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 .
Claim Objections
Claim 13 appears to be written in independent form, but also refers to another independent claim (claim 1). In one interpretation, claim 13 can be construed as an independent claim. Yet in another interpretation, claim 13 can be construed as a dependent claim. In order to prevent any ambiguity, it is suggested to incorporate the entirety of claim 1 into claim 13 to have the claim construed as a proper independent claim. Alternatively, Applicant may correct the preamble of claim 13 so that is construed as a proper dependent claim. For example, claim 13 can be amended as follows: “ The ultrasound image capturing apparatus of claim 1,….”
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.
Such claim limitation(s) is/are:
movement mechanism that moves the first transducer in a direction along the contact surface in claims 1 and 16.
attachment/detachment device that attaches the first transducer to the grid… and that detaches the first transducer from the grid in claim 15.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
The claim limitations noted above are being interrupted to cover the following corresponding structure and equivalents thereof:
“movement mechanism that moves the first transducer in a direction along the contact surface” is being interpreted to include the transducer movement unit 9A discussed at [0073]-[0074] and the transducer drive unit 22 discussed at [0109] and [0120]-[0121].
“attachment/detachment device that attaches the first transducer to the grid… and that detaches the first transducer from the grid” is being interpreted to include the attachment/detachment device 17 at [0159], [0163], and [0181]-[0187].
If applicant does not intend to have this/these limitation(s) 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(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 1-16 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 (and claim 16 similarly recites): “an imaging table in which a first transducer…and a movement mechanism…are built in advance,…”
It is not clear what is meant by “built in advance” and Applicant does not specify. Moreover, Applicant does not specify in the specification. Applicant could be referring to the following limitations relating to the plurality of carbon fiber sheets. Applicant could also intend to mean “built in advance [of usage of the imaging table],” which is confusing and unnecessary as claim 1 is directed to an “imaging table” not to a kit of parts. (see, e.g., [0024] and ]0073]).
Examiner is interpreting the claims without the “are built in advance” limitation.
Claim 1 also recites (and claim 16 similarly recites): “at least one of the plurality of carbon fiber sheets has higher rigidity with respect to the contact with the breast than the other laminated carbon fiber sheets.” It is not clear how “with respect to the contact with the breast” modifies “higher rigidity” or if the higher rigidity only occurs when the carbon fiber sheet is in contact with the breast.
Examiner is interpreting the claim language as “at least one of the plurality of carbon fiber sheets has a higher rigidity with respect to the other laminated carbon fiber sheets.”
Claim 11 recites “wherein the controller sets a boundary surface between the contact surface of the imaging table and the compression surface of the compression plate at a predetermined distance from the contact surface of the imaging table,….”
It is clear from Applicant’s disclosure that a “boundary surface” is a line that extends through tissue and represents an interface between image data from a first transducer and image data from a second transducer. (see, e.g., Figure 10 and [0136], [0137], and [0139]). “Although the ultrasound image of the region beyond the boundary surface 11 as seen from the transducer 15A has a lower image quality than the ultrasound image of the region up to the boundary surface 11, the ultrasound image of the region beyond the boundary surface 11 is replaced with the ultrasound image captured by the transducer 15B,….” ([0139]). As such, the boundary surface represents a line where image data from one transducer ends and image data from another transducer beings. It does not distinguish one tissue from a different tissue or represent a surface of any kind. Thus, the term “surface” is misleading and unclear.
Examiner is replacing the term “boundary surface” in claim 11 with “image boundary.”
Claim 11 also recites “wherein the controller…performs control of combining the ultrasound image, which is captured by the first transducer, from the contact surface of the imaging table to the boundary surface and the ultrasound image, which is captured by the second transducer, from the compression surface of the compression plate to the boundary surface, to generate one ultrasound image of the same breast.”
Claim 11 appears to recite that the ultrasound image captured by the first transducer extends between the contact surface of the imaging table and the boundary surface (now image boundary) and that the ultrasound image captured by the second transducer extends between the compression surface to the boundary surface. Based on Applicant’s disclosure, however, that is not the case. (see, e.g., Figure 10 and [0136], [0137], and [0139]). Applicant is not controlling the transducers to limit their respective imaging to the boundary surface. Instead, the ultrasound images captured by the first and second transducer extend beyond the image boundary such that the images overlap one another. (see [0139]). When combining the two images, the image data from one transducer is replaced with the image of another transducer.
Examiner is interpreting claim 11 as follows:
wherein the controller sets [[a]] an image boundary generating a combined ultrasound image, the combined ultrasound image including image data from the first transducer that extends from the contact surface of the imaging table to the image boundary and image data from the second transducer extending from the compression surface of the compression plate to the image boundary.
Claim 14 recites that “a grid….is used as the movement mechanism.” One skilled in the art understands that a grid is an object that reduces an amount of scattered radiation that reaches the detector. While the grid itself can be movable, the grid is not a movement mechanism. Applicant’s disclosure does not contradict this interpretation and does not provide any description that the grid can cause movement. As best understood by the Examiner, the grid is moved by a movement unit (see, e.g., [0179]-[0186]). A transducer can be moved by attaching itself to the grid, which is then moved by the movement unit.
Examiner is interpreting claim 14 to recite “a grid….is is moved by the movement mechanism.”
Claims 2-15 depend directly or indirectly from claim 1 and are therefore rejected for being indefinite based on their dependency of claim 1.
Therefore, claims 1-16 are indefinite and rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Furthermore, with respect to claim 1, the claim limitation “movement mechanism that moves the first transducer in a direction along the contact surface” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The specification is devoid of adequate structure to perform the claimed function. There is no disclosure of any particular structure, either explicitly or inherently, to perform these steps. The specification describes generic terms, “transducer movement unit” and “transducer drive unit,” but does not describe how the first transducer is moved with any greater specificity. (see, e.g., [0055]: “The transducer drive unit 22 controls a transducer movement unit 9A (see FIG. 4 ) described later in response to an instruction from the controller 20” and also [0073]: “[T]he transducer movement unit 9A moves the movement table 14A in the front-rear direction (in the example of FIG. 4 , a direction represented by an arrow W1) under the control of the controller 20 via the transducer drive unit 22.”).
With respect to claim 15, the claim limitation “attachment/detachment device that attaches the first transducer to the grid… and that detaches the first transducer from the grid” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The specification is devoid of adequate structure to perform the claimed function. There is no disclosure of any particular structure, either explicitly or inherently, to perform these steps. The specification simply repeats the term, “attachment/detachment device,” but does not describe how the first transducer is attached to the grid. (see, e.g., [0163]: “The attachment/detachment device 17 is a device that attaches and detaches the transducer 15A to and from a grid 13 (see FIG. 18 ). Details of the grid 13 and the attachment/detachment device 17 will be described later.” Subsequent paragraphs do not provide any further detail as to the structure of the attachment/detachment device. (see, e.g., [0184], [0186]).
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Claims 1-16 have been rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. As described above, the disclosure does not provide adequate structure to perform the claimed functions of moving the first transducer and attaching/detaching the transducer to the grid. The specification does not demonstrate that applicant has made an invention that achieves the claimed function because the invention is not described with sufficient detail such that one of ordinary skill in the art can reasonably conclude that the inventor had possession of the claimed invention.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 1-16 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Claim 1 recites (and claim 16 similarly recites) “a first transducer that transmits an ultrasonic wave toward a contact surface in contact with a breast,…a movement mechanism that moves the first transducer in a direction along the contact surface with the breast….” (emphasis added). As such, claims 1 and 16 positively recite a breast (i.e., human organism/part thereof) as part of the claimed invention. Examiner recommends amending the claims to recite that the “contact surface is configured to be in contact with a breast…” or similar language in order to overcome the Section 101 rejection.
Claims 2-15 depend directly or indirectly from claim 1 and, as such, are also rejected to for encompassing a human organism.
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.
Claims 1, 2, 6, 13, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over a translation of JP 2008-173291A (hereinafter “SATO”) (foreign patent document was previously recited in Information Disclosure Statement dated 28 January 2025) and U.S. Patent Appl. Publ. No. 2008/0277813 A1 (hereinafter “CAIA ZZO”).
SATO teaches a “medical imaging apparatus that images breasts and breasts using radiation and ultrasound in order to diagnose breast cancer.” ([0001]). Unlike prior systems, SATO teaches using an ultrasound transducer underneath the breast within the platform in order to acquired an image while the breast is compressed and simultaneously with radiographic imaging. ([0009]).
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With respect to claim 1 (and in light of the Section 112(b) rejection), SATO teaches an ultrasound image capturing apparatus ([0001]) comprising:
an imaging table (see, e.g., Figure 6) in which a first transducer (20a in Fig. 6; [0047]: “in order to transmit and receive ultrasonic waves, a rectangular ultrasonic transducer array 20a that is short in the X-axis direction and long in the Y-axis direction is used.”) that transmits an ultrasonic wave toward a contact surface in contact with a breast ([0048]: “Here, a cover fixed to the imaging table 12 may be provided above the trajectory of the ultrasonic transducer array 20a. The acoustic impedance of the cover is preferably set between the acoustic impedance of the piezoelectric body and the acoustic impedance of the subject (living body)”), to capture an ultrasound image of the breast, and
a movement mechanism that moves the first transducer in a direction along the contact surface with the breast (see Fig. 6 and [0048]: “a moving mechanism 110 is provided to move…the ultrasonic transducer array 20a in response to scanning of the subject by radiation.”).
are built in advance (NOTE: The imaging table, the first transducer, and the movement mechanism are all built and assembled prior to imaging)
However, SATO does not explicitly teach that the cover (i.e., the contact surface of the imaging table) is composed of a plurality of laminated carbon fiber sheets having different acoustic impedances, and at least one of the plurality of carbon fiber sheets has higher rigidity with respect to the contact with the breast than the other laminated carbon fiber sheets, as recited in claim 1. However, SATO does teach that “[t]he acoustic impedance of the cover is preferably set between the acoustic impedance of the piezoelectric body and the acoustic impedance of the subject (living body).” ([0048]).
CAIA ZZO teaches “a reinforced plastic sonar dome having a low acoustical insertion loss combined with sufficient mechanical strength.” (Abstract). CAIA ZZO also emphasizes the necessity of having adjacent layers with smaller differential impedances. (see, e.g., [0015] and [0010]: “The greater the difference in characteristic impedance between the sea water and the sonar dome window, the greater the change in direction of the acoustical energy and hence the greater the amount of acoustical energy that will be reflected away from sonar dome window.”). “To form the sonar dome of the Invention, discrete acoustical fibers and structural fibers are selected and mixed together in a random (“stochastic”) manner…Many layers of blended fabric are incorporated into a solidified polymer resin. The reinforced solidified plastic resin, incorporating the acoustical and structural fibers, forms the ‘window’ of the sonar dome through which sound passes on its way from or to the transducers.” ([0017]). The structural fibers may be carbon fibers. (see, e.g., [0016], [0039]).
The sonar dome is essentially a stack of carbon fiber layers. “The blended fabric stack 32 may be laid up either wet or dry, using conventional reinforced plastic technology. In a wet lay up, each sheet of blended fabric 30 is wetted with a liquid plastic resin prior to placing the sheet of blended fabric in the mold. In the dry lay up method, all sheets of blended fabric 30 are placed within the mold without wetting. The liquid plastic resin then is introduced to the stack 32 of sheets of blended fabric 30 while the blended stack 32 is in the mold.” ([0046]). Note, a stack of layers bonded together with a common resin is considered a laminate.
Notably, each carbon fiber layer within the stack has a ratio of structural fibers or acoustical fibers to provide the desired impedance. “The location of the blended yarn 28 within the cross section of the sonar dome window 22 is a consideration because the ratio of acoustical to structural fibers is not uniform through the thickness of the sonar dome window 22. To optimize the strength of the sonar dome 2 while also maintaining good acoustical transmission capability, blended fabrics 30 having relatively great strength are selected for the outside and inside surfaces 18, 20 of the cross section of the sonar dome window 22 while blended fabric 30 having superior acoustical properties are selected for the center of the cross section of the sonar dome window 22.” ([0052]).
It would have been obvious to one having ordinary skill in the art at the time of filing to construct the cover in SATO using a technique like that taught by CAIA ZZO such that a plurality of laminated carbon fiber sheets having different acoustic impedances. SATO teaches that the cover is preferably “set between the acoustic impedance of the piezoelectric body and the acoustic impedance of the subject (living body).” ([0048]). CAIA ZZO teaches a method that enables one to progressively reduce the impedance of the cover as the material approaches the tissue. More specifically, one would laminate a stack of carbon fiber layers, as taught in CAIA ZZO, in which the carbon fiber layers closer to the ultrasound transducer will have an impedance closer to that of the transducer and the carbon fiber layers closer to the tissue will have an impedance closer to that of the tissue. There would have been a reasonable expectation of success as CAIA ZZO teaches that such a laminate can be constructed.
Note: At least one of the carbon fiber layers (sheets) would necessarily have a higher rigidity than the other laminated carbon fiber layers because CAIA ZZO teaches that the more rigid sheets (higher impedance) have more “structural fibers.”
With respect to claim 2, SATO teaches wherein the first transducer has a shape that extends longer in a chest wall surface direction along a chest wall of a subject than in a front-rear direction along a direction intersecting the chest wall of the subject (see Fig. 6 and [0047]: “in order to transmit and receive ultrasonic waves, a rectangular ultrasonic transducer array 20a that is short in the X-axis direction [i.e., front-rear direction] and long in the Y-axis direction [i.e., chest wall surface direction] is used.”), and the movement mechanism moves the first transducer in the front-rear direction (see Fig. 6 showing the “moving mechanism 110” moving the transducer in the front-rear direction).
With respect to claim 6, SATO does not teach wherein, in the contact surface of the imaging table, the carbon fiber sheets are laminated such that the acoustic impedance is decreased from a carbon fiber sheet in contact with the first transducer toward a carbon fiber sheet in contact with the breast.
However, CAIA ZZO teaches that different layers may have different characteristic impedances based on the ratio of structural fibers to acoustical fibers. “The location of the blended yarn 28 within the cross section of the sonar dome window 22 is a consideration because the ratio of acoustical to structural fibers is not uniform through the thickness of the sonar dome window 22. To optimize the strength of the sonar dome 2 while also maintaining good acoustical transmission capability, blended fabrics 30 having relatively great strength are selected for the outside and inside surfaces 18, 20 of the cross section of the sonar dome window 22 while blended fabric 30 having superior acoustical properties are selected for the center of the cross section of the sonar dome window 22.” ([0052]).
It would have been obvious to one having ordinary skill in the art at the time of filing to laminate the carbon fiber sheets such that the acoustic impedance is decreased from a carbon fiber sheet in contact with the first transducer toward a carbon fiber sheet in contact with the breast. SATO teaches that the cover is preferably “set between the acoustic impedance of the piezoelectric body and the acoustic impedance of the subject (living body).” ([0048]). CAIA ZZO teaches a method that enables one to progressively reduce the impedance of the cover as the material approaches the tissue. More specifically, one would laminate a stack of carbon fiber layers, as taught in CAIA ZZO, in which the carbon fiber layers closer to the ultrasound transducer will have an impedance closer to that of the transducer and the carbon fiber layers closer to the tissue will have an impedance closer to that of the tissue. There would have been a reasonable expectation of success as CAIA ZZO teaches that such a laminate can be constructed.
With respect to claim 13, SATO teaches a mammography apparatus that includes the ultrasound image capturing apparatus according to claim 1. “The present invention relates to a medical imaging apparatus that images breasts and breasts using radiation and ultrasound in order to diagnose breast cancer and the like.” ([0001]).
With respect to claim 16, SATO teaches a non-transitory computer-readable storage medium storing a control program executable by computer to execute a process, with respect to an ultrasound image capturing apparatus ([0045]: “In this embodiment, the radiation image data generation unit 34, the signal processing unit 45, the B-mode image data generation unit 46, the DSC 47, and the image processing unit 50 are also configured by a CPU and software. You may comprise. This software is stored in a storage unit 100 configured by a hard disk or a memory. Further, the storage unit 100 may store the transmission delay pattern and the reception delay pattern selected by the scanning control unit 41.”) including
an imaging table (see, e.g., Figure 6) in which a first transducer (20a in Fig. 6; [0047]: “in order to transmit and receive ultrasonic waves, a rectangular ultrasonic transducer array 20a that is short in the X-axis direction and long in the Y-axis direction is used.”) that transmits an ultrasonic wave toward a contact surface in contact with a breast ([0048]: “Here, a cover fixed to the imaging table 12 may be provided above the trajectory of the ultrasonic transducer array 20a. The acoustic impedance of the cover is preferably set between the acoustic impedance of the piezoelectric body and the acoustic impedance of the subject (living body)”), to capture an ultrasound image of the breast, and
a movement mechanism that moves the first transducer (see Fig. 6 and [0048]: “a moving mechanism 110 is provided to move…the ultrasonic transducer array 20a in response to scanning of the subject by radiation.”), wherein the process includes: controlling the movement mechanism to move the first transducer in a direction along the contact surface of the imaging table with the breast (see Fig. 6 and [0048]: “a moving mechanism 110 is provided to move…the ultrasonic transducer array 20a in response to scanning of the subject by radiation.”) and controlling the first transducer to capture the ultrasound image of the breast from the contact surface of the imaging table with the breast ([0039]: “The receiving circuit 43 amplifies a plurality of ultrasonic detection signals respectively output from the plurality of ultrasonic transducers, and the A / D converter 44 converts the analog ultrasonic detection signal amplified by the receiving circuit 43 into a digital signal ( (Ultrasonic detection data).”)
are built in advance (NOTE: The imaging table, the first transducer, and the movement mechanism are all built and assembled prior to imaging)
However, SATO does not explicitly teach that the cover (i.e., the contact surface of the imaging table) is composed of a plurality of laminated carbon fiber sheets having different acoustic impedances, and at least one of the plurality of carbon fiber sheets has higher rigidity with respect to the contact with the breast than the other laminated carbon fiber sheets. However, SATO does teach that “[t]he acoustic impedance of the cover is preferably set between the acoustic impedance of the piezoelectric body and the acoustic impedance of the subject (living body).” ([0048]).
CAIA ZZO teaches “a reinforced plastic sonar dome having a low acoustical insertion loss combined with sufficient mechanical strength.” (Abstract). CAIA ZZO also emphasizes the necessity of having adjacent layers with smaller differential impedances. (see, e.g., [0015] and [0010]: “The greater the difference in characteristic impedance between the sea water and the sonar dome window, the greater the change in direction of the acoustical energy and hence the greater the amount of acoustical energy that will be reflected away from sonar dome window.”). “To form the sonar dome of the Invention, discrete acoustical fibers and structural fibers are selected and mixed together in a random (“stochastic”) manner…Many layers of blended fabric are incorporated into a solidified polymer resin. The reinforced solidified plastic resin, incorporating the acoustical and structural fibers, forms the ‘window’ of the sonar dome through which sound passes on its way from or to the transducers.” ([0017]). The structural fibers may be carbon fibers. (see, e.g., [0016], [0039]).
The sonar dome is essentially a stack of carbon fiber layers. “The blended fabric stack 32 may be laid up either wet or dry, using conventional reinforced plastic technology. In a wet lay up, each sheet of blended fabric 30 is wetted with a liquid plastic resin prior to placing the sheet of blended fabric in the mold. In the dry lay up method, all sheets of blended fabric 30 are placed within the mold without wetting. The liquid plastic resin then is introduced to the stack 32 of sheets of blended fabric 30 while the blended stack 32 is in the mold.” ([0046]). Note, a stack of layers bonded together with a common resin is considered a laminate.
Notably, each carbon fiber layer within the stack has a ratio of structural fibers or acoustical fibers to provide the desired impedance. “The location of the blended yarn 28 within the cross section of the sonar dome window 22 is a consideration because the ratio of acoustical to structural fibers is not uniform through the thickness of the sonar dome window 22. To optimize the strength of the sonar dome 2 while also maintaining good acoustical transmission capability, blended fabrics 30 having relatively great strength are selected for the outside and inside surfaces 18, 20 of the cross section of the sonar dome window 22 while blended fabric 30 having superior acoustical properties are selected for the center of the cross section of the sonar dome window 22.” ([0052]).
It would have been obvious to one having ordinary skill in the art at the time of filing to construct the cover in SATO using a technique like that taught by CAIA ZZO such that a plurality of laminated carbon fiber sheets having different acoustic impedances. SATO teaches that the cover is preferably “set between the acoustic impedance of the piezoelectric body and the acoustic impedance of the subject (living body).” ([0048]). CAIA ZZO teaches a method that enables one to progressively reduce the impedance of the cover as the material approaches the tissue. More specifically, one would laminate a stack of carbon fiber layers, as taught in CAIA ZZO, in which the carbon fiber layers closer to the ultrasound transducer will have an impedance closer to that of the transducer and the carbon fiber layers closer to the tissue will have an impedance closer to that of the tissue. There would have been a reasonable expectation of success as CAIA ZZO teaches that such a laminate can be constructed.
Note: At least one of the carbon fiber layers (sheets) would necessarily have a higher rigidity than the other laminated carbon fiber layers because CAIA ZZO teaches that the more rigid sheets (higher impedance) have more “structural fibers.”
Claims 3-5 are rejected under 35 U.S.C. 103 as being unpatentable over a translation of JP 2008-173291A (hereinafter “SATO”) (foreign patent document was previously recited in Information Disclosure Statement dated 28 January 2025) and U.S. Patent Appl. Publ. No. 2008/0277813 A1 (hereinafter “CAIA ZZO”) as applied to claims 1 and 2 above, and further in view of U.S. Patent Appl. Publ. No. 2009/0088637 A1 (hereinafter “MIKAMI”).
With respect to claim 3, SATO does not teach that the movement mechanism further moves the first transducer in the chest wall surface direction.
In the same field of endeavor, MIKAMI teaches a system for diagnoses of mammary glands and breasts using radiation and ultrasonic waves in combination so that the images can be correlated for easier visual recognition.
Figure 6 shows a compression plate 13 pressing the breast into the imaging stage 19 while an ultrasonic probe 16 images the breast. ([0062]). Although not shown, the probe is moved by a movement mechanism 17 (see, e.g., [0061]). The probe 16 does not cover an entire dimension (e.g., x-dimension or y-dimension). As such, in order for the probe 16 to cover the entire breast, the probe 16 moves along adjacent lanes back-and-forth until imaging is complete. ([0062]). The lanes move along the chest-wall direction. However, even if the lanes moved along the front-rear direction, the moving mechanism would necessarily move along the chest-wall
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direction to change lanes.
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the SATO system such that the transducer moves along both chest-wall and front-rear directions as the probe moves along adjacent lanes to image the entire breast as taught in MIKAMI. If the transducer is significantly smaller than the compressed breast (as shown in MIKAMI), then one having ordinary skill would choose a path similar to that shown in MIKAMI (i.e., imaging multiple adjacent lanes) as it would be an efficient way to image the entire breast. Whether the longest dimension of the probe was along the chest-wall or front-rear, the path would necessarily include moving along the other direction in order to shift to the next lane. There would have been a reasonable expectation of success as MIKAMI demonstrates that probes can move in both directions (chest-wall or front-rear) while imaging the breast.
With respect to claim 4, SATO does not teach the claim limitations. However, MIKAMI teaches that wherein the first transducer has a shape that extends longer in a front-rear direction along a direction intersecting a chest wall of a subject than in a chest wall surface direction along the chest wall of the subject (see Figure 6 of MIKAMI the longest dimension extends along the y-direction that intersects the chest wall), and the movement mechanism moves the first transducer in the chest wall surface direction (as explained with respect to claim 3, the probe would necessarily move in the chest wall surface direction as it moves along the lanes in Figure 6).
It would have been obvious to one having ordinary skill in the art at the time of filing to combine the SATO system with the MIKAMI probe and path. One of ordinary skill in the art could have combined the MIKAMI probe and path with the SATO system using known methods. In combination, each element would perform the same function as it does separately. Moreover, one of ordinary skill in the art would have recognized that the results of the combination were predictable.
NOTE: Although the MIKAMI probe moves along a compression plate, the probe and path could be added to the SATO system and would perform the same function (i.e., the probe would image the breast through the cover and the movement mechanism could move along the same path).
With respect to claim 5 (depending from claim 4), as explained above with respect to claim 3, MIKAMI teaches that wherein the movement mechanism further moves the first transducer in the front-rear direction. As discussed above, provided that the probe is significantly smaller than both dimensions (i.e., depth and width) of the breast, the path would necessarily move the probe in a front-rear direction and in a chest-wall direction whether to move along the lanes or to shift to the next lane. This would occur regardless of the longest dimension of the probe or the longest dimension of the path.
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the SATO system such that the transducer moves along both chest-wall and front-rear directions as the probe moves along adjacent lanes to image the entire breast as taught in MIKAMI. If the transducer is significantly smaller than the compressed breast (as shown in MIKAMI), then one having ordinary skill would choose a path similar to that shown in MIKAMI (i.e., imaging multiple adjacent lanes) as it would be an efficient way to image the entire breast. Whether the longest dimension of the probe was along the chest-wall or front-rear, the path would necessarily include moving along the other direction in order to shift to the next lane. There would have been a reasonable expectation of success as MIKAMI demonstrates that probes can move in both directions (chest-wall or front-rear) while imaging the breast.
Claims 7 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over a translation of JP 2008-173291A (hereinafter “SATO”) (foreign patent document was previously recited in Information Disclosure Statement dated 28 January 2025) and U.S. Patent Appl. Publ. No. 2008/0277813 A1 (hereinafter “CAIA ZZO”) as applied to claim 6 above, and further in view of “Common Lay-up Terms and Conditions,” P. Joyce presentation, 2003 (hereinafter “JOYCE”).
With respect to claim 7 (depending from claim 6), SATO does not explicitly teach wherein a fiber direction of at least one carbon fiber sheet among the plurality of laminated carbon fiber sheets is disposed along a chest wall surface direction along a chest wall of a subject.
JOYCE teaches laminates having at least four layers that have two different orientations in which the laminates form a mirror-image about a mid-plane. (See slides 2 and 3 of JOYCE). Symmetrical layups avoid warping during the curing process.
It would have been obvious to one having ordinary skill in the art to design the carbon-fiber lay up such that a fiber direction of at least one carbon fiber sheet among the plurality of laminated carbon fiber sheets is disposed along a chest wall surface direction along a chest wall of a subject. As the compression of the breast would be symmetrical about an axis that extends perpendicular to the chest wall direction, one skilled in the art would choose to have at least one orientation of the different layers to extend parallel to the chest-wall in order to better absorb the load of the compressed breast.
With respect to claim 8 (depending from claim 7), SATO does not explicitly teach wherein the fiber direction of each of the carbon fiber sheet in contact with the first transducer and the carbon fiber sheet in contact with the breast is disposed along the chest wall surface direction.
JOYCE teaches laminates having at least four layers that have two different orientations in which the laminates form a mirror-image about a mid-plane. (See slides 2 and 3 of JOYCE). Symmetrical layups avoid warping during the curing process. A symmetrical lay-up would necessitate the two outer layers to have the same orientation (see, e.g., “symmetrical layup” on slide 3).
It would have been obvious to one having ordinary skill in the art to design the carbon-fiber lay up such that a fiber direction of each of the carbon fiber sheet in contact with the first transducer and the carbon fiber sheet in contact with the breast is disposed along the chest wall surface direction. As the compression of the breast would be symmetrical about an axis that extends perpendicular to the chest wall direction, one skilled in the art would choose to have the exterior layers be parallel to one another and extend along the chest wall direction to better absorb the load of the compressed breast.
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Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over a translation of JP 2008-173291A (hereinafter “SATO”) (foreign patent document was previously recited in Information Disclosure Statement dated 28 January 2025) and U.S. Patent Appl. Publ. No. 2008/0277813 A1 (hereinafter “CAIA ZZO”) as applied to claim 1 above, and further in view of U.S. Patent Appl. Publ. No. 2021/0267571 A1 (hereinafter “HOLOGIC”).
With respect to claim 9, neither SATO nor CAIA ZZO teach the claim limitations. However, in the same field of endeavor, HOLOGIC teaches a compression assembly is coupled to the gantry of an ultrasound breast imaging system. The compression assembly includes a pair of compression paddles mounted on a positioning track. Each compression paddle houses a transducer. HOLOGIC teaches that “depending on the depth of sound wave penetration, beam spread, breast size, angle of transducer relative to the breast, and other factors, any one of these scans may provide sufficient imaging of the breast. In other examples, however, it may be desirable to perform multiple scans in various scan configurations to completely image the breast… The overlap of scan areas between the various positions enable the volume of the entire breast 600 to be scanned quickly.” ([0032]).
Accordingly, HOLOGIC teaches a second transducer 418a that captures an ultrasound image of the breast from a compression surface of a compression plate 408a that compresses the breast to bring the breast into close contact with the contact surface of the imaging tables (see Figure 4 with opposing compression plates). HOLOGIC also teaches a controller that captures the ultrasound images of the breast by using the first transducer and the second transducer. “Each of the various motors 410, 414, 416, as well as the transducers 418 may be controlled by one or more controllers 420 disposed in the gantry 402.” ([0029]).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify SATO system to include a transducer that images along a compression plate. One of ordinary skill in the art would have been motivated to add another transducer because, as taught in HOLOGIC, having a transducer on an opposite side of the breast enables more comprehensive imaging of the breast. There would have been a reasonable expectation of success as HOLOGIC demonstrates one can have two opposing ultrasound transducers.
With respect to claim 10, neither SATO nor CAIA ZZO teach the claim limitations. However, HOLOGIC teaches that the controller switches an imaging mode of the ultrasound image of the breast by controlling imaging ranges of the first transducer and the second transducer. Figures 7A-7E illustrate various scan patterns that may be performed by HOLOGIC. “The transducers 300 a, 302 a, 300 b, 302 b are coupled to a scanning arm (not shown) which controls the speed of and path taken by the transducer 300 a, 302 a, 300 b, 302 b during its scan. The scanning arm controls movement of the transducers 300 a, 300 b in the x direction (as depicted in FIG. 3), and transducers 302 a, 302 b in they direction. This enables scanning of the full contour of the immobilized breast in as little as a single scan (depending on breast size and position, transducer size, etc.). The two transducers 300 a, 302 a, 300 b, 302 b are positioned so as to not interfere with each other's scan. Indeed, by using two transducers located on opposite sides of the breast (in certain orientations) a 3D reconstruction of the breast may be generated, with features detected in the opposing scans being identified as matching pairs. The opposing scans may then be combined, using the matching pairs of features as points of alignment between the two scans. It should be noted that the present technology envisions other transducer arrangements, for example different numbers and configurations of transducers. In addition, although a simple vertical and horizontal scan path is shown, other scan paths, including a helical scan path or the like, could be substituted readily herein by one of skill in the art. In such a configuration, it may be advantageous to utilize transducers having smaller dimensions. The transducer scanning arm also controls the speed with which the transducer scans the breast.”
It would have been obvious to one having ordinary skill in the art at the time of filing to modify SATO system such that the controller switches an imaging mode such that the opposing transducers image a respective side of the breast but without interfering with each other and by controlling imaging ranges of the first transducer and the second transducer. One of ordinary skill in the art would have been motivated to include this feature, as taught in HOLOGIC, to enable better quality scanning and 3D reconstruction of the breast. There would have been a reasonable expectation of success as HOLOGIC demonstrates one can have two opposing ultrasound transducers controlled by the system.
With respect to claim 11 (and in light of the Section 112(b) rejection above), neither SATO nor CAIA ZZO teach the claim limitations. However, HOLOGIC teaches that wherein the controller sets an image boundary between the contact surface of the imaging table and the compression surface of the compression plate at a predetermined distance from the contact surface of the imaging table, and then performs control of the imaging ranges such that the first transducer and the second transducer image the same range of the breast and performs control of generating a combined ultrasound image, the combined ultrasound image including image data from the first transducer that extends from the contact surface of the imaging table to the image boundary and image data from the second transducer extending from the compression surface of the compression plate to the image boundary.
“As noted above, the size of the breast, size of the compression paddles, depth of penetration of the ultrasound signals, and other factors, may dictate the number of scans required to completely image the breast. As with other ultrasound systems, the depth of penetration of the ultrasound waves may be adjusted as required or desired for a particular application. Similarly, beam forming may be used to direct the ultrasound waves in various directions relative to the transducer, so as to increase the imaging area within the breast tissue. With these and other considerations in mind, the areas depicted within FIGS. 7A-7D show the areas along which scanning transducers may image the breast in a single pass, specifically areas of the breast in contact with the patient contact surfaces of the compression paddles during compression. The depth of penetration of the sound waves are not depicted and for the purposes of illustration, it is assumed that the sound wave penetration is in a direction orthogonal to the patient contact surfaces.” (emphasis added) ([0031]).
“In other examples, however, it may be desirable to perform multiple scans in various scan configurations to completely image the breast. FIG. 7E depicts the result of such a scan, where a scan areas for CC 602 a, frontal 602 c, and lateral 602 d are all performed on a single breast 600. The overlap of scan areas between the various positions enable the volume of the entire breast 600 to be scanned quickly.” ([0032]). To this end, a scanning arm “controls movement of the transducers 300 a, 300 b in the x direction (as depicted in FIG. 3), and transducers 302 a, 302 b in they direction. This enables scanning of the full contour of the immobilized breast in as little as a single scan (depending on breast size and position, transducer size, etc.). The two transducers 300 a, 302 a, 300 b, 302 b are positioned so as to not interfere with each other's scan. Indeed, by using two transducers located on opposite sides of the breast (in certain orientations) a 3D reconstruction of the breast may be generated….” ([0028]).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify SATO system such that the controller controls the scanning of the breasts by the ultrasound transducers as recited in claim 11. After selecting depths of the opposing transducers, an image boundary is determined and each of the transducers are controlled to image about half of the breast. One of ordinary skill in the art would have been motivated to include this feature, as taught in HOLOGIC, in order to enable higher quality imaging of the breast as wells as 3D reconstruction. There would have been a reasonable expectation of success as HOLOGIC demonstrates one can have two opposing ultrasound transducers controlled by the system.
With respect to claim 12, neither SATO nor CAIA ZZO teach the claim limitations. However, HOLOGIC teaches that wherein the controller performs control of the imaging ranges such that the first transducer and the second transducer image different ranges. As explained above with respect to claim 11, the controller determines the scan areas so that the entire breast may be imaged. As shown in Figures 7A and 7B, the two transducers may image different ranges.
Claims 14 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over a translation of JP 2008-173291A (hereinafter “SATO”) (foreign patent document was previously recited in Information Disclosure Statement dated 28 January 2025) and U.S. Patent Appl. Publ. No. 2008/0277813 A1 (hereinafter “CAIA ZZO”) as applied to claim 1 above, and in further view of U.S. Patent Appl. Publ. No. 2005/0283063 A1 (hereinafter “BESSON”) and U.S. Patent Appl. Publ. No. 2007/0104313 A1 (hereinafter “TESIC”).
With respect to claim 14 (and in light of the Section 112 rejection), SATO and CAIA ZZO do not explicitly teach that the system includes an anti-scatter grid that is located between the contact surface of the imaging table and a radiation detector and that is moved by the movement mechanism.
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In the same field of endeavor, BESSON teaches “[a]n integrated x-ray and ultrasound medical imaging system” in which “a radiation detection means and ultrasound transducer may be disposed for scanning movement for image acquisition along either the same or substantially coincidental paths. The radiation detection means and ultrasound transducer may be advantageously located on the same side of the imaged body portion. The x-ray and ultrasound imaging operations may be sequential, partially overlapping, or synchronous.” (Abstract). The system “employs x-ray imaging and ultrasound imaging in a manner that yields enhanced accuracy and multiple efficiencies.” ([0002]).
Figure 2A is shown here and illustrates an ultrasound imager 50 and an x-ray detector 40 that may be “selectively interconnected and disconnected” through a linkage member 82. ([0048]). “[T]he inventive apparatus may be provided so that the ultrasound transducer is disposed for scanning co-movement with and in fixed relation to the radiation detection means. In this regard, the radiation detection means and ultrasound transducer may be physically interconnected or interconnectable. For example, one of the radiation detection means and ultrasound transducer may be supportably carried by the other, wherein the carrier is supportably interconnected to a drive means.” ([0015]). The support layer 36, which the breast is in contact with and supported by, may be arcuate or planar. ([0017]).
It would have been obvious to one having ordinary skill in the art to modify the SATO system to include a mechanism that can move the x-ray detector and the ultrasound transducer synchronously or sequentially, as taught in BESSON. One would have been motivated to incorporate the movement mechanism of BESSON because the simultaneous movement of the x-ray detector and the ultrasound transducer eases registration of the x-ray images and the ultrasound images. There would have been a reasonable expectation of success as BESSON teaches that the system can be used with a dual-modality system.
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However, the combined teachings of SATO and BESSON do not teach a grid moved by the movement mechanism.
In the same field of endeavor, TESIC teaches a grid that may be positioned on top of a detector strip in a system that is similarly configured as the BESSON system. “The detector strip 60 defines an array of detector elements.” ([0049]). The grip shown in Figure 10 is positioned over the detector strip. “[T]he grid of FIG. 10 may be disposed on the detector assembly above the scintillator for movement with the detector assembly. The illustrated angling of the slats 90 blurs the slats 90 so that lines do not appear in the resulting image. Moreover, the blurring is accomplished via a unidirectional movement of the slats 90 together with the detector, as opposed to reciprocating Bucky-style movement, thereby eliminating the issues of source/grid drive synchronization, increased exposure period to allow sufficient blurring movement (though some dosage increase may be associated with grid shadowing of the primary signal), and potential grid drive malfunctions.” ([0064]).
It would have been obvious to one having ordinary skill in the art to modify the SATO-BESSON x-ray detector to include the TESIC grid positioned on top of the x-ray detector. One would have been motivated to add the grid with angled slats “so that lines [from x-rays being blocked] do not appear in the resulting image.” There would have been a reasonable expectation of success as TESIC teaches that the grid may be incorporated with a system that is similar to the BESSON system.
With the anti-scatter grid of TESIC attached to the x-ray detector and with the ultrasound transducer being connected to the x-ray detector, as taught in BESSON, the anti-scatter grid would be moved by the movement mechanism that also moves the ultrasound transducer.
With respect to claim 15, SATO and CAIA ZZO do not explicitly teach wherein the imaging table includes an attachment/detachment device that attaches the first transducer to the grid in a case in which the grid is moved to a predetermined position and that detaches the first transducer from the grid in a case in which the grid to which the first transducer is attached returns to the position.
BESSON teaches various options in which the x-ray detector and the ultrasound transducer may be selectively connected to each other. “The linkage member 80 may be provided so that ultrasound imager 50 and x-ray detector 40 may be selectively interconnected and disconnected (e.g. via mating engagement between complimentary shaft and cylinder members provided on the radiation detector 40 and ultrasound imager 50, respectively). In another arrangement, two separate bracket members may be interconnected to pendulum member 27 for separate interconnection to x-ray detector 40 and ultrasound imager 50, respectively. In yet another approach, a single bracket member may be utilized, wherein the x-ray detector 40 and ultrasound imager 50 may be separately.” ([0048]). One of the x-ray detector and the ultrasound transducer may also be “supportably carried” by the other. ([0015]).
It would have been obvious to one having ordinary skill in the art at the time of filing for the x-ray detector (having the anti-scatter grid attached thereto) to selectively attach and detach to the ultrasound transducer at the same position. One would have been motivated to include this feature as it provides the system and operator with more options for imaging sequences but also for alternative types of transducers and/or x-ray detectors. There would have been a reasonable expectation of success as TESIC teaches that selectively attachable feature can be incorporated into a system that is similar to the BESSON system.
Conclusion
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/JASON P GROSS/Examiner, Art Unit 3797
/SERKAN AKAR/Primary Examiner, Art Unit 3797