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 .
Status of Claims and Rejections
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
Claims 1-5, 7, 9, 11, and 13-16 have been amended. Claim 6 has been cancelled.
Claims 1-5 and 7-16 are currently pending.
In light of the claim amendments, some of the Section 112(b) rejections have been withdrawn while others have been maintained as explained below.
In light of Applicant’s arguments, the Section 101 rejection of claims 1-16 have been withdrawn.
Claim Objections
Claim 1 is objected to because of the following informalities:
The conditional limitation’s location in claim 1 could be moved to be clearer. Examiner is interpreting the relevant limitation in claim 1 as follows: “wherein, in a case in which the breast of the subject is in contact with the contact surface, at least one of the plurality of carbon fiber sheets has a flexural rigidity against a load applied that is greater than a flexural rigidity of the other laminated carbon fiber sheets.”
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:
transducer movement unit configured to move the movement table in claim 1;
transducer drive unit, as recited in claim 1;
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.
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.
RESPONSE TO APPLICANT’S ARGUMENTS
Applicant does not set forth any particular argument with respect to the 112(f) interpretation other than stating that the claims do not invoke 112(f). As explained above, the amended claims include the phrases “transducer movement unit,” “transducer drive unit,” and “attachment/detachment device,” which invoke a 112(f) interpretation.
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.
With respect to claim 1, the claim limitations “a transducer movement unit configured to move the movement table” and a “transducer drive unit” invoke 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 only repeats the term “transducer movement unit” and “transducer drive unit” but does not provide 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.”); and [0109]: “In step S30, the controller 20 moves the transducer 15A by controlling the transducer movement unit 9A via the transducer drive unit 22.”
For the purpose of a compact prosecution, Examiner is interpreting “a transducer movement unit” and a “transducer drive unit” as connected components that cooperate in moving the transducer.
With respect to claim 15, the claim limitation “an attachment/detachment device configured to attach the first transducer to 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]).
For the purpose of a compact prosecution, Examiner is interpreting “an attachment/detachment device” as a component that is configured to attach and detach the transducer to another component.
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 movement table 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.
RESPONSE TO APPLICANT’S ARGUMENTS
Applicant does not set forth any particular argument with respect to the Section 112(a) and (b) rejections other than stating that the claims “fully satisfy the requirements of” Section 112(a) and (b). As explained above, the amended claims include the phrases “transducer movement unit,” “transducer drive unit,” and “attachment/detachment device,” which invoke a 112(f) interpretation, and the specification does not describe adequate structure to perform the claimed functions.
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, 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. 2022/0233165 A1 (hereinafter “PARK”) and U.S. Patent Appl. Publ. No. 2008/0277813 A1 (hereinafter “CAIA ZZO”) in view of U.S. Patent Appl. Publ. No. 2022/0008037 A1 (hereinafter “HAMADA”).
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]).
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) having a contact surface configured to be in contact with a breast of a subject (NOTE: Although Figure 6 shows the breast in contact with transducer array 20a, SATO also teaches a “cover” that would be in contact with the breast of the subject: “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
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(living body).” [0048]), wherein a first transducer and a movement table supporting the first transducer are built in the imaging table. (With the cover positioned between the breast and the transducer, the first transducer and the movement table (i.e., structure holding the transducer) would be “built in” the imaging table. NOTE: Examiner is interpreting the term “built in” as to mean “positioned within the imaging table and assembled prior to imaging.”)
a controller (see Figure 5, “control part 90”); and
a transducer movement unit (see Figure 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.”) configured to move the movement table in a direction along the contact surface (see Fig. 6, the transducer array 20a would be moved along the contact surface) wherein the first transducer transmits an ultrasonic wave toward a contact surface configured to be in contact with the breast of the subject, to capture an ultrasound image of the breast of the subject (transducer array 20a would transmit ultrasonic wave toward contact surface to capture an image of the breast; 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 and long in the Y-axis direction is used.”).
However, SATO does not explicitly teach a transducer drive unit and a movement table that supports the transducer in which the transducer movement unit is configured to move the movement table under the control of the controller vias the transducer drive unit. Nonetheless, the moving mechanism in SATO has a link (see., line extending between 110 and 20a) that appears to push and pull the transducer array 20a and the moving mechanism must receive instructions from some element to move the transducer array during scanning. Figure 6 also shows the transducer array 20a being supported or held by a planar component (i.e., movement table).
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In the same field of endeavor, PARK teaches an all-in-one mammography and breast ultrasonography apparatus. (Abstract). Figures 5 and 6 are shown here and illustrate a scanning table. The scanning table is configured to move an x-ray detector and ultrasound probes when a breast is placed on top of the scanning table. ([0035]). In particular, PARK teaches using an “orbital motion device” that moves both the x-ray detector and the ultrasound probes. “[T]he apparatus 10 according to the present invention includes an orbital motion device 80 mounted inside the scanning table 50 so as to reciprocate the X-ray flat panel detector 64 and the ultrasound probes 70 and 72 together along the first axis X2 of the scanning table 50.” ([0039]). The orbital motion device includes a transducer drive unit and a transducer movement unit. “The orbital motion device 80 includes a carriage 82 [transducer movement unit], a pair of caterpillars 84, a pair of sliding plates 86, and a horizontal linear actuator 90 [transducer drive unit].” ([0039]). NOTE: Examiner is interpreting the carriage 82 as a transducer movement unit. However, the assembly of the carriage 82, caterpillars 84, and sliding plates 86 could also be interpreted as a transducer movement unit.
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the SATO system to include a motion device (i.e., a device similar to PARK’s orbital motion device) that includes a carriage and a horizontal linear actuator. One of ordinary skill in the art would have used a motion device like PARK’S because it could simultaneously move the x-ray detector and the ultrasound probe or probes. One having ordinary skill in the art would also know to control the movement of the motion device through the controller, which communicates instructions to the transducer drive unit. There would have been a reasonable expectation of success as PARK teaches that a device for controlling movement of the ultrasound transducer can be used in an all-in-one mammography apparatus.
Alternatively, it would have been obvious to one having ordinary skill in the art at the time of filing to modify the SATO system to include a motion device (i.e., a device similar to PARK’s orbital motion device) that includes a carriage and a horizontal linear actuator for each of the transducer and the x-ray detector. One of ordinary skill in the art would have used a motion device like PARK’S because in order to move the x-ray detector and the ultrasound probe or probes to their proper positions. One having ordinary skill in the art would also know to control the movement of the motion device through the controller, which communicates instructions to the transducer drive unit. There would have been a reasonable expectation of success as PARK teaches that a device for controlling movement of the ultrasound transducer can be used in an all-in-one mammography apparatus.
However, neither SATO nor PARK explicitly teaches that the contact surface of the imaging table is composed of a plurality of laminated carbon fiber sheets having different acoustic impedances, wherein, in the contact surface of the imaging table and wherein at least one of the plurality of carbon fiber sheets has a flexural rigidity against a load applied in a case in which the breast of the subject is in contact with the contact surface greater than that of the other laminated carbon fiber sheets, as recited in claim 1. Nonetheless, 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 flexural rigidity against a load applied that is greater than that of the other laminated carbon fiber sheets because CAIA ZZO teaches that the more rigid sheets have more “structural fibers.”
However, CAIA ZZO does not explicitly teach that the carbon fiber sheets are laminated such that the acoustic impedance decreases from a carbon fiber sheet in contact with the first transducer toward a carbon fiber sheet configured to be in contact with the breast of the subject, as recited in claim 1. Nonetheless, 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]).
While CAIA ZZO’s concern is a sonar dome that must resist deforming under pressure exerted by sea water ([0038]), one having ordinary skill in the art would not be concerned with such a scenario for a mammography apparatus. As such, one would select a structure that would provide the best quality imaging and it is common knowledge to reduce the acoustic impedance from the transducer to the imaged tissue in order to reduce unwanted reflections caused by a difference in acoustic impedance. CAIA ZZO teaches a method that enables one to progressively reduce the impedance of the cover as the material approaches the tissue. As such, 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.
HAMADA confirms this analysis. HAMADA’s background discussion teaches the following: “In addition, in recent years, the development of an acoustic matching layer with more efficient propagation of an ultrasonic wave has been underway by providing a gradient in acoustic impedance from the piezoelectric element side to the acoustic lens side, through a configuration of an acoustic matching layer having a multi-layer structure in which a plurality of acoustic matching sheets (acoustic matching layer materials) are laminated.” ([0010]). Moreover, HAMADA’s summary section provides the following: “The gradient of the acoustic impedance in the above-mentioned acoustic matching layer is designed such that the closer to the piezoelectric element, the larger the acoustic impedance of the acoustic matching sheet, and the closer to the acoustic lens, the smaller the acoustic impedance of the acoustic matching sheet.” ([0011]).
HAMADA teaches that the reason for reducing the acoustic impedance as the matching layer approaches the tissue. “There is usually a difference in acoustic impedance (density x acoustic velocity) between the acoustic lens and the living body. In a case where this difference is large, the ultrasonic wave is easily reflected on the surface of the living body, and the incident efficiency of the ultrasonic wave into the living body is lowered. Therefore, the acoustic lens is required to have an acoustic impedance characteristic close to that of the living body.” ([0008]).
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 carbon fiber sheets are laminated such that the acoustic impedance decreases from a carbon fiber sheet in contact with the first transducer toward a carbon fiber sheet configured to be in contact with the breast of the subject as taught in HAMADA. One of ordinary skill in the art would have been motivated to use such a laminated structure to reduce unwanted reflections caused by difference in acoustic impedance.
RESPONSE TO APPLICANT’S ARGUMENTS
Applicant argues “that SATO does not specifically disclose configuring the cover (the contact surface) as a laminate of a plurality of carbon fiber sheets in which the respective sheets have different acoustic impedances.” Applicant also argues that “it is clear that SATO alone does not satisfy the specific material configuration and layer arrangement of the contact surface that are required by the amended claims.” Examiner agrees, which is why SATO was not relied upon for teaching these features.
Applicant also argues that the references do not describe certain features. For example, Applicant argues:
that SATO does not disclose or suggest “the thickness-direction design concept that the carbon fiber sheets are laminated such that the acoustic impedance decreases from the transducer side toward the breast side, i.e., a directional, stepwise impedance matching (a monotonic-decrease layered arrangement) as recited in the amended claims.” (Page 10 of response).
“that CAIA ZZO does not directly disclose a design concept in which, for the purpose of one-directional matching ‘from the transducer side toward the tissue (breast) side’, the acoustic impedance is monotonically decreased along the thickness direction so as to stepwise approach the impedance of the tissue.” (Page 11 of response).
“[T]he essence of the amended claims lies in adopting a thickness-direction layer arrangement (directional, stepwise impedance matching) in which the acoustic impedance decreases from the transducer side toward the breast side under a clear objective: reducing reflections caused by the large acoustic-impedance difference between the transducer and the human body (breast) by progressively approaching the tissue-side impedance along the thickness direction.” (Page 11 of response).
“Applicant contends that the design concept of the amended claims, directional, stepwise impedance matching with a monotonic-decrease arrangement, would be improperly disregarded.” (Page 11 of response).
NOTE: These alleged limitations are not recited in the claims. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
For what is recited in the claims, however, the cited art teaches the claim limitations. As explained above, one having ordinary skill in the art would select carbon fiber sheets of the laminated structure so that the acoustic impedance of the different layers is reduced as the layers approach the breast of the subject. As taught in HAMADA, it is a requirement that the surface that contacts the tissue has an “acoustic impedance characteristic close to that of the living body.” ([0008]).
Lastly, Applicant argues that one having ordinary skill in the art would not use CAIA ZZO’s “center-optimized” design concept and place “strength-oriented layers” at the outer and inner surfaces. (Page 11 of response). Even assuming, for argument’s sake, that CAIA ZZO teaches this design concept, there is no reason why one having ordinary skill in the art would follow the undersea design. As explained above, the circumstances of an underwater sea dome are different than a mammography apparatus. One having ordinary skill in the art would know not to use this alleged design in CAIA ZZO but one that is more suitable for imaging breast tissue, i.e., one in which the acoustic impedance of the contact surface decreases as it extends from the transducer to the imaged tissue.
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 transducer movement unit 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 13, SATO teaches a mammography apparatus. “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]). The remainder of claim 13 recites the claim limitations of claim 1. As discussed above, the combination of SATO, PARK, CAIA ZZO, and HAMADA teach the limitations of claim 1.
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).”)
an imaging table (see, e.g., Figure 6) having a contact surface configured to be in contact with a breast of a subject (NOTE: Although Figure 6 shows the breast in contact with transducer array 20a, SATO also teaches a “cover” that would be in contact with the breast of the subject: “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).” [0048]), wherein a first transducer and a movement table supporting the first transducer are built in the imaging table. (With the cover positioned between the breast and the transducer, the first transducer and the movement table (i.e., structure holding the transducer) would be “built in” the imaging table. NOTE: Examiner is interpreting the term “built in” as to mean “positioned within the imaging table and assembled prior to imaging.”)
a controller (see Figure 5, “control part 90”); and
a transducer movement unit (see Figure 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.”) configured to move the movement table in a direction along the contact surface (see Fig. 6, the transducer array 20a would be moved along the contact surface) wherein the first transducer transmits an ultrasonic wave toward a contact surface configured to be in contact with the breast of the subject, to capture an ultrasound image of the breast of the subject (transducer array 20a would transmit ultrasonic wave toward contact surface to capture an image of the breast; 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 and long in the Y-axis direction is used.”).
the process comprising: controlling the controller to move the first transducer in a direction along the contact surface of the imaging table (see Figure 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 (transducer array 20a would transmit ultrasonic wave toward contact surface to capture an image of the breast; 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 and long in the Y-axis direction is used.”).
However, SATO does not explicitly teach a transducer drive unit and a movement table that supports the transducer in which the transducer movement unit is configured to move the movement table under the control of the controller vias the transducer drive unit. Nonetheless, the moving mechanism in SATO has a link (see., line extending between 110 and 20a) that appears to push and pull the transducer array 20a and the moving mechanism must receive instructions from some element to move the transducer array during scanning. Figure 6 also shows the transducer array 20a being supported or held by a planar component (i.e., movement table).
In the same field of endeavor, PARK teaches an all-in-one mammography and breast ultrasonography apparatus. (Abstract). Figures 5 and 6 are shown here and illustrate a scanning table. The scanning table is configured to move an x-ray detector and ultrasound probes when a breast is placed on top of the scanning table. ([0035]). In particular, PARK teaches using an “orbital motion device” that moves both the x-ray detector and the ultrasound probes. “[T]he apparatus 10 according to the present invention includes an orbital motion device 80 mounted inside the scanning table 50 so as to reciprocate the X-ray flat panel detector 64 and the ultrasound probes 70 and 72 together along the first axis X2 of the scanning table 50.” ([0039]). The orbital motion device includes a transducer drive unit and a transducer movement unit. “The orbital motion device 80 includes a carriage 82 [transducer movement unit], a pair of caterpillars 84, a pair of sliding plates 86, and a horizontal linear actuator 90 [transducer drive unit].” ([0039]). NOTE: Examiner is interpreting the carriage 82 as a transducer movement unit. However, the assembly of the carriage 82, caterpillars 84, and sliding plates 86 could also be interpreted as a transducer movement unit.
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the SATO system to include a motion device (i.e., a device similar to PARK’s orbital motion device) that includes a carriage and a horizontal linear actuator. One of ordinary skill in the art would have used a motion device like PARK’S because it could simultaneously move the x-ray detector and the ultrasound probe or probes. One having ordinary skill in the art would also know to control the movement of the motion device through the controller, which communicates instructions to the transducer drive unit. There would have been a reasonable expectation of success as PARK teaches that a device for controlling movement of the ultrasound transducer can be used in an all-in-one mammography apparatus.
Alternatively, it would have been obvious to one having ordinary skill in the art at the time of filing to modify the SATO system to include a motion device (i.e., a device similar to PARK’s orbital motion device) that includes a carriage and a horizontal linear actuator for each of the transducer and the x-ray detector. One of ordinary skill in the art would have used a motion device like PARK’S because in order to move the x-ray detector and the ultrasound probe or probes to their proper positions. One having ordinary skill in the art would also know to control the movement of the motion device through the controller, which communicates instructions to the transducer drive unit. There would have been a reasonable expectation of success as PARK teaches that a device for controlling movement of the ultrasound transducer can be used in an all-in-one mammography apparatus.
However, neither SATO nor PARK explicitly teaches that the contact surface of the imaging table is composed of a plurality of laminated carbon fiber sheets having different acoustic impedances, wherein, in the contact surface of the imaging table and wherein at least one of the plurality of carbon fiber sheets has a flexural rigidity against a load applied in a case in which the breast of the subject is in contact with the contact surface greater than that of the other laminated carbon fiber sheets, as recited in claim 1. Nonetheless, 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 flexural rigidity against a load applied that is greater than that of the other laminated carbon fiber sheets because CAIA ZZO teaches that the more rigid sheets have more “structural fibers.”
However, CAIA ZZO does not explicitly teach that the carbon fiber sheets are laminated such that the acoustic impedance decreases from a carbon fiber sheet in contact with the first transducer toward a carbon fiber sheet configured to be in contact with the breast of the subject, as recited in claim 1. Nonetheless, 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]).
While CAIA ZZO’s concern is a sonar dome that must resist deforming under pressure exerted by sea water ([0038]), one having ordinary skill in the art would not be concerned with such a scenario for a mammography apparatus. As such, one would select a structure that would provide the best quality imaging and it is common knowledge to reduce the acoustic impedance from the transducer to the imaged tissue in order to reduce unwanted reflections caused by a difference in acoustic impedance. CAIA ZZO teaches a method that enables one to progressively reduce the impedance of the cover as the material approaches the tissue. As such, 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.
HAMADA confirms this analysis. HAMADA’s background discussion teaches the following: “In addition, in recent years, the development of an acoustic matching layer with more efficient propagation of an ultrasonic wave has been underway by providing a gradient in acoustic impedance from the piezoelectric element side to the acoustic lens side, through a configuration of an acoustic matching layer having a multi-layer structure in which a plurality of acoustic matching sheets (acoustic matching layer materials) are laminated.” ([0010]). Moreover, HAMADA’s summary section provides the following: “The gradient of the acoustic impedance in the above-mentioned acoustic matching layer is designed such that the closer to the piezoelectric element, the larger the acoustic impedance of the acoustic matching sheet, and the closer to the acoustic lens, the smaller the acoustic impedance of the acoustic matching sheet.” ([0011]).
HAMADA teaches that the reason for reducing the acoustic impedance as the matching layer approaches the tissue. “There is usually a difference in acoustic impedance (density x acoustic velocity) between the acoustic lens and the living body. In a case where this difference is large, the ultrasonic wave is easily reflected on the surface of the living body, and the incident efficiency of the ultrasonic wave into the living body is lowered. Therefore, the acoustic lens is required to have an acoustic impedance characteristic close to that of the living body.” ([0008]).
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 carbon fiber sheets are laminated such that the acoustic impedance decreases from a carbon fiber sheet in contact with the first transducer toward a carbon fiber sheet configured to be in contact with the breast of the subject as taught in HAMADA. One of ordinary skill in the art would have been motivated to use such a laminated structure to reduce unwanted reflections caused by difference in acoustic impedance.
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. 2022/0233165 A1 (hereinafter “PARK”) and U.S. Patent Appl. Publ. No. 2008/0277813 A1 (hereinafter “CAIA ZZO”) in view of U.S. Patent Appl. Publ. No. 2022/0008037 A1 (hereinafter “HAMADA”) 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 transducer movement unit 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
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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 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 transducer movement unit 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 transducer movement unit 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. 2022/0233165 A1 (hereinafter “PARK”) and U.S. Patent Appl. Publ. No. 2008/0277813 A1 (hereinafter “CAIA ZZO”) in view of U.S. Patent Appl. Publ. No. 2022/0008037 A1 (hereinafter “HAMADA”) as applied to claim 1 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.
Claims 9-12 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. 2022/0233165 A1 (hereinafter “PARK”) and U.S. Patent Appl. Publ. No. 2008/0277813 A1 (hereinafter “CAIA ZZO”) in view of U.S. Patent Appl. Publ. No. 2022/0008037 A1 (hereinafter “HAMADA”) 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
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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, neither SATO nor CAIA ZZO teach the claim limitations. However, HOLOGIC teaches that wherein the controller sets an image boundary at a predetermined distance from the contact surface of the imaging table between the contact surface of the imaging table and the compression surface of the compression plate; performs control of the imaging ranges such that the first transducer and the second transducer capture ultrasound images of a same predetermined range of the breast; and performs control of generating one ultrasound image of the breast by the combining the ultrasound image such that image data of a region beyond the image boundary as seen from the first transducer is replaced with image data captured by the second transducer.
“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.
Claim 14 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. 2022/0233165 A1 (hereinafter “PARK”) and U.S. Patent Appl. Publ. No. 2008/0277813 A1 (hereinafter “CAIA ZZO”) in view of U.S. Patent Appl. Publ. No. 2022/0008037 A1 (hereinafter “HAMADA”) as applied to claim 13 above, and U.S. Patent Appl. Publ. No. 2007/0104313 A1 (hereinafter “TESIC”).
With respect to claim 14, SATO and CAIA ZZO do not explicitly teach that the system includes a grid provided between the contact surface of the imaging table and a radiation detector and configured to reduce an amount of scattered rays incident on the radiation detector, and a grid movement unit configured to move the grid, and wherein the grid is used as the movement table, and the grid movement unit is used as the transducer movement unit.
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]).
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It would have been obvious to one having ordinary skill in the art to modify the SATO-PARK 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.” As such, the grid would be provided between the contact surface of the imaging table and a radiation detector. Moreover, the grid would be attached to the PARK carriage and form part of the movement table that supports the transducer. The transducer movement unit would also be the grid movement unit. 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 SATO system.
Claim 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. 2022/0233165 A1 (hereinafter “PARK”) and U.S. Patent Appl. Publ. No. 2008/0277813 A1 (hereinafter “CAIA ZZO”) in view of U.S. Patent Appl. Publ. No. 2022/0008037 A1 (hereinafter “HAMADA”) and U.S. Patent Appl. Publ. No. 2007/0104313 A1 (hereinafter “TESIC”) as applied to claim 14 above, and in further view of U.S. Patent Appl. Publ. No. 2005/0283063 A1 (hereinafter “BESSON”).
With respect to claim 15, SATO and CAIA ZZO do not explicitly teach wherein the imaging table includes an attachment/detachment device configured to attach the first transducer to the grid, in a case in which the grid is moved to a predetermined position that is an attachment/detachment position by a grid movement unit, such that a longitudinal direction of the first transducer is along a chest wall surface direction, and configured to detach the first transducer from the grid, in a case in which the grid is returned to the attachment/detachment position by the grid movement unit.
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]).
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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]).
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.
Prior Art Made of Record
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US-20070161903-A1 describes ultrasonic probes having laminated matching layers that can comprise carbon fibers.
US-20020161301-A1 describes matching layers for ultrasound transducers and teaches stepwise reduction in impedance to minimize signal loss.
Conclusion
THIS ACTION IS MADE FINAL. 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.
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/JASON P GROSS/Examiner, Art Unit 3797
/SERKAN AKAR/Primary Examiner, Art Unit 3797
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