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 .
A complete action on the merits of pending claims 1-20 appears herein.
Claim Objections
Claim 17 objected to because of the following informalities:
Regarding claim 17, the phrase “a heating controller for steam ablation apparatus” should read -- a heating controller for a steam ablation apparatus--
Appropriate correction is required.
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 2-15 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.
Regarding claims 2, 3, 5, and 13, the claims recite the limitation “the specified anti-dry burning water level and/or minimum normal water level” renders the claim unclear as to if both the specified anti-dry burning water level and the minimum normal water level are required by the claims or if only one is required. For the purpose of examination, the limitation “the specified anti-dry burning water level and/or minimum normal water level” is interpreted as “the specified anti-dry burning water level or minimum normal water level” Claims 3-15 are rejected due to their respective dependencies on claims 2, 3, 5, and 13.
Claim 14 recites the limitation "the set heat-discharging pressure threshold" in the twelfth line of the claim. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, the limitation “the set heat-discharging pressure threshold” is interpreted as “a set heat-discharging pressure threshold.”
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.
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.
Claim(s) 1-4, and 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over Sharma (US 2017/0231677 A1) in view of Barry (US 2008/0110457 A1).
Regarding claim 1, Sharma teaches
a steam ablation apparatus (Fig. 12) comprises a steam generator (Fig. 12, Char. 1242, 1243, and 124) and a heating device, (Fig. 12, Char. 1264: RF heater) and the heating device is capable of being controlled by the control device (Fig. 12, Char. 1224: controller; Par. [0161]: controller (1224) controls RF heater (1264)) and heat the steam generator when the heating device is controlled to be turned on; (Par. [0159])
the heating control method comprises steps of:
monitoring a current pressure and a current temperature in the generator; (Par. [0159]) and
controlling the heating device according to the current pressure and the current temperature in the generator. (Par. [0159])
Sharma, as applied to claim 1 above, is silent regarding monitoring a current water level in the steam generator and controlling a heating device according to the current water level.
Barry, in a similar field of endeavor, teaches monitoring a current water level in a steam generator and controlling a heating device according to the current water level. (Par. [0031]: A controller interrupts operation of a vapor generator (300) if a sensed water level falls below a threshold.)
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Sharma, as applied to claim 1 above, to incorporate the teachings of Barry, and configure the controller (1224) of Sharma to sense the current water level in the pressure vessel (1242) and vapor generation if said water level falls below a minimum threshold. Doing so would ensure pressure vessel (1242) always has enough fluid for safe vapor generation, minimizing the risk of damage to the system caused by operation of the heater (1264) in absence of water.
Regarding claim 2, the combination of Sharma/Barry, as applied to claim 1 above, teaches the step of controlling the heating device according to the current water level, the current pressure and the current temperature in the generator comprises:
controlling the heating device to be turned on or off according to the current water level, and a specified anti-dry-burning water level (When the pressure vessel (1242) is empty of liquid water) and / or minimum normal water level; (Barry: Par. [0031]: The lower fluid level threshold sensed by the lower water level sensor of Barry – it is implicit that this feature be present in the Sharma/Barry combination based on the rejection to claim 1 above.) and
controlling a heating power of the heating device according to the current pressure and the current temperature in the generator after the heating device is turned on. (Sharma: Par. [0159])
Regarding claim 3, the combination of Sharma/Barry, as applied to claim 2 above, teaches the step of controlling the heating device to be turned on or off according to the current water level, and the specified anti-dry-burning water level and / or minimum normal water level comprises:
turning on the heating device if the current water level is higher than or equal to the specified minimum normal water level; (Barry: Par. [0031]: The operation of the vapor generator (300) would resume once the water level rises above the minimum threshold – it is implicit that this feature be present in the Sharma/Barry combination based on the rejection to claim 1 above.) and
turning off the heating device if the current water level is lower than the minimum normal water level and higher than or equal to the anti-dry-burning water level. (Barry: Par. [0031]: The operation of the vapor generator (300) would be paused for any water level below the minimum threshold, including when the water level is between being empty and the minimum threshold – it is implicit that this feature be present in the Sharma/Barry combination based on the rejection to claim 1 above.)
Regarding claim 4, the combination of Sharma/Barry, as applied to claim 2 above, teaches the step of controlling the heating power of the heating device according to the current pressure and the current temperature in the generator comprises:
controlling the turned-on heating device to heat with a target power when the current pressure or the current temperature in the generator falls within a set first range; (Sharma: Par. [0159]: Rf heater (1264) heats the vessel (1242) until the temperature and pressure reach respective threshold values) the target power matching a heating power when all heaters of the heating device are turned on; (Whatever power level the RF heater (1264) is operating at while heating vessel (1242) would be considered a “target power” at least in that said power would be set by the controller) and
adjusting the heating power of the heating device according to the current temperature in the generator, the current pressure and set target parameters when the current pressure or the current temperature in the generator falls within a second range, wherein values in the second range are greater than the first range, the target parameters comprise a target temperature and a target pressure, and the target temperature or the target pressure falls within the second range. (Sharma: Par. [0159]: Once the temperature of the liquid (1244) reaches a predetermined temperature, the thermal switch (1246) shuts off RF heater (1264))
The combination of Sharma/Barry, as applied to claim 2 above, is silent regarding the RF heater of Sharma comprising a plurality of heaters.
However, absent a statement of criticality AND unexpected results, it would have been obvious to one having ordinary skill in the art at the time the invention was made to use a plurality of heaters instead of a single heater, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8.
Regarding claim 16, the combination of Sharma/Barry, as applied to claim 1 above, teaches the steam ablation apparatus has a plurality of operating states, and the plurality of operating states comprise filling state, (The reservoir of Sharma would need to be filled or refilled with fluid) preheating state, (Sharma: Par. [0159]: RF heater heats vessel (1242) in turn heating the liquid (1244)) standby state, (Sharma: Par. [0159]: The liquid begins to evaporate, causing an increase in pressure inside vessel (1242)) ablation preparation state (Sharma: once the temperature of the liquid (1244) reaches a predetermined temperature, the thermal switch (1246) shuts off RF heater (1264)) and shutdown operation state; (Sharma: The device would have a shut off switch/mechanism for turning off the device when desired by a user.) the steam ablation apparatus is capable of entering the filling state, the preheating state, the standby state and the ablation preparation state sequentially. (The steam ablation device of Sharma is capable of entering the states discussed above sequentially by turning the device off after the temperature of the liquid (1244) reaches the predetermined temperature.)
Regarding claim 17, the combination of Sharma/Barry, as applied to claim 1 above, teaches a heating controller (The sensors of Sharma and Barry in the Sharma/Barry combination, as applied to claim 1 above, configured to measure temperature, pressure, and water level and the controller (1224) of Sharma) for steam ablation apparatus, (Fig. 12) applied to a control device of the steam ablation apparatus, (Sharma: Par. [0108]: the memory storing the control instructions executed by the controller) wherein the steam ablation apparatus comprises a steam generator (Fig. 12, Char. 1242, 1243, and 124) and a heating device, (Fig. 12, Char. 1264: RF heater) and the heating device is configured to be controlled by the control device and heat the steam generator when the heating device is controlled to be turned on; (Sharma: Par. [0108] and [0159])
the heating controller comprises:
a monitoring module, configured to monitor a current water level in the steam generator, a current pressure and a current temperature in the generator; (The sensors of Sharma and Barry in the Sharma/Barry combination, as applied to claim 1 above, configured to measure temperature, pressure, and water level) and
a heating control module, configured to control the heating device according to the current water level, the current pressure and the current temperature in the generator. (Sharma: Fig. 12, Char. 1224: controller; Par. [0108] and [0159])
Regarding claim 18, the combination of Sharma/Barry, as applied to claim 1 above, teaches a steam generator, (Sharma: Fig. 12) a heating device (Sharma: Fig. 12, Char. 1264) and a control device, (Sharma: Fig. 12, Char. 1224: controller) the heating device is configured to be controlled by the control device and heat the steam generator when the heating device is controlled to be turned on, (Sharma: Par. [0108] and [0159]) and the control device is configured to execute the heating control method of claim 1. (Sharma: Par. [0108])
Regarding claim 19, the combination of Sharma/Barry, as applied to claim 1 above, teaches a processor and a memory, wherein the memory is configured to store codes; and the processor is configured to execute the codes in the memory to implement the heating control method of claim 1. (Sharma: Par. [0108]; The control instructions would be saved on some medium accessible to the microprocessor/controller)
Regarding claim 20, the combination of Sharma/Barry, as applied to claim 1 above, teaches a computer program is stored, and when the program is executed by a processor, the heating control method of claim 1 is implemented. (Sharma: Par. [0108]; The control instructions would be saved on some medium accessible to the microprocessor/controller)
Claim(s) 5-9, 11, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Sharma (US 2017/0231677 A1) in view of Barry (US 2008/0110457 A1), as applied to claim 3 above, and further in view of Chee (US 2015/0335380 A1).
Regarding claim 5, the combination of Sharma/Barry, as applied to claim 3 above, is silent regarding before the step of controlling the heating device to be turned on or off according to the current water level, and the specified anti-dry-burning water level and / or minimum normal water level, the method further comprises:
determining that the steam ablation apparatus enters a target operating state being any one of a preheating state, a standby state, and an ablation preparation state.
Chee, in a similar field of endeavor, teaches performing a pre-procedural sterilization of a vapor generator and connected ablation device. (Claim 1)
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combination of Sharma/Barry, as applied to claim 3 above, to incorporate the teachings of Chee, and configure the controller (1224) of Sharma to perform a pre-procedural sterilization of at least the pressure vessel (1242). Doing so would minimize the risk of any bacteria or unsanitary vapor from coming into contact with a patient’s tissue.
In this combination, the pre-procedural sterilization state could be considered a a standby state, or an ablation preparation state
Regarding claim 6, the combination of Sharma/Barry, as applied to claim 5 above, teaches monitoring a current steam temperature of the steam generator; (Sharma: Par. [0159])
before the step of determining that the steam ablation apparatus enters the target operating state, the method further comprises:
determining that the steam ablation apparatus has met requirements for the target operating state according to at least one of the current water level, the current steam temperature and the current pressure, and a current operating state of the steam ablation apparatus. (Barry: Par. [0031]: – it is implicit that this feature be present in the Sharma/Barry combination based on the rejection to claim 1 above.)
Regarding claims 7, the combination of Sharma/Barry/Chee, as applied to claim 6 above, teaches if the target operating state is the preheating state: the step of determining that the steam ablation apparatus has met requirements for the target operating state according to at least one of the current water level, the current steam temperature and the current pressure, and the current operating state of the steam ablation apparatus comprises:
detecting that the current water level of the steam generator meets requirements for preheating when the steam ablation apparatus is in a filling state. (Barry: Par. [0031]: Operation of the vapor generating heaters would be paused/halted until the water level reaches a minimum threshold – it is implicit that this feature be present in the Sharma/Barry combination based on the rejection to claim 1 above.)
Regarding claims 8, the combination of Sharma/Barry/Chee, as applied to claim 7 above, teaches the step of detecting that the current water level of the steam generator meets requirements for preheating comprises:
detecting that the current water level is higher than the specified minimum normal water level. (Barry: Par. [0031]: Operation of the vapor generating heaters would be paused/halted until the water level reaches a minimum threshold – it is implicit that this feature be present in the Sharma/Barry combination based on the rejection to claim 1 above.)
Regarding claims 9, the combination of Sharma/Barry/Chee, as applied to claim 6 above, teaches if the target operating state is the standby state: the step of determining that the steam ablation apparatus has met requirements for the target operating state according to at least one of the current water level, the current steam temperature and the current pressure, and the current operating state of the steam ablation apparatus comprises:
detecting that the current water level and the current steam temperature of the steam generator meet requirements for standby when the steam ablation apparatus is in the preheating state. (Chee: Par. [0019]: During a pre-ablation sterilization, vapor is created/used to sterilize an ablation device/generator – it is implicit that this feature be present in the Sharma/Barry/Chee combination based on the rejection to claim 5 above; Sharma: Par. [0159]; Barry: Par. [0031]: The water level is sensed during any vapor generation – it is implicit that this feature be present in the Sharma/Barry/Chee combination based on the rejection to claim 1 above.)
Regarding claim 11, the combination of Sharma/Barry/Chee, as applied to claim 6 above, teaches wherein if the target operating state is the ablation preparation state: the step of determining that the steam ablation apparatus has met requirements for the target operating state according to at least one of the current water level, the current steam temperature and the current pressure, and the current operating state of the steam ablation apparatus comprises:
detecting that the current water level of the steam generator meets requirements for steam ablation and the steam ablation apparatus has been disinfected when the steam ablation apparatus is in the standby state. (Chee: Par. [0019]: During a pre-ablation sterilization, vapor is created/used to sterilize an ablation device/generator – it is implicit that this feature be present in the Sharma/Barry/Chee combination based on the rejection to claim 5 above; Sharma: Par. [0159]; Barry: Par. [0031]: The water level is sensed during any vapor generation – it is implicit that this feature be present in the Sharma/Barry/Chee combination based on the rejection to claim 1 above.)
Regarding claim 12, the combination of Sharma/Barry/Chee, as applied to claim 11 above, teaches the step of detecting that the current water level of the steam generator meets requirements for steam ablation comprises:
detecting that the current water level is higher than or equal to a specified maximum normal water level. (Barry: Par. [0031]: The water level is sensed during any vapor generation via a number of sensors; a plurality of sensors would suggest a “maximum” normal water level at least at the location of the top most water level sensor – it is implicit that this feature be present in the Sharma/Barry/Chee combination based on the rejection to claim 1 above.)
Allowable Subject Matter
As allowable subject matter has been indicated, applicant's reply must either comply with all formal requirements or specifically traverse each requirement not complied with. See 37 CFR 1.111(b) and MPEP § 707.07(a).
Claim 10, and 13-15 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 10, the prior art of record fails to explicitly teach all of the claim limitations of claim 9 and further teach the limitation “wherein, the step of detecting that the current water level and the current steam temperature of the steam generator meet requirements for standby comprises: detecting that the current water level is higher than or equal to a specified maximum normal water level, and the current steam temperature is higher than a set disinfection temperature threshold.”
Regarding claim 13, the prior art of record fails to explicitly teach all of the claim limitations of claim 2 and further teach the limitation “the step of controlling the heating device to be turned on or off according to the current water level, and the specified anti-dry-burning water level and / or minimum normal water level comprises: turning on the heating device when the current water level is higher than or equal to the anti-dry- burning water level and the current temperature in the generator is higher than a set heat- discharging temperature threshold.”
Claim 15 would be allowable due to its dependency on claim 13.
Regarding claim 14, the prior art of record fails to explicitly teach all of the claim limitations of claim 2 and further teach the limitation “wherein the heating device comprises a plurality of heaters; the step of controlling the heating power of the heating device according to the current pressure and the current temperature in the generator comprises: controlling the turned-on heating device to heat with a target power matching a heating power when all heaters of the heating device are turned on; controlling the heating device to keep heating with the target power when the current pressure is lower than a set heat-discharging pressure threshold and the current pressure or the current temperature in the generator falls within a set first range; and adjusting the heating power of the heating device according to the current temperature in the generator, the current pressure and set target parameters when the current pressure is lower than the set heat-discharging pressure threshold and the current pressure or the current temperature in the generator falls within a set second range; values in the second range are greater than the first range, and a target temperature in the generator or a target pressure falls within the second range.”
Conclusion
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/LINDA C DVORAK/Primary Examiner, Art Unit 3794
/N.S.B./Examiner, Art Unit 3794