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 .
DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 06/02/26 has been entered.
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.
2. Claims 1, 4-12, 14-16, 21-24 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Hyde et al. (US 2017/0136265).
An ultrasound therapy device for generating ultrasound therapy, the ultrasound therapy device comprising (see [0008], [0168] and [0173]):
a housing including a skin-facing side (see Fig. 6, device 100 attach to skin);
a grouping of ultrasound transducer units on the skin-facing side to generate and deliver ultrasound therapy to a target therapy area of a user including a user’s organ in the torso (see Fig. 6 and [0173], element 101);
a communications bus to receive from a minimally invasive physiological sensor a health status data of the user and organ information (see Fig. 7, abstract, [0220]; obvious to one of ordinary skill in the art that the bus receive sensor data from sensor step 814; physiological sensor provide organ information);
memory including ultrasound therapy instructions (see Fig. 9, [0074], [0083]; processor has memory for therapy instructions to effector/ultrasound transducers);
a processor for processing the ultrasound therapy instructions, the ultrasound therapy instructions comprising: determining a non-acute health status of the user based on the health status data of the user received from the minimally invasive physiological sensor; determining optimal timing to trigger the ultrasound therapy based on the organ information, a minimum or a maximum respiration cycle of the user, and a minimum or a maximum of an ECG of the user; receiving ultrasonic data from the ultrasound transducer units; determining a body location of the grouping of ultrasound transducer units from the ultrasonic data; transmitting ultrasound therapy information to the ultrasound transducer units; and generating ultrasound therapy by the ultrasound transducer units in a target therapy area of the user based on the determined optimal timing, after a non-acute health state of the user and the body location of the grouping has been established and determined to be acceptable (see Figs. 7, 9, 11, 13, [0009], [0057], [0069], [0075], [0096], [0118] and [0199] discloses determine position of the treatment device (ultrasound); physiological sensor sense the health status; the sensors send data to processor to determine treatment device in correct position and health status and processor send instruction to effector (ultrasound transducer) for treatment; perform/trigger treatment base on physiological data/parameter; applicant point out paragraph [0258] of the specification; paragraph [0258] discloses optimal time treatment base on maximum or minimum of the respiration cycle; the respiration cycle can be estimate from ECG signal of the organ/heart; when ECG maximum or minimum is equivalent to the respiration cycle at minimum/exhale or maximum/inhale; Hyde discloses activate treatment base on physiological sensors sense the health status; Hyde discloses ECG signals of the heart and respiration sensor; ECG signals provide organ information and minimum or maximum amplitude of the signal; respiration sensor provides minimum or maximum of the respiration cycle; the claim does not require to activate at minimum or maximum point).
4, Addressing claims 4-12, 14-16, 21-24 and 27, Hyde discloses:
addressing claims 4, 9 and 21, wherein the optimal timing is determined based on a physical position of an organ; wherein the organ is the user’s heart, and the triggering is based on a max or min of a lung respiration cycle of the user (when or optimal time to activate treatment is a designer choice that only require routine skill in the art as applicant discloses optimal time to trigger treatment base on many different parameters as in each claims 4 and 9; Hyde discloses activate treatment or optimal timing to trigger treatment is based on orientation/position/movement of body/organ or physiological parameters (see Fig. 7, [0009], [0057], [0075] and [0183]); respiration cycle is sense by physiological sensor; Hyde’s system disclose all the sensors and information that allow the system to be capable of determine optimal timing to trigger treatment based on these parameters (minimum or maximum of a respiration cycle, etc.); it is only designer choice that only require routine skill in the art to determine optimal time to trigger treatment based on one of the parameters).
addressing claims 5-7 and 27, wherein the physical position of the organ is estimated based on imaging data; wherein the physical position of the organ is estimated based on non-imaging sensor data; wherein the physical position of the organ is estimated based on periodic movement of another organ; wherein movement of a first organ is used to determine a treatment timing associated with a second organ (there are many ways to determine position of organs that only require routine skill in the art; it is only designer choice to choose one way or another; see [0107] and [0212]; the ultrasound imaging allows one to determine position of the organ; Hyde discloses activate treatment or optimal timing to trigger treatment is based on orientation/position/movement of body/organ; one is capable of using ultrasound images to determine the movement of a first organ then activate treatment of the second organ).
addressing claim 8, wherein the body location is based on a pre- determined area of an organ provided as part of the health status data and includes alignment and organ position for acceptable body location (see Fig. 7 and [0057]; attach treatment device to organ such as heart; using sensors to obtain health data and position of these organs).
addressing claim 10, wherein the ultrasound therapy is prevented from delivering acoustic waves in an interval less than 425 ms (Hype’s system is capable of delivering acoustic waves in an interval less than 425 ms).
addressing claim 11, wherein the ultrasound therapy is prevented from delivering acoustic waves in an interval less than 500 ms (Hype’s system is capable of delivering acoustic waves in an interval less than 500 ms).
addressing claim 12, wherein the organ is subcutaneous (see [0057], lung and heart).
addressing claim 14, wherein scanning of the ultrasound therapy in the target therapy area is based on a predetermined scan pattern (see [0173] and [0213]).
addressing claim 15, wherein the predetermined scan pattern and other therapy parameters are inputted into a device by someone other than the user during a therapy set up mode (see Fig. 14; remote location could provide therapy parameters or instruction; the remote location would be someone else other than the user).
addressing claim 16, wherein at least some of the ultrasound transducer units of the grouping can be partially or fully utilized to allow for beam steering of the ultrasound and shifting focal points of the ultrasound to implement the predetermined scan pattern (Hype’s system is capable of steering ultrasound beam; this is well-known in the field).
addressing claim 22, wherein the organ is the lungs, kidneys, stomach or diaphragm of the user (see [0057] and [0119]).
addressing claim 23, the optimal timing is only trigger when the target therapy area of the organ undergoing movement relative to when some or all of the grouping of ultrasound transducer units is in or is estimated to be in alignment with correct organ position (see Figs. 7, 9, 11, 13, [0009], [0069], [0075], [0096]; and [0118] discloses determine position of the treatment device (ultrasound); physiological sensor sense the health status; the sensors send data to processor to determine treatment device in correct position and health status and processor send instruction to effector (ultrasound transducer) for treatment; optimal timing for triggering treatment is when treatment device is in correct position).
addressing claim 24, a non-imaging element wherein with every new use of the device, the non-imaging element checks if the device is correctly positioned based on a memorized directional target (see Fig. 7, the device include plurality of sensors, the device is capable of checking to see if the device is correctly positioned).
5. Claims 13 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Hyde et al. (US 2017/0136265) and in view of Kindlein et al. (US 2003/0233123).
6. Addressing claims 13 and 25, Hyde discloses sensor to determine body location of organ and attaching treatment device to organ. However, he does not disclose the organ is selected from a list of organs and presets for the selected organ are loaded to determine type of therapy and wherein the preset comprises at least one of a triggering criterion, scan pattern, treatment duration, treatment frequency, treatment intensity, or target body location associated with the selected organ. Kindlein discloses the organ is selected from a list of organs and presets for the selected organ are loaded to determine type of therapy and wherein the preset comprises at least one of a triggering criterion, scan pattern, treatment duration, treatment frequency, treatment intensity, or target body location associated with the selected organ (see [0118] and Figs. 13-14; select urethra from list of multiple organs (urethra; rectum) and preset the urethra type of therapy is less than 50% dose; 50% dose is a treatment intensity; preset dwell time (treatment duration)). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Hyde to select organ and determine type of therapy and wherein the preset comprises at least one of a triggering criterion, scan pattern, treatment duration, treatment frequency, treatment intensity, or target body location associated with the selected organ as disclose by Kindlein because this allow user to select specific organ and appropriate treatment for that organ.
7. Claims 17 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Hyde et al. (US 2017/0136265) and in view of Samec et al. (US 2017/0323485).
8. Addressing claims 17 and 26, Hyde does not disclose wherein the ultrasound therapy is delivered based on a user-specific reconstruction template and wherein the user-specific reconstruction template is generated using one or more of electronic medical record information, patient-specific anatomical information, physiological sensor information, or imaging information. Samec discloses treatment is delivered based on a user-specific reconstruction template (see [0014], administer treatment based on user-specific data; user specific data is user-specific reconstruction template; Hyde disclose ultrasound treatment) and wherein the user-specific reconstruction template is generated using one or more of electronic medical record information, patient-specific anatomical information, physiological sensor information, or imaging information (see [0224]; user-specific reconstruction template (user specific data) generate from physiological sensor information such as heart rate). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Hyde to treatment is delivered based on a user-specific reconstruction template and wherein the user-specific reconstruction template is generated using one or more of electronic medical record information, patient-specific anatomical information, physiological sensor information, or imaging information as taught by Samec because this improves the treatment.
9. Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Hyde et al. (US 2017/0136265), in view of Cannata et al. (US 2019/0275353) and further in view of Vaitkunas (US 2006/0184069).
10. Addressing claim 18, Hyde does not disclose controlling with the ultrasound therapy at least one of expansion or compression of bubbles and at least one of jetting or microstreaming around the bubbles. Cannata explicitly discloses controlling with the ultrasound therapy at least one of expansion or compression of bubbles (see [0051] and Fig. 4; expand from one bubble to cloud of bubble). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Hyde to control expansion or compression of bubbles as taught by Cannata because this allows for control of treatment (see [0004-0005]).
Vaitkunas discloses control jetting or microstreaming around the bubbles (see [0004] and [0039]; examiner interprets according to applicant’s specification paragraph as generate microstream). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Hyde to have control jetting or microstreaming around the bubbles as taught by Vaitkunas because this produce bioeffect (see [0039]).
Claims 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Hyde et al. (US 2017/0136265) and in view of Kliot et al. (US 2006/0100530).
Addressing claims 19-20, Hyde discloses a device that perform all the method steps except for putting ultrasound transducer on ultrasound gel to treat patient. Kliot discloses ultrasound gel (see [0069]) and comparing health status data of the user in one or more regions over time to determine efficacy of the ultrasound therapy; and updating the ultrasound therapy based on the determined efficacy of the ultrasound therapy over time (see [0031-0032], [0035], [0066], [0069] and [0076]; monitor vein condition to assess/compare then adjust ultrasound focus; Kliot also explicitly discloses beam steering, select adjusting phase and magnitude/amplitude (see [0072] and [0097])). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Hyde to use ultrasound gel as taught by Kliot because this help improve acoustic transmission and help detect problem and improve treatment (see [0099]).
Response to Arguments
Applicant's arguments filed 06/02/26 have been fully considered but they are not persuasive. Regarding claim 1, applicant argues Hyde use surface sensing feedback. Applicant argues Hype fails to teach how to dynamically control an active therapy in real-time and how or why someone would trigger therapy to a moving organ based on heart rate/ECG and respiration cycle. Applicant’s argument is not persuasive because Hyde discloses sensor to monitor organ then perform treatment (see [0075] and [0199], heart rate sensor, respiratory sensor to monitor heart rate, respiration rate then performs treatment; respiration rate include information on moving chest/lung which is moving organ). Further claim 1 and other independent claim do not claim a moving organ. Also, the respiration sensor, heart rate sensor, ECG signal provide physiological information as well as motion of the internal organ then perform treatment base on this information. Applicant argues regarding claim 23, that Hyde only teaches that there’s a physiological signal -> trigger therapy. Applicant argues applicant’s Figure 14 is not only about physiological timing. Applicant’s argument is not persuasive because Hyde also discloses respiration sensor and ultrasound imaging which allow for viewing of target region and determine motion of the target region. Further not all features of Figure 14 is in the claims. With these information Hyde’s system is capable of activating the device when the target area is aligned with treatment transducer (see [0075] and [0212]). Also see the prior art below US 2006/0241443, trigger therapy by monitor organ motion to synchronize and align with treatment beam is not new and novel feature.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US 2010/0094147 (see [0031]; perform therapy based on minimum ECG); US 2023/0310893 (see [0073]; trigger treatment based on minimum and maximum respiration point; based on minimum and maximum respiration point select the mid-point to trigger treatment) and US 2006/0241443 (see abstract, [0009] and [0059]).
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 HIEN NGOC NGUYEN whose telephone number is (571)270-7031. The examiner can normally be reached Monday-Thursday 8:30am-6:30pm.
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.
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.
/HIEN N NGUYEN/
Primary Examiner
Art Unit 3793
