DETAILED ACTION
This office action is in response to the communication received on July 10, 2025 concerning application No. 18/109,730 filed on February 14, 2023.
Claims 1-3, 5-13 and 15-20 are currently pending.
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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on July 10, 2025 has been entered.
Response to Arguments
Applicant's arguments filed 07/10/2025 regarding the claim objections have been fully considered. The amendments to the claims have been entered and overcome the claim objections of claims 1, 5, and 6 previously set forth.
Applicant's arguments filed 07/10/2025 regarding the 35 USC 103 rejection of claim 1 have been fully considered. The amendments to the claims have been entered and overcome the 35 USC 103 rejection of claim 1 previously set forth.
Applicant's arguments filed 07/10/2025 regarding the 35 USC 103 rejection of claim 11 have been fully considered but they are not persuasive. In response to the applicant’s arguments that the prior art fails to teach “reconfiguring a UI in response to an indication of a sterile procedure” as stated on pg. 8 of the remarks, examiner respectfully disagrees. [0051]-[0052] of Dickie discloses monitoring the temperature (parameter) of the scanner to determine whether the scanner is in a poor cooling environment and if the scanner is in a poor cooling state configuring the settings of the scanner to reduce (lower) power. [0027] discloses the poor cooling environment coincides with the scanner being in a sterile bag (sterile imaging procedure. [0059] further teaches “upon receiving the signal of the poor cooling state operation, the display device 50 may change a user interface element displayed on the display device 50 in response to receiving the signal indicative of the poor cooling state”. For at least these reasons Dickie teaches the argued limitation recited above. Additionally, examiner notes that claim 11 was not amended in a similar way to claim 1 as stated on the bottom of pg. 7 of the remarks.
Additionally, Applicant did not address the objection to the drawings set forth in the previous office action, therefore the drawing objection as previously set forth stands.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: “223” in fig. 2. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
“a power control module” in claim 1,
“a reconfiguration module” in claim 1,
“a timer module” in claims 2 and 12,
“an image comparator module” in claim 8.
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. For the purpose of examination and this office action “a power control module”, “a reconfiguration module”, “timer module” and “an image comparator module” will be interpreted as computer code instructions or equivalent thereof for performing the determined function (see [0045] of the present applications specification).
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-3 and 5-10 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation "a sterile imaging procedure" in lines 13 and 14-15. There is insufficient antecedent basis for this limitation in the claim. It is not clear to the examiner whether the sterile imaging procedure in lines 13 and 14-15 is the same as or different from a sterile imaging procedure recited in lines 11. For the purpose of examination and this office action it is being interpreted that the sterile imaging procedures are all the same.
Claims dependent upon the rejected claims above, but not directly addressed, are also rejected because they inherit the indefiniteness of the claim(s) they respectively depend upon.
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.
Claim(s) 11-13, 15-16 and 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Willsie (US 20170303899) in view of Dickie et al. (US 20210186463, hereinafter Dickie).
Regarding claim 11, Willsie teaches a method for ultrasound imaging (Abstract) using a handheld device ([0024] discloses the portable computing device 14 is handheld) and a probe ([0024] ultrasound transducer 12 in fig. 1) with a UI control button disposed on the probe ([0029] capacitive sensors 104 on the transducer (probe) 12 in fig. 1), comprising:
activating a low-power mode to reduce power consumed by at least one of the handheld device and the probe ([0018] “a power management module or controller configured to selectively enter the ultrasound device into one or more ‘low power’ (i.e., reduced power) modes”),
generating a wake-up configuration signal representative of a command to reconfigure a function of the UI control button ([0029] discloses the capacitive sensors 104 sense whether the transducer is being held by the user and [0064] discloses the power management controller receives the signals from the capacitive sensor and dynamically adjusts the power consumption based on the received signal), and
in response to the wake-up configuration signal, reconfiguring an interface coupled to the UI control button to respond to activation of the UI control button by deactivating the low-power mode and having the probe or the handheld device enter a power mode that consumes an amount of power sufficient to perform ultrasound imaging procedures ([0067] discloses “the ultrasound device may be returned to a normal (i.e., non-sleep mode) mode of operation…upon detecting that the ultrasound transducer is held”, by detecting the ultrasound transducer is held, the capacitive sensor (UI control button) is being activated. Therefore the interface of the power management controller is reconfigured to detect activation of the UI control button [0044] further discloses the normal operating levels include operating in an image acquisition mode, meaning the power is being sufficiently consumed to perform imaging procedures).
Willsie does not specifically teach storing preset parameters for configuring the probe for a predetermined imaging procedure and reconfiguring the interface if the preset parameters indicate a sterile imaging procedure and refrain from reconfiguring the interface if the preset parameters indicate a non-sterile imaging procedure.
However,
Dickie in a similar field of endeavor teaches storing preset parameters for configuring the probe for a predetermined imaging procedure ([0030]-[0031] discloses computer readable data that includes settings for the scanner 10 is stored in the memory 34 and includes preset parameters for each of the detected cooling environment of the scanning, the detected cooling environment is considered the predetermined imaging procedure) and reconfiguring the interface if the preset parameters indicate a sterile imaging procedure ([0051]-[0052] discloses monitoring the temperature (parameter) of the scanner to determine whether the scanner is in a poor cooling environment and if the scanner is in a poor cooling state configuring the settings of the scanner to reduce (lower) power. [0027] discloses the poor cooling environment coincides with the scanner being in a sterile bag (sterile imaging procedure). [0059] further teaches “upon receiving the signal of the poor cooling state operation, the display device 50 may change a user interface element displayed on the display device 50 in response to receiving the signal indicative of the poor cooling state”) and refrain from reconfiguring the interface if the preset parameters indicate a non-sterile imaging procedure ([0050] discloses monitoring the temperature (parameter) of the scanner to determine whether the scanner is in a poor cooling environment and if the scanner is not in a poor cooling environment, the scanner retains (refrains) its current settings).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method disclosed by Willsie to store preset parameters for configuring the probe for a predetermined imaging procedure and reconfiguring the interface if the preset parameters indicate a sterile imaging procedure and refrain from reconfiguring the interface if the preset parameters indicate a non-sterile imaging procedure in order to avoid overheating and failure of the ultrasound scanner, as recognized by Dickie (Abstract).
Regarding claim 12, Willsie in view of Dickie teaches the method of claim 11, as set forth above. Willsie further teaches a timer module configured to generate a timeout signal, wherein the power control module activates the low-power mode responsive to receiving the timeout signal from the timer module wherein the timeout signal represents expiration of a timeout period ([0067] discloses “the sleep mode may be initiated when the ultrasound transducer has not been held (e.g., as sensed by the capacitive sensor 104) for a period of time that exceeds a predetermined threshold”. [0068] further teaches the power management controller initiates the low power mode after monitoring an amount of time the transducer has not been held. The initiation signal to initiate the low power mode is considered the timeout signal and because the initiation signal is sent only after the threshold time has been reached it represents expiration of a timeout period).
Regarding claim 13, Willsie in view of Dickie teaches the method of claim 12, as set forth above. Willsie further teaches a data memory that stores a preset timeout parameter representative of a timeout period ([0067]-[0068] discloses the use of a predetermined threshold/period of time that is used by the power management controller for determining whether the transducer has been held for a certain amount of time (timeout period). The part of the power management controller where the predetermined threshold/period is stored is considered the data memory), and wherein the timer module counts down in response to the stored preset timeout period to generate the timeout signal ([0067]-[0068] discloses only initiating the low power mode after the time has reached a predetermined threshold/period such as 10 or 20 seconds, meaning the power management controller (timer module) is counting down from that time in order to determine that time has been reached or not).
Regarding claim 15, Willsie in view of Dickie teaches the method of claim 11, as set forth above. Dickie further teaches the preset memory stores preset parameters for a plurality of predetermined imaging procedures ([0030]-[0031] discloses computer readable data that includes settings for the scanner 10 is stored in the memory 34 and includes preset parameters for each of the detected cooling environment of the scanning, each of the detected cooling environments is considered the predetermined imaging procedures) and stores a timeout period for each of the respective predetermined imaging procedures ([0072] discloses “the time duration of inactivity needed to trigger the reversion back to the lower power consumption setting may be shorter (or zero) in the poor cooling state of operation compared to when in the regular cooling state of operation”, therefore each of the predetermined imaging procedures (cooling state) has its own timeout period).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system and method disclosed by Willsie in view of Dickie to have the preset memory store preset parameters for a plurality of predetermined imaging procedures and store a timeout period for each of the respective predetermined imaging procedures in order to avoid overheating and failure of the ultrasound scanner, as recognized by Dickie ([0072]).
Regarding claim 16, Willsie in view of Dickie teaches the method of claim 11, as set forth above. Willsie further teaches comprises providing a memory for storing an override parameter representative of an operator instruction to override the wake-up configuration signal and thereby prevent reconfiguring the interface ([0065] discloses the ultrasound device is provided with an override feature that allows a user to activate an override mode which prevents the system from being reconfigured. The part of the system in which the override feature software is stored is considered the memory for storing an override parameter).
Regarding claim 19, Willsie in view of Dickie teaches the method of claim 11, as set forth above. Willsie further teaches the probe is a hand-held ultrasound probe ([0029] discloses the transducer is held by a user making it a hand-held ultrasound probe) having a transducer for transmitting and receiving ultrasound signals ([0011] “transducer including transmit and receive elements for respectively transmitting and receiving ultrasound signals”) and a housing connected to the transducer and shaped to allow a clinician to grip the probe with a hand (transducer 12 in fig. 1 shows that the transducer includes a housing that is connected to the transducer elements 20 and is shaped to allow a clinician to grip the probe with a hand as disclosed in [0029]) and thereby position the transducer proximate a patient ([0030] discloses the transducer makes contact with the patient) and wherein the UI control button is disposed on the housing at a location that can be reached by a hand holding the probe (fig. 1 shows the sensors 104 (UI control button) disposed on the housing at a location that can be reached by the hand holding the probe as disclosed in [0029]).
Regarding claim 20, Willsie in view of Dickie teaches the method of claim 11, as set forth above. Willsie further the UI control button, when not in low-power mode, is configured to operate a different function of the probe to generate a reading of remaining battery power or perform an image capture procedure to capture ultrasound images ([0029] discloses “during normal operation of the ultrasound device 10, an operator’s hand contacts the capacitive sensor 104”, therefore the UI control button is active and not in a low-power mode. [0008] further teaches during a “normal operating level….obtain ultrasound images of a desired quality” meaning by having the UI control button be active the ultrasound probe is operated to perform an image capture procedure to capture ultrasound images).
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Willsie in view of Dickie as applied to claim 12 above, and further in view of Dickie et al. (US 20190175149, hereinafter Dickie ‘149).
Regarding claim 17, Willsie in view of Dickie teaches the method of claim 12, as set forth above. Willsie in view of Dickie does not specifically teach an image comparator module to detect changes in a sequence of ultrasound images and to reset the timer module responsive to detecting changes in the sequence of ultrasound images.
However,
Dickie ‘149 in a similar field of endeavor teaches an image comparator module (the electronic circuitry of system 100 in fig. 1) to detect changes in a sequence of ultrasound images ([0049] discloses determining how the ultrasound machine is moving by analyzing two or more first ultrasound images by determining the type of material being imaged. By determining the type of material being imaged in each image, changes in a sequence of ultrasound images are able to be detected) and to reset the timer module responsive to detecting changes in the sequence of ultrasound images ([0049] discloses the type of material being imaged is used to determine whether the ultrasound image is for viewing. When there is a change from imaging air to tissue it is determined that the ultrasound image is for viewing. [0072] discloses when it is determined that the ultrasound image is for viewing (change in the sequence) a first timer is reset. [0075] further discloses when the image is not for viewing and the timer exceeds a first time period the power consumption of the ultrasound machine is reduced).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system and method disclosed by Willsie in view of Dickie to have an image comparator module to detect changes in a sequence of ultrasound images and to reset the timer module responsive to detecting changes in the sequence of ultrasound images in order to ensure that the system does transition into a low power mode while the operator is actively performing a procedure, thereby ensuring the accuracy of the system.
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Willsie in view of Dickie and Dickie ‘149 as applied to claim 17 above, and further in view of Kim et al. (US 20070081711, hereinafter Kim).
Regarding claim 18, Willsie in view of Dickie and Dickie ‘149 teaches the method of claim 17, as set forth above. Willsie in view of Dickie and Dickie ‘149 does not specifically teach detecting changes in a sequence of images includes performing an edge detection and comparison process to determine whether similar edges of images the sequence of images are changing.
However,
Kim in similar field of endeavor teaches detecting changes in a sequence of images includes performing an edge detection ([0013] “the image difference may be calculated by comparing the edge displacement of images”) and comparison process to determine whether similar edges of images the sequence of images are changing ([0013] “if the image difference is greater than a critical value in step S150, then it is determined that the currently sampled image is difference from the previously sampled ultrasound image”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the detecting changes in a sequence of ultrasound images of Willsie in view of Dickie and Dickie ‘149 for the detecting changes in a sequence of images using edge detection of Kim because it amounts to simple substitution of one known element for another to obtain the predictable results of detecting a change in a sequence of obtained images.
Allowable Subject Matter
Claims 1-3 and 5-10 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
The following is a statement of reasons for the indication of allowable subject matter: the prior art of record fails to reasonably teach or in combination render obvious the following limitations when the claims taken as a whole to include, “a preset memory for storing a preset parameter for configuring the probe for a predetermined imaging procedure and wherein the power control module is configured to process the preset parameter to determine whether the preset parameter indicates that the predetermined imaging procedure is a sterile imaging procedure, and a reconfiguration module configured to receive the wake-up configuration signal and determine if the preset parameter indicates a sterile imaging procedure, and in response to receiving the wake-up configuration signal and an indication of a sterile imaging procedure, reconfigure an interface coupled to the UI control button to detect activation of the UI control button and, in response to activation of the UI control button, the interface deactivates the low-power mode to have the handheld device and the probe consume power sufficient to perform imaging procedures.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW BEGEMAN whose telephone number is (571)272-4744. The examiner can normally be reached Monday-Thursday 8:30-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Keith Raymond can be reached at 5712701790. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANDREW W BEGEMAN/Examiner, Art Unit 3798