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 .
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.
Claim 16 is 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.
In re claim 16, it is unclear what the metes and bounds of “generate the ultrasonic waves with parameter values selected to cause apoptosis of fat cells” are. Applicant has failed to indicate any scope of parameter values would cause apoptosis of fat cells in the select tissue volume. It seems that any limitation that satisfy claim 2 would read on claim 16.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 2-11, 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Donskoy et al. (US 2010/0280419, hereinafter Donskoy ‘419) in view of Barthe et al. (US 2011/0112405, hereinafter Barthe ‘405).
In re claim 2, Donskoy ‘419 teaches a system for treating fat tissue of a subject, the system comprising:
a user interface configured to receive input of at least one treatment control parameter (0023-0024) including: an age of the subject, a gender of the subject, or a location of an anatomical treatment target (0021, 0043);
a memory configured for treatment protocol storage;
at least one ultrasound applicator, including:
a plurality of
a plurality of electrical connections associated with each of the plurality of
control circuitry electrically connected to the plurality of ultrasound transducers, wherein the control circuitry is configured to:
receive the selected at least one treatment control parameter, including an age of the subject, a gender of the subject, or a location of an anatomical treatment target; select from the memory an associated treatment protocol based on the received selected treatment control parameter (0021, 0023-0024, 0043); and
activate the plurality of ultrasound transducers to heat the selected tissue volume according to the selected treatment protocol associated with the received selected at least one treatment control parameter (fig. 4, 112, 0029, the large volume of 113 has multiple volumes within, or 112 has volume 113 or 115).
Donskoy ‘419 merely fail to teach PZT plates.
Barthe ‘405 teaches a plurality of piezoelectric (PZT) plates configured to generate non-converging ultrasound waves; a plurality of electrical connections associated with each of the plurality of PZT plates, wherein the plurality of PZT plates and the plurality of electrical connections form a plurality of ultrasound transducers (0082); electrical circuitry configured to cause controlled emission of first non-converging (0055, unfocused or defocused are non-converging) ultrasonic waves from a first ultrasound transducer and emission of second non-converging ultrasonic waves from a second ultrasound transducer such that the first non-converging ultrasonic waves are delivered to fat tissue at a first depth within a depth range of 2–20 mm beneath the skin surface and the second non-converging ultrasonic waves are delivered to fat tissue at a second depth within the depth range of 2–20 mm beneath the skin surface, the first depth being different from the second depth (0103, 0137, 0139).
It would have been prima facie obvious to one of ordinary skills in the art at the time of invention to modify the method/device of Donskoy ‘419 to include the features of Barthe ‘405 in order to treat multiple fat regions of different depths.
In re claim 3, Donskoy ‘419 teaches further comprising a fastener mechanically coupled to the plurality of ultrasound transducers, wherein the fastener is shaped and sized to fasten the plurality of ultrasound transducers to a skin surface at a treatment region (0020, 0022, fig. 1, 4).
In re claim 4, Donskoy ‘419 teaches wherein the fastener includes a strap or a belt (0022, fig. 1, 4).
In re claim 5, Donskoy ‘419 teaches wherein the plurality of ultrasound transducers are arranged side by side, and wherein the fastener is configured to fasten the plurality of ultrasound transducers arranged side-by-side to the skin surface (0020, 0022, fig. 1, 4).
In re claim 6, Barthe ‘405 teaches wherein the control circuitry is configured to cause the plurality of PZT plates to generate unfocused ultrasonic waves (0055, unfocused or defocused are non-converging).
In re claim 7, Barthe ‘405 teaches control circuitry is configured to cause the plurality of PZT plates configured to generate the unfocused ultrasonic waves in a frequency selected from a range of 1-10 MHz (0044, 0120).
In re claim 8, control circuitry is configured to cause the plurality of PZT plates to generate the unfocused ultrasonic waves with intensity values selected from a range of 5 - 90 W/cm^2.
In re claim 9, Barthe ‘405 teaches wherein the control circuitry is configured to activate the plurality of ultrasound transducers to generate unfocused ultrasonic waves with parameter values selected to heat the selected tissue volume to a temperature between 45C and 70C (0138).
In re claim 10, Barthe ‘405 teaches wherein the control circuitry is configured to activate the plurality of ultrasound transducers to generate the unfocused ultrasonic waves with parameter values selected to heat the selected tissue volume for a time period of at least 2 seconds (0152).
In re claim 11, Donskoy ‘419 teaches wherein each of the plurality of
Donskoy ‘419 merely fail to teach PZT plates.
Barthe ‘405 teaches a plurality of piezoelectric (PZT) plates configured to generate non-converging ultrasound waves; a plurality of electrical connections associated with each of the plurality of PZT plates, wherein the plurality of PZT plates and the plurality of electrical connections form a plurality of ultrasound transducers (0082); electrical circuitry configured to cause controlled emission of first non-converging (0055, unfocused or defocused are non-converging) ultrasonic waves from a first ultrasound transducer and emission of second non-converging ultrasonic waves from a second ultrasound transducer such that the first non-converging ultrasonic waves are delivered to fat tissue at a first depth within a depth range of 2–20 mm beneath the skin surface and the second non-converging ultrasonic waves are delivered to fat tissue at a second depth within the depth range of 2–20 mm beneath the skin surface, the first depth being different from the second depth (0103, 0137, 0139).
It would have been prima facie obvious to one of ordinary skills in the art at the time of invention to modify the method/device of Donskoy ‘419 to include the features of Barthe ‘405 in order to treat multiple fat regions of different depths.
In re claim 16, Donskoy ‘419 teaches wherein the control circuitry is configured to cause the plurality of ultrasound transducers configured to generate the ultrasonic waves with parameter values selected to cause apoptosis of fat cells in the selected tissue volume (cell death is apoptosis, cell reduction is a cell death, 0027).
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Donskoy ‘419 and Barthe ‘405 in view of Redding, Bruce K. JR (US 2002/0156415, hereinafter Redding ‘415).
In re claim 12, Donskoy ‘419 and Barthe ‘405 fail to teach an overall thickness of each of the plurality of ultrasound transducers is between 0.1mm and 7 mm.
Redding ‘415 teaches an overall thickness of each of the plurality of ultrasound transducers is between 0.1mm and 7 mm (0075, 1 mm is between 0.1 mm to 7mm).
It would have been prima facie obvious to one of ordinary skills in the art at the time of invention to modify the method/device of Donskoy ‘419 to include the features of Barthe ‘405 in order to treat multiple fat regions of different depths, and to include the features of Redding ‘415 in order to use readily available transducer with compact design.
Claim(s) 13-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Donskoy ‘419 and Barthe ‘405 in view of DeBenedictis et al. (US 2015/0216720, hereinafter DeBenedictis ‘720).
In re claim 13-14, Donskoy ‘419 and Barthe ‘405 fail to wherein the at least one ultrasound applicator includes at least one cooling element attached to the plurality of ultrasound transducers or to a transducer holder, and wherein the at least one cooling element is configured to cool a skin layer of a tissue contacting the at least one ultrasound applicator during the generation of the ultrasonic waves; wherein the control circuitry is configured to regulate a temperature of the cooling element in a range of -15°C to -5°C.
Note that Donskoy ‘419 teaches the plurality of ultrasound transducers that form the belt-shaped ultrasound applicator (fig. 1).
DeBenedictis ‘720 teaches teach wherein the at least one ultrasound applicator includes at least one cooling element attached to the plurality of ultrasound transducers or to a transducer holder (0082-0084), and wherein the at least one cooling element is configured to cool a skin layer of a tissue contacting the at least one ultrasound applicator during the generation of the ultrasonic waves (0082-0084, 0087-0095, 0099, 0100-0103, 0110-0113), wherein the at least one cooling element is configured to reach a temperature between −15°C and −5°C (0081, 0125, etc.).
It would have been prima facie obvious to one of ordinary skills in the art at the time of invention to modify the method/device of Donskoy ‘419 to include the features of Barthe ‘405 in order to treat multiple fat regions of different depths, and to include the features of DeBenedictis ‘720 in order to avoid thermal injury.
DeBenedictis ‘720 also teaches claim 15, wherein the at least one cooling element includes at least one thermoelectric cooler (TEC) (0079, 0113, 0122), and wherein a cold surface of the TEC is attached to flat surfaces of the plurality of PZT plates or to a surface of at least one thermal conducting transducer holder contacting the plurality of PZT plates (0079, 0122, 0113, fig. 1B, fig. 7).
In re claim 16, DeBenedictis ‘720 also teaches wherein the control circuitry is configured to cause the plurality of ultrasound transducers configured to generate the ultrasonic waves with parameter values selected to cause apoptosis of fat cells in the selected tissue volume (0062, 0063).
Claim(s) 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Donskoy ‘419 and Barthe ‘405 in view of Eshel (US 2006/0241440, hereinafter Eshel ‘440).
In re claim 22, Donskoy ‘419 and Barthe ‘405 fail to teach wherein each of the plurality of PZT plates includes at least one channel that crosses through each PZT plate from a first surface to a second surface.
Eshel ‘440 teaches wherein each of the plurality of PZT plates includes at least one channel that crosses through each PZT plate from a first surface to a second surface (fig. 1, each piezoelectric element 15 has at least one channel from top to bottom show in different shades of color).
It would have been prima facie obvious to one of ordinary skills in the art at the time of invention to modify the method/device of Donskoy ‘419 to include the features of Barthe ‘405 in order to treat multiple fat regions of different depths, and to include the features of Eshel ‘440 in order to produce an acoustic beam capable of modifying tissue in a target volume in a tissue-containing region of a body, an acoustic beam director, directing the acoustic beam at the target volume and a plurality of sensors operative to determine the extent of acoustic coupling between the acoustic beam director and the body.
Claim(s) 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Donskoy ‘419 and Barthe ‘405 in view of Pollock et al. (US 2012/0277639, hereinafter Pollock ‘639).
In re claim 23, Donskoy ‘419 and Barthe ‘405 fail to teach wherein the at least one ultrasound applicator includes a flex printed circuit board (PCB) attached to flat surfaces of the plurality of PZT plates.
Pollock ‘639 teaches teach wherein the at least one ultrasound applicator includes a flex printed circuit board (PCB) attached to flat surfaces of the plurality of PZT plates (0015, 0045-0047).
It would have been prima facie obvious to one of ordinary skills in the art at the time of invention to modify the method/device of Donskoy ‘419 to include the features of Barthe ‘405 in order to treat multiple fat regions of different depths, and to include the features of Pollock ‘639 in order to conform to a complex 3D surface and deliver ultrasound efficiently to the underlying surface.
Claim(s) 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Donskoy ‘419 and Barthe ‘405 in view of Pollock ‘639, and still further in view of Eshel ‘440.
In re claim 24, Donskoy ‘419 and Barthe ‘405 fail to teach wherein the at least one ultrasound applicator includes a plurality of sensors configured to measure a temperature at a contact point between a corresponding PZT plate and contacting tissue.
Pollock ‘639 teaches wherein the at least one ultrasound applicator includes a plurality of sensors configured to measure a temperature at a contact point (0063-0071).
Pollock ‘639 also teaches [0011] It is known to mount an array of transducers on a flexible printed circuit board (flexi-PCB). Previous studies (e.g. Arunachalam et al., 2008, `Performance evaluation of a conformal TMS sensor array` Int. J. Hyperthermia, 24(4), 313-325) describe flexible PCB mounted temperature sensors for measuring skin surface temperatures.
Eshel ‘440 teaches wherein the at least one ultrasound applicator includes a plurality of sensors configured to measure a temperature at a contact point between a corresponding PZT plate (0095-0098) and contacting tissue (0106, fig. 1; 0130).
It would have been prima facie obvious to one of ordinary skills in the art at the time of invention to modify the method/device of Donskoy ‘419 to include the features of Barthe ‘405 in order to treat multiple fat regions of different depths, and to include the features of Pollock ‘639 in order to conform to a complex 3D surface and deliver ultrasound efficiently to the underlying surface, and to include the features of Eshel ‘440 in order to produce an acoustic beam capable of modifying tissue in a target volume in a tissue-containing region of a body, an acoustic beam director, directing the acoustic beam at the target volume and a plurality of sensors operative to determine the extent of acoustic coupling between the acoustic beam director and the body.
Response to Arguments
Applicant’s arguments with respect to claim(s) 2-16 and 22-24 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BO JOSEPH PENG whose telephone number is (571)270-1792. The examiner can normally be reached Monday thru Friday: 8:00 AM-5:00 PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, ANNE M KOZAK can be reached at (571) 270-0552. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BO JOSEPH PENG/Primary Examiner, Art Unit 3797
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