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 Arguments
Applicant’s arguments, see pg. 10, filed 02 Jul 2026, with respect to the drawing objections have been fully considered and are persuasive. The drawing objections of 07 Jan 2026 have been withdrawn in view of the amended specification and claim.
Applicant’s arguments, see pg. 10, filed 02 Jul 2026, with respect to specification objections have been fully considered and are persuasive. The specification objection of 07 Jan 2026 has been withdrawn in view of the amended specification.
Applicant’s arguments, see pg. 10, filed 02 Jul 2026, with respect to the claim objections have been fully considered and are persuasive. The claim objections of 07 Jan 2026 have been withdrawn in view of the amended claims.
Applicant’s arguments, see pg. 10, filed 02 Jul 2026, with respect to the 35 U.S.C. 112(b) rejections have been fully considered and are persuasive in part.
The 35 U.S.C. 112(b) rejections to claims 6, 15, 21, and 23 of 07 Jan 2026 have been withdrawn in view of the amended claims.
Regarding claim 1, Applicant argues, see pg. 10, that “the amendments clarify the positional and functional relationship of the non-aqueous mobile as it relates to the acoustic coupling article”. However, the Examiner respectfully disagrees. Amended claim 1 still recites a circular reference to “the acoustic coupling article” of claim 1 in the limitation “wherein the non-aqueous mobile phase is disposed partially or completely between the at least one ultrasound transducer array and a surface of the acoustic coupling article”. Therefore, it is unclear whether the non-aqueous mobile phase itself, as a surface of the acoustic coupling article of claim 1, is being disposed between the at least one ultrasound transducer array and itself, or otherwise. See the 35 U.S.C. 112(b) rejection to claim 1 below.
Regarding claims 5, 17, 18-22, and 29-30, Applicant argues, see pg. 10, that “Applicant accepts the Office’s interpretation”. Applicant is reminded that these claims were subject to the 35 U.S.C. 112(b) rejections that require an amendment and that “accepting the Office’s interpretation” does not overcome the rejections. See the 35 U.S.C. 112(b) rejections below that are hereby being maintained.
Applicant's arguments, see pg. 11-13, filed 02 Jul 2026, with respect to the 35 U.S.C. 102 and 103 rejections have been fully considered but they are not persuasive in part.
The 35 U.S.C. 102 rejections of 07 Jan 2026 have been withdrawn in view of the amended claims.
However, regarding at least the amended independent claims 1 and 18 in view of Wang et al. (US PG Pub No. 2008/0194959) previously presented in the 35 U.S.C. 102 rejections, Applicant argues, see pg. 11, that “the cavity of the current invention is not a reservoir for liquid (like Wang et al.’s), but rather a dry holding element for the probe and associated electronics”. However, the Examiner respectfully disagrees. First, as presented in the 35 U.S.C. 112(a) rejections below, a review of the original specification of the instant application does not disclose any electronic components associated with operation of the at least one ultrasound transducer array contained within the internal cavity. In particular, the original specification merely discloses one or more motors within the claimed internal cavity (see Fig. 5 and [00026] of the original specification). Additionally, the claims do not require the internal cavity to be dry. Furthermore, claim 1 recites the new limitation “wherein the internal cavity is blocked from allowing insertion of an anatomy to be imaged or a portion of the anatomy to be imaged by one or more substantially rigid layers comprising one or more acoustic transmissive materials, the one or more substantially rigid layers configured to both (a) restrict motion of the at least one ultrasound transducer array in at least one direction and/or dimension, and (b) block the anatomy to be imaged or the portion of the anatomy to be imaged from being inserted completely or partially into the internal cavity” and claim 18 recites the limitation “wherein the one or more substantially rigid layers are configured to restrict motion of the at least one ultrasound transducer array in at least one direction and/or dimension and block all or part of the receiving body from entering the internal cavity”. These claims currently require only the one or more substantially rigid layers to restrict a motion of the ultrasound transducer array in a direction or dimension and to block a part of the anatomy or receiving body from entering the internal cavity. Previously presented Wang et al. discloses its surface 106 in Fig. 2 restricting a motion of the ultrasound transducer array (i.e., the ultrasound transducer array moving through the surface 106) and blocking a part of breast from entering the cavity bounded by lower housing 104 and containing sonically conductive fluid 204 (i.e., breast cannot enter the cavity on surface 106, but breast still can enter the cavity through flexible membrane 108). As suggested in the 35 U.S.C. 103 rejections below, Applicant may consider specifying the layered positions of the substantially rigid layer and the conformable layer relative to each other in view of Fig. 1A-B and 2 of the instant application to overcome at least Wang et al. See the 35 U.S.C. 103 rejections below.
Status of Claims
Claims 1-30 and 32-33 are currently under examination. Claims 32-33 have been newly added since the Non-Final Office Action of 07 Jan 2026.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required:
Claims 1 and 18 each recites “one or more conformable layers”, whose antecedent basis is not supported by the original specification: the original specification rather discloses “exterior layer 114” in [00031]; and
Claim 23 recites “a receptable holding the non-aqueous mobile phase, the receptable configured to …”, whose antecedent basis is not supported by the original specification: the original specification rather discloses “reservoir” in [00023].
Claim Objections
Claims 1, 12, 18, and 32-33 are objected to because of the following informalities:
“restriction motion” should read “restrict a motion” (claims 1 and 18);
“wherein the one or more conformable layers is …” should read “wherein the one or more conformable layers are …” (claim 12);
“the same acoustic transmissive materials” should read “same acoustic transmissive materials” (claims 32-33).
Appropriate correction is required.
Claim Interpretation
The Claim Interpretation of claim 29 with respect to “ultrasound probe positioning system” as noted in the Non-Final Office Action of 07 Jan 2026 is hereby being maintained.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-30 and 32 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 recites the new limitation “an internal cavity containing the at least one ultrasound transducer array and electronic components associated with operation of the at least one ultrasound transducer”. A review of the original specification, however, discloses in Fig. 5 and [00026] the internal cavity containing “ultrasound transducer array 104” and “mechanical actuator 500 incorporating one or more motors 502”, not any electronic component. Therefore, the new limitation introduces new matter. Claims 2-17 and 32 inherit the deficiency by the nature of their dependency on claim 1.
Claim 1 recites the new limitations “one or more substantially rigid layers” and “one or more conformable layers”. A review of the original specification does not disclose two or more substantially rigid layer nor two or more conformable layers within a single acoustic coupling article. Fig. 1A-B and 2 disclose only a single substantially rigid layer 102 and a single conformable layer 114 within a single acoustic coupling article. It is noted that Fig. 6B and 7A appear to suggest each of two acoustic coupling articles 100 comprising a single substantially rigid layer and a single conformable layer, not a single acoustic coupling article 100 comprising a plurality of substantially rigid layers and a plurality of conformable layers. Therefore, the scope of each new limitation is not fully supported by the original specification of the instant application. Claims 2-17 and 32 inherit the deficiency of claim 1.
Claim 18 recites the new limitation “the internal cavity containing the at least one ultrasound transducer array and electronic components associated with operation of the ultrasound imaging and medical instrument guidance system”. A review of the original specification, however, discloses in Fig. 5 and [00026] the internal cavity containing “ultrasound transducer array 104” and “mechanical actuator 500 incorporating one or more motors 502”, not any electronic component. Therefore, the new limitation introduces new matter. Claims 19-30 and 33 inherit the deficiency by the nature of their dependency on claim 18.
Claim 18 recites the new limitations “one or more substantially rigid layers” and “one or more conformable layers”. A review of the original specification does not disclose two or more substantially rigid layer nor two or more conformable layers within a single acoustic coupling article. Fig. 1A-B and 2 disclose only a single substantially rigid layer 102 and a single conformable layer 114 within a single acoustic coupling article. It is noted that Fig. 6B and 7A appear to suggest each of two acoustic coupling articles 100 comprising a single substantially rigid layer and a single conformable layer, not a single acoustic coupling article 100 comprising a plurality of substantially rigid layers and a plurality of conformable layers. Therefore, the scope of each new limitation is not fully supported by the original specification of the instant application. Claims 19-30 and 33 inherit the deficiency by the nature of their dependency on claim 18.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-30 and 32 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 new limitation “an internal cavity containing the at least one ultrasound transducer array and electronic components associated with operation of the at least one ultrasound transducer array”. As noted above in the 35 U.S.C. 112(a) rejection, a review of the original specification does not disclose any electronic component contained within the internal cavity other than “a mechanical actuator 500 incorporating one or more motors 502”. Therefore, the metes and bounds of the claim are unclear in view of the new limitation reciting new matter. Claims 2-17 and 32 inherit the deficiency by the nature of their dependency on claim 1. For the purposes of the examination, the limitation is being given a broadest reasonable interpretation as “an internal cavity containing the at least one ultrasound transducer array and one or more motors associated with operation of the at least one ultrasound transducer array”.
Claim 1 recites the new limitation “wherein the non-aqueous mobile phase is disposed partially or completely between the at least one ultrasound transducer array and a surface of the acoustic coupling article, between the one or more substantially rigid layers, between the one or more conformable layers, between the one or more substantially rigid layers and the one or more conformable layers, between the at least one ultrasound transducer array and the anatomy to be imaged or the portion of the anatomy to be imaged, or combinations thereof”. First, the limitation recites a circular reference to “the acoustic coupling article” for a surface on which the non-aqueous mobile phase is disposed, and the non-aqueous mobile phase is also claimed to be a component of the acoustic coupling article of claim 1. Second, the limitation recites “between the one or more substantially rigid layers” and “between the one or more conformable layers”. It is unclear whether the limitation requires at least two substantially rigid layers or at least two conformable layers, since the limitation encompasses one substantially rigid layer or one conformable layer, respectively. Lastly, the metes and bounds of “combinations thereof” for the non-aqueous mobile phase being disposed between are unclear. The limitation lists a plurality of layers, including more than one same layer, and “combinations thereof” does not specify where the non-aqueous mobile phase is disposed. Claims 2-17 and 32 inherit the deficiency of claim 1, and claims 7-8 and 15 further explicitly each recites “the surface of the acoustic coupling article”. For purposes of the examination, the limitation is being given a broadest reasonable interpretation as “wherein the non-aqueous mobile phase is disposed partially or completely on the at least one ultrasound transducer array, between the one or more substantially rigid layers and the one or more conformable layers, or between the at least one ultrasound transducer array and the anatomy to be imaged or the portion of the anatomy to be imaged”.
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 attached to the ultrasound probe for use in volumetric ultrasound imaging”. Claim 6 is directed to the acoustic coupling article, yet the limitation recites a circular reference to the claimed acoustic coupling article being 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 attached to the ultrasound probe for use in a volumetric ultrasound imaging”, thus reciting an intended use of the claimed acoustic coupling article of claim 6.
Claim 11 recites the limitation “wherein a surface of the one or more conformable layers is treated with a surface coating to increase hydrophilicity, wettability, lubricity, or combinations thereof, of the surface”. It is unclear whether the limitation attempts to recite the method of treating the one or more conformable layers with a surface coating within the product claim 15. For the purposes of the examination, the limitation is being given a broadest reasonable interpretation as “wherein a surface of the one or more conformable layers comprises a surface coating to increase hydrophilicity, wettability, lubricity, or combinations thereof, of the surface”.
Claim 15 recites the limitation “wherein the non-aqueous mobile phase is applied substantially uniformly to the surface or surfaces of the acoustic coupling article, the one or more substantially rigid layers, the one or more conformable layers, or combinations thereof”. First, the limitation recites a circular reference to the claimed acoustic coupling article itself, thus it is unclear whether the non-aqueous mobile phase is a component of the acoustic coupling article or otherwise, and whether the non-aqueous mobile phase itself can be the surface of the acoustic coupling article. Second, it is unclear whether the limitation attempts to recite the method of applying the non-aqueous mobile phase within the product claim 15. For the purposes of the examination, the limitation is being given a broadest reasonable interpretation as “wherein the non-aqueous mobile phase is substantially uniformly to the one or more substantially rigid layers, the one or more conformable layers, or combinations thereof”.
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 new limitation “the internal cavity containing the at least one ultrasound transducer array and electronic components associated with operation of the ultrasound imaging and medical instrument guidance system”. First, as noted above in the 35 U.S.C. 112(a) rejection, a review of the original specification does not disclose any electronic component contained within the internal cavity other than “a mechanical actuator 500 incorporating one or more motors 502”. Therefore, the metes and bounds of the claim are unclear in view of the new limitation reciting new matter. Second, the limitation recites a circular reference to “the ultrasound imaging and medical instrument guidance system” of claim 18 itself. Claims 19-30 and 33 inherit the deficiency by the nature of their dependency on claim 18. For the purposes of the examination, the limitation is being given a broadest reasonable interpretation as “the internal cavity containing the at least one ultrasound transducer array and one or more motors associated with operation of the at least one ultrasound transducer array”.
Claim 18 recites the new limitation “a non-aqueous mobile phase distributed on a surface of the acoustic coupling article”. Claim 18 currently recites that the non-aqueous mobile phase is a component of the acoustic coupling article. Therefore, it is unclear whether the metes and bounds of the claim includes the non-aqueous mobile phase is distributed on a surface of itself or not. Claims 19-30 and 33 inherit the deficiency by the nature of their dependency on claim 18. For the purposes of the examination, the limitation is being given a broadest reasonable interpretation as “a non-aqueous mobile phase distributed on a surface of the at least one ultrasound transducer array”.
Claim 18 recites the new limitation “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, between the one or more substantially rigid layers, between the one or more conformable layers, between the one or more substantially rigid layers and the one or more conformable layers, between the at least one ultrasound transducer array and the anatomy to be imaged or the portion of the anatomy to be imaged, or combinations thereof”. The limitation recites “between the one or more substantially rigid layers” and “between the one or more conformable layers”. It is unclear whether the limitation requires at least two substantially rigid layers or at least two conformable layers, since the limitation encompasses one substantially rigid layer or one conformable layer, respectively. Second, the metes and bounds of “combinations thereof” for the non-aqueous mobile phase being disposed between are unclear. The limitation lists a plurality of layers, including more than one same layer, and “combinations thereof” does not specify where the non-aqueous mobile phase is disposed. Claims 19-30 and 33 inherit the deficiency of claim 18. For purposes of the examination, the limitation is being given a broadest reasonable interpretation as “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, between the one or more substantially rigid layers and the one or more conformable layers, or between the at least one ultrasound transducer array and the receiving body”.
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 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 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 an 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 an 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 32 recites the new limitation “wherein the one or more acoustic transmissive materials of (a) the one or more conformable layers, (b) the one or more substantially rigid layers, or (c) both, are the same acoustic transmissive materials or different acoustic transmissive materials”. It is unclear whether the limitation requires at least two acoustic transmissive materials so that these materials “are the same acoustic transmissive materials or different acoustic transmissive materials”: the limitation currently encompasses one acoustic transmissive material, which cannot be “the same acoustic transmissive materials or different acoustic transmissive materials”. For the purposes of the examination, the limitation is being given a broadest reasonable interpretation as “wherein the one or more acoustic transmissive materials of the one or more conformable layers and the one or more substantially rigid layers are the same acoustic transmissive materials or different acoustic transmissive materials”.
Claim 33 recites the new limitation “wherein the one or more acoustic transmissive materials of (a) the one or more conformable layers, (b) the one or more substantially rigid layers, or (c) both, are the same acoustic transmissive materials or different acoustic transmissive materials”. It is unclear whether the limitation requires at least two acoustic transmissive materials so that these materials “are the same acoustic transmissive materials or different acoustic transmissive materials”: the limitation currently encompasses one acoustic transmissive material, which cannot be “the same acoustic transmissive materials or different acoustic transmissive materials”. For the purposes of the examination, the limitation is being given a broadest reasonable interpretation as “wherein the one or more acoustic transmissive materials of the one or more conformable layers and the one or more substantially rigid layers are the same acoustic transmissive materials or different acoustic transmissive materials”.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 3, 6-13, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over 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 (‘959) – in view of Wang (US PG Pub No. 2003/0007598) – hereinafter referred to as Wang (‘598).
Regarding claim 1, Wang (‘959) discloses an acoustic coupling article (at least Fig. 2) comprising:
a structural member (Fig. 2: surface 106) configured to attach to an ultrasound probe (Fig. 2: probe 210; [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);
an internal cavity (Fig. 2: cavity within lower frame 104 where sonically conductive fluid 204 is present) containing the at least one ultrasound transducer array (Fig. 2: probe 210),
wherein the internal cavity is blocked from allowing insertion of an anatomy to be imaged or a portion of the anatomy to be imaged by one or more substantially rigid layers (Fig. 2: surface 106 blocking insertion of any portion of anatomy to be imaged) comprising one or more acoustic transmissive materials (Fig. 2: flexible membrane 108 within orifice 107),
the one or more substantially rigid layers configured to both (a) restrict motion of the at least one ultrasound transducer array in at least one direction and/or dimension (Fig. 2: surface 106 would restrict any motion of probe 210 through surface 106) and (b) block the anatomy to be imaged or the portion of the anatomy to be imaged from being inserted completely or partially into the internal cavity (Fig. 2 and [0033]: breast to be imaged is inserted into the orifice 107, but would be blocked by surface 106 from being inserted into the internal cavity);
one or more conformable layers (Fig. 2: flexible membrane 108 within orifice 107) comprising one or more acoustic transmissive materials configured to conform to a surface of the anatomy to be imaged or the portion of the anatomy to be imaged (Fig. 6A-B and [0039]-[0041]: breast 304 is chestwardly compressed by the flexible membrane 108; [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); and
a non-aqueous mobile phase (Fig. 2: sonically conductive fluid 204; [0033]: sonically conductive fluid 204 comprises mineral oil, Jojoba oil, or generally any kind of oil that is acoustically conductive) configured to provide acoustic coupling between the at least one ultrasound transducer array and the one or more conformable layers ([0033]-[0034]: fluid 204 for maintaining acoustic coupling between the probe 210 and the flexible membrane 108),
wherein the non-aqueous mobile phase is disposed partially or completely on the at least one ultrasound transducer array ([0033]-[0034]: fluid 204 for maintaining acoustic coupling between the probe 210 and the flexible membrane 108).
It is noted that a broadest reasonable interpretation has been given to “one or more acoustic transmissive materials of one or more substantially rigid layers” and “one or more acoustic transmissive materials of one or more conformable layers” to include Wang (‘959)’s flexible membrane 108 that is within surface 106 and is configured to conform to a shape of a breast. Applicant may consider specifying positions of the substantially rigid layer and the conformable layer relative to each other in view of Fig. 1A-B and 2 of the instant application to overcome Wang (‘959)’s flexible membrane 108.
Wang (‘959) does not disclose:
the internal cavity containing one or more motors associated with operation of the at least one transducer array.
In the same field of acoustically coupling a transducer array to an anatomy to be imaged, Wang (‘598), however, teaches:
a motor (Fig. 3: motor 310 within chamber 204) associated with operation of a transducer array contained within an internal cavity with the transducer array (Fig. 3: ultrasound probe 304 within chamber 204; [0102]: motor 310 increments the position of probe 302 as the ultrasound scans are taken).
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 (‘959)’s product to include Wang (‘598)’s motor. One of ordinary skill in the art would have modified Wang (‘959)’s product as claimed by known methods (i.e., coupling a motor to the ultrasound transducer array, as disclosed by Wang (‘598)), and the combination would have yielded a reasonable expectation of success since both Wang (‘959) and Wang (‘598) are directed to an acoustic coupling article. The motivation for the combination would have been to automate translating the ultrasound transducer relative to the anatomy to be imaged (Fig. 3 and [0102] of Wang (‘598)).
Regarding claim 3, Wang (‘959) in view of Wang (‘598) discloses all limitations of claim 1, as discussed above, and Wang (‘959) further discloses:
wherein the one or more acoustic transmissive materials of the one or more substantially rigid layers, the one or more conformable layers, or both, 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 (‘959) 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 (‘959)’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 (‘959) in view of Wang (‘598) discloses all limitations of claim 1, as discussed above, and Wang (‘959) further discloses:
wherein the acoustic coupling article is 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 (‘959) in view of Wang (‘598) discloses all limitations of claim 1, as discussed above, and Wang (‘959) further discloses:
wherein the 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 (‘959) in view of Wang (‘598) discloses all limitations of claim 1, as discussed above, and Wang (‘959) further discloses:
wherein the 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 (‘959) in view of Wang (‘598) discloses all limitations of claim 1, as discussed above, and Wang (‘959) further discloses:
wherein the one or more transmissive acoustic materials of the one or more substantially rigid layers, the one or more conformable layers, or both, comprise 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 (‘959) in view of Wang (‘598) discloses all limitations of claim 1, as discussed above, and Wang (‘959) further discloses:
wherein the one or more transmissive acoustic materials of the one or more substantially rigid layers, the one or more conformable layers, or both, 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 (‘959) 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 (‘959)’s flexible membrane of polyurethane inherently has a speed of sound between 900 m/s and 2,100 m/s.
Regarding claim 11, Wang (‘959) in view of Wang (‘598) discloses all limitations of claim 1, as discussed above, and Wang (‘959) further discloses:
wherein a surface of the one or more conformable layers is treated with a surface coating to increase 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 (‘959) in view of Wang (‘598) discloses all limitations of claim 1, as discussed above, and Wang (‘959) further discloses:
wherein the one or more conformable layers are of malleable composition that can be deformed, thermoformed, or molded, into a shape and substantially retain 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 (‘959) 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 (‘959)’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 (‘959) in view of Wang (‘598) discloses all limitations of claim 1, as discussed above, and Wang (‘959) further discloses:
wherein the one or more conformable layers provide a protective barrier layer configured to shield the one or more substantially rigid layers, the one or more conformable layers, or both, 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 (‘959) 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 (‘959) in view of Wang (‘598) discloses all limitations of claim 1, as discussed above, and Wang (‘959) further discloses:
wherein the non-aqueous mobile phase (Fig. 7B: fluid 204) is applied substantially uniformly to the surface or surfaces of the acoustic coupling article, the one or more substantially rigid layers, the one or more conformable layers, or combinations thereof (Fig. 7B: flexible membrane 108; [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).
Regarding claim 32, Wang (‘959) in view of Wang (‘598) discloses all limitations of claim 1, as discussed above, and Wang (‘959) further discloses:
wherein the one or more acoustic transmissive materials of (a) the one or more conformable layers, (b) the one or more substantially rigid layers, or (c) both (Fig. 2: flexible membrane 108), are the same acoustic transmissive materials or different acoustic transmissive materials ([0033]-[0034]: the probe and the flexible membrane 108 are acoustically matched by the sonically conductive fluid 204).
As noted above in claim 1, a broadest reasonable interpretation has been given to “one or more acoustic transmissive materials of one or more substantially rigid layers” and “one or more acoustic transmissive materials of one or more conformable layers” to include Wang (‘959)’s flexible membrane 108 that is within surface 106 and is configured to conform to a shape of a breast. Therefore, the acoustic transmissive material of a single component would be the same.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Wang (‘959) in view of Wang (‘598), 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 (‘959) in view of Wang (‘598) discloses all limitations of claim 1, as discussed above, and Wang (‘959) does not disclose:
wherein a 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 (‘959)’s product to include Hayakawa’s acoustic coupling article thickness. One of ordinary skill in the art would have modified Wang (‘959)’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 (‘959) 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 (‘959) in view of Wang (‘598), 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 (‘959) in view of Wang (‘598) discloses all limitations of claim 1, as discussed above, and Wang (‘959) 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 (‘959)’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 (‘959) 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 (‘959) in view of Wang (‘598) discloses all limitations of claim 1, as discussed above, and Wang (‘959) 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 (‘959) 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 (‘959)’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 (‘959) 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 (‘959) in view of Wang (‘598) discloses all limitations of claim 1, as discussed above, and Wang (‘959) 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 (‘959)’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 (‘959) 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 (‘959) in view of Wang (‘598), 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 (‘959) in view of Wang (‘598) discloses all limitations of claim 1, as discussed above, and Wang (‘959) does not disclose:
wherein the non-aqueous mobile phase is impregnated into the one or more substantially rigid layers, the one or more conformable layers, or both, 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 a layer of acoustic transmissive material (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 (‘959)’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 (‘959)’s acoustic coupling article, since both Wang (‘959) 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 (‘959)’s acoustic coupling article for ultrasound imaging) that was ready for improvement, and the results (in this case, Wang (‘959)’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 (‘959)) by allowing fluid 204 be released towards the breast.
Regarding claim 17, Wang (‘959) in view of Wang (‘598) discloses all limitations of claim 1, as discussed above, and Wang (‘959) 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 (‘959)’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 (‘959)’s acoustic coupling article, since both Wang (‘959) 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 (‘959)’s acoustic coupling article for ultrasound imaging) that was ready for improvement, and the results (in this case, Wang (‘959)’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 (‘959)) by allowing fluid 204 be released towards the breast.
Claims 18-26, 28-29, and 33 are rejected under 35 U.S.C. 103 as being unpatentable over Wang (‘959) in view of Wang (‘598) and Stopek.
Regarding claim 18, Wang (‘959) 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) comprising an internal cavity (Fig. 2: cavity within lower frame 104 where sonically conductive fluid 204 is present),
the internal cavity containing the at least one ultrasound transducer array (Fig. 2: probe 210),
one or more conformable layers (Fig. 2: flexible membrane 108 within orifice 107) comprising one or more acoustic transmissive materials configured to conform to a surface of the receiving body (Fig. 6A-B and [0039]-[0041]: breast 304 is chestwardly compressed by the flexible membrane 108; [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);
one or more substantially rigid layers (Fig. 2: surface 106 blocking insertion of any portion of anatomy to be imaged) comprising one or more acoustic transmissive materials (Fig. 2: flexible membrane 108 within orifice 107),
wherein the one or more substantially rigid layers configured to restrict motion of the at least one ultrasound transducer array in at least one direction and/or dimension (Fig. 2: surface 106 would restrict any motion of probe 210 through surface 106) and block all or part of the receiving body from entering the internal cavity (Fig. 2 and [0033]: breast to be imaged is inserted into the orifice 107, but would be blocked by surface 106 from being inserted into the internal cavity); and
a non-aqueous mobile phase (Fig. 2: sonically conductive fluid 204; [0033]: sonically conductive fluid 204 comprises mineral oil, Jojoba oil, or generally any kind of oil that is acoustically conductive) distributed on a surface of the at least one ultrasound transducer array ([0033]-[0034]: fluid 204 for maintaining acoustic coupling between the probe 210 and the flexible membrane 108),
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 ([0033]-[0034]: fluid 204 for maintaining acoustic coupling between the probe 210 and the flexible membrane 108),
wherein the non-aqueous mobile phase is disposed partially or completely on the at least one ultrasound transducer array.
It is noted that a broadest reasonable interpretation has been given to “one or more acoustic transmissive materials of one or more substantially rigid layers” and “one or more acoustic transmissive materials of one or more conformable layers” to include Wang (‘959)’s flexible membrane 108 that is within surface 106 and is configured to conform to a shape of a breast. Applicant may consider specifying positions of the substantially rigid layer and the conformable layer relative to each other in view of Fig. 1A-B and 2 of the instant application to overcome Wang (‘959)’s flexible membrane 108.
Wang (‘959) does not disclose:
the internal cavity containing one or more motors associated with operation of the at least one ultrasound transducer array;
one or more computer processors operative to process acquired data received from the at least one ultrasound transducer array,
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 the surface of the acoustic coupling article to acquire the data at multiple spatial locations.
In the same field of acoustically coupling a transducer array to an anatomy to be imaged, Wang (‘598), however, teaches:
a motor (Fig. 3: motor 310 within chamber 204) associated with operation of a transducer array contained within an internal cavity with the transducer array (Fig. 3: ultrasound probe 304 within chamber 204; [0102]: motor 310 increments the position of probe 302 as the ultrasound scans are taken).
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 (‘959)’s apparatus to include Wang (‘598)’s motor. One of ordinary skill in the art would have modified Wang (‘959)’s product as claimed by known methods (i.e., coupling a motor to the ultrasound transducer array, as disclosed by Wang (‘598)), and the combination would have yielded a reasonable expectation of success since both Wang (‘959) and Wang (‘598) are directed to an acoustic coupling article. The motivation for the combination would have been to automate translating the ultrasound transducer relative to the anatomy to be imaged (Fig. 3 and [0102] of Wang (‘598)).
In the same field of ultrasound imaging, Stopek additionally 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 (‘959)’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 (‘959) 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 (‘959) in view of Wang (‘598) and 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 (‘959)’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 (‘959) 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 (‘959) in view of Wang (‘598) and 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 (‘598)’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 (‘598) 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 (‘959) in view of Wang (‘598) and Stopek discloses all limitations of claim 18, as discussed above, and Stopek further teaches:
performing a calibration sequence to verify installation of the acoustic coupling article and data acquisition 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 (‘959)’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 (‘959) 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 (‘959) in view of Wang (‘598) and 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 (‘959)’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 (‘959) 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 (‘959) in view of Wang (‘598) and Stopek discloses all limitations of claim 18, as discussed above, and Wang (‘959) further discloses:
a receptacle (Fig. 2: reservoir housing formed by lower housing 104 and surface 106) for holding the 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),
the receptacle configured 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 (‘959) in view of Wang (‘598) and Stopek discloses all limitations of claim 18, as discussed above, and Wang (‘959) 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 (‘959) in view of Wang (‘598) and 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, reporting system state information, reporting 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 (‘959)’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 (‘959) 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 (‘959) in view of Wang (‘598) and 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 (‘959)’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 (‘959) 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 (‘959) in view of Wang (‘598) and 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 (‘959)’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 (‘959) 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 (‘959) in view of Wang (‘598) and Stopek discloses all limitations of claim 18, as discussed above, and Wang (‘959) 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).
Regarding claim 33, Wang (‘959) in view of Wang (‘598) and Stopek discloses all limitations of claim 18, as discussed above, and Wang (‘959) further discloses:
wherein the one or more acoustic transmissive materials of (a) the one or more conformable layers, (b) the one or more substantially rigid layers, or (c) both (Fig. 2: flexible membrane 108), are the same acoustic transmissive materials or different acoustic transmissive materials ([0033]-[0034]: the probe and the flexible membrane 108 are acoustically matched by the sonically conductive fluid 204).
As noted above in claim 18, a broadest reasonable interpretation has been given to “one or more acoustic transmissive materials of one or more substantially rigid layers” and “one or more acoustic transmissive materials of one or more conformable layers” to include Wang (‘959)’s flexible membrane 108 that is within surface 106 and is configured to conform to a shape of a breast. Therefore, the acoustic transmissive material of a single component would be the same.
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over Wang (‘959) in view of Wang (‘598) and 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 (‘959) in view of Wang (‘598) and Stopek discloses all limitations of claim 18, as discussed above, and Wang (‘959) in view of Wang (‘598) and 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 an 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 an 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 (‘959)’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 (‘959) 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 (‘959) in view of Wang (‘598) and 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 (‘959) in view of Wang (‘598) and Stopek discloses all limitations of claim 29, as discussed above, and Wang (‘959) in view of Wang (‘598) and Stopek does not disclose:
wherein the wheeled cart also provides a physical structure for supporting a patient's anatomy during an 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 an 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 (‘959)’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 (‘959) 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
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 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
/ANHTUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795
09/09/26
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