DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 3, and 9-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Harmouche, US 20190247105, herein referred to as “Harmouche”.
Regarding claim 1, Harmouche discloses a method for estimating an amount of cryogenic fluid in a cryogenic fluid supply vessel (Figure 2), the method comprising: releasing pressure from the cryogenic fluid supply vessel at a predetermined frequency via a control valve ([0036]: “The control system 14 can also control various structures that are responsible for maintaining and/or adjusting a flow rate and/or pressure of the cryogenic fluid 28 that is released to the balloon catheter 18 during a cryoablation procedure.” And [0050]: “In certain embodiments, the first fluid sensor 230 and/or the second fluid sensor 232 can be positioned adjacent to the fluid container 216 in order to monitor the fluid pressure immediately after the cryogenic fluid 228 exits and/or is released from the fluid container 216.”); detecting a disturbance in an output signal of a pressure feedback sensor, the disturbance occurring at the predetermined frequency (Figure 2: second fluid sensor 232 and [0050]: “the second fluid sensor 232 can include a pressure gauge that monitors the fluid pressure of the cryogenic fluid 228 within the fluid container 216”); determining a magnitude of the disturbance in the output signal of the pressure feedback sensor (Figure 2: second fluid sensor 232 and [0050]: “the second fluid sensor 232 can include a pressure gauge that monitors the fluid pressure of the cryogenic fluid 228 within the fluid container 216”); and estimating the amount of the cryogenic fluid in the cryogenic fluid supply vessel based on the magnitude of the disturbance in the output signal of the pressure feedback sensor ([0051]: “In this example, the first fluid sensor 230 and/or the second fluid sensor 232 can sense and/or measure the residual fluid quantity based on a pressure of the cryogenic fluid 228 within the fluid container 216, a weight of the cryogenic fluid 228 therein, and/or a combination of the pressure and/or weight.”).
Regarding claim 3, Harmouche discloses the method of claim 1, wherein releasing the pressure from the cryogenic fluid supply vessel at the predetermined frequency via the control valve comprises operating a pressure regulator to open and close the control valve ([0036]: “The control system 14 can also control various structures that are responsible for maintaining and/or adjusting a flow rate and/or pressure of the cryogenic fluid 28 that is released to the balloon catheter 18 during a cryoablation procedure.”).
Regarding claim 9, Harmouche discloses the method of claim 1, wherein the cryogenic fluid in the cryogenic fluid supply vessel comprises liquid nitrogen ([0037]: “In another non-exclusive embodiment, the cryogenic fluid 28 can include liquid nitrogen.”), and wherein estimating the amount of the cryogenic fluid in the cryogenic fluid supply vessel based on the magnitude of the disturbance in the output signal of the pressure feedback sensor comprises estimating the amount of the liquid nitrogen in the cryogenic fluid supply vessel based on the magnitude of the disturbance in the output signal of the pressure feedback sensor ([0051]: “In this example, the first fluid sensor 230 and/or the second fluid sensor 232 can sense and/or measure the residual fluid quantity based on a pressure of the cryogenic fluid 228 within the fluid container 216, a weight of the cryogenic fluid 228 therein, and/or a combination of the pressure and/or weight.”).
Regarding claim 10, Harmouche discloses the method of claim 1, further comprising providing an indication regarding the amount of cryogenic fluid present in the cryogenic fluid supply vessel (Claim 8).
Regarding claim 11, Harmouche discloses the method of claim 10, wherein providing the indication regarding the amount of cryogenic fluid present in the cryogenic fluid supply vessel comprises providing an indication that the amount of cryogenic fluid present is sufficient to complete a freezing cycle and/or a treatment cycle of a cryogen delivery system utilizing the cryogenic fluid supply vessel and/or providing an indication that the amount of cryogenic fluid present is insufficient to complete a freezing cycle and/or a treatment cycle of the cryogen delivery system ([0043]).
Regarding claim 12, Harmouche discloses the method of claim 1, wherein: detecting a disturbance in the output signal of the pressure feedback sensor comprises detecting a ripple in the output signal of the pressure feedback sensor, and determining the magnitude of the disturbance in the output signal of the pressure feedback sensor comprising calculating a magnitude of the ripple in the output signal of the pressure feedback sensor ([0050]: “the second fluid sensor 232 can include a pressure gauge that monitors the fluid pressure of the cryogenic fluid 228 within the fluid container 216.” And [0051]).
Regarding claim 13, Harmouche discloses the method of claim 12, wherein the magnitude of the ripple is proportional to a volume of the cryogenic fluid in the cryogenic fluid supply vessel ([0050]: “the second fluid sensor 232 can include a pressure gauge that monitors the fluid pressure of the cryogenic fluid 228 within the fluid container 216.” And [0051]).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Harmouche in view of Huster et al., US 20080000477, herein referred to as “Huster”.
Regarding claim 2, Harmouche discloses the method of claim 1, wherein: detecting the disturbance in the output signal of the pressure feedback sensor comprises detecting a 3.33 Hz disturbance in the output signal of the pressure feedback sensor (Figure 2: second fluid sensor 232 and [0050]: “the second fluid sensor 232 can include a pressure gauge that monitors the fluid pressure of the cryogenic fluid 228 within the fluid container 216”). Harmouche does not explicitly disclose a method wherein: releasing the pressure from the cryogenic fluid supply vessel at the predetermined frequency comprises releasing the pressure from the cryogenic fluid supply vessel at a rate of about 3.33 Hz.
However, Huster teaches a method wherein: releasing the pressure from the cryogenic fluid supply vessel at the predetermined frequency comprises releasing the pressure from the cryogenic fluid supply vessel at a rate of about 3.33 Hz (Figure 3: frequency control 136 and [0083]: “The pressure control 134 is operable to vary a base line pressure or steady state pressure about which the air pulses oscillate and the frequency control 136 is operable to vary the frequency of the air pulses.” And [0086]: “In the illustrated embodiment, the frequency of the air pulses applied to the bladder 114 of vest 106 is adjustable to be from about 0 Hertz (Hz) to about 20 Hz as indicated by the indicia adjacent to control 136 shown in FIG. 3.”).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to release the pressure from the cryogenic fluid supply vessel at a rate of about 3.33 Hz, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Claims 4-8 and 14-19 are rejected under 35 U.S.C. 103 as being unpatentable over Harmouche in view of Tegg et al., US 20210177484, herein referred to as “Tegg”.
Regarding claim 4, Harmouche discloses the method of claim 1, but does not explicitly disclose a method further comprising, prior to releasing the pressure from the cryogenic fluid supply vessel, supplying a constant pressure to the cryogenic fluid supply vessel via a compressor.
However, Tegg teaches a method comprising, prior to releasing the pressure from the cryogenic fluid supply vessel, supplying a constant pressure to the cryogenic fluid supply vessel via a compressor ([0038]).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the method disclosed by Harmouche so it includes, prior to releasing the pressure from the cryogenic fluid supply vessel, supplying a constant pressure to the cryogenic fluid supply vessel via a compressor as taught by Tegg to ensure that the cryogenic fluid avoids a pre-mature phase change (Tegg [0038]).
Regarding claim 5, Harmouche in view of Tegg discloses the method claim 4, and Tegg further discloses a method wherein releasing the pressure from the cryogenic fluid supply vessel comprises releasing a combined pressure from the cryogenic fluid supply vessel, the combined pressure including the supplied constant pressure ([0038]: “the ablation subsystem 180 may pressure/re-pressurize the cryogenic fluid, for example, via compressor.”) and a fluid pressure from the cryogenic fluid in the cryogenic fluid supply vessel ([0047]).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the method disclosed by Harmouche so it includes releasing a combined pressure from the cryogenic fluid supply vessel, the combined pressure including the supplied constant pressure and a fluid pressure from the cryogenic fluid in the cryogenic fluid supply vessel as taught by Tegg to ensure that the cryogenic fluid avoids a pre-mature phase change (Tegg [0038]).
Regarding claim 6, Harmouche in view of Tegg discloses the method claim 5, and Tegg further discloses a method wherein releasing the combined pressure from the cryogenic fluid supply vessel comprises regulating the pressure in the cryogenic fluid supply vessel to a pre- established level ([0038]).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the method disclosed by Harmouche so it includes releasing the combined pressure from the cryogenic fluid supply vessel comprises regulating the pressure in the cryogenic fluid supply vessel to a pre- established level as taught by Tegg to ensure that the cryogenic fluid avoids a pre-mature phase change (Tegg [0038]).
Regarding claim 7, Harmouche discloses the method of claim 1, but does not explicitly disclose a method wherein estimating the amount of the cryogenic fluid in the cryogenic fluid supply vessel comprises estimating a volume of the cryogenic fluid in the cryogenic fluid supply vessel during a cryogenic procedure utilizing the cryogenic fluid supply vessel.
However, Tegg teaches a method wherein estimating the amount of the cryogenic fluid in the cryogenic fluid supply vessel comprises estimating a volume of the cryogenic fluid in the cryogenic fluid supply vessel during a cryogenic procedure utilizing the cryogenic fluid supply vessel ([0007]).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the method disclosed by Harmouche so it includes estimating the amount of the cryogenic fluid in the cryogenic fluid supply vessel comprises estimating a volume of the cryogenic fluid in the cryogenic fluid supply vessel during a cryogenic procedure utilizing the cryogenic fluid supply vessel as taught by Tegg to regulate the cryogenic fluid based on the progress of an ablation therapy on target tissue (Tegg [0008]).
Regarding claim 8, Harmouche discloses the method of claim 1, but does not explicitly disclose a method wherein determining the magnitude of the disturbance in the output signal of the pressure feedback sensor comprises extracting the disturbance from the output signal and applying a min/max detection algorithm and/or a discrete Fourier transform (DFT) to the disturbance.
However, Tegg teaches a method wherein determining the magnitude of the disturbance in the output signal of the pressure feedback sensor comprises extracting the disturbance from the output signal and applying a min/max detection algorithm and/or a discrete Fourier transform (DFT) to the disturbance ([0047]: “The controller circuitry 176 monitors the head pressure, and in response to a head pressure exceeding a threshold pressure, a valve fluidly coupled to lumen 170.sub.4 may be opened to exhaust some or all of the cryogenic fluid within the lumen.” And [0074]: “However, in some embodiments, for example where the exhaust pressure is below a threshold range, the normally open valve 588 may be closed and a flow control valve 572 actuated.”).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the method disclosed by Harmouche so it includes determining the magnitude of the disturbance in the output signal of the pressure feedback sensor comprises extracting the disturbance from the output signal and applying a min/max detection algorithm and/or a discrete Fourier transform (DFT) to the disturbance as taught by Tegg to ensure that the cryogenic fluid avoids a pre-mature phase change (Tegg [0038]).
Regarding claim 14, Harmouche discloses a method for estimating an amount of liquid nitrogen ([0037]: “In another non-exclusive embodiment, the cryogenic fluid 28 can include liquid nitrogen.”) in a cryogenic fluid supply vessel during a cryoablation procedure (Figure 2), the method comprising: regulating a pressure in the cryogenic fluid supply vessel by releasing the pressure from the cryogenic fluid supply vessel ([0036]: “The control system 14 can also control various structures that are responsible for maintaining and/or adjusting a flow rate and/or pressure of the cryogenic fluid 28 that is released to the balloon catheter 18 during a cryoablation procedure.” And [0050]: “In certain embodiments, the first fluid sensor 230 and/or the second fluid sensor 232 can be positioned adjacent to the fluid container 216 in order to monitor the fluid pressure immediately after the cryogenic fluid 228 exits and/or is released from the fluid container 216.”); detecting a ripple in an output signal of a pressure feedback sensor of the cryogen delivery system, the ripple occurring at a frequency corresponding to a rate of pressure release from the cryogenic fluid supply vessel (Figure 2: second fluid sensor 232 and [0050]: “the second fluid sensor 232 can include a pressure gauge that monitors the fluid pressure of the cryogenic fluid 228 within the fluid container 216”); determining a magnitude of the ripple in the output signal of the pressure feedback sensor (Figure 2: second fluid sensor 232 and [0050]: “the second fluid sensor 232 can include a pressure gauge that monitors the fluid pressure of the cryogenic fluid 228 within the fluid container 216”); and estimating a remaining amount of the liquid nitrogen in the cryogenic fluid supply vessel based on the magnitude of the ripple in the output signal of the pressure feedback sensor ([0051]: “In this example, the first fluid sensor 230 and/or the second fluid sensor 232 can sense and/or measure the residual fluid quantity based on a pressure of the cryogenic fluid 228 within the fluid container 216, a weight of the cryogenic fluid 228 therein, and/or a combination of the pressure and/or weight.”). Harmouche does not explicitly disclose a method comprising: supplying a constant pressure to the cryogenic fluid supply vessel via a compressor of a cryogen delivery system; the pressure from the cryogenic fluid supply vessel comprising a combination of the constant pressure from the compressor and a fluid pressure from a volume of liquid nitrogen in the cryogenic fluid supply vessel.
However, Tegg teaches a method comprising supplying a constant pressure to the cryogenic fluid supply vessel via a compressor of a cryogen delivery system ([0038]); the pressure from the cryogenic fluid supply vessel comprising a combination of the constant pressure from the compressor ([0038]: “the ablation subsystem 180 may pressure/re-pressurize the cryogenic fluid, for example, via compressor.”) and a fluid pressure from a volume of liquid nitrogen in the cryogenic fluid supply vessel ([0047]).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the method disclosed by Harmouche so it includes supplying a constant pressure to the cryogenic fluid supply vessel via a compressor of a cryogen delivery system; the pressure from the cryogenic fluid supply vessel comprising a combination of the constant pressure from the compressor and a fluid pressure from a volume of liquid nitrogen in the cryogenic fluid supply vessel as taught by Tegg to ensure that the cryogenic fluid avoids a pre-mature phase change (Tegg [0038]).
Regarding claim 15, Harmouche in view of Tegg discloses the method of claim 14, and Tegg further discloses a method wherein regulating the pressure in the cryogenic fluid supply vessel comprises releasing the pressure from the cryogenic fluid supply vessel at a predetermined frequency by operating a pressure regulator to open and close a control valve at the predetermined frequency to regulate the pressure in the cryogenic fluid supply vessel to about 30 psi ([0049]: “Where the pressure within the exhaust lumen, and thereby the pressure in the balloon, exceeds safe operating limits (e.g., greater than 30 PSI, or greater than 35 PSI) the pressure blow-off valve reduces the pressure therein by releasing some of the exhaust into the surrounding atmosphere to mitigate the likelihood of a rupture of the balloon 130.”).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the method disclosed by Harmouche so it includes regulating the pressure in the cryogenic fluid supply vessel comprises releasing the pressure from the cryogenic fluid supply vessel at a predetermined frequency by operating a pressure regulator to open and close a control valve at the predetermined frequency to regulate the pressure in the cryogenic fluid supply vessel to about 30 psi as taught by Tegg to mitigate the likelihood of a rupture of the device (Tegg [0049]).
Regarding claim 16, Harmouche discloses a method of ablating a target tissue during a cryoablation procedure (Abstract), the method comprising: inserting a cryogenic probe of a cryogen delivery system into a treatment region of a patient ([0038]: “As shown, the balloon catheter 18 is inserted into the body of the patient 12 during the cryoablation procedure.”), the cryogenic probe being in fluid communication with a cryogenic fluid supply vessel containing liquid nitrogen (Figure 2: fluid container 216 and [0037]: “In another non-exclusive embodiment, the cryogenic fluid 28 can include liquid nitrogen.”); supplying a pressure to the cryogenic fluid supply vessel during a freeze cycle of the cryoablation procedure to supply the liquid nitrogen to the cryogenic probe ([0004] and [0036]: “The control system 14 can also control various structures that are responsible for maintaining and/or adjusting a flow rate and/or pressure of the cryogenic fluid 28 that is released to the balloon catheter 18 during a cryoablation procedure.”); regulating a pressure in the cryogenic fluid supply vessel by releasing the pressure from the cryogenic fluid supply vessel ([0036]: “The control system 14 can also control various structures that are responsible for maintaining and/or adjusting a flow rate and/or pressure of the cryogenic fluid 28 that is released to the balloon catheter 18 during a cryoablation procedure.” And [0050]: “In certain embodiments, the first fluid sensor 230 and/or the second fluid sensor 232 can be positioned adjacent to the fluid container 216 in order to monitor the fluid pressure immediately after the cryogenic fluid 228 exits and/or is released from the fluid container 216.”), and monitoring an amount of liquid nitrogen remaining in the cryogenic fluid supply vessel during the freeze cycle (Figure 1: residual fluid measurement system) by: detecting a ripple in an output signal of a pressure feedback sensor of the cryogen delivery system, the ripple occurring at a frequency corresponding to a rate of pressure release from the cryogenic fluid supply vessel (Figure 2: second fluid sensor 232 and [0050]: “the second fluid sensor 232 can include a pressure gauge that monitors the fluid pressure of the cryogenic fluid 228 within the fluid container 216”); determining a magnitude of the ripple in the output signal of the pressure feedback sensor (Figure 2: second fluid sensor 232 and [0050]: “the second fluid sensor 232 can include a pressure gauge that monitors the fluid pressure of the cryogenic fluid 228 within the fluid container 216”); and based on the magnitude of the ripple in the output signal of the pressure feedback sensor, estimating an amount of the liquid nitrogen remaining in the cryogenic fluid supply vessel ([0051]: “In this example, the first fluid sensor 230 and/or the second fluid sensor 232 can sense and/or measure the residual fluid quantity based on a pressure of the cryogenic fluid 228 within the fluid container 216, a weight of the cryogenic fluid 228 therein, and/or a combination of the pressure and/or weight.”). Harmouche does not explicitly disclose a method comprising: supplying a constant pressure to the cryogenic fluid supply vessel via a compressor of a cryogen delivery system; the pressure from the cryogenic fluid supply vessel comprising a combination of the constant pressure from the compressor and a fluid pressure from a volume of liquid nitrogen in the cryogenic fluid supply vessel.
However, Tegg teaches a method comprising supplying a constant pressure to the cryogenic fluid supply vessel via a compressor of a cryogen delivery system ([0038]); the pressure from the cryogenic fluid supply vessel comprising a combination of the constant pressure from the compressor ([0038]: “the ablation subsystem 180 may pressure/re-pressurize the cryogenic fluid, for example, via compressor.”) and a fluid pressure from a volume of liquid nitrogen in the cryogenic fluid supply vessel ([0047]).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the method disclosed by Harmouche so it includes supplying a constant pressure to the cryogenic fluid supply vessel via a compressor of a cryogen delivery system; the pressure from the cryogenic fluid supply vessel comprising a combination of the constant pressure from the compressor and a fluid pressure from a volume of liquid nitrogen in the cryogenic fluid supply vessel as taught by Tegg to ensure that the cryogenic fluid avoids a pre-mature phase change (Tegg [0038]).
Regarding claim 17, Harmouche in view of Tegg discloses the method of claim 16, and Harmouche further discloses a method wherein: monitoring the amount of liquid nitrogen remaining in the cryogenic fluid supply vessel during the freeze cycle comprises monitoring an amount of liquid nitrogen remaining in the cryogenic fluid supply vessel during the first freeze cycle (Figure 2: second fluid sensor 232 and [0050]: “the second fluid sensor 232 can include a pressure gauge that monitors the fluid pressure of the cryogenic fluid 228 within the fluid container 216”). Tegg discloses a method wherein: supplying the constant pressure to the cryogenic fluid supply vessel via the compressor of the cryogen delivery system during the freeze cycle of the cryoablation procedure comprises supplying a constant pressure to the cryogenic fluid supply vessel via the compressor of the cryogen delivery system during a first freeze cycle of the cryoablation procedure ([0038]).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the method disclosed by Harmouche so it includes supplying the constant pressure to the cryogenic fluid supply vessel via the compressor of the cryogen delivery system during the freeze cycle of the cryoablation procedure comprises supplying a constant pressure to the cryogenic fluid supply vessel via the compressor of the cryogen delivery system during a first freeze cycle of the cryoablation procedure as taught by Tegg to ensure that the cryogenic fluid avoids a pre-mature phase change (Tegg [0038]).
Regarding claim 18, Harmouche in view of Tegg discloses the method of claim 17, and Harmouche further discloses a method wherein: monitoring the amount of liquid nitrogen remaining in the cryogenic fluid supply vessel during the freeze cycle comprises monitoring an amount of liquid nitrogen remaining in the cryogenic fluid supply vessel during the second freeze cycle (Figure 2: second fluid sensor 232 and [0050]: “the second fluid sensor 232 can include a pressure gauge that monitors the fluid pressure of the cryogenic fluid 228 within the fluid container 216”). Tegg discloses a method wherein: supplying the constant pressure to the cryogenic fluid supply vessel via the compressor of the cryogen delivery system during the freeze cycle of the cryoablation procedure comprises supplying a constant pressure to the cryogenic fluid supply vessel via the compressor of the cryogen delivery system during a second freeze cycle of the cryoablation procedure, the second freeze cycle occurring at a later time than the first freeze cycle ([0038]).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the method disclosed by Harmouche so it includes supplying the constant pressure to the cryogenic fluid supply vessel via the compressor of the cryogen delivery system during the freeze cycle of the cryoablation procedure comprises supplying a constant pressure to the cryogenic fluid supply vessel via the compressor of the cryogen delivery system during a second freeze cycle of the cryoablation procedure, the second freeze cycle occurring at a later time than the first freeze cycleas taught by Tegg to ensure that the cryogenic fluid avoids a pre-mature phase change (Tegg [0038]).
Regarding claim 19, Harmouche in view of Tegg discloses the method of claim 17, and Harmouche further discloses a method further comprising, based on an estimated amount of liquid nitrogen remaining in the cryogenic fluid supply vessel at an end of the first freeze cycle (Figure 2: second fluid sensor 232 and [0050]: “the second fluid sensor 232 can include a pressure gauge that monitors the fluid pressure of the cryogenic fluid 228 within the fluid container 216”), initiating a second freeze cycle of the cryoablation procedure ([0043]).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Harmouche in view of Tegg, further in view of DeLonzor, US 20080255551, herein referred to as “DeLonzor”.
Regarding claim 20, Harmouche in view of Tegg discloses the method of claim 16, but does not explicitly disclose a method wherein inserting the cryogenic probe of the cryogen delivery system into the treatment region of the patient comprises inserting the cryogenic probe into breast tissue of the patient or inserting the cryogenic probe in the treatment region to freeze a cancerous lesion and/or a benign tumor.
However, DeLonzor teaches a method wherein inserting the cryogenic probe of the cryogen delivery system into the treatment region of the patient comprises inserting the cryogenic probe into breast tissue of the patient or inserting the cryogenic probe in the treatment region to freeze a cancerous lesion and/or a benign tumor ([0002]-[0003]).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the method disclosed by Harmouche so that inserting the cryogenic probe of the cryogen delivery system into the treatment region of the patient comprises inserting the cryogenic probe into breast tissue of the patient or inserting the cryogenic probe in the treatment region to freeze a cancerous lesion and/or a benign tumor as taught by DeLonzor to provide an optimal treatment of fibroadenomas without leaving a scar or requiring general anesthesia (DeLonzor [0003]).
Conclusion
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/SEAN W COLLINS/Primary Examiner, Art Unit 3794
/NORA W RHODES/Examiner, Art Unit 3794
