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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on March 11, 2026 has been entered.
Response to Amendment
This Office action is responsive to the amendment filed with the request noted above. As directed by the amendment, claim 1 has been amended and claims 2-20 has been added. Thus, claims 1-20 are presently pending.
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 1-20 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.
As to claims 1-20, independent claim 1 as amended requires the limitation “determining whether a power coupling of the ultrasonic energy to the patient's skin surface satisfies a threshold condition based on the phase of the ultrasonic energy”, a substantially similar limitation is to be found in claim 13 and 20. The most relevant section of the specification as filed is [0105] that teaches determining and/or measurement of power delivered on each transmit pulse to confirm proper coupling i.e., proper coupling is determined based on a calculated electrical power delivered. In view of these, the disclosure as filed fails to convey to those of ordinary skill in the art that the Applicant was in possession of the invention now claimed. For this reason, independent claims 13 and 20, and dependent claims 2-12 and 14-19 are likewise rejected for failing to meet the written description requirement for the same rationale as claim 1. If examiner is mistaken, Applicant is respectfully requested to cite specific section of the original disclosure that provides adequate written description for the subject matter in question.
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 1-20 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.
Claims 1-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential steps and/or elements, such omission amounting to a gap between the steps. See MPEP § 2172.01. The omitted steps are: determining and/or measurement of power delivered on each transmit pulse to confirm proper coupling (i.e., to determine whether a power coupling of the ultrasonic energy to the patient’s skin satisfies a threshold).
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 1-3, 8, 10-16, 18 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over previously cited CHANDRARATINA US 20060241522 A1 in view of previously SVERDLIK et al., WO 2017212489 A2 hereinafter “SVERDLIK” and further in view of BARSOTTI US 4791915.
Regarding claims 1 and 13, CHANDRARATINA discloses a method of treating peripheral vascular disease by stimulating angiogenesis and/or vasodilation within a patient (a method of treating ischemia in the legs by stimulating angiogenesis in a patient - [0012], [0032],[0037]), comprising:
providing a wearable non-invasive device comprising a flexible housing material and an array of ultrasound transducers operably attached to the flexible housing material (an ultrasound device comprising a flexible substrate and an array of ultrasound transducers attached to the flexible substrate is worn on the leg, Fig. 3 - [0013], [0043-0044]);
positioning the wearable non-invasive device and the array of transducers proximate a skin surface of a patient over at least one target site angiosome where angiogenesis and/or vasodilation is desired (the ultrasound device is positioned on the calf 7 of the patient for treatment of vessel and tissue disorders and for promotion of angiogenesis, and thus is positioned over a target site angiosome, Fig. 3, [0044], [0055], [0057], the ultrasound may also cause vasodilation [0037]), and such that the flexible housing material and the array of ultrasound transducers substantially conforms to the skin surface of one or more of the thigh, calf, ankle, or foot of the patient (illustration Fig.3, [0044]);
causing a therapeutically effective amount of ultrasonic energy to be directed toward the target site angiosome over a set time period (a therapeutic amount of ultrasound energy is delivered for a prolonged period of time toward the calf - [0055], [0057]), thereby stimulating cavitation and shear stress within tissue at the target site angiosome, thereby promoting angiogenesis and/or vasodilation within the patient (power to the ultrasound transducer elements can be adjusted to bring about the desired ultrasound-induced effects, wherein the delivered ultrasound energy to the target site promotes angiogenesis, thus the delivered ultrasound energy would cause cavitation and shear stress within the tissue at the target site – [0033], [0055]-[0056]).
CHANDRARATINA does not explicitly disclose determining a phase of the ultrasound energy; determining whether a power coupling of the ultrasonic energy to the patient’s skin surface satisfies a threshold condition based on the phase of the ultrasonic energy; and stopping delivery of the ultrasonic energy if the threshold condition is not satisfied.
SVERDLIK in the same field of endeavor of applying ultrasound energy to a tissue volume, discloses various methods for assessing contact between an ultrasound applicator and skin (page 13, 3-4), specifically, discussion associated with Fig. 16D1 in page 57, from line 25 to page 58 line 6, determining the power delivered through an array of transducers (at 1615); comparing the determined power delivered to a reference value to determine proper coupling to the patient's skin surface (at 1617 and “a change in power above a certain threshold is indicative of loss of contact”) and if loss of contact is detected, ultrasound emission is automatically ceased.
BARSOTTI in the same field of endeavor of ultrasound therapy device discloses a device and associated method that includes monitoring transducer current, voltage and phase angle for servo control, coupling detection and fault protection ([abstract]), and further in [col. 8: 49-63] discloses that “the device also include phase detector which quantifies the phase relationship between the voltage and current at the transducer 12. The ultrasound transducer dynamically changes its impedance depending on the degree of coupling it makes with the patient's tissue. The changing impedance is easily determined from the instantaneous phase angle between the transducer voltage and the transducer current. The phase detector provides phase information to the processor 70 which, in addition to a voltage or current signal, enables the processor through software control to drive a visual coupling indicator, change output levels in response to varying tissue loads, and reduces output power to incidental levels when gross uncoupling occurs” and/or [col. 7: 40-52] “An operational amplifier 260 filters and integrates the output from the exclusive OR gate 258 to produce a voltage which reflects the relative phase difference between the voltage and current. This phase voltage is transmitted to the A/D converter 90 over lead 262 for use by the processor 70, from which, among other things, the degree of transducer/patient coupling is determined. If the processor through software senses that coupling has remained below a predetermined level for a set time, such as two seconds, the output power level is significantly reduced to prevent heating of the transducer 12”.
In view of the combined teachings of SVERDLICK and BARSOTTI, it would have been obvious to one of ordinary skill in the art, at the time of filing the claimed invention, to have modified the ultrasonic treatment method of CHANDRARATINA, to include monitoring and/or determining a phase, current and voltage of the ultrasound energy to determine a power delivered by the ultrasound energy, determine whether a power coupling of the ultrasonic energy to the patient’s skin surface satisfies a threshold condition based on the delivered power determined from the phase, current and voltage of the ultrasonic energy; or alternatively, in view of the teachings of BARSOTTI, determine a phase between voltage and current of transducer and dynamically change impedance of the transducer based on degree of coupling of transducer with patients tissue from instantaneous phase angle between transducer voltage and current, and in either case noted above, stopping/ceasing delivery of the ultrasonic energy if the threshold condition is not satisfied when gross uncoupling occurs or loss of contact is detected, to enhance efficiency in treatment since improper coupling or poor contact between a transducer and patient’s skin would result with attenuation of ultrasound which would reduce efficiency of treatment and ceasing or stopping delivery of ultrasonic energy if the threshold is not satisfied would allow a user to reposition the device on the skin surface for proper contact, as taught by SVERDLIK and/or would prevent heating of the transducer(s) as taught by BARSOTTI in [col. 7: 44-51].
Regarding claim 2, the combination of CHANDRARATINA, SVERDLIK and BARSOTTI discloses the method of Claim 1. CHANDRARATINA further discloses wherein the ultrasonic energy has a frequency of between about 0.25 MHz and about 5 MHz (ultrasound within a frequency range of about 1.6 MHz to about 8 MHz - [0039]).
Regarding claim 3, the combination of CHANDRARATINA, SVERDLIK and BARSOTTI discloses the method of Claim 1, as modified by the teachings of SVERDLIK in page 58, lines 5-6, an alert is provided to a user, BARSOTTI discloses wherein the alert is inform of a visual alert [Col. 3: 28-39 “light bar”) .
Regarding claim 8, the combination of CHANDRARATINA, SVERDLIK and BARSOTTI discloses the method of Claim 1, as modified by the teachings of BARSOTTI as discussed in claim 1 above, specifically BASOTTI teachings in [col. 7: 25-51] and Fig. 7 structure of phase detector “… the phase detector 106 includes a pair of small toroid transformers 250 and 252 connected to sample the voltage and current, respectively, at the, transducer load 12, while maintaining the transducer circuit in direct isolation. The voltage transformer 250 has a primary across the output of the filter 238 and the current transformer 252 has its primary winding in series with the output of the filter 238. The secondary windings of the transformers 250 and 252 are connected to comparison circuits 254 and 256, respectively, which convert the voltage and current sine waves to square waves of equal amplitude while maintaining their respective phase relationship. An exclusive OR logic gate 258 produces either a logic zero when the signals are instantaneously in phase, or a logic 1 when the signals are instantaneously out of phase. An operational amplifier 260 filters and integrates the output from the exclusive OR gate 258 to produce a voltage which reflects the relative phase difference between the voltage and current”, an amplitude is necessarily determined to make a determination of whether the signal are in phase (i.e., equal amplitude) or out of phase for logic 1 (different amplitude).
Regarding claim 10, the combination of CHANDRARATINA, SVERDLIK and BARSOTTI discloses the method of Claim 1. CHANDRARATINA does not disclose wherein a surface area of the array of transducers covers at least about 40% of a surface area of the entire wearable device. However, since CHANDRARATINA discloses wherein the device may comprise any number of suitable transducers elements [0028]), it would have been obvious to one of ordinary skill in the art, at the time of filing the claimed invention, to have modified the ultrasonic device of CHANDRARATINA, wherein a surface area of the array of transducers covers at least about 40% of a surface area of the entire wearable device, in order to have a device that can radiate ultrasound into a surface of highly varying contour and to tailor the device based on the desired treatment ([0030]).
Regarding claim 11, the combination of CHANDRARATINA, SVERDLIK and BARSOTTI discloses the method of Claim 1. CHANDRARATINA does not disclose wherein a surface area of the array of transducers covers at least about 60% of a surface area of the entire wearable device. However, since CHANDRARATINA discloses wherein the device may comprise any number of suitable transducers elements ( [0028]), it would have been obvious to one of ordinary skill in the art, at the time of filing the claimed invention, to have modified the ultrasonic device of CHANDRARATINA, wherein a surface area of the array of transducers covers at least about 60% of a surface area of the entire wearable device, in order to have a device that can radiate ultrasound into a surface of highly varying contour and to tailor the device based on the treatment desired ([0030]).
Regarding claim 12, the combination of CHANDRARATINA, SVERDLIK and BARSOTTI discloses the method of Claim 1. CHANDRARATINA does not disclose wherein a surface area of the array of transducers covers at least about 80% of a surface area of the entire wearable device. However, since CHANDRARATINA discloses wherein the device may comprise any number of suitable transducers elements ([0028]), it would have been obvious to one of ordinary skill in the art, at the time of filing the claimed invention, to have modified the ultrasonic device of CHANDRARATINA, wherein a surface area of the array of transducers covers at least about 80% of a surface area of the entire wearable device, in order to have a device that can radiate ultrasound into a surface of highly varying contour and to tailor the device based on the treatment (CHANDRARATINA – [0030]).
Regarding claim 14, the combination of CHANDRARATINA, SVERDLIK and BARSOTTI discloses the method of Claim 13. CHANDRARATINA further discloses wherein the transducer comprises an array of multiple, single-element TUS transducers (an array of transducers for delivering therapeutic ultrasound- Fig. 3, [0044), [0057]).
Regarding claim 15, the combination of CHANDRARATINA, SVERDLIK and BARSOTTI discloses the method of Claim 13. CHANDRARATINA further discloses wherein the wearable device is applied continuously for at least 2 hours a day (the transducer elements transmit ultrasound continuously for about 4 hours a day - [0056]).
Regarding claim 16, the combination of CHANDRARATINA, SVERDLIK and BARSOTTI discloses the method of Claim 13. CHANDRARATINA further discloses wherein the wearable device is applied continuously for at least 4 hours a day (the transducer elements transmit ultrasound continuously for about 4 hours a day – 0056]).
Regarding claim 18, the combination of CHANDRARATINA, SVERDLIK and BARSOTTI discloses the method of Claim 13. CHANDRARATINA further discloses wherein the wearable device is non-circumferentially wrapped around a portion of an extremity of the patient (see illustration Fig. 3).
Regarding claim 19, the combination of CHANDRARATINA, SVERDLIK and BARSOTTI discloses the method of Claim 18. CHANDRARATINA further discloses wherein the extremity is a lower extremity (see illustration Fig. 3, [0044]).
Claims 1-3, 5-6, 8, 13-14, 17 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over HUCKLE et al. US 2003/0153849 A1 hereinafter 'HUCKLE' (cited by Applicant) in view of SVERDLIK.
Regarding claims 1 and 13, HUCKLE discloses a method of treating peripheral vascular disease by stimulating angiogenesis and/or vasodilation within a patient (a method of treating ischemic tissues within the lower extremities which have restricted blood flow or lack of adequate vascular supply by promoting angiogenesis - [0067], [0079], [0083], note: vasodilation is an effect of ultrasound on tissue), comprising:
providing a wearable non-invasive device comprising a flexible housing material and an array of ultrasound transducers operably attached to the flexible housing material (Figs. 7-8, apparatus 400 comprising strip 406 (flexible housing material) that is wrapped around the ankle of the user with transducer assemblies 402 operably attached to the strip 406 - [0099]-[0100]);
positioning the wearable non-invasive device and the array of ultrasound transducers proximate a skin surface of a patient over at least one target site angiosome where angiogenesis and/or vasodilation is desired (the apparatus is placed over the desired treatment site, wherein ultrasonic energy is delivered to promote angiogenesis – Fig. 8, [0083], [0099]-[0100]), and such that the flexible housing material and the array of ultrasound transducers substantially conforms to the skin surface of one or more of the thigh, calf, ankle or foot of the patient (see illustration Fig. 8),
causing a therapeutically effective amount of ultrasonic energy to be directed toward the target site angiosome over a set time period (a therapeutic amount of ultrasound is delivered to promote angiogenesis and/or vasodilation - [0083], [0099]-[0100]), thereby stimulating cavitation and shear stress within tissue at the target site angiosome, thereby simulating angiogenesis within the patient (ultrasound energy is delivered to the target tissue to promote angiogenesis, thus the ultrasound energy would stimulate cavitation and shear stress within tissue at the target site angiosome, thereby promoting angiogenesis and/or vasodilation within the patient - [0083], [0100]).
HUCKLE does not disclose determining a phase of the ultrasound energy; determining whether a power coupling of the ultrasonic energy to the patient’s skin surface satisfies a threshold condition based on the phase of the ultrasonic energy; and stopping delivery of the ultrasonic energy if the threshold condition is not satisfied.
SVERDLIK in the same field of endeavor of applying ultrasound energy to a tissue volume, discloses various methods for assessing contact between an ultrasound applicator and skin (page 13, 3-4), specifically, discussion associated with Fig. 16D1 in page 57, from line 25 to page 58 line 6, determining the power delivered through an array of transducers (at 1615); comparing the determined power delivered to a reference value to determine proper coupling to the patient's skin surface (at 1617 and “a change in power above a certain threshold is indicative of loss of contact”) and if loss of contact is detected, ultrasound emission is automatically ceased.
BARSOTTI in the same field of endeavor of ultrasound therapy device discloses a device and associated method that includes monitoring transducer current, voltage and phase angle for servo control, coupling detection and fault protection ([abstract]), and further in [col. 8: 49-63] discloses that “the device also include phase detector which quantifies the phase relationship between the voltage and current at the transducer 12. The ultrasound transducer dynamically changes its impedance depending on the degree of coupling it makes with the patient's tissue. The changing impedance is easily determined from the instantaneous phase angle between the transducer voltage and the transducer current. The phase detector provides phase information to the processor 70 which, in addition to a voltage or current signal, enables the processor through software control to drive a visual coupling indicator, change output levels in response to varying tissue loads, and reduces output power to incidental levels when gross uncoupling occurs” and/or [col. 7: 40-52] “An operational amplifier 260 filters and integrates the output from the exclusive OR gate 258 to produce a voltage which reflects the relative phase difference between the voltage and current. This phase voltage is transmitted to the A/D converter 90 over lead 262 for use by the processor 70, from which, among other things, the degree of transducer/patient coupling is determined. If the processor through software senses that coupling has remained below a predetermined level for a set time, such as two seconds, the output power level is significantly reduced to prevent heating of the transducer 12”.
In view of the combined teachings of SVERDLICK and BARSOTTI, it would have been obvious to one of ordinary skill in the art, at the time of filing the claimed invention, to have modified the ultrasonic treatment method of HUCKLE to include monitoring and/or determining a phase, current and voltage of the ultrasound energy to determine a power delivered by the ultrasound energy, determine whether a power coupling of the ultrasonic energy to the patient’s skin surface satisfies a threshold condition based on the delivered power determined from the phase, current and voltage of the ultrasonic energy; or alternatively, in view of the teachings of BARSOTTI, determine a phase between voltage and current of transducer and dynamically change impedance of the transducer based on degree of coupling of transducer with patients tissue from instantaneous phase angle between transducer voltage and current, and in either case noted above, stopping/ceasing delivery of the ultrasonic energy if the threshold condition is not satisfied when gross uncoupling occurs or loss of contact is detected, to enhance efficiency in treatment since improper coupling or poor contact between a transducer and patient’s skin would result with attenuation of ultrasound which would reduce efficiency of treatment and ceasing or stopping delivery of ultrasonic energy if the threshold is not satisfied would allow a user to reposition the device on the skin surface for proper contact, as taught by SVERDLIK and/or would prevent heating of the transducer(s) as taught by BARSOTTI in [col. 7: 44-51].
Regarding claim 2, the combination of HUCKLE, SVERDLIK and BARSOTTI discloses the method of Claim 1. HUCKLE further discloses wherein the ultrasonic energy has a frequency of between about 0.25 MHz and about 5 MHz ([0084] - the ultrasound comprises a frequency ranging between about 1 and about 2 MHz).
Regarding claim 3, the combination of HUCKLE, SVERDLIK and BARSOTTI discloses the method of Claim 1, as modified by the teachings of SVERDLIK in page 58, lines 5-6, an alert is provided to a user, BARSOTTI discloses wherein the alert is inform of a visual alert [Col. 3: 28-39 “light bar”) .
Regarding claim 5, the combination of HUCKLE, SVERDLIK and BARSOTTI discloses the method of Claim 1. HUCKLE further discloses positioning the array of transducers above at least two target site angiosomes, wherein the target site angiosomes are selected from a group consisting of: the posterior tibial artery angiosome, the anterior tibial artery angiosome, the medial calcaneal artery angiosome; the medial plantar artery angiosome; the dorsalis pedis artery angiosome; the lateral calcaneal artery angiosome, and the anterior perforating branch artery angiosome (the ultrasound transducers are shown positioned over the ankle on the anterior, lateral, and medial surfaces, and thus would be positioned over the anterior tibial artery angiosome and the lateral calcaneal artery angiosome – Fig. 8).
Regarding claim 6, the combination of HUCKLE, SVERDLIK and BARSOTTI discloses the method of Claim 1. HUCKLE does not explicitly disclose positioning the array of transducers above each of the following target site angiosomes: the posterior tibial artery angiosome, the anterior tibial artery angiosome, the medial calcaneal artery angiosome; the medial plantar artery angiosome; the dorsalis pedis artery angiosome; the lateral calcaneal artery angiosome, and the anterior perforating branch artery angiosome. However, since HUCKLE discloses wherein multiple transducer assemblies 402 can be positioned within the pockets 404 in a plurality of configurations (Fig. 7, [0099]), and wherein the pockets 404 are arranged at a plurality of positions along the strip 406 ([0099]). It would have been obvious to one of ordinary skill in the art, at the time of filing the claimed invention, to have modified the method of HUCKLE, and position the array of transducers above each of the following target site angiosomes as claimed, since each of the listed arteries is located within the ankle and is accessible for being targeted via at least one of the pockets 404.
Regarding claim 8, the combination of HUCKLE, SVERDLIK and BARSOTTI discloses the method of Claim 1, as modified by the teachings of BARSOTTI as discussed in claim 1 above, specifically BASOTTI teachings in [col. 7: 25-51] and Fig. 7 structure of phase detector “… the phase detector 106 includes a pair of small toroid transformers 250 and 252 connected to sample the voltage and current, respectively, at the, transducer load 12, while maintaining the transducer circuit in direct isolation. The voltage transformer 250 has a primary across the output of the filter 238 and the current transformer 252 has its primary winding in series with the output of the filter 238. The secondary windings of the transformers 250 and 252 are connected to comparison circuits 254 and 256, respectively, which convert the voltage and current sine waves to square waves of equal amplitude while maintaining their respective phase relationship. An exclusive OR logic gate 258 produces either a logic zero when the signals are instantaneously in phase, or a logic 1 when the signals are instantaneously out of phase. An operational amplifier 260 filters and integrates the output from the exclusive OR gate 258 to produce a voltage which reflects the relative phase difference between the voltage and current”, an amplitude is necessarily determined to make a determination of whether the signal are in phase (i.e., equal amplitude) or out of phase for logic 1 (different amplitude).
Regarding claim 14, the combination of HUCKLE, SVERDLIK and BARSOTTI discloses the method of Claim 13. HUCKLE further discloses wherein the transducer comprises an array of multiple, single-element TUS transducers (Figs. 7-8, [0083], [0100]).
Regarding claim 17, the combination of HUCKLE, SVERDLIK and BARSOTTI discloses the method of Claim 13. HUCKLE further discloses wherein the wearable device is circumferentially wrapped around a portion of an extremity of the patient (see Fig. 8).
Regarding claim 19, the combination of HUCKLE, SVERDLIK and BARSOTTI discloses the method of Claim 18. HUCKLE further discloses wherein the extremity is a lower extremity (see Fig. 8).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over HUCKLE in view of SVERDLIK and BARSOTTI as applied to claim 1 above, and further in view of DEEM et al., US 20070055179 A1 (cited by Applicant) hereinafter “DEEM”.
Regarding claim 4, the combination of HUCKLE, SVERDLIK and BARSOTTI discloses the method of Claim 1. HUCKLE does not disclose wherein the ultrasonic energy has a peak negative pressure of between about 1 MPa and about 6 MPa. DEEM discloses an ultrasonic energy with a peak negative pressure of between about 1 MPa and about 6 MPa (a method of treating tissue with ultrasound having a peak negative pressure from 0.1 MPa to 10.0 MPa; claims 86 and 87). It would have been obvious to one of ordinary skill in the art, at the time of filing the claimed invention, to have modified the method of HUCKLE, to include an ultrasonic energy with a peak negative pressure of between about 1 MPa and about 6 MPa, for the added advantage of causing disruption and cavitation in the target tissue as taught by DEEM in [0025].
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over HUCKLE in view of SVERDLIK and BARSOTTI as applied to claim 1 above, and further in view of FRIEMEL et al., US 20100106019 A1 (cited by Applicant) hereinafter FRIEMEL.
Regarding claim 7, the combination of HUCKLE, SVERDLIK and BARSOTTI discloses the method of Claim 1. HUCKLE as modified by the teachings of SVERDLIK in discussion associated with Fig.16D1 in page 57 from line 25 teaches measuring power of the ultrasonic energy from at least one transducer of the array of transducers (at 1611 1615 and 1671); and discontinuing directing the ultrasonic energy from the at least one transducer found to have a reflected acoustic power above a predetermined threshold (“ultrasound emission is automatically ceased”). However, HUCKLE as modified by SVERDLIK fails to explicitly disclose that the measured power is reflected acoustic power.
However, FRIEMEL discloses measuring reflected acoustic power of the ultrasonic energy from at least one transducer of the array of transducers (measuring a reflected backscatter signal in response to applied HIFU (high intensity focused ultrasound); paragraph [0037]); and discontinuing directing the ultrasonic energy from the at least one transducer found to have a reflected acoustic power above a predetermined threshold (the backscatter is analyzed and the HIFU treatment is halted when the energy applied to a predetermined location within the body has reached a threshold value or when the cumulative backscatter energy changes by more than a threshold amount; [0017], [0047]). It would have been obvious to one of ordinary skill in the art, at the time of filing the claimed invention, to have modified the method of HUCKLE, SVERDLIK and BARSOTTI, to include measuring reflected acoustic power of the ultrasonic energy from at least one transducer of the array of transducers, and discontinuing directing the ultrasonic energy from the at least one transducer found to have a reflected acoustic power above a predetermined threshold, as taught by FRIEMEL, for the advantage of halting treatment to the tissue when treatment of a desired tissue site is complete or is potentially spreading to tissue beyond the treatment site as taught by FRIEMEL in [0009]).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over HUCKLE in view of SVERDLIK and BARSOTTI as applied to claim 1 above, and further in view of BURTON US 20080132790 A1 (cited by Applicant).
Regarding claim 9, HUCKLE, SVERDLIK and BARSOTTI discloses the method of Claim 1. HUCKLE further discloses the angiosome (therapeutic treatment of vessels for promoting angiogenesis - [0083]; claim 47). HUCKLE does not disclose measuring blood flow in real time over the at least one angiosome, and adjusting parameters of the ultrasonic energy based on the measured blood flow. BURTON discloses measuring blood flow in real time (a method of treating blood vessels comprises measuring the blood flow in the region of interest - [0052], [0054]), and adjusting parameters of the ultrasonic energy based on the measured blood flow (adjustment of intensity or power of ultrasonic treatments based on the blood flow - [0072]). It would have been obvious to one of ordinary skill in the art, at the time of filing the claimed invention, to have modified the treatment method of HUCKLE in view of SVERDLIK, to include measuring blood flow in real time and adjusting parameters of the ultrasonic energy based on the measured blood flow, as taught by BURTON, for the advantage of determining the effectiveness of the therapeutic treatment and adjusting the ultrasound parameters as necessary in view of teachings of BURTON in [0054] and [0072]).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over HUCKLE in in view of SVERDLIK and in view of BARSOTTI.
Regarding claim 20, HUCKLE discloses a system for stimulating angiogenesis and/or vasodilation within a patient ([0083] apparatus for promoting angiogenesis e.g., Fig. 13A and 13B), comprising: an elastic sleeve comprising at least one therapeutic ultrasound (TUS) transducer configured to be positioned proximate a skin surface of a patient above a target site below the skin surface where angiogenesis and/or vasodilation is desired (placement modules of Figs. 13A -15, 17 and 19 [0105] and associated discussion in specification, each disclose a wearable non-invasive device comprising an elastic/stretchable sleeve comprising an ultrasound transducer for therapy, details of transducer are disclosed with reference to Fig. 4-4A); the therapeutic ultrasound transducer configured to cause a therapeutically effective amount of ultrasonic energy over a set time period to be directed toward the target site(a therapeutic amount of ultrasound is delivered to promote angiogenesis - [0083],[0099]-[0100]), thereby stimulating cavitation and shear stress within tissue at the target site thereby promoting angiogenesis within the patient at the target site patient (ultrasound energy is delivered to the target tissue promotes angiogenesis, thus the ultrasound energy stimulates cavitation and shear stress within tissue at the target site angiosome, thereby promoting angiogenesis and/or vasodilation within the patient - [0083], [0100], note vasodilation is an effect of therapeutic ultrasound) and a controller {0086-0087] main operating unit (MOU 12).
HUCKLE does not explicitly disclose that the controller is configured to determine a phase of the ultrasonic energy; determine whether a power coupling of the ultrasonic energy to the patient’s skin surface satisfies a threshold condition based on the phase of the ultrasonic energy; and stop delivery of the ultrasonic energy if the threshold condition is not satisfied.
SVERDLIK in the same field of endeavor of applying ultrasound energy to a tissue volume, discloses a device (100 - Fig. 1) comprising a controller (108) and associated methods for assessing contact between an ultrasound applicator and skin (page 13, 3-4), specifically, discussion associated with Fig. 16D1 in page 57, from line 25 to page 58 line 6, determining the power delivered through an array of transducers (at 1615); comparing the determined power delivered to a reference value to determine proper coupling to the patient's skin surface (at 1617 and “a change in power above a certain threshold is indicative of loss of contact”) and if loss of contact is detected, ultrasound emission is automatically ceased.
BARSOTTI in the same field of endeavor of ultrasound therapy device discloses a device (10 - Fig. 1) comprising a controller (base unit 16) and associated method that includes monitoring transducer current, voltage and phase angle for servo control, coupling detection and fault protection ([abstract]), and further in [col. 8, 49-63] discloses that “the device also include phase detector which quantifies the phase relationship between the voltage and current at the transducer 12. The ultrasound transducer dynamically changes its impedance depending on the degree of coupling it makes with the patient's tissue. The changing impedance is easily determined from the instantaneous phase angle between the transducer voltage and the transducer current. The phase detector provides phase information to the processor 70 which, in addition to a voltage or current signal, enables the processor through software control to drive a visual coupling indicator, change output levels in response to varying tissue loads, and reduces output power to incidental levels when gross uncoupling occurs” and/or [col. 7: 40-52] “An operational amplifier 260 filters and integrates the output from the exclusive OR gate 258 to produce a voltage which reflects the relative phase difference between the voltage and current. This phase voltage is transmitted to the A/D converter 90 over lead 262 for use by the processor 70, from which, among other things, the degree of transducer/patient coupling is determined. If the processor through software senses that coupling has remained below a predetermined level for a set time, such as two seconds, the output power level is significantly reduced to prevent heating of the transducer 12”.
In view of the combined teachings of SVERDLICK and BARSOTTI, it would have been obvious to one of ordinary skill in the art, at the time of filing the claimed invention, to have modified the system of HUCKLE, to include monitoring and/or determining a phase, current and voltage of the ultrasound energy to determine a power delivered by the ultrasound energy, determine whether a power coupling of the ultrasonic energy to the patient’s skin surface satisfies a threshold condition based on the delivered power determined from the phase, current and voltage of the ultrasonic energy; or alternatively, in view of the teachings of BARSOTTI, determine a phase between voltage and current of transducer and dynamically change impedance of the transducer based on degree of coupling of transducer with patients tissue from instantaneous phase angle between transducer voltage and current and/or determine a degree of transducer/patient coupling based on phase, and in either case noted above, stopping/ceasing delivery of the ultrasonic energy if the threshold condition is not satisfied when gross uncoupling occurs or loss of contact is detected, to enhance efficiency in treatment since improper coupling or poor contact between a transducer and patient’s skin would result with attenuation of ultrasound which would reduce efficiency of treatment, and ceasing or stopping delivery of ultrasonic energy if the threshold is not satisfied would allow a user to reposition the device on the skin surface for proper contact as taught by SVERDLIK and/or would prevent heating of the transducer(s) as taught by BARSOTTI in [col. 7: 44-51].
Response to Arguments
Rejection(s) or objection(s) from the previous Office action not reiterated herein, are withdrawn. Applicant’s arguments with respect to the pending claims 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
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/BONIFACE N NGANGA/Primary Examiner, Art Unit 3797
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