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
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.
Claim 24 is 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. Limitation “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” is not sufficiently disclose in the specification. The specification does not sufficiently disclose how CW Doppler (non-imaging element) memorize the directional “in-line” target therapy area and with every new use of the device, the non-imaging element checks if the therapeutic device is correctly positioned based on its memorized directional target. CW Doppler is an ultrasound technique that continuously sends and receives sound waves to measure blood flow speeds, especially high velocities, used for diagnosing heart valve problems (stenosis, regurgitation), assessing peripheral artery/vein disease (PAD/PVD), detecting blood clots, and finding abnormal flow in major vessels or congenital heart issues, providing detailed waveforms for pressure/gradient calculations. How is this used to memorize the directional “in-line” target therapy area?
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 and 21-24 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 of a 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], [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; perform/trigger treatment base on physiological data/parameter; obvious to one of ordinary skill in the art that physiological data/parameter is organ information; there is no embodiment in the specification that disclose determining optimal timing to trigger the ultrasound therapy based on all 3 the organ information, a minimum or a maximum of a respiration cycle of the user, and a minimum or a maximum of an ECG of the user; examiner interpret the claim limitation as determining optimal timing to trigger the ultrasound therapy based on the organ information, or a minimum or a maximum of a respiration cycle of the user, or a minimum or a maximum of an ECG of the user; basically determining optimal timing to trigger the ultrasound therapy base on one of the 3 conditions; Hyde discloses perform/trigger treatment base on physiological data/parameter (organ information)).
Also see the prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Trigger treatment base on minimum, maximum point of respiration and ECG. The specification does not disclose start treatment at minimum or maximum point of respiration cycle. It discloses start treatment based on minimum or maximum point of respiration cycle.
4, Addressing claims 4-12, 14-16, 21-24, 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, 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 (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).
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. Claim 13 is 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 claim 13, Hyde disclose sensor to determine body location of organ and attaching treatment device to organ. However, the organ is selected from a list of organs and presets for the selected organ are loaded to determine type of therapy. Kindlein discloses the organ is selected from a list of organs and presets for the selected organ are loaded to determine type of therapy (see [0118] and Figs. 13-14; select urethra from list of multiple organs (urethra; rectum) and determine that urethra type of therapy is less than 50% dose). 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 as disclose by Kindlein because this allow user to select specific organ and appropriate treatment for that organ.
7. Claim 17 is 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 claim 17, Hyde does not disclose wherein the ultrasound therapy is delivered based on a user-specific reconstruction template. 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). 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 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 11/24/25 have been fully considered but they are not persuasive. Applicant argues Hyde 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 this is not in the claim. The claims are claiming determining optimal timing to trigger the ultrasound therapy based on the organ information, a minimum or maximum of a respiration cycle of the user, and a minimum or a maximum of an ECG of the user. Since no embodiment discloses trigger ultrasound therapy when meet all 3 conditions organ information, minimum or maximum of a respiration cycle and minimum or a maximum of an ECG, examiner interprets the claim as determining optimal timing to trigger the ultrasound therapy based on the organ information. Hyde discloses sensor to monitor organ then perform treatment (see [0075], heart rate sensor, respiratory sensor to monitor heart rate, respiration rate then performs treatment). Regarding claims 5-7, applicant argues accelerometers sense motion but can not localize organ depth or tissue layer. Applicant’s argument is not persuasive because Fig. 7, element 818 discloses estimate position. The system is capable of determine position of organ base on information from variety of sensors and images. Regarding claim 17, applicant argues Samec only mentions general patient customization. Applicant’s argument is not persuasive because Samec discloses modify treatment is delivered based on a user-specific data (see [0014]). User specific data is user-specific reconstruction template and this is not general patient customization. Regarding claim 19, Kliot does not disclose treatment over time, only real-time adjustment. Applicant’s argument is not persuasive because assess treatment and modify treatment in real-time is treatment over time. Monitor treatment and adjust current treatment to be different from past treatment is over time.
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) and 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).
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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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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/HIEN N NGUYEN/
Primary Examiner
Art Unit 3793