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 .
DETAILED ACTION
Claim Interpretation - 35 USC § 112(f)
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-AlA 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.
1. 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 comm only referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AlA 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 place holder 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 place holder 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-AlA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under35 U.S.C. 112(f) or pre-AlA 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-AlA 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-AlA 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 under35 U.S.C. 112(f) or pre-AlA 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 limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic place holder is not preceded by a structural modifier. Such claim limitation(s) is/are:
“moving mechanism” in claim 25;
“a pressure measuring unit” in claim 28;
“time measuring means” in claims 38 and 39;
“a pressure measurement unit” in claims 47, 48, and 49;
“compression unit” in claims 25 and 41-42
“controller unit” in claims 25, 28-29, 31-36, 40 and 47-49
because these claims limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AlA 35 U.S.C. 112, sixth paragraph, it/they is/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-AlA 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-AlA 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 § 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 of this title, 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.
2. Claims 25, 28-29, 36-40, 42, 45-46 and 51-52 are rejected under 35 U.S.C. 103 as being unpatentable over Lacoste et al.,(hereafter Lacoste ), US 20170001043 A1, published on Jan.5 , 2017, in view of Anderson et al. (hereafter Anderson), US 6306130 B1, pub. 10/23/2001.
Regarding claim 25, Lacoste teaches an ultrasound treatment device (Abstract, Fig.1, A device for treatment of a tissue (8) of a living being), the ultrasound treatment device comprising: a probe head comprising an ultrasound transducer for delivering treatment ultrasound waves focused onto a target within a patient tissue (Fig.1, Abstract, [0049]-[0050] A device including a transducer (4) for emitting a beam of ultrasound waves mounted on a movable treatment head (1), an ultrasonic imaging device (2, 3). The transducer 4 is of a fixed-focal-point type, the beam of ultrasound waves emitted by the transducer 4 being focused on a focal point F. The transducer (4) include a membranes where the membranes is contacting a skin 6 of the patient (see [0050])),
- a compression unit for applying a compression force to the higher patient tissue ([0027], device is equipped with a fluid system coupled to the balloon for handling the coupling fluid, preferably including at least one pump for filling and/or emptying the balloon. In this case the pump compress the balloon filled with air or liquid, casing the balloon to expand and forcibly compress the tissue in contact with the balloon),
wherein the compression unit is formed by one of a balloon and a moving mechanism of the probe head ([0029]-[0030]), Lacoste specifically teaches a movable treatment head , and a balloon where the pressure within the balloon can be increased or decreased, and increasing the pressure in the balloon produce compression forces on the tissue ), and
- a controller unit connected at least to the probe head and the compression unit ([0022], [0027], the control unit is adapted to move the treatment head from the travel position to the monitoring position to monitor the tissue, and a pressure sensor and the at least one pump preferably being connected to the control unit or other adequate means for regulating the pressure in the balloon (see [0027]),
a switch for switching between a first operating mode and a second operating mode (Claim 17 and [0014] The control unit is further adapted to trigger(switch) the transducer to emit ultrasound waves when the treatment head is in the treatment position; transducer 4 is switch on for second operating mode (treatment mode))
wherein the probe head comprises an ultrasound imaging device for imaging of the patient tissue ([0002], [0030], the ultrasonic imaging device is mounted on the treatment head and has an imaging plane intersecting the focal point);
wherein the ultrasound treatment device is adapted to switch between at least two operating modes ([0014], [0029]-[0030], the control unit is adapted to bring the pressure in the balloon to a first value and to a second. Thus, the controller switch the pump between two alternative states; the control unit also switch on the device to emit ultrasound pulse during treatment position; no ultrasound is emit during travel position and switch to emit ultrasound pulse in treatment position; also no treatment ultrasound pulse during monitor position), upon detection of a switch signal by the controller unit, wherein the switch signal is generated by actuation of the switch ([0021], where the transducer is triggered (switched) to emit an ultrasound pulse of given power and duration),
- in a first operating mode, the compression force applied to the patient tissue by the compression unit is maintained at a first compression force value ([0029]-[0030], the control unit is adapted to bring the pressure in the balloon from a travel position to monitor position; the pressure at the monitor position is the first compression force value), the controller unit controls the imaging device to perform imaging of the patient tissue and wherein the first compression force value is defined such that a vein is visible by means of the imaging device (claim 17, [0014] and [0029], the control unit is adapted to: trigger the transducer to emit at least one beam of ultrasound waves when the treatment head is in the treatment position, and perform imaging of an area surrounding the tissue at least when the treatment head is in the monitoring position. The first operating mode corresponds to when the controller set the treatment head in the monitoring position; in [0029] at most is the compression reduces blood flow therefore the vein is still visible by means of imaging device; one would see the vein as a smaller lumen; according to applicant’s specification paragraph [0038] only completely block blood flow then the vein would not be visible) and
- in a second operating mode, the compression force applied to the patient tissue by the compression unit is maintained at a second compression force value, second compression force value higher than the first compression force value ([0029-0030], the control unit is adapted to bring the pressure in the balloon from the travel position to treatment position; the pressure at the treatment position is the second compression force value; [0030] discloses “In order to improve imaging and fix the tissue, the pressure in the balloon is then raised when the treatment head is in the treatment position. The pressure may be additionally raised/lowered accordingly when the treatment head is in the imaging position; when the pressure is lower in the imaging position (first operation mode) then the pressure (second compression force) in the treatment position (second operation mode) is higher than the pressure (first compression force) in the imaging position (first operation mode)), and the controller unit controls the ultrasound transducer to emit at least one pulse of treatment ultrasound waves (claim 17,[0014], the control unit is adapted to: trigger the transducer to emit at least one beam of ultrasound waves when the treatment head is in the treatment position. The second operating mode corresponds to when the controller set the treatment head is in the treatment position), wherein the second mode is adapted for at least partial collapsing of the blood vessel ([0029-0030], by increasing the pressure when the treatment head is in the treatment position (second mode) and/or in the monitoring position, the compression reduces blood flow in the tissue, thereby reducing also heat dissipation which is partially collapsing the blood vessel; according to applicant’s specification paragraphs [0006], [0014], [0038], [0159], [0169] vein collapse mean a device compress skin so that partially or completely restrict blood flow; partially collapse is when the device compress on the skin that reduce the vein and reduce blood flow; totally collapse is when the device compress the skin that completely restrict blood flow; in treatment position the compression reduce blood flow which is partially collapsing the blood vessel therefore Lacoste implicitly teaches wherein the second mode is adapted for at least partial collapsing of the blood vessel).
Lacoste does not explicitly disclose the blood vessel is a vein. On the other hand Anderson explicitly teaches at least partially collapsing of the vein (abstract, Figs. 2B, 3B, claims 1-3, A method of inducing a blood vessel in a tissue to degrade, the method comprising: non-invasively heating walls of the blood vessel to a temperature of at least about 60 degrees centigrade, and subsequently collapsing
the blood vessel and applying sufficient pressure to maintain the blood vessel in a collapsed state for at least one thermal relaxation time of the blood vessel; Anderson explicitly uses the term vein collapse). Anderson is used to explicitly disclose the term vein collapse and further clarify that reduce blood flow such as close vessel lumen is collapsing blood vessel/vein. Lacoste disclose reduce blood flow therefore Lacoste implicitly disclose blood vessel collapse. It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to incorporate method of collapsing the as taught by Anderson into modified Lacoste because doing so would have been allows user of modified Lacoste to treat various vein conditions.
Regarding claim 28, Lacoste teaches the ultrasound treatment device comprises:
a deformable coupling balloon arranged at a target side of the probe head ([0002], [0012], an inflatable balloon surrounding at least partially the treatment head, containing a coupling fluid and defining a contact surface of the treatment head is provided),
wherein a cavity between the probe head and the coupling balloon is filled or fillable with a coupling liquid ([0054], the transducer is enclosed by a flexible membrane 5 of a material with low ultrasound reflection and is filled with an ultrasound coupling fluid),
a pressure measuring unit for determining a pressure of the coupling liquid in the cavity ([0028]-[0029], Pressure control adjusts the pressure in the balloon to an optimal value. Specifically the control unit is adapted to bring the pressure in the balloon to a first value and to a second value different from the first value)
a fluid control system for controlling the pressure or a volume of the coupling liquid in the cavity, ([0027], the control unit control the pressure in the balloon. The pressure sensor and the at least one pump connected to the control unit for regulating the pressure in the balloon. The volume of the coupling fluid also be controlled and regulated by known means. The fluid control system corresponds to a sub a system of the control system that contain the pressure sensor and the at least one pump),
wherein the controller unit is connected at least to the pressure measuring unit(as discuss above pressure control measure the first pressure value and the second pressures value) the fluid control system ( as discuss above the sub a system of the control system that contain the pressure sensor and the at least one pump), the probe head ([0022], the control unit includes the treatment head) and the compression unit ([0022] the pumps that compress the balloon filled with air or liquid) and
in the first operating mode, the pressure of the coupling liquid is maintained at a first compression force value or at a first volume value ([0029]-[0030], the control unit is adapted to bring the pressure in the balloon to a first value when the treatment head is in the travel position), and in the second operating mode, the pressure of the coupling liquid is maintained at a second pressure value higher than the first compression force value ([0029], the control unit is adapted to bring the pressure in the balloon to a second value higher than the first value when the treatment head is in the treatment position and/or in the monitoring position).
Regarding claim 29, Lacoste teaches the controller unit is adapted to: - monitor the pressure of the coupling liquid determined by the at least one pressure measurement unit and to detect an increase of the pressure of the coupling liquid in the cavity ([0029], the control unit is adapted to bring the pressure in the balloon to a second value higher than the first value when the treatment head is in the treatment position and/or in the monitoring position. Further, by increasing the pressure when the treatment head is in the treatment position and/or in the monitoring position, the compression reduces blood flow in the tissue) when the ultrasound treatment device is in the first operating mode and the coupling balloon is arranged on the patient tissue(0028]-[0029], Pressure control adjusts the pressure in the balloon to an optimal value. Specifically the control unit is adapted to bring the pressure in the balloon to a first value and to a second value different from the first value),
- switch from the first operating mode to the second operating mode upon detection of a switching signal ([0005]-[0006], pause period is used to pause irradiation, in order allow the tissue region to cool down. Thus at the beginning of the pause period the treatment head move (switch)from the travel position to treatment position ),
- trigger emission of at least one pulse of treatment ultrasound waves after switching from the first operating mode to the second operating mode (claims19 and 22, [0022], the control unit is adapted to move the treatment head, after emission of an ultrasound pulse from the transducer, from the treatment position to the monitoring position. Thus at the beginning of the pause period the controller move (switch) treatment head from traveling position to treatment position), and
- switch from the second operating mode to the first operating mode after the emission of at least one pulse of treatment ultrasound waves (claims19 and 22, [0022], control unit is adapted to move the treatment head, after emission of an ultrasound pulse from the transducer, from the treatment position to the monitoring position. Thus, at the end of the pause period the controller move (switch) back the treatment head from the monitoring position to traveling position).
Regarding claim 36, Lacoste the controller unit is further adapted to automatically trigger emission of at least one pulse of treatment ultrasound waves after activation of the second operating mode ([0023], the control unit is adapted to move the treatment head, after emission of an ultrasound pulse from the transducer, from the treatment position to the monitoring position, in order to monitor the effect of the delivered ultrasound waves).
Regarding claim 37, Lacoste teaches the ultrasound treatment device further comprises a manual switch for triggering the emission of at least one pulse of treatment ultrasound waves by an operator([0022], first treatment head move from the travel position to the monitoring position by controlling the movement either manually by an operator by means of a display), and switching from the first operating mode to the second operating mode is performed automatically after triggering the emission of at least one pulse of treatment ultrasound waves (claims 18-22, [0022], the treatment head is adapted to be moved automatically to the treatment position for further emission of an ultrasound pulse from the transducer after the treatment head is brought from the treatment position to the monitoring position).
Regarding claim 38, Lacoste teaches wherein the ultrasound treatment device further comprises time measuring means for delaying the emission of at least one pulse of treatment ultrasound waves by a predetermined amount of time after the second operating mode is activated ([0005], it is common to operate a device for treatment in a way known as "pulse and pause method" wherein an irradiation period is followed by a pause period without irradiation, in order allow the tissue region to cool down.).
Regarding claim 39, Lacoste teaches the time measuring means are further adapted to automatically switch from the second operating mode to the first operating mode with a delay of a predetermined amount of time after emission of the treatment ultrasound waves ([0005]-[0006], pause period is used to pause irradiation, in order allow the tissue region to cool down. In addition pause period is used to allow the treatment head to the next location in a scanning pattern. Thus, at the end of the pause period treatment head move back from the monitoring position to the travel position).
Regarding claim 40, Lacoste teaches the controller unit is adapted to determine a position of the target based on the images captured by the imaging device ([0015], imaging is preferably performed only with the treatment head in the monitoring position. The control unit is adapted to allow the imaging operation only when the treatment head is in the appropriate position) and to switch to the second operating mode automatically when the position of the target is stable over a predetermined amount of time (claim 22, [0005], [0022], the treatment head is adapted to be moved automatically to the treatment position for further emission of an ultrasound pulse from the transducer after the treatment head is brought from the treatment position to the monitoring position. Thus, during the pause period the captured image is remain stable)
Regarding claim 42, the device perform the method therefore claim 42 is being rejected for the same reason as claim 25
Regarding claim 45, Lacoste teaches the method comprising the following steps:
a) placing a deformable coupling balloon arranged at a target side of the probe head ([0002], [0012], an inflatable balloon surrounding at least partially the treatment head, containing a coupling fluid and defining a contact surface of the treatment head is provided), wherein a cavity between the probe head and the coupling balloon is filled with a coupling liquid onto the patient tissue ([0054], the transducer is enclosed by a flexible membrane 5 of a material with low ultrasound reflection and is filled with an ultrasound coupling fluid) and activating a first operating mode where a pressure of the coupling liquid is maintained at a first compression force value (([0029]-[0030], the control unit is adapted to bring the pressure in the balloon to a first value when the treatment head is in the travel position)).
b) switching from the first operating mode to a second operating mode, wherein in the second operating mode the pressure of the coupling liquid is maintained at a second pressure value which is higher than the first compression force value ([0029], the control unit is adapted to bring the pressure in the balloon to a second value higher than the first value when the treatment head is in the treatment position and/or in the monitoring position) .
Regarding claim 46, Lacoste teaches wherein switching from the first operating mode to the second operating mode is performed upon detection of a switching signal(claims 19 and 22, [0022], control unit is adapted to move the treatment head, after emission of an ultrasound pulse from the transducer, from the treatment position to the monitoring position. Thus, at the end of the pause period the controller move (switch) back the treatment head from the monitoring position to traveling position).
Regarding claim 51, Anderson teaches the ultrasound treatment device is adapted for causing partial collapse of a vein by applying a pressure between 5 - 40 mbar (col.7 lines 30-43, col.2 line 30-38, the amount of pressure applied must be sufficient to bring the heated vessel walls fully into contact. At a minimum, this is somewhat greater than the blood pressure, which is at most about 1/3 atmosphere (atm) to directly compressing the blood vessel . Collapsing the blood vessel by applying pressure (e.g., 1 to 10 atmospheres) to the tissue surrounding the blood vessel for a period of time and with a force sufficient to collapse the blood vessel and to permanently weld the apposed walls of the blood vessel together, whereby the blood vessel undergoes necrosis.).
Regarding claim 52 Anderson teaches wherein the ultrasound treatment device is adapted for causing a complete collapse of the vein by applying a pressure between 30 - 200 mbar (col.7 lines 30-43, col.2 line 30-38, the amount of pressure applied must be sufficient to bring the heated vessel walls fully into contact. At a minimum, this is somewhat greater than the blood pressure, which is at most about 1/3 atmosphere (atm) to directly compressing the blood vessel . Collapsing the blood vessel by applying pressure (e.g., 1 to 10 atmospheres) to the tissue surrounding the blood vessel for a period of time and with a force sufficient to collapse the blood vessel and to permanently weld the apposed walls of the blood vessel together, whereby the blood vessel undergoes necrosis.
3. Claims 31-35 and 47-49 are rejected under 35 U.S.C. 103 as being unpatentable over Lacoste, US 20170001043 A1,in view of Anderson, US 6306130 B1, still further in view of McEwen et al., (hereafter McEwen), US Patent Application Publication No.: US 20100191277 A1, published on Jan.29, 2010.
Regarding claim 31, Lacoste teaches the controller unit is further adapted to switch from the first operating mode to the second operating mode when the detected pressure increase ([0029], the control unit is adapted to bring the pressure in the balloon to a second value higher than the first value when the treatment head is in the treatment position and/or in the monitoring position. Further, by increasing the pressure when the treatment head is in the treatment position and/or in the monitoring position, the compression reduces blood flow in the tissue);
however, it is noted that Lacoste doesn’t specifically teach switching by comparing the pressure with the predetermined threshold.
On the other hand McEwen teaches the controller unit is further adapted to switch from the first operating mode to the second operating mode when the detected pressure increase ( [0032], first automatically increasing the pressure until blood flow sensed is less than a predetermined minimum. Then, pressure is continuously varied (switched) by incrementally increasing and decreasing the pressure applied by proximal bladder 28 to maintain the rate of blood flow sensed below and near the predetermined minimum threshold.)
It would have been obvious to a person of ordinary skill in the art at the time of filing to incorporate a method of controlling a pressure continuously by incrementally increasing the pressure when the pressure is below a predetermined value and decreasing the pressure when the pressure is above a predetermined threshold value taught by McEwen into modifide Lacoste
The suggestion motivation doing so is allow dynamical controlling blood flow through a zone of a patient by adjusting the pressure, further adjusting the pressure minimize blood loss during a surgery by stopping blood flow from the selected portion of the surgical patient's (McEwen: [0007]).
Regarding claim 32, McEwen teaches the controller unit is further adapted to switch from the first operating mode to the second operating mode when the detected pressure increase is above a threshold value and then below a second threshold value ([0032], first automatically increasing the pressure until blood flow sensed
It would have been obvious to a person of ordinary skill in the art at the time of filing to incorporate a method of controlling a pressure near to a minimum pressure in order to stop arterial blood flow into a portion of a surgical patient's limb taught by Lacoste into McEwen.
The suggestion motivation doing so is to minimize blood loss during a surgery by stopping
blood flow from the selected portion of the surgical patient's (McEwen: [0007]).
Regarding claim 33, McEwen teaches the controller unit is further adapted to switch from the second operating mode to the first operating mode when a detected pressure decrease is below a threshold value (TS3) ([0032], first automatically increasing the pressure until blood flow sensed beneath the cuff is less than a predetermined minimum. Then, pressure is continuously varied (switched) by incrementally increasing and decreasing the pressure. Thus, the pressure incrementally increases from the near predetermined minimum threshold value until it reaches the predetermined minimum value)
It would have been obvious to a person of ordinary skill in the art at the time of filing to incorporate a method of controlling a pressure continuously by incrementally increasing the pressure when the pressure is below a predetermined value and decreasing the pressure when the pressure is above a predetermined threshold value taught by McEwen into Lacoste
The suggestion motivation doing so is allow dynamical controlling blood flow through a zone of a patient by adjusting the pressure, further adjusting the pressure minimize blood loss during a surgery by stopping blood flow from the selected portion of the surgical patient's (McEwen: [0007])
Regarding claim 34, Lacoste teaches the ultrasound treatment device further comprises at least one force sensor connected to the controller unit [0027]-[0029], as discussed in claim 25 above the pressure sensor and the at least one pump are connected to the control unit for regulating the pressure in the balloon. The control unit bring the pressure in the balloon to a first value when the treatment head is in the travel position and to the second value higher than the first value when the treatment head is in the treatment position. Thus, force sensor corresponds to the pressure sensor, since the pressure measure the compression force), and to switch the ultrasound treatment device in the second operating mode ([0029]-[0030], the control unit is adapted to bring the pressure in the balloon to a first value and to a second. Thus, the controller switch the pump between two alternative states).
However, it is noted that Lacoste does not specifically teach” the controller unit is further adapted to compare a force determined by the force sensor with a threshold value and to switch the ultrasound treatment device in the second operating mode when the force determined by the force sensor is above the threshold value.”
On the other hand McEwen specifically teaches the controller unit is further adapted to compare a force determined by the force sensor with a threshold value (([0032], McEwen specifically teaches first automatically increasing the pressure until blood flow sensed is less than a predetermined minimum threshold. The force corresponds to the pressure since pressure is force per unit area) and to switch when the force determined by the force sensor is above the threshold value ([0032], after the pressure reaches the predetermined minimum threshold , is pressure is continuously varied (switched) by incrementally increasing and decreasing the pressure to maintain the rate of blood flow sensed below and near the predetermined minimum threshold. Thus, based on the above discussion the pressure is oscillating (switch) between the predetermined minimum threshold value and the value near to the predetermined minimum threshold value which is equal to the predetermined minimum threshold value minus the increment value).
Regarding claim 35, Lacoste teaches the controller unit is further adapted to switch from the second operating mode to the first operating mode after emission of at least one pulse of treatment ultrasound waves (claims18-20, [0021], Lacoste teaches the control unit move the treatment head from the travel position to the treatment position before an ultrasound pulse is emitted from the transducer, and the control unit trigger the transducer to emit at least one beam of ultrasound waves when the treatment head is in the treatment position, position. Thus, in travel position the ultrasound pulse is not emitted)
However, it is noted that Lacoste does not specifically teach “when the force determined by the force sensor is below a second threshold value “
On the other hand McEwen specifically teaches when the force determined by the force sensor is below a second threshold value ([0032], McEwen specifically teaches as discuss above pressure is continuously varied (switched) by incrementally increasing and decreasing the pressure to maintain the rate of blood flow sensed below and near the predetermined minimum threshold. Thus, based on the above discussion the pressure is oscillating (switch) between the predetermined minimum threshold value and the value near to the predetermined minimum threshold value which is equal to the predetermined minimum threshold value minus the increment value. The second threshold value corresponds to predetermined minimum threshold value minus the increment value)
Regarding claim 47, Lacoste teaches the step of monitoring the pressure of the coupling liquid by means of a controller unit connected to a pressure measurement unit for determining the pressure of the coupling liquid in the cavity and to detecting an increase of the pressure of the coupling liquid in the cavity ([0029], the control unit is adapted to bring the pressure in the balloon to a second value higher than the first value when the treatment head is in the treatment position and/or in the monitoring position. Further, by increasing the pressure when the treatment head is in the treatment position and/or in the monitoring position, the compression reduces blood flow in the tissue),
however, it is noted that Lacoste does not specifically teach “wherein the switching signal is generated if the detected pressure increase is above a predetermined pressure threshold value.”
On the other hand McEwen specifically teaches wherein the switching signal is generated if the detected pressure increase is above a predetermined pressure threshold value (([0032], McEwen specifically teaches when the pressure reaches the predetermined minimum threshold, the is pressure is continuously varied (switched) by incrementally increasing and decreasing the pressure to maintain the rate of blood flow sensed below and near the predetermined minimum threshold).
Regarding claim 48, Lacoste teaches the step of monitoring the pressure of the coupling liquid by means of a controller unit connected to a pressure measurement unit for determining a pressure of the coupling liquid in the cavity and to detecting an increase of the pressure of the coupling liquid in the cavity ([0029], the control unit is adapted to bring the pressure in the balloon to a second value higher than the first value when the treatment head is in the treatment position and/or in the monitoring position. Further, by increasing the pressure when the treatment head is in the treatment position and/or in the monitoring position, the compression reduces blood flow in the tissue),
however, it is noted that Lacoste does not specifically teach” the switching signal is generated if the detected pressure increase is above a predetermined pressure threshold value and the measured pressure then drops below a second threshold value”
On the other hand McEwen specifically teaches the switching signal is generated if the detected pressure increase is above a predetermined pressure threshold value and the measured pressure then drops below a second threshold value” ([0032], McEwen specifically teaches first automatically increasing the pressure until blood flow sensed is less than a predetermined minimum threshold. The force corresponds to the pressure since pressure is force per unit area, after the pressure reaches the predetermined minimum threshold , the is pressure is continuously varied (switched) by incrementally increasing and decreasing the pressure to maintain the rate of blood flow sensed below and near the predetermined minimum threshold. Thus, based on the above discussion the pressure is oscillating (switch) between the predetermined minimum threshold value(first threshold ) and the value near to the predetermined minimum threshold value which is equal to the predetermined minimum threshold value minus the increment value (second threshold))
Regarding claim 49, Lacoste teaches the step of monitoring the pressure of the coupling liquid by means of a controller unit connected to a pressure measurement unit for determining a pressure of the coupling liquid in the cavity and to detecting an increase of the pressure of the coupling liquid in the cavity ([0029], the control unit is adapted to bring the pressure in the balloon to a second value higher than the first value when the treatment head is in the treatment position and/or in the monitoring position. Further, by increasing the pressure when the treatment head is in the treatment position and/or in the monitoring position, the compression reduces blood flow in the tissue), and to detecting a decrease of the pressure of the coupling liquid in the cavity ([0027], the control unit or other adequate means for regulating the pressure in the balloon. Thus, the controller regulate the pressure by increasing and decreasing the pressure), and a switching signal for switching the ultrasound treatment device from the second operating mode to the first operating mode is generated ([0029], the control unit is adapted to bring the pressure in the balloon to a second value higher than the first value when the treatment head is in the treatment position and/or in the monitoring position. Thus, the controller includes trigger unit that switch pressure from the first level to the second level);
however, it is noted that Lacoste does not specifically teach” if the detected pressure decrease is below a pre-determined pressure threshold value.
On the other hand McEwen specifically teaches the switching signal is generated if the detected pressure increase is above a predetermined pressure threshold value and the measured pressure then drops below a second threshold value ([0032], McEwen specifically teaches the is pressure is continuously varied (switched) by incrementally increasing and decreasing the pressure to maintain the rate of blood flow sensed below and near the predetermined minimum threshold. Thus, based on the above discussion the pressure is oscillating (switch) between the predetermined minimum threshold value(first threshold ) and the value near to the predetermined minimum threshold value which is equal to the predetermined minimum threshold value minus the increment value (second threshold). The pressure is incrementally increasing when the pressure is below the near the predetermined minimum threshold).
4. Claims 41 and 50 are rejected under 35 U.S.C. 103 as being unpatentable over Lacoste, US 20170001043 A1, in view of Anderson, US 6306130 B1, further in view of Germain et al. ,( hereafter Germain), US20130172870 , published on July 4, 2013.
Regarding claim 41, Lacoste teaches the ultrasound treatment device is further adapted to switch to an operating mode, and in the operating mode the compression force applied to the patient tissue by the compression unit ([0029], the control unit is adapted to bring the pressure in the balloon to a second value higher than the first value when the treatment head is moved(switched) from travelling position to in the treatment position and/or in the monitoring position);
however, it is noted that Lacoste does not specifically teach “ third operation mode, and the compression force applied to the patient tissue by the compression unit is maintained at a third compression force value, or the volume of the liquid in a cavity is maintained to a third volume value”
On the other hand Germain specifically teaches the volume of the liquid in the cavity is maintained to a third volume value ([0090]-[0091], Germain specifically teaches a fluid management system comprising a distending fluid source, a pump mechanism and a controller for controlling inflows and outflows of a distending fluid from the body cavity, wherein the fluid management system is configured to deliver a distension fluid volume of less than 400 mL/min, less than 300 mL/min or less than 200 mL/min).
It would have been obvious to a person of ordinary skill in the art at the time of filing to incorporate a method of capture fluid loss through the access to the body space, measure such lost fluid volume, and calculate the fluid deficit taking into account the lost fluid volume taught by Germain (see [0100]) into Lacoste. The suggestion motivation doing so is to allow user of Lacoste to monitor and signal one or more fluid deficit parameters on an intermittent or continuous basis
Claim 50 is rejected the same as claim 41 except claim 50 is directed to a method claim. Thus, argument analogous to that presented above for claim 41 is applicable to claim 50.
Response to Argument
Applicant's arguments filed 02/06/26 have been fully considered but they are not persuasive. Applicant argues Lacoste does not explicitly discuss compression forces or pressures exerted on the tissue at all. Applicant’s argument is not persuasive because Lacoste explicitly discloses compression force put pressure on the tissue that cause a reduction in blood flow (see [0029]; “the control unit is adapted to bring the pressure in the balloon to a first value when the treatment head is in the travel position and to a second value higher than the first value when the treatment head is in the treatment position and/or in the monitoring position… by increasing the pressure when the treatment head is in the treatment position and/or in the monitoring position, the compression reduces blood flow in the tissue”; increasing the pressure mean increase the pressure in the balloon to exert pressure on the tissue). It is clear Lacoste disclose increase balloon pressure to increase compression force on the tissue. Applicant argues Lacoste’s paragraph [0013] discloses the distance between tissue and transducer is reduced in the monitoring position, then the transducer moves close to the tissue and the pressure is higher. Applicant’s argument is not persuasive because applicant does not look at the whole prior art, but only focus on certain paragraph and Figure. It is correct that when the distance between tissue and transducer is reduced in the monitoring position, then the transducer moves close to the tissue and the pressure/compression force is higher on the tissue and this is opposite with claims 24 and 42. The pressure in the balloon is higher then the distance between tissue and transducer is reduced. When the pressure in the balloon is higher, the pressure/compression force on the tissue also higher. However, in paragraph [0030], Lacoste discloses “the pressure may be additionally raised/lowered accordingly when the treatment head is in the imaging position”, when the distance between tissue and transducer is reduced in the monitoring position, this is when pressure is additionally raised when the treatment head is in the imaging position compare to treatment position. This is only one embodiment and paragraph [0013] and Fig. 1 disclose this embodiment. When the pressure is lowered when the treatment head in the imaging position compare to treatment position then the distance between tissue and transducer is increase and the pressure on the tissue decrease. Applicant’s argument pointed to just one paragraph and one embodiment and fail to see examiner citation of paragraphs [0029-0030]. The distance between tissue and transducer depends on increase or decrease pressure of the balloon. When an operator presses the treatment head cover by balloon with fluid against the skin that is when operator exert pressure in the balloon. Therefore, when the treatment head is closer to skin the pressure in the balloon increase. An operator/control unit increases the pressure in the balloon by pressing it harder/closer to the skin. The distance between tissue and transducer increase, pressure in the decrease. The distance between tissue and transducer decreases, pressure in the balloon increase. Applicant argues paragraph [0030] refers to the pressure in the balloon and not the pressure exerted on the patient’s tissue as required by claim 25 and 42. Applicant’s argument is not persuasive because the pressure in the balloon is the pressure exerted on the patient’s tissue (see [0029]). Only the pressure in the balloon exert pressure on the tissue. Applicant argues nothing in Lacoste indicates that the pressure raise in the balloon would offset increase distance. Applicant’s argument is not persuasive because when the treatment head is closer to the tissue is when the pressure in the balloon increase therefore when there is less pressure in the balloon the distance between the transducer and the tissue reduce as see in paragraphs [0029-0030] and Fig. 1. In travel position the pressure in the balloon is lower therefore the treatment head is farther away from the tissue.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US 7,153,298 (see claim 1 and Figs. 3-4) and US 2007/0239041 (see [0013] and Fig. 4).
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HIEN NGOC NGUYEN whose telephone number is (571)270-7031. The examiner can normally be reached Monday-Thursday 8:30am-6:30pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anne Kozak can be reached at 571-270-0552. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/HIEN N NGUYEN/
Primary Examiner
Art Unit 3797