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 .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: in figure 5, any mentions of element 1, 501, 3, Conv1, Conv2, AvgPool, 1020, and in fig. 6, element 1, 4, 12, 16, 8, Conv1, Conv2, Conv3, Conv4 Conv5, 15, 7, 5, 24, FC1, FC2, FC3, and in fig. 7, element 303, 115 (or 1 15, or 1 5, unclear with the label), 40, 288, 103, 53, 50, 5, 30, 276, 24, 274, 16, 272, 12, 270, 3240, FC1, FC2, FC3. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim 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 5 and 10 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In re claim 5, claim 1 already mentions a machine learning model. So is the machine learning model of claim 5 different than the one in claim 1? And how does claim 5’s machine learning model narrows claim 1?
In re claim 10, claim 1 already mentions a machine learning model. So is the machine learning model of claim 10 different than the one in claim 1?
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.
Claim 13 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. A claim drawn to such a computer readable medium that covers both transitory and non-transitory embodiments may be amended to narrow the claim to cover only statutory embodiments to avoid a rejection under 35 U.S.C. 101 by adding the limitation "non-transitory" to the claim.
Limitations with “a computer program product comprising computer-readable instructions such that when executed on a processing unit” include both transitory and non-transitory embodiments. With claim 13 as example, examiner suggests amending it to “A non-transitory memory storing a computer program product comprising computer-readable instructions such that when executed on a processing unit …” or the like.
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 (i.e., changing from AIA to pre-AIA ) 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.
Claim(s) 1, 5, 6, 7, 12, 13, 14, 15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Suri; Jasjit S. (US 2012/0078099, hereinafter Suri ‘099).
In re claims 1, 13, 14, Suri ‘099 teaches a method for determining a cross-sectional width of an artery, said method comprising: receiving a time sequence of sets of ultrasound data (0227, 0303, 0341, note that a real-time includes time sequence when checking one time after another time for a continuously monitors), each set representing reflection of ultrasound along a line extending through tissue including the artery at a single point in time in the time sequence (0296, 0303, fig. 22); and for each set of ultrasound data: determining, using a machine learning model (0097, 0103, 0154-0157, 0209), a region of interest within the ultrasound data, wherein the region of interest is determined using one or more kernels being compared to the ultrasound data, wherein each kernel (figs. 30-32, fig. 39) represents a first wall portion at a first side of a cross-section of the artery (fig. 17, near edges; figs. 34-37, 0149), a second wall portion at a second side of the cross-section of the artery (fig. 17, far edges; figs. 34-37; 0149), and a lumen between the first and the second wall portions (fig. 17, fig. 40; 0149); and determining the cross-sectional width of the artery based on analysis of the region of interest of the ultrasound data (0204, chord length is the cross-sectional width, figs. 40, 42).
In re claim 5, Suri ‘099 teaches a method according to claim 1, wherein determining the cross-sectional width of the artery is performed using a machine learning model which is configured to receive the region of interest of the ultrasound data (0097, 0103, 0154-0157, 0209).
In re claim 6, Suri ‘099 teaches wherein determining the cross-sectional width of the artery is performed individually for each set of ultrasound data by the machine learning model (0303, 0341, a still image is an individually image of a data set).
In e claim 7, Suir ‘099 teaches further comprising applying a smoothing process to a time sequence of determined cross-sectional widths based on the sets of ultrasound data (0160).
In re claim 12, Suri ‘099 teaches a method for determining a biomedical marker, said method comprising the method for determining the cross-sectional width of the artery according to claim 1 (see above for claim 1) and computing a value representing the biomedical marker based on the determined cross-sectional width of the artery in the time sequence (0331, 0341).
In re claim 15, Suri ‘099 teaches further comprising an ultrasound sensor configured to be arranged in relation to the tissue including the artery, to emit ultrasound into the tissue, to detect the time sequence of sets of ultrasound data, and to transfer the time sequence of sets of ultrasound data to the processing unit (0303, 0341, note that a real-time includes time sequence when checking one time after another time for a continuously monitors).
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 (i.e., changing from AIA to pre-AIA ) 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Suir ‘099 in view of Bedi et al. (US 2021/0045710, hereinafter Bedi ‘710).
In re claim 10, Suir ‘099 fails to teach further comprising processing the time sequence of sets of ultrasound data using a machine learning model, for identifying a segment in the time sequence corresponding to a cardiac cycle.
Bedi ‘710 teaches further comprising processing the time sequence of sets of ultrasound data using a machine learning model (0059-0066, etc.), for identifying a segment in the time sequence corresponding to a cardiac cycle (0178).
It would have been prima facie obvious to one of ordinary skills in the art at the time of invention to modify the method/device of Suir ‘099 to include the features of Bedi ‘710 in order to provide clinically relevant physiological information about cardiovascular disease process in addition to the morphological information provided by atheroma detection based on measurements of intima-media thickness, intima-media area and intima-media volume.
Allowable Subject Matter
Claims 2-4, 8-9, 11 are 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, and all other rejections (112, 101) are resolved.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BO JOSEPH PENG whose telephone number is (571)270-1792. The examiner can normally be reached Monday thru Friday: 8:00 AM-5:00 PM 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, ANNE M KOZAK can be reached at (571) 270-0552. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BO JOSEPH PENG/Primary Examiner, Art Unit 3797