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 .
Examiner Notes
Claims 1-20 are identical to the original claims filed in parent application US18671236.
Claim Objections
Claims 1, 4, 10-11, & 14-16 are objected to because of the following informalities: the claims are replete with formatting & grammatical errors.
For example, Claim 1 recites:
“wherein the pre-treatment values for a first one or more of the corresponding plurality of transmission parameters are different than the treatment values for the first one or more of the corresponding plurality of transmission parameters and the pre-treatment values for a second one or more of the corresponding plurality of transmission parameters are the same as the treatment values for the second one or more of the corresponding plurality of transmission parameters.”
This phrase appears to be a run-on and it unclear what is explicitly different and what is the same. For the purposes of compact prosecution, the limitation will be interpreted as:
“wherein:
the pre-treatment values for a first one or more of the corresponding plurality of transmission parameters are different than the treatment values for the first one or more of the corresponding plurality of transmission parameters, and
the pre-treatment values for a second one or more of the corresponding plurality of transmission parameters are the same as the treatment values for the second one or more of the corresponding plurality of transmission parameters.”
With regards to Claim 4, the semicolon in line 5 should be a comma.
Similarly, Claim 10 appears to be a run-on sentence. For the purposes of compact prosecution, the limitation will be interpreted as:
“wherein applying the receive focus profile
φ
x
,
v
i
to the filtered return signals to determine phase-adjusted signals or time-adjusted signals comprises, for each filtered return signal, adjusting a phase of the filtered return signal by the phase offset of a corresponding element
φ
x
,
v
i
n
of the receive focus profile
φ
x
,
v
i
to thereby determine:
a corresponding phase-adjusted signal,
or adjusting a time of the filtered return signal by the time offset of a corresponding element
φ
x
,
v
i
n
of the receive focus profile
φ
x
,
v
i
to thereby determine a corresponding time-adjusted signal.”
Claim 11 is incomplete, For the purposes of compact prosecution, the limitation will be interpreted as “determining the treatment focus location based on the extracted value
S
x
,
v
i
I
.”
Claim 14, line 6 includes an extraneous “c” which will not be interpreted on the merits.
Claim 15 relies upon inconsistent punctuation.
Claim 16 is missing a space between “nth” and “one” in line 14.
Appropriate correction is required.
Claim Interpretation
With regards to Claim 18, the claim recites “if the determined treatment characteristic is confirmed to be within a threshold similarity metric of the treatment characteristic, delivering ultrasound according to the proposed ultrasound treatment to open a blood brain barrier of the patient” which is contingent upon the determined treatment characteristic being within a threshold similarity metric of the treatment characteristic. Since neither the confirmation nor the delivery of ultrasound are required, under a broadest reasonable interpretation, those steps are not required to be performed, see MPEP § 2111.04(II).
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 4, 7, 8, 12, 15, & 19 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.
Regarding claims 4, 7, 8, 12, 15, & 19, the phrase "e.g." {i.e. for example} renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). For the purposes of compact prosecution, the claims will be interpreted without the example parenthetical.
Dependent claims are rejected by virtue of dependency upon the above-mentioned claims.
Claim Rejections - 35 USC § 102
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 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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-3, 5, 17-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Angelsen (US PGPUB 20140135681).
With regards to Claim 1, Angelsen discloses a method for confirming a treatment characteristic of an ultrasound therapy system, the ultrasound therapy system comprising a plurality of transmit transducers for transmitting ultrasound energy into the brain of a patient and a plurality of receive transducers for receiving reflected ultrasound energy from the brain of the patient (A method and instrumentation for ultrasound mediated delivery of drugs to diseased tissue use ultrasound beams with frequency and focusing {i.e. treatment characteristic} that provides an ultrasound radiation force acting on the drug and surrounding fluid, which produces a convection of drugs and compensates for the lack of a pressure gradient; see Angelsen Abstract), the method comprising:
obtaining a proposed ultrasound treatment parameterized by, for each of the plurality of transmit transducers, treatment values for a corresponding plurality of transmission parameters (Act 504 the outer boundaries of the diseased tissue, particularly the depth range, are determined; see Angelsen ¶ [0100]; calculating transmit parameter of ultrasound radiation force (URF) foci based on the treatment depth zone);
transmitting pre-treatment ultrasound energy into the brain of the patient (ultrasound is used to stimulate transport across the blood brain barrier, i.e. brain; see Angelsen Abstract), wherein transmitting the pre-treatment ultrasound energy comprises causing each of the plurality of transmit transducers to transmit ultrasound energy according to pre-treatment values for the corresponding plurality of transmission parameters (Act 507 imaging during treatment or Act 502 imaging the diseased tissue; see Angelsen ¶ [0100 & 0105]), wherein:
the pre-treatment values for a first one or more of the corresponding plurality of transmission parameters are different than the treatment values for the first one or more of the corresponding plurality of transmission parameters (the pre-treatment frequency {i.e. imaging} is different from the treatment frequency {i.e. high mechanical index (MI)treatment}; see Angelsen ¶ [0100 & 0105]), and
the pre-treatment values for a second one or more of the corresponding plurality of transmission parameters are the same as the treatment values for the second one or more of the corresponding plurality of transmission parameters (the frequency for imaging and URF are the same; see Angelsen ¶ [0094-0095]; i.e. the imaging Act 507 during the treatment is considered the pre-treatment transmission while the treatment (URF and/or MI)is the treatment transmission);
receiving return pre-treatment signals at the plurality of receive transducers (transmitting and receiving an image beam; see Angelsen ¶ [0073]); and
determining the treatment characteristic based at least in part on the received return pre-treatment signals (calculating the URF foci {i.e. focus or treatment characteristic} based on the imaged treatment depth range; see Angelsen ¶ [0036]).
With regards to Claim 21, Angelsen discloses wherein the treatment characteristic is a treatment focus location of the proposed ultrasound treatment (calculating the URF foci {i.e. focus or treatment characteristic} based on the imaged treatment depth range; see Angelsen ¶ [0036]).
With regards to Claim 31, Angelsen discloses wherein the first one or more of the corresponding plurality of transmission parameters comprises a power of the ultrasound transmission by the transmit transducer (the pre-treatment frequency {i.e. imaging} is different from the treatment frequency {i.e. high mechanical index (MI)treatment}; see Angelsen ¶ [0100 & 0105]; i.e. the power changes due to the change in frequency).
With regards to Claim 51, Angelsen discloses wherein the treatment characteristic is a treatment focus location of the proposed ultrasound treatment (3D image of the diseased tissue as a basis input to guide steering of the scanning of the URF beam direction and foci; see Angelsen ¶ [0072]) and wherein the method comprises:
determining a plurality of receive focus profiles
φ
x
,
v
i
(The pulse can be given a spatial appodization A(r 0) across the transmit array aperture, where r 0 is the spatial coordinate of the array elements. To focus the beam onto a focus location r t, the transmit signals is given a focusing delay τ(r 0; r t) that can be calculated; see Angelsen ¶ [0113] & eq. A9; wherein the transmit delay for each array element is based on the transmit delay τ, i.e. focus profile );
each receive focus profile
φ
x
,
v
i
corresponding to a candidate treatment focus location x from among a plurality of X candidate locations and corresponding to an assumed ultrasound propagation velocity profile vi from among a plurality of I of assumed ultrasound propagation velocity profiles (the delay profile τ for each array element is based on the propagation velocity, i.e. propagation velocity profiles; see Angelsen ¶ [0108]), and
each receive focus profile
φ
x
,
v
i
comprising N elements
φ
x
,
v
i
n
, where N corresponds to a number of the plurality of receive transducers and the element
φ
x
,
v
i
comprises a phase offset or a time offset for an nth one of the plurality of receive transducers (transmit delay τ as noted above; see Angelsen ¶ [0108-116]); and
wherein determining the plurality of receive focus profiles
φ
x
,
v
i
comprises, for each of the plurality of receive focus profiles
φ
x
,
v
i
determining the phase offset or the time offset for each element
φ
x
,
v
i
n
based on the candidate treatment focus location x, a location of the nth
receive transducer relative to the treatment focus location x and the assumed velocity profile vi (the transmit signal is based on the propagation velocity, transmit delay τ as noted above; see Angelsen ¶ [0108-0116]); and
wherein determining the treatment characteristic based at least in part on the received return pre-treatment signals comprises determining the treatment focus location based at least in part on the received return pre- treatment signals and the receive focus profiles
φ
x
,
v
i
(target location rt is based on the relationship of the pixel relationships between the imaging beam and the therapy beam foci; see Angelsen ¶ [0076 & 0108-0116]).
With regards to Claim 175, Angelsen discloses comprising graphically displaying the determined treatment focus location in an image of the brain of the patient (The instrument processor can be set up to analyze 3D images to automatically determine the boundaries of the diseased tissue, or the boundaries can be defined by the instrument operator using pointing devices to the image on the screen, or a combination of both; see Angelsen ¶ [0093]; i.e. the boundaries of the diseased tissue {i.e. treatment focus location} is selected by an operator based on the selection displayed a screen).
With regards to Claim 181, Angelsen discloses comprising, (contingent limitation, see Claim Interpretation section).
With regards to Claim 19, Angelsen discloses an ultrasound therapy system (a method and instrumentation for ultrasound mediated delivery of drugs to diseased tissue use ultrasound beams with frequency and focusing {i.e. treatment characteristic} that provides an ultrasound radiation force acting on the drug and surrounding fluid, which produces a convection of drugs and compensates for the lack of a pressure gradient; see Angelsen Abstract) comprising:
a plurality of transmit transducers for transmitting ultrasound energy into the brain of a patient (ultrasound array 301; see Angelsen FIG. 3 & ¶ [0090-0091, & 0094]);
a plurality of receive transducers for receiving reflected ultrasound energy from the brain of the patient (ultrasound array 301; see Angelsen FIG. 3 & ¶ [0090-0091, & 0094]); and
a controller (instrument processor 303; see Angelsen ¶ [0091] & FIG. 3), the controller configured to:
obtain a proposed ultrasound treatment parameterized by, for each of the plurality of transmit transducers, treatment values for a corresponding plurality of transmission parameters (Act 504 the outer boundaries of the diseased tissue, particularly the depth range, are determined; see Angelsen ¶ [0100]; calculating transmit parameter of ultrasound radiation force (URF) foci based on the treatment depth zone);
cause the transmit transducers to transmit pre-treatment ultrasound energy into the brain of the patient (ultrasound is used to stimulate transport across the blood brain barrier, i.e. brain; see Angelsen Abstract), wherein transmitting the pre-treatment ultrasound energy comprises causing each of the plurality of transmit transducers to transmit ultrasound energy according to pre-treatment values for the corresponding plurality of transmission parameters (Act 507 imaging during treatment or Act 502 imaging the diseased tissue; see Angelsen ¶ [0100 & 0105]), wherein:
the pre-treatment values for a first one or more of the corresponding plurality of transmission parameters are different than the treatment values for the first one or more of the corresponding plurality of transmission parameters (the pre-treatment frequency {i.e. imaging} is different from the treatment frequency {i.e. high mechanical index (MI)treatment}; see Angelsen ¶ [0100 & 0105]), and
the pre-treatment values for a second one or more of the corresponding plurality of transmission parameters are the same as the treatment values for the second one or more of the corresponding plurality of transmission parameters (the frequency for imaging and URF are the same; see Angelsen ¶ [0094-0095]; i.e. the imaging Act 507 during the treatment is considered the pre-treatment transmission while the treatment (URF and/or MI)is the treatment transmission);
receive return pre-treatment signals received at the plurality of receive transducers (transmitting and receiving an image beam; see Angelsen ¶ [0073]); and
determine the treatment characteristic based at least in part on the received return pre-treatment signals (calculating the URF foci {i.e. focus or treatment characteristic} based on the imaged treatment depth range; see Angelsen ¶ [0036]).
With regards to Claim 20, Angelsen discloses a method for confirming a treatment focus location of a proposed ultrasound treatment to be effected by an ultrasound therapy system, the ultrasound therapy system comprising a plurality of transmit transducers for transmitting ultrasound energy into the brain of a patient and a plurality of receive transducers for receiving reflected ultrasound energy from the brain of the patient (A method and instrumentation for ultrasound mediated delivery of drugs to diseased tissue use ultrasound beams with frequency and focusing {i.e. treatment characteristic} that provides an ultrasound radiation force acting on the drug and surrounding fluid, which produces a convection of drugs and compensates for the lack of a pressure gradient; see Angelsen Abstract), the method comprising:
determining a plurality of receive focus profiles
φ
x
,
v
i
(The pulse can be given a spatial appodization A(r 0) across the transmit array aperture, where r 0 is the spatial coordinate of the array elements. To focus the beam onto a focus location r t, the transmit signals is given a focusing delay τ(r 0; r t) that can be calculated; see Angelsen ¶ [0113] & eq. A9; wherein the transmit delay for each array element is based on the transmit delay τ, i.e. focus profile );
each receive focus profile
φ
x
,
v
i
corresponding to a candidate treatment focus location x from among a plurality of X candidate locations and corresponding to an assumed ultrasound propagation velocity profile vi from among a plurality of I of assumed ultrasound propagation velocity profiles (the delay profile τ for each array element is based on the propagation velocity, i.e. propagation velocity profiles; see Angelsen ¶ [0108]), and
each receive focus profile
φ
x
,
v
i
comprising N elements
φ
x
,
v
i
n
, where N corresponds to a number of the plurality of receive transducers and the element
φ
x
,
v
i
comprises a phase offset or time offset for an nth one of the plurality of receive transducers (transmit delay τ as noted above; see Angelsen ¶ [0108-116]); and
wherein determining the plurality of receive focus profiles
φ
x
,
v
i
comprises, for each of the plurality of receive focus profiles
φ
x
,
v
i
, determining the phase offset or time offset for each element
φ
x
,
v
i
n
in based on the candidate treatment focus location x, a location of the nth receive transducer relative to the treatment focus location x and the assumed velocity profile vi (the transmit signal is based on the propagation velocity, transmit delay τ as noted above; see Angelsen ¶ [0108-0116]);
transmitting pre-treatment ultrasound energy into the brain of the patient using the plurality of transmit transducers (ultrasound is used to stimulate transport across the blood brain barrier, i.e. brain; see Angelsen Abstract);
receiving return pre-treatment signals at the plurality of receive transducers, each return pre-treatment signal corresponding to one of the receive transducers (transmitting and receiving an image beam; see Angelsen ¶ [0073]); and
determining the treatment focus location based at least in part on the received return pre-treatment signals and the receive focus profiles
φ
x
,
v
i
(target location rt is based on the relationship of the pixel relationships between the imaging beam and the therapy beam foci; see Angelsen ¶ [0076 & 0108-0116]).
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 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.
Claim 4, 6, & 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over Angelsen in further view of Sutton et al. (US PGPUB 20200107811; hereinafter "Sutton").
With regards to Claim 41, while Angelsen discloses comprising:
at least one of:
injecting microbubbles into the patient before transmitting pre-treatment ultrasound energy into the brain of the patient (introducing micro-bubbles to the capillaries to stimulate opening the blood-brain barriers; see Angelsen ¶ [0079]-); and
(claimed in the alternative);
wherein the second one or more of the corresponding plurality of transmission parameters comprises a treatment frequency of the ultrasound transmission by the transmit transducer (treatment scanning Act 506; see Angelsen FIG. 5 & ¶ [0105]; wherein the URF, UH have a frequency associated with them; see Angelsen ¶ [0099]);
While Angelsen discloses a imaging parameters for imaging such as frequency and that image can be adjusted for optimal (see Angelsen ¶ [0100]), it appears that Angelsen may be silent to wherein filtering the return pre-treatment signals to extract filtered return signals comprises band-pass filtering the return pre-treatment signals to extract, as the filtered return signals, a higher order (see Sutton Abstract & ¶ [0005]). In particular, Sutton teaches of filtering the return pre-treatment signals to extract filtered return signals comprises band-pass filtering the return pre-treatment signals to extract, as the filtered return signals, a higher order (imaging the microbubble signal based on a bandpass filtering of ultraharmonic returns {i.e. higher order harmonic} to isolate the microbubble signal ; see Sutton ¶ [0022-0023]).
Angelsen and Sutton are both considered to be analogous to the claimed invention because they are in the same field of transcranial ultrasound therapy & imaging . Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Angelsen to incorporate the above teachings of Sutton to provide at least filtering the return pre-treatment signals to extract filtered return signals comprises band-pass filtering the return pre-treatment signals to extract, as the filtered return signals, a higher order harmonic of the treatment frequency. Doing so would aid in microbubbles to be clearly segmented in an image in most applications (see Sutton ¶ [0023]).
It should be appreciated that the same logic pattern and rationale are applied to Claims 7-8 as applied to Claim 4.
With regards to Claim 65, Angelsen discloses wherein determining the treatment focus location based at least in part on the received return pre-treatment signals and the receive focus profiles
φ
x
,
v
i
(target location rt is based on the relationship of the pixel relationships between the imaging beam and the therapy beam foci; see Angelsen ¶ [0076]) comprises:
φ
x
,
v
i
While Angelsen discloses determining the treatment focus location based at least in part on the return signals {i.e. image coordinates of the boundary of the diseased tissue; see Angelsen ¶ [0076]} and the receive focus profiles
φ
x
,
v
i
(target location rt is based on the relationship of the pixel relationships between the imaging beam and the therapy beam foci; see Angelsen ¶ [0076 & 0108-0116]), It appears that Angelsen may be silent to filtering the return signals. However, as noted above, Sutton teaches of imaging the microbubble signal based on a bandpass filtering of ultraharmonic returns {i.e. higher order harmonic} to isolate the microbubble signal, i.e. the image from which the coordinates of the diseased tissue of Angelsen is based on the filtered signals of Sutton (see Sutton ¶ [0022-0023]).
Angelsen and Sutton are both considered to be analogous to the claimed invention because they are in the same field of transcranial ultrasound therapy & imaging . Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Angelsen to incorporate the above teachings of Sutton to provide at least filtering the return pre-treatment signals to extract filtered return signals and determining the treatment focus location based at least in part on the filtered return signals and the receive focus profiles
φ
x
,
v
i
. Doing so would aid in microbubbles to be clearly segmented in an image in most applications (see Sutton ¶ [0023]).
With regards to Claim 96, modified Angelsen teaches of wherein determining the treatment focus location based at least in part on the filtered return signals and the receive focus profiles
φ
x
,
v
i
comprises:
for each receive focus profile
φ
x
,
v
i
:
applying the receive focus profile
φ
x
,
v
i
to the filtered return signals to determine phase-adjusted signals or time- adjusted signals; and
summing the phase-adjusted signals or time-adjusted signals to determine a sum signal
S
x
,
v
i
corresponding to the receive focus profile
φ
x
,
v
i
; and
determining the focus location based at least in part on the sum signals
S
x
,
v
i
corresponding to the plurality of receive focus profiles (to focus the therapy beam, transit signals are applied a delay; see Angelsen ¶ [0108-0116]; the plurality of the “transmit signals” would indicate to one of ordinary skill in the art that multiple transducer elements are energized accordingly which requires a summation of each individual transmit signal, i.e. steering of the therapy beam to the focus location rt; see Angelsen ¶ [0073, 0097, 0108-0116]).
With regards to Claim 109, modified Angelsen teaches of wherein applying the receive focus profile
φ
x
,
v
i
to the filtered return signals to determine phase-adjusted signals or time-adjusted signals comprises, for each filtered return signal, adjusting a phase of the filtered return signal by the phase offset of a corresponding element
φ
x
,
v
i
n
of the receive focus profile
φ
x
,
v
i
to thereby determine:
a corresponding phase-adjusted signal, or
adjusting a time of the filtered return signal by the time offset of a corresponding element
φ
x
,
v
i
n
of the receive focus profile
φ
x
,
v
i
to thereby determine a corresponding time-adjusted signal (This image shows as 101 an ultrasound probe that is able to steer an ultrasound transmit/receive beam 102 from a linear array 103 within a 3D volume 104 to provide a 3D image of the diseased tissue 105; see Angelsen ¶ [0073]; i.e. one of ordinary skill in the art would understand that beam steering of an imaging signal requires imparting delays on various elements to guide the signal).
With regards to Claim 119, modified Angelsen teaches of wherein determining the treatment focus location based at least in part on the sum signals
S
x
,
v
i
corresponding to the plurality of receive focus profiles
φ
x
,
v
i
comprises:
extracting a value
S
x
,
v
i
I
from each sum signal
S
x
,
v
i
; and
determining the treatment focus location based on the extracted (The detected boundaries of the diseased tissue in the image can then be used for defining the scanning of the URF beam direction and focus, and also other therapy beams, such as high MI beams and high UH beams discussed below. To achieve this, embodiments of the invention have a well-defined geometric relationship between the image pixel coordinates and coordinates of the therapy beams and foci; see Angelsen ¶ [0076]; i.e. the pixel coordinates amount the extracted value).
Claims 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over modified Angelsen as applied to claim 6 above, and further in view of Vortman et al. (US PGPUB 20090088623; hereinafter "Vortman")
With regards to Claim 126, modified Angelsen teaches of wherein determining the treatment focus location based at least in part on the filtered return signals and the receive focus profiles
φ
x
,
v
i
(see Angelsen ¶ [0076 & 0108-0116] & Sutton ¶ [0022-0023] as detailed above) comprises:
γ
γ
γ
n
γ
n
γ
φ
x
,
v
i
It appears that modified Angelsen may be silent to the struck-through limitations directly above. However, Vortman teaches of motion compensated image guided focused ultrasound therapy (see Vortman Abstract). In particular, Vortman teaches of:
cross-correlating each of the filtered return signals with a reference one of the filtered return signals or another one (e.g. a nearest neighbor of the plurality of receive transducers) of the filtered return signals to obtain a return phase offset or time offset profile γ, where the return phase offset or time offset profile γ comprises one cross-correlation parameter γn for each of the plurality of receive transducers, the cross-correlation parameter γn indicative of a phase offset or time offset of the nth filtered return signal relative to the reference filtered return signal (The target tissue mass 16 may be located by performing an image-based maximum correlation algorithm on the currently acquired image of the target tissue mass 16 and a reference image of the target tissue mass 16; see Vortman ¶ [0053]); and
determining the treatment focus location based at least in part on the return phase offset or time offset profile γ and the plurality of receive focus profiles
φ
x
,
v
i
(The motion compensation processor 28 uses the tracked relative movement between the focal zone 34 of the ultrasound energy beam 32 and the target tissue mass 16 and the adjusted electrical and/or mechanical parameter values are passed to the FUS controller 54 which adjusts the thermal dose properties of the transducer 30 to maintain the location of the focal zone 34; see Vortman ¶ [0055]).
Modified Angelsen and Vortman are both considered to be analogous to the claimed invention because they are in the same field of guided ultrasound therapy. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have further modified Angelsen to incorporate the above teachings of Vortman to provide at least the struck-through limitations directly above. Doing so would aid in compensating for the change in the relative position between the transducer and the target tissue mass (see Vortman ¶ [0055]).
With regards to Claim 1312, modified Angelsen teaches of wherein the reference one of the filtered return signals (see Sutton ¶ [0022-0023]) used to obtain the return phase offset or time offset profile
γ
corresponds to the filtered return signal from a reference one of the plurality of receive transducers used for determining the receive focus profile
φ
x
,
v
i
(the FUS controller 54 adjust the focus of the therapy beam; see Vortman ¶ [0055]; FUS controller 54 adjust the phase & frequency of the signal to control the location, shape, size, and depth of the focal zone 34; see Vortman ¶ [0035]).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Angelsen in view of Vortman as applied to claim 12 above, and further in view of Sumi et al. (US PGPUB 20190129026; hereinafter "Sumi")
With regards to Claim 1412, it appears the modified Angelsen may be silent to wherein determining the treatment focus location based at least in part on the return phase offset or time offset profile
γ
and the plurality of receive focus profiles
φ
x
,
v
i
comprises:
for each receive focus profile
φ
x
,
v
i
, comparing the return phase offset or time offset profile
γ
to the focus profile
φ
x
,
v
i
, to obtain a corresponding similarity metric as between the return phase offset or time offset profile
γ
and the receive focus profile
φ
x
,
v
i
; and
determining the focus location based on the similarity metrics for the plurality of receive focus profiles
φ
x
,
v
i
.
However Sumi teaches of ultrasound image via transmitting high intensity waves or waves including harmonic waves, or implementing nonlinear processing onto received coherent signals or phased and summed coherent signals (see Sumi ¶ [0037]) and phase matching with delay-and-summing (DAS) processing using phase aberration (see Sumi ¶ [0568 & 0577]). In particular, Sumi teaches of for each receive focus profile
φ
x
,
v
i
, comparing the return phase offset or time offset profile
γ
to the focus profile
φ
x
,
v
i
, to obtain a corresponding similarity metric as between the return phase offset or time offset profile
γ
and the receive focus profile
φ
x
,
v
i
(phase matching in the frequency domain based on a time delay based on a cross-correlation; see Sumi ¶ [0567]); and
determining the focus location based on the similarity metrics for the plurality of receive focus profiles
φ
x
,
v
i
(the desired waveform increases measurement accuracy of target observation at an observation position or a reception position, i.e. focus location, during beamforming; see Sumi ¶ [0567]).
Modified Angelsen and Sumi are both considered to be analogous to the claimed invention because they are in the same field of ultrasound imaging and therapy. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have further modified Angelsen to incorporate the above teachings of Sumi to provide at least the above limitations. Doing so would aid in motion compensation of the target location (see Sumi ¶ [0567]).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Angelsen as applied to claim 5 above, and further in view of Ramamurthy (US PGPUB 20190184204; Applicant admitted prior, see IDS 16 October 2023)
With regards to Claim 155, while modified Angelsen teaches of accounting for acoustic impedance {i.e. acoustic modelling} to determine transmit signals (see Angelsen ¶ [0114]), it appears that modified Angelsen may be silent to wherein determining the phase offset or time offset for each element
φ
x
,
v
i
n
is based on:
an aligned model which specifies a physical and acoustic model of the head of the patient to be treated by the ultrasound therapy system, and
alignment between the model and at least one of:
an estimated position of the nth receive transducer; and
an estimated position of a structure
However, Ramamurthy is admitted prior art as noted above. In particular, Ramamurthy teaches of wherein determining the phase offset or time offset for each element
φ
x
,
v
i
n
is based on:
an aligned model which specifies a physical and acoustic model of the head of the patient to be treated by the ultrasound therapy system (generating a 3D model of the patient’s head based on layers of patient anatomy such as skin, skull, and brain tissue along with estimations of sound velocity in said layers; see Ramamurthy ¶ [0188-0189]), and
alignment between the model and at least one of:
an estimated position of the nth receive transducer; and
an estimated position of a structure (Given the head model, and the prescribed goals, the location and orientation of ultrasound transducer elements that may be used to deliver ultrasound energy to the target region is calculated; see Ramamurthy [0193]).
Modified Angelsen and Ramamurthy are both considered to be analogous to the claimed invention because Ramamurthy is applicant admitted prior art. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have further modified Angelsen to incorporate the above teachings of Ramamurthy to provide at least the limitation of Claim 15 detailed above. Doing so would aid in ensuring the minimum acoustic power to open the blood-brain barrier is achieved (see Ramamurthy ¶ [0192]).
Allowable Subject Matter
Claim 16 is 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 following is a statement of reasons for the indication of allowable subject matter.
While Sumi teaches of independent signal separation and determining a signal with the same component as a reference signal (see Sumi ¶ [0577]), Sumi does not teach of selecting a reference transducer.
Conclusion
This is a continuation of applicant's earlier Application No. 18671236. All claims are identical to, patentably indistinct from, or have unity of invention with the invention claimed in the earlier application (that is, restriction (including lack of unity) would not be proper) and could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the earlier application. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action in this case. See MPEP § 706.07(b). 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 ASHISH S. JASANI whose telephone number is (571)272-6402. The examiner can normally be reached M-F 8:00 am - 4:00 pm (CST).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey G. Hoekstra can be reached on (571) 272-7232. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ASHISH S JASANI/Examiner, Art Unit 3798
/KEITH M RAYMOND/Supervisory Patent Examiner, Art Unit 3798
Prosecution Insights