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 .
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.
Claim(s) 1-7, 12, 15-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Salcudean (US 2019/0192119) in view of Myers (WO 2012156881) in view of Warlich et al (US 2007/0142753) in view of Darlington (US 2010/0036291).
Regarding claim 1, Salcudean teaches An ultrasound probe, comprising:
a housing comprising a front wall, a rear wall, a right wall, a left wall (figure 1, where item 101 is a transducer and has a front wall, a rear wall, a right wall, a left wall)
and a segment that is sized and shaped to fit inan external area of a patient betweena right rib cage section and a left rib cage section;(paragraph 47, “FIGS. 3Aand 3B res pectively show transducer placements that may be applied to image the liver from either between the ribs”)
a plurality of piezoelectric elements disposed within the housing; and (paragraph 67, A “transducer” or “ultrasound transducer’ is a probe that contains an array of piezo-electric crystals and figure 1, where item 101is a transducer with housing)
Salcudean does not teach a plurality of cavitation detectors disposed within the housing.
Myers teaches from within a similar field of endeavor of high ultrasound transducer with piezoelectric sensors, a plurality of cavitation detectors disposed within the housing. (page 13, line 3-5 “FIGURE 10 illustrates the placement of three cavitation sensors 90 in the central region of the HIFU transducer.” And page 13 line33- page 14 line 4 “A circular printed circuit board behind the cavitation sensors has electrical contacts which make spring contact with the contact electrodes 96, 98 of the cavitation sensors, coupling the electrical signals received by a cavitation sensor to the printed circuit board for subsequent distribution and processing for indicia of cavitation events.” —where the cavitation detectors are detecting the cavitation done by the ultrasound transducer).
It would have been obvious to modify Salcudean to include cavitation detectors in the housing as taught by Myers. One would be motivated to do so to detect cavities while performing the ultrasound. As a result one would expect to cavitate only the tissue necessary and not the surrounding tissue.
Salcudean as modified fails to explicitly teach that the piezoelectric elements are arrange to provide non-focused ultrasound energy to isonate substantially an entire pancreas.
Warlich in the same field of endeavor in the subject of pancreas regeneration treatment using extracorporeal acoustic shock waves disclose isonating substantially an entire pancreas using non focus waves (see para. 0002 “This invention relates to the field of treating the pancreas of diabetic patients with acoustic pressure pulse shock waves generally. More specifically to treating the various abnormal conditions found in the pancreas of a diabetic using shock waves that are generated as either focused waves at high or low energy levels or non-focused waves at preferably low energy levels or a combination of such waves”.
It would have been obvious to one skilled in the art before the effective filling date to provide such an ultrasound system to treat the pancreas because doing so will allow to treat conditions such as diabetes (see para. 0002). Furthermore, it would have been obvious to one skilled in the art that specifically isonate the entire pancreas in order to cover the entire pancreas for any application.
However, although Warlich does discloses non focus emission, they are acoustic pulse shock waves, not ultrasound waves.
Darlington et al discloses providing for dynamically adjusting the emission of non focused ultrasound insonation to the patient (see para. 0057 “Therefore, the scope of the technology is to be determined solely by the following claims and equivalents thereof. In addition, the disclosed technology is not limited to the delivery of HIFU signals to the patient but can be applied to the delivery of any waveform such as non-focused ultrasound or laser light energy to a non-linear medium such as tissue.”
It would have been obvious to one skilled in the art before the effective filling date to further modify Salcudean to emit non focused ultrasound insonation as disclosed by Darlington because doing so will allow to expand the are to be targeted by the ultrasound emission.
Regarding claim 2, Salcudean teaches The ultrasound probe of Claim 1, whereby the plurality of piezoelectric elements are each configured to emit ultrasound energy of the same frequency. (paragraph 82, “Each exciter may be driven by a selected excitation signal which may comprise one or more than one frequencies.”)
Regarding claim 4, Salcudean teaches The ultrasound probe of Claim1, whereby respective one of the plurality of piezoelectric elementsare configured to emit ultrasound energy of different frequencies. (paragraph 82, “Each exciter may be driven bya selected excitation signal which may comprise one or more than one frequencies.”)
Regarding claim 5, Salcudean teaches The ultrasound probe of Claim1 further comprising a control unit electrically coupled to the ultrasound probe. (see figure 12, where the controller (item 1210) is connected to the ultrasound probe (item 101). Further see paragraph 136, “Transducer 101 outputs ultrasound echo data to imaging system 1208 which provides imaging system data to controller 1210.”).
Regarding claim 6, Salcudean teaches The ultrasound probe of Claim5, whereby the control unit is configured to control functions of the ultrasound probe. (paragraph 143, “Controller 1210 then checks whether all the excitation parameters ofa list of parameters have beenrun1242.” And paragraph 157, “Control systems in example embodiments of the invention (e.g. a controller1210)” and “Any of these technologies may be configured to provide functionality as described herein suchas, for example processing ultrasound data to determine tissue motions, processing determined tissue motions to determine tissue properties, generating images for dis play, controlling an external vibrator to perform optimizations as described herein, generating quality measures, performing feedback control over parameters for driving one or more exciters, etc.” —where the controlleris ableto process the data).
Regarding claim 7, Salcudean teaches The ultrasound probe of Claim6, whereby the functions comprise one or more duration of emission of ultrasound energy, intensity of ultrasound energy, frequency of transmitted waveforms and length of ultrasound energy bursts. (paragraph 33, The processor may be configured to control the one or more operating parameters of the external vibratorin realtime as the orientation of the ultrasound transducer is changed to minimize the apparent wavelength of the shear waves foreach orientation of the ultrasound transducer. The processor may be configured to control relative phases of a plurality of exciters of the at least one exciterto minimize the apparent wavelength of the shear waves.” And “The one or more operating parameters of the external vibrator may comprise one or more of: a frequency of operation of one or more exciters of the at least one exciter, a relative phase of operation of first and second exciters of the at least one exciter, an amplitude of operation of one or more exciters of the at least one exciter, and a direction of vibration of one or more exciters of the at least one exciter’)
Regarding claim 12, see Warlich para. 0002 (“0002] This invention relates to the field of treating the pancreas of diabetic patients with acoustic pressure pulse shock waves generally. More specifically to treating the various abnormal conditions found in the pancreas of a diabetic using shock waves that are generated as either focused waves at high or low energy levels or non-focused waves at preferably low energy levels or a combination of such waves”
Regarding claim 15, Salcudean teaches the ultrasound probe of Claim1 wherein the housing isa flat shape arranged to emit and receive ultrasound perpendicularly toa large face of the housing. (Paragraph 24 “ultrasound transducer to trans mit ultrasound pulses and to receive ultrasound echo signal” )
Regarding claim 16, Salcudean teaches the ultrasound probe of Claim1 wherein a linear dimension of the front wall of the housing is greater than a distance between the front wall and the back wall of the housing. (fig 8b, where the front wall (the area on the patient), is longer than the area to the back).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Salcudean (US 2019/0192119) in view of Myers (WO 2012156881) in view of Warlich et al (US 2007/0142753), in view of Darlington as applies to claims 1, 2 above and further in view of Khoklova (US-20190117243 -A1).
Regarding claim 3, Salcudean and Myers discloses all features of the claimed invention as discussed with respect to claim 1, however, Salcudean does not teach the ultrasound probe of Claim2, whereby the same frequency is a frequency in a range between 2MHz-4MHz.
Khoklova teaches from within a similar field of endeavor, the ultrasound probe of Claim 2, whereby the same frequency is a frequency in a range between 2MHz-4MHz. (Paragraph 10 “a frequency of the ultrasound waveforms within the first burst and the second burst ranges from 0.5 MHz to 3 MHz.”)
It would have been obvious to modify Salcudean to keep the frequency range between 2MHz- 4M#z as taught by Khoklova. One would be motivated to do so to have a greater imaging depth in the body and to suppress the backscattering of the pulsed high intensity focused ultrasound (Khoklova paragraph 57). As a result one would expect to be able to have the frequency not be limited and be able to go as deep into the body as desired.
Allowable Subject Matter
Claims 8-10, 13-14, 17-19 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The prior art fails to explicitly teach limitations from claim 8 (from which the rest of the dependent claims set forth here depend).
Response to Arguments
In view of applicant’s arguments, claims 8-10, 13-14, 17-19 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Regarding the applicant’s arguments, as best understood, highlight on the limitation “wherein the piezoelectric elements are arranged to provide non focused ultrasound energy to isonate an entire pancreas with ultrasound waves.”
In response to this, it should be noted that independent claim 1 is a device claim (i.e. ultrasound probe), which comprises a housing…and piezoelectric elements. The limitation of “isonate an entire pancreas with ultrasound waves” is a functional limitation; while features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function. In re Schreiber, 128 F.3d 1473, 1477-78, 44 USPQ2d 1429, 1431-32 (Fed. Cir. 1997).
In addition, claim 1 does not set forth a control unit or controller or processor configured to perform such functions; which then it will not be merely functional limitation.
Furthermore, it should be noted, that the claim limitation does not set forth to isonate the entire pancreas at the same time, but merely that it is isonated, so the reference, but setting forth isonating the pancreas, one of skilled in the art that the entired pancreas could be isonated by isonating individual areas until the entire pancreas is completely isonated .
In summary, the Examiner recommends amending the claims so that it reflects applicant arguments by (1) introducing a control unit configured to perform such argued function and (2) setting forth the pancreas is completely isonated at the same time. Such amendments will overcome the current rejection as set forth.
Conclusion
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 JOSEPH M SANTOS RODRIGUEZ whose telephone number is (571)270-7782. The examiner can normally be reached Monday-Friday 8:30am to 5:30pm.
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/JOSEPH M SANTOS RODRIGUEZ/Primary Examiner, Art Unit 3797