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 .
Special Status (Patent Prosecution Highway)
Acknowledgment is made of this application’s special status under the Patent Prosecution Highway (see decision mailed August 12, 2025).
Response to Amendment
This Office action is responsive to the preliminary amendment filed July 28, 2025. The amendment to the specification and claims is hereby acknowledged. By the amendment, claims 1, 7-11, 13, 16, 24, 26, 28 and 31 have been amended and claims 14-15, 17-21, 23, 27, 29 and 30 have been cancelled. Thus, claims 1-13, 16, 22, 24-26, 28 and 31 are presently pending.
Claim Objections
Claim 28 is objected to because of the following informalities: the phrase “ a control device to:” appears to be missing a word or phrase such as “configured” or “adapted”, to associate the control device functionally with the claimed system. Moreover, line 11 of the claim that begins with “maintaining” is grammatically incorrect and should be amended to consistent with the prior recitation of “control device to”. Appropriate correction is required.
Specification
The disclosure is objected to because of the following informalities:[0096], [0099] and at least [0161] use the phrase “last negative pressure” and “maximum negative pressure”, while [0097] use the phrase “least negative pressure” and “greatest maximum pressure”, which appear to be referring to the same values of the ratio in equation 1, thus raising inconsistencies. It is suggested to amend the specification with terms that are consistent throughout, for proper interpretation of claims in light of the specification.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 1-13, 16, 22, 24-26 and 31 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 1 and 31 each recite the limitation "the homogenate" in second to last line of each claim. There is insufficient antecedent basis for this limitation in the claim considering each claim previously sets forth a homogenate in the first and the second target volumes. For examination purposes only, it is presumed that the recitation in question refers to each previously set forth homogenate. Claims 2-13, 16, 22 and 24-26 are likewise rejected, only because they include all limitations and deficiencies of claim 1.
Claim 3 recite in part “wherein the high frequency component wave and the low frequency component wave have frequencies in accordance with equation 1”. However, equation 1 is directed towards determining a ratio “p”, which as specified in [0097] of the specification, is a ratio between least negative pressure in a burst relative to greatest negative pressure and can be used to determine whether a threshold pressure has been exceeded,. For the high frequency component wave and the low frequency component wave to have frequencies in accordance with equation 1, at the very least, the limiting values of the other variables of the equation, i.e., “p”, “n” AHigh and ALOW must be provided. Most importantly, because the value and/or range of “p” is not provided, the value(s) of high frequency component and low frequency component in accordance to equation 1 are unbounded, as the equation encompasses all possible solutions in the universe, as such, the meets and bounds of the claims is not clearly defined as the claim would read on all combinations of low and high frequency components, thus rendering the claim indefinite. Claim 3 is therefore rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential elements, such omission amounting to a gap between the elements. See MPEP § 2172.01. The omitted elements are: the values of “p” “n” AHigh and ALOW in equation 1, to limit the value of the high frequency component and the low frequency component.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 31 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because claim 28 is directed towards “a computer storage medium” which are presumed to include ineligible transitory signals. “When the broadest reasonable interpretation of a claim covers a signal per se, the claim must be rejected under 35 U.S.C. § 101 as covering non-statutory subject matter. See In re Nuijten, 500 F.3d 1346, 1356-57 (Fed. Cir. 2007) (transitory embodiments are not directed to statutory subject matter) “… A claim drawn to such a computer readable medium that covers both transitory and non-transitory embodiments may be amended to narrow the claim to cover only statutory embodiments to avoid a rejection under 35 U.S.C. § 101 by adding the limitation "non-transitory" to the claim. Cf. Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (suggesting that applicants add the limitation "non-human" to a claim covering a multi-cellular organism to avoid a rejection under 35 U.S.C. § 101). A signal is a form of energy. Thus, a signal is not a machine, not a process, not a manufacturing and composition of matter. Therefore, the claimed subject matter, i.e. a “computer-readable medium” in claim 31 is directed to a non-statutory subject matter.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 2, 7, 11-13, 16, 22, 24-26, 28 and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Applicant cited Cain et al US 20100069797 A1 (“Cain”) in view of Desilets US 20060122509 A1.
Regarding claim 1, Cain discloses a method of treating a region of biological tissue of a patient in need thereof (performing pulsed cavitational ultrasound therapy on target tissue 108, [0068], Fig. 1), the method (performing pulsed cavitational ultrasound therapy on target tissue 108, [0068]) comprising: positioning an ultrasound pressure wave in a target volume of the region of biological tissue to form a cavitation bubble cloud in the target volume ("During the initiation step, cavitation nuclei are generated, placed, or seeded in the therapy volume, which is the portion of tissue to which the therapy is directed. The cavitation nuclei reduce the threshold for cavitation by subsequent therapy pulses", [0070]. "Initiation introduces cavitation threshold-reducing cavitation nuclei and can be accomplished with a therapy transducer using acoustic energy", [0076]. "Once initiated, each pulse produces a bubble cloud, or set of cavitationally active microbubbles, that, as indicated herein, produces part of the tissue therapy and produces microbubbles predisposing the volume to subsequent pulses. After initiation the process can progress with assurance that each pulse effectively participates in the therapy process", [0066]); and maintaining the cavitation bubble cloud in the target volume for a time period sufficient to produce homogenate within the target volume, wherein the homogenate is fractionated within nonhomogenized biological tissue in the region of biological tissue ("During the maintenance step, the presence of micro-nuclei in the therapy volume is actively maintained, assuring that subsequent therapy pulses will produce the appropriate tissue effect. In some embodiments, an appropriate tissue effect can include at least a portion of the final desired tissue fractionation",[0071]. "therapy process is the interaction of ultrasound on existing cavitation nuclei to produce sufficiently vigorous cavitation to mechanically subdivide tissue within the therapy volume", [0085]).
Although the method of Cain is applicable in body shaping and/or fat reduction, [0118], Cain does not explicitly disclose positioning the pressure wave in a second target volume of the region of biological tissue to form a second cavitation bubble cloud in the second target volume; and maintaining the second cavitation bubble cloud in the second target volume for a second time period sufficient to produce homogenate within the second target volume, wherein the second target volume differs from the first target volume. Desilets teaches in [0035], [0040] that it was known in the prior art to generate lesion fields sequentially, by jumping the transducer from one focal zone to the next, to produce a new lesion field at each position, as illustrated in Figs. 3 and 4 as a prior art known technique for destroying adipose tissue. In view of these teachings, at the time of filing the claimed invention, it would have been obvious to one of ordinary skill in the art to include an additional step of positioning the pressure wave in a second target volume of the region of biological tissue to form a second cavitation bubble cloud in the second target volume, and maintaining the second cavitation bubble cloud in the second target volume for a second time period sufficient to produce homogenate within the second target volume, wherein the second target volume differs from the first target volume, so as to allow for targeting of adipose tissue for destruction in a large volume as taught by Desilets in [0036].
Regarding claim 2, Cain in view of Desilets discloses the method of claim 1, Cain further discloses wherein the pressure wave is a composite pressure wave comprising a high frequency component wave and a low frequency component wave ("An effective acoustic approach is to use a separate acoustic transducer... to initiate, and then use the therapy transducer for the maintenance and therapy sub-processes. This would enable one to use high frequency ultrasound for initiation thus making use of the higher resolution of high frequency transducers or arrays. In this embodiment, initiation could aid in determining the outlines of the therapy volume with high spatial resolution. Therapy could then progress at lower frequencies using the therapy transducer or an array of transducers. For example, lower frequencies would propagate through some bone and air", [0077]).
Regarding claims 4-6, Cain in view of Desilets discloses the method of claim 2, Cain further discloses as discussed in [0077] lower frequency can cover the entire therapy field, when compared to high frequency, it follows that a trough of low frequency component is larger/wider than a trough of high frequency component. Cain further teaches in [0083] “sustaining sequences or pulses (of lower intensity, for example) can be interleaved between the therapy pulses to sustain the microbubble or nuclei population and characteristics necessary to allow the next therapy pulse to be effective”. In the event the high frequency wave component is interleaved with the low frequency component at the same focal zone, the high frequency component would be positioned in a trough or within each trough of the low frequency component or in a compression part, i.e., the focal zone of the low frequency component wave, owing to the low frequency component wave being characterized with a larger/wider trough.
Regarding claim 7, Cain in view of Desilets discloses the method of claim 1, Cain further discloses wherein maintaining the cavitation bubble cloud in the target volume delivers a thermal dose to tissue that does not cause denaturation or coagulation within the target volume ("maintenance can be continued by ... thermal means", [0083], and does not cause denaturation or coagulation within the therapy volume).
Regarding claim 11, Cain in view of Desilets discloses the method of claim 1, Cain further discloses wherein positioning the pressure wave in the target volume comprises applying an ultrasound beam to the target volume ("During the initiation step, cavitation nuclei are generated, placed, or seeded in the therapy volume, which is the portion of tissue to which the therapy is directed. The cavitation nuclei reduce the threshold for cavitation by subsequent therapy pulses", [0070]. "Initiation introduces cavitation threshold-reducing cavitation nuclei and can be accomplished with a therapy transducer using acoustic energy", [0076]).
Regarding claim 12, Cain in view of Desilets discloses the method of claim 11, Cain further discloses wherein the ultrasound beam is a pulsed ultrasound beam ("Initiation introduces ... cavitation nuclei and can be accomplished with a therapy transducer using acoustic energy, usually high intensity pulses", [0076]).
Regarding claim 13, Cain in view of Desilets discloses the method of claim 11, Cain further discloses a focus of the ultrasound beam is positioned in the target volume ("therapy transducer 102 ... focus ultrasound onto the target tissue 108", [0068], Fig. 1).
Regarding claim 16, Cain in view of Desilets discloses the method of claim 1, Cain further discloses detecting an onset of cavitation, wherein the onset of cavitation is defined as a time t=0 when the cavitation bubble cloud in the target volume begins to form ("detecting initiation of said bubble cloud in the soft tissue in response to said initiation pulse sequence comprising detecting initiation of said bubble cloud in the soft tissue in response to said initiation pulse sequence using feedback techniques", Claim 21, Pg. 27. "feedback on the bubble cloud presence ... can be obtained by monitoring the therapy pulse backscatter from the bubble cloud ... The backscatter is monitored by ... a simple (and separate) monitoring transducer", [0073]).
Regarding claim 22, Cain in view of Desilets discloses the method of claim 1, Cain further discloses wherein the pressure wave has a peak negative pressure of 10- 100 MPa ("Ultrasound treatment consisted of scanning the therapeutic transducer focus electronically over 42 locations ... one high intensity (>18 MPa peak negative pressure) 25 cycle burst was delivered", [0237]).
Regarding claim 24, Cain in view of Desilets discloses the method of claim 1, as modified by Desilets teachings associated with Figs. 3 and 4, discrete lesion fields greater than 2 are disclosed, the method would thus include positioning the pressure wave in additional target volumes to form additional cavitational bubbles in the additional target volumes that differ from one another and from the first and second target volumes.
Regarding claim 25, Cain in view of Desilets discloses the method of claim 1, Cain further discloses wherein the biological tissue comprises skin tissue ("Using the histotripsy process to break drug resistant barriers... skin... the feedback and monitoring processes of the present disclosure allow control of the tissue disruption process, enabling temporal disruption of tissues with minimal or no permanent tissue damage", [0122]), adipose tissue, connective tissue, or muscle tissue.
Regarding Claim 26, Cain in view of Desilets discloses the method of claim 1, Cain further discloses wherein the method provides an aesthetic effect ("Applications of the present disclosure can also provide utility in the art of cosmetic body shaping", [0120] when pulsed cavitational ultrasound is used in the art of cosmetic body shaping, it does not provide a medical or therapeutic effect).
Regarding claim 28 and 31, Cain discloses a system for treating a region of biological tissue of a patient in need thereof (apparatus 100 for performing pulsed cavitational ultrasound therapy on target tissue 108, [0068], Fig. 1), the system (apparatus 100, Fig. 1) is disclosed as comprising a "Computer Control and Data Collection 112" - Fig. 1, the computer reads on a control unit, and a computer storage medium storing computer readable instructions is an inherent feature of a computer), the system comprising: one or more ultrasound transducers (therapy transducer 102, Fig. 1) to provide an ultrasound pressure wave to a target volume in the region of biological tissue and to form a cavitation bubble cloud in the target volume ("During the initiation step, cavitation nuclei are generated, placed, or seeded in the therapy volume, which is the portion of tissue to which the therapy is directed. The cavitation nuclei reduce the threshold for cavitation by subsequent therapy pulses", [0070]. "Initiation introduces cavitation threshold-reducing cavitation nuclei and can be accomplished with a therapy transducer using acoustic energy", [0076]. "Once initiated, each pulse produces a bubble cloud, or set of cavitationally active microbubbles, that, as indicated herein, produces part of the tissue therapy and produces microbubbles predisposing the volume to subsequent pulses. After initiation the process can progress with assurance that each pulse effectively participates in the therapy process", [0066]); and a control device (computer control and data collection 112 and a separate sustaining transducer producing ultrasound to maintain the appropriate nuclei characteristics and population, [0083], Fig. 1) to maintain the cavitation bubble cloud in the target volume for a time period sufficient to produce homogenate within the target volume ("During the maintenance step, the presence of micro-nuclei in the therapy volume is actively maintained, assuring that subsequent therapy pulses will produce the appropriate tissue effect. In some embodiments, an appropriate tissue effect can include at least a portion of the final desired tissue fractionation", [0071]. "therapy process is the interaction of ultrasound on existing cavitation nuclei to produce sufficiently vigorous cavitation to mechanically subdivide tissue within the therapy volume", [0085]). Cain does not explicitly disclose positioning the pressure wave in a second target volume of the region of biological tissue to form a second cavitation bubble cloud in the second target volume; and maintaining the second cavitation bubble cloud in the second target volume for a second time period sufficient to produce homogenate within the second target volume, wherein the second target volume differs from the first target volume. However, this limitation would have been obvious for substantially similar rationale, in view of Desilets as discussed in claim 1 above.
Claims 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over Cain in view of Desilets as applied to claim 1 above, and further in view of DeBenedictis et al., US 20160089550 A1 (“DeBenedictis”).
Regarding claims 8-10, Cain in view of Desilets as discussed in claim 1 above does not explicitly disclose wherein maintaining the cavitational bubble delivers a thermal dose that causes denaturation or coagulation and the thermal dose is sufficient to thermally ablate all or substantially all tissue or forming a thermal coagulation zone around the first or second target volume. However, DeBenedictis in the same field of endeavor of altering tissue for aesthetic purposes ([abstract]) , teaches that conventional procedures in the art involve delivering energy or heating tissue using focused ultrasound energy, to ablate, coagulate or denature volumes of tissue to result in tissue tightening and other beneficial cosmetic effects ([0032], [0063]). In view of these teachings, at the time of filing the claimed invention, it would have been obvious to one having ordinary skill in the art to apply the conventionally known technique to deliver a thermal dose to cause denaturization, coagulation or ablation of the first or second target volume, for the added benefit of reducing wrinkles, tighten tissue, lift tissue or other beneficial cosmetic effect.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BONIFACE N NGANGA whose telephone number is (571)270-7393. The examiner can normally be reached Mon. - Thurs. 5:30 am - 4:00 pm.
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/BONIFACE N NGANGA/Primary Examiner, Art Unit 3797