Prosecution Insights
Last updated: October 22, 2026
Application No. 19/320,368

METHODS OF SONODYNAMIC TREATMENT USING ULTRASOUND

Non-Final OA §103§112
Filed
Sep 05, 2025
Priority
Aug 08, 2018 — provisional 62/716,153 +2 more
Examiner
DAVIS, AMELIE R
Art Unit
3798
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
Alpheus Medical, Inc.
OA Round
1 (Non-Final)
65%
Grant Probability
Favorable
1-2
OA Rounds
2y 4m
Est. Remaining
98%
With Interview

Examiner Intelligence

Grants 65% — above average
65%
Career Allowance Rate
306 granted / 470 resolved
-4.9% vs TC avg
Strong +33% interview lift
Without
With
+33.2%
Interview Lift
resolved cases with interview
Typical timeline
3y 6m
Avg Prosecution
33 currently pending
Career history
521
Total Applications
across all art units

Statute-Specific Performance

§101
9.2%
-30.8% vs TC avg
§103
36.0%
-4.0% vs TC avg
§102
8.3%
-31.7% vs TC avg
§112
38.7%
-1.3% vs TC avg
Black line = Tech Center average estimate • Based on career data from 470 resolved cases

Office Action

§103 §112
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) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date as follows: The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994). The disclosure of the prior-filed application, Application No. 17/266,157 fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. Claims 2 and 12 recite limitations directed towards emitting defocused ultrasound energy from the array of ultrasound transducers (2nd to last paragraph). The prior-filed application discloses an array of transducers (figs. 10A - 10D and 21A - 21D). However, the prior-filed application does not disclose an array of transducers that emits defocused energy. In contrast, the prior-filed application discloses that in some alternative embodiments that do not use an array of transducers, but instead use a single transducer element 303 ([0103], as published, and fig. 11) or 1902 ([0104] and fig. 19A), a lens may be used to defocus the energy (figs. 19A - 19D, [0104]). Similar logic applies to the limitations directed towards the array(s) in claims 4, 7, 15, 16, and 17 - 20. Claims 2 - 21 are therefore denied benefit of the prior-filed application, and are instead afforded priority to 9/5/2025, which is the effective filing date of the instant application. Specification The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification. Claim Rejections - 35 USC § 112 The following is a quotation of the first paragraph of 35 U.S.C. 112(a): (a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention. The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112: The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention. Claims 2 - 21 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claims 2 and 12 recite limitations directed towards emitting defocused ultrasound energy from the array of ultrasound transducers (2nd to last paragraph). The specification discloses an array of transducers (figs. 10A - 10D and 21A - 21D). However, the specification does not disclose an array of transducers that emits defocused energy. In contrast, the specification discloses that in some alternative embodiments that do not use an array of transducers, but instead use a single transducer element 303 ([0103], as published, and fig. 11) or 1902 ([0104] and fig. 19A), a lens may be used to defocus the energy (figs. 19A - 19D, [0104]). The independent claims have thus confounded features of the disclosed embodiments and lack written description support. Similar logic applies to the limitations directed towards the array(s) in claims 4, 7, 15, 16, and 17 - 20. 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 2 - 21 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. Claim 2 is indefinite for the following reasons: There is unclear antecedent basis for “acoustic energy” in the 4th paragraph. It is unclear if this is the energy recited in line 3. There is insufficient antecedent basis for “the cancerous tissue in which a sensitizer has preferentially accumulated” in the 6th paragraph. It is unclear if the method requires said preferential accumulation. There is unclear antecedent basis for “an intensity of less than 60 W/cm2” in the last paragraph. It is unclear if this is the “intensity configured to kill at least a portion of the cancerous tissue by activating the sensitizer.” It is unclear how the array is configured to produce defocused ultrasound. As explained in the written description rejections above, the specification discloses that defocused ultrasound is achieved by using a lens with a single transducer element 1300 ([0103] and fig. 11) or 1902 ([0104] and fig. 19A), rather than via use of an array of transducers. Those of ordinary skill in the art would not understand the structure of the ultrasound system, or how it can function as intended to emit defocused ultrasound. Claim 4 is indefinite because it is unclear how “the flexible acoustic transmission material comprises one or more acoustic matching layers coated on at least one individual ultrasound transducer in the array.” As explained in the written description rejections above, the specification discloses that defocused ultrasound is achieved by using a lens with a single transducer element 1300 ([0103] and fig. 11) or 1902 ([0104] and fig. 19A), rather than via use of an array of transducers. Those of ordinary skill in the art would not understand the structure of the ultrasound system, or how it can function as intended to emit defocused ultrasound. Claim 6 is indefinite because it is unclear what method step or material modification thereof is intended by “the defocused ultrasound energy is configured to activate the sensitizer to affect the cancerous tissue while minimizing impact on a portion of an internal tissue not targeted for treatment. It is unclear what the difference is between defocused ultrasound energy that is configured as recited versus defocused ultrasound energy that is not configured as recited. Claim 7 is indefinite because it is unclear how the plurality of ultrasound arrays relates to the previously recited array. Moreover, it is unclear how the minimally invasive housing comprises a plurality of ultrasound arrays. As explained in the written description rejections above, the specification discloses that defocused ultrasound is achieved by using a lens with a single transducer element 1300 ([0103] and fig. 11) or 1902 ([0104] and fig. 19A), rather than via use of an array of transducers. Those of ordinary skill in the art would not understand the structure of the ultrasound system, or how it can function as intended to emit defocused ultrasound. Claim 9 is indefinite for the following reasons: There is unclear antecedent basis for “defocused ultrasound energy” in line 1. It is unclear if this is the “defocused ultrasound energy” recited in claim 2. It is unclear how the “emitting” step in line 1 relates to the emitting step in claim 2. It is unclear is these are two different steps. There is unclear antecedent basis for “the emitted defocused ultrasound energy” in line 2. It is unclear if this is the “defocused ultrasound energy” recited in claim 2 or in claim 9. Claim 12 is indefinite for the following reasons: There is unclear antecedent basis for “acoustic energy” in the 4th paragraph. It is unclear if this is the energy recited in line 3. There is insufficient antecedent basis for “the cancerous tissue in which a sensitizer has preferentially accumulated” in the 6th paragraph. It is unclear if the method requires said preferential accumulation. There is unclear antecedent basis for “an intensity of less than 5 W/cm2” in the last paragraph. It is unclear if this is the “intensity configured to kill at least a portion of the cancerous tissue by activating the sensitizer.” It is unclear how the array is configured to produce defocused ultrasound. As explained in the written description rejections above, the specification discloses that defocused ultrasound is achieved by using a lens with a single transducer element 1300 ([0103] and fig. 11) or 1902 ([0104] and fig. 19A), rather than via use of an array of transducers. Those of ordinary skill in the art would not understand the structure of the ultrasound system, or how it can function as intended to emit defocused ultrasound. Claim 15 is indefinite because it is unclear what is meant by “wherein emitting defocused ultrasound energy from the array into the internal tissue of the patient comprises …” No step of “emitting defocused ultrasound energy from the array into the internal tissue” has been explicitly recited. It is unclear if the claim intends to refer to the emission into the “cancerous tissue”. Moreover, it is unclear how the array is used. As explained in the written description rejections above, the specification discloses that defocused ultrasound is achieved by using a lens with a single transducer element 1300 ([0103] and fig. 11) or 1902 ([0104] and fig. 19A), rather than via use of an array of transducers. Those of ordinary skill in the art would not understand the structure of the ultrasound system, or how it can function as intended to emit defocused ultrasound. Claims 16 - 20 are indefinite because it is unclear how the array is used. As explained in the written description rejections above, the specification discloses that defocused ultrasound is achieved by using a lens with a single transducer element 1300 ([0103] and fig. 11) or 1902 ([0104] and fig. 19A), rather than via use of an array of transducers. Those of ordinary skill in the art would not understand the structure of the ultrasound system, or how it can function as intended to emit defocused ultrasound. Claim 19 is indefinite because it is unclear what is meant by “wherein emitting defocused ultrasound energy from the first and second ultrasound transducers into the internal tissue of the patient comprises…” No step of “emitting defocused ultrasound energy from the first and second ultrasound transducers into the internal tissue” has been explicitly recited. It is unclear if the claim intends to refer to the emission into the “cancerous tissue”. It is further unclear if the claim intends to require that the emitting comprises emitting “from the first and second ultrasound transducers”. Dependent claims that are listed in the rejection header above as being rejected while not having been specifically addressed are rejected by virtue of dependency. The following is a quotation of 35 U.S.C. 112(d): (d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers. The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph: Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers. Claim 18 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 18 recites “the array of the ultrasound transducers comprises at least first and second ultrasound transducers.” This fails to further limit claim 12 because an array of object necessarily comprises “at least first and second” of the objects, by definition. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements. 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 (i.e., changing from AIA to pre-AIA ) 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. Claims 2 - 4, 6 - 7, 9 - 12, 14, and 16 - 21 are rejected under 35 U.S.C. 103 as being unpatentable over Tachibana et al. (US 2003/0092667, of record) in view of Lauten et al. (US 2011/0020429, of record). Regarding claim 2, Tachibana shows a minimally invasive method of treating cancer (“delivery of high concentrations of anti-cancer drugs … using ultrasound at specific locations such as in blood vessels within cancerous tissue”, [0011]), the method comprising: identifying cancerous tissue in a patient (implicit, as the cancer is necessarily diagnosed before it is treated by delivering ultrasound energy to activate a light activated drug, [0019] - [0026], [0028] - [0034]); positioning a device internally in said patient to deliver energy to the cancerous tissue (“catheter for … delivering ultrasound energy to the light activated drug within the tissue site”, [0109]); wherein the device comprises a minimally invasive housing (exterior surface of catheter 10, [0142] and figs. 1 - 13 inter alia) to deliver acoustic energy ([0109]); delivering the acoustic energy to the cancerous tissue in which a sensitizer has preferentially accumulated (delivering ultrasound energy to activate a light activated drug, [0019] - [0026], [0028] - [0034]); wherein the acoustic energy is provided with an intensity configured to kill at least a portion of the cancerous tissue by activating the sensitizer ([0011]; [0012]; [0128]); wherein the minimally invasive housing comprises: an array of ultrasound transducers (transducers 20, [0175] - [0176] and figs. 14A - 14C), a conductive pair of conductive materials, the conductive pair having a first end configured to be connected to a power supply and a second end connected to the array of ultrasound transducers (“lines to individually power N ultrasound transducers 20”, [0175] - [0176] and figs. 14A - 14C), and a flexible (flexibility, [0175]; [0176]; [0178]; [0180]) acoustic transmission material (i.e., the material of the housing through which the ultrasound energy passes to be delivered to activate a light activated drug, [0019] - [0026], [0028] - [0034]), wherein each individual ultrasound transducer in the array is a piezo-electric material (piezoceramics, [0143]; piezoelectric element, [0230]) comprising an emitting surface (implicit) that is positioned within the minimally invasive housing (catheter 10 includes an ultrasound assembly 12 for delivering ultrasound energy to light activated drug within the tissue, [0142] and fig. 1A); and emitting ultrasound energy from the array of ultrasound transducers through the flexible acoustic transmission material into the cancerous tissue of the patient to activate the sensitizer (delivering ultrasound energy to activate a light activated drug, [0019] - [0026], [0028] - [0034]), wherein the ultrasound energy reaches a target tissue depth at an intensity of less than 60 W/cm2(10-50 W/cm2 … 0.3 W/cm2, [0157]; [0243]; [0429] - [0439]). Tachibana is silent as to whether or not the ultrasound energy is defocused. Lauten discloses ultrasound sensitive drug carrying particles (abstract). Lauten teaches ultrasound energy that is defocused (“… drug may be released by low-frequency nonfocused ultrasound transducers”, [0046]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Tachibana to have the ultrasound energy be defocused, as taught by Lauten, in order to treat a disease or condition in a patient in need thereof, as suggested by Lauten ([0046]). Regarding claim 3, the combined invention of Tachibana and Gentsler discloses the claimed invention substantially as noted above. Further, the housing’s material has an acoustic impedance that is interpreted as being “similar” to an acoustic impedance of a surrounding tissue of the patient. Regarding claim 4, the combined invention of combined invention of Tachibana and Lauten discloses the claimed invention substantially as noted above. Tachibana further shows the acoustic transmission material comprises an acoustic matching layer coated on at least one individual ultrasound transducer in the array (“… outer coating 18 …polyimide, parylene and polyester”, [0143]). Regarding claim 6, the combined invention of Tachibana and Gentsler discloses the claimed invention substantially as noted above. Further, in the combined invention of the prior art, the defocused ultrasound energy is configured to activate the sensitizer to affect the cancerous tissue while minimizing impact on a portion of an internal tissue not targeted for treatment, as the intent of the clinician, and thus the configuration of the treatment, is understood to comprise minimizing impact on a portion of an internal tissue not targeted for treatment. Regarding claim 7, the combined invention of combined invention of Tachibana and Lauten discloses the claimed invention substantially as noted above. Tachibana further shows the minimally invasive housing comprises a plurality of ultrasound arrays (transducers 20, [0175] - [0176] and figs. 14A - 14C), as any subset of two or more transducers is an “array”. Regarding claims 9 - 11, the combined invention of combined invention of Tachibana and Lauten discloses the claimed invention substantially as noted above. Tachibana further shows the emitting defocused ultrasound energy in a particular direction (delivering ultrasound energy to activate a light activated drug, [0019] - [0026], [0028] - [0034]), wherein the emitted defocused ultrasound energy extends beyond the minimally invasive housing at an intensity of less than 10 W/cm2 and reaches the target tissue depth at an intensity of less than 3 W/cm2 (10-50 W/cm2 … 0.3 W/cm2, [0157]; [0243]; [0429] - [0439]). Regarding claim 12, Tachibana shows a minimally invasive method of treating cancer (“delivery of high concentrations of anti-cancer drugs … using ultrasound at specific locations such as in blood vessels within cancerous tissue”, [0011]), the method comprising: identifying cancerous tissue in a patient (implicit, as the cancer is necessarily diagnosed before it is treated by delivering ultrasound energy to activate a light activated drug, [0019] - [0026], [0028] - [0034]); positioning a device internally in said patient to deliver energy to the cancerous tissue (“catheter for … delivering ultrasound energy to the light activated drug within the tissue site”, [0109]); wherein the device comprises a minimally invasive housing (exterior surface of catheter 10, [0142] and figs. 1 - 13 inter alia) to deliver acoustic energy ([0109]); delivering the acoustic energy to the cancerous tissue in which a sensitizer has preferentially accumulated (delivering ultrasound energy to activate a light activated drug, [0019] - [0026], [0028] - [0034]); wherein the acoustic energy is provided with an intensity configured to kill at least a portion of the cancerous tissue by activating the sensitizer ([0011]; [0012]; [0128]); wherein the minimally invasive housing comprises: an array of ultrasound transducers (transducers 20, [0175] - [0176] and figs. 14A - 14C), and a flexible (flexibility, [0175]; [0176]; [0178]; [0180]) acoustic transmission material (i.e., the material of the housing through which the ultrasound energy passes to be delivered to activate a light activated drug, [0019] - [0026], [0028] - [0034]), wherein each individual ultrasound transducer in the array comprises an emitting surface (implicit) that is positioned within the minimally invasive housing (catheter 10 includes an ultrasound assembly 12 for delivering ultrasound energy to light activated drug within the tissue, [0142] and fig. 1A); and emitting ultrasound energy from the array of ultrasound transducers through the flexible acoustic transmission material into the cancerous tissue of the patient to activate the sensitizer (delivering ultrasound energy to activate a light activated drug, [0019] - [0026], [0028] - [0034]), wherein the ultrasound energy reaches a target tissue depth at an intensity of less than 5 W/cm2(10-50 W/cm2 … 0.3 W/cm2, [0157]; [0243]; [0429] - [0439]). Tachibana is silent as to whether or not the ultrasound energy is defocused. Lauten discloses ultrasound sensitive drug carrying particles (abstract). Lauten teaches ultrasound energy that is defocused (“… drug may be released by low-frequency nonfocused ultrasound transducers”, [0046]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Tachibana to have the ultrasound energy be defocused, as taught by Lauten, in order to treat a disease or condition in a patient in need thereof, as suggested by Lauten ([0046]). Regarding claim 14, the combined invention of Tachibana and Gentsler discloses the claimed invention substantially as noted above. Further, the housing’s material has an acoustic impedance that is interpreted as being “similar” to an acoustic impedance of a surrounding tissue of the patient. Regarding claim 16, the combined invention of combined invention of Tachibana and Lauten discloses the claimed invention substantially as noted above. Tachibana further shows pulsing the ultrasound energy (pulses, [0157]; [0247]). Regarding claim 17, the combined invention of combined invention of Tachibana and Lauten discloses the claimed invention substantially as noted above. Tachibana further shows individual ultrasound transducers of the array of ultrasound transducers are electrically independent (transducers can be operated independently, [0171]; [0176]; [0188]). Regarding claim 18, the combined invention of combined invention of Tachibana and Lauten discloses the claimed invention substantially as noted above. Tachibana further shows the array of the ultrasound transducers comprises at least first and second ultrasound transducers (transducers 20, [0175] - [0176] and figs. 14A - 14C). Regarding claim 19, the combined invention of combined invention of Tachibana and Lauten discloses the claimed invention substantially as noted above. Tachibana further shows electrically stimulating the second ultrasound transducer with a different amplitude or phase relative to the first ultrasound transducer (transducers can be operated independently, [0171]; [0176]; [0188]). Regarding claim 20, the combined invention of combined invention of Tachibana and Lauten discloses the claimed invention substantially as noted above. Tachibana further shows the first ultrasound transducer is electrically stimulated later than the second transducer (transducers can be operated independently, [0171]; [0176]; [0188]) to create an angled ultrasound energy pattern (implicit). Regarding claim 21, the combined invention of combined invention of Tachibana and Lauten discloses the claimed invention substantially as noted above. Tachibana further shows wherein cancerous tissue comprises a brain tissue (brain tumors, [0135], [0263]). Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Tachibana and Lauten as applied to claim 2 above, and further in view of Hinders (US 2012/0040312, of record). Regarding claim 5, the combined invention of Tachibana and Lauten discloses the claimed invention substantially as noted above. Tachibana fails to show the acoustic transmission material comprises an elastic boot. Hinders discloses dental ultrasonography. Hinders teaches acoustic transmission material that comprises an elastic boot (“compliant gel boot of the device is intended to optimize the coupling of ultrasound energy”, [0028]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Tachibana and Lauten to have the acoustic transmission material comprise an elastic boot, as taught by Hinders, in order to optimize coupling of ultrasound energy, as suggested by Hinders ([0028]). Claims 8, 13, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Tachibana and Lauten as applied to claims 2 and 12 above, and further in view of Hardy (US 2008/0319375, of record). Regarding claims 8 and 13, the combined invention of Tachibana and Lauten discloses the claimed invention substantially as noted above. Tachibana is not specific to one of the ultrasound transducers comprising a flat emitting surface. Hardy discloses cavitation-mediated ultrasonic drug delivery. Hardy teaches an ultrasound transducer comprising a flat emitting surface (“a flat linear array”, [0525]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Tachibana and Lauten to have one of the ultrasound transducers comprise a flat emitting surface, as taught by Hardy, in order to alter the shape of the transducer to direct the ultrasound waves through a desired portion of the catheter to treat tissue as desired, as is well-understood and conventional in the art. It is noted that applicant discloses no criticality of the claimed transducer arrangement/shape, but discloses that the transducer arrangement/shape may equivalently be any of a variety of arrangements/shapes (see various transducer shapes and arrangements 303 in instant figs. 1 - 11). Regarding claim 15, the combined invention of Tachibana and Lauten discloses the claimed invention substantially as noted above. Tachibana is not specific to modifying a direction at which the ultrasound energy enters the internal tissue of the patient with an acoustic element. Hardy discloses cavitation-mediated ultrasonic drug delivery. Hardy teaches modifying a direction at which ultrasound energy enters the internal tissue of the patient with an acoustic element (lens of a transducer, [0527]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Tachibana and Lauten to have include modifying a direction at which the ultrasound energy enters the internal tissue of the patient with an acoustic element, as taught by Hardy, in order to direct the ultrasound waves to treat tissue as desired, as is well-understood and conventional in the art. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMELIE R DAVIS whose telephone number is (571)270-7240. The examiner can normally be reached Monday-Friday, 9:30 - 6:00 PST. 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, Pascal Bui-Pho can be reached at (571)272-2714. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /AMELIE R DAVIS/Primary Examiner, Art Unit 3798
Read full office action

Prosecution Timeline

Sep 05, 2025
Application Filed
Jun 29, 2026
Non-Final Rejection mailed — §103, §112 (current)

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Prosecution Projections

1-2
Expected OA Rounds
65%
Grant Probability
98%
With Interview (+33.2%)
3y 6m (~2y 4m remaining)
Median Time to Grant
Low
PTA Risk
Based on 470 resolved cases by this examiner. Grant probability derived from career allowance rate.

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