DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
This action is in response to Applicant’s remarks, filed on 5/21/2026, and subsequent correspondence. The amendments to claim(s) 1, 4-6, 12, 14-15, 18, 21-22 and 25 have been entered. Claim(s) 3, 7, 9-11, 16 and 20 were cancelled by Applicant and therefore withdrawn from further consideration pursuant to 37 CFR 1.142(b). Claims 2, 19 and 23 were withdrawn by Applicant. New claim(s) 26-28 have been entered. Accordingly, claim(s) 1, 4-6, 8, 12-15, 17-18, 21-22 and 24-28 remain pending for examination.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 4/23/2026 and 6/5/2026 was filed after the mailing date of the Non-Final office action on 1/23/2026. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Arguments
Applicant’s arguments, see p. 6-14, with respect to claim(s) 1, 4-6, 8, 12-15, 17-18, 21-22 and 24-25 have been fully considered.
Regarding the objections(s) to claims 14 and 18, Examiner respectfully agrees with the Applicant and the prior objections have been withdrawn. After review of the Applicant’s remarks regarding the rejection for Nonstatutory Obviousness-Type Double Patenting to the claim(s), Examiner respectfully agrees with the Applicant and maintains the previous rejection. Regarding the interpretation(s) under 35 U.S.C. §112(f), Examiner respectfully agrees with Applicant and maintains the prior interpretations.
Regarding the rejection(s) under 35 U.S.C. § 112, Examiner respectfully disagrees with the remarks and does not find Applicant’s arguments persuasive. The prior 35 U.S.C. §112(b) rejections have been withdrawn; however, new rejections under 35 U.S.C. § 112 are presented in view of the amendments to the claim language and Applicant’s instant specification. Regarding the rejection(s) under 35 U.S.C. § 101, Examiner respectfully agrees with the amendments to the claim(s). The prior 35 U.S.C. § 101 rejections have been withdrawn.
New grounds of rejection are made in view of the following: new amendments provided by Applicant and attached remarks; updated search and review of pertinent, eligible prior art; newly added claims; and/or different interpretation of the previously applied references. Regarding the rejection of claim(s) 1, 4-6, 8, 12-15, 17-18, 21-22 and 24-25 under 35 U.S.C. § 102, Applicant provides the following:
Independent Claim 1
Independent claim 1 has been amended to recite:
... and a second communication channel providing to an operator instructions
from the trained health care professional arc provided in real time visually on a display
screen or audibly from speakers by a trained health care professional located at a remote
terminal. (Amendments indicated).
Prior to the amendments herein, the Patent Office asserts the above limitation is disclosed by paragraphs [0120], [0123]-[0164], and [0208]-[0213] of Rothberg and FIG. 11 of Rothberg. Office Action, pp. 19-21. Applicant submits that Rothberg fails to teach or suggest the above limitations as amended herein.
In particular, at page 21 of the Office Action, the Patent Office presents FIG. 11 of Rothberg and the following explanation:
However, Rothberg only refers to a "medical professional" eight times throughout the description of Rothberg. These eight instances have been reproduced below:
[…]
Thus, the assertion by the Patent Office that a "... medical professional receives
ultrasound data in real-time and transmits data to guide acquisition of ultrasound images to the operator of ultrasound device, wherein a host device present images and instructions to the operator (Rothberg [fig. 11])" is inconsistent with the actual teachings of the Rothberg reference.
These passages from Rothberg reproduced hereinabove make it clear that Rothberg never teaches or suggests "a second communication channel providing to an operator instructions from the trained health care professional in real time visually on a display screen or audibly from speakers" as recited in amended claim 1.
In particular, paragraph [0209] of Rothberg discloses "[i]n some embodiments, an
individual (e.g., a remote expert operating a remote processing device) may generate or select the predetermined path and transmit the path (or an indication thereof) to the host device." Applicant submits that paragraph [0209] of Rothberg fails to teach or suggest "a second communication channel providing to an operator instructions from the trained health care professional in real time visually on a display screen or audibly from speakers." Specifically, there is no indication by Rothberg of a real-time transmission. For at least the foregoing reasons, Applicant submits that claim 1 is patentably distinct from the cited art.
Applicant has provided no evidence to establish an unobvious difference between the claimed product and the prior art, but rather has merely argued such alleged difference. Mere arguments can not take the place of evidence. In re Walters, 168 F.2d 79,80, 77 USPQ 609,610 (CCPA 1948); In re Cole, 326 F.2d. 769,773, 140 USPQ 230,233 (CCPA 1964); In re Schulze, 346 F.2d 600,602, 145 USPQ 716,718 (CCPA 1965); In re Lindner, 457 F.2d 506,508, 173 USPQ 356,358 (CCPA 1972); In re Pearson, 494 F.2d 1399,1405, 181 USPQ 641,646 (CCPA 1974); Meitzner v. Mindick, 549 F.2d 775,782, 193 USPQ 17,22 (CCPA), cert. Denied, 434 U.S. 854 (1977); In re DeBlauwe, 736 F.2d 699,705, 222 USPQ 191,196 (Fed. Cir. 1984). Applicant's arguments do not comply with 37 CFR 1.111(c) because they do not clearly point out the patentable novelty which he or she thinks the claims present in view of the state of the art disclosed by the references cited or the objections made. Further, they do not show how the amendments avoid such references or objections.
Applicant submits that Rothberg fails to teach or suggest the limitations as amended, specifically the limitations “and a second communication channel providing to an operator instructions from the trained health care professional arc provided in real time visually on a display screen or audibly from speakers Examiner respectfully disagrees with the Applicant, and respectfully maintains that Rothberg teaches the claimed invention. The systems provided by Rothberg facilitate two-way communication between a remotely located medical professional and the operator of the ultrasound device (Rothberg [0120]). Rothberg further provides:
“In some embodiments, a medical professional (e.g., a doctor, nurse, or imaging technician) or another individual, who may be remote, may receive the ultrasound data and determine which is the target ultrasound data and which is the non-target ultrasound data (e.g., by viewing ultrasound images generated from the ultrasound data).”
[0120]
“The input/output (I/O) devices 1203 may be configured to facilitate communication with other systems and/or an operator. […] Example I/O devices that may facilitate communication with other systems include wired and/or wireless communication circuitry such as BLUETOOTH, ZIGBEE, WiFi, and/or USB communication circuitry.”
[0131]
“The host device 1302 may be configured to process the ultrasound data from the ultrasound device 1314 to generate ultrasound images for display on the display screen 1308. The processing may be performed by, for example, the processor 1310. The processor 1310 may also be adapted to control the acquisition of ultrasound data with the ultrasound device 1314. The ultrasound data may be processed in real-time during a scanning session as the echo signals are received.”
[0139]
“In some embodiments, the host device 1302 may communicate with one or more external devices via the network 1316. The host device 1302 may be connected to the network 1316 over a wired connection (e.g., via an Ethernet cable) and/or a wireless connection (e.g., over a WiFi network). As shown in FIG. 13, these external devices may include servers 1318, workstations 1320, and/or databases 1322. The host device 1302 may communicate with these devices to, for example, off-load computationally intensive tasks. For example, the host device 1302 may send ultrasound data over the network 1316 to the server 1318 to be transformed into ultrasound image and analyzed (e.g., to identify whether the ultrasound images contain a target anatomical view).”
[0143] (emphasis added)
The Applicant asserts that “These passages from Rothberg reproduced hereinabove make it clear that Rothberg never teaches or suggests "a second communication channel providing to an operator instructions from the trained health care professional in real time visually on a display screen or audibly from speakers" as recited in amended claim 1.” In response to Applicant's argument, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
As demonstrated by the teachings of Rothberg, a medical professional may provide instructions to a user of the ultrasound device in real time. The ‘communication link’ between the ultrasound device and host device, and the input/output devices which connect the host device with the network, constitute a first communication channel. The connection of a medical professional’s external device (e.g., a workstation, remote server, etc.) with the network constitute the second channel of communication. Rothberg clearly teaches real time two-way communication between a local ultrasound device user and a remotely located medical professional (Rothberg [fig. 13], [see claim 1 rejection]).
Examiner respectfully notes that Applicant’s arguments only address independent claim(s) 1, and no remarks regarding the subject matter of the dependent claim(s) have been presented. Accordingly, the rejections to dependent claims 4-6, 8, 12-15, 17-18, 21-22, 24-25 are modified to address Applicant’s amendments and the new rejection to independent claim(s) 1 and are sustained. New claims 26-28 are rejected as provided below. The rejections of claim(s) 1, 4-6, 8, 12-15, 17-18, 21-22 and 24-28 under 35 U.S.C. § 102 and 35 U.S.C. §103 are maintained.
CLAIM INTERPRETATION
35 U.S.C. 112(f)
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.
Claim limitations which use the word “means” are found in the following:
“vii) a user interface comprising means to accept user's instructions; and” in claim 12. Upon review of the Applicant’s specification, the instant disclosure provides:
“vii) a user interface comprising a display screen and means to accept user's instructions, e.g. a keyboard or touch screen;”
[p.14, ln.27-28] (emphasis added)
For the purposes of examination, any keyboard or touch screen meets the present “means” limitation.
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:
“electronic components for wired or wireless communication with remote terminals” in claim 8. Upon review of the Applicant’s specification, the instant disclosure provides:
“communication components can be provided as separate integrated circuits (ICs) or integrated into one or more ASICs that comprise at least some of the ICs”
[p.4, ln.19-20] (emphasis added)
For the purposes of examination, any integrated circuit or ASIC meets the present “electronic component” limitation.
“device component adapted to store” in claim 12. Upon review of the Applicant’s specification, the instant disclosure provides:
“memory device […] memory devices, and communication components can be provided as separate integrated circuits (ICs) or integrated into one or more ASICs that comprise at least some of the ICs.”
[p.4, ln.4, 17-19] (emphasis added)
For the purposes of examination, any ‘memory device’ meets the present “device component” limitation.
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.
Claim Rejections - 35 USC § 112
35 USC § 112(b)
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.
Claim(s) 6 is/are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 6 recites the limitation "a housing that is ergonomically designed to be held by an operator and moved". There is insufficient antecedent basis for this limitation in the claim. The use of ‘an operator’ may be interpreted as either the ‘operator’ recited in claim 1 or to a new and distinct ‘operator’ of the system. It is suggested to amend the claim to clearly point out which ‘operator’ performs the scan (e.g., –a housing that is ergonomically designed to be held by [[an]]the operator and moved–).
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 4-6, 8, 12-15, 17-18, 21-22 and 24-26 is/are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being clearly anticipated by Rothberg et al. (US20190059851A1, 2019-02-28; hereinafter “Rothberg”).
Regarding claim 1, Rothberg teaches a system for acquiring ultrasound images of an organ of a human body (“an exemplary system 1100 for collecting ultrasound data from a subject” [0123]; [0123-0164], [fig. 11, 13-15, 20]), comprising
a scanner providing image data (“the ultrasound device 1102” [0123]; “The ultrasound device 1314 may be configured to generate ultrasound data that may be employed to generate an ultrasound image.” [0134]; The ultrasound device (i.e., scanner) is in communication with a host device [0123-0164], [fig. 11, 13-15, 18; see fig. 11 reproduced below]) and
at least one inertial measurement unit (IMU) associated therewith providing additional data (“The ultrasound device 1314 includes ultrasound circuitry 1324, […] and a motion and/or orientation sensor 1332.” [0133]; “The motion and/or orientation sensor 1332 may be configured to generate motion and/or orientation data regarding the ultrasound device 1314. […] The motion and/or orientation sensor 1332 may include an accelerometer, a gyroscope, and/or a magnetometer.” [0137]; The motion and/or orientation sensor (i.e., IMU) comprised within ultrasound device generates data describing the motion and orientation of the ultrasound device during an ultrasound examination [0123-0164], [fig. 11, 13-15]), and
a first communication channel providing a trained health care professional located at a remote location with an output of image analysis circuitry receiving said image data and said additional data (“a medical professional (e.g., a doctor, nurse, or imaging technician) or another individual may generate the predetermined path and load/cause to be loaded the predetermined path onto the host device. For example, an individual operating a remote processing device may select or generate the predetermined path and transmit the predetermined path to the host device local to the ultrasound device.” [0113]; “a medical professional (e.g., a doctor, nurse, or imaging technician) or another individual, who may be remote, may receive the ultrasound data and determine which is the target ultrasound data and which is the non-target ultrasound data (e.g., by viewing ultrasound images generated from the ultrasound data).” [0120]; “The host device 1302 may communicate with one or more external devices over a network 1316. For example, the host device 1302 may communicate with one or more workstations 1320, servers 1318, and/or databases 1322. [0133]; “The processing circuitry 1326 may control operation of the ultrasound device 1314, and in particular, operation of the ultrasound circuitry 1324, the memory circuitry 1328, and the communication circuitry 1330.” [0136]; [0123-0164, 0208-0213], [fig. 11, 13-15, 18, 20; see fig. 11, 13 reproduced below]), and
a second communication channel providing, to an operator, instructions from the trained health care professional in real time visually on a display screen or audibly from speakers (“The communication circuitry 1330 may include an antenna and circuitry capable of transmitting and receiving signals according to a certain wireless communication protocol […] and/or a data connector port for accepting a data connector of a particular type and circuitry capable of transmitting and receiving signals according to a certain protocol.” [0136]; “The ultrasound data may be processed in real-time during a scanning session as the echo signals are received.” [0139]; “the host device 1302 may be configured to provide instructions to an operator of the ultrasound device 1314 for moving the ultrasound device 1314 in order to collect ultrasound data.” [0140]; “the host device 1302 may communicate with one or more external devices via the network 1316 […] external devices may include servers 1318, workstations 1320, and/or databases 1322.” [0143]; “an individual (e.g., a remote expert operating a remote processing device) may generate or select the predetermined path and transmit the path (or an indication thereof) to the host device.” [0209]; Ultrasound data and motion/orientation data may be processed and transmitted to a medical professional at a remote processing device (i.e., remote terminal) via network in real-time, wherein the medical professional may transmit a path and instructions for capturing ultrasound images to the operator’s host device via network communication [0123-0164, 0208-0213], [fig. 11, 13-15, 18, 20; see fig. 11, 13 reproduced below]).
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The ultrasound device operator transmits ultrasound data from host device to medical professional at external location in real-time over a network, wherein instructions from medical professional are transmitted to operator to guide acquisition of ultrasound images (Rothberg [fig. 11, 13])
Regarding claim 4, Rothberg teaches the system according to claim 1,
Rothberg further teaching wherein the at least one IMU is associated with the scanner and moving therewith during operation (“The ultrasound device 1314 includes ultrasound circuitry 1324, […] and a motion and/or orientation sensor 1332.” [0133]; “The motion and/or orientation sensor 1332 may be configured to generate motion and/or orientation data regarding the ultrasound device 1314.” [0137]; [0123-0164], [fig. 11, 13-15], [see claim 1 rejection]).
Regarding claim 5, Rothberg teaches the system of claim 1,
Rothberg further teaching wherein the system is configured to issue instructions to the operator of the system, said instructions allowing scans to be performed by persons not trained for ultrasound scanning (“a medical professional (e.g., a doctor, nurse, or imaging technician) or another individual, who may be remote, may receive the ultrasound data and determine which is the target ultrasound data and which is the non-target ultrasound data (e.g., by viewing ultrasound images generated from the ultrasound data).” [0120]; “the host device 1302 may be configured to provide instructions to an operator of the ultrasound device 1314 for moving the ultrasound device 1314 in order to collect ultrasound data.” [0140]; “the host device 1302 may communicate with one or more external devices via the network 1316 […] external devices may include servers 1318, workstations 1320, and/or databases 1322.” [0143]; “In some embodiments, an individual (e.g., a remote expert operating a remote processing device) may generate or select the predetermined path and transmit the path (or an indication thereof) to the host device.” [0209]; The operator of the ultrasound device may be untrained in how to use the ultrasound device to capture the desired ultrasound image [0050, 0123-0164, 0208-0213], [fig. 11, 13-15, 18, 20], [see claim 1 rejection]).
Regarding claim 6, Rothberg teaches the system of claim 1,
Rothberg further teaching wherein the scanner comprises a housing that is ergonomically designed to be held by an operator and moved across the skin (“The ultrasound device 1102 may be implemented in any of variety of ways. For example, the ultrasound device 1102 may be implemented as a handheld device” [0124]; “The ultrasound device 1314 includes ultrasound circuitry 1324, processing circuitry 1326, memory circuitry 1328, communication circuitry 1330, and a motion and/or orientation sensor 1332.” [0133]; The ultrasound device may be embodied in a handheld device containing circuitry, transducer elements and sensors [0123-0164], [fig. 11, 13-15, 18], [see claim 1 rejection])
Regarding claim 8, Rothberg teaches the system of claim 6,
Rothberg further teaching wherein components in, or associated with the housing are: i) an ultrasound probe head of said scanner (“The ultrasound circuitry 1324 may include one or more ultrasonic transducers monolithically integrated onto a single semiconductor die.” [0135]; “the ultrasound device 1400 may include one or more transducer arrangements (e.g., arrays) 1402,” [0144]; [0123-0164], [fig. 11, 13-15, 18; see fig. 18 reproduced below]);
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‘Probe head’ of ultrasound device comprising transducer elements (Rothberg [fig. 18], annotated)
ii) the at least one IMU, which comprises a three-axis accelerometer and a three-axis gyroscope (“The ultrasound device may include an accelerometer, a gyroscope, and/or a magnetometer” [0090]; “The motion and/or orientation sensor 1332 may include an accelerometer, a gyroscope, and/or a magnetometer. Depending on the sensors present in the motion and/or orientation sensor 1332, the motion and/or orientation data generated by the motion and/or orientation sensor 1332 may describe three degrees of freedom, six degrees of freedom, or nine degrees of freedom for the ultrasound device 1314. For example, the motion and/or orientation sensor may include an accelerometer, a gyroscope, and/or magnetometer. Each of these types of sensors may describe three degrees of freedom.” [0137]; The motion and/or orientation sensor may comprise an accelerometer and a gyroscope, wherein the accelerometer and gyroscope may generate data describing three degrees of freedom (i.e., three-axis) each respectively [0123-0164], [fig. 11, 13-15, 18]);
iii) electronic components for wired or wireless communication with remote terminals (“the ultrasound system 1300 includes an ultrasound device 1314 in wired and/or wireless communication with a host device 1302. The ultrasound device 1314 includes ultrasound circuitry 1324, processing circuitry 1326, memory circuitry 1328, communication circuitry 1330,” [0133]; “The communication circuitry 1330 may be configured to enable communication between the ultrasound device 1314 and the computing device 1302.” [0136]; “the host device 1302 may communicate with one or more external devices via the network 1316. The host device 1302 may be connected to the network 1316 over a wired connection (e.g., via an Ethernet cable) and/or a wireless connection (e.g., over a WiFi network).” [0143]; “The handheld device 1820 may be configured to transmit data collected by the device 1820 wirelessly to one or more external device for further processing. In other embodiments, the handheld device 1820 may be configured transmit data collected by the device 1820 to one or more external devices using one or more wired connections,” [0168]; [0123-0164], [fig. 11, 13-15; see fig. 13 reproduced below]), and
iv) a power source (“the ultrasound device 1400 may include one or more transducer arrangements (e.g., arrays) 1402, […] a power management circuit 1418,” [0144]; “The power management circuit 1418 may, for example, be responsible for converting one or more input voltages VIN from an off-chip source into voltages needed to carry out operation of the chip, and for otherwise managing power consumption within the device 1400 [...] the power management circuit 1418 may step that voltage up or down, as necessary, using a charge pump circuit” [0150]; The power management circuit of ultrasound device may use a charge pump which comprises capacitors [0123-0164], [fig. 11, 13-15]).
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(Rothberg [fig. 13])
Regarding claim 12, Rothberg teaches the system of claim 1,
Rothberg further teaching comprising: v) an Analog Front End (AFE) that transmits and receives ultrasound signals (“The ultrasound circuitry 1324 may be configured to generate the ultrasound data. […] the ultrasonic transducers may be formed the same chip as other electronic components in the ultrasound circuitry 1324 (e.g., transmit circuitry, receive circuitry, control circuitry, power management circuitry, and processing circuitry) to form a monolithic ultrasound device.” [0135]; “the ultrasound device 1400 may include one or more transducer arrangements (e.g., arrays) 1402, transmit (TX) circuitry 1404, receive (RX) circuitry 1406, a timing and control circuit 1408, a signal conditioning/processing circuit 1410,” [0144]; The ultrasound device includes transducer arrays and transmit TX and receive RX circuitry (i.e., AFE) which drive the transducers to generate ultrasonic pulses and to receive and process electronic signals generated by the transducer array, respectively [0123-0164], [fig. 11, 13-15; see fig. 14 reproduced below]);
vi) a processor containing software (“The host device 1104 may include one or more processing elements (such as a processor), for example, to provide instructions for moving the ultrasound device 1102 relative to the subject 1101.” [0126]; “The processing circuitry 1326 may control operation of the ultrasound device 1314 […] To perform any of the functionality of the ultrasound device 1314 described herein, the processing circuitry 1326 may execute one or more processor-executable instructions stored in one or more non-transitory computer-readable storage media (e.g., the memory circuitry 1328),” [0136]; [0123-0164], [fig. 11, 13-15]);
vii) a user interface comprising means to accept user's instructions (“the host device 1302 may be configured to perform any of the processes described herein (e.g., using the processor 1310) and/or display any of the user interfaces described herein (e.g., using the display screen 1308).” [0140]; [0123-0164], [fig. 11, 13-15], [see claim 1 rejection]); and
viii) device component adapted to store data and images processed by the software in the processor (“The ultrasound device 1314 includes ultrasound circuitry 1324, processing circuitry 1326, memory circuitry 1328, […] The host device 1302 includes an audio output device 1304, an imaging device 1306, a display screen 1308, a processor 1310, a memory 1312,” [0133]; “The memory circuitry 1328 may include non-transitory computer-readable storage media.” [0136]; “the host device 1302 may include one or more processors 1310 (e.g., computer hardware processors) and one or more articles of manufacture that include non-transitory computer-readable storage media such as the memory 1312.” [0140]; [0123-0164], [fig. 11, 13-15; see fig. 14 reproduced below]).
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(Rothberg [fig. 14])
Regarding claim 13, Rothberg teaches the system of claim 12,
Rothberg further teaching wherein the AFE comprises transmitters, receivers, amplifiers, and analog to digital (A/D) and digital to analog (D/A) converters (“The ultrasound circuitry 1324 may be configured to generate the ultrasound data. […] the ultrasonic transducers may be formed the same chip as other electronic components in the ultrasound circuitry 1324 (e.g., transmit circuitry, receive circuitry, control circuitry, power management circuitry, and processing circuitry) to form a monolithic ultrasound device.” [0135]; “the ultrasound device 1400 may include one or more transducer arrangements (e.g., arrays) 1402, transmit (TX) circuitry 1404, receive (RX) circuitry 1406, a timing and control circuit 1408, a signal conditioning/processing circuit 1410,” [0144]; “the RX circuitry 1406 for a respective transducer element 1502 includes an analog processing block 1518, an analog-to-digital converter (ADC) 1520, and a digital processing block 1522.” [0162]; [0123-0164], [fig. 11, 13-15; see fig. 15 reproduced below], [see claim 12 rejection]).
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(Rothberg [fig. 15])
Regarding claim 14, Rothberg teaches the system of claim 12,
Rothberg further teaching wherein the processor responds to software instructions to operate the system and to receive and process ultrasound signals received from the AFE to produce ultrasound images and the processor receives and processes inertial measurement signals from the IMU in accord with software instructions (“The processing circuitry 1326 may control operation of the ultrasound device 1314, and in particular, operation of the ultrasound circuitry 1324, the memory circuitry 1328, and the communication circuitry 1330. As one example, the processing circuitry 1326 may control collection of ultrasound data by the ultrasound device 1314. […] To perform any of the functionality of the ultrasound device 1314 described herein, the processing circuitry 1326 may execute one or more processor-executable instructions stored in one or more non-transitory computer-readable storage media (e.g., the memory circuitry 1328)” [0136]; “The host device 1302 may be configured to process the ultrasound data from the ultrasound device 1314 to generate ultrasound images for display on the display screen 1308. The processing may be performed by, for example, the processor 1310. The processor 1310 may also be adapted to control the acquisition of ultrasound data with the ultrasound device 1314.” [0139]; The processing circuitry of the ultrasound device controls the TX/RX circuitry to acquire ultrasound data, wherein the host device may process ultrasound data and motion/orientation data to generate ultrasound images and operator instructions [0123-0164], [fig. 11, 13-15], [see claim 1, 12 rejections]).
Regarding claim 15, Rothberg teaches the system of claim 12,
Rothberg further teaching wherein the AFE, the IMU, a processor, memory devices, and communication components are provided as separate integrated circuits (ICs) or integrated into application-specific integrated circuits (ASICS) that comprise at least some of the ICs (“the processing circuitry 1201 may include specially-programmed and/or special-purpose hardware such as an application-specific integrated circuit (ASIC).” [0130]; “the ultrasonic transducers may be formed the same chip as other electronic components in the ultrasound circuitry 1324 (e.g., transmit circuitry, receive circuitry, control circuitry, power management circuitry, and processing circuitry) to form a monolithic ultrasound device.” [0135]; “the TX circuitry 1404/RX circuitry 1406 includes a separate TX circuit and a separate RX circuit for each transducer element 1502 in the array(s) 1502, but there is only one instance of each of the timing & control circuit 1408 and the signal conditioning/processing circuit 1410.” [0159]; The TX circuit, RX circuit, memory circuitry, processing circuitry, communication circuitry, and motion/orientation circuitry may be comprised as separate circuits [0123-0164], [fig. 11, 13-15], [see claim 12, 13 rejections]).
Regarding claim 17, Rothberg teaches the system of claim 12,
Rothberg further teaching further comprising at least one of: ix) a remote terminal (“a medical professional (e.g., a doctor, nurse, or imaging technician) or another individual, who may be remote, may receive the ultrasound data and determine which is the target ultrasound data and which is the non-target ultrasound data (e.g., by viewing ultrasound images generated from the ultrasound data).” [0120]; “the host device 1302 may communicate with one or more external devices via the network 1316 […] external devices may include servers 1318, workstations 1320, and/or databases 1322.” [0143]; “an individual (e.g., a remote expert operating a remote processing device) may generate or select the predetermined path and transmit the path (or an indication thereof) to the host device.” [0209]; [0123-0164, 0208-0213], [fig. 11, 13-15], [see claim 1 rejection]);
x) at least one additional IMU; xi) at least one three-axis magnetometer (“The ultrasound device may include an accelerometer, a gyroscope, and/or a magnetometer, and these devices may be used by the ultrasound device to generate the motion and/or orientation data.” [0090]; “The motion and/or orientation sensor 1332 may include an accelerometer, a gyroscope, and/or a magnetometer.” [0137]; [0123-0164], [fig. 11, 13-15], [see claim 8 rejection]);
xii) at least one pressure sensor; and xiii) a speaker and a microphone for communicating with a remote health care provider (“The input/output (I/O) devices 1203 may be configured to facilitate communication with other systems and/or an operator. Example I/O devices that may facilitate communication with an operator include: a keyboard, a mouse, a trackball, a microphone, a touch screen, a printing device, a display screen, a speaker, and a vibration device.” [0131]; “the host device 1302 may include one or more input and/or output devices such as the audio output device 1304, the imaging device 1306, the display screen 1308, and the vibration device 1309. The audio output device 1304 may be a device that is configured to emit audible sound such as a speaker.” [0141]; [0123-0164], [fig. 11, 13-15], [see claim 1 rejection]).
Regarding claim 18, Rothberg teaches the system of claim 12,
Rothberg further teaching wherein the processor responds to software instructions to execute at least one of the following: to produce the ultrasound images (“The host device 1302 may be configured to process the ultrasound data from the ultrasound device 1314 to generate ultrasound images for display on the display screen 1308. The processing may be performed by, for example, the processor 1310.” [0139]; [0123-0164, 0208-0213], [fig. 11, 13-15], [see claim 1 rejection]);
to analyze the data; to decide which of said ultrasound images to display on the display screen; to discard some of said ultrasound images; to instruct an operator to hold the scanner in a predetermined manner; to compute the location and attitude of the scanner including roll, pitch, and yaw; to determine if the scanner is exerting enough pressure on the skin; and to provide instructions how to move the scanner correctly in order to obtain images.
Regarding claim 21, Rothberg teaches the system of claim 8,
Rothberg further teaching wherein the electronic component for wired or wireless communication with remote terminals is selected from one or more of USB (United Serial Bus), fiber optic, UWB (ultra wideband), and IR (infrared) (“Example I/O devices that may facilitate communication with other systems include wired and/or wireless communication circuitry such as BLUETOOTH, ZIGBEE, WiFi, and/or USB communication circuitry.” [0131]; [0123-0164], [fig. 11, 13-15]).
Regarding claim 22, Rothberg teaches the system of claim 18,
Rothberg further teaching adapted to alert the operator in case of insufficient coupling between the scanner and the body as detected via image processing via said display screen or said speakers (“moving the ultrasound device along the predetermined path 107 should result in the ultrasound device collecting the target ultrasound data when the ultrasound device moves over the region 115 along the predetermined path 107 […] As a side effect of moving the ultrasound device along the predetermined path 107, non-target ultrasound data may be collected when the ultrasound device moves over other regions along the predetermined path 107.” [0062]; “the host device 1302 may be configured to provide instructions to an operator of the ultrasound device 1314 for moving the ultrasound device 1314 in order to collect ultrasound data” [0140]; The instructions guide the operator during an ultrasound imaging examination to acquire an ultrasound image of a desired anatomical feature by moving the ultrasound device along a predetermined path, wherein the ultrasound images acquired during the examination are analyzed in real-time (i.e., determining insufficient coupling relative to desired anatomical feature) to determine how to move the ultrasound device [0123-0164, 0208-0213], [fig. 11, 13-15, 20; see fig. 4 reproduced below], [see claim 1 rejection]).
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860
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(Rothberg [fig. 4])
Regarding claim 24, Rothberg teaches the system of claim 15,
Rothberg further teaching wherein the processor includes one or more members of the group consisting of MCU (microcontroller unit), FPGA (field- programmable gate array), and CPLD (Complex programmable logic device) (“the ultrasonic transducers may be formed the same chip as other electronic components in the ultrasound circuitry 1324 (e.g., transmit circuitry, receive circuitry, control circuitry, power management circuitry, and processing circuitry) to form a monolithic ultrasound device.” [0135]; The electronic components in the ultrasound circuitry may be formed on the same chip (i.e., a microcontroller) [0123-0164, 0208-0213], [fig. 11, 13-15], [see claim 1, 15 rejections]).
Regarding claim 25, Rothberg teaches the system according to claim 1,
wherein the system provides two way communication between the operator and the trained health care professional (“The input/output (I/O) devices 1203 may be configured to facilitate communication with other systems and/or an operator. Example I/O devices that may facilitate communication with an operator include: a keyboard, a mouse, a trackball, a microphone, a touch screen, a printing device, a display screen, a speaker, and a vibration device. Example I/O devices that may facilitate communication with other systems include wired and/or wireless communication circuitry” [0131]; [0123-0164], [fig. 11, 13-15], [see claim 17 rejection]).
Regarding claim 26, Rothberg teaches a system for acquisition of ultrasound images (“an exemplary system 1100 for collecting ultrasound data from a subject” [0123]; [0123-0164], [fig. 11, 13-15, 20]), comprising:
a scanner and at least one inertial measurement unit (IMU) associated therewith, the scanner providing an output signal comprising ultrasound image data (“the ultrasound device 1102” [0123]; “The ultrasound device 1314 includes ultrasound circuitry 1324, […] and a motion and/or orientation sensor 1332.” [0133]; “The ultrasound device 1314 may be configured to generate ultrasound data that may be employed to generate an ultrasound image.” [0134]; “The motion and/or orientation sensor 1332 may be configured to generate motion and/or orientation data regarding the ultrasound device 1314. […] The motion and/or orientation sensor 1332 may include an accelerometer, a gyroscope, and/or a magnetometer.” [0137]; [0123-0164], [fig. 11, 13-15, 18], [see claim 1 rejection]);
a portable communication device coupled to said scanner and relaying said output signal (“A host device may receive ultrasound data from the ultrasound device, analyze the ultrasound data in real time” [0053]; “the host device 101 may be a mobile smartphone, a tablet, a laptop, […] or a smart wearable device.” [0061]; “To provide instructions for placing the ultrasound device at the target tilt and the target rotational orientation, the host device may receive motion and/or orientation data from the ultrasound device.” [0090]; “The system 1100 includes an ultrasound device 1102 that is communicatively coupled to a host device 1104 by a communication link 1112.” [0123]; Ultrasound data and motion/orientation data are received by host device (i.e., portable communication device) from the ultrasound device [0123-0164, 0208-0213], [fig. 11, 13-15, 18], [see claim 1 rejection]);
a remote terminal receiving said output signal and having a user interface to receive real time instructions from a trained health care professional in response to said output signal (“a medical professional (e.g., a doctor, nurse, or imaging technician) or another individual may generate the predetermined path and load/cause to be loaded the predetermined path onto the host device. For example, an individual operating a remote processing device may select or generate the predetermined path and transmit the predetermined path to the host device local to the ultrasound device.” [0113]; “a medical professional (e.g., a doctor, nurse, or imaging technician) or another individual, who may be remote, may receive the ultrasound data and determine which is the target ultrasound data and which is the non-target ultrasound data (e.g., by viewing ultrasound images generated from the ultrasound data).” [0120]; “The host device 1302 may communicate with one or more external devices over a network 1316. For example, the host device 1302 may communicate with one or more workstations 1320, servers 1318, and/or databases 1322. [0133]; [0123-0164, 0208-0213], [fig. 11, 13-15, 18, 20], [see claim 1 rejection]);
a channel of communication between said remote terminal and said portable communication device transmitting said real time instructions to said portable communication device (“The input/output (I/O) devices 1203 may be configured to facilitate communication with other systems and/or an operator. […] Example I/O devices that may facilitate communication with other systems include wired and/or wireless communication circuitry such as BLUETOOTH, ZIGBEE, WiFi, and/or USB communication circuitry.” [0131]; “The host device 1302 may communicate with one or more external devices over a network 1316. For example, the host device 1302 may communicate with one or more workstations 1320, servers 1318, and/or databases 1322.” [0133]; The host device uses input/output devices (e.g., wired and/or wireless communication circuitry) to communicate ultrasound and motion/orientation data with an external device (i.e., remote terminal) over a network (i.e., channel of communication) to facilitate remote guidance [0123-0164, 0208-0213], [fig. 11, 13-15, 18], [see claim 1 rejection]); and
a display screen and/or speakers on said portable communication device presenting said real time instructions (“a host device 101 that includes a display 103.” [0060]; “The host device 1302 may be configured to process the ultrasound data from the ultrasound device 1314 to generate ultrasound images for display on the display screen 1308. […] The ultrasound data may be processed in real-time during a scanning session as the echo signals are received.” [0139]; “host device 1302 may be configured to provide instructions to an operator of the ultrasound device 1314 for moving the ultrasound device 1314 in order to collect ultrasound data” [0140]; “an individual (e.g., a remote expert operating a remote processing device) may generate or select the predetermined path and transmit the path (or an indication thereof) to the host device.” [0209]; [0123-0164, 0208-0213], [fig. 11, 13-15, 18], [see claim 1 rejection]).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 27-28 is/are rejected under 35 U.S.C. 103 as being obvious over Rothberg as applied to claims 1 and 26, and further in view of Silberman et al. (US20200037987A1, 2020-02-06; hereinafter “Silberman”), as provided by Applicant.
Regarding claim 27, Rothberg teaches the system of claim 26,
Rothberg further teaching a speed with which the scanner is moved (“the motion and/or orientation sensor may be configured to generate to generate data regarding acceleration of the ultrasound device, data regarding angular velocity of the ultrasound device,” [0090]; [0123-0164, 0208-0213], [fig. 11, 13-15, 18], [see claim 1 rejection]);
but Rothberg may fail to explicitly teach providing instructions to the operator indicating speed with which the scanner should be moved.
However, in the same field of endeavor, Silberman teaches a system for acquisition of ultrasound images (“An apparatus, comprising: a processing device in operative communication with an ultrasound imaging device,” [clm 1]; “The ultrasound system 100 includes an ultrasound imaging device 114, a processing device 102, a network 116, and one or more servers 134.” [0028]; [fig. 1, 5]);
Silberman further teaching wherein said real time instructions indicate a speed with which the scanner should be moved (“To provide the instruction for slowing the velocity of the ultrasound imaging device, the processing device may display the instruction on a display screen (e.g., display screen 108) of the processing device.” [0073]; “In some embodiments, the processing device may determine whether ultrasound data and motion and/or orientation data indicates a velocity of the ultrasound imaging device that is less than a threshold velocity, and if so, provide an instruction to speed up movement of the ultrasound imaging device.” [0074]; [0028-0039, 0068-0076], [fig. 1, 5, 7]).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the invention to combine the system for acquiring ultrasound images taught by Rothberg with the instructions to the operator indicating speed with which the scanner should be moved as taught by Silberman. Ultrasound examinations often include the acquisition of ultrasound images that contain a view of a particular anatomical structure (e.g., an organ) of a subject. Acquisition of these ultrasound images typically requires considerable skill (Rothberg [0048]). Moving an ultrasound imaging device too fast may result in blurry ultrasound images, and providing instructions to a user to slow down movement of the ultrasound imaging device may help to improve the quality of ultrasound images collected (Silberman [0072]).
Regarding claim 28, Rothberg teaches the system of claim 1,
Rothberg further teaching a speed with which the scanner is moved (“the motion and/or orientation sensor may be configured to generate to generate data regarding acceleration of the ultrasound device, data regarding angular velocity of the ultrasound device,” [0090]; [0123-0164, 0208-0213], [fig. 11, 13-15, 18], [see claim 1 rejection]);
but Rothberg may fail to explicitly teach providing instructions to the operator indicating speed with which the scanner should be moved.
However, in the same field of endeavor, Silberman teaches a system for acquiring ultrasound images of an organ of a human body (“An apparatus, comprising:
a processing device in operative communication with an ultrasound imaging device,” [clm 1]; “The ultrasound system 100 includes an ultrasound imaging device 114, a processing device 102, a network 116, and one or more servers 134.” [0028]; [fig. 1, 5]);
Silberman further teaching wherein said instructions to the operator indicate a speed with which the scanner should be moved (“To provide the instruction for slowing the velocity of the ultrasound imaging device, the processing device may display the instruction on a display screen (e.g., display screen 108) of the processing device.” [0073]; “In some embodiments, the processing device may determine whether ultrasound data and motion and/or orientation data indicates a velocity of the ultrasound imaging device that is less than a threshold velocity, and if so, provide an instruction to speed up movement of the ultrasound imaging device.” [0074]; [0028-0039, 0068-0076], [fig. 1, 5, 7]).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the invention to combine the system for acquiring ultrasound images of an organ of a human body taught by Rothberg with the instructions to the operator indicating speed with which the scanner should be moved as taught by Silberman. Ultrasound examinations often include the acquisition of ultrasound images that contain a view of a particular anatomical structure (e.g., an organ) of a subject. Acquisition of these ultrasound images typically requires considerable skill (Rothberg [0048]). Moving an ultrasound imaging device too fast may result in blurry ultrasound images, and providing instructions to a user to slow down movement of the ultrasound imaging device may help to improve the quality of ultrasound images collected (Silberman [0072]).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim(s) 1, 4-6, 8, 12-15, 17-18, 21-22 24-25 and 28 in the instant Application No. 17/920,948 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 and 22-24 of copending Application No. 17/920,957 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding claim 1 of Application No. 17/920,948, the copending Application No. 17/920,957 teaches a system for acquiring ultrasound images of an organ of a human body (“A system for acquiring ultrasound images of internal body organs, comprising” [clm 1]), comprising
a scanner providing image data (“a scanner,” [clm 1]) and
at least one inertial measurement unit (IMU) associated therewith providing additional data (“at least one inertial measurement unit (IMU) associated therewith,” [clm 1]), and
a first communication channel providing a trained health care professional located at a remote location with an output of image analysis circuitry receiving said image data and said additional data, and a second communication channel providing, to an operator, instructions from the trained health care professional in real time visually on a display screen or audibly from speakers (“and an image processing module adapted to audibly alert the user in case of insufficient coupling between the apparatus and the body; wherein the system is configured to issue instructions to an operator of the system that allow scans to be performed also by persons not trained for ultrasound scanning including a patient themself, and wherein the scans are transmitted to a remote location for analysis by a healthcare professional.” [clm 1]; “The system of claim 14, wherein instructions to the operator are provided visually on the display screen or audibly from the speakers by a trained health care professional located at a remote terminal.” [clm 16]).
Regarding the dependent claims:
Instant Application No. 17/920,948
Copending Application No. 17/920,957
4
5
1
6
1, 14
8
8
12
9
17
10
18
14
21
19
22, 27
20
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Additionally, Applicant's submission of an information disclosure statement under 37 CFR 1.97(c) with the timing fee set forth in 37 CFR 1.17(p) on 6/5/2026 prompted the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 609.04(b), MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to James F. McDonald III whose telephone number is (571)272-7296. The examiner can normally be reached M-F; 8AM-6PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chris Koharski can be reached at 5712727230. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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JAMES FRANKLIN MCDONALD III
Examiner
Art Unit 3797
/JOSEPH M SANTOS RODRIGUEZ/Primary Examiner, Art Unit 3797
Prosecution Insights