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 .
Election/Restrictions
Restriction Requirement of 26 Sep 2023 is hereby withdrawn in view of the amended claims of 25 Nov 2025.
Status of Claims
Claims 1-30 are currently under examination. Claim 31 has been cancelled since the Restriction Requirement of 26 Sep 2025.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has complied with all conditions for receiving the benefit of earlier filing dates of 21 Sep 2022 and 01 Sep 2023 under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) for the subject matter disclosed in provisional applications 63/408,490 and 63/536,181, respectively.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 09 Sep 2024, 06 Feb 2025, and 25 Nov 2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDS has been considered by the Examiner.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “504” has been used to designate both housing body and compressive force in [00026].
The drawings are also objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “valve” recited in claim 23 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities:
“FIG 5.,” should read “FIG. 5,” ([00026]);
Reference character “504” is used for both housing body and compressive force ([00026]).
Appropriate correction is required.
Claim Objections
Claims 2, 6, 11, 14, 18, 25, 27, and 29-30 are objected to because of the following informalities:
“the total thickness” should read “a total thickness” (claim 2);
“volumetric ultrasound imaging” should read “a volumetric ultrasound imaging” (claim 6);
“the hydrophilicity” should read “hydrophilicity” (claim 11);
“a silicone-based lubricant a petroleum-based lubricant,” should read “a silicone-based lubricant, a petroleum-based lubricant, ” (claim 14);
“, and one or more displays” should read “; one or more displays” (claim 18);
“report system state information, reports error conditions,” should read “reporting a system state information, or reporting error conditions,” (claim 25);
“during ultrasound data acquisition” should read “during an ultrasound data acquisition” (claims 27 and 29-30).
Appropriate correction is required.
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.
Because this claim limitation is being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it is being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this 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 limitation to avoid it 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 limitation recites sufficient structure to perform the claimed function so as to avoid it being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim 29 recites the limitation “an ultrasound probe positioning system that compresses a patient's anatomy onto the at least one ultrasound probe and restricts anatomical motion during ultrasound data acquisition.” Since this claim limitation invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, claim 29 has been interpreted to cover the corresponding structure described in the specification that achieves the claimed function, and equivalents thereof.
A review of the specification shows that the following appears to be the corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation:
[00029] In a preferred embodiment depicted in FIG. 7A, two acoustic coupling articles 100 affixed to two ultrasound probes 302 make contact with a patient's anatomy 700 during an ultrasound scan. The movable ultrasound probe 302 compresses the patient's anatomy 700 to effectuate consistent contact between acoustic coupling article 100 on both ultrasound probes 302 and the patient's anatomy 700. Those skilled in the art will appreciate that this imaging configuration also stabilizes the patient anatomy 700 and reduces anatomical motion which might lead to image degradation or artifacts.
Fig. 7A discloses two ultrasound probes 302 compressing the patient’s anatomy onto at least one ultrasound probe and restricting an anatomical motion during an ultrasound data acquisition.
For purposes of the examination, examiner will interpret “ultrasound probe positioning system” as a frame for positioning a patient’s anatomy in between as shown in Fig. 7A or equivalents thereof.
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 1-30 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.
Claim 1 recites the limitation “wherein a non-aqueous mobile phase is distributed on a surface of the acoustic coupling article, and wherein the non-aqueous mobile phase provides acoustic coupling between the at least one ultrasound transducer array and the surface of the acoustic coupling article”. The limitation recites a circular reference to the acoustic coupling article of claim 1 itself, and further recites that the non-aqueous mobile phase is distributed on the acoustic coupling article of claim 1 itself. Thus, it is unclear whether the recited non-aqueous mobile phase is a component of the acoustic coupling article of claim 1 or not. Claims 2-17 inherit the deficiency by the nature of their dependency on claim 1. For purposes of the examination, the limitation is being given a broadest reasonable interpretation as “wherein a non-aqueous mobile phase is distributed on a surface of the layers of one or more acoustic transmissive materials, and wherein the non-aqueous mobile phase provides acoustic coupling between the at least one ultrasound transducer array and the surface of the layers of one or more acoustic transmissive materials”.
Claim 5 recites the limitation “a fluid-tight seal positioned at a joining surface of the acoustic coupling article and the ultrasound probe, the seal comprising a gasket, an O-ring, or a sealant, and structural elements including grooves, mating surfaces, or alignment features”. The limitation recites a circular reference to the acoustic coupling article of claim 5 itself, and further recites that the fluid-tight seal is positioned at a joining surface of the acoustic coupling article and the ultrasound probe. Therefore, it is unclear whether the recited fluid-tight seal is a component of the acoustic coupling article of claim 5 or not. For purposes of the examination, the limitation is being given a broadest reasonable interpretation as “a fluid-tight seal positioned at a joining surface of the structural member and the ultrasound probe, the seal comprising a gasket, an O-ring, or a sealant, and structural elements including grooves, mating surfaces, or alignment features”.
Claim 6 recites the limitation “wherein the acoustic coupling article is included in the ultrasound probe or attached to the ultrasound probe for use in volumetric ultrasound imaging”. Claim 6 is directed to the acoustic coupling article, yet the limitation recites that the claimed acoustic coupling article is included in the ultrasound probe or attached to the ultrasound probe. Therefore, it is unclear whether the claim attempts to recite both the acoustic coupling article and the ultrasound probe or attempts to recite the intended use of being included in or attached to the ultrasound probe. For purposes of the examination, the limitation is being given a broadest reasonable interpretation as “wherein the acoustic coupling article is configured to be included in the ultrasound probe or attached to the ultrasound probe for use in volumetric ultrasound imaging”.
Claim 15 recites the limitation “wherein the non-aqueous mobile phase is applied substantially uniformly to a surface of one or more layers of the layers of one or more acoustic transmissive materials that makes contact with the one or more ultrasound transducer arrays”. The antecedent basis for “the one or more ultrasound transducer arrays” in the limitation is unclear. Claim 1, to which claim 15 depends, recites “at least one ultrasound transducer array” but does not recite “one or more ultrasound transducer arrays”. For purposes of the examination, the limitation is being given a broadest reasonable interpretation as “wherein the non-aqueous mobile phase is applied substantially uniformly to a surface of one or more layers of the layers of one or more acoustic transmissive materials that makes contact with the at least one ultrasound transducer array”.
Claim 17 recites the limitation “wherein the saturated porous material is applied such that it continuously contacts a surface of the ultrasound probe and at least one non-imaging surface of the at least one ultrasound transducer array, including during translation or rotation of the at least one ultrasound transducer array”. First, it is unclear whether the limitation attempts to recite the method of applying the saturated porous material for the intended result of “it continuously contacts a surface of the ultrasound probe and at least one non-imaging surface of the at least one ultrasound transducer array, including during translation or rotation of the at least one ultrasound transducer array” in the product claim of claim 17. Second, the metes and bounds of “it” in the limitation is unclear. For purposes of the examination, the limitation is being given a broadest reasonable interpretation as “wherein the saturated porous material is configured to continuously contact a surface of the ultrasound probe and at least one non-imaging surface of the at least one ultrasound transducer array, including during translation or rotation of the at least one ultrasound transducer array”.
Claim 18 recites the limitation “a structural member configured to removably attach to at least one ultrasound probe, the ultrasound probe comprising the at least one ultrasound transducer array”. First, it is unclear whether “at least one ultrasound probe” recited in the limitation is the same or different from “at least one ultrasound probe” recited in claim 3 of claim 18. Second, it is unclear whether “the ultrasound probe” recited in the limitation is: a) referring to “at least one ultrasound probe” recited in line 3 of claim 18 and if so, a specific one of “at least one ultrasound probe”; b) being redundant of “at least one ultrasound probe comprising at least one ultrasound transducer array” in line 3 of claim 18; c) referring to “at least one ultrasound probe” also recited in the limitation and if so, a specific one of “at least one ultrasound probe”; or d) otherwise. Claims 19-30 inherit the deficiency by the nature of their dependency on claim 18. For purposes of the examination, the limitation is being given a broadest reasonable interpretation as “a structural member configured to removably attach to the at least one ultrasound probe”.
Claim 18 recites the limitation “wherein a non-aqueous mobile phase is distributed on a surface of the acoustic coupling article, and wherein the non-aqueous mobile phase provides acoustic coupling between the at least one ultrasound transducer array and the surface of the acoustic coupling article”. It is unclear whether “a non-aqueous mobile phase” in the limitation is a component of the claimed acoustic coupling article or even a component of the claimed ultrasound imaging and medical instrument guidance system of claim 18 or not. The limitation recites that the non-aqueous mobile phase is distributed on the acoustic coupling article, an explicitly recited component of the ultrasound imaging and medical instrument guidance system of claim 18. Claim 18 currently recites at least one ultrasound probe, an acoustic coupling article, one or more computer processors, one or more displays, and a non-transitory computer memory as specific components of the ultrasound imaging and medical instrument guidance system of claim 18. Claims 19-30 inherit the deficiency by the nature of their dependency on claim 18. For purposes of the examination, the limitation is being given a broadest reasonable interpretation as “a non-aqueous mobile phase is distributed on a surface of the acoustic coupling article, and wherein the non-aqueous mobile phase provides acoustic coupling between the at least one ultrasound transducer array and the surface of the acoustic coupling article”, thus the non-aqueous mobile phase being given a broadest reasonable interpretation to be a component of the ultrasound imaging and medical instrument guidance system of claim 18.
Claims 18-22 recite “instructions that cause the system to …” It is unclear which component of the ultrasound imaging and medical instrument guidance system of at least claim 18 is configured to perform the recited functions of translating or rotating (claims 18-22), generating a three-dimensional image (claim 19), detecting and reporting a condition (claim 20), performing a calibration sequence (claim 21), and detecting and reporting an error condition (claim 22). At least claim 18 currently recites at least one ultrasound probe, an acoustic coupling article, one or more computer processors, one or more displays, and a non-transitory computer memory as specific components of the ultrasound imaging and medical instrument guidance system of claim 18. It would not be clear to one of ordinary skill in the art to cause, for example, the acoustic coupling article performing any of the recited functions of translation or rotating (claims 18-22), generating a three-dimensional image (claim 19), detecting and reporting a condition (claim 20), performing a calibration sequence (claim 21), and detecting and reporting an error condition (claim 22). Claim 23-30 inherit the deficiency by the nature of its dependency on claim 18. For purposes of the examination, a broadest reasonable interpretation is being given to any of “instructions that cause the system to …” in claims 18-22 as “instructions that cause the one or more computer processors to …”
Claim 21 recites the limitation “perform a calibration sequence to verify proper installation of the acoustic coupling article and data acquisition precision of the at least one ultrasound probe”. The terms “proper” and “precision” recited in the limitation are relative terms, which render the claim indefinite. The terms “proper” and “precision” are not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. For purposes of the examination, the limitation is being given a broadest reasonable interpretation as “perform a calibration sequence to verify installation of the acoustic coupling article and data acquisition of the at least one ultrasound probe”.
Claim 22 recites the limitation “detect and report an error condition related to insufficient non-aqueous mobile phase on the surface of the acoustic coupling article”. The term “insufficient” recited in the limitation is a relative term, which renders the claim indefinite. The term “insufficient” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. For purposes of the examination, the limitation is being given a broadest reasonable interpretation as “detect and report an error condition related to the non-aqueous mobile phase on the surface of the acoustic coupling article”.
Claim 23 recites the limitation “a reservoir for holding non-aqueous mobile phase and including a valve designed to release the non-aqueous mobile phase at a location adjacent to the at least one ultrasound transducer array during translation or rotation”. It is unclear whether “non-aqueous mobile phase” recited in the limitation is the same or different from “a non-aqueous mobile phase” recited in claim 18, to which claim 23 depends. Additionally, the antecedent basis for “the non-aqueous mobile phase” recited in the limitation is unclear between “a non-aqueous mobile phase” recited in claim 18 or “non-aqueous mobile phase” recited in the limitation. For purposes of the examination, the limitation is being given a broadest reasonable interpretation as “a reservoir for holding the non-aqueous mobile phase and including a valve designed to release the non-aqueous mobile phase at a location adjacent to the at least one ultrasound transducer array during translation or rotation”.
Claim 27 recites the limitation “wherein the fiducial markings indicate a preferred orientation of the at least one ultrasound probe relative to a patient anatomy during ultrasound data acquisition”. The term “preferred” recited in the limitation is a relative term, which renders the claim indefinite. The term “preferred” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. For purposes of the examination, the limitation is being given a broadest reasonable interpretation as “wherein the fiducial markings indicate a predetermined orientation of the at least one ultrasound probe relative to a patient anatomy during ultrasound data acquisition”.
Claim 30 recites the limitation “wherein the wheeled cart also provides a physical structure for supporting a patient's anatomy during ultrasound data acquisition”. It is unclear whether the limitation recites a method of using the claimed system of claim 30 or an intended use of the claimed wheeled cart. For purposes of the examination, the limitation is being given a broadest reasonable interpretation as “wherein the wheeled cart comprises a physical structure for supporting a patient's anatomy during an ultrasound data acquisition”.
Claim Rejections - 35 USC § 102
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.
Claims 1, 3, 6-13, and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wang et al. (US PG Pub No. 2008/0194959, provided by the Applicant in the IDS of 06 Feb 2025) – hereinafter referred to as Wang.
Regarding claim 1, Wang discloses an acoustic coupling article (at least Fig. 2) comprising:
a structural member (Fig. 2: surface 106) configured to removably attach to an ultrasound probe (Fig. 2: probe 2; [0032]-[0033]: surface 106 removable from lower housing 104, which houses sonically conductive fluid and linear array probe 210),
the ultrasound probe (Fig. 2: probe 2) comprising at least one ultrasound transducer array ([0033]: linear array probe 210);
wherein the acoustic coupling article comprises layers of one or more acoustic transmissive materials (Fig. 2: flexible membrane 108) configured to conform to both a surface of a receiving body (Fig. 6A-B and [0039]-[0041]: breast 304 is chestwardly compressed by the flexible membrane 108) and to the at least one ultrasound transducer array ([0033]-[0034]: the probe and the flexible membrane 108 are acoustically matched by the sonically conductive fluid 204 for obtaining ultrasound slices sufficient to construct a three-dimensional volumetric representation of a breast);
wherein the one or more acoustic transmissive materials is substantially rigid ([0041]: flexible membrane comprises a modestly stretchable material such as polyurethane), and
wherein the one or more acoustic transmissive materials (Fig. 7A-B: flexible membrane 108) are configured to restrict motion of the at least one ultrasound transducer array in at least one direction and/or dimension (Fig. 2, 7A-B and [0041]: linear probe cannot pass through flexible membrane 108 to be in direct contact with breast 304); and
wherein a non-aqueous mobile phase (Fig. 2: sonically conductive fluid 204; [0033]: fluid 204 comprises oil that is acoustically conductive) is distributed on a surface of the acoustic coupling article ([0033]-[0034]: fluid 204 for maintaining acoustic coupling between the probe 210 and the flexible membrane 108, thus fluid 204 is distributed on a surface of the layer of acoustic transmissive material), and
wherein the non-aqueous mobile phase (Fig. 2: sonically conductive fluid 204; [0033]: fluid 204 comprises oil that is acoustically conductive) provides acoustic coupling between the at least one ultrasound transducer array and the surface of the acoustic coupling article (([0033]-[0034]: fluid 204 for maintaining acoustic coupling between the probe 210 and the flexible membrane 108).
It is noted that regarding “layers of one or more acoustic transmissive materials” recited in the claim, a broadest reasonable interpretation has been given to include layers of one same acoustic transmissive material, or a single layer of one same acoustic transmissive material.
Regarding claim 3, Wang discloses all limitations of claim 1, as discussed above, and Wang further discloses:
wherein the one or more acoustic transmissive materials have Shore hardness greater than Shore 000 5, a speed of sound between 900 m/s and 2,100 m/s, and an acoustic impedance of less than 3 MRayl ([0041]: flexible membrane 108 comprising a modestly stretchable material such as polyurethane).
It is noted that while Wang does not explicitly disclose that its flexible membrane of polyurethane have Shore hardness greater than Shore 000 5, a speed of sound between 900 m/s and 2,100 m/s, and an acoustic impedance of less than 3 MRayl, a review of the specification discloses in [00021]-[00022] that the claimed acoustic transmissive material includes polyurethane. Therefore, Wang’s flexible membrane of polyurethane inherently have Shore hardness greater than Shore 000 5, a speed of sound between 900 m/s and 2,100 m/s, and an acoustic impedance of less than 3 MRayl.
Regarding claim 6, Wang discloses all limitations of claim 1, as discussed above, and Wang further discloses:
wherein the acoustic coupling article is included in the ultrasound probe or attached to the ultrasound probe for use in volumetric ultrasound imaging (Fig. 2 and [0033]-[0034]: the probe and the flexible membrane 108 are acoustically matched by the sonically conductive fluid 204 for obtaining ultrasound slices sufficient to construct a three-dimensional volumetric representation of a breast).
Regarding claim 7, Wang discloses all limitations of claim 1, as discussed above, and Wang further discloses:
wherein a surface of the acoustic coupling article is substantially flat, providing a linear or planar path of translation or rotation for the at least one ultrasound transducer array (Fig. 6A and [0039]-[0040]: flexible membrane 108 chestwardly compresses breast 304, resulting in the breast 304 into a state of flattened compression while exerting an upward force).
Regarding claim 8, Wang discloses all limitations of claim 1, as discussed above, and Wang further discloses:
wherein a surface of the acoustic coupling article is curved (Fig. 6B and [0041]: flexible membrane 108 comprising a modestly stretchable material elastically compressing the breast upward, or the flexible membrane 108 being curved),
wherein the curvature provides a concave, convex, curvilinear, non-linear, or non-planar path of translation for the at least one ultrasound transducer array (Fig. 6B: flexible membrane 108 being concave/convex).
Regarding claim 9, Wang discloses all limitations of claim 1, as discussed above, and Wang further discloses:
wherein the one or more transmissive acoustic materials comprises a thermoplastic material chosen from one or more of polymethylpentene, cross-linked polystyrene and divinylbenzene, polypropylene, polyether block amide, polyester, polyethylene, polyethylene terephthalate, nylon, and polyimide (Fig. 2 and [0040]: flexible membrane 108 comprising a substantially inelastic material such as polyester film).
Regarding claim 10, Wang discloses all limitations of claim 1, as discussed above, and Wang further discloses:
wherein the one or more transmissive acoustic materials comprise a thermoplastic, a polyurethane, a cured silicone rubber material, or combinations thereof, having a speed of sound between 900 m/s and 2,100 m/s ([0041]: flexible membrane 108 comprising a modestly stretchable material such as polyurethane).
It is noted that while Wang does not explicitly disclose that its flexible membrane of polyurethane has a speed of sound between 900 m/s and 2,100 m/s, a review of the specification discloses in [00021]-[00022] that the claimed acoustic transmissive material includes polyurethane. Therefore, Wang’s flexible membrane of polyurethane inherently has a speed of sound between 900 m/s and 2,100 m/s.
Regarding claim 11, Wang discloses all limitations of claim 1, as discussed above, and Wang further discloses:
wherein a surface of an outermost acoustic transmissive material of the layers of one or more acoustic transmissive materials is treated with a surface coating to increase the hydrophilicity, wettability, lubricity, or combinations thereof, of the surface ([0035]: breast 304 is coated with a layer of acoustic couplant prior to insertion through the orifice 107 (or the layer of acoustic couplant would be coated onto the flexible membrane 108) or alternatively, flexible membrane 108 maintains a small pool of acoustic couplant or be outfitted with a prefabricated couplant sheet).
Regarding claim 12, Wang discloses all limitations of claim 1, as discussed above, and Wang further discloses:
wherein an outermost acoustic transmissive material of the layers of one or more acoustic transmissive materials is of malleable composition that can be deformed, thermoformed, or molded, into a shape and substantially retains the shape without significant deformation over a one year period of time ([0041]: flexible membrane 108 comprising a modestly stretchable material such as polyurethane).
It is noted that while Wang does not explicitly disclose that its flexible membrane of polyurethane can be deformed, thermoformed, or molded, into a shape and substantially retains the shape without significant deformation over a one year period of time, a review of the specification of the instant application discloses in [00031] that the claimed outermost acoustic transmissive material includes polyurethane. Therefore, Wang’s flexible membrane of polyurethane inherently can be deformed, thermoformed, or molded, into a shape and substantially retains the shape without significant deformation over a one year period of time.
Regarding claim 13, Wang discloses all limitations of claim 1, as discussed above, and Wang further discloses:
wherein an outermost acoustic transmissive material of the layers of one or more acoustic transmissive materials provides a protective barrier layer configured to shield internal layers of the layers of one or more acoustic transmissive materials from environmental degradation ([0041]: flexible membrane 108 comprising a modestly stretchable material such as polyurethane),
wherein the protective barrier layer comprises a material that is resistant to one or more of moisture, ultraviolet radiation, chemical exposure, or mechanical damage ([0041]: flexible membrane 108 comprising a modestly stretchable material such as polyurethane).
It is noted that while Wang does not explicitly disclose that its flexible membrane of polyurethane provides a protective barrier layer configured to shield internal layers of the layers of one or more acoustic transmissive materials from environmental degradation, wherein the protective barrier layer comprises a material that is resistant to one or more of moisture, ultraviolet radiation, chemical exposure, or mechanical damage, a review of the specification of the instant application discloses in [00021] that the claimed outermost acoustic transmissive material includes polyurethane.
Regarding claim 15, Wang discloses all limitations of claim 1, as discussed above, and Wang further discloses:
wherein the non-aqueous mobile phase (Fig. 7B: fluid 204) is applied substantially uniformly to a surface of one or more layers of the layers of one or more acoustic transmissive materials (Fig. 7B: flexible membrane 108) that makes contact with the one or more ultrasound transducer arrays (Fig. 7B: probe 710; [0033]: probe disposed within sonically conductive fluid 204, wherein the fluid 204 maintains acoustic coupling between the probe 210 and the flexible membrane 108 when the probe is in motion without distortion of the breast contours).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Wang, as applied to claim 1 above, and further in view Hayakawa et al. (US Patent No. 5265614) – hereinafter referred to as Hayakawa.
Regarding claim 2, Wang discloses all limitations of claim 1, as discussed above, and Wang does not disclose:
wherein the total thickness of the acoustic coupling article is between 0.05 cm and 10 cm.
In the same field of providing an acoustic coupling article, Hayakawa, however, teaches:
a total thickness of an acoustic coupling article between 1 and 10 cm (Col 1, lines 45-51: acoustic coupler having a thickness of approximately 1 to 10 cm is used between the ultrasound probe and the surface of the body).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Wang’s product to include Hayakawa’s acoustic coupling article thickness. One of ordinary skill in the art would have modified Wang’s product as claimed by known methods (i.e., arranging the acoustic coupling article with a total thickness between 1 to 10 cm, as disclosed by Hayakawa), and the combination would have yielded a reasonable expectation of success since both Wang and Hayakawa are directed to an acoustic coupling article. The motivation for the modification would have been “when the surface of the body is not soft or not flat to the ultrasound probe … Furthermore, when the affected part is located near the surface of the body … The thickness of the acoustic coupler is varied in accordance with the flatness of the surface of the body and/or the location of the affected part from the surface of the body”, as taught by Hayakawa (Col 1, lines 35-51).
It is noted that a review of the original specification of the instant application does not disclose any criticality of the claimed total thickness of the acoustic coupling article between 0.05 cm and 10 cm: the original specification does not even discuss any thickness of the acoustic coupling article.
Claims 4-5 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Wang, as applied to claim 1 above, and further in view of Stopek et al. (US PG Pub No. 2023/0218930, priority date of 18 Jun 2020) – hereinafter referred to as Stopek.
Regarding claim 4, Wang discloses all limitations of claim 1, as discussed above, and Wang does not disclose:
mechanical retention features, including one or more of grooves, ridges, clips, holes, or threads, that removably mate with the ultrasound probe.
In the same field of ultrasound imaging, Stopek, however, teaches:
mechanical retention features (Fig. 4D: mechanical lock 464), including one or more of grooves, ridges, clips, holes, or threads, that removably mate with the ultrasound probe (Fig. 4D: mechanical lock 464 comprising at least grooves, ridges; [0162]: mechanical lock 464 mechanically coupled to the transducer assembly by tabs, screws, clips, etc., and the mechanical lock 464 can be removable).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Wang’s acoustic coupling article to include Stopek’s mechanical retention features. One of ordinary skill in the art would have combined the elements as claimed by known methods (i.e., providing the mechanical retention features as disclosed by Stopek), and the combination would have yielded a reasonable expectation of success since both Wang and Stopek are directed to ultrasound imaging using an acoustic coupling article. The motivation for the combination would have been “to hold the transducer assembly in place relative to the UMC while the UMC is filled with fluid”, as taught by Stopek ([0162]).
Regarding claim 5, Wang discloses all limitations of claim 1, as discussed above, and Wang further discloses:
a fluid-tight seal positioned at a joining surface of the acoustic coupling article and the ultrasound probe (Fig. 2 and [0031]: surface 106 defining an orifice 107 across which is sealably secured a compressive member in the form of a flexible membrane 108; [0047]: probe positioned relative to the flexible membrane 108).
Wang does not disclose:
the seal comprising a gasket, an O-ring, or a sealant, and structural elements including grooves, mating surfaces, or alignment features.
In the same field of ultrasound imaging, Stopek, however, teaches:
a seal comprising a gasket, an O-ring, or a sealant (Fig. 4A-D: boot ring 460 as an O-ring), and structural elements including grooves, mating surfaces, or alignment features (Fig. 4A-D and [0160]: flexible boot held in place between the boot ring 460 and upper frame 442 with boot clamps 458).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Wang’s acoustic coupling article to include Stopek’s seal. One of ordinary skill in the art would have combined the elements as claimed by known methods (i.e., providing the seal as disclosed by Stopek), and the combination would have yielded a reasonable expectation of success since both Wang and Stopek are directed to ultrasound imaging using an acoustic coupling article. The motivation for the combination would have been to provide a tight seal so that the non-aqueous mobile phase of the acoustic coupling article would not leak.
Regarding claim 14, Wang discloses all limitations of claim 1, as discussed above, and Wang does not disclose:
wherein the non-aqueous mobile phase comprises a synthetic lubricant, a silicone-based lubricant a petroleum-based lubricant, or combinations thereof.
In the same field of ultrasound imaging, Stopek, however, teaches:
a non-aqueous mobile phase comprises a synthetic lubricant, a silicone-based lubricant, a petroleum-based lubricant, or combinations thereof ([0153]: ultrasound coupling medium 348 includes carbapol R940 polymer, a synthetic lubricant).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Wang’s acoustic coupling article to include Stopek’s synthetic lubricant. One of ordinary skill in the art would have substituted the non-aqueous mobile phase, and the substitution would have yielded a reasonable expectation of success since both Wang and Stopek are directed to ultrasound imaging using an acoustic coupling article. The motivation for the substitution would have been “ultrasound coupling medium should be thin and a consistent thickness, in a material which has minimal absorption of ultrasound, is biocompatible, does not migrate from the application site and which does not contain bubbles”, as taught by Stopek ([0153]).
Claims 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Wang, as applied to claim 1 above, and further in view of Rothberg et al. (US PG Pub No. 2020/0383660) – hereinafter referred to as Rothberg.
Regarding claim 16, Wang discloses all limitations of claim 1, as discussed above, and Wang does not disclose:
wherein the non-aqueous mobile phase is impregnated into one or more layers of the layers of one or more acoustic transmissive materials, and
wherein the non-aqueous mobile phase is released in response to compression or contact forces.
In the same field of providing an acoustic coupling, Rothberg, however, teaches:
a non-aqueous mobile phase impregnated into one or more layers of one or more acoustic transmissive materials (Fig. 1 and [0059]: ultrasound gel is deposited in the coupling body 102; [0069]: ultrasound gel includes oils) , and
wherein the non-aqueous mobile phase is released in response to compression or contact forces ([0060]: user pressing down on coupling body 102 with a typical amount of force, ultrasound gel flows from openings 116).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Wang’s acoustic coupling article to include Rothberg’s non-aqueous mobile phase impregnated layer of acoustic transmissive material. Rothberg discloses a technique of releasing non-aqueous mobile phase from impregnated layer of acoustic transmissive material, and Rothberg’s technique is applicable to Wang’s acoustic coupling article, since both Wang and Rothberg are directed to providing non-aqueous acoustic coupling for ultrasound imaging, one of ordinary skill in the art would recognize that an optimized coupling between an ultrasound probe and a tissue of interest would be advantageous for improved ultrasound imaging of the tissue of interest. Therefore, one of ordinary skill in the art would apply a known technique (in this case, Rothberg’s technique of providing an impregnated layer of acoustic transmissive material with a non-aqueous mobile phase) to a known device (in this case, Wang’s acoustic coupling article for ultrasound imaging) that was ready for improvement, and the results (in this case, Wang’s layer of acoustic transmissive material, or flexible membrane 108, being impregnated with non-aqueous mobile phase, or fluid 204, and be porous to release fluid 204 towards the breast under ultrasound imaging) would have been predictable to one of ordinary skill in the art. See MPEP 2143.I.D. The motivation would have been to avoid coating breast 304 “with a layer of acoustic couplant prior to insertion through the orifice 107” ([0035] of Wang) by allowing fluid 204 be released towards the breast.
Regarding claim 17, Wang discloses all limitations of claim 1, as discussed above, and Wang does not disclose:
a porous material saturated with the non-aqueous mobile phase,
wherein the saturated porous material is applied such that it continuously contacts a surface of the ultrasound probe and at least one non-imaging surface of the at least one ultrasound transducer array, including during translation or rotation of the at least one ultrasound transducer array.
In the same field of providing an acoustic coupling, Rothberg, however, teaches:
a porous material saturated with a non-aqueous mobile phase (Fig. 1 and [0059]: ultrasound gel is deposited in the coupling body 102 and coupling body 102 comprises openings 116; [0069]: ultrasound gel includes oils) , and
wherein the saturated porous material is applied such that it continuously contacts a surface of the ultrasound probe and at least one non-imaging surface of the at least one ultrasound transducer array (Fig. 1: coupling body 102 with end portions 108, 110 wrapping around acoustic lens 124 and the sides of head portion 122 of the ultrasound device 104), including during translation or rotation of the at least one ultrasound transducer array (Fig. 1 and [0053]: coupling body 102 adhered to ultrasound device 104).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Wang’s acoustic coupling article to include Rothberg’s porous material saturated with a non-aqueous mobile phase. Rothberg discloses a technique of providing a porous material saturated with a non-aqueous mobile phase relative to the ultrasound probe, and Rothberg’s technique is applicable to Wang’s acoustic coupling article, since both Wang and Rothberg are directed to providing non-aqueous acoustic coupling for ultrasound imaging, one of ordinary skill in the art would recognize that an optimized coupling between an ultrasound probe and a tissue of interest would be advantageous for improved ultrasound imaging of the tissue of interest. Therefore, one of ordinary skill in the art would apply a known technique (in this case, Rothberg’s technique of providing a porous material saturated with a non-aqueous mobile phase relative to the ultrasound probe) to a known device (in this case, Wang’s acoustic coupling article for ultrasound imaging) that was ready for improvement, and the results (in this case, Wang’s layer of acoustic transmissive material, or flexible membrane 108, being porous to release non-aqueous mobile phase, or fluid 204, towards the breast under ultrasound imaging) would have been predictable to one of ordinary skill in the art. See MPEP 2143.I.D. The motivation would have been to avoid coating breast 304 “with a layer of acoustic couplant prior to insertion through the orifice 107” ([0035] of Wang) by allowing fluid 204 be released towards the breast.
Claims 18-26, and 28-29 are rejected under 35 U.S.C. 103 as being unpatentable over Wang in view of Stopek.
Regarding claim 18, Wang discloses an ultrasound imaging and medical instrument guidance system (at least Fig. 2) comprising:
at least one ultrasound probe (Fig. 2: probe 2) comprising at least one ultrasound transducer array ([0033]: linear array probe 210);
an acoustic coupling article (Fig. 2: scanning apparatus 102) for conveyance of ultrasound energy from the at least one ultrasound probe to a receiving body ([0031]-[0033]: scanning apparatus 102 for ultrasound scanning a breast of a patient to construct a three-dimensional volumetric representation of the breast),
the acoustic coupling article (at least Fig. 2) comprising:
a structural member (Fig. 2: surface 106) configured to removably attach to an ultrasound probe (Fig. 2: probe 2; [0032]-[0033]: surface 106 removable from lower housing 104, which houses sonically conductive fluid and linear array probe 210),
the ultrasound probe (Fig. 2: probe 2) comprising at least one ultrasound transducer array ([0033]: linear array probe 210);
wherein the acoustic coupling article comprises layers of one or more acoustic transmissive materials (Fig. 2: flexible membrane 108) capable of configured to conform to both a surface of a receiving body (Fig. 6A-B and [0039]-[0041]: breast 304 is chestwardly compressed by the flexible membrane 108) and to the at least one ultrasound transducer array ([0033]-[0034]: the probe and the flexible membrane 108 are acoustically matched by the sonically conductive fluid 204 for obtaining ultrasound slices sufficient to construct a three-dimensional volumetric representation of a breast);
wherein the one or more acoustic transmissive materials is substantially rigid ([0041]: flexible membrane comprises a modestly stretchable material such as polyurethane), and
wherein the one or more acoustic transmissive materials (Fig. 7A-B: flexible membrane 108) are configured to restrict motion of the at least one ultrasound transducer array in at least one direction and/or dimension (Fig. 2, 7A-B and [0041]: linear probe cannot pass through flexible membrane 108 to be in direct contact with breast 304); and
wherein a non-aqueous mobile phase (Fig. 2: sonically conductive fluid 204; [0033]: fluid 204 comprises oil that is acoustically conductive) is distributed on a surface of the acoustic coupling article ([0033]-[0034]: fluid 204 for maintaining acoustic coupling between the probe 210 and the flexible membrane 108, thus fluid 204 is distributed on a surface of the layer of acoustic transmissive material), and
wherein the non-aqueous mobile phase (Fig. 2: sonically conductive fluid 204; [0033]: fluid 204 comprises oil that is acoustically conductive) provides acoustic coupling between the at least one ultrasound transducer array and the surface of the acoustic coupling article (([0033]-[0034]: fluid 204 for maintaining acoustic coupling between the probe 210 and the flexible membrane 108).
It is noted that regarding “layers of one or more acoustic transmissive materials” recited in the claim, a broadest reasonable interpretation has been given to include layers of one same acoustic transmissive material, or a single layer of one same acoustic transmissive material.
Wang does not disclose:
one or more computer processors operative to process acquired data received from the at least one ultrasound transducer array, and
one or more displays for displaying acquired data as an image; and
a non-transitory computer memory comprising instructions that cause the system to translate or rotate the at least one ultrasound transducer array along a surface of the acoustic coupling article to acquire the data at multiple spatial locations.
In the same field of ultrasound imaging, Stopek, however, teaches:
one or more computer processors ([0052]: computers and networking devices) operative to process acquired data received from the at least one ultrasound transducer array ([0086]: system comprises onboard ultrasound to visualize, monitor and receive feedback), and
one or more displays (Fig. 1A: display and control panel 106) for displaying acquired data as an image ([0084]: displaying and characterizing regions of interest); and
a non-transitory computer memory ([0052]: computers and networking devices) comprising instructions that cause the system to translate or rotate the at least one ultrasound transducer array along a surface of the acoustic coupling article to acquire the data at multiple spatial locations ([0151]: robotic arm and transducer assembly move with respect to the membrane and mechanical support because of the flexible boot 324, which allows for movement of the transducer assembly while still containing fluid within the coupling assembly and membrane).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Wang’s system to include Stopek’s processors, display, and memory. One of ordinary skill in the art would have combined the elements as claimed by known methods (i.e., providing processors, display, and memory, as disclosed by Stopek), and the combination would have yielded a reasonable expectation of success since both Wang and Stopek are directed to ultrasound imaging using an acoustic coupling article. The motivation for the combination would have been to “provide multiple views of the target tissue … and to integrate these images into a single 3-D image”, as taught by Stopek ([0054]).
Regarding claim 19, Wang in view of Stopek discloses all limitations of claim 18, as discussed above, and Stopek further teaches:
generating a three-dimensional image based on volumetric ultrasound data ([0054]: imaging transducers provide multiple views of the target tissue to integrate these images into a single 3-D image; [0084]: 3D reconstruction to identify, define and inform various aspects of using imaging during the procedure, as displayed in the various system user interfaces and displays).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Wang’s system to include Stopek’s generation of a 3-D image. One of ordinary skill in the art would have combined the elements as claimed by known methods (i.e., generating the image based on the acquired ultrasound data, as disclosed by Stopek), and the combination would have yielded a reasonable expectation of success since both Wang and Stopek are directed to ultrasound imaging using an acoustic coupling article. The motivation for the combination would have been to “provide multiple views of the target tissue … and to integrate these images into a single 3-D image”, as taught by Stopek ([0054]).
Regarding claim 20, Wang in view of Stopek discloses all limitations of claim 18, as discussed above, and Stopek further teaches:
detecting and reporting a condition indicating a need for a servicing event of the ultrasound imaging and medical instrument guidance system ([0116]: software provides error messages or warnings to the user if said therapy transducer, amplifier and/or function generator selections or parameters are erroneous, yield a fault or failure).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Wang’s system to include Stopek’s detection and reporting of the system condition. One of ordinary skill in the art would have combined the elements as claimed by known methods (i.e., detecting and alerting an error or warning, as disclosed by Stopek), and the combination would have yielded a reasonable expectation of success since both Wang and Stopek are directed to ultrasound imaging using an acoustic coupling article. The motivation for the combination would have been to “provide error messages or warnings to the user if said therapy transducer, amplifier and/or function generator selections or parameters are erroneous, yield a fault or failure. This may further comprise reporting the details and location of such”, as taught by Stopek ([0116]).
Regarding claim 21, Wang in view of Stopek discloses all limitations of claim 18, as discussed above, and Stopek further teaches:
performing a calibration sequence to verify proper installation of the acoustic coupling article and data acquisition precision of the at least one ultrasound probe ([0114]: software initializes and sets up the system, including pre-treatment assessments and calibration; [0187]: perform a system check and calibrating crosshairs of the system).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Wang’s system to include Stopek’s calibration performance. One of ordinary skill in the art would have combined the elements as claimed by known methods (i.e., performing a calibration, as disclosed by Stopek), and the combination would have yielded a reasonable expectation of success since both Wang and Stopek are directed to ultrasound imaging using an acoustic coupling article. The motivation for the combination would have been to “initialize and set up the system”, as taught by Stopek ([0114]), for the intended procedure with no system malfunction.
Regarding claim 22, Wang in view of Stopek discloses all limitations of claim 18, as discussed above, and Stopek further teaches:
detecting and reporting an error condition related to insufficient non-aqueous mobile phase on the surface of the acoustic coupling article ([0177]: pressure sensors measure pressure of the medium within the ultrasound medium container (UMC); [0114]: software provides warning and alerts).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Wang’s system to include Stopek’s detection and reporting of an error condition. One of ordinary skill in the art would have combined the elements as claimed by known methods (i.e., detecting and reporting an error, as disclosed by Stopek), and the combination would have yielded a reasonable expectation of success since both Wang and Stopek are directed to ultrasound imaging using an acoustic coupling article. The motivation for the combination would have been “to measure the pressure of the medium within the UMC, which can be used to detect leaks or over-pressure events”, as taught by Stopek ([0177]).
Regarding claim 23, Wang in view of Stopek discloses all limitations of claim 18, as discussed above, and Wang further discloses:
a reservoir (Fig. 2: reservoir housing formed by lower housing 104 and surface 106) for holding non-aqueous mobile phase (Fig. 2: fluid 204; [0032]: reservoir casing formed by lower housing 104 and surface 106 to be sufficiently filled with sonically conductive fluid) and including a valve designed to release the non-aqueous mobile phase at a location adjacent to the at least one ultrasound transducer array during translation or rotation ([0032]-[0033]: pressure/volume relief valve system provided to facilitate proper fluid volumes within the reservoir casing, and probe 210 is disposed within fluid 204 within the reservoir casing).
Regarding claim 24, Wang in view of Stopek discloses all limitations of claim 18, as discussed above, and Wang further discloses:
a mechanism (Fig. 5: C-arm and backplane arrangement 404) that applies compressive force to the at least one ultrasound transducer array to maintain contact with the surface of the acoustic coupling article (Fig. 5 and [0037]: the C-arm and backplane arrangement 404 is configured to springably maintain a constant compression force that is reminiscent of the force that would be exerted by operation of the natural body weight of the patient),
the mechanism comprising a spring, an elastomeric material, or a pneumatic system (Fig. 5 and [0037]: the C-arm and backplane arrangement 404 is configured to springably maintain a constant compression force that is reminiscent of the force that would be exerted by operation of the natural body weight of the patient).
Regarding claim 25, Wang in view of Stopek discloses all limitations of claim 18, as discussed above, and Stopek further teaches:
a user interface incorporated on or into the at least one ultrasound probe that provides controls for operating the system, report system state information, reports error conditions, or combinations thereof ([0116]: error messages or warnings provided to the user if said therapy transducer, amplifier and/or function generator selections or parameters are erroneous, yield a fault or failure. This may further comprise reporting the details and location of such).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Wang’s system to include Stopek’s user interface into the ultrasound probe. One of ordinary skill in the art would have combined the elements as claimed by known methods (i.e., incorporating a user interface into the ultrasound probe, as disclosed by Stopek), and the combination would have yielded a reasonable expectation of success since both Wang and Stopek are directed to ultrasound imaging using an acoustic coupling article. The motivation for the combination would have been to “provide error messages or warnings to the user if said therapy transducer, amplifier and/or function generator selections or parameters are erroneous, yield a fault or failure”, as taught by Stopek ([0116]).
Regarding claim 26, Wang in view of Stopek discloses all limitations of claim 18, as discussed above, and Stopek further teaches:
one or more ultrasound probes of the at least one ultrasound probe including grips or handles to facilitate handheld operation and positioning of the at least one ultrasound probe on or near a patient's body (Fig. 3A: probe rotation handle 334; [0096]: a manual ultrasound probe e.g., diagnostic hand-held probe) to conduct the procedure).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Wang’s system to include Stopek’s handheld ultrasound probe. One of ordinary skill in the art would have combined the elements as claimed by known methods (i.e., providing a handheld ultrasound probe, as disclosed by Stopek), and the combination would have yielded a reasonable expectation of success since both Wang and Stopek are directed to ultrasound imaging using an acoustic coupling article. The motivation for the combination would have been to allow the user to manually maneuver the ultrasound probe where appropriate.
Regarding claim 28, Wang in view of Stopek discloses all limitations of claim 18, as discussed above, and Stopek further teaches:
a wheeled cart (Fig. 1A: cart 100 with wheels and imaging system 104) to facilitate an alignment of the at least one ultrasound probe with an anatomical scan plane of a patient's anatomy ([0057]-[0058]: cart 110 positioned to provide sufficient work-space and access to various anatomical locations on the patient, and cart interfaces and communications with ultrasound to support the procedures).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Wang’s system to include Stopek’s wheeled cart. One of ordinary skill in the art would have combined the elements as claimed by known methods (i.e., providing the system on a wheeled cart, as disclosed by Stopek), and the combination would have yielded a reasonable expectation of success since both Wang and Stopek are directed to ultrasound imaging using an acoustic coupling article. The motivation for the combination would have been “As such and depending on the procedure environment based on the aforementioned embodiments, the cart may be positioned to provide sufficient work-space and access to various anatomical locations on the patient (e.g., torso, abdomen, flank, head and neck, etc.), as well as providing work-space for other systems (e.g., anesthesia cart, laparoscopic tower, surgical robot, endoscope tower, etc.)”, as taught by Stopek ([0057]).
Regarding claim 29, Wang in view of Stopek discloses all limitations of claim 28, as discussed above, and Wang further discloses:
an ultrasound probe positioning system (Fig. 5: C-arm and backplane arrangement 404) that compresses a patient's anatomy onto the at least one ultrasound probe and restricts anatomical motion during ultrasound data acquisition (Fig. 5 and [0037]: the C-arm and backplane arrangement 404 is configured to springably maintain a constant compression force that is reminiscent of the force that would be exerted by operation of the natural body weight of the patient).
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over Wang in view of Stopek, as applied to claim 18 above, and further in view Okamoto et al. (US PG Pub No. 2024/0225604, priority date of 18 Jan 2022) – hereinafter referred to as Okamoto.
Regarding claim 27, Wang in view of Stopek discloses all limitations of claim 18, as discussed above, and Wang in view of Stopek does not disclose:
fiducial markings on the at least one ultrasound probe and/or on the acoustic coupling article,
wherein the fiducial markings indicate a preferred orientation of the at least one ultrasound probe relative to a patient anatomy during ultrasound data acquisition.
In the same field of ultrasound imaging, Okamoto, however, teaches:
fiducial markings on at least one ultrasound probe (Fig. 2A-B, 3A-B: probe distal end 32; [0040]-[0044]: probe distal end 32 with differently colored sides),
wherein the fiducial markings indicate a preferred orientation of the at least one ultrasound probe relative to a patient anatomy during ultrasound data acquisition (Fig. 1, 2A-B, 3A-B: probe distal end 32; [0040]-[0044]: probe distal end 32 with differently colored sides indicating directivity of the ultrasound probe 10 relative to the target surface of patient 30).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Wang’s system to include Okamoto’s fiducial markings on an ultrasound probe. One of ordinary skill in the art would have combined the elements as claimed by known methods (i.e., providing different colors to different sides of an ultrasound probe, as disclosed by Okamoto), and the combination would have yielded a reasonable expectation of success since both Wang and Okamoto are directed to ultrasound imaging using an acoustic coupling article. The motivation for the combination would have been “the orientation of the observation surface of the ultrasound probe 10 is easily perceived by the user. Accordingly, it becomes easy to match the observation surface of the ultrasound probe 10 with the observation target surface of the patient 30”, as taught by Okamoto ([0043]).
Claim 30 is rejected under 35 U.S.C. 103 as being unpatentable over Wang in view of Stopek, as applied to claim 29 above, and further in view of Summers et al. (US PG Pub No. 2008/0269613) – hereinafter referred to as Summers.
Regarding claim 30, Wang in view of Stopek discloses all limitations of claim 29, as discussed above, and Wang in view of Stopek does not disclose:
wherein the wheeled cart also provides a physical structure for supporting a patient's anatomy during ultrasound data acquisition.
In the same field of ultrasound imaging, Summers, however, teaches:
a wheeled cart providing a physical structure (Fig. 7-9: scanning assembly 514 with gel pad 702) for supporting a patient's anatomy during ultrasound data acquisition (]0056]: gel pad 702 of scanning assembly 514 promotes improved patient comfort while also promoting better acoustic coupling with a chestwardly-compressed breast for head-on scans).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Wang’s system to include Summers’s wheeled cart providing the physical structure. One of ordinary skill in the art would have combined the elements as claimed by known methods (i.e., providing the physical structure on a wheeled cart, as disclosed by Summers), and the combination would have yielded a reasonable expectation of success since both Wang and Summers are directed to ultrasound imaging using an acoustic coupling article. The motivation for the combination would have been to allow “improved patient comfort while also promoting better acoustic coupling with a chestwardly-compressed breast for head-on scans”, as taught by Summers ([0056]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Arai et al. (US PG Pub No. 2017/0281124) discloses layers of different acoustic coupling materials between an ultrasound probe and a tissue of interest (at least Fig. 16);
Arai et al. (US PG Pub No. 2020/0305836) discloses layers of different acoustic coupling materials disposed between an ultrasound probe and a tissue of interest (at least Fig. 6B and [0079]); and
McLaughlin et al. (US PG Pub No. 2024/0065674, priority date of 30 Aug 2022) discloses releasing acoustic coupling medium by applying pressure (at least Fig. 1B, 5).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Younhee Choi whose telephone number is (571)272-7013. The examiner can normally be reached M-F 9AM-5PM EST.
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/Y.C./Examiner, Art Unit 3797
/ANH TUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795
01/05/26