0011] The RF ablation system can further include a transseptal needle having an ablation electrode in electrical communication with the electrical ablation output terminal). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Mayer to include during a transseptal crossing procedure. Doing so allows for ablating the tissue for a specific operation.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ASHLEIGH LAUREN KERN whose telephone number is (703)756-4577. The examiner can normally be reached 7:30 am - 4:30 pm.
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/ASHLEIGH LAUREN KERN/Examiner, Art Unit 3794
/ADAM Z MINCHELLA/Primary Examiner, Art Unit 3794
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