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 .
Response to Amendment
The amendment filed 03/27/2026 has been entered. Claims 1-7 remain pending in the application. Applicant’s amendments to the claims have overcome each and every objection and 112(a)/(b) rejections previously set forth in the Non-Final Office Action mailed 12/31/2025.
Response to Arguments
Applicant’s arguments with respect to the prior art rejections of claims 1-7 as filed on November 10, 2025 have been considered but are mostly moot because the new ground of rejection does not rely on all of the reference applied in the prior rejection of record for all the teachings or matters specifically challenged in the argument.
Applicant argues Ramamurthy’s “matching” is limited to data-level registration, without any concept of image-guided mechanical alignment, in which the transducer’s position is controlled such that the actual position of the diagnostic ultrasound focused image spatially coincides with the lesion shown in the medical image.
Examiner respectfully disagrees. Ramamurthy at least teaches a position alignment unit comprising robotic manipulators configured to position imaging transducers at a target location ([0020], [0034]). Ramamurthy teaches wherein the target location may comprise a tumor (i.e., a lesion) ([0076], [0211]). Moreover, Ramamurthy teaches wherein the target location may be identified in a pre-operative image (i.e., a medical image) ([0076]), thereby facilitating delivery of ultrasound to the identified or selected target region ([0077]). Ramamurthy further teaches discerning the target region or tumor in the ultrasound image ([0211]), thereby teaching wherein the ultrasound image coincides with a lesion which is shown in a medical image. Ramamurthy therefore also teaches image-guided mechanical alignment (wherein the target is first identified in the pre-operative image, ¶ [0076]), in which the transducer’s position is controlled such that the actual position of the diagnostic ultrasound focused image spatially coincides with the lesion shown in the medical image (wherein the robotic manipulator positions the imaging transducer at the identified location, ¶ [0020], [0034], “Some embodiments involve operating a robotic manipulator to place the ultrasound imaging transducer or the ultrasound treatment transducer at the determined location”).
While Ramamurthy does not teach the exact “matching” method as claimed (i.e. an image matching unit) or as specified in the specification, newly cited reference Ng (US20170164931) teaches such a feature. Ng teaches a system for image alignment including an alignment mechanism (132) (i.e. a position alignment unit) (Fig. 1, Abstract, [0030], [0033]). Ng teaches aligning live ultrasound images with pre-op CT images using the alignment mechanism (132) (position alignment unit) ([0039], [0041], [0047], [0061]). Ng further teaches wherein the point of interest or target is a lesion (Figs. 3A-3B, [0050-0052], [0065]). Ng teaches aligning the lesion (T1) in the CT image (352) with the lesion (T1) in the ultrasound image (354) (Figs. 3A-3B & 6, [0051-0052], [0060-0061], wherein the centers of a point of interest, i.e. the lesion, are aligned). Ng teaches that once the ultrasound image and CT image is aligned, a registration module (115) may register (i.e. match) the images with one another (Figs. 1, 4-5, & 7, Abstract, “A registration module (115) is stored in memory and configured to register the first images with corresponding second images in the multiple planes when alignment in the multiple planes has been achieved”, [0030], [0038], [0056], [0062], “In block 518, registration between the first images with corresponding second images in the multiple planes is locked in when alignment in the multiple planes has been achieved”). Ng therefore teaches an image matching unit (115) which matches the position of a diagnostic ultrasound focused image and the position of the lesion visually represented in the medical image based on positions aligned by the position alignment unit (alignment mechanism 132). Ng teaches wherein registering the two imaging modalities (ultrasound and CT) may comprise fusing the images (i.e. matching the images) (Figs. 3A-3B & 6-7, [0020], [0030], [0051], [0057], [0062-0063], [0065]). In addition, Ng teaches displaying the fused/matched image by using the matched position (alignment) of the diagnostic ultrasound focused image and the position of the lesion, using an image display unit (118) (Fig. 3A, [0025], [0036], [0051], [0058], [0065]). Ng teaches wherein the fused/matched image includes the point of interest which may be the lesion ([0065]). Ng therefore cures any deficiency Ramamurthy may have regarding “matching” and image-guided mechanical alignment based on a visually indicated lesion position in a medical image, in which a transducer’s position is controlled such that an actual position of a diagnostic ultrasound focused image spatially coincides with a lesion shown in a medical image. Figures 3A and 6 of Ng in particular shows a matched or fused image in which a position of a lesion (T1) in an ultrasound image coincides with the position of the lesion (T1) in a medical CT image ([0051], [0057]).
Applicant’s arguments with respect to withdrawal of the claim interpretation under 112(f) are not persuasive. Applicant argues that a person of ordinary skill in the art reading the specification would understand the terms subject to 112(f) to have sufficiently definite meanings as the names for the structures that perform the functions.
Examiner respectfully disagrees. Claim interpretation under 112(f) is invoked when the claim language itself does not specify the structure; the structure of the terms subject to 112(f) need to be recited in the claim rather than in the specification to avoid claim interpretation under 112(f). See TriMed, Inc. v. Stryker Corp., 514 F.3d 1256, 1259-60, 85 USPQ2d 1787, 1789 (Fed. Cir. 2008) ("Sufficient structure exists when the claim language specifies the exact structure that performs the function in question without need to resort to other portions of the specification or extrinsic evidence for an adequate understanding of the structure"). Moreover, the presumption that 35 U.S.C. 112(f) does not apply to a claim limitation that does not use the term "means" is overcome when "the claim term fails to 'recite sufficiently definite structure' or else recites 'function without reciting sufficient structure for performing that function.'" Williamson, 792 F.3d at 1349, 115 USPQ2d at 1111 (Fed. Cir. 2015) (en banc) (quoting Watts v. XL Systems, Inc., 232 F.3d 877, 880, 56 USPQ2d 1836, 1838 (Fed. Cir. 2000). Accordingly, the claim terms fail to recite sufficiently definite structure and thus 35 U.S.C. 112(f) does apply. MPEP § 2181 (I) further states “Application of 35 U.S.C. 112(f) is driven by the claim language, not by applicant’s intent or mere statements to the contrary included in the specification or made during prosecution”. Therefore, the claim limitations “image obtainment unit”, “image generation unit”, “position alignment unit”, and “image matching unit” will remain being interpreted under 112(f).
Examiner reminds applicant that interpretation under 112(f) is not a rejection of the claims, meaning that the application may still be found allowable despite having claim limitations be interpreted under 112(f).
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitations, found in claim 1, are:
An image obtainment unit
An image generation unit
A position alignment unit
An image matching unit
Because these claim limitations are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, they are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
A review of the specification filed 07/17/2023 shows that the following appear to be the corresponding structure for the 35 U.S.C. 112(f), sixth paragraph limitation:
“An image obtainment unit” – The specification on page 6 lines 6-12 points to Figure 1 of the drawings, disclosing that each block of the block diagram may be executed by computer program instructions executed by a processor. “Image obtainment unit 11” is pictured in the block diagram. Page 7 lines 3-9 of the specification discloses “each block or each step may represent a module, a segment, or a part of a code, which includes one or more executable instructions for performing specified logical functions”. Therefore, “an image obtainment unit” will be interpreted to comprise a module, segment, or part of a code.
“An image generation unit” – The image generation unit 13 similarly appears in the block diagram of Figure 1. Page 7 lines 3-9 of the specification discloses “each block or each step may represent a module, a segment, or a part of a code, which includes one or more executable instructions for performing specified logical functions”. Therefore, “an image generation unit” will be interpreted to comprise a module, segment, or part of a code.
“A position alignment unit” – The position alignment unit 14 similarly appears in the block diagram of Figure 1. Page 7 lines 3-9 of the specification discloses “each block or each step may represent a module, a segment, or a part of a code, which includes one or more executable instructions for performing specified logical functions”. Therefore, “a position alignment unit” will be interpreted to comprise a module, segment, or part of a code. The position alignment unit is also disclosed that it may be in the form of a headset and figure 3 shows its structure as disclosed on page 11 lines 1-6. Therefore, “a position alignment unit” will be interpreted to further comprise a structure of a headset in addition to code.
“An image matching unit” – The image matching unit 15 similarly appears in the block diagram of Figure 1. Page 7 lines 3-9 of the specification discloses “each block or each step may represent a module, a segment, or a part of a code, which includes one or more executable instructions for performing specified logical functions”. Therefore, “an image matching unit” will be interpreted to comprise a module, segment, or part of a code.
If applicant does not intend to have these limitations interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitations to avoid them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitations recite sufficient structure to perform the claimed function so as to avoid them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Objections
Claim 3 is objected to because of the following informalities:
“…configured to perform both imaging of the medical image of the brain of the patient…” should be corrected to:
“…configured to perform both imaging of the diagnostic ultrasound focused image of the brain of the patient…”
Claim 4 is objected to because of the following informalities:
“…align a focal position of the generated diagnostic ultrasound focused image…” should be corrected to:
“…align a position of the generated diagnostic ultrasound focused image…”
Appropriate correction is required.
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.
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 1-7 are rejected under 35 U.S.C. 103 as being unpatentable over Ramamurthy (US20190184204), Ng (US20170164931), Park (US20170065835), and Rincker (US20150297176). Ramamurthy is cited in the IDS filed 06/11/2024.
Regarding claim 1, Ramamurthy teaches an ultrasound imaging apparatus (700) for brain disease treatment (Figs. 2 & 7A, [0071], [0076], [0135]), comprising:
an image obtainment unit which obtains a medical image of a brain of a patient captured before a procedure ([0073], “At step 305, pre-op CT or MRI images are imported into a system 200”, [0093], [0165], “Returning to example method 300 in FIG. 3, after pre-op MRI or CT images of the head are obtained and imported into an ultrasound system in step 305…It is desirable to obtain an image of parts of the patient's brain which include certain structures within the brain”, [0239], “the ultrasound system to import pre-op images of the patient's brain”);
an ultrasound transducer unit (710) which transmits a focused ultrasound signal to the brain of the patient (Fig. 7A, [0026], [0135], [0149-0151]);
an image generation unit (510D) which generates a diagnostic ultrasound focused image based on an ultrasound signal received from the brain (Fig. 5 & 15A-B, [0093], [0113], “Module 510D may perform computations related to image formation and image processing. Module 510D may apply any suitable technology for ultrasound image formation”, [0149], [0209], [0215]);
a position alignment unit which mechanically controls a position of the ultrasound transducer unit such that a position of the diagnostic ultrasound focused image coincides with a position of a lesion in the medical image obtained by the image obtainment unit ([0020], [0034], wherein operating a robotic manipulator to place the ultrasound imaging transducer at the determined target location, determined from the pre-op MRI or CT image, comprises mechanically controlling a position of the ultrasound transducer unit such that a position of the diagnostic ultrasound focused image coincides with a position of a target in the medical image, [0076], “Target regions may be selected in the pre-op image. Step 325 may comprise, for example, identifying a tumor or other diseased area requiring treatment”, wherein ¶ [0076] specifies the target is a lesion, [0211-0212]); and
an image display unit (520) which detects and displays a brain lesion (Fig. 18, [0117], [0211], “For example, it may be possible that a target region or tumor in the brain is highly vascularized. In these scenarios, it may be possible to discern these areas in the ultrasound image when imaging microbubbles are used”, [0238]).
However, Ramamurthy fails to teach an image matching unit which matches the position of the diagnostic ultrasound focused image and the position of the lesion visually represented in the medical image based on positions aligned by the position alignment unit; and wherein the image display unit detects and displays the brain lesion by using a matched position of the diagnostic ultrasound focused image and the position of the lesion.
In an analogous ultrasound imaging field of endeavor, Ng teaches such a feature. Ng teaches a system for image alignment including an alignment mechanism (132) (i.e. a position alignment unit) (Fig. 1, Abstract, [0030], [0033]). Ng teaches aligning live ultrasound images with pre-op CT images using the alignment mechanism (132) (position alignment unit) ([0039], [0041], [0047], [0061]). Ng further teaches wherein the point of interest or target is a lesion (Figs. 3A-3B, [0050-0052], [0065]). Ng teaches aligning the lesion (T1) in the CT image (352) with the lesion (T1) in the ultrasound image (354) (Figs. 3A-3B, [0051-0052], [0060-0061], wherein the centers of a point of interest, i.e. lesion, are aligned). Ng teaches that once the ultrasound image and CT image is aligned, a registration module (115) may register (i.e. match) the images with one another (Figs. 1, 4-5, & 7, Abstract, “A registration module (115) is stored in memory and configured to register the first images with corresponding second images in the multiple planes when alignment in the multiple planes has been achieved”, [0030], [0038], [0056], [0062], “In block 518, registration between the first images with corresponding second images in the multiple planes is locked in when alignment in the multiple planes has been achieved”). Ng therefore teaches an image matching unit (115) which matches the position of a diagnostic ultrasound focused image and the position of the lesion visually represented in the medical image based on positions aligned by the position alignment unit (alignment mechanism 132). Ng teaches wherein registering the two imaging modalities (ultrasound and CT) may comprise fusing the images (i.e. matching the images) (Figs. 3A-3B & 6-7, [0020], [0030], [0051], [0057], [0062-0063], [0065]). In addition, Ng teaches displaying the fused/matched image by using the matched position (alignment) of the diagnostic ultrasound focused image and the position of the lesion, using an image display unit (118) (Fig. 3A, [0025], [0036], [0051], [0058], [0065]). Ng teaches wherein the fused/matched image includes the point of interest which may be the lesion ([0065]). Ng therefore further teaches the image display unit (118) detects and displays the brain lesion by using a matched position of the diagnostic ultrasound focused image and the position of the lesion.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Ramamurthy to include an image matching unit which registers and fuses the live ultrasound images with the pre-operative images based on their alignment and to display the fused/matched image as taught by Ng (Figs. 1, 3A, & 4-7, Abstract, [0035], [0030], [0033], [0036], [0051-0052], [0057], [0060-0065]). The alignment and display of the fused images may help facilitate targeting of small lesions that are poorly visualized in only live ultrasound as recognized by Ng ([0004], [0024-0025], [0050]).
However, the modified combination noted above fails to teach wherein the position alignment unit comprises a medical headset worn on the head of the patient, and the medical headset is configured to move the ultrasound transducer unit to a predetermined position such that the position of the diagnostic ultrasound focused image physically coincides with the position of the lesion visually represented in the medical image, wherein the position alignment unit is configured to change an ultrasound focusing area by adjusting a focus depth through position adjustment of the ultrasound transducer unit.
In an analogous ultrasound treatment field of endeavor, Park teaches such a feature. Park teaches a position alignment unit (100) comprising a medical headset worn on the head of a patient (Figs. 1-11, Abstract, [0064], [0068]). Park teaches an ultrasound transducer (47) is attached to the helmet (100) (Fig. 6, Abstract, [0077]). Park teaches the ultrasound transducer (47) is configured to be movable along longitudinal and transverse directions using the guides of the helmet (Figs. 1-11, Abstract, [0074], [0076]). Moreover, Park teaches receiving preoperative images such as from CT or MRI and matching the received image data with a relative coordinate value of the head of the body, allowing for the position of the transducer to be linked/aligned with a specific position in the brain requiring treatment via motors of the helmet (100) ([0098-0103]). Park teaches the position of the transducer is precisely controlled according to a desired stimulation/treatment method via motors ([0004], [0100-0101]). Park further teaches wherein the helmet includes a distance adjusting unit (45) which allows the transducer (47) to move up and down, thereby adjusting a focus depth through position adjustment of the transducer (47) (Fig. 6, [0011], [0079-0080]). Park further teaches wherein the target for treatment comprises a lesion ([0007], [0041]). Park therefore teaches wherein a position alignment unit comprises a medical headset (100) worn on the head of the patient, and the medical headset (100) is configured to move an ultrasound transducer unit (47) to a predetermined position such that a position of a diagnostic ultrasound focused image from an ultrasound transducer may physically coincide with a position of the lesion visually represented in a medical image, wherein the position alignment unit is configured to change an ultrasound focusing area by adjusting a focus depth through position adjustment of the ultrasound transducer unit. While Park does not teach imaging with the transducer, Ramamurthy does teach imaging, and thus the modification of Ramamurthy with the teaching of Park to include a headset configured to move the transducer would result in allowing for the ultrasound transducer unit to move such that the position of the diagnostic ultrasound focused image generated from the ultrasound transducer physically coincides with the position of the lesion visually represented in the medical image.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Ramamurthy to have the position alignment unit comprise a headset configured to move the ultrasound transducer and to adjust the focus depth as taught by Park (Figs. 1-11, Abstract, [0007], [0011], [0040-0041], [0074], [0076], [0079-0080], [0098-0103]). By using a helmet configured to move and position an ultrasound transducer, precise treatment with ultrasound waves may more easily be performed on a lesion in a brain of a patient as recognized by Park ([0038-0044]).
However, the modified combination noted above fails to teach wherein the medical headset comprises a tiltable and rotatable device and a driving unit configured to drive the device.
In an analogous ultrasound imaging field of endeavor, Rincker teaches such a feature. Rincker teaches a head frame (100) configured for the head of a medical patient (108) and wherein the headframe includes an ultrasound probe (Fig. 1A, Abstract, [0026-0028]). Rincker teaches wherein the probe and corresponding transducer’s positioning may be controlled via a motor (Abstract, [0018], [0028]). Rincker teaches an automatic probe positioning system (400) which includes ultrasound probes (404) and a motorized assembly (408) (Fig. 4, [0033]). Rincker teaches wherein the motorized assembly (408) can perform X-Y-Z translations for positioning the probe (404) and wherein the probe (404) includes transducers ([0035], wherein the motorized assembly 408 comprises a driving unit). Rincker teaches probe rotation and angulation may be motorized to assist in finding an optimal acoustic window ([0028], [0035], wherein probe angulation comprises tilting and wherein the probe/transducer comprises a tiltable and rotatable device). Rincker therefore teaches a medical headset comprising a tiltable and rotatable device and a driving unit configured to drive the device.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Ramamurthy to have the headset include a motor configured for probe/transducer rotation and angulation as taught by Rincker (Fig. 1A, [0028], [0035]). Having the probe or transducer rotation/angulation be motorized may assist in finding an optimal acoustic window as recognized be Rincker ([0035]) and may predictably also facilitate in precise alignment of a focal position of the ultrasound transducer.
Regarding claim 2, Ramamurthy in view of Ng, Park, and Rincker teaches the invention as claimed above in claim 1.
Ramamurthy further teaches wherein the medical image is an image of the brain that is any one of a magnetic resonance (MR) image, a computed tomography (CT) image, a positron emission tomography (PET) image, and a PET- CT image captured respectively through a magnetic resonance imaging (MRI) device, a CT device, a PET device, and a PET-CT device ([0034], [0073], [0165], wherein pre-op images may be MRI or CT images, [0239], “the user may be requested by the ultrasound system to import pre-op images of the patient's brain”).
Regarding claim 3, Ramamurthy in view of Ng, Park, and Rincker teaches the invention as claimed above in claim 1.
Ramamurthy further teaches wherein the ultrasound transducer unit (710) comprises an ultrasound array transducer configured to perform both imaging of the image of the patient and ultrasound focusing of the brain lesion (Fig. 7A, [0076], [0211], wherein target region being a tumor in the brain comprises a brain lesion, [0136], [0157], “In other embodiments, a single transducer may be provided which an operator could appropriately place in one or more positions to both perform imaging and facilitate treatment”, [0209], “For the sake of simplicity, it is assumed that all transducers/transducer elements in this example are capable of operating in both imaging and treatment modes”).
Regarding claim 4, Ramamurthy in view of Ng, Park, and Rincker teaches the invention as claimed above in claim 3.
Ramamurthy further teaches wherein the image generation unit (510D) is configured to generate a diagnostic ultrasound focused image based on a diagnostic ultrasound signal received from the brain (Figs. 15A-B, [0088], [0113], [0209], [0215], wherein ultrasound images of the brain comprise diagnostic ultrasound focused images) and
the position alignment unit is configured to align a tumor or other diseased area requiring treatment”, wherein ¶ [0076] specifies the target is a lesion, [0211-0212], wherein discerning the tumor in the ultrasound image and delivering ultrasound to the target region comprising a tumor/lesion implies a position of the generated ultrasound focused image is aligned with a position of a lesion in the medical image).
Regarding claim 5, Ramamurthy in view of Ng, Park, and Rincker teaches the invention as claimed above in claim 1.
Ramamurthy further teaches wherein the ultrasound transducer unit (710) comprises an imaging transducer configured to transmit and receive a diagnostic ultrasound signal for imaging an image of the brain of the patient and a treatment transducer configured to transmit the focused ultrasound signal to the brain lesion ([0020], “The system may comprise a robotic manipulator connected to selectively position one or both of the imaging transducer and the treatment transducer…”, [0026], “Each of the treatment transducers may be controlled to focus ultrasound energy on the target region. Ultrasound energy may be focused on a target region…”, [0034], [0076], [0211], wherein target region being a tumor in the brain comprises a brain lesion).
Regarding claim 6, Ramamurthy in view of Ng, Park, and Rincker teaches the invention as claimed above in claim 5.
Ramamurthy further teaches wherein the imaging transducer is a phased array imaging transcranial transducer (Figs. 7A & 16, wherein [0026], [0095-0103], [0136], [0220], & [0225] describes features of a phased array transducer (e.g. beam steering, beam focusing, and applying time delays), [0020], [0036], wherein the imaging transducer placed proximate a patient’s skull comprises an imaging transcranial transducer).
Regarding claim 7, Ramamurthy in view of Ng, Park, and Rincker teaches the invention as claimed above in claim 5.
Ramamurthy further teaches wherein the image generation unit (510D) is configured to generate a transcranial ultrasound image on the based on a diagnostic ultrasound signal received from the brain (Figs. 15A-B, Abstract, [0020], “The imaging location may correspond to a low attenuation acoustic window in the skull of the patient”, [0036], “The low attenuation acoustic window may, for example, comprise the temple, back of the head…”, [0113], [0182], [0209], [0215]) and
the position alignment unit is configured to align a position of the generated transcranial ultrasound image with the position of the lesion in the obtained medical image ([0020], [0034], wherein operating a robotic manipulator to place an ultrasound imaging transducer at a location of a target determined within a pre-operative MRI or CT image comprises controlling a position of the transducer unit to align the corresponding generated transcranial ultrasound image with a position of a target in the obtained medical image, [0076], “Target regions may be selected in the pre-op image. Step 325 may comprise, for example, identifying a tumor…”, wherein the target is a tumor/lesion in the obtained medical image).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TOMMY T LY whose telephone number is (571)272-6404. The examiner can normally be reached M-F 12:00pm-8:00pm eastern time.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anhtuan Nguyen can be reached at 571-272-4963. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TOMMY T LY/ Examiner, Art Unit 3797
/SERKAN AKAR/ Primary Examiner, Art Unit 3797
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