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 .
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) is acknowledged.
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-19) in the reply filed on October 27, 2025 is acknowledged. Claims 20-32 are hereby withdrawn as being directed towards a non-elected invention.
Claim Objections
Claims 11 and 13 are objected to because of the following informalities: In Claim 11, the semicolons in the list should be commas. In Claim 13, line 4, “an second” should be “a second”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-19 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In Claim 1, line 4, the limitation “a specified range of diameters” is considered indefinite because a range of diameters has not been “specified” in the claim. It is unclear if this is meant to be a specific range of values and what those values are or a general, arbitrary range. During examination, it is assumed to be equivalent to “a range of diameters”.
Similarly, in Claim 6, it is not clear what is meant by “a specified intermediate diameter”. During examination, it is assumed to be equivalent to “an intermediate diameter”.
Regarding claim 9, the phrase "in particular" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Further regarding claim 9, “about 5mL/min”, “about 40 mL/min”, “about 10 mL/min”, “about 15 mL/min” are not sufficiently defined because “about” can be subjective and there does not seem to anything in the disclosure to suggest what bounds to put on the values covered by the claim. For example, is 4 close enough to be “about” 5 mL/min or needs to be more like 4.9 mL/min?
Regarding Claim 11, “about 2 mm”, “about 2.5 mm”, “about 3.0 mm”, “about 7.5 mm”, “about 8.0 mm”, “about 8.5 mm” are not sufficiently defined because “about” can be subjective and there does not seem to be anything in the disclosure to suggest what bounds to put on the values covered by the claim. For example, is 1.5 mm “about 2 mm”, 1.99 mm, etc.
In Claim 17, it is not understood what is meant by “tolerance range” and “below 15%, below 11%, and below 8%” since a comparison has not been defined, i.e. a percentage of what?
Regarding Claim 18, being “about 30.1 or 32.0 watts” and “about 36.0 watts” is not sufficiently defined because “about” can be subjective and there does not seem to be anything in the disclosure to suggest what bounds to put on “about”, e.g. is 25 watts or 31 watts close enough?
Regarding Claim 19, “about 2 mm to about 10 mm” is not sufficiently defined because “about” can be subjective and there does not seem to be anything in the disclosure to suggest what bounds to put on the values covered by the claim.
Claim Rejections - 35 USC § 102
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 1-2, 4-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20230026169 to Mazzone (published January 26, 2023).
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).
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 a specified intermediate diameter separates the lower subrange from the upper subrange and wherein the nominal balloon diameter is larger than the specified 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 4.0 mm, for example, then the nominal diameter of 8 mm is at least 30% more.).
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).
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 3 is rejected under 35 U.S.C. 103 as being unpatentable over US 20230026169 to Mazzone in 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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US 20250345573 to McCaffrey, US 20240238620 to Reo, US 20230027712 to Zhai, US 20220265302, US 12419662 to Thirumalai, US 20220008753, 20230057488, 20230135085, 20240123263, 20240123262, 20240366967, 11565135, 11607568, 12502559 to Warnking teaches balloon diameters and power levels are related.
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.
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, 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