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 .
Response to Amendment
Acknowledgment is made to the amendment received 3/18/2026.
Applicant’s amendments to the specification are not sufficient to overcome the specification objections set forth in the previous office action.
Applicant’s amendments to the claims are sufficient to overcome the 35 USC § 101 rejections set forth in the previous office action.
Response to Arguments
Applicant’s arguments with respect to claims 1, 4, and 9 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Previously, claims 1 and 9 were rejected under 35 U.S.C. 103 as being unpatentable over Xu in view of Ma. Now, based on amendments to the claim language, claims 1 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Xu in view of Woloszko and claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Xu in view of Woloszko and Yates.
Specification
The disclosure is objected to because of the following informalities: Paragraph [0007], line 1: “determining” should read –Determining--.
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitations use a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitations are: acquisition module in claims 1 and 9, detection module in claims 1 and 9, and comparison module in claims 1 and 9.
Because these claim limitations are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, they are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
Regarding claims 1 and 9, claim limitations “acquisition module” in claims 1 and 9, “detection module” in claims 1 and 9, and “comparison module” in claims 1 and 9” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The disclose is devoid of any structure that performs the function in the claim for all of these claim limitations. Therefore, claims 1 and 9 are indefinite and are rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Regarding dependent claims 2-8 and 10, dependent claims inherit the deficiencies from the claims from which they depend and are similarly rejected over 35 U.S.C. 112(b).
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-3, 7, and 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Xu et al., CN 110074856, herein referred to as “Xu” (citations below are to the attached translated document), in view of Woloszko et al., US 20170143401, herein referred to as “Woloszko”.
Regarding claim 1, Xu discloses a method for dynamically adjusting a radio frequency parameter (Figures 21-22), applied to a radio frequency host (Figure 23), wherein the radio frequency host comprises a radio frequency generation apparatus (Figure 23: radio frequency signal generator 100), an acquisition module (Page 18, lines 11-12 and Figure 20: input device), a detection module (Figure 23: sensor module 120), a comparison module (Figure 23: control module and Figure 20: operating system and computer program), and a processor (Figure 23: control module and Figure 20: processor), the radio frequency host is connected to a syringe pump (Figure 23: microperfusion pump 130), the radio frequency host and the syringe pump are connected to an operation object (Figure 23: ablation catheter 110), the radio frequency host is configured to send radio frequency energy to the operation object through the radio frequency generation apparatus (Page 23: “In the present embodiment, the radio frequency signal generator 100 is connected to the control module 140 for receiving a command of the control module 140 to generate a radio frequency signal and transmitting the radio frequency signal to the ablation catheter 110”) and is configured to control the syringe pump to inject a cooling liquid to the operation object (Page 19, lines 33-38), and the method comprises steps of: determining an operation stage of a radio frequency operation (Figure 21) and acquiring a radio frequency data standard range (Page 20, lines 35-37: “In one embodiment, step S500 further includes pre-calibrating a steady-state impedance, and calculating a threshold according to the steady-state impedance, wherein the threshold is used for comparing with the impedance information in step S510 to generate a corresponding control instruction.”) and a radio frequency data limit range (Page 21, lines 45-48: “For another example, when the temperature is too high, it may be that the output of the heat exchange medium is abnormal, and the control module may output the prompt instruction for giving an alarm. In one of the embodiments, the distance electrode of the collection point of the temperature information is 0.5-3 cm; and after the temperature information reaches 43-60°C and the preset time is maintained, a stop ablation instruction is sent.”) corresponding to an operation object of the radio frequency operation at the operation stage by the acquisition module (Figure 19A: step s120 wherein the preset relationship corresponds to an operation object); detecting radio frequency data of the operation object in real time by the detection module (Figure 21: step s500 and Figure 22), and comparing the radio frequency data of the operation object with the radio frequency data standard range and the radio frequency data limit range by the comparison module (Page 20, lines 42-43: “step S511, comparing the impedance information with a threshold, and determining an increase or decrease of the flow according to a relationship between the impedance information and a threshold;” and Page 21, lines 42-43: “In this embodiment, the temperature information collected from the peripheral part of the electrode is received in real time in the ablation process, and the ablation process is prompted or controlled according to the temperature information.”); controlling the radio frequency data to be within the radio frequency data standard range by controlling an injection volume of a syringe pump to the operation object by the processor (Figure 21: step s510 and Figure 22) when the radio frequency data detected by the detection module in real time exceeds the radio frequency data standard range but does not exceed the radio frequency data limit range and lasts for a preset duration (Page 20, lines 53-56: “The increase or decrease may be either a fixed value or a dynamic value, for example related to the current impedance information, or the difference between the set impedance information and the threshold is Z, while the increase or decrease is a dynamic value and is related to Z. For example, the closer the current impedance information to the threshold, the smaller the increase or decrease, so that the control is finer and the hysteresis of the feedback is reduced as much as possible.” And Page 21, lines 34-36: “The end of the ablation process may be based on a preset time, or may be based on the temperature of the electrode or the lesion site, and in one of the embodiments, the ablation process may also be prompted or controlled by using the radio frequency ablation method, the control method, or the impedance monitoring method in the foregoing embodiments.”); and stopping outputting radio frequency energy from the radio frequency generation apparatus by the processor when the radio frequency data detected by the detection module in real time exceeds the radio frequency data limit range (Page 21, lines 34-36: “The end of the ablation process may be based on a preset time, or may be based on the temperature of the electrode or the lesion site, and in one of the embodiments, the ablation process may also be prompted or controlled by using the radio frequency ablation method, the control method, or the impedance monitoring method in the foregoing embodiments.” And Page 21, lines 45-48: “For another example, when the temperature is too high, it may be that the output of the heat exchange medium is abnormal, and the control module may output the prompt instruction for giving an alarm. In one of the embodiments, the distance electrode of the collection point of the temperature information is 0.5-3 cm; and after the temperature information reaches 43-60°C and the preset time is maintained, a stop ablation instruction is sent.”). Xu does not explicitly disclose a method wherein the radio frequency data standard range has a maximum value and a minimum value, the radio frequency data limit range has a maximum value and a minimum value, and the radio frequency data standard range is within the radio frequency data limit range with the maximum value being less than the maximum value, and the minimum value being greater than the minimum value of the radio frequency data limit range; and wherein the method comprises comparing the radio frequency data of the operation object with the maximum value and the minimum value of the radio frequency data standard range and the maximum value and the minimum value of the radio frequency data limit range by the comparison module.
However, Woloszko teaches a method (Figure 9) wherein the radio frequency data standard range has a maximum value and a minimum value (Figures 8A and 9: T1 and TL), the radio frequency data limit range has a maximum value and a minimum value (Figures 8A and 9: T2 and <TL, as seen in Figures 8A-B: the RF does not turn back on until the temperature is below TL, this is a different value and is the minimum value of the data limit range), and the radio frequency data standard range is within the radio frequency data limit range with the maximum value being less than the maximum value (Figure 8A: T1 is less than T2), and the minimum value being greater than the minimum value of the radio frequency data limit range (Figure 8A: TL is greater than the temperature at which the RF turns back on); and wherein the method comprises comparing the radio frequency data of the operation object with the maximum value and the minimum value of the radio frequency data standard range and the maximum value and the minimum value of the radio frequency data limit range by the comparison module (Figure 9)).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the method of Xu so that the radio frequency data standard range has a maximum value and a minimum value, the radio frequency data limit range has a maximum value and a minimum value, and the radio frequency data standard range is within the radio frequency data limit range with the maximum value being less than the maximum value, and the minimum value being greater than the minimum value of the radio frequency data limit range; and wherein the method comprises comparing the radio frequency data of the operation object with the maximum value and the minimum value of the radio frequency data standard range and the maximum value and the minimum value of the radio frequency data limit range by the comparison module as taught by Woloszko to sense, limit and actively reduce the temperature of the fluid being drawn through the device and thereby the temperature of the tubing to prevent patient or surgeon burns (Woloszko [0005]-[0006]).
Regarding claim 2, Xu in view of Woloszko discloses the method according to claim 1, and Xu further discloses a method wherein the radio frequency data of the operation object comprises an impedance value of the operation object (Page 20, lines 35-37: “In one embodiment, step S500 further includes pre-calibrating a steady-state impedance, and calculating a threshold according to the steady-state impedance, wherein the threshold is used for comparing with the impedance information in step S510 to generate a corresponding control instruction.”), and the step of acquiring the radio frequency data standard range corresponding to the operation object of the radio frequency operation at the operation stage comprises: acquiring a standard value range of the impedance value of the operation object and a standard change slope of the impedance value of the operation object at the operation stage (Page 20, lines 50-56: “For example, when the current flow rate is X ml/s, the flow rate is further increased, the control instruction is sent to the heat exchange medium conveying device, the flow rate becomes X + Y ml/s, and Y can be regarded as an increase, and the same reasoning needs to be further reduced. The increase or decrease may be either a fixed value or a dynamic value, for example related to the current impedance information, or the difference between the set impedance information and the threshold is Z, while the increase or decrease is a dynamic value and is related to Z. For example, the closer the current impedance information to the threshold, the smaller the increase or decrease, so that the control is finer and the hysteresis of the feedback is reduced as much as possible.”). Woloszko teaches a method wherein the step of acquiring the radio frequency data limit range ([0059]: “The non-volatile memory 308 may also store parameters associated with temperature threshold values indicative of temperature, which parameters are discussed in greater detail below.”) comprises: acquiring a limit value range of the value of the operation object ([0069]). In combination with Xu, the radio frequency data limit range of Woloszko would also increase a limit change slope of the impedance value of the operation object at the operation stage, just as the radio frequency data standard range of Xu includes a limit change slope of the impedance value.
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the method of Xu so that acquiring the radio frequency data standard range comprises acquiring a limit value range of the value of the operation object as taught by Woloszko to sense, limit and actively reduce the temperature of the fluid being drawn through the device and thereby the temperature of the tubing to prevent patient or surgeon burns (Woloszko [0005]-[0006]).
Regarding claim 3, Xu in view of Woloszko discloses the method according to claim 2, and Xu further discloses a method comprising, before the step of determining the operation stage of the radio frequency operation, steps of: displaying an input interface of a minimum value, a maximum value and a change rate of the impedance value in response to a setting operation of a user (Figure 20: display screen and input device), and acquiring a first minimum value, a first maximum value, a first change rate (Page 20, lines 53-56: “The increase or decrease may be either a fixed value or a dynamic value, for example related to the current impedance information, or the difference between the set impedance information and the threshold is Z, while the increase or decrease is a dynamic value and is related to Z. For example, the closer the current impedance information to the threshold, the smaller the increase or decrease, so that the control is finer and the hysteresis of the feedback is reduced as much as possible.”), a second minimum value, a second maximum value and a second change rate; and taking the first minimum value and the first maximum value as the minimum value and the maximum value of the standard value range respectively, and taking the first change rate input by the user as the standard slope; and taking the second minimum value and the second maximum value as the minimum value and the maximum value of the limit value range respectively, and taking the second change rate input by the user as the limit slope (Page 24, line 63 – Page 25, line 2: “In other embodiments, the control module 140 May comprehensively determine the ablation situation according to data transmitted by the plurality of sensors, and control devices such as the micro perfusion pump 130 and the radio frequency signal generator 100 to adjust when the preset condition is met, so as to ensure that the ablation process is smoothly performed, and the preset condition may be set by the user according to the actual situation of the lung radio frequency ablation system during operation and the configuration of the sensor.”).
Regarding claim 7, Xu in view of Woloszko discloses the method according to claim 1, and Xu further discloses a method further comprising, before the radio frequency operation is performed, steps of: detecting whether the impedance value of the operation object exceeds the maximum value of a preset initial value range (Page 21, lines 59-61); and controlling the syringe pump to inject liquid to the operation object to reduce the impedance value when the impedance value of the operation object exceeds the maximum value of the preset initial value range, until the impedance value meets the preset initial value range (Page 21, line 62 – Page 22, line 10).
Regarding claim 9, Xu discloses an apparatus for dynamically adjusting a radio frequency parameter (Figure 23), the apparatus being provided in a radio frequency host (Figure 23), the radio frequency host being connected to a syringe pump (Figure 23: microperfusion pump 130), the radio frequency host and the syringe pump being connected to an operation object (Figure 23: ablation catheter 110), the radio frequency host being configured to send radio frequency energy to the operation object (Page 23: “In the present embodiment, the radio frequency signal generator 100 is connected to the control module 140 for receiving a command of the control module 140 to generate a radio frequency signal and transmitting the radio frequency signal to the ablation catheter 110”) and being configured to control the syringe pump to inject a cooling liquid to the operation object (Page 19, lines 33-38), the apparatus comprising: an acquisition module (Figure 23: sensor module 23), configured to determine an operation stage of a radio frequency operation (Figure 21) and acquire a radio frequency data standard range (Page 20, lines 35-37: “In one embodiment, step S500 further includes pre-calibrating a steady-state impedance, and calculating a threshold according to the steady-state impedance, wherein the threshold is used for comparing with the impedance information in step S510 to generate a corresponding control instruction.”) and a radio frequency data limit range (Page 21, lines 45-48: “For another example, when the temperature is too high, it may be that the output of the heat exchange medium is abnormal, and the control module may output the prompt instruction for giving an alarm. In one of the embodiments, the distance electrode of the collection point of the temperature information is 0.5-3 cm; and after the temperature information reaches 43-60°C and the preset time is maintained, a stop ablation instruction is sent.”) corresponding to an operation object of the radio frequency operation at the operation stage (Page 21, lines 51-53: “the flow of the heat exchange medium may be controlled by using the impedance information to focus on the ablation process, and the temperature information may be used to prompt or control the ablation process to only intervene on the important process node”); a detection module (Figure 23: sensor module 120), configured to detect radio frequency data of the operation object in real time (Figure 21: step s500 and Figure 22); a comparison module (Figure 23: control module 140), configured to compare the detected radio frequency data with the radio frequency data standard range and the radio frequency data limit range (Page 20, lines 42-43: “step S511, comparing the impedance information with a threshold, and determining an increase or decrease of the flow according to a relationship between the impedance information and a threshold;” and Page 21, lines 42-43: “In this embodiment, the temperature information collected from the peripheral part of the electrode is received in real time in the ablation process, and the ablation process is prompted or controlled according to the temperature information.”); and a processor (Figure 23: control module 140), configured to control the radio frequency data to be within the radio frequency data standard range by controlling an injection volume of a syringe pump to the operation object (Figure 21: step s510 and Figure 22) when the radio frequency data detected by the detection module in real time exceeds the radio frequency data standard range but does not exceed the radio frequency data limit range and lasts for a preset duration (Page 20, lines 53-56: “The increase or decrease may be either a fixed value or a dynamic value, for example related to the current impedance information, or the difference between the set impedance information and the threshold is Z, while the increase or decrease is a dynamic value and is related to Z. For example, the closer the current impedance information to the threshold, the smaller the increase or decrease, so that the control is finer and the hysteresis of the feedback is reduced as much as possible.” And Page 21, lines 34-36: “The end of the ablation process may be based on a preset time, or may be based on the temperature of the electrode or the lesion site, and in one of the embodiments, the ablation process may also be prompted or controlled by using the radio frequency ablation method, the control method, or the impedance monitoring method in the foregoing embodiments.”), and stop outputting radio frequency energy from a radio frequency generation apparatus of the radio frequency host when the radio frequency data detected by the detection module in real time exceeds the radio frequency data limit range (Page 21, lines 34-36: “The end of the ablation process may be based on a preset time, or may be based on the temperature of the electrode or the lesion site, and in one of the embodiments, the ablation process may also be prompted or controlled by using the radio frequency ablation method, the control method, or the impedance monitoring method in the foregoing embodiments.” And Page 21, lines 45-48: “For another example, when the temperature is too high, it may be that the output of the heat exchange medium is abnormal, and the control module may output the prompt instruction for giving an alarm. In one of the embodiments, the distance electrode of the collection point of the temperature information is 0.5-3 cm; and after the temperature information reaches 43-60°C and the preset time is maintained, a stop ablation instruction is sent.”). Xu does not explicitly disclose an apparatus wherein the radio frequency data standard range has a maximum value and a minimum value, the radio frequency data limit range has a maximum value and a minimum value, and the radio frequency data standard range is within the radio frequency data limit range with the maximum value being less than the maximum value, and the minimum value being greater than the minimum value of the radio frequency data limit range; and comprising a comparison module, configured to compare the radio frequency data of the operation object with the maximum value and the minimum value of the radio frequency data standard range and the maximum value and the minimum value of the radio frequency data limit range.
However, Woloszko teaches an apparatus (Figure 9) wherein the radio frequency data standard range has a maximum value and a minimum value (Figures 8A and 9: T1 and TL), the radio frequency data limit range has a maximum value and a minimum value (Figures 8A and 9: T2 and <TL, as seen in Figures 8A-B: the RF does not turn back on until the temperature is below TL, this is a different value and is the minimum value of the data limit range), and the radio frequency data standard range is within the radio frequency data limit range with the maximum value being less than the maximum value (Figure 8A: T1 is less than T2), and the minimum value being greater than the minimum value of the radio frequency data limit range (Figure 8A: TL is greater than the temperature at which the RF turns back on); and comprising a comparison module, configured to compare the radio frequency data of the operation object with the maximum value and the minimum value of the radio frequency data standard range and the maximum value and the minimum value of the radio frequency data limit range (Figure 9)).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the apparatus of Xu so that the radio frequency data standard range has a maximum value and a minimum value, the radio frequency data limit range has a maximum value and a minimum value, and the radio frequency data standard range is within the radio frequency data limit range with the maximum value being less than the maximum value, and the minimum value being greater than the minimum value of the radio frequency data limit range; and comprising a comparison module, configured to compare the radio frequency data of the operation object with the maximum value and the minimum value of the radio frequency data standard range and the maximum value and the minimum value of the radio frequency data limit range as taught by Woloszko to sense, limit and actively reduce the temperature of the fluid being drawn through the device and thereby the temperature of the tubing to prevent patient or surgeon burns (Woloszko [0005]-[0006]).
Regarding claim 10, Xu in view of Woloszko teaches the method for dynamically adjusting the radio frequency parameter according to claim 1, and Xu further discloses a radio frequency host (Figure 23), comprising: a memory and a processor, wherein the memory stores an executable program code (Page 2, lines 62-64: “This application further provides a radio frequency ablation control apparatus, including a memory and a processor, where the memory stores a computer program, and the processor, when executing the computer program, implements the steps of the radio frequency ablation control method.”); and the processor coupled with the memory calls the executable program code stored in the memory to execute the method for dynamically adjusting the radio frequency parameter according to claim 1 (Page 2, lines 62-64: “This application further provides a radio frequency ablation control apparatus, including a memory and a processor, where the memory stores a computer program, and the processor, when executing the computer program, implements the steps of the radio frequency ablation control method.”).
Claims 4 is rejected under 35 U.S.C. 103 as being unpatentable over Xu in view of Woloszko, further in view of Yates et al., US 20170000542, herein referred to as “Yates”.
Regarding claim 4, Xu in view of Woloszko discloses the method according to claim 3, but does not explicitly disclose a method wherein the limit slope comprises a first limit slope for indicating a decrease rate of the impedance value, and a second limit slope for indicating an increase rate of the impedance value, and wherein the step of stopping outputting the radio frequency energy comprises: stopping outputting radio frequency energy to the operation object when the impedance value of the operation object detected in real time meets at least one of preset conditions comprising: the impedance value of the operation object detected in real time exceeds the limit value range, the decrease rate of the impedance value of the operation object detected in real time is greater than the first limit slope, and the increase rate of the impedance value of the operation object detected in real time is greater than the second limit slope.
However, Yates teaches a method wherein the limit slope comprises a first limit slope for indicating a decrease rate of the impedance value ([0218]: “The application of the energy modality may cease upon the tissue impedance matching a predetermined threshold value of tissue impedance or a predetermined threshold rate of change of tissue impedance.”), and a second limit slope for indicating an increase rate of the impedance value ([0218]: “The application of the energy modality may cease upon the tissue impedance matching a predetermined threshold value of tissue impedance or a predetermined threshold rate of change of tissue impedance.”; there is no requirement that limit slopes must be different), and wherein the step of stopping outputting the radio frequency energy comprises: stopping outputting radio frequency energy to the operation object when the impedance value of the operation object detected in real time meets at least one of preset conditions comprising: the impedance value of the operation object detected in real time exceeds the limit value range, the decrease rate of the impedance value of the operation object detected in real time is greater than the first limit slope, and the increase rate of the impedance value of the operation object detected in real time is greater than the second limit slope ([0218]: “The application of the energy modality may cease upon the tissue impedance matching a predetermined threshold value of tissue impedance or a predetermined threshold rate of change of tissue impedance.”).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the method of Xu so that the limit slope comprises a first limit slope for indicating a decrease rate of the impedance value, and a second limit slope for indicating an increase rate of the impedance value, and wherein the step of stopping outputting the radio frequency energy comprises: stopping outputting radio frequency energy to the operation object when the impedance value of the operation object detected in real time meets at least one of preset conditions comprising: the impedance value of the operation object detected in real time exceeds the limit value range, the decrease rate of the impedance value of the operation object detected in real time is greater than the first limit slope, and the increase rate of the impedance value of the operation object detected in real time is greater than the second limit slope as taught by Yates to determine if a tissue has been sealed (Yates [0219]).
Claims 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Xu in view of Woloszko and Yates, further in view of Hoey et al., US 6409722, herein referred to as “Hoey”.
Regarding claim 5, Xu in view of Woloszko and Yates discloses the method according to claim 4, and Woloszko further discloses a method further comprising steps of: providing an audible and visual alarm when the impedance value of the operation object detected in real time is less than the minimum value of the limit value range or the decrease rate of the impedance value of the operation object detected in real time is greater than the first limit slope ([0009]: “An alarm, audible or visual may be indicated to the user that a first over-temperature cycle has been initiated.”); providing an audible and visual alarm when the impedance value of the operation object detected in real time is greater than the maximum value of the limit value range or the increase rate of the impedance value of the operation object detected in real time is greater than the first limit slope ([0072]: “Visual or audible alarms may be triggered should this during the phase, so as to inform the user of the change in expected tissue treatment.”). Xu in view of Woloszko and Yates does not explicitly disclose a method that comprises: displaying a first text prompt and displaying a second text prompt.
However, Hoey teaches a method that comprises: displaying a first text prompt (Table 1: impedance approaching mac/min limit) and displaying a second text prompt (Table 2: impedance out of range).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the method of Xu so that it includes displaying a first text prompt and displaying a second text prompt as taught by Hoey to indicate to a user that a therapy session has ended prematurely (Hoey Col 13, line 64 – Co. 14, line 9).
Regarding claim 6, Xu in view of Woloszko, Yates, and Hoey discloses the method according to claim 5, and Xu further discloses a method wherein the step of controlling the radio frequency data to be within the radio frequency data standard range by controlling the injection volume of the syringe pump to the operation object when the radio frequency data detected in real time exceeds the radio frequency data standard range but does not exceed the radio frequency data limit range and lasts for a preset duration (Page 24, line 63 – Page 25, line 2: “In other embodiments, the control module 140 May comprehensively determine the ablation situation according to data transmitted by the plurality of sensors, and control devices such as the micro perfusion pump 130 and the radio frequency signal generator 100 to adjust when the preset condition is met, so as to ensure that the ablation process is smoothly performed, and the preset condition may be set by the user according to the actual situation of the lung radio frequency ablation system during operation and the configuration of the sensor.” And Page 20, lines 35-37: “In one embodiment, step S500 further includes pre-calibrating a steady-state impedance, and calculating a threshold according to the steady-state impedance, wherein the threshold is used for comparing with the impedance information in step S510 to generate a corresponding control instruction.” And Page 21, lines 34-36: “The end of the ablation process may be based on a preset time, or may be based on the temperature of the electrode or the lesion site, and in one of the embodiments, the ablation process may also be prompted or controlled by using the radio frequency ablation method, the control method, or the impedance monitoring method in the foregoing embodiments.” And Page 21, lines 45-48: “For another example, when the temperature is too high, it may be that the output of the heat exchange medium is abnormal, and the control module may output the prompt instruction for giving an alarm. In one of the embodiments, the distance electrode of the collection point of the temperature information is 0.5-3 cm; and after the temperature information reaches 43-60°C and the preset time is maintained, a stop ablation instruction is sent.”) comprises: controlling the injection pump to reduce an amount of the liquid injected to the operation object according to a preset first injection volume when the impedance value of the operation object detected in real time is less than the minimum value of the standard value range and/or a decrease rate of the impedance value of the operation object is greater than the first standard slope and lasts for the preset duration (Page 20, lines 53-56: “The increase or decrease may be either a fixed value or a dynamic value, for example related to the current impedance information, or the difference between the set impedance information and the threshold is Z, while the increase or decrease is a dynamic value and is related to Z. For example, the closer the current impedance information to the threshold, the smaller the increase or decrease, so that the control is finer and the hysteresis of the feedback is reduced as much as possible.”); and controlling the injection pump to increase the amount of the liquid injected to the operation object according to a preset second injection volume when the impedance value of the operation object detected in real time is greater than the maximum value of the standard value range and/or an increase rate of the impedance value of the operation object is greater than the second standard slope and lasts for the preset duration (Page 20, lines 53-56: “The increase or decrease may be either a fixed value or a dynamic value, for example related to the current impedance information, or the difference between the set impedance information and the threshold is Z, while the increase or decrease is a dynamic value and is related to Z. For example, the closer the current impedance information to the threshold, the smaller the increase or decrease, so that the control is finer and the hysteresis of the feedback is reduced as much as possible.”). Hoey discloses a method wherein the standard slope comprises a first standard slope for indicating a decrease rate of the impedance value, and a second standard slope for indicating an increase rate of the impedance (Figure 16: ΔZ could be negative or positive and Col. 29, lines 39-56 and Col. 30, lines 1-33).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the method of Xu so that the standard slope comprises a first standard slope for indicating a decrease rate of the impedance value, and a second standard slope for indicating an increase rate of the impedance as taught by Hoey to indicate to a user that a therapy session has ended prematurely (Hoey Col 13, line 64 – Co. 14, line 9).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Xu in view of Woloszko, further in view of Halter, US 20160081585, herein referred to as “Halter”.
Regarding claim 8, Xu in view of Woloszko discloses the method according to claim 1, but does not explicitly disclose a method further comprising, after the detected radio frequency data is compared with the radio frequency data standard range in real time, steps of: displaying a correspondence relationship between the impedance value of the operation object and the time of the radio frequency operation on a display interface in the form of a line with a first color when the detected impedance value of the operation object exceeds the radio frequency data standard range; displaying a correspondence relationship between the impedance value of the operation object and the time of the radio frequency operation on the display interface in the form of a line with a second color when the detected impedance value of the operation object does not exceed the radio frequency data standard range; and wherein a reflectivity of the first color is greater than a reflectivity of the second color.
However, Halter teaches a method comprising, after the detected radio frequency data is compared with the radio frequency data standard range in real time, steps of: displaying a correspondence relationship between the impedance value of the operation object and the time of the radio frequency operation on a display interface (Figure 8) in the form of a line with a first color when the detected impedance value of the operation object exceeds the radio frequency data standard range ([0059]: “Near-probe and far-from-probe properties are displayed as a color-coded display, with low impedances in a first color, such as blue, and high impedances as a second color, such as red”; wherein red is the first color); displaying a correspondence relationship between the impedance value of the operation object and the time of the radio frequency operation on the display interface in the form of a line with a second color when the detected impedance value of the operation object does not exceed the radio frequency data standard range ([0059]: “Near-probe and far-from-probe properties are displayed as a color-coded display, with low impedances in a first color, such as blue, and high impedances as a second color, such as red”; wherein blue is the second color); and wherein a reflectivity of the first color is greater than a reflectivity of the second color (Red has a higher reflectivity than blue according to applicant’s specification paragraph [0067]).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the method of Xu so that it includes displaying a line with a first color when the detected impedance value of the operation object exceeds the radio frequency data standard range and displaying a line with a second color when the detected impedance value of the operation object does not exceed the radio frequency data standard range as taught by Halter so that differences and changes in impedance are highlighted (Halter [0056]).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/N.W.R./Examiner, Art Unit 3794 /SEAN W COLLINS/Primary Examiner, Art Unit 3794
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