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
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Election/Restrictions
Claims 46-51 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 19 December 2025.
Applicant’s election without traverse of Claims 52-65 in the reply filed on 19 December 2025 is acknowledged.
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: information provision system 1000, system 1000. 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.
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: 432, 434 (Fig. 4), S610, S620 (Fig. 6), 560, 570 (Fig. 14). 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.
Specification
The disclosure is objected to because of the following informalities: improper figure numbering. Page 12 Line 5 should be amended to “FIGS. 14 to 19E […].” Appropriate correction is required.
The use of the term BluetoothTM, Wi-FiTM, MACTM, WindowsTM which are trade names or marks used in commerce, have been noted in this application. The terms should be accompanied by the generic terminology; furthermore the terms should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the terms.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Objections
Claims 52 and 60 are objected to because of the following informalities: a minor error in antecedent basis. The claim should be amended to “[…] information on an M-mode ultrasound image of a subject […] [[an]] the M-mode ultrasound image of [[a]] the subject […]” in order to establish proper antecedent basis. Appropriate correction is required.
Claim 58 is objected to because of the following informalities: a minor error in antecedent basis. The claim should be amended to “[…] the plurality of cardiac tomographic regions are at least two regions selected from the RV anterior wall, the right ventricle (RV), the anterior wall of aorta, the aorta, the posterior wall of the aorta, the left atrium (LA), and the posterior wall of the LA […]” in order to establish proper antecedent basis. Appropriate correction is required.
Claim 60 is objected to because of the following informalities: a minor error in antecedent basis. The claim should be amended to “[…] [[an]] the M-mode ultrasound image of [[a]] the subject […]” in order to establish proper antecedent basis. 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 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.
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: communication unit in Claim 60.
The disclosure merely cites: the communication unit is configured to receive an M-mode ultrasound image of a subject (Page 7 Lines 13-14); to receive an electrocardiogram (ECG) for the subject (Page 7 Lines 21-22); and to selectively receive an ECG for the subject (Page 8 Lines 19-20).
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 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.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
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 of carrying out his invention.
Claims 60-65 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, 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, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding Claim 60, the claim recites the limitation “communication unit” which is interpreted under 35 U.S.C. 112(f) according to analysis made of record. The “communication unit” is described exclusively in terms of the functions it performs, without naming a structure intended to be used, and therefore applicant has not demonstrated possession of that structure.
Claims not explicitly addressed above are rejected as depending from a rejected claim and failing to cure deficiencies of the parent claim.
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 60-65 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 limitation “communication unit” in Claim 60 invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The disclosure is devoid of any specific, sufficient structure that performs the function in the claim. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Claims not explicitly addressed above are rejected as depending from a rejected claim and failing to cure deficiencies of the parent claim.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 52-56 and 58-64 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hare, II et al. (US 20210259664), hereinafter referred to as Hare.
Regarding Claim 52, Hare teaches a method for providing information on an M-mode ultrasound image implemented by a processor, (Fig. 6J, [0039] “an automated clinical workflow diagnoses heart disease based on both cardiac biomarker measurements and AI recognition of 2D and Doppler modality Echocardiographic images,” and [0043] “The technician has the option of adding to these 2D echo images a waveform captured from various possible modalities including: […] m-mode”), the method comprising:
a) receiving an M-mode ultrasound image of a subject ([0043] “The technician has the option of adding to these 2D echo images a waveform captured from various possible modalities including: […] m-mode” and [0092] “Doppler modality images comprise two images, an echocardiogram image of the heart and a corresponding waveform, both of which are extracted from the echo file for image processing. In one embodiment, Doppler modality image classification of […] M-mode images is performed as follows. If the DICOM file contains a waveform modality ([…] M-mode), the two extracted images are input to one of the CNNs 200A trained for […] M-mode view classification to further classify the echo images as one of: […] M-mode (TrV) and M-mode Other.”));
b) segmenting a plurality of cardiac tomographic regions within the M-mode ultrasound image, respectively, by using a first model that is trained so as to segment the M-mode ultrasound image into the plurality of cardiac tomographic regions by inputting the M-mode ultrasound image ([0064] “a third set of neural networks 200C, including adversarial networks, are employed for each classified 2D view type in order to segment the cardiac chambers in the 2D images and produce segmented 2D images.”);
c) removing the segmented regions other than the M-mode region or filling holes within the segmented regions so as to obtain a plurality of post-processed cardiac tomographic regions ([0100] “For M-mode views, a third U-Net CNN can be trained to segment the waveform, remove small pieces of the segments to find likely candidates for the region of interest, and then reconnect the segments to provide a full trace of the movement of the mitral valve.”);
d) determining diastole and systole within the M-mode ultrasound image, by using a second model that is trained to predict diastole and systole of the M-mode ultrasound image by inputting the M-mode ultrasound image ([0101] “the Doppler modality pipeline continues by processing the annotated Doppler modality images with a sliding window to identify cycles, peaks are measured in the cycles, and key points in the cardiac cycle are determined by finding systolic/diastolic end points (block 432).” Where the Doppler modality includes an M-mode ultrasound image, as discussed above.); and
e) determining measurements for the plurality of segmented post-processed cardiac tomographic regions based on the diastole and the systole ([0102] “FIGS. 8A and 8B are diagrams illustrating examples of finding systolic/diastolic end points in the cardiac cycle, for both 2D and Doppler modalities, respectively, which are key points in order to take accurate cardiac measurements.”).
Regarding Claim 53, Hare teaches all limitations of Claim 52, as discussed above. Furthermore, Hare teaches wherein the second model is a model that predicts end-diastole and end-systole by inputting the M-mode ultrasound image ([0102] “FIGS. 8A and 8B are diagrams illustrating examples of finding systolic/diastolic end points in the cardiac cycle, for both 2D and Doppler modalities, respectively, which are key points in order to take accurate cardiac measurements.”).
Regarding Claim 54, Hare teaches all limitations of Claim 53, as discussed above. Furthermore, Hare teaches wherein the determining of the measurements includes determining measurements for the plurality of cardiac tomographic regions based on the predicted end-diastole and the end systole ([0102] “FIGS. 8A and 8B are diagrams illustrating examples of finding systolic/diastolic end points in the cardiac cycle, for both 2D and Doppler modalities, respectively, which are key points in order to take accurate cardiac measurements.”).
Regarding Claim 55, Hare teaches all limitations of Claim 52, as discussed above. Furthermore, Hare teaches wherein the second model is a model that predicts each period of the diastole and the systole by inputting the M-mode ultrasound image ([0101] “the Doppler modality pipeline continues by processing the annotated Doppler modality images with a sliding window to identify cycles, peaks are measured in the cycles, and key points in the cardiac cycle are determined by finding systolic/diastolic end points (block 432). Typically a Doppler modality video may capture three heart cycles and the sliding window is adjusted in size to block out two of the cycles so that only one selected cycle is analyzed. Within the selected cycle, the sliding window is used to identify cycles, peaks are measured in the cycles, and key points in the cardiac cycle are determined by finding systolic/diastolic end points.”).
Regarding Claim 56, Hare teaches all limitations of Claim 55, as discussed above. Furthermore, Hare teaches wherein the determining of the measurements includes determining measurements for the plurality of cardiac tomographic regions at transition points of each period of the predicted diastole and the systole (Table 1 (Page 10), where measurements of specific regions of the heart are taken during multiple points in the predicted diastole and the systole, e.g., “left ventricular end systolic volume” and “left atrial volume rate during early diastole”).
Regarding Claim 58, Hare teaches all limitations of Claim 52, as discussed above. Furthermore, Hare teaches wherein
a) the plurality of cardiac tomographic regions are at least two regions selected from the RV anterior wall, (Table 1 “Right Ventricular Anterior Wall Thickness”), the right ventricle (RV), (Table 1 “Right Ventricular End Diastolic Internal Diameter,” “Right Ventricular Area”), the anterior wall of aorta, the aorta, the posterior wall of aorta, the left atrium (LA), (Table 1 “Left Atrial End Systolic Volume”), and the posterior wall of LA, (Table 1 “Left Ventricular Posterior Wall thickness measured end diastolic”), and
b) the measurements are an aorta diameter, (Table 1 “Ascending Aorta diameter” and “Descending Aortic diameter”) or a LA diameter.
Regarding Claim 59, Hare teaches all limitations of Claim 52, as discussed above. Furthermore, Hare teaches wherein
a) the plurality of cardiac tomographic regions are at least two regions selected from the RV anterior wall, (Table 1 “Right Ventricular Anterior Wall Thickness”), the right ventricle, (Table 1 “Right Ventricular End Diastolic Internal Diameter,” “Right Ventricular Area”), the interventricular septum (IVS), ([0168] “interventricular septal thickness”), the left ventricle (LV), (Table 1 “Left Ventricular End Systolic Volume” and “Left Ventricular Area measured at end diastole”), and the LV posterior wall, (Table 1 “Left Ventricular Posterior Wall thickness measured end diastolic”), and
b) the measurements are at least one of an IVS diameter, ([0168] “interventricular septal thickness”), an LV internal diameter (LVID), (Table 1 “Left Ventricular internal Diameter measured at end diastole,” “Left Ventricular internal Diameter measured at end systole”), and an LV posterior wall diameter.
Regarding Claim 60, Hare teaches a device for providing information on an M-mode ultrasound image, (Fig. 6J, [0039] “an automated clinical workflow diagnoses heart disease based on both cardiac biomarker measurements and AI recognition of 2D and Doppler modality Echocardiographic images,” and [0043] “The technician has the option of adding to these 2D echo images a waveform captured from various possible modalities including: […] m-mode”), the device comprising:
a) a communication unit, ([0040] “computer 14 may include typical hardware components (not shown) including a processor”), configured to receive an M-mode ultrasound image of a subject ([0043] “The technician has the option of adding to these 2D echo images a waveform captured from various possible modalities including: […] m-mode” and [0092] “Doppler modality images comprise two images, an echocardiogram image of the heart and a corresponding waveform, both of which are extracted from the echo file for image processing. In one embodiment, Doppler modality image classification of […] M-mode images is performed as follows. If the DICOM file contains a waveform modality ([…] M-mode), the two extracted images are input to one of the CNNs 200A trained for […] M-mode view classification to further classify the echo images as one of: […] M-mode (TrV) and M-mode Other.”)); and
b) a processor operably connected with the communication unit, ([0040] “computer 14 may include typical hardware components (not shown) including a processor”), wherein the processor is configured to
i) receive an M-mode ultrasound image of a subject, ([0043] “The technician has the option of adding to these 2D echo images a waveform captured from various possible modalities including: […] m-mode” and [0092] “Doppler modality images comprise two images, an echocardiogram image of the heart and a corresponding waveform, both of which are extracted from the echo file for image processing. In one embodiment, Doppler modality image classification of […] M-mode images is performed as follows. If the DICOM file contains a waveform modality ([…] M-mode), the two extracted images are input to one of the CNNs 200A trained for […] M-mode view classification to further classify the echo images as one of: […] M-mode (TrV) and M-mode Other.”)),
ii) segment a plurality of cardiac tomographic regions within the M-mode ultrasound image, respectively, by using a first model that is trained so as to segment the M- mode ultrasound image into the plurality of cardiac tomographic regions by inputting the M- mode ultrasound image, ([0064] “a third set of neural networks 200C, including adversarial networks, are employed for each classified 2D view type in order to segment the cardiac chambers in the 2D images and produce segmented 2D images.”),
iii) determine diastole and systole within the M-mode ultrasound image, by using a second model that is trained to predict the diastole and the systole of the M-mode ultrasound image by inputting the M-mode ultrasound image, ([0101] “the Doppler modality pipeline continues by processing the annotated Doppler modality images with a sliding window to identify cycles, peaks are measured in the cycles, and key points in the cardiac cycle are determined by finding systolic/diastolic end points (block 432).” Where the Doppler modality includes an M-mode ultrasound image, as discussed above.), and
iv) determine measurements for the plurality of segmented cardiac tomographic regions based on the diastole and the systole ([0102] “FIGS. 8A and 8B are diagrams illustrating examples of finding systolic/diastolic end points in the cardiac cycle, for both 2D and Doppler modalities, respectively, which are key points in order to take accurate cardiac measurements.”).
Regarding Claim 61, Hare teaches all limitations of Claim 60, as discussed above. Furthermore, Hare teaches wherein the second model is a model that predicts end-diastole and end-systole by inputting the M-mode ultrasound image ([0102] “FIGS. 8A and 8B are diagrams illustrating examples of finding systolic/diastolic end points in the cardiac cycle, for both 2D and Doppler modalities, respectively, which are key points in order to take accurate cardiac measurements.”).
Regarding Claim 62, Hare teaches all limitations of Claim 61, as discussed above. Furthermore, Hare teaches wherein the determining of the measurements includes determining measurements for the plurality of cardiac tomographic regions based on the predicted end-diastole and the end systole ([0102] “FIGS. 8A and 8B are diagrams illustrating examples of finding systolic/diastolic end points in the cardiac cycle, for both 2D and Doppler modalities, respectively, which are key points in order to take accurate cardiac measurements.”).
Regarding Claim 63, Hare teaches all limitations of Claim 60, as discussed above. Furthermore, Hare teaches wherein the second model is a model that predicts each period of the diastole and the systole by inputting the M-mode ultrasound image ([0101] “the Doppler modality pipeline continues by processing the annotated Doppler modality images with a sliding window to identify cycles, peaks are measured in the cycles, and key points in the cardiac cycle are determined by finding systolic/diastolic end points (block 432). Typically a Doppler modality video may capture three heart cycles and the sliding window is adjusted in size to block out two of the cycles so that only one selected cycle is analyzed. Within the selected cycle, the sliding window is used to identify cycles, peaks are measured in the cycles, and key points in the cardiac cycle are determined by finding systolic/diastolic end points.”).
Regarding Claim 64, Hare teaches all limitations of Claim 60, as discussed above. Furthermore, Hare teaches wherein the determining of the measurements includes determining measurements for the plurality of cardiac tomographic regions at transition points of each period of the predicted diastole and the systole (Table 1 (Page 10), where measurements of specific regions of the heart are taken during multiple points in the predicted diastole and the systole, e.g., “left ventricular end systolic volume” and “left atrial volume rate during early diastole”).
Allowable Subject Matter
Claim 57 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim 65 would be allowable if rewritten 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 and to include all of the limitations of the base claim and any intervening claims.
The prior art does not disclose or reasonably suggest wherein each of the first model and the second model includes a sampling stage and an upsampling stage, wherein the first model and the second model share the same sampling stage, and wherein a filter size of the upsampling stage of the second model is smaller than the filter size of the upsampling stage of the first model.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARIA CHRISTINA TALTY whose telephone number is (571)272-8022. The examiner can normally be reached M-Th 8:30-5:30 EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Mike Carey can be reached at (571) 270-7235. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARIA CHRISTINA TALTY/Examiner, Art Unit 3797
/MICHAEL J CAREY/Supervisory Patent Examiner, Art Unit 3795