NON-FINAL REJECTION
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 Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 12-17 are rejected under 35 U.S.C. 112(d) as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Regarding claims 12-17: These claims are written in the form of dependent claims by reciting the handheld ultrasound device of claim 1, and then further reciting additional features regarding the external device, presumably in an attempt to further limit the handheld ultrasound device of claim 1. However, upon closer inspection, the external device itself is not part of the claimed invention (i.e., the claims do not ever recite that the handheld ultrasound device comprises the external device). Therefore, claims 12-14 do not further limit claim 1.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 2, 4-9, and 12-17 are rejected under 35 U.S.C. 103 as being unpatentable over Halmann et la., US 2019/0328361 A1 (hereinafter “Halmann”) in view of Sumi et al., US 2016/0157828 A1 (hereinafter “Sumi”).
Regarding claims 1, 2, 5, and 6: Halmann discloses a handheld ultrasound device (system 100, Fig. 1; at least probe 106 as shown in Fig. 3 is considered handheld) configured to detect a breast mass (see discussion below), comprising:
a transducer cover (housing 300, Fig. 3; ¶ [0038]) having a contact area to be in contact with a user’s breast and located on one end of the handheld ultrasound device;
a contact part (face surface 302, Fig. 3) whose outer surface is located on at least a portion of the contact area (“The housing 300 of the probe 106 interfaces (e.g., contacts) the person 204 along a face surface 302 of the housing 300.” ¶ [0038]);
an ultrasound transducer unit (elements 104, Fig. 1; ¶ [0028]-[0030]) including N number (N is a natural number of 2 or more) of ultrasound transducers each configured to irradiate an ultrasound signal through the outer surface of the contact part and receive the reflected ultrasound signal (“The probe 106 can have a housing 300 that holds the drive elements 104 (not visible inside the housing 300 in FIG. 3). The housing 300 of the probe 106 interfaces (e.g., contacts) the person 204 along a face surface 302 of the housing 300.” ¶ [0038]; it is therefore understood that an ultrasound signal is irradiated through the face suface 302 of the probe 106);
a controller (collectively 101, 102, 108, 110, 116, Fig. 1) configured to output a control signal to control the ultrasound transducer unit and generate ultrasound images based on the received ultrasound signals (“The processors 116 may control the probe 106 to acquire data. The processors 116 control which of the elements 104 are active and the shape of a beam emitted from the probe 106. The processors 116 also are in electronic communication with a display device 118, and the processors 116 may process the data into images for display on the display device 118.” ¶ [0030]); and
a communication unit configured to transmit the ultrasound images to an external device (“A memory 120 is included for storing processed volumes of acquired data. In one embodiment, the memory 120 is of sufficient capacity to store at least several seconds worth of volumes of ultrasound data. The volumes of data are stored in a manner to facilitate retrieval thereof according to its order or time of acquisition. The memory 120 may comprise any known data storage medium, such as one or more tangible and non-transitory computer-readable storage media (e.g., one or more computer hard drives, disk drives, universal serial bus drives, or the like).” ¶ [0034]; a universal serial bus drive (USB drive) implies a USB controller and USB port which reads on a communication unit),
With respect to the recitation of device being “configured to detect a breast mass” in the preamble of the claim, this is not being construed as a limitation per se.
MPEP 2111.02 Effect of the Preamble recites in part:
The determination of whether a preamble limits a claim is made on a case-by-case basis in light of the facts in each case; there is no litmus test defining when a preamble limits the scope of a claim. Catalina Mktg. Int’l v. Coolsavings.com, Inc., 289 F.3d 801, 808, 62 USPQ2d 1781, 1785 (Fed. Cir. 2002). See id. at 808-10, 62 USPQ2d at 1784-86 for a discussion of guideposts that have emerged from various decisions exploring the preamble’s effect on claim scope, as well as a hypothetical example illustrating these principles.
"[A] claim preamble has the import that the claim as a whole suggests for it." Bell Communications Research, Inc. v. Vitalink Communications Corp., 55 F.3d 615, 620, 34 USPQ2d 1816, 1820 (Fed. Cir. 1995). "If the claim preamble, when read in the context of the entire claim, recites limitations of the claim, or, if the claim preamble is ‘necessary to give life, meaning, and vitality’ to the claim, then the claim preamble should be construed as if in the balance of the claim." Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165-66 (Fed. Cir. 1999). See also Jansen v. Rexall Sundown, Inc., 342 F.3d 1329, 1333, 68 USPQ2d 1154, 1158 (Fed. Cir. 2003) (In considering the effect of the preamble in a claim directed to a method of treating or preventing pernicious anemia in humans by administering a certain vitamin preparation to "a human in need thereof," the court held that the claims’ recitation of a patient or a human "in need" gives life and meaning to the preamble’s statement of purpose.). Kropa v. Robie, 187 F.2d 150, 152, 88 USPQ 478, 481 (CCPA 1951) (A preamble reciting "[a]n abrasive article" was deemed essential to point out the invention defined by claims to an article comprising abrasive grains and a hardened binder and the process of making it. The court stated "it is only by that phrase that it can be known that the subject matter defined by the claims is comprised as an abrasive article. Every union of substances capable inter alia of use as abrasive grains and a binder is not an ‘abrasive article.’" Therefore, the preamble served to further define the structure of the article produced.).
I. PREAMBLE STATEMENTS LIMITING STRUCTURE
Any terminology in the preamble that limits the structure of the claimed invention must be treated as a claim limitation. See, e.g., Corning Glass Works v. Sumitomo Elec. U.S.A., Inc., 868 F.2d 1251, 1257, 9 USPQ2d 1962, 1966 (Fed. Cir. 1989) (The determination of whether preamble recitations are structural limitations can be resolved only on review of the entirety of the application "to gain an understanding of what the inventors actually invented and intended to encompass by the claim" as drafted without importing "‘extraneous’ limitations from the specification."); Pac-Tec Inc. v. Amerace Corp., 903 F.2d 796, 801, 14 USPQ2d 1871, 1876 (Fed. Cir. 1990) (determining that preamble language that constitutes a structural limitation is actually part of the claimed invention). See also In re Stencel, 828 F.2d 751, 4 USPQ2d 1071 (Fed. Cir. 1987) (The claim at issue was directed to a driver for setting a joint of a threaded collar; however, the body of the claim did not directly include the structure of the collar as part of the claimed article. The examiner did not consider the preamble, which did set forth the structure of the collar, as limiting the claim. The court found that the collar structure could not be ignored. While the claim was not directly limited to the collar, the collar structure recited in the preamble did limit the structure of the driver. "[T]he framework - the teachings of the prior art - against which patentability is measured is not all drivers broadly, but drivers suitable for use in combination with this collar, for the claims are so limited." Id. at 1073, 828 F.2d at 754.).
II. PREAMBLE STATEMENTS RECITING PURPOSE OR INTENDED USE
The claim preamble must be read in the context of the entire claim. The determination of whether preamble recitations are structural limitations or mere statements of purpose or use "can be resolved only on review of the entirety of the [record] to gain an understanding of what the inventors actually invented and intended to encompass by the claim" as drafted without importing "‘extraneous’ limitations from the specification." Corning Glass Works, 868 F.2d at 1257, 9 USPQ2d at 1966. If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Shoes by Firebug LLC v. Stride Rite Children’s Grp., LLC, 962 F.3d 1362, 2020 USPQ2d 10701 (Fed. Cir. 2020) (The court found that the preamble in one patent’s claim is limiting but is not in a related patent); Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See also Rowe v. Dror, 112 F.3d 473, 478, 42 USPQ2d 1550, 1553 (Fed. Cir. 1997) ("where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention, the preamble is not a claim limitation"); Kropa v. Robie, 187 F.2d at 152, 88 USPQ2d at 480-81 (preamble is not a limitation where claim is directed to a product and the preamble merely recites a property inherent in an old product defined by the remainder of the claim); STX LLC. v. Brine, 211 F.3d 588, 591, 54 USPQ2d 1347, 1350 (Fed. Cir. 2000) (holding that the preamble phrase "which provides improved playing and handling characteristics" in a claim drawn to a head for a lacrosse stick was not a claim limitation). Compare Jansen v. Rexall Sundown, Inc., 342 F.3d 1329, 1333-34, 68 USPQ2d 1154, 1158 (Fed. Cir. 2003) (In a claim directed to a method of treating or preventing pernicious anemia in humans by administering a certain vitamin preparation to "a human in need thereof," the court held that the preamble is not merely a statement of effect that may or may not be desired or appreciated, but rather is a statement of the intentional purpose for which the method must be performed. Thus the claim is properly interpreted to mean that the vitamin preparation must be administered to a human with a recognized need to treat or prevent pernicious anemia.); Nantkwest , Inc. v. Lee, 686 Fed. App'x 864, 867 (Fed. Cir. 2017) (nonprecedential) (The court found that the preamble phrase "treating a cancer" "’require[s] lysis of many cells, in order to accomplish the goal of treating cancer’ and not merely lysing one or a few cancer cells."); In re Cruciferous Sprout Litig., 301 F.3d 1343, 1346-48, 64 USPQ2d 1202, 1204-05 (Fed. Cir. 2002) (A claim at issue was directed to a method of preparing a food rich in glucosinolates wherein cruciferous sprouts are harvested prior to the 2-leaf stage. The court held that the preamble phrase "rich in glucosinolates" helps define the claimed invention, as evidenced by the specification and prosecution history, and thus is a limitation of the claim (although the claim was anticipated by prior art that produced sprouts inherently "rich in glucosinolates")).
During examination, statements in the preamble reciting the purpose or intended use of the claimed invention must be evaluated to determine whether or not the recited purpose or intended use results in a structural difference (or, in the case of process claims, manipulative difference) between the claimed invention and the prior art. If so, the recitation serves to limit the claim. See, e.g., In re Otto, 312 F.2d 937, 938, 136 USPQ 458, 459 (CCPA 1963) (The claims were directed to a core member for hair curlers and a process of making a core member for hair curlers. The court held that the intended use of hair curling was of no significance to the structure and process of making.); In re Sinex, 309 F.2d 488, 492, 135 USPQ 302, 305 (CCPA 1962) (statement of intended use in an apparatus claim did not distinguish over the prior art apparatus). To satisfy an intended use limitation which is limiting, a prior art structure which is capable of performing the intended use as recited in the preamble meets the claim. See, e.g., In re Schreiber, 128 F.3d 1473, 1477, 44 USPQ2d 1429, 1431 (Fed. Cir. 1997) (anticipation rejection affirmed based on Board’s factual finding that the reference dispenser (a spout disclosed as useful for purposes such as dispensing oil from an oil can) would be capable of dispensing popcorn in the manner set forth in appellant’s claim 1 (a dispensing top for dispensing popcorn in a specified manner)) and cases cited therein. See also MPEP § 2112 - MPEP § 2112.02.
However, a "preamble may provide context for claim construction, particularly, where … that preamble’s statement of intended use forms the basis for distinguishing the prior art in the patent’s prosecution history." Metabolite Labs., Inc. v. Corp. of Am. Holdings, 370 F.3d 1354, 1358-62, 71 USPQ2d 1081, 1084-87 (Fed. Cir. 2004). The patent claim at issue was directed to a two-step method for detecting a deficiency of vitamin B12 or folic acid, involving (i) assaying a body fluid for an "elevated level" of homocysteine, and (ii) "correlating" an "elevated" level with a vitamin deficiency. Id. at 1358-59, 71 USPQ2d at 1084. The court stated that the disputed claim term "correlating" can include comparing with either an unelevated level or elevated level, as opposed to only an elevated level because adding the "correlating" step in the claim during prosecution to overcome prior art tied the preamble directly to the "correlating" step. Id. at 1362, 71 USPQ2d at 1087. The recitation of the intended use of "detecting" a vitamin deficiency in the preamble rendered the claimed invention a method for "detecting," and, thus, was not limited to detecting "elevated" levels. Id.
See also Catalina Mktg. Int’l, 289 F.3d at 808-09, 62 USPQ2d at 1785 ("[C]lear reliance on the preamble during prosecution to distinguish the claimed invention from the prior art transforms the preamble into a claim limitation because such reliance indicates use of the preamble to define, in part, the claimed invention.…Without such reliance, however, a preamble generally is not limiting when the claim body describes a structurally complete invention such that deletion of the preamble phrase does not affect the structure or steps of the claimed invention." Consequently, "preamble language merely extolling benefits or features of the claimed invention does not limit the claim scope without clear reliance on those benefits or features as patentably significant."). In Poly-America LP v. GSE Lining Tech. Inc., 383 F.3d 1303, 1310, 72 USPQ2d 1685, 1689 (Fed. Cir. 2004), the court stated that "a ‘[r]eview of the entirety of the ’047 patent reveals that the preamble language relating to ‘blown-film’ does not state a purpose or an intended use of the invention, but rather discloses a fundamental characteristic of the claimed invention that is properly construed as a limitation of the claim.’" Compare Intirtool, Ltd. v. Texar Corp., 369 F.3d 1289, 1294-96, 70 USPQ2d 1780, 1783-84 (Fed. Cir. 2004) (holding that the preamble of a patent claim directed to a "hand-held punch pliers for simultaneously punching and connecting overlapping sheet metal" was not a limitation of the claim because (i) the body of the claim described a "structurally complete invention" without the preamble, and (ii) statements in prosecution history referring to "punching and connecting" function of invention did not constitute "clear reliance" on the preamble needed to make the preamble a limitation).
In this case, the recitation in question is located in the preamble and describes merely the function/purpose of the claimed device (i.e., that is configured to detect a breast mass. Further, the body of the claim appears to recite a full and complete invention for the recited function/purpose by reciting a transducer unit for transmitting and receiving ultrasound signals and a controller for controlling the transducer unit and generating an image from the received ultrasound signals. This appears to be a full and complete invention at least with respect to the aforementioned recitation of function/purpose because the transducer unit and controller is what enables the detection of breast mass; e.g., the breast mass –if it is present– would show up in an ultrasound image of the breast. Since the recitation merely describes a function/purpose (i.e., non-structural) and the body of the claim recites a full and complete invention, the preamble (more specifically the recitation of “configured to detect a breast mass”) is deemed to not be a limitation; i.e., the recitation of “configured to detect a breast mass” does not limit the claim.
Halmann does not disclose that the controller turns on only one ultrasound transducer while turning off the others within one cycle T and generates an ultrasound image based on an ultrasound signal received from the turned-on ultrasound transducer; however, this is widely-known in radar, sonar, ultrasound, and the like, as synthetic aperture imaging, more specifically monostatic synthetic aperture imaging.
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For example, the examiner cites Sumi which teaches a short overview of monostatic synthetic aperture imaging in Fig. 9 and ¶ [0302]-[0325]. Of particular note, in any one given arbitrary cycle, only a single transducer element is turned on while the rest of the transducer elements are off. In other words, in said given arbitrary cycle, the same single transducer element is used for both transmission and reception to generate imaging data. The cycle starts with the first element on the left and is repeated for next transducer element to the right, and each transducer element thereafter until imaging data has been collected for every transducer element.
Therefore, Sumi can be considered to teach that the controller turns on only one ultrasound transducer while turning off the others within one cycle T and generates an ultrasound image based on an ultrasound signal received from the turned-on ultrasound transducer (claim 1); that the controller turns on only a first ultrasound transducer in a first cycle and turns on only a second ultrasound transducer in a second cycle, and on-periods of the first and second ultrasound transducers do not overlap (claim 2); that the N number of ultrasound transducers of the ultrasound transducer unit sequentially and individually transmits the ultrasound signals to the controller (claim 5); and the controller receives the ultrasound signals sequentially and individually from the N number of ultrasound transducers and generates the ultrasound images sequentially and individually (claim 6).
The ordinarily skilled artisan would have recognized that the monostatic synthetic aperture imaging technique provides advantages over other techniques such as the multistatic synthetic aperture, phased array, etc. such as simplicity (single transducer per cycle reduces hardware complexity), fast scanning (the same element can be used for both transmit and receive, enabling rapid data acquisition), real-time potential (efficient reconstruction algorithms (e.g., FFT-based) can make the method suitable for real-time imaging), and good dynamic resolution.
It would have been obvious to one having ordinary skill in the art to modify the invention of Halmann such that the controller turns on only one ultrasound transducer while turning off the others within one cycle T and generates an ultrasound image based on an ultrasound signal received from the turned-on ultrasound transducer (claim 1); that the controller turns on only a first ultrasound transducer in a first cycle and turns on only a second ultrasound transducer in a second cycle, and on-periods of the first and second ultrasound transducers do not overlap (claim 2); that the N number of ultrasound transducers of the ultrasound transducer unit sequentially and individually transmits the ultrasound signals to the controller (claim 5); and the controller receives the ultrasound signals sequentially and individually from the N number of ultrasound transducers and generates the ultrasound images sequentially and individually (claim 6), as taught by Sumi as part of the monostatic synthetic aperture technique; and the ordinarily skilled artisan would have been motivated to make this modification in order to realize advantages thereof such as simplicity, fast scanning, real-time potential, and good dynamic resolution.
Regarding claims 4 and 7: In phased-array techniques, signal phases of the N elements of the transducer array are adjusted (by modifying/adjusting the control signals that controls the transducer elements) so that the ultrasound signals of the elements constructively and destructively interfere to form a beam (i.e., beamforming and beam steering, including adjusting the angle/direction of the beam and the depth of the focus, etc.). The ordinarily skilled artisan would understand that the timing of the signal phases (by adjusting the timing of the control signals) depends on a variety of factors including the number of elements, the shape/cross-sectional size of the elements, the spacing between the elements, the desired depth of focus, the desired steering angle, etc.
However, in monostatic synthetic aperture imaging, the transducer elements are activated one at a time. Therefore, the ultrasound signals themselves (i.e., the actual ultrasonic waves propagating through the medium) of the various transducer elements in the transducer array do not constructively and destructively interfere to form a beam; i.e., the ultrasound signal of one transducer element does not constructively and destructively interfere with that of another transducer element because the ultrasound signals of different transducer elements are transmitted and received during different cycles. As such, there is no need for the phases or the control signals that determine the phases to depend on the number of elements, the shapes and cross-sectional sizes of the transducer elements, and the spacing therebetween. It therefore would have been obvious to determine phase differences and have the control signals be independent of (i.e., not necessarily dependent on) the number N, the shapes and cross-sectional sizes of the ultrasound transducers, the spacing therebetween, and any other parameter related to beamforming and/or beam steering for that matter.
Regarding claims 8 and 9: Halmann further discloses a movement speed sensing unit configured to sense a movement speed of the contact area in contact with the breast and generate movement speed information wherein the movement speed sensing unit includes at least one of a speed calculator that calculates a speed of the handheld ultrasound device based on a change in the received ultrasound signal, an acceleration sensor, or an optical sensor (“The processor 116 can calculate a velocity at which the probe 106 is moved by dividing the estimated distance that the probe 106 is moved (e.g., based on how much image data of additional portions of the person 204 are acquired) by the time period over which the probe 106 is moved. Alternatively, the probe 106 can include one or more sensors, such as accelerometers, that can output data signals indicative of how rapidly the probe 106 is moving.” ¶ [0049])
Regarding claim 12-17: These dependent claims further specify features of the external device; however, the external device is not part of the claimed invention. Therefore, claims 12-17 do not appear to actually further limit the device of claim 1. Therefore, claims 12-17 are also found to be obvious for the same reasons as claim 1.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Halmann in view of Sumi as applied to claim 1 above, and further in view of Shung, Diagnostic Ultrasound: Imaging and Blood Flow Measurements, second edition, CRC Press, Taylor & Francis Group, 2015 (hereinafter “Shung”).
Regarding claim 3: Halmann/Sumi does not teach that the cycle T is determined based on a value obtained by dividing a measurement depth of the ultrasound transducer by a propagation speed of ultrasound in the breast; however, this is well-understood, routine, and conventional in ultrasound.
Shung is a textbook used in undergraduate and graduate level studies in biomedical engineering. Shung teaches on page 105:
“A-mode is the simplest and earliest mode of ultrasonic imaging. A block diagram for A-mode instruments is shown in Figure 4.1. A signal gen-erator that produces high-amplitude short pulses or a pulser is used to excite a single-element transducer. Two types of pulses may be used: spike and multicycle, illustrated in Figure 4.2. A spike yields wider bandwidth, whereas multicycle bursts provide more energy and allow tuning capability. The returned echoes from the tissues are detected by the same transducer, amplified, and processed for display. The pulses are repeatedly transmitted typically at a rate of a few kHz, which is called pulse repetition frequency (PRF). PRF determines the depth of penetration of the pulse. In order to avoid range ambiguity, all echoes from targets of interest must be received before the next pulse is trans-mitted. Otherwise, uncertainty of the actual distance between the echo and source may arise.”
Shung further teaches on pages 115-116:
For most of the B-mode scanners, only one ultrasound pulse is being transmitted at any one instant of time. As seen from Figure 4.15, the time needed to form one frame of image,
t
f
, can be readily calculated from the following equation:
t
f
=
2
D
N
c
(4.1)
where D is the depth of penetration determined by the pulse repetition frequency of the pulser, N is the number of scan lines in the image, and c is the sound speed in tissue. Rearranging this equation,
F
D
N
=
c
2
(4.1)
where F = 1/
t
f
is the frame rate. The depth of penetration D is specified by the pulse repetition period of the scanner, which should be long enough to allow all the echoes of interest to be detected. Range ambiguity can result if the pulse repetition period is too short. For instance, range ambiguitycan occur, i.e., it is not clear which pulse causes the echo from the object, if the time of flight from an object of interest is longer than the pulse repeti-tion period. Looking at Equation (4.2), it is readily apparent that to change any one of these parameters, F, D, and N, the rest will be affected because sound velocity in tissues is assumed to be a constant. One example is that if the depth of penetration is increased, either the frame rate or the number of scan lines will have to be reduced.
The ordinarily skilled artisan would understand that the time for a single cycle, T, is the time needed for a one frame,
t
f
, divided by the number of scan lines, N, in each frame.
T
=
t
f
N
Rearranging equation 4.1, we get:
t
f
N
=
2
D
c
Therefore:
T
=
2
D
c
In other words, the time of a single cycle, T, should be twice the depth of penetration (measurement depth), D, divided by the speed of sound, c, in the medium.
It therefore would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to determine the cycle time T based on a value obtained by dividing a measurement depth of the ultrasound transducer by a propagation speed of ultrasound in the particular medium being imaged (in the case of breast, the speed of sound in breast), as is well understood, routine, and conventional (as evidenced by Shung) for the purposes of avoiding range ambiguity (i.e., avoiding uncertainty of the actual distance between the echo and source) by ensuring all echoes from targets of interest are received before the next pulse is transmitted.
Claim 10, 11, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Halmann in view of Sumi as applied to claim 1 above, and further in view of Murakami et al., JP 2015-62453 A (hereinafter “Murakami”).
Regarding claims 10: Halmann does not teach that N is natural number between 3 and 10, and the N number of ultrasound transducers are arranged in a zigzag pattern in two rows.
Murakami teaches an ultrasound array comprising N number of ultrasound transducers arranged in a zigzag pattern in two rows (K rows between 1 and n-1 which is inclusive of 2 rows; Figs. 4-7, ¶ [0009]-[0023], [0031]) where N is natural number between 3 and 10 (n is an integer of 2 or more, ¶ [0006] which overlaps with the claimed range of 3-10). Murakami teaches that this arrangement improves the resolution of the image without needing to reduce element size (¶ [0005], [0007]), where a reduction in element size increases cost and manufacturing load (¶ [0002]).
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It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to further modify the invention of Halmann such that N is natural number between 3 and 10, and the N number of ultrasound transducers are arranged in a zigzag pattern in two rows, as taught by Murakami; and the ordinarily skilled artisan would have been motivated to make this modification in order to improve without needing to reduce element size in order to avoid costs and manufacturing load associated with a reduction in element size.
Regarding claim 11: By implementing the Murakami’s zigzag pattern in two rows in the modified invention of Halmann as discussed above regarding claim 10, the ordinarily skilled artisan would have recognized that the first and third ultrasound transducers (UE1 and UE3 in Murakami’s Fig. 5) would be arranged in a first row (top row in Murakami’s Fig. 5) and the second transducer (UE2 in Murakami’s Fig. 5) would be arranged in a second row (bottom row in Murakami’s Fig. 5) between the first and second ultrasound transducers.
Regarding the limitation of “the second ultrasound transducer measures a blind spot at edges of the first and third ultrasound transducers”, this feature appears to be an inherent property or result of the zigzag arrangement discussed above as evidenced by Applicant’s own specification which recites in part:
[00113] A plurality of ultrasound transducers 310 and 320 included in the ultrasound transducer unit 300 may be arranged in two rows as shown in FIG. 8A. When the ultrasound transducers 310 and 320 in the ultrasound transducer unit 300 are arranged in two or more rows, the ultrasound transducers 310 may be arranged in a zigzag pattern in each row as shown in FIG. 8A. This arrangement can reduce blind spots caused by the spacing between the ultrasound transducers 310 during operation. For example, in areas corresponding to spacings S between adjacent ultrasound transducers 131 in a first row, it may be difficult to accurately receive ultrasound signals with the ultrasound transducers 311 in the first row. However, if ultrasound transducers 312 in a second row are arranged corresponding in position to the spacings S between the ultrasound transducers 311 in the first row, they can receive ultrasound signals in the uncovered areas corresponding to the spacings S.
[00114] When the ultrasound transducers of the ultrasound transducer unit 300 are arranged in two or more rows, first and third ultrasound transducers may be arranged in a first row and second ultrasound transducers may be arranged in a second row. In this case, the ultrasound transducers arranged in the second row may be desirably arranged to scan areas corresponding to spacings between the first and third ultrasound transducers. This arrangement allows the second ultrasound transducers to measure blind spots at edges of the first and third ultrasound transducers. Although FIG. 8A and FIG. 8B illustrate an example where the ultrasound transducer unit 300 includes five ultrasound transducers, the number of ultrasound transducers may be adjusted between 3 and 10 depending on the design.
Applicant’s Specification seems to make the case that the blind spot feature (i.e., the second transducer being able to measure the blind spot at the edges of and between the first and third transducer) is enabled by zigzag pattern itself which places the second transducer somewhat between the first and third transducers at the edges thereof. Since the prior art as discussed above teaches the same arrangement as disclosed and claimed, it is assumed that the structure of the prior art can therefore also perform the same as claimed.
Regarding claim 19: see above regarding claim 10 which addresses N being a natural number between 3 and 10 which is narrower than the range claimed in claim 19 (between 2 and 10).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Halmann in view of Sumi as applied to claim 1 above, and further in view of Yoo et al., US 2011/0079082 A1 (hereinafter “Yoo”).
Regarding claim 18: Halmann modified in view of the teachings of Sumi teaches the invention of claim 1; but does not teach that the controller detects an axial movement along a vertical direction while the contact area moves in contact with the breast in a horizontal direction, and generates the ultrasound images by correcting the received ultrasound signals based on the detected axial movement.
Yoo teaches a controller detects an axial movement along a vertical direction while the contact area moves in contact with the breast in a horizontal direction, and generates the ultrasound images by correcting the received ultrasound signals based on the detected axial movement (displacement vectors between T plane, S plane, and C plane are calculated and used to correct alignment between successive image frames ¶ [0029]-[0032]; where Figs. 3-5 show the relation of the planes as being both vertical and horizontal and the movement directions including "up", "down", "left" and "right" which encompasses "axial" movement). Yoo further teaches that without alignment of acquired frames the resultant image will have geometric distortions (¶ [0002]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to further modify the invention of Halmann such that the controller detects an axial movement along a vertical direction while the contact area moves in contact with the breast in a horizontal direction, and generates the ultrasound images by correcting the received ultrasound signals based on the detected axial movement, as taught by Yoo; and the ordinarily skilled artisan would have been motivated to make this modification in order to prevent geometric distortions in the resultant image.
Additional Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Noguchi et al. US 2020/0170624 A1: relevant for teaching breast diagnosis using ultrasound
Ramamurthy, US 2019/0183457 A1: relevant for teaching PACS workstations separate from (i.e., external to) the ultrasound imaging apparatus (e.g., see Fig. 1)
Goksel, US 2018/0263595 A1: relevant for teaching breast ultrasound
Robinson et al., US 10,074,199 B2: relevant for teaching breast ultrasound
Tadayyon et al., US 2018/0189947 A1: relevant for teaching breast ultrasound
Hunter et al., US 2018/0000453 A1: relevant for teaching breast ultrasound including displaying the size of the mass (e.g., see Fig. 5).
Fear et al., US 2010/0113921 A1: relevant for teaching monostatic radar for imaging the breast.
Tierney et al., US 2017/0135675 A1: relevant for teaching axial/depth correction.
Cahill et la., US 7,738,683 B2: relevant for teaching ultrasound imaging-based abnormality detection and differentiating benign/malignant lesions using trained image classifiers.
Conclusion
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COLIN T. SAKAMOTO
Primary Examiner
Art Unit 3798
/COLIN T. SAKAMOTO/Primary Examiner, Art Unit 3798
9 June 2026
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