DETAILED ACTION
Notice of 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 .
Response to Arguments
Applicant's arguments filed 07/08/2026 have been fully considered but they are not persuasive.
In response to the arguments on page 8, the claim language recites that the claimed parameter is ‘related’ to the functioning of the disposable acoustic coupler or the transducer element. The citation of Fearnside states that the temperature probe may be placed within the coupling medium to monitor and indicate occurrence of cavitation due to a temperature rise. Therefore, a rise in temperature would be considered ‘related’ to the functioning of the transducer element since the transducer element is performing the irradiation.
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.
Claim(s) 14, 16, 17, and 20-34 is/are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Regarding claim 14, it is unclear as to how the coupler is used for modifying renal function. The claim recites this in the preamble but the body of the claim is solely directed to the coupler. It is also unclear if the disposable acoustic coupler is actually being used in a device for modifying renal function because the claim merely recites that it is ‘to be’ used.
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.
Claim(s) 14, 16, 17, and 20-32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fearnside (US 6575922, of record).
Regarding claim 14, Fearnside discloses a disposable acoustic coupler (Fig. 1: “coupling medium 16” may be disposed), comprising: a. an encasement comprising at least one acoustically transparent material (5:31-48, “coupling medium 16 is more preferably silicone in conjunction with glycerin”); b. at least one interface for coupling at least one transducer element so said at least one transducer element is in contact with said at least one acoustically transparent material (Fig. 1, 3:53-67…4:1-8: “ultrasound transducer 14”); c. at least one interface to form contact of the skin with said disposable acoustic coupler (Fig.1, 6:15-22, “skin”); and d. at least one circuitry incorporated in said encasement; wherein said encasement and said at least one acoustically transparent material are configured to enable transfer of acoustic energy from said transducer element across the coupling material to the skin; and wherein said circuitry is used for monitoring a status of at least one parameter (5:63-67…6:1-5, “placing a temperature probe 26 in the coupling medium 16”). Fearnside discloses that at least one parameter is at least one parameter related to a functioning of one or more of said disposable acoustic coupler and said least one transducer element (5:63-67…6:1-5, “placing a temperature probe 26 in the coupling medium 16…Excessive cavitation in the coupling medium can cause excessive heating”). While Fearnside does not explicitly disclose that the coupler is to be used in a device for modifying renal function, the claims recite performing routine and conventional assessments performed in evaluating an effectiveness of ultrasound-based treatment, at least as it relates to kidney function, which would have been obvious to one with ordinary skill in the art of diagnosing kidney function.
Regarding claim 16, Fearnside discloses that at least one parameter is overheating of device (5:63-67…6:1-5, “placing a temperature probe 26 in the coupling medium 16…Excessive cavitation in the coupling medium can cause excessive heating”).
Regarding claim 17, Fearnside discloses that at least one parameter is at least one parameter related to an effectiveness level of a treatment provided to a patient while using said disposable acoustic coupler and said least one transducer element (5:63-67…6:1-5, “placing a temperature probe 26 in the coupling medium 16…Excessive cavitation in the coupling medium can cause excessive heating” – excessive heating affects effectiveness).
Regarding claim 20, Fearnside discloses that the at least one parameter related to a state of a patient while using said disposable acoustic coupler and said least one transducer element (6:20-23, “injury to the skin…damage to the brain beneath the skull bone”).
Regarding claim 21, Fearnside discloses that the at least one parameter is overheating of skin and tissue (6:20-23, “injury to the skin…damage to the brain beneath the skull bone”).
Regarding claim 22, Fearnside discloses at least one sensor to enable monitoring (5:63-67…6:1-5, “placing a temperature probe 26 in the coupling medium 16”).
Regarding claim 23, Fearnside does not explicitly disclose that at least one sensor requires skin contact. However, Fearnside says that a needle thermocouple may be used to monitor temperature (6:1-5, “needle thermocouple”). Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to apply the thermocouple to the skin, as to provide direct temperature monitoring of skin during the application to ultrasound therapy upon tissue.
Regarding claim 24, Fearnside discloses that the at least one sensor is included in a disposable sensor portion (Fig. 1: “coupling medium 16” may be disposed, along with the “temperature probe 26” within).
Regarding claim 25, Fearnside discloses that the at least one sensor is configured to provide feedback on treatment parameters (6:9-11, “In response to the monitored temperature…”).
Regarding claim 26, Fearnside discloses at least one transducer element (Fig. 1, 3:53-67…4:1-8: “ultrasound transducer 14”).
Regarding claim 27, Fearnside discloses at least one means for communication with one or more external units (Fig. 1: “24”).
Regarding claim 28, Fearnside discloses that there is at least one circuitry configured to amend a treatment parameter in view of said status of at least one parameter (6:6-14, “In response to the monitored temperature…”).
Regarding claim 29, Fearnside discloses that at least one acoustically transparent material is in alignment with said at least one transducer element (Fig, 1 shows such an alignment).
Regarding claim 30, Fearnside discloses that the disposable acoustic coupler comprises a silicone layer material (5:31-48, “silicone”).
Regarding claim 31, Fearnside does not explicitly disclose an adhesive to said skin and an adhesive to a Transducer Subunit (TSU). However, the coupler is taught to be reliably interfaced with both skin and a transducer unit (Fig. 1). Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to apply an adhesive, so as to provide robust physical contact of the acoustic coupler to both its transducer and to the skin of a subject.
Regarding claim 32, Fearnside does not explicitly disclose a disposable belt or cushion or wearable garment and mechanism to attach and adjust said disposable acoustic coupler to the patient. However, one with ordinary skill in the art of ultrasound therapy would know that the placement of the ultrasound transducer device is critical to the effectiveness of the procedure. One with ordinary skill in the art would be aware that a device such as a belt may be adjustable and used to secure one object to another. Thus, it would have been obvious to one of ordinary skill in the art to use a well-known and conventional belt to secure and adjust the fitment of the disposable acoustic coupler to the patient.
Claim(s) 33 and 34 is/are rejected under 35 U.S.C. 103 as being unpatentable over “Non-invasive Renal Denervation: Update on External Ultrasound Approaches” by R.E. Schmieder et al. Curr Hypertens Rep. (2016) 18:48 (Schmieder, of record) in view of Fearnside (US 6575922, of record).
Regarding claim 33, Schmieder discloses a system for modifying renal function, comprising: a. a plurality of rigid transducer elements (pg. 2 of 7, right column, “phased array transducer with 220 phased elements”). Schmieder does not explicitly disclose, b. one or more disposable acoustic couplers according to claim 14, in direct communication with said plurality of rigid transducer elements and configured to achieve acoustic coupling between said plurality of rigid transducer elements and skin of a patient. However, Fearnside teaches the limitations of claim 14 (see above) and thus it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to combine the transducer array of Schmieder to the transducer of Fearnside, as to provide a robust phased array for therapy.
Regarding claim 34, Schmieder discloses a User Interface Subunit (Fig. 1 – Surround Sound system has a user interface because it is operated by a user).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
US 20200188696 to Rousso - teaches improving kidney functions by delivering acoustic energy to the kidneys
THIS ACTION IS MADE FINAL. 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 extension fee 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.
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/JASON M IP/
Primary Examiner, Art Unit 3793
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