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
The amendment filed on January 05, 2026 in response to the Office action dated October 06, 2026 is acknowledged and entered. Claims 2, 3, 6, 8, 10, 13, 15-21 have been amended. Claims 1, 4-5 and 7 have been canceled. Claims 22-24 are new. Claims 2-3, 6 and 8-24 are pending and under examination in this Office action.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on January 05, 2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Amendment
The rejections to claims 5-7 under 35 U.S.C. 112(b) are now withdrawn in view of the claim cancellation.
The rejections to claims 2-21 under 35 U.S.C. 103 are now withdrawn in view of ethe claim amendment or claim cancelation. New ground of rejection is now made.
New grounds of rejection under 35 U.S.C. 112(a), written description support and 112(d) are now made in view of the amendment to claims 1, 16 and 21.
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 2-3, 6 and 8-24 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, 16 and 21 recite “operate the first ultrasound transducer and the second ultrasound transducer in a manner preventing convergence of the first ultrasonic waves and the second ultrasonic waves while the fat tissue volume is heated by the first ultrasonic waves and the second ultrasonic waves and in a manner causing apoptosis in fat cells of the tissue volume”. Proper written description support cannot be identified for operate the first ultrasound transducer and the second ultrasound transducer in a manner preventing convergence of the first ultrasonic waves and the second ultrasonic waves while the fat tissue volume is heated by the first ultrasonic waves and the second ultrasonic waves.
The specification discloses that the ultrasound waves are unfocused, non-converging, meaning not focused to converge in two dimensions. Further, in the specification, various embodiments are disclosed in regard to how the first ultrasound transducer and the second ultrasound transducers are operated, including having the two transducers activated alternatively, intermittently or sequentially. And more critically, on p.3, Example 3, it discloses that “ultrasonic waves generated by said two or more ultrasound transducers converge in said selected tissue volume”. Hence, for the situation that when both the first and the second transducers emit ultrasound waves ( as the claim recites “while the fat tissue volume is hearted by the first ultrasonic waves and the second ultrasonic waves”), though the specification discloses that the transducer emits non-converging ultrasound waves, , there is no disclosure that the ultrasound waves generated by the first and the second transducers are operated “in a manner preventing convergence”. Note that when the first and the second ultrasound waves are emitted sequentially or alternatively, i.e., not at the same time, there would not be a concern whether they converge or not as they do not exist at the same time.
The dependent claims of the above rejected claims are rejected due to their dependency.
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 9 and 23-24 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 9 recites treatment parameters of “ultrasonic waves”. Yet in claim 1 that claim 9 depends upon, only “non-converging ultrasonic waves” is generated. Hence it is unclear whether the “ultrasonic waves” in claim 9 refers to the “non-converging ultrasonic waves” in claim 1. However, Applicant is reminded that when claim 9 is amended to recite “non-converging ultrasonic waves”, it would be identical to claim 10.
Claims 22 and 23 recite that the first and the second ultrasonic transducers are operated to be activated in alternation or intermittently. However, claim 1 recites “while the fat tissue is heated by the first ultrasonic waves and the second ultrasonic waves”, which has been interpreted (please refer to the rejection under 35 U.S.C. 112(a), written description support) such that the two transduces are activated simultaneously. Hence, it is unclear how they can be activated simultaneously (claim 1) while being activated in alternation or intermittently. Clarification with proper amendment is required.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 2, 8-11, 13-19 and 21-24 are rejected under 35 U.S.C. 103 as being unpatentable over Sverdlik et al., US 2019/0143149 A1, hereinafter Sverdlik, in view of Mo et al., US 7,878,977 B2, hereinafter Mo.
Claims 2, 16 and 21. Sverdlik teaches in FIGS.1,2 and 11 a system, a method and a non-transitory computer readable medium containing instructions that when executed by at least one processor cause the at least one processor to perform operations for a non-converging ultrasound fat treatment ([0001]: treating tissue using ultrasound energy with an ultrasonic transducer and applicator for skin treatments; and [0334]: two or more transducers of the array are activated simultaneously to emit unfocused ultrasound for targeting a plurality of spaced apart tissue regions), the system comprising:
a plurality of ultrasound transducers configured to generate non-converging ultrasonic waves, the plurality of ultrasound transducers including a first ultrasound transducer and a second ultrasound transducer ([0149]: an array of a plurality of independently operable ultrasound transducers from a large transducer construct; and [0334]: two or more transducers of the array are activated simultaneously to emit unfocused ultrasound for targeting a plurality of spaced apart tissue region);
one or more joints for interconnecting the plurality of ultrasound transducers ([0278]: emitting elements 602 are arranged in series, for example, in a chain like configuration); and
at least one processor configured to:
receive a selection of a fat tissue volume to be treated by the non-converging ultrasonic waves beneath an epithelium layer ([0202]: the effect of the emitted energy on other types of tissue such as fat tissue…so that fat tissue forms a natural barrier to the damage (e.g., a layer of fat tissue below the dermis); and [0334]: two or more transducers of the array are activated simultaneously to emit unfocused ultrasound for targeting a plurality of spaced apart tissue region;
adjust operation of the first ultrasound transducer using at least one first treatment parameter value to generate first non-converging ultrasonic waves and thereby heat the fat tissue volume; adjust operation of the second ultrasound transducer using at least one second treatment parameter value to generate second non-converging ultrasonic waves and thereby heat the fat tissue volume ([0149]: an array of a plurality of independently operable ultrasound transducers from a large transducer construct; [0147] and [0210] teaches a list of parameters taken into consideration when controlling heating of the tissue surface; and [0300]: in an operation mode in which one or more transducers are activated with a first set of energy parameters (e.g. frequency, intensity) and one or more other transducers are activated with a second set of energy parameters); and
operate the first ultrasound transducer and the second ultrasound transducer in a manner preventing convergence of the first ultrasonic waves and the second ultrasonic waves while the fat tissue volume is heated by the first ultrasonic waves and the second ultrasonic waves ([0334]: two or more transducers of the array are activated simultaneously to emit unfocused ultrasound for targeting a plurality of spaced apart tissue region) – having different transducers targeting regions that are spaced apart is considered “in a manner preventing convergence of the first ultrasound wave and the second ultrasound waves” as claimed, and in a manner causing apoptosis in fat cells of the tissue volume ([0467]: higher intensities produced thermal damage that starts closer or even at the epidermis layer…the larger the extent of smudging, the higher the thermal damage. In some cases, observing of numerous cell death…are indicative of a relatively low level of thermal damage).
Sverdlik does not teach that the plurality of ultrasound transducers are interconnected via one or more joints that allow relative movement of at least some of the plurality of ultrasound transducers to conform to a contour of a treatment region.
However, in an analogous flexible ultrasound transducer array configuration field of endeavor, Mo teaches
that the plurality of ultrasound transducers are interconnected via one or more joints that allow relative movement of at least some of the plurality of ultrasound transducers to conform to a contour of a treatment region (Col.2, line 66 to Col.3, line 10: The transducer housing 12 includes a hinge or joint for flexing or adapting to a contour. The transducer housing 12 is flexible at least between the transducer arrays or sub-arrays 16. The sub-arrays 16 change position relative to each other by flexing or bending of the transducer housing 12. By allowing the sub-arrays 16 to move relative to each other, the surface of the transducer array 14 is flexible or adapts to a contour).
Therefore, it would have been obvious to one of the ordinary skilled in the art before the effective filing date of the claimed invention to have the plurality of ultrasound transducers in a chain like configuration of Sverdlik employ such a feature of being interconnected via one or more joints that allow relative movement of at least some of the plurality of ultrasound transducers to conform to a contour of a treatment region as taught in Mo for the advantage of “being flexible or adapts to a contour”, as suggested in Mo, Col.3, line 10.
Claim 8. Sverdlik further teaches that
the at least one processor is configured to determine the at least one first treatment parameter value and the at least one second treatment parameter value based on the selection ([0149]: an array of a plurality of independently operable ultrasound transducers from a large transducer construct; [0147] and [0210] teaches a list of parameters taken into consideration when controlling heating of the tissue surface; and [0300]: in an operation mode in which one or more transducers are activated with a first set of energy parameters (e.g. frequency, intensity) and one or more other transducers are activated with a second set of energy parameters).
Claim 9. Sverdlik further teaches that
each of the at least one first treatment parameter and the at least one second treatment parameter includes at least one of a frequency of ultrasonic waves, an intensity of ultrasonic waves, a number ultrasonic waves pulses, or a duration of ultrasonic waves pulses ([0210]: parameters of the emitted ultrasound beam (e.g., intensity profile, frequency profile).
Claim 10. Sverdlik further teaches that
the at least one first treatment parameter and the at least one second treatment parameter include frequency of non-converging ultrasonic waves and intensity of non-converging ultrasonic waves ([0210]: parameters of the emitted ultrasound beam (e.g., intensity profile, frequency profile; [0334]: two or more transducers of the array are activated simultaneously to emit unfocused ultrasound for targeting a plurality of spaced apart tissue regions).
Claim 11. Sverdlik further teaches that
the plurality of ultrasound transducers includes at least three ultrasound transducers (FIG.6 illustrated 4 transducers 62 and FIG.7 illustrates 9 transducers 702; and [0261] In some embodiments, an array comprising a plurality of ultrasound transducers, such as 2, 3, 5, 7, 10, 20, 30 or intermediate, larger or smaller number of transducers is provided) configured for side-by-side arrangement ([0003]: the transducers arranged side by side).
Claim 13. Sverdlik further teaches that
the at least one processor is configured to control generation of the first non-converging ultrasonic waves and the second non-converging ultrasonic waves such that the second non-converging ultrasonic waves are delivered in a timed relationship with first non-converging ultrasonic waves ([0334]: two or more transducers of the array are activated simultaneously to emit unfocused ultrasound for targeting a plurality of spaced apart tissue regions).
Claim 14. Sverdlik further teaches
at least one cooling element located in proximity to the plurality of ultrasound transducers, wherein the at least one cooling element is configured to reach a temperature between -15°C and -5C (FIG.7: the cooling module 701 is located in proximity to the transducers 702; [0304]: cooling module 701 comprises a thermal reservoir block…that is pre-cooled to a temperature sufficient to cool transducer 7022; and [0339]: cooling is applied to maintain a temperature of the epidermis…the applicator’s cooling module is set to a temperature of between -5 to -20).
Claim 15. Sverdlik further teaches that
the at least one cooling element includes at least one thermoelectric cooler (TEC), and wherein a cooling surface of the at least one TEC contacts an associated surface of at least one ultrasound transducer or a surface of at least one thermally conductive transducer holder attached to the at least one ultrasound transducer ([0295]: cooling module comprises one more cooling elements, such as a Peltier element, for example in the form of a thermoelectric cooler (TEC)…one or more TEC elements are positioned in contact with base 704; and [0304]: the thermal reservoir block is pre-cooled to a temperature sufficient to cool transducers via base 704).
Claim 17. Sverdlik further teaches that
adjusting operation of at least one of the first ultrasound transducer and controlling the second ultrasound transducer takes into account an associated transducer angle relative to a selected target volume ([0210]: one or more parameters are taken into consideration, such as…beam angle).
Claim 18. Sverdlik further teaches
adjusting operation of at least one of the first ultrasound transducer and the second ultrasound transducer includes activating a plurality of PZT plates for a duration of at least two seconds without causing damage to adjacent tissue layers located near the fat tissue volume ([0135]: a thin ultrasound emitting element, e.g. a PZT plate; and [0355]: applicator is held against the tissue and energy is emitted for a time period of between 1-20 seconds, such as 3 seconds, 5 seconds, 9 seconds, 10 seconds, 20 seconds or intermediate, longer or shorter time period).
Claim 19. Sverdlik further teaches that
the fat tissue volume includes a first area of fat tissue associated with the first non- converging ultrasonic waves and a second area of fat tissue associated with the second non-converging ultrasonic waves, and wherein the first area of fat tissue and the second area of fat tissue are separated by regions of undamaged tissue ([0334]: two or more transducers of the array are activated simultaneously to emit unfocused ultrasound for targeting a plurality of spaced apart tissue regions; and [0353]: a squared, circular, or semicircular transducer surface…is moved intermittently across the tissue surface to generate spaced apart points of thermal damage with undamaged tissue between them, in a fractional manner).
Claim 22. Sverdlik further teaches
activating the first ultrasound transducer and the second ultrasound transducer in alternation ([0268]: unfocused ultrasound…are applied simultaneously or successively; and [0219]: treatment is repeated) – repeating a successive activation is activating the first and the second transducers in alternation .
Claim 23. Sverdlik further teaches
intermittently operating the first ultrasound transducer and the second ultrasound transducer ([0268]: unfocused ultrasound…are applied simultaneously or successively; and [0219]: treatment is repeated) – repeating a successive activation is activating the first and the second transducers intermittently.
Claim 24. Sverdlik further teaches that
the first ultrasonic waves and the second ultrasonic waves are non-converging so as to be unfocused ([0334]: two or more transducers of the array are activated simultaneously to emit unfocused ultrasound for targeting a plurality of spaced apart tissue regions).
Claims 3 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Sverdlik et al., US 2019/0143149 A1, hereinafter Sverdlik, in view of Mo et al., US 7,878,977 B2, hereinafter Mo, further in view of Emelianov et al., US 2009/0105588 A1, hereinafter Emelianov.
Claims 3 and 6. Sverdlik and Mo combined teaches all the limitations of claim 2.
Neither Sverdlik nor Mo teaches that the at least one processor is configured to determine boundaries of the fat volume based on ultrasound scans, wherein the selection is based on the determined boundaries.
However, in an analogous ultrasound imaging-based tissue boundary identification for heat treatment field of endeavor, Emelianov teaches
determine boundaries of the fat volume based on ultrasound scans, wherein the selection is based on the determined boundaries ([0123]: ultrasound imaging was used to identify the dermis-fat boundary in porcine tissue with high contract and to compute the temperature elevations during laser heating. Application of the ultrasound technique reported here may be relevant to clinical laser procedures to reduce fat).
Therefore, it would have been obvious to one of the ordinary skilled in the art before the effective filing date of the claimed invention to have the processor of Sverdlik and Mo combined employ such a feature of determining boundaries of the fat volume based on ultrasound scans, wherein the selection is based on the determined boundaries as taught in Emelianov for the advantage of compute the temperature elevations during the heat treatment, as suggested in Emelianov, [0123].
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Sverdlik et al., US 2019/0143149 A1, hereinafter Sverdlik, in view of Mo et al., US 7,878,977 B2, hereinafter Mo, further in view of Tosaya et al., US 2006/0094988 A1, hereinafter Tosaya.
Claim 12. Sverdlik and Mo combined teaches all the limitations of claims 1 and 11, including the at least three ultrasound transducers (Sverdlik: FIG.6 illustrated 4 transducers 62 and FIG.7 illustrates 9 transducers 702).
Neither Sverdlik nor Mo teaches that the treatment region includes at least one of an abdomen, a thigh, or a buttocks, and wherein the system further comprises a strap configured to fasten the at least three ultrasound transducers on a skin layer of the treatment region.
However, in an analogous ultrasound-based body contouring treatment planning field of endeavor, Tosaya teaches that
the treatment region includes at least one of an abdomen, a thigh, or a buttocks, and wherein the system further comprises a strap configured to fasten the ultrasound transducers on a skin layer of the treatment region ([0056]: one could perform one last defocusing…function to further beneficially steer, distribute, homogenize or direct the acoustical energy before it impacts the treatment subject 11; [0043]: FIG.3c shows a wearable therapy-delivery portion of the apparatus of the invention for strapping onto the thigh; and [0107]: a snap-on or conforming apparatus could be placed on the thing, on the buttocks, or on the belly).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Sverdlik et al., US 2019/0143149 A1, hereinafter Sverdlik, in view of Mo et al., US 7,878,977 B2, hereinafter Mo, further in view of Slayton et al., US 2016/0016015 A1, hereinafter Slayton.
Claim 20. In regard to the range of the delivery energy, such a feature depends on the overall tissue condition and the desired setting of the non-converging ultrasonic beam. As the delivery energy is merely among one of the parameters, such as the frequency of the acoustic wave, the duration of the pulses, that together control the effectiveness of the treatment and often times it is the balance among the parameters that needs to be considered, the particular range of the delivery energy is considered a design choice that is obvious to one of ordinary skill in the art to obtain through routine optimization based on the overall tissue condition and the adjustment of other parameters associated with the heat treatment.
Alternatively, in an analogous unfocused ultrasound-based fat tissue treatment field of endeavor, Slayton teaches that
the first ultrasonic waves deliver energy in a range of 1 to 18 Joules to the first fat tissue and the second ultrasonic waves deliver energy in a range of 1 to 18 Joules to the second fat tissue ([0050]: step 14 is directing ultrasound energy to ROI. The ultrasound energy may be focused, defocused, or unfocused; and [0051]: the ultrasound energy level is in a range of about 0.1 joules to about 500 joules in order to create an ablative lesion. However, the ultrasound energy level can be in a range of…from about 1 joules to about 50 joules).
Therefore, it would have been obvious to one of the ordinary skilled in the art before the effective filing date of the claimed invention to have the non-converging ultrasound beam of Sverdlik and Mo combined employ such a feature associated with the range of the acoustic energy as taught in Slayton as an example of one parameter among numerous parameters that have to be considered together when planning for an effective ultrasound-based tissue treatment.
Conclusion
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.
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/YI-SHAN YANG/Primary Examiner, Art Unit 3798