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 .
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. FR 2105473, filed on 05/26/2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/27/2023 was filed in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description:
FIG. 1: Although the specification states “If ultrasound scanner 1 thus comprises three transducer elements 9a, 9b, 9c, the latter are arranged on drum 8b with angular spacing designed to minimize the total angular excursion of drum 8b between the most distant transducer elements (e.g., 9a and 9b according to figs. 1 and 3)” [0047], this figure does not include the label 9c. Rather, this figure includes two labels 9a.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) 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.
Specification
The disclosure is objected to because of the following informalities:
[0046]: As written it reads “Transducer element 9 is also able to pick up several echo lines LEA, LER when receiving the pulses. […] The operating method used for probe 2 therefore ensures that an AFI imaging algorithm is implemented to visually reconstruct the area of interest ZI by juxtaposing the image points in echo lines LEA, LER and an animated model of the area of interest ZI is produced based on the successive to-and-fro scans”. However, this is the first indication of the terms ”LEA”, “LER” and “AFI” therefore, the terms should be spelled out to provide clarity.
Page 18: The examiner notes that the last paragraph on this page is labelled at [0001]. The examiner believes this is a typo which should instead read [0066].
Appropriate correction is required.
Claim Objections
Claims 1, 3-4 and 12 are objected to because of the following informalities:
Regarding claim 1, the claim recites “An operating procedure for an ultrasound scanner […]”. However, claims 2-11 were amended to recite “The method”. Therefore, to maintain proper antecedent basis the examiner would recommend amending the claim to recite “A method for operating an ultrasound scanner […]”.
Regarding claims 1 and 12, as written they read “the transducer element used to acquire multiple echo lines (LEA, LER) […]” (Claim 1) and “the transducer element able to pick up several echo lines (LEA, LER) when receiving multiple successive ultrasound pulses emitted towards the area of interest” (Claim 12). However, this is the first indication of the terms “LEA” and “LER” in the claims, therefore, the terms should be spelled out to provide clarity.
Regarding claim 3, the claim reads “the series of echo lines (LEA) for the emission image is acquired […] the series of echo lines (LER) of the return image is acquired”. However, to be grammatically correct, “is” should be “are”.
Regarding claims 3 and 4, the claim reads “we use a gradient descent algorithm to minimize the distance between the points on the curve CA of the emission arc (AA) and the curve (CB) of the return arc (AR) by progressively offsetting each curve with respect to the other until we retain the offset giving the minimum distance as the angular offset between the emission and return echo lines” (Claim 3) and “we apply a gradient descent algorithm to an initial emission arm and an initial return arc to obtain an initial offset d1” (Claim 4). The examiner would recommend amending the claims such that pronouns (i.e. we) are not used.
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The 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) 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):
(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). The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) 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). The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) 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) 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) except as otherwise indicated in an Office action.
This application includes one or more claim limitations that use the word “means,” and are therefore being interpreted under 35 U.S.C. 112(f). Such claim limitation(s) is/are: “means for analyzing the image points along an arc at a given depth (P) or the area of interest […]” in claim 12; “means for correcting the offset by image approximation […]” in claim 12, “means of correcting this offset” in claim 10.
Additionally, 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) because the claim limitations(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 limitation(s) is/are: the “firing and movement scheduling pilot” in claims 1 and 12.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. That being said, the “means for analyzing the image points along an arc at a given depth (P) or the area of interest […]”, although discussed in paragraph [0026], it is the same language utilized within claim 12 itself and therefore does not provide additional structure to describe this feature. Therefore, claim 12 and its corresponding dependent claims are subject to further rejection under 35 U.S.C. 112(a) and 35 U.S.C. 112(b) regarding the “means for analyzing the image points along an arc at a given depth (P) or the area of interest […]”.
Furthermore, the “means for correcting the offset by image approximation”, although discussed in paragraph [0026], it is the same language utilized within claim 12 itself and therefore does not provide additional structure to describe this feature. Therefore, claim 12 and its corresponding dependent claims are subject to further rejection under 35 U.S.C. 112(a) and 35 U.S.C. 112(b) regarding the “means for correcting the offset by image approximation […]”.
Additionally, the “means of correcting this offset” is not described within the specification. Therefore claim 10 is subject to further rejection under 35 U.S.C. 112(a) and 35 U.S.C. 112(b) regarding the “means of correcting this offset”.
Furthermore, the “firing and movement scheduling pilot” is described within the specification when it states “In addition, transducer element 9 is able to emit ultrasound pulses towards the area of interest ZI corresponding to several successive firing operations, controlled by one firing and movement scheduling pilot 14 in probe 2” [0046]. Therefore, the examiner is interpreting the firing and movement scheduling pilot to be a controller configured to control when the transducer element emits ultrasound pulses towards the area of interest ZI. Thus, claims 1 and 12 are not subject to further rejection under 35 U.S.C. 112(a)/(b) with respect to the “firing and movement scheduling pilot”.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) (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).
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Claims 10-19 are rejected under 35 U.S.C. 112(a) as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor at the time the application was filed, had possession of the claimed invention.
Regarding claim 10, the recites “a probe is provided for exploring an area of interest (ZI) on the human body (C), comprising a drive system including a stepping motor, a motion transmission system, and a carrier for transducer elements secured on the carrier, a resource able to analyze image points along an arc at a given depth (P), such that, with the detects affecting the mechanical drive system, angular offset between the emission echo lines (LEA) and the return echo lines (LER) is associated with the operation of the mechanism drive system, the probe being fitted with a means of correcting this offset” which invokes 35 U.S.C. 112(f).
However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and fails to clearly link the structure, material or acts to the function.
Therefore, there is a lack of written description regarding what structures are necessary to perform the claimed function. Due to this lack of sufficient disclosure, one of ordinary skill in the art would not be appraised of the possession of the invention given the specification in the instant application. Thus, claim 10 is rejected under 35 U.S.C. 112(a).
Regarding claim 11, due to its dependence on claim 10, this claim is subject to the reasoning provided therein. Additionally, this claim does not provide additional information regarding the “means of correcting this offset”. Thus, claim 11 is rejected under 35 U.S.C. 112(a).
Regarding claim 12, the claim recites “means for analyzing the image points along an arc at a given depth (P) of the area of interest for two series of successive emission and return echo lines (LEA, LER), in order to determine said angular offset of the image points in the two successive emission and return arcs (AA, AR), and calculate the angular offset of the emission and return echo lines (LEA, LER), associated with the operation of the drive system” and “means for correcting the offset by image approximation, and in particular by superimposing or almost superimposing the emission images and the successive return images, incorporating the calculated offset associated with the operation of the drive systems” which invokes 35 U.S.C. 112(f).
However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and fails to clearly link the structure, material or acts to the function. Although the specification does include these means in paragraph [0026], this paragraph merely repeats the claim language. Thus, there is a lack of written description as to what structural components may be incorporated or excluded from the “means for analyzing the image points along an arc at a given depth (P) of the area of interest for two series of successive emission and return echo lines (LEA, LER), in order to determine said angular offset of the image points in the two successive emission and return arcs (AA, AR), and calculate the angular offset of the emission and return echo lines (LEA, LER), associated with the operation of the drive system” and the “means for correcting the offset by image approximation, and in particular by superimposing or almost superimposing the emission images and the successive return images, incorporating the calculated offset associated with the operation of the drive systems”.
Therefore, there is a lack of written description regarding what structures are necessary to perform the claimed function. Due to this lack of sufficient disclosure, one of ordinary skill in the art would not be appraised of the possession of the invention given the specification in the instant application. Thus, claim 12 is rejected under 35 U.S.C. 112(a).
Regarding claims 13-19, due to their dependence on claim 12, either directly or indirectly these claims are subject to the reasoning provided therein. Additionally, these claims do not provide further information regarding what structures are necessary to perform the claimed function. Thus, claims 13-19 are rejected under 35 U.S.C. 112(a).
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.
Claims 1-19 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Regarding claim 1, the claim reads “an image algorithm is applied to visually reconstruct the area of interest (ZI) by juxtaposing the echo line image points (LEA, LER) and an animated model of the area of interest produced based on the successive to-and-fro scans”. However, this limitation appears to be describing a component of the ultrasound scanner, not the method (i.e. operating procedure) itself. Therefore, it is unclear if this limitation needs to be performed in order to carry out the operating procedure or not. The examiner would recommend clarifying whether this limitation represents a required step of the operating procedure.
Additionally, the claim recites “due to defects affecting the mechanical drive system, angular offset between the emission echo lines (LEA) and the return echo lines (LER) is associated with the operation and initial motion of the stepper motor, the motion transmission system and the carrier of the mechanical drive system”. It is unclear whether the limitation is intended to represent a determining, identifying or calculating step performed within the operating procedure or not. As stated, this limitations appears to merely stating that defects affect the system rather than identifying/determining defects themselves. The examiner recommends clarifying the purpose of this limitation (i.e. whether it identifies or determines defects).
Furthermore, the claim reads “the effects of the defects affecting the mechanical drive system on the final image are harnessed directly, and the image is corrected in order to reduce image shaking caused by offset between successive images, associated with the operation and initial motion of the mechanical drive system”. However, there is no step requiring the generation of “a final image” prior to this limitation, therefore it is unclear what image is being referred to within this limitation and what image is corrected. Furthermore, it is unclear whether “offset” is intended to represent “angular offset”. If they are intended to be the same, the examiner would recommend updating “offset” to be “angular offset”.
Additionally, the claim recites “the image points along an arc (AA, AR) at a given depth (P) of the area of interest (ZI) are analyzed for two series of successive emission and return echo lines (LEA, LER) to determine the angular offset of the image points in the two successive emission and return arcs (AA, AR) and calculate the angular offset of the emission echo lines (LEA) and the return echo lines (LER), associated with the operation of the drive system”. However there is a lack of antecedent basis for the terms “the image points along an arc (AA, AR)”. Therefore, it is unclear whether these image points are the same as or different from the information obtained when the transducer element is mechanically driven by the stepper motor and scans alternating sectors from a reference position, as recited earlier within the claim. Additionally, the examiner believes that “the drive system” (underlined above) is intended to be the same as the “mechanical drive system” recited earlier in the claim. Therefore, the examiner would recommend updating the claim language to maintain proper antecedent basis for this term.
Furthermore, the claim recites “the offset is corrected by approximating the successive emission and return images, particularly by superimposing or almost superimposing these images, incorporating the calculated offset associated with the operation of the drive system”. However, there is a lack of antecedent basis for the term “the offset”, therefore it is unclear whether this is referring to “the angular offset” recited in the previous limitation or not. Furthermore, it is unclear what is meant by the term “almost superimposing these images”. The term “almost superimposing” is a relative term which renders the claim indefinite because this term is not defined by the claim and the specification does not provide a standard for ascertaining the requisite degree to which images are considered to be “almost superimposed”. Thus, one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Additionally, the examiner believes that “the drive system” (underlined above) is intended to be the same as the “mechanical drive system” recited earlier in the claim. Therefore, the examiner would recommend updating the claim language to maintain proper antecedent basis for this term.
Regarding claim 3, the claim recites “the series of echo lines (LEA) for the emission image is acquired and the curve (CA) of an emission arc (AA) is reconstructed […] the series of echo lines (LER) of the return image is acquired and the curve (CR) of a return arc (AR) is reconstructed”, however there is a lack of antecedent basis for the terms “the emission image” and “the return image”. Therefore, it is unclear what these terms are referring to in the context of the method because there is no limitation in claim 1 in which “an emission image” and “a return image” and generated.
Regarding claims 3 and 4, the claim recites “wherein to measure offset: […]” (Claim 3) and “to measure offset” (Claim 4), however there is a lack of antecedent basis for the term “offset”. If this is the same as the “angular offset” recited in claim 1, the examiner would recommend updating the claim language accordingly.
Regarding claims 5 and 6, the claims recite “in which, in order to correct offset, angular offset is repeatedly calculated, then when an offset value calculated in this way is considered to be reliable, the return images are corrected using the imaging algorithm by applying an inverse rotation of the offset calculated in this way and considered to be reliable” (Claim 5) and “in which, in order to correct offset, angular offset is repeatedly calculated, then when an offset value calculated in this way is considered reliable, it is saved on a permanent basis and the firing and movement scheduling pilot is instructed to time-shift firing with respect to the return movement, as a function of the offset calculated in which way and considered to be reliable” (Claim 6). However, it is unclear what characteristic(s) of the offset value make it reliable (i.e. what is considered a reliable offset value). The examiner recommends clarifying what characteristics of an offset value are considered to be reliable. Additionally, there is a lack of antecedent basis for the term “the return images” in claim 5. Therefore, it is unclear whether this term is referring to image generated by the series of echo lines (LER) or something else.
Regarding claim 7, the claim recites “in which, on the one hand, probe (2) movement is sensed, and on the other hand:- if the first step is to identify a target area of interest (ZI), the probe (2) is moved across a large area in order to identify the location, the probe (2) is then set to nominal fast frame rate mode and the final image has nominal resolution, and - if, in a second phase, the target area of interest (ZI) has been identified and a higher resolution image is required, the probe (2) is kept static or quasi-static, the probe (2) can then be set to a slower frame rate and the image obtained has a higher resolution”. However, it is unclear what happens in the first step, when it does not involve identifying a target area of interest (ZI). Furthermore, it is unclear what happens in the second step if a higher resolution image is not required. The examiner would recommend updating the claim language such that these limitations are not conditional (i.e. involving “if” statements) and/or clarifying what steps the method performs when the if statements are not required.
Furthermore, there is a lack of antecedent basis for the term “the probe” therefore, it is unclear whether this is the same as or different from the “ultrasound probe” recited in claim 1.
Regarding claim 8, the claim reads “including:- a carrier (8b) with n transducer elements, each with its own frequency, - the n frequencies are chosen to allow for n examination depths (P), - the frequency corresponding to the required examination depth (P) is selected, and - the stepper motor (8a) is instructed to move the carrier (8b) and bring the transducer element (9) corresponding to the selected frequency to its reference position”. However, this claim appears to describe apparatus components (i.e. carrier with n transducer elements, each with its own frequency, the n frequencies are chosen to allow for n examination depths (P)) within the method claim, which creates confusion as to when direct infringement occurs. A single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112, second paragraph. See In re Katz Interactive Call Processing Patent Litigation, 639 F.3d 1303 (Fed. Cir. 2011). It is unclear "whether infringement … occurs when one creates a system that allows the user [to use the input means], or whether infringement occurs when the user actually uses the input means." See IPXL Holdings v. Amazon.com, Inc., 430 F.2d 1377, 1384, 77 USPQ2d 1140, 1145 (Fed. Cir. 2005). See MPEP 2173.05(p).
The examiner recommends using language such as “the processor is configured to […]” in order to clarify that the component(s) of the ultrasound scanner (i.e. stepper motor) is/are the device(s) which is/are designed to perform these steps.
Regarding claim 10, the claim reads “including: a portable digital device, capable of running an application suitable for the execution of a functionality with communications capabilities, a screen, a control device, and memory (MEM), a probe is provided for exploring an area of interest (ZI) on the human body (C), comprising a drive system including a stepping motor, a motion transmission system, and a carrier for transducer elements secured on the carrier, a resource able to analyze image points along an arc at a given depth (P), such that, with the detects affecting the mechanical drive system, angular offset between the emission echo lines (LEA) and the return echo lines (LER) is associated with the operation of the mechanism drive system, the probe being fitted with a means of correcting this offset, and communications capabilities and the portable digital device and the probe being configured to communicate with each other, the portable digital device is used to parameterize and control the probe, display the images obtained by and received from the probe on the screen of the portable digital device, and transmit the images obtained by and received from the probe to an external storage platform”.
However, this claim appears to describe apparatus components (i.e. portable digital device and probe) within the method claim, which creates confusion as to when direct infringement occurs. Additionally, it is unclear what method steps are actually being performed within this claim. A single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112, second paragraph. See In re Katz Interactive Call Processing Patent Litigation, 639 F.3d 1303 (Fed. Cir. 2011). It is unclear "whether infringement … occurs when one creates a system that allows the user [to use the input means], or whether infringement occurs when the user actually uses the input means." See IPXL Holdings v. Amazon.com, Inc., 430 F.2d 1377, 1384, 77 USPQ2d 1140, 1145 (Fed. Cir. 2005). See MPEP 2173.05(p).
Furthermore, the examiner recommends clarifying what method steps are required by this claim. The examiner recommends using language such as “the portable digital device is configured to […]” or “the probe is configured to” in order to clarify that the component(s) of the ultrasound scanner (i.e. probe) is/are the device(s) which is/are designed to perform these steps
Furthermore, it is unclear whether “a probe” recited in this claim is the same as or different from “an ultrasound probe” recited in the preamble of claim 1. The examiner would recommend clarifying why two probes are necessary if the probe recited in claim 10 and the probe recited in claim 1 are in fact different devices.
Regarding claims 2-11, due to their dependence on claim 1, either directly or indirectly, these claims are subject to the reasoning provided therein. Thus, these claims are also rejected under 35 U.S.C. 112(b) for the reasons stated above.
Regarding claim 12, the claim recites “due to defects affecting the mechanical drive system, angular offset between the emission echo lines (LEA) and the return echo lines (LER) is associated with the operation of the mechanical drive system”. It is unclear whether the limitation is intended to represent a component of the ultrasound scanner. As stated, this limitations appears to merely state that defects affect the system rather than identifying/determining defects themselves. The examiner recommends clarifying the purpose of this limitation (i.e. whether it identifies or determines defects). Additionally, there is a lack of antecedent basis for the term “the mechanical drive system”. Thus, it is unclear whether this is the same as or different from the “drive system” recited in line 5 of claim 12. If they are the same, the examiner would recommend maintaining the same language throughout the claim.
Additionally, the claim recites “a means for analyzing the image points along an arc (AA, AR) at a given depth (P) of the area of interest for two series of successive emission and return echo lines (LEA, LER) to determine said angular offset of the image points in the two successive emission and return arcs (AA, AR) and calculate the angular offset of the emission and return echo lines (LER), associated with the operation of the drive system”. However there is a lack of antecedent basis for the terms “the image points along an arc (AA, AR)”. Therefore, it is unclear whether these image points are the same as or different from the information obtained when the transducer element is mechanically driven (i.e. by the stepper motor) and scans alternating sectors from a reference position, as recited earlier in the claim.
Furthermore, the claim recites “means for correcting the offset by image approximation, and in particular by superimposing or almost superimposing the emission images and the successive return images, incorporating the calculated offset associated with the operation of the drive system”. However, there is a lack of antecedent basis for the term “the offset”, therefore it is unclear whether this is referring to “the angular offset” recited in the previous limitation or not. Furthermore, it is unclear what is meant by the term “almost superimposing these images”. The term “almost superimposing” is a relative term which renders the claim indefinite because this term is not defined by the claim and the specification does not provide a standard for ascertaining the requisite degree to which images are considered to be “almost superimposed”. Thus, one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Additionally, the examiner believes that “the drive system” (underlined above) is intended to be the same as the “mechanical drive system” recited earlier in the claim. Therefore, the examiner would recommend updating the claim language to maintain proper antecedent basis for this term.
Furthermore, the claim recites “means for analyzing the image points along an arc at a given depth (P) of the area of interest for two series of successive emission and return echo lines (LEA, LER), in order to determine said angular offset of the image points in the two successive emission and return arcs (AA, AR), and calculate the angular offset of the emission and return echo lines (LEA, LER), associated with the operation of the drive system” and “means for correcting the offset by image approximation, and in particular by superimposing or almost superimposing the emission images and the successive return images, incorporating the calculated offset associated with the operation of the drive systems” which invokes 35 U.S.C. 112(f).
Although the specification does include these means in paragraph [0026], this paragraph merely repeats the claim language. Therefore, it is unclear what structural components may be incorporated or excluded from the “means for analyzing the image points along an arc at a given depth (P) of the area of interest for two series of successive emission and return echo lines (LEA, LER), in order to determine said angular offset of the image points in the two successive emission and return arcs (AA, AR), and calculate the angular offset of the emission and return echo lines (LEA, LER), associated with the operation of the drive system” and the “means for correcting the offset by image approximation, and in particular by superimposing or almost superimposing the emission images and the successive return images, incorporating the calculated offset associated with the operation of the drive systems” to perform the claimed function.
Additionally, there is a lack of antecedent basis for the term “the drive systems” (underlined above), as claim 12 only recites “a drive system” in line 5. Therefore, the examiner recommends clarifying whether the “drive systems” are the same as or different from the drive system disclosed in line 5 of claim 12. If they are the same, the examiner would recommend amending this limitation to recite “the drive system”.
Therefore, one of ordinary skill in the art would not be appraised of the metes and bounds of the claim scope given the specification in the instant application and thus the claim is rendered indefinite and is rejected under 35 U.S.C. 112(b).
Regarding claim 17, as written it reads “a dry compartment housing the electronic equipment, communications capabilities, a power supply unit, and ports for a battery charger and a computer”. However, there is a lack of antecedent basis for the term “the electronic equipment”, therefore, it is unclear which components are included or excluded from the electronic equipment.
Regarding claim 18, as written it reads “in which the drive system includes a motion transmission system between the stepper motor and the carrier supporting the transducer element, such as a toothed belt interlocking with notches on a rotary pinion at the stepper motor outlet and the notches on a rotary pinion at the inlet of the carrier supporting the transducer element”. The phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Additionally, there is a lack of antecedent basis for “the notches on a rotary pinion at the inlet of the carrier”. The examiner would recommend amending this portion of the limitation to state “notches on a rotary pinion at the inlet of the carrier supporting the transducer element”.
Regarding claim 19, as written it reads “the resources of the portable digital device can be used to calculate the angular offset of the lines associated with the operation of the drive system and/or the compensation of the angular offset thus calculated; and/or probe resources can be used to calculate the angular offset of the lines associated with the operation of the drive system and/or compensation of the angular offset thus calculated”. However, there is a lack of antecedent basis for the terms “the resources” and “probe resources”. Therefore, it is unclear what is being referred to by these terms.
Regarding claims 13-19, due to their dependence on claim 12, either directly or indirectly these claims are subject to the reasoning provided therein. Additionally, these claims do not provide further information regarding what structures are necessary to perform the claimed function. Thus, claims 13-19 are rejected under 35 U.S.C. 112(b).
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-11 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception in the form of an abstract idea, specifically a mental process, without significantly more.
Regarding claim 1, the examiner notes that the claim is directed to an operating procedure for an ultrasound scanner comprising an ultrasound probe for exploring an area of interest on the human body. Therefore, the claims fall within one of the statutory categories of invention.
With reference to Step 2A, Prong One, the claim recites “the image points along an arc (AA, AR) at a given depth (P) of the area of interest (ZI) are analyzed for two series of successive emission and return echo lines (LEA, LER), to determine the angular offset of the image points in the two successive emission and return arcs (AA, AR) and calculate the angular offset of the emission echo lines and the return echo lines (LER), associated with the operation of the drive system, and the offset is corrected by approximating the successive emission and return images, particularly by superimposing or almost superimposing these images, incorporating the calculated offset associated with the operation of the drive system”.
The limitations, under broadest reasonable interpretation, cover performance of the limitation in the mind and/or read on analyzing images, determining whether there is an angular offset between images, calculating the angular offset and correcting for it by moving (i.e. superimposing images). In this case, analyzing images to determine and calculate angular offset such that it can be corrected for by superimposing images, represent actions which can be practically performed in the human mind by a user analyzing images and determining the angular offset between them (i.e. by inspection) and superimposing the images (i.e. by clicking/dragging them along a screen, for example). If a claim limitation under its broadest reasonable interpretation covers performance of the limitation in the mind but for the recitation of generic computer components (i.e. a processor), then it falls within the “mental processes” grouping of abstract ideas.
Following step 2A, Prong Two of the two-prong analysis, the claim recites the following additional elements: “the transducer element, fixed to the carrier, is mechanically driven by the stepper motor and scans alternating sectors from a reference position”. These additional elements do not integrate the judicial exception into a practical application because the claim as written does not include elements to 1) improve the functioning of a computer (See MPEP 2106.05(a)); 2) effect a particular treatment or prophylaxis (See MPEP 2106.04(d)(2)); 3) use a particular machine (See MPEP 2106.05(b)); 4) use the judicial exceptions in a meaningful way beyond generally linking the use to a particular technological environment (See MPEP 2106.05(h)). Furthermore, these mechanical driving step does not integrate the judicial exception into a practical application because it adds insignificant extra-solution activity to the judicial exception using a well-known device (i.e. transducer element) (See MPEP 2106.05(g)).
Following step 2B, the additional element(s) (i.e. “the transducer element, fixed to the carrier, is mechanically driven by the stepper motor and scans alternating sectors from a reference position”) do not amount to significantly more than the judicial exception because these limitations represent data gathering steps which utilize conventional tools (i.e. transducer element and step motor)) to perform well understood, routine and conventional activity (i.e., see [0026] in Hwang US 2007/0016060 A1) to perform the abstract idea.
Regarding claims 2-11, the claims add additional limitations that append the judgement of claim 1 and/or do not include additional elements that are sufficient to amount to significantly more than the judicial exception, nor a practical application of the judicial exception because they disclose:
steps that can be practically performed within the mind (i.e. as a mental processing: “we use a gradient descent algorithm to minimize the distance between the points on the curve (CA) of the emission arc (AA) and the curve (CB) of the return arc (AR) by progressively offsetting each curve with respect to the other until we retain the offset giving the minimum distance as the angular offset between the emission and return echo lines” (Claim 3); “we apply a gradient descent algorithm to an initial emission arc and an initial return arc to obtain an initial offset d1, then apply a gradient descent algorithm to the initial return arc and a subsequent second emission arc, to obtain a second offset d2” (Claim 4); “in order to correct offset, angular offset is repeatedly calculated, then when an offset value calculated in this way is considered to be reliable, the return images are corrected using the imaging algorithm […]” (Claim 5); “in order to correct offset, angular offset is repeatedly calculated, then, when an offset value calculated in this way is considered to be reliable, it is saved on a permanent basis […]” (Claim 6); “in which the angular offset of the lines associated with the operation of the drive system is calculated using either the portable digital device or the probe);
provide additional information about the device used to obtain imaging data (i.e. “a stepper motor without an encoder is used” (Claim 2), “the probe is moved across a large area in order to identify the location […] the probe is kept static or quasi-static, the probe can then be set to a slower frame rate and the image obtained has a higher resolution” (Claim 7); “a carrier with n transducer elements, each with its own frequency, the n frequencies are chosen to allow for n examination depths (P) […] the stepper motor is instructed to move the carrier” (Claim 8); “in which n is equal to three, and the frequencies are equal to or close to 3.5 MHz, 5 MHz, and 7.5 MHz, respectively (Claim 9); “a portable digital device capable of running an application suitable for the execution of a functionality, with communications capabilities, a screen, a control device, and memory (MEM)” (Claim 10).
Allowable Subject Matter
Claims 1-19 are free of art and, as best understood, would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) and/or 35 U.S.C. 101 set forth in this Office action.
During the examiner’s search the following prior art references were found: Kim et al. US 2009/030326 A1 “Kim”, El-Aklouk et al. US 2010/0324418 A1 “El-Aklouk”, Cerofolini US 5,740,804 A “Cerofolini” and Bai CN 106671758 A “Bai”.
Kim discloses an ultrasound probe coupled to a stepper motor in order to scan several lines (see FIG. 1-FIG. 4 and paragraphs [0014], [0028], [0033], [0046]. However, Kim does not disclose the possibility or capability of detecting mechanical faults or angular offset(s) and correcting them by controlling the motor on the basis of acquired images, wherein correcting is performed by approximating the successive emission and return images, particularly by superimposing or almost superimposing these images, incorporating the calculated offset associated with the operation of the drive system, as required by claims 1 and 12.
Additionally, El-Aklouk discloses an ultrasound transducer probe which is mechanically moved with respect to the body portion, wherein the movement of the transducer is able to be controlled to return to a selected position relative to the body portion with an error of less than 100 micro meters (see [0015]). Therefore, in El-Aklouk an error of the mechanical system is taken into account, however it is not corrected on the basis of acquired images, wherein correcting is performed by approximating the successive emission and return images, particularly by superimposing or almost superimposing these images, incorporating the calculated offset associated with the operation of the drive system, as required by claims 1 and 12.
Furthermore, Cerofolini discloses “In an exemplary embodiment, the ultrasonic probe includes first and second rotating mechanisms, comprising first and second stepper motors, respectively, operatively connected to a transducer array. The first stepper motor is disposed in the probe housing and rotates the transducer array through a particular scan plane. The second stepper motor is disposed in the second housing and rotates the transducer array through a plurality of scan planes” [Column 3, Lines 34-41]; “Another advantage of a stepper motor based system is that the system is extremely stable and is not subject to drift errors because such a system is digitally controlled using open loop commands. The velocity of the rotor is proportional to the frequency of the drive signal and the position of the rotor is determined by the number of pulses sent by the control system. Therefore, any drift errors that may be present are not cumulative and the movement of the rotor is highly accurate and repeatable” [Column 4, Lines 32-41]. Therefore, the stepper motor based system of Cerefolini recognizes drift errors, but they are not corrected on the basis of acquired images, wherein correcting is performed by approximating the successive emission and return images, particularly by superimposing or almost superimposing these images, incorporating the calculated offset associated with the operation of the drive system, as required by claims 1 and 12.
Additionally, Bai discloses a stepping motor stepping compensation method used to realize control of the ultrasonic probe (see [Abstract]). However, this compensation method does not perform correction on the basis of acquired images, wherein correcting is performed by approximating the successive emission and return images, particularly by superimposing or almost superimposing these images, incorporating the calculated offset associated with the operation of the drive system, as required by claims 1 and 12.
Therefore, no prior art references were found to teach “the image points along an arc (AA,AR) at a given depth (P) of the area of interest (ZI) are analyzed for two series of successive emission and return echo lines (LEA, LER), to determine the angular offset of the image points in the two successive emission and return arcs (AA, AR) and calculate the angular offset of the emission echo lines (LEA) and the return echo lines (LER), associated with the operation of the drive system, and the offset is corrected by approximating the successive emission and return images, particularly by superimposing or almost superimposing these images, incorporating the calculated offset associated with the operation of the drive system” (Claim 1) and “means for analyzing the image points along an arc at a given depth (P) of the area of interest for two series of successive emission and return echo lines (LEA, LER), in order to determine said angular offset of the image points in the two successive emission and return arcs (AA, AR) and calculate the angular offset of the emission and return echo lines (LEA, LER), associated with the operation of the drive system, and means for correcting the offset by image approximation and in particular by superimposing or almost superimposing the emission images and the successive return image, incorporating the calculated offset associated with the operation of the drive systems” (Claim 12).
Thus, claims 1 and 12 along with their corresponding dependent claims (i.e. claims 2-11 and 13-19) would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) and/or 35 U.S.C. 101 set forth in this Office action.
As allowable subject matter has been indicated, applicant's reply must either comply with all formal requirements or specifically traverse each requirement not complied with. See 37 CFR 1.111(b) and MPEP § 707.07(a).
Conclusion
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