DETAILED ACTION
This office action is in response to the communication received on 12/23/2025 concerning application no. 18/765,763 filed on 07/08/2024.
Claims 1-20 are pending (Claims 1-11 and 20 are withdrawn from consideration).
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 .
Election/Restrictions
Applicant’s election without traverse of Group II (Claims 12-19) in the reply filed on 12/23/2025 is acknowledged.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Drawings
The drawings are objected to because:
The drawings (Figs. 2-3) are objected to because, according to MPEP 608.02 and 67 CFR 1.84, "India ink, or its equivalent that secures solid black lines, must be used for drawings". Drawings should be presented as India ink drawings unless the illustration is not capable of being accurately or adequately depicted by India ink drawings.
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. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. 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
Claim 17, contains an optional limitation “when the detection result is a first result”. According to MPEP 2111.04, “The broadest reasonable interpretation of a method (or process) claim having contingent limitation acquires only those steps that must be performed and does not include steps that are not required to be performed because the condition(s) precedent are not met”.
Therefore, the claim element starting with “when the detection result is a first result” and ending with “the pattern is a first pattern” is not required to be performed.
Claim 17, contains an optional limitation “when the detection result is a second result”. According to MPEP 2111.04, “The broadest reasonable interpretation of a method (or process) claim having contingent limitation acquires only those steps that must be performed and does not include steps that are not required to be performed because the condition(s) precedent are not met”.
Therefore, the claim element starting with “when the detection result is a second result” and ending with “the pattern is a second pattern” is not required to be performed.
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 scanning device configured to scan…” in claim 12: Paragraphs 0003-04 teach “A medical imaging system is capable of obtaining an internal tissue image of a subject to undergo detection in a non-intrusive manner. For example, a scanning device of the medical imaging system can scan a predetermined site of a subject to undergo detection, to obtain imaging data containing information about the predetermined site. A common medical imaging system is, for example, an ultrasound imaging system, a nuclear magnetic resonance imaging (MRI) system, or a computed tomography (CT) scanning system, and so on.”
“an indicator configured to emit light…” in claim 12: Paragraph 0040 teaches “In some examples, the indication apparatus 2 may be a matrix of light emitting elements, for example, a matrix of light emitting diodes. Therefore, the indication apparatus 2 can form a required pattern on a predetermined surface.”
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
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 13-16 and 18 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 13 is indefinite for the following reasons:
Recites “an image of the predetermined site in the medical image”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art how an image can be located within a medical image (i.e. another image). An image is a fixed representation1. A medical image with the predetermined site already includes a representation of the site within it. It is unclear if the claim is establishing that the medical image is a representation of another image. For example, a camera picture of an ultrasound image.
Applicant is encouraged to provide consistent and clear language.
Claim 14 is indefinite for the following reasons:
Recites “the image of the predetermined site relative to a central position of the medical image”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art how an image can be located within a medical image (i.e. another image). An image is a fixed representation2. A medical image with the predetermined site already includes a representation of the site within it. It is unclear if the claim is establishing that the medical image is a representation of another image. For example, a camera picture of an ultrasound image.
Applicant is encouraged to provide consistent and clear language.
Claim 15 is indefinite for the following reasons:
Recites “a second threshold”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art what is undergoing thresholding.
Applicant is encouraged to provide consistent and clear language.
Recites “a second threshold”. There is insufficient antecedent basis for this limitation in the claim. Claim fails to establish a first threshold. It would be unclear to one with ordinary skill in the art what the second threshold is second to.
Claim 16 is indefinite for the following reasons:
Recites “real-time analysis”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art if the “real-time analysis” is the same as the “analysis” established in claim 12 or is a separate and distinct feature.
Applicant is encouraged to provide consistent and clear language.
Recites “real-time pattern”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art if the “real-time pattern” is the same as the “pattern” established in claim 12 or is a separate and distinct feature.
Applicant is encouraged to provide consistent and clear language.
Claim 18 is indefinite for the following reasons:
Recites “a second target translation direction of the scanning device”. There is insufficient antecedent basis for this limitation in the claim. Claim fails to establish a first target translation direction of the scanning device. It would be unclear to one with ordinary skill in the art what the second target translation direction of the scanning device is second to.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 12-13 and 16-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Boctor et al. (PGPUB No. US 2013/0218024).
Regarding claim 12, Boctor teaches method of controlling a medical imaging system, the medical imaging system comprising:
a scanning device configured to scan a predetermined site of a subject to undergo detection, to obtain imaging data containing information about the predetermined site; an indicator configured to emit light; and a controller (Paragraph 0032 teaches the overlay guidance can be placed with the medical device like ultrasound probes and C-arms. Paragraph 0033 teaches that imaging of a target is performed. Paragraph 0032 teaches a projection system can project directionality. Paragraph 0166 teaches light projection. It is inherent that a computational system will utilize a processor and memory for the performance of its computational functions. Paragraph 0230 teaches different combinations of software components are possible for different applications and/or different hardware embodiments);
the method comprising performing analysis of a medical image generated based on the imaging data, and controlling, according to an analysis result, the indicator to project a light beam to a predetermined surface, to form a pattern on the predetermined surface (Paragraph 0032 teaches that the images are captured and registered. This provides the bases for guidance on how to move the probe to visualize a given target. For example, suppose that a tumor is identified in a diagnostic image, or in a previous scan. After registration the projection system can project an arrow on the patient showing in which direction the probe should move).
Regarding claim 13, Boctor teaches the control method of a medical imaging system in claim 12, as discussed above.
Boctor further teaches a control method of a medical imaging system, wherein
the analysis comprises analysis of a difference between an image of the predetermined site in the medical image and a target, and the pattern indicates target movement information for the scanning device to reduce the difference (Paragraph 0032 teaches that the images are captured and registered. This provides the bases for guidance on how to move the probe to visualize a given target. For example, suppose that a tumor is identified in a diagnostic image, or in a previous scan. After registration the projection system can project an arrow on the patient showing in which direction the probe should move. One of ordinary skill will realize that these same ideas can be used to guide a user to visualize a particular organ based on a prior model of the patient or a patient-specific scan, or could be used to aid in tracking or orienting relative to a given target. Paragraph 0033 teaches that the patient images can be recorded and in subsequent imaging, the images are used as guidance on how to move the probe toward a desired target, and an indication when the previous imaging position is reached).
Regarding claim 16, Boctor teaches the control method of a medical imaging system in claim 13, as discussed above.
Boctor further teaches a control method of a medical imaging system, wherein the controller further performs real-time analysis while the scanning device is being moved, and controls, according to a real-time analysis result, the indicator to form a real- time pattern (Paragraph 0016 teaches real-time feedback and quality control system to choose actively the right pattern design. Paragraph 0173 teaches that the guidance is in real-time).
Regarding claim 17, Boctor teaches the control method of a medical imaging system in claim 12, as discussed above.
Boctor further teaches a control method of a medical imaging system, wherein
the analysis result comprises a detection result obtained by performing detection on the medical image, when the detection result is a first result, the pattern is a first pattern, when the detection result is a second result, the pattern is a second pattern, and the first pattern and the second pattern are different in at least one of shape, color, and position (Paragraph 0225 teaches this guidance can be either (a) registered to the underlying image or environment geometry such that overlaid symbols correspond to environment features (such as target areas) in location and possibly size and/or shape. Paragraph 0032 teaches that the images are captured and registered. This provides the bases for guidance on how to move the probe to visualize a given target. Paragraph 0033 teaches that the patient images can be recorded and in subsequent imaging, the images are used as guidance on how to move the probe toward a desired target, and an indication when the previous imaging position is reached).
Regarding claim 18, Boctor teaches the control method of a medical imaging system in claim 12, as discussed above.
Boctor further teaches a control method of a medical imaging system, wherein
the control method further comprises:
after detection performed based on the medical image is completed, the controller further controls the indicator to project a light beam to the predetermined surface, to form a movement indication pattern on the predetermined surface, and the movement indication pattern indicates a second target translation direction of the scanning device (Paragraph 0032 teaches that the images are captured and registered. This provides the bases for guidance on how to move the probe to visualize a given target. For example, suppose that a tumor is identified in a diagnostic image, or in a previous scan. After registration the projection system can project an arrow on the patient showing in which direction the probe should move. Paragraph 0033 teaches that the guidance allows for the probe to move toward the desired target. See Fig. 6).
Regarding claim 19, Boctor teaches the control method of a medical imaging system in claim 12, as discussed above.
Boctor further teaches a control method of a medical imaging system, wherein
an end point of the movement indication pattern in the second target translation direction is used to indicate a target position for the scanning device moving in the second target translation direction (Paragraph 0032 teaches that the images are captured and registered. This provides the bases for guidance on how to move the probe to visualize a given target. For example, suppose that a tumor is identified in a diagnostic image, or in a previous scan. After registration the projection system can project an arrow on the patient showing in which direction the probe should move. Paragraph 0033 teaches that the guidance allows for the probe to move toward the desired target. See Fig. 6).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Boctor et al. (PGPUB No. US 2013/0218024) in view of Rouet et al. (PGPUB No. US 2019/0015076).
Regarding claim 14, Boctor teaches the control method of a medical imaging system in claim 13, as discussed above.
However, Boctor is silent regarding a control method of a medical imaging system, wherein the difference comprises an offset of the image of the predetermined site relative to a central position of the medical image, and the target movement information comprises first target translation information for reducing the offset.
In an analogous imaging field of endeavor, regarding probe guidance, Rouet teaches a control method of a medical imaging system, wherein the difference comprises an offset of the image of the predetermined site relative to a central position of the medical image, and the target movement information comprises first target translation information for reducing the offset (Paragraph 0024 teaches the assessment of the positional relation that is a distance of a center of the anatomical feature from a center of the two-dimensional ultrasound image in the image plane. Paragraph 0062 teaches that the alignment can be improved of the image planes and can provide indication of the rotation or translation to align the anatomical feature with respect to the field of view. Paragraph 0055 teaches that that the centering of the feature is considered for the alignment with the field of view).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Boctor with Rouet’s teaching of assessment of offset from a center of an image and provide alignment information based on the assessment. This modified method would allow the user to provides a possibility to determine the position of the ultrasound probe with respect to the anatomical feature with low technical effort on the basis of the two-dimensional ultrasound image data (Paragraph 0024 of Rouet). Furthermore, the modification provides possibility to continuously align the anatomical feature to the ultrasound probe so that a quantification and/or a size measurement can be performed comfortable with low time consumption (Paragraph 0028 of Rouet).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Boctor et al. (PGPUB No. US 2013/0218024) in view of Ebata (PGPUB No. US 2022/0183663).
Regarding claim 15, Boctor teaches the control method of a medical imaging system in claim 13, as discussed above.
However, Boctor is silent regarding a control method of a medical imaging system, wherein the difference comprises a difference between a size difference, between a first size in a first direction and a second size in a second direction of the image of the predetermined site, and a second threshold, and the target movement information comprises second target rotation information for reducing the difference.
In an analogous imaging field of endeavor, regarding probe guidance, Ebata teaches a control method of a medical imaging system, wherein the difference comprises a difference between a size difference, between a first size in a first direction and a second size in a second direction of the image of the predetermined site, and a second threshold, and the target movement information comprises second target rotation information for reducing the difference (Paragraph 0154 teaches the assessment of the difference with respect to the minor and maximum axis with. This difference is thresholded and the manipulation assist is based on that thresholding. Paragraph 0082 teaches that the assisted slide position can be about a rotation axis and the probe can be rotated about that axis).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Boctor with Ebata’s teaching of assessment in size difference and providing rotation according to its thresholding. This modified method would allow the user to improve the accuracy of calculating the maximum feature quantity (Paragraph 0077 of Ebata). Furthermore, the modification to improve measurement accuracy (Paragraphs 0006-007 of Ebata).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Dhatt et al. (PGPUB No. US 2022/0343494): Teaches indication of the target from the center of an image. Teaches the assessment of the difference of the axial lengths of the target and thresholding accordingly.
Sauer et al. (PGPUB No. US 2003/0120154): Teaches projection of light for probe guidance.
Striano (PGPUB No. US 2016/0051224): Teaches projection of light for probe guidance.
Patacsil et al. (US Patent No. 6,132,379): Teaches projection of light for probe guidance.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ADIL PARTAP S VIRK whose telephone number is (571)272-8569. The examiner can normally be reached Mon-Fri 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Pascal Bui-Pho can be reached on 571-272-2714. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ADIL PARTAP S VIRK/Primary Examiner, Art Unit 3798
1 “a visual representation of something” (Link: https://www.merriam-webster.com/dictionary/image)
2 “a visual representation of something” (Link: https://www.merriam-webster.com/dictionary/image)