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 .
Response to Amendment
This Office Action is a response to applicant’s arguments and amendment filed 03/11/2026. Claims 6-7 are amended. Claims 1-20 are currently pending, with claims 8-20 withdrawn from consideration.
The objection of claim 7 has been withdrawn due to applicant’s amendment.
Response to Arguments
Applicant’s arguments, see Remarks, filed 03/11/2026, with respect to the rejection(s) of claim(s) 1-7 under 35 U.S.C. 103 as being unpatentable over Geva in view of Law, have been fully considered but are not persuasive.
1) Applicant argues Geva does not disclose or suggest placing a catheter in proximity to the target biomineralization, because the bladder is not a hard mineralized deposit such as a biomineralization (Remarks, pgs. 7-8).
In response to applicant’s first argument, it is respectfully submitted the arguments are narrower than the claim limitations. The claim language does not positively recite the target biomineralization or provide any further structure to the type of tissue of the biomineralization, such as the biomineralization being a hard mineralized deposit. The preamble recites intended use of the method, which the body of the claim refers back to (see lines 3 of claim 1). Further, para. [0080] of Geva describes the device being utilized to treat a wide variety of conditions and includes the treatment of kidney stones, such that Geva is considered to disclose the method for treatment of a target biomineralization such as kidney stones or minerals being deposited within the bladder.
2) Applicant further argues a fluid does not flow when it fills a balloon, and Geva does not disclose the ultrasound energy having a focal zone, instead disclosing non-focused diverging acoustic energy (Remarks, pgs. 8-9).
In response to applicant’s second argument, it is respectfully submitted the arguments are narrower than the claim limitations. Balloon 130 of Geva is filled with an acoustic coupling medium, which is understood to encompass a fluid moving from one location to another or moving in a specific direction to fill the balloon, meeting the claim limitation of “flowing the LDGL” as discussed below.
Further, the instant spec. does not provide a specific definition for the term “focal zone”, such that under broadest reasonable interpretation, the term may be interpreted as a zone of focus, or a region of concentrated waves. As further discussed below, since waves are concentrated in the bladder 190 itself (as opposed to other regions of the body) when transducers 120 are activated and waves 125 move in a certain direction, the definition of flowing the LDGL in a focal zone is considered to be met.
3) Applicant further argues Geva does not disclose the cavitation bubbles fragmenting anything (Remarks, pg. 9).
In response to applicant’s third argument, it is respectfully submitted the presence of cavitation bubbles is disclosed as increasing the permeability of bladder 190 and facilitating the delivery of agent 145 to the bladder (para. [0136]), by opening up pores in the tissue (para. [0005]), which Geva describes as occurring when cavitation bubbles collapse on the tissue, thereby increasing its permeability. Accordingly, the act of cavitation of the bubbles itself is considered to fragment the tissue by at least opening the pores of the tissue, as disclosed by Geva.
4) Applicant further argues Geva does not disclose cavitation bubbles formed in a boundary layer defined between the internal surface of bladder 190 and the acoustic coupling medium (Remarks, pg. 10).
In response to applicant’s fourth argument, it is respectfully submitted the arguments are narrower than the claim limitations. The claim language does not include any “consisting of” language, such that the boundary layer could only be defined by an internal surface of tissue and the LDGL with no further structures defining the boundary layer. As disclosed in Geva, the LDGL is located between the surface of bladder 190 and the ultrasound transducers, and the boundary layer is defined at least between the internal surface of bladder 190 and the LDGL such that the claim limitation is met.
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(s) 1-7 are rejected under 35 U.S.C. 103 as being unpatentable over Geva (US 2018/0104455 A1) in view of Law (US 5762066) (all references previously of record).
Regarding claim 1, Geva discloses (see abstract; paras. [0059]-[0190]; figs. 1-15c) a method for treating a target biomineralization (190, para. [0101]) in a mammalian subject (para. [0136]), comprising:
placing a catheter (110, para. [0101]; fig. 1) in proximity to the target biomineralization (introduced into 190, fig. 1), the catheter fluidly coupled to a source of a low-dissolved-gas liquid (LDGL) (acoustic coupling medium, which may be a degassed solution, paras. [0074] and [0102]);
introducing the LDGL through the catheter (introduced into balloon 130, para. [0136]);
flowing the LDGL towards the target biomineralization (introduced towards bladder 190) such that at least some of the LDGL is in a focal zone of one or more ultrasound transducers (120, focal zone is considered to include area in which transducers 120 are activated and direction of waves 125, para. [0136]; fig. 1) and between the target biomineralization and the one or more ultrasound transducers (fills balloon 130 which is located between transducers 120 and bladder 190, fig. 1), the focal zone aligned with the target biomineralization (fig. 1);
applying focused ultrasound energy to the target biomineralization with the one or more ultrasound transducers (via ultrasound waves 125, para. [0136]), the focused ultrasound energy passing through the LDGL (passes through acoustic coupling medium within balloon 130); and
forming cavitation bubbles (185, para. [0130]), with the focused ultrasound energy (formed in therapeutic fluid when ultrasound waves 125 are activated, para. [0136]), at a surface of the target biomineralization to fragment the target biomineralization (depicted in fig. 1, adjacent to internal surface of bladder 190),
wherein the LDGL reduces acoustic shielding in the focal zone between the target biomineralization and the one or more ultrasound transducers compared to when the LDGL is not introduced (acoustic coupling medium allows efficient progression of ultrasound energy by not blocking ultrasound energy as it progresses to the bladder internal surface and distancing the cavitation phenomenon from the transducer, considered to reduce acoustic shielding, paras. [0074] and [0130]).
However, Geva fails to specifically disclose the LDGL having a dissolved-gas concentration of less than or equal to about 20% of an oxygen saturation level of the LDGL.
Law teaches (col. 7 lines 36-55), in the same field of endeavor, a method for treating a target biomineralization in a mammalian subject (abstract) comprising a low-dissolved-gas liquid (LDGL) (degassed liquid) having a dissolved-gas concentration of less than or equal to about 30% of an oxygen saturation level of the LDGL (entrapped oxygen content of less than 3 parts per million, which is equivalent to less than or equal to 3 mg/L and therefore equivalent to less than or equal to about 30% of an oxygen saturation level, see para. [0037] of the published application describing 2 mg/L as equivalent to 20% of the dissolved gas saturation level), for the purpose of improving resolution and efficiency by absorbing bubbles which are formed having a specific entrapped oxygen content (col. 7 lines 36-55).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the acoustic coupling medium of Geva to have a dissolved-gas concentration of less than or equal to about 30% and therefore encompassing the claimed range, in order to further improve resolution and efficiency by absorbing any bubbles formed by utilizing a specific entrapped oxygen content, based on the suggestions and teachings of Law (col. 7 lines 36-55).
Regarding claim 2, Geva (as modified) teaches the method of claim 1. Geva further discloses wherein the catheter is placed upstream of the target biomineralization such that bodily fluids flow from the catheter towards the target biomineralization (catheter considered to be placed upstream of at least a portion of internal surface of bladder 190 such that urine/bodily fluids flow towards the internal surface of bladder 190, see fig. 1).
Regarding claim 3, Geva (as modified) teaches the method of claim 1. Geva further discloses wherein the LDGL reduces the acoustic shielding in a region that begins at least 2 mm from the surface of the target biomineralization (transducers mounted in a distance of less than one centimeter relative to the internal surface of the bladder, therefore the acoustic coupling medium surrounding the transducers would exist within this distance, which includes the claimed range, para. [0061]).
Regarding claim 4, Geva (as modified) teaches the method of claim 3. Geva further discloses wherein the LDGL reduces spontaneous cavitation in the region compared to when the LDGL is not introduced (acoustic coupling medium considered to reduce spontaneous cavitation by distancing the cavitation phenomenon from the transducers, paras. [0074] and [0130]).
Regarding claim 5, Geva (as modified) teaches the method of claim 1. Geva further discloses further comprising introducing a stream of the LDGL through the catheter (para. [0069]).
Regarding claim 6, Geva (as modified) teaches the method of claim 1. Geva further discloses wherein: when the at least some of the LDGL is in the ultrasound focal zone (fig. 1) and between the target biomineralization and the one or more ultrasound transducers (fig. 1), a boundary layer of bodily fluids is located along the surface of the target biomineralization, the boundary layer defined between the target biomineralization and the LDGL (considered to be located between internal surface of bladder 190 and the acoustic coupling medium), and the cavitation bubbles are formed in the boundary layer of bodily fluids (fluid is in entire bladder space and bubbles form in fluid near bladder internal surface, considered to encompass a layer near the internal surface of the bladder, paras. [0061], [0069], [0130] and [0139]).
Regarding claim 7, Geva (as modified) teaches the method of claim 1. Geva (as modified) further teaches wherein a dissolved-oxygen concentration of the LDGL is less than or equal to about 2 mg/L (combination considered to teach dissolved oxygen content of less than 3 mg/L, therefore encompassing the claimed range).
Conclusion
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 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 BRIGID K BYRD whose telephone number is (571)272-7698. The examiner can normally be reached Mon-Fri 8:00-5:00.
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/BRIGID K BYRD/Examiner, Art Unit 3771