DETAILED ACTION
This action is pursuant to claims filed on 3/19/2026. Claims 1-24 are pending. A non-final action on the merits of claims 1-24 is as follows.
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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 3/19/2026 has been entered.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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) 1-7, 11, 13-19, and 23 are rejected under rejected under 35 U.S.C. 103 as being unpatentable over Liu et al. (hereinafter ‘Liu’, CN 113952021 A), in view of Turner et al. (hereinafter ‘Turner’, US RE47996 E) and in further view of Kollman et al. (hereinafter ‘Kollman’, US 20190142491 A1).
Regarding independent claim 1, Liu discloses a system (system shown in Fig. 1) to perform cryoablation treatments ([Pages 3 of Translation]: the embodiment of the present invention provides cryo-high frequency system for various treatment and operation methods including cryoablation combined with electrocoagulation hemostasis), the system comprising:
a cryoprobe ([Page 4 of translation]: cryoprobe 201);
at least one impedance sensor coupled to the cryoprobe ([Page 6 of translation]: impedance data is collected between the cryoprobe and the neutral plate through the acquisition plate – thus impedance is being measured by a sensor that is coupled to the cryoprobe);
a probe heater (heating module 105), wherein the probe heater is configured to heat the cryoprobe ([Pages 5-6 of translation]: the cryoablation is done by outputting freezing energy and heating energy together; the heating module is part of the system and heats the working medium so that the device has the heating ability; the outputs of the heating energy are through the freezing and melting output interface); and
at least one computing device (main control board 102 in Fig. 1), the at least one computing device configured to:
obtain at least one impedance measurement ([page 4 of translation]: the main control board receives impedance information detected by the acquisition board in real time) from the at least one impedance sensor ([Page 6 of translation]: impedance data is collected between the cryoprobe and the neutral plate through the acquisition plate);
determine whether blood is proximate to the cryoprobe based on the at least one impedance measurement ([Page 4 of translation]: the main control board receives the impedance information detected by the acquisition board, which is collecting information from to the cryoprobe, detects the coagulation impedance of the tissue to evaluate the coagulation effect; the “coagulation effect” is used to determine if hemostasis is achieved, i.e. whether the bleeding has stopped, and therefore the impedance measurement is measuring the blood level at the treatment site to determine the level of blood flow present as that is the coagulation effect); and
adjust one or more inputs ([Page 4 of Translation]: the main control board controls the high-frequency output module to output high-frequency coagulation energy) to the heater and a coagulator ([Page 3 of translation]: the board controls the heating module to heat the low-temperature working medium, and outputs heating energy through the cryoablation output interface; the main control board receives the temperature information and impedance information detected by the acquisition board in real time, and controls the high temperature according to the temperature information. The frequency output module works to output high frequency coagulation energy) in the cryoprobe in response to determining that that blood is proximate to the cryoprobe to promote coagulation of the blood proximate the cryoprobe ([Page 4 of Translation]: the main control board receives the temperature information and impedance information detected in real time and when the main control board receives a temperature reading that the cryoprobe reaches above 0 degrees C, the main control board outputs high frequency coagulation energy and the collection board performs coagulation impedance detection on the tissue to evaluate coagulation effect).
Even though the coagulation procedure of Liu is mainly started on the basis of temperature measurement, it is further controlled continuously by collecting coagulation impedance data. If the impedance measurement at the end of the initial coagulation returns that the coagulation has not been completed, i.e. the site is still bleeding and thus there is still blood present, it is inherent that the high-frequency coagulation energy continues with the procedure as that is the process in order to achieve the desired goal of hemostasis.
As best understood by the examiner, Liu discloses measuring the impedance to determine the coagulation effect, thus indicating whether blood is proximate the probe since incomplete coagulation would mean the site is still bleeding, and then adjusting an input to the heater in response to determining that the hemostasis has not been achieved.
Alternatively, Liu discloses constantly monitoring both temperature and impedance ([Page 4 of Translation]). Once the temperature at the treatment site reaches above 0 degrees C, the coagulation energy is turned on by the main control board ([Page 4 of Translation]). This in turn indicates that when the temperature is above freezing, bleeding starts and needs to be coagulated. Detecting temperature is merely one method of determining whether the patient is bleeding and Liu discloses an alternate method of utilizing impedance to determine the presence of blood or bleeding as well, as that is the final measurement taken to determine if the coagulation was successful ([Page 4 of Translation]). Utilizing impedance to measure coagulation and then determine the energy output to treat the tissue is known in the art as evidenced by Cohn et al. (US 20210393332 A1) ([0332]). Therefore, it would have been obvious to one of ordinary skill in the art to choose one of the two possibilities to determine if blood is present at the treatment site, namely using temperature to indicate blood is present or impedance to indicate blood is present, as selecting one of two possibilities to determine bleeding level/coagulation effect involves routine skill in the art and a predictable result of measuring the coagulation effect to control the electrocoagulation energy will occur.
However, while Liu discloses that impedance is measured, Liu is silent to the impedance sensor being on the cryoprobe.
Turner teaches an electrosurgical device as seen in Fig. 1. The device can be used to supply RF energy to the end effector for coagulation with the electrical characteristics of the tissue being measured to control the operational aspects of the generator ([Col 20, lines 10-35]). While not particularly directed towards cryoablation, the claims of the instant application are directed towards applying heat to perform coagulation steps, which is consistent with the goal of Turner. Additionally, Liu utilizes high-frequency energy as well to stop bleeding and ensure coagulation is achieved. Due to the common goals of utilizing high-frequency energy to stop bleeding, the art is analogous. Turner further teaches that end effector of the device comprises electrodes on the end effector to measure the impedance of the tissue ([Col 17, lines 15-24]). Placing the electrodes on the exterior of the device allows for the impedance of the tissue in contact with the electrodes to be measured. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to place the electrodes of Liu on the exterior of the device near the cryoprobe such that the impedance at the treatment site can actually be measured.
Liu further discloses the presence two types of heaters. One which heats the low-temperature working medium and outputs heating energy through the cryoablation interface and a frequency output module which outputs the high-frequency coagulation energy to heat the tissue ([Page 3 of translation]).
However, the Liu/Turner combination is silent to a single heater within the cryoprobe configured to heat the cryoprobe and promote coagulation of the blood proximate the cryoprobe via thermal contact with the cryoprobe.
Kollman teaches a cryoprobe comprising a resistance heater that thaws and cauterizes the tissue when current is supplied to the resistance heater ([0005]). As seen in Fig. 3, the resistance heater 116 coils around the cryofluid supply tube such that when the heater is activated, it would heat the cryogenic fluid ([0073]). This is a similar type of heater to the heating module of Liu which can be a resistance wire as well ([Page 5 of translation]). Utilizing a single heater as taught by Kollman would reduce the number of parts required to both thaw and cauterize the tissue as the number of heaters would simply reduce from two separate heaters to a single heater. Furthermore, this would maintain the functionality of Liu because instead of switching from the heating module to the high-frequency module after thawing, the single heater can both thaw and heat the tissue to cauterize the area and achieve hemostasis. The goal of the high frequency output module is simply to heat the tissue to cause hemostasis in the tissue ([Page 6 of the translation of Liu]). Thus, the end result is the same between the two heaters and the single heater, the preferred modality is simply changed to a known and obvious tissue heating modality. Additionally, the main control board would simply control the single heater to thaw and cauterize the tissue based on the impedance information rather than having to control the resistance heater and the electrocoagulator. This combination would simply yield the predictable result of thawing and cauterizing the tissue using a single heater instead of two. Kollman further states that utilizing the coiled heater taught results in less artifact when utilizing MRI ([0076]), and lower forces caused by magnetic fields acting upon the heater when compared to conventional cryoprobes with electric heaters, of which Liu has one ([0080]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to combine the single heater of Kollman with the Liu/Turner combination such that the two heaters of Liu are simplified into a single resistive heater in the distal tip of the probe that both warms the cryofluid for thawing and cauterizes the tissue while providing for improved performance in MRI.
Regarding claim 2, the Liu/Turner/Kollman combination discloses the system of claim 1, wherein the at least one computing device is configured to determine whether blood is proximate the cryoprobe while adjusting one or more inputs to the probe heater ([Page 5 of Translation]: the main control board receives temperature and impedance information detected by the acquisition board in real time and controls the output module to output coagulation energy).
It is the opinion of the examiner that the real time monitoring of the impedance by the acquisition board means that the impedance is being recorded, which determines the presence of blood, while the inputs of the heaters are adjusted.
However, in order to advance prosecution Turner further teaches this limitation.
Turner teaches that during the coagulation process, tissue impedance generally increases ([Col 52, lines 5-16]). Determining the coagulation effect or process is a direct equivalent to determining the presence of blood because the coagulation process is the process of stopping the bleeding and the impedance measurement is based on the amount of blood present at the treatment site. Turner further states that power can be applied to the tissue in order to achieve coagulation ([Col 50, lines 57-64]). The power curve defines the relationship between the power delivered to the tissue and the impedance of the tissue ([Col 50, lines 57-64]). Thus, as the impedance of the tissue changes (i.e. the impedance increases during coagulation), the power provided can also change (i.e. decrease as coagulation is completed) according to the applied power curve ([Col 50, lines 57-64]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to ensure that the impedance, which determines the presence of blood, is constantly monitored in order to accurately adjust the power delivered as coagulation occurs.
Regarding claim 3, the Liu/Turner/Kollman combination discloses the system of claim 2 as described above. Turner further teaches wherein the at least one impedance sensor is disposed on an external surface of the cryoprobe ([Col 17, lines 15-24]: electrodes 157 and 159 are on an external surface of the end effector of the device comprises electrodes on the end effector to measure the impedance of the tissue – thus in the combination, the impedance sensing electrodes would be on the external surface of the cryoprobe in order to sense the impedance at the treatment site).
Regarding claim 4, the Liu/Turner/Kollman combination discloses the system of claim 1 substantially as described above. Liu further discloses that the computing device determines whether blood is proximate to the cryoprobe by measuring the impedance to determine the coagulation effect ([Page 4 of Translation]).
Turner further teaches that during the coagulation process, tissue impedance generally increases ([Col 52, lines 5-16]). As described above, determining the coagulation effect or process is a direct equivalent to determining the presence of blood because the coagulation process is the process of stopping the bleeding and the impedance measurement is based on the amount of blood present at the treatment site. That is why as the coagulation process proceeds, the impedance rises as the presence of liquid blood is removed. Turner further teaches that the coagulation procedure is progressing correctly based on whether the measured impedance value meets an impedance threshold ([Col 52, lines 16-32]). Utilizing an impedance threshold allows for the coagulation progress to be appropriately determine and ensure that the power is being correctly applied ([Col 52, lines 16-32]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to combine the impedance threshold of Turner with the system of the combination such that the coagulation effect can be effectively measured and ensure enough power is being applied to achieve coagulation.
Regarding claim 5, the Liu/Turner/Kollman combination discloses the system of claim 1 substantially as described above. Liu further discloses that the computing device is configured to determine an amount of blood proximate the cryoprobe ([Page 4 of Translation]: the impedance measurement is used to determine the coagulation effect; an incomplete coagulation would inherently result in a bleeding level comprising an amount of blood).
Turner further teaches that during the coagulation process, tissue impedance generally increases ([Col 52, lines 5-16]). As described above, determining the coagulation effect or process is a direct equivalent to determining the presence of blood because the coagulation process is the process of stopping the bleeding and the impedance measurement is based on the amount of blood present at the treatment site. That is why as the coagulation process proceeds, the impedance rises as the presence of liquid blood is removed. Turner further teaches that the coagulation procedure is progressing correctly based on whether the measured impedance value meets an impedance threshold ([Col 52, lines 16-32]). Turner further teaches that when the impedance threshold is met, sufficient power is being supplied to bring about suitable coagulation, indicating that blood flow is being slowed and the tissue is being sealed ([Col 53, lines 6-17]). Once the impedance threshold is met, the power is maintained until a termination threshold is reached which indicates complete coagulation and the stoppage of blood flow ([Col 53, lines 27-39]). Thus, three ranges are disclosed: under the impedance threshold, between the impedance threshold and the termination threshold, and above the termination threshold. Because the claim does not state what the impedance ranges are or describe requirements for each range, Turner teaches the claim language. Under the initial impedance threshold is the significant condition as the impedance is low and thus bleeding is occurring. Between the initial impedance threshold and the termination threshold is the mild condition because coagulation is occurring but a complete seal has not been formed. Finally, the dry condition is when the measured impedance is above the termination threshold, indicating a complete seal. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to compare the measured impedance value of the combination to a range of impedance values as taught by Turner in order to determine what stage of coagulation the tissue has achieved, thus ensuring the correct power is being applied.
Regarding claim 6, the Liu/Turner/Kollman combination discloses the system of claim 1 substantially as described above. Liu further discloses that impedance measurements are utilized to determine the coagulation effect ([Page 4 of Translation]).
Turner further teaches utilizing tissue information for the formulation of a treatment plan as shown in Fig. 70. The treatment plan loaded into the generator utilizes the tissue impedance measurements to evaluate the coagulation effect and determine if more aggressive power curves are necessary to realize complete coagulation ([Col 52, line 33 – Col 53, line 55]). Utilizing such a process in the computing device allows for the correct power to be applied in order to allow for proper coagulation in varying tissue types ([Col 52, line 33 – Col 53, line 55]). As written in the claim, “obtain” is broadly interpreted as loaded into the processor such that the generator can execute the process. Because the generator is disclosed to be executing the process, the device obtained the treatment plan. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to combine the treatment plan of Turner with the system of the combination such that the coagulation effect can be monitored and additional power applied if needed based on the impedance information such that delicate tissues are protected and complete coagulation is achieved.
Regarding claim 7, the Liu/Turner/Kollman combination discloses the system of claim 1, wherein the one or more inputs comprises at least one of a current, a frequency, a power profile and a voltage (in the combination, the heater is a resistance wire, thus the main control board is controlling the current through the resistance wire).
Regarding claim 11, Liu/Turner/Kollman discloses the system of claim 1 substantially as described above. Liu further discloses that impedance measurements are constantly recorded in real time and are utilized to determine the coagulation effect ([Page 4 of Translation]).
Turner further teaches that the coagulation procedure is progressing correctly based on whether the measured impedance value meets an impedance threshold, which can be the rate of change of the tissue impedance ([Col 52, lines 16-32]). Utilizing an impedance threshold based on the rate of change of the tissue impedance allows for the coagulation progress to be appropriately determine and ensure that the power is being correctly applied ([Col 52, lines 16-32]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to combine the rate of change of tissue impedance threshold of Turner with the system of the combination such that the coagulation effect can be effectively measured and ensure enough power is being applied to achieve coagulation.
Regarding independent claim 13, Liu discloses a method of performing a cryoablation treatment ([Pages 3-4 of Translation]: the embodiment describes the operation of a system for providing cryoablation and electrocoagulation) comprising:
obtaining at least one impedance measurement from at least one impedance sensor coupled to a cryoprobe ([page 4 of translation]: the main control board receives impedance information detected by the acquisition board in real time from the cryoprobe when connected for cryoablation);
determining whether blood is present proximate the cryoprobe based on the at least one impedance measurement ([Page 4 of translation]: the main control board receives the impedance information detected by the acquisition board, which is collecting information from to the cryoprobe, detects the coagulation impedance of the tissue to evaluate the coagulation effect; the “coagulation effect” is used to determine if hemostasis is achieved, i.e. whether the bleeding has stopped, and therefore the impedance measurement is measuring the blood level at the treatment site to determine the level of blood flow present as that is the coagulation effect); and
adjusting one or more inputs ([Page 4 of Translation]: the main control board controls the high-frequency output module, which is interpreted as the heater, to output high-frequency coagulation energy) to a probe heater the cryoprobe in response to determining that the at least one impedance measurement indicates that blood is proximate to the cryoprobe to promote coagulation of the blood proximate the cryoprobe ([Page 4 of Translation]: the main control board receives the temperature information and impedance information detected in real time and when the main control board receives a temperature reading that the cryoprobe reaches above 0 degrees C, the main control board outputs high frequency coagulation energy and the collection board performs coagulation impedance detection on the tissue to evaluate coagulation effect).
Even though the coagulation procedure of Liu is mainly started on the basis of temperature measurement, it is further controlled continuously by collecting coagulation impedance data. If the impedance measurement at the end of the initial coagulation returns that the coagulation has not been completed, i.e. the site is still bleeding and thus there is still blood present, it is inherent that the high-frequency coagulation energy continues with the procedure as that is the process in order to achieve the desired goal of hemostasis.
As best understood by the examiner, Liu discloses measuring the impedance to determine the coagulation effect and then adjusting an input to the heater in response to determining that the hemostasis has not been achieved.
Alternatively, Liu discloses constantly monitoring both temperature and impedance ([Page 4 of Translation]). Once the temperature at the treatment site reaches above 0 degrees C, the coagulation energy is turned on by the main control board ([Page 4 of Translation]). This in turn indicates that when the temperature is above freezing, bleeding starts and needs to be coagulated. Detecting temperature is merely one method of determining whether the patient is bleeding and Liu discloses an alternate method of utilizing impedance to determine the presence of blood or bleeding as well, as that is the final measurement taken to determine if the coagulation was successful ([Page 4 of Translation]). Utilizing impedance to measure coagulation and then determine the energy output to treat the tissue is known in the art as evidenced by Cohn et al. (US 20210393332 A1) ([0332]). Therefore, it would have been obvious to one of ordinary skill in the art to choose one of the two possibilities to determine if blood is present at the treatment site, namely using temperature to indicate blood is present or impedance to indicate blood is present, as selecting one of two possibilities to determine bleeding level/coagulation effect involves routine skill in the art and a predictable result of measuring the coagulation effect to control the electrocoagulation energy will occur.
However, while Liu discloses that impedance is measured, Liu is silent to the impedance sensor being on the cryoprobe.
Turner teaches an electrosurgical device as seen in Fig. 1. The device can be used to supply RF energy to the end effector for coagulation with the electrical characteristics of the tissue being measured to control the operational aspects of the generator ([Col 20, lines 10-35]). While not particularly directed towards cryoablation, the claims of the instant application are directed towards applying heat to perform coagulation steps, which is consistent with the goal of Turner. Additionally, Liu utilizes high-frequency energy as well to stop bleeding and ensure coagulation is achieved. Due to the common goals of utilizing high-frequency energy to stop bleeding, the art is analogous. Turner further teaches that end effector of the device comprises electrodes on the end effector to measure the impedance of the tissue ([Col 17, lines 15-24]). Placing the electrodes on the exterior of the device allows for the impedance of the tissue in contact with the electrodes to be measured. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to place the electrodes of Liu on the exterior of the device near the cryoprobe such that the impedance at the treatment site can actually be measured.
Liu further discloses the presence two heaters. One which heats the low-temperature working medium and outputs heating energy through the cryoablation interface and a frequency output module which outputs the high-frequency coagulation energy to heat the tissue ([Page 3 of translation]).
However, the Liu/Turner combination is silent to a single heater configured to heat a the cryoprobe and promote coagulation of the blood proximate the cryoprobe via thermal contact with the cryoprobe.
Kollman teaches a cryoprobe comprising a resistance heater that thaws and cauterizes the tissue when current is supplied to the resistance heater ([0005]). As seen in Fig. 3, the resistance heater 116 coils around the cryofluid supply tube such that when the heater is activated, it would heat the cryogenic fluid ([0073]). This is a similar type of heater to the heating module of Liu which can be a resistance wire as well ([Page 5 of translation]). Utilizing a single heater as taught by Kollman would reduce the number of parts required to both thaw and cauterize the tissue as the number of heaters would simply reduce from two separate heaters to a single heater. Furthermore, this would maintain the functionality of Liu because instead of switching from the heating module to the high-frequency module after thawing, the single heater can both thaw and heat the tissue to cauterize the area and achieve hemostasis. The goal of the high frequency output module is simply to heat the tissue to cause hemostasis in the tissue ([Page 6 of the translation of Liu]). Thus, the end result is the same between the two heaters and the single heater, the preferred modality is simply changed to a known and obvious tissue heating modality. Additionally, the main control board would simply control the single heater to thaw and cauterize the tissue based on the impedance information rather than having to control the resistance heater and the electrocoagulator. This combination would simply yield the predictable result of thawing and cauterizing the tissue using a single heater instead of two. Kollman further states that utilizing the coiled heater taught results in less artifact when utilizing MRI ([0076]), and lower forces caused by magnetic fields acting upon the heater when compared to conventional cryoprobes with electric heaters, of which Liu has one ([0080]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to combine the single heater of Kollman with the Liu/Turner combination such that the two heaters of Liu are simplified into a single resistive heater in the distal tip of the probe that both warms the cryofluid for thawing and cauterizes the tissue while providing for improved performance in MRI.
Regarding claim 14, Liu/Turner/Kollman combination discloses the method of claim 13, wherein the step of determining whether blood is present is performed while adjusting one or more inputs to the probe heater ([Page 5 of Translation]: the main control board receives temperature and impedance information detected by the acquisition board in real time and controls the high-frequency output module to output coagulation energy).
It is the opinion of the examiner that the real time monitoring of the impedance by the acquisition board means that the impedance is being recorded, which determines the presence of blood, while the inputs of the heaters are adjusted.
However, in order to advance prosecution Turner further teaches this limitation.
Turner teaches that during the coagulation process, tissue impedance generally increases ([Col 52, lines 5-16]). Determining the coagulation effect or process is a direct equivalent to determining the presence of blood because the coagulation process is the process of stopping the bleeding and the impedance measurement is based on the amount of blood present at the treatment site. Turner further states that power can be applied to the tissue in order to achieve coagulation ([Col 50, lines 57-64]). The power curve defines the relationship between the power delivered to the tissue and the impedance of the tissue ([Col 50, lines 57-64]). Thus, as the impedance of the tissue changes (i.e. the impedance increases during coagulation), the power provided can also change (i.e. decrease as coagulation is completed) according to the applied power curve ([Col 50, lines 57-64]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to ensure that the impedance, which determines the presence of blood, is constantly monitored in order to accurately adjust the power delivered as coagulation occurs.
Regarding claim 15, the Liu/Turner/Kollman combination discloses the method of claim 14 as described above. Turner further teaches wherein the at least one impedance sensor is disposed on an external surface of the cryoprobe ([Col 17, lines 15-24]: electrodes 157 and 159 are on an external surface of the end effector of the device comprises electrodes on the end effector to measure the impedance of the tissue – thus in the combination, the impedance sensing electrodes would be on the external surface of the cryoprobe in order to sense the impedance at the treatment site).
Regarding claim 16, the Liu/Turner/Kollman combination discloses the method of claim 13 substantially as described above. Liu further discloses that the computing device determines whether blood is proximate to the cryoprobe by measuring the impedance to determine the coagulation effect ([Page 4 of Translation]).
Turner further teaches that during the coagulation process, tissue impedance generally increases ([Col 52, lines 5-16]). As described above, determining the coagulation effect or process is a direct equivalent to determining the presence of blood because the coagulation process is the process of stopping the bleeding and the impedance measurement is based on the amount of blood present at the treatment site. That is why as the coagulation process proceeds, the impedance rises as the presence of liquid blood is removed. Turner further teaches that the coagulation procedure is progressing correctly based on whether the measured impedance value meets an impedance threshold ([Col 52, lines 16-32]). Utilizing an impedance threshold allows for the coagulation progress to be appropriately determine and ensure that the power is being correctly applied ([Col 52, lines 16-32]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to combine the impedance threshold of Turner with the method of the combination such that the coagulation effect can be effectively measured and ensure enough power is being applied to achieve coagulation.
Regarding claim 17, the Liu/Turner/Kollman combination discloses the method of claim 13 substantially as described above. Liu further discloses that the computing device is configured to determine an amount of blood proximate the cryoprobe ([Page 4 of Translation]: the impedance measurement is used to determine the coagulation effect; an incomplete coagulation would inherently result in a bleeding level comprising an amount of blood).
Turner further teaches that during the coagulation process, tissue impedance generally increases ([Col 52, lines 5-16]). As described above, determining the coagulation effect or process is a direct equivalent to determining the presence of blood because the coagulation process is the process of stopping the bleeding and the impedance measurement is based on the amount of blood present at the treatment site. That is why as the coagulation process proceeds, the impedance rises as the presence of liquid blood is removed. Turner further teaches that the coagulation procedure is progressing correctly based on whether the measured impedance value meets an impedance threshold ([Col 52, lines 16-32]). Turner further teaches that when the impedance threshold is met, sufficient power is being supplied to bring about suitable coagulation, indicating that blood flow is being slowed and the tissue is being sealed ([Col 53, lines 6-17]). Once the impedance threshold is met, the power is maintained until a termination threshold is reached which indicates complete coagulation and the stoppage of blood flow ([Col 53, lines 27-39]). Thus, three ranges are disclosed: under the impedance threshold, between the impedance threshold and the termination threshold, and above the termination threshold. Because the claim does not state what the impedance ranges are or describe requirements for each range, Turner teaches the claim language. Under the initial impedance threshold is the significant condition as the impedance is low and thus bleeding is occurring. Between the initial impedance threshold and the termination threshold is the mild condition because coagulation is occurring but a complete seal has not been formed. Finally, the dry condition is when the measured impedance is above the termination threshold, indicating a complete seal. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to compare the measured impedance value of the combination to a range of impedance values as taught by Turner in order to determine what stage of coagulation the tissue has achieved, thus ensuring the correct power is being applied.
Regarding claim 18, the Liu/Turner/Kollman combination discloses the method of claim 13 substantially as described above. Liu further discloses that impedance measurements are utilized to determine the coagulation effect ([Page 4 of Translation]).
Turner further teaches utilizing tissue information for the formulation of a treatment plan as shown in Fig. 70. The treatment plan loaded into the generator utilizes the tissue impedance measurements to evaluate the coagulation effect and determine if more aggressive power curves are necessary to realize complete coagulation ([Col 52, line 33 – Col 53, line 55]). Utilizing such a process in the computing device allows for the correct power to be applied in order to allow for proper coagulation in varying tissue types ([Col 52, line 33 – Col 53, line 55]). As written in the claim, “obtain” is broadly interpreted as loaded into the processor such that the generator can execute the process. Because the generator is disclosed to be executing the process, the device obtained the treatment plan. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to combine the treatment plan of Turner with the method of the combination such that the coagulation effect can be monitored and additional power applied if needed based on the impedance information such that delicate tissues are protected and complete coagulation is achieved.
Regarding claim 19, the Liu/Turner/Kollman combination discloses the method of claim 13, wherein the one or more inputs comprises at least one of a current, a frequency, a power profile and a voltage (in the combination, the heater is a resistance wire, thus the main control board is controlling the current through the resistance wire).
Regarding claim 23, the Liu/Turner/Kollman combination discloses the method of claim 13 substantially as described above. Liu further discloses that impedance measurements are constantly recorded in real time and are utilized to determine the coagulation effect ([Page 4 of Translation]).
Turner further teaches that the coagulation procedure is progressing correctly based on whether the measured impedance value meets an impedance threshold, which can be the rate of change of the tissue impedance ([Col 52, lines 16-32]). Utilizing an impedance threshold based on the rate of change of the tissue impedance allows for the coagulation progress to be appropriately determine and ensure that the power is being correctly applied ([Col 52, lines 16-32]). In order to determine the rate of change of impedance, a plurality of impedance measurements taken ([Col 54, lines 50-67]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to combine the rate of change of tissue impedance threshold of Turner with the method of the combination such that the coagulation effect can be effectively measured and ensure enough power is being applied to achieve coagulation.
Claim(s) 8-10 and 20-22 are rejected under 35 U.S.C. 103 as being unpatentable over the Liu/Turner/Kollman combination as applied to claims 1 and 13 respectively and described above in further view of Ryba et al. (hereinafter ‘Ryba’, CA 2807277 A1)
Regarding claim 8, the Liu/Turner/Kollman combination discloses the system of claim 1 substantially as described above. Liu further discloses that the cryoprobe has a control board that is constantly recording temperature and impedance data ([Page 4 of Translation]).
As described above, the Liu/Turner/Kollman combination discloses an external impedance sensor for monitoring the coagulation effect.
However, the combination is silent to the system having an internal impedance sensor.
Ryba teaches a catheter apparatus for cryogenically modulating neural structures in the renal plexus ([Abstract]). Ryba further teaches that a thermistor can be implemented in the cryocatheter to provide valuable data and feedback to the cryosystem ([00260]). Placing the thermistor inside of the applicator allows for the cryo-fluid to be properly monitored ([00260]). A thermistor is a temperature known in the art to determine temperature based on impedance, making it an impedance measurement. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to combine internal impedance measurement of Ryba with the system of the Liu/Turner/Kollman combination such that an internal impedance measurement can be taken to determine the internal temperature of the cryoprobe to provide valuable feedback of the cryoprobe system.
Regarding claim 9, the Liu/Turner/Kollman /Ryba combination discloses the system substantially in claim 8/1 as described above. The combination further teaches that the computing device determines the temperature of the cryoprobe based on the internal impedance measurement (Ryba [00260]: the thermistor can monitor the inside of the cryocatheter, thermistors are known in the art to measure temperature).
Regarding claim 10, the Liu/Turner/Kollman/Ryba combination discloses the system of claim 9/8/1 as described above.
However, the combination is silent to the computing device obtaining an internal measurement from the heater.
It would be an obvious design choice to one of ordinary skill in the art to place a thermistor near the heater to determine the temperature of the heater as Ryba has disclosed the importance of placing temperature sensors inside of the cryoprobe to provide valuable feedback about the system. Placing a thermistor to measure the temperature of the heater is within the level of ordinary skill in the art and would simply lead to the predicted effect of providing temperature information of the heater of the cryoprobe.
Regarding claim 20, Liu/Turner/Kollman combination discloses the method of claim 13 substantially as described above. Liu further discloses that the cryoprobe has a control board that is constantly recording temperature and impedance data ([Page 4 of Translation]).
As described above, the Liu/Turner/Kollman combination discloses an external impedance sensor for monitoring the coagulation effect.
However, the combination is silent to an internal impedance sensor.
Ryba teaches a catheter apparatus for cryogenically modulating neural structures in the renal plexus ([Abstract]). Ryba further teaches that a thermistor can be implemented in the cryocatheter to provide valuable data and feedback to the cryosystem ([00260]). Placing the thermistor inside of the applicator allows for the cryo-fluid to be properly monitored ([00260]). A thermistor is a temperature known in the art to determine temperature based on impedance, making it an impedance measurement. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to combine internal impedance measurement of Ryba with the method of the Liu/Turner/Kollman combination such that an internal impedance measurement can be taken to determine the internal temperature of the cryoprobe to provide valuable feedback of the cryoprobe system.
Regarding claim 21, the Liu/Turner/Kollman/Ryba combination discloses the method substantially in claim 20/13 as described above. The combination further teaches that the computing device determines the temperature of the cryoprobe based on the internal impedance measurement (Ryba [00260]: the thermistor can monitor the inside of the cryocatheter, thermistors are known in the art to measure temperature).
Regarding claim 22, the Liu/Turner/Kollman/Ryba combination discloses the method of claim 21/20/13 as described above.
However, the combination is silent to the computing device obtaining an internal measurement from the heater.
It would be an obvious design choice to one of ordinary skill in the art to place a thermistor near the heater to determine the temperature of the heater as Ryba has disclosed the importance of placing temperature sensors inside of the cryoprobe to provide valuable feedback about the system. Placing a thermistor to measure the temperature of the heater is within the level of ordinary skill in the art and would simply lead to the predicted effect of providing temperature information of the heater of the cryoprobe.
Claim(s) 12 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over the Liu/Turner/Kollman combination as applied to claims 1 and 13 respectively and described above, in view of Avitall et al. (hereinafter ‘Avitall’, US 20210290285 A1).
Regarding claim 12, the Liu/Turner/Kollman combination discloses the system substantially in claim 1 as described above. Liu further discloses the device takes real-time impedance measurements throughout the coagulation process ([Page 4 of Translation]).
However, the Liu/Turner/Kollman combination is silent to the device creating a predicted impedance profile and comparing the measurements to the impedance profile.
Avitall teaches a cryoablation system that allows for pulmonary vein assessment and monitoring through the use of impedance measurements recorded by electrodes ([Abstract]). The device utilizes electrodes 30 and 31 which are configured to measure tissue impedance ([0029]). Avitall further teaches that the computing device generates an impedance curve from a plurality of impedance measurement for each of the plurality of electrodes and the impedance curves of the electrodes are compared against each other to determine the presence of a complete occlusion ([0011]). While directed towards forming a complete occlusion of the pulmonary vein, rather than coagulating a bleed, the ultimate goal of Avitall is to stop blood flow past the balloon, and the impedance measurement provides as indication as to whether there is blood flow present (as shown in paragraph [0036] where the flow of blood slows the impedance rise). Because Avitall utilizes impedance to measure blood flow, it would be obvious to combine with the Liu/Turner/Kollman combination to provide a system for determining the level of blood flow at a specific site. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to combine impedance profile derivation of Avitall with the system of the Liu/Turner/Kollman combination such that the constant impedance measurements that are being recorded by the combination can be used to form an impedance profile, which can then be compared against each other to determine if there is still blood flow present at the treatment site, thus providing pertinent information as to the level of coagulation achieved.
Regarding claim 24, the Liu/Turner/Kollman combination discloses the method substantially in claim 13 as described above. Liu further discloses the device takes real-time impedance measurements throughout the coagulation process ([Page 4 of Translation]).
However, the Liu/Turner/Kollman combination is silent to the device creating a predicted impedance profile and comparing the measurements to the impedance profile.
Avitall teaches a cryoablation system that allows for pulmonary vein assessment and monitoring through the use of impedance measurements recorded by electrodes ([Abstract]). The device utilizes electrodes 30 and 31 which are configured to measure tissue impedance ([0029]). Avitall further teaches that the computing device generates an impedance curve from a plurality of impedance measurement for each of the plurality of electrodes and the impedance curves of the electrodes are compared against each other to determine the presence of a complete occlusion ([0011]). While directed towards forming a complete occlusion of the pulmonary vein, rather than coagulating a bleed, the ultimate goal of Avitall is to stop blood flow past the balloon, and the impedance measurement provides as indication as to whether there is blood flow present (as shown in paragraph [0036] where the flow of blood slows the impedance rise). Because Avitall utilizes impedance to measure blood flow, it would be obvious to combine with the Liu/Turner/Kollman combination to provide a system for determining the level of blood flow at a specific site. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to combine impedance profile derivation of Avitall with the system of the Liu/Turner/Kollman combination such that the constant impedance measurements that are being recorded by the combination can be used to form an impedance profile, which can then be compared against each other to determine if there is still blood flow present at the treatment site, thus providing pertinent information as to the level of coagulation achieved.
Response to Arguments
Applicant’s arguments filed 3/19/2026 regarding the 112b rejections of claims 5 and 17 have been fully considered and are persuasive in light of the amendments. The 112b rejections of claims 5 and 17 have been withdrawn.
Applicant’s arguments with respect to the 103 rejections of claims 1 and 13 have been fully considered but are not persuasive.
The applicant initially argues that the proposed modification of Liu in view of Kollman renders Liu unsatisfactory for its intended purpose because Liu no longer performs electrocoagulation. However, this is not persuasive. The high-frequency energy portion of Liu is intended to heat the tissue such that the tissue is coagulated ([page 6 of translation]). This is the preferred embodiment of Liu. Liu never states that this coagulation can only be performed through electrocoagulation. Liu simply provides a method for coagulating the tissue through electrocoagulation after freezing energy is applied. Kollman simply teaches an alternative method for coagulating the tissue after applying freezing energy. Kollman utilizes a resistance wire, one of which Liu already possesses, to both thaw and cauterize/coagulate the tissue. Eliminating the high-frequency output module of Liu does not render Liu inoperable or unsatisfactory because the overall function is maintained. Namely, the tissue is still cauterized and hemostasis is achieved after freezing energy is applied. The way in which the goal is accomplished is simply different but it is a method that is known and obvious to those of ordinary skill in the art, as taught by Kollman. Therefore, the arguments are not persuasive because the overall functionality of Liu is maintained when combined with Kollman.
The applicant additionally argues that the cited references fail to teach that inputs to the probe heater are not adjusted based on the impedance measurements, rather Liu teaches that high-frequency energy is adjusted. This is not persuasive. In the combination of record, the two heaters that are controlled by the main control board to thaw and cauterize the tissue in Liu are modified to be a single heater as taught by Kollman. Since the heaters are combined, the controller is simply adjusting the inputs to the single heater, rather than the two heaters to promote coagulation via thermal contact with the cryoprobe. Heating the probe, as taught by Kollman, means that the tissue is coagulated upon contact with the heated end of the cryoprobe. In the combination, the controller is still controlling the output of the heating energy based on the impedance information, it is simply controlling the single heater to thaw and coagulate rather than two heaters. Therefore, the arguments are not persuasive because in the combination of record, the controller is coagulating the tissue in response to impedance information via thermal contact with the cryoprobe.
The same reasoning applies for the rejection of claim 13.
Applicant’s arguments regarding the dependent claims have been fully considered but are not persuasive since the art applied to the dependent claims was not specifically challenged and the rejections to claims 1 and 13 remain.
Therefore, claims 1-24 remain rejected.
The examiner recommends incorporating how the controller determines blood is proximate the cryoprobe beyond the generic threshold, rate of change, or ranges currently claimed. Specifically providing for the thresholds, ranges, or desired rate of change that indicates that blood is present or the bleeding level could be beneficial in overcoming the prior art of record. Additionally, providing for how the impedance determines blood is proximate the cryoprobe would be beneficial. Currently, the prior art of record teaches monitoring the impedance to determine the coagulation level. This discloses that blood is present proximate the probe because incomplete coagulation at the treatment site means it is still bleeding and blood is present. Defining exactly what impedance is being measured could prove beneficial in overcoming the prior art. Any amendments should have support in the original disclosure as filed and would be subject to further search and consideration.
Conclusion
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/W.M./Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794
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