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 .
Status of Claims
Claims 1-19 and 33-45 are pending.
Claim Objections
Claims 6 and 38 are objected to because of the following informalities: In Claims 6 (line 3) and 38, the “specified” should be deleted (i.e. . Appropriate correction is required.
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.
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 1-2, 4-19, 33-45 are rejected under 35 U.S.C. 103 as being unpatentable over US 20230026169 to Mazzone (published January 26, 2023) in view of US 20220265302 to Thirumalai (previously cited by examiner).
Regarding Claim 1, Mazzone teaches a tissue treatment system (par. 0002), comprising:
a catheter (212, Figure 2A) including a distal portion on which is located an ultrasound transducer (ultrasound transducer 214, Figure 2A), wherein the catheter is configured such that at least the distal portion of the catheter is insertable into a segment of a body lumen having a diameter within a specified range of diameters, wherein the range of diameters has a lower subrange and an upper subrange (vessels of various diameters, par. 0053);
an excitation source configured to selectively provide energy to the ultrasound transducer of the catheter (par. 0048, the transducer is activated to deliver ultrasound energy to treat tissue); and
a controller communicatively coupled to the excitation source (controller 104, Figure 1), the controller configured to control the excitation source to cause the ultrasound transducer to emit two different amounts of acoustic energy (par. 0071 the controller 104 controls the activation current to the ultrasound transducer), which include
a first amount of acoustic energy (lower acoustic energy/power at smaller diameters, par. 0111); and
a second amount of acoustic energy, which is greater than the first amount of acoustic energy (higher acoustic energy/power at larger diameters, par. 0111); wherein
the controller is configured to control the excitation source to cause the ultrasound transducer to emit the first amount of acoustic energy into a body lumen having a diameter within the lower subrange, and the second amount of acoustic energy into a body lumen having a diameter within the upper subrange (par. 0111, the acoustic energy is adjusted based on lumen diameter, i.e. power increases with lumen diameter).
However, Mazzone does not teach wherein the amounts of acoustic energy are a fixed set of only two different amounts of acoustic energy. That is, Mazzone does not teach adjusting the energy based on only two discrete intervals of lumen diameter.
Thirumalai teaches adjusting treatment power with balloon/lumen diameter at discrete intervals. Specifically, Thuramulai gives the example of power at 20-30 W for smaller diameter balloons (e.g. 3.5-5 mm) and 30-40 W for larger diameter balloons (e.g. 5-8 mm) (par. 0079).
As such, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to utilize the discrete power intervals of Thirumalai in the system of Mazzone to provide the predictable result of effective treatment with simple power control.
Regarding Claim 2, Mazzone further teaches wherein the controller is further configured to:
automatically estimate a diameter of the segment of the body lumen (programmable logic automatically adjusts the acoustic energy based on diameter, therefore diameter is implicitly estimated, par. 0111; par. 0075 teaches automated measurements of the lumen size/diameter);
control the excitation source to cause the ultrasound transducer to emit the first amount of acoustic energy when the controller estimated a diameter of the segment of the body lumen to be within the lower subrange of the specified range of diameters (par. 0111, the acoustic energy is adjusted based on lumen diameter, i.e. power increases with lumen diameter); and
control the excitation source to cause the ultrasound transducer to emit the second amount of acoustic energy when the controller estimated a diameter of the segment of the body lumen to be within the upper subrange of the specified range of diameters (par. 0111, the acoustic energy is adjusted based on lumen diameter, i.e. power increases with lumen diameter).
Regarding Claim 4, Mazzone further teaches wherein the distal portion of the catheter further includes a balloon within which is located the ultrasound transducer (balloon 108, Figure 2A with transducer 214 inside); and the balloon is configured to generally center the ultrasound transducer within the body lumen (the balloon provides a centering function, par. 0039) and to have a fluid circulated through the balloon to cool at least a portion of tissue adjacent to the body lumen within which the ultrasound transducer is positioned (par. 0057).
Regarding Claim 5, Mazzone further teaches wherein the balloon comprises a compliant balloon (par. 0049-0050), wherein the compliant balloon is configured such that when the compliant balloon is partially inflated, such that its diameter is less than a nominal balloon diameter of the compliant balloon, the compliant balloon includes one or more folds (par. 0096 the balloon folds and has wrinkles when it is not fully inflated in a smaller vessel) that at least partially attenuate the acoustic energy emitted by the ultrasound transducer (par. 0135 the balloon wall naturally attenuates the acoustic energy, i.e. the thicker the balloon wall, the more attenuation).
Regarding Claim 6, Mazzone further teaches wherein an intermediate diameter separates the lower subrange from the upper subrange and wherein the nominal balloon diameter is larger than the intermediate diameter by an amount selected from the group consisting of at least 10%, at least 20%, and at least 30% (as shown in Figure 7, the balloon can expand from about 3.5 mm to 8 mm, par. 0092; if the intermediate diameter is designated as 2.0 mm, for example, then the nominal diameter of 3.5 mm is at least 30% more than the intermediate diameter. Examiner notes there are no control functions claimed based on the intermediate diameter; it can be arbitrarily defined and read on the claim).
Regarding Claim 7, Mazzone further teaches the one or more folds are configured to occur such that when the balloon is inserted into a body lumen segment and partially inflated to less than its nominal balloon diameter, a folded surface of the balloon generates additional acoustic reflections compared to when the balloon is inflated to the point that there are no, or less, or smaller folds (par. 0096, folds 802, Figure 8; additional acoustic interfaces, i.e. wrinkles/folds, necessarily cause additional acoustic reflections compared to when they don’t exist, even if the overall effect does not significantly impact the treatment).
Regarding Claim 8, Mazzone further teaches a fluid supply subsystem configured to circulate the fluid through the balloon, wherein the controller is also configured to control the fluid supply subsystem (cartridge 112, the controller 104 interfaces with the cartridge 112 to provide cooling fluid to the catheter 102 for inflating and deflating the balloon, par. 0049, Figure 1).
Regarding Claim 9, Mazzone further teaches an amount of energy absorbed by tissue surrounding the segment of the body lumen in which the ultrasound transducer is located depends in part on a flowrate of the fluid circulated through the balloon, and wherein the controller is configured to control the flowrate of the fluid circulated through the balloon to be within a flowrate range of about 5 mL/min to about 40 mL/min, in particular about 10 mL/min to about 15 mL/min (par. 0087 e.g. 15 mL/min, see also Table 2).
Regarding Claim 10, Mazzone further teaches the controller is configured to control the fluid supply system to circulate the fluid through the balloon, after the first amount of energy has been emitted by the ultrasound transducer, for a predetermined amount of time within a range of 0.5 second to 20 seconds (the fluid is continuously circulated prior, during, and after activation, par. 0057).
Regarding Claim 11, Mazzone further teaches wherein a lower end of the specified range of diameters is selected from the group consisting of about 2 mm, about 2.5 mm, and about 3.0 mm (par. 0074, 3 mm to 8 mm); and an upper end of the specified range of diameters is selected from the group consisting of about 7.5 mm, about 8.0 mm, and about 8.5 mm (par. 0074, 3 mm to 8 mm).
Regarding Claim 12, Mazzone further teaches wherein the second amount of acoustic energy is selected from the group consisting of at least 8%, at least 10%, at least 12%, and at least 15% greater than the first amount of acoustic energy (par. 0111, e.g. 27 at the smaller diameter to 38 W at the larger diameter which is over 40% difference).
Regarding Claim 13, Mazzone further teaches wherein the first amount of acoustic energy is based on a first acoustic signal having a first acoustic frequency, a first acoustic power and a first duration; and the second amount of acoustic energy is based on a second acoustic signal having a second acoustic frequency, a second acoustic power and a second duration (implicit for ultrasound treatment schema, the treatment has a frequency, time, and energy level, par. 0048); wherein the second acoustic power is greater than the first acoustic power (power increases with lumen size, ar. 0111).
Regarding Claim 14, Mazzone further teaches wherein the second acoustic power is selected from the group consisting of at least 8%, at least 10%, at least 12%, and at least 15% greater than the first acoustic power (par. 0111, e.g. 27 at the smaller diameter to 38 W at the larger diameter which is over 40% difference).
Regarding Claims 15-16, Mazzone further teaches wherein the first acoustic frequency equals the second acoustic frequency and the first duration equals the second duration (Mazzone only changes the acoustic power level based on the changing diameter, so the other parameters are assumed to remain unchanged, par. 0111).
Regarding Claim 17, Mazzone further teaches wherein a total tolerance range for generating the first and second acoustic powers is selected from the group consisting of below 15%, below 11%, and below 8% (powers between 27 and 38 W, par. 0111; see 112(b) rejection above).
Regarding Claim 18, Mazzone further teaches wherein the first amount of acoustic energy is obtained by a first acoustic power of about 30.1 or 32.0 watts; and the second amount of acoustic energy is obtained by a second acoustic power of about 36.0 watts (the upper range of 27-38 W in par. 0111 includes about 36 watts, the lower range of 27-38 W includes about 30.1 or 32 watts).
Regarding Claim 19, Mazzone further teaches wherein the system is configured to produce at least one lesion in tissue surrounding the body lumen in which the ultrasound transducer is positioned, such that a lesion depth of the one or more lesions is within a lesion depth range of about 2 mm to about 10 mm (e.g. depth of 1 mm to 6 mm, par. 0222, creates a circumferential lesion, par. 0118).
Regarding Claim 33, Mazzone further teaches wherein the controller is configured to control the flowrate of the fluid circulated through the balloon to be within a flowrate of about 10 mL/min to about 15 mL/min (par. 0087 e.g. 15 mL/min, see also Table 2).
Regarding Claim 34, Mazzone further teaches wherein the compliant balloon has a nominal balloon diameter of about 6.5 mm. (par. 0098, nominal diameter of 6.75 mm is “about 6.5 mm” since it is within 10%).
Regarding Claim 35, Mazzone further teaches wherein the one or more folds comprise at least one of wrinkles, one or more helical folds, or one or more longitudinal folds (par. 0096 the balloon folds and has wrinkles when it is not fully inflated in a smaller vessel).
Regarding Claim 36, Mazzone further teaches wherein the compliant balloon has a nominal balloon wall thickness, and wherein the compliant balloon is configured to stretch when inflated beyond its nominal diameter, causing the balloon wall to become thinner than the nominal balloon wall thickness and provide less attenuation of the acoustic energy emitted by the ultrasound transducer (these are implicit characteristics of a balloon, e.g. nominal size of 3.5 mm but can expand to 9 mm, par. 0088).
Regarding Claim 37, Mazzone further teaches wherein the compliant balloon is made from thermoplastic polyurethane (par. 0045).
Regarding Claim 38, Mazzone further teaches wherein the [specified] intermediate diameter is selected from the group consisting of about 4.5 mm, about 5.0 mm, and about 5.5 mm (e.g. if the nominal diameter if 6.75 mm, the intermediate diameter can be selected as 4.5 mm, par. 0098-0099).
Regarding Claim 39, Mazzone further teaches wherein the predetermined amount of time is within a range of 2 seconds to 12 seconds (the fluid is continuously circulated prior, during, and after activation, par. 0057).
Regarding Claim 40, Mazzone further teaches wherein the predetermined amount of time is within a range of 5 seconds to 9 seconds (the fluid is continuously circulated prior, during, and after activation, par. 0057).
Regarding Claim 41, Mazzone further teaches wherein the body lumen comprises a renal artery (par. 0098).
Regarding Claim 42, Mazzone further teaches wherein the body lumen is at least one of a renal artery, a hepatic artery, a pulmonary artery, a celiac artery, or a splenic artery (par. 0098 renal artery).
Regarding Claim 43, Mazzone further teaches wherein the lesion depth is within a depth range from about 2.5 mm to about 8.0 mm (par. 0222).
Regarding Claim 44, Mazzone further teaches wherein the lesion depth is within a depth range from about 5.5 mm to about 6.0 mm (par. 0222).
Regarding Claim 45, wherein the compliant balloon has a Shore D durometer between 50 and 60 (par. 0084).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over US 20230026169 to Mazzone in view of in view of US 20220265302 to Thirumalai, as applied to claim 1 above, in further view of US 20210316161 to Warnking.
Regarding Claim 3, while Mazzone teaches controlling the excitation source to cause the ultrasound transducer to emit the first amount of acoustic energy when in the lower subrange of the range of diameters and controlling the excitation source to cause the ultrasound transducer to emit the second amount of acoustic energy in the upper subrange of the range of diameters (par. 0111, the acoustic energy is adjusted based on lumen diameter, i.e. power increases with lumen diameter), Mazzone does not specify a user interface for receiving a selection of the lower subrange and the upper subrange of diameters. Examiner’s interpretation of this limitation is that a user interacts with the user interface to select an ON mode, i.e. initiate treatment.
Warnking teaches an ultrasound device to increase and decrease power according to a lumen diameter (par. 0045). Warnking teaches wherein a user interacts with a user interface to initiate the ultrasound treatment (par. 0049).
As such, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide a user interface in the system of Mazzone to allow the user to initiate treatment, as in Warnking, when the catheter is placed at the target treatment location.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-19 and 33-45 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. The newly applied reference Thirumalai is used to address the amended features of claim 1.
Examiner thanks Applicant for clarifying the “about” limitations to mean within 10%. The previous rejections under USC 112(b) for “about” claim language are withdrawn.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANGELA MARIE HOFFA whose telephone number is (571)270-7408. The examiner can normally be reached Monday - Friday 9:30 am - 6:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Keith Raymond can be reached at (571)270-1790. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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ANGELA M. HOFFA
Primary Examiner
Art Unit 3799
/Angela M Hoffa/Primary Examiner, Art Unit 3799
Prosecution Insights